On January 16, 2004 (69 FR 2497), the NRC published a direct final rule amending its regulations in 10 CFR part 72 to revise the NAC International, Inc., NAC-UMS cask system listing within the “List of Approved Spent Fuel Storage Casks” to include Amendment No. 3 to Certificate of Compliance Number 1015. This amendment adds an alternate poison material, revises fuel assembly dimensions, revises thermal analyses, increases Boiling Water Reactor fuel assembly weight, and incorporates Interim Staff Guidance-11 revision provisions. The amendment also reorganizes Section 6.5 of the Safety Evaluation Report, revises Technical Specification A.5.5, and requests several editorial and administrative changes. In the direct final rule, NRC stated that if no significant adverse comments were received, the direct final rule would become final on March 31, 2004. The NRC did not receive any comments that warranted withdrawal of the direct final rule. Therefore, this rule will become effective as scheduled.

The purpose of the Truth in Lending Act (TILA), 15 U.S.C. 1601 et seq. , is to promote the informed use of consumer credit by providing for disclosures about its terms and cost. The act requires creditors to disclose the cost of credit as a dollar amount (the finance charge) and as an annual percentage rate (APR). Uniformity in creditors' disclosures is intended to assist consumers in comparison shopping for credit. TILA requires additional disclosures for loans secured by consumers' homes and permits consumers to rescind certain transactions that involve their principal dwelling. In addition, the act regulates certain practices of creditors.

TILA is implemented by the Board's Regulation Z (12 CFR part 226). An official staff commentary interprets the requirements of Regulation Z (12 CFR part 226 (Supp. I)), and is updated annually.

In December 2003, the Board published for comment proposed revisions to Regulation Z and to the staff commentary. 68 FR 68793, December 10, 2003. The revisions sought to add a rule of construction to clarify that the word “amount” represents a numerical amount throughout Regulation Z and the staff commentary; and to provide guidance on consumers' exercise of rescission rights for certain home-secured loans. Several technical revisions to the staff commentary were proposed. In addition, the staff requested information regarding debt cancellation and debt suspension products. Finally, as part of a rulemaking under several of the Board's consumer financial services and fair lending regulations, the Board sought to establish a more uniform standard for providing clear and conspicuous disclosures and provide guidance on how to meet that standard.

The Board received approximately 150 comment letters; about 140 letters were from financial institutions, other creditors and their representatives, and insurance providers. Eight letters were received from consumer representatives, and two letters from government officials. Most comment letters focused on the proposed definition of “clear and conspicuous” and related guidance. About 30 comment letters discussed the other proposed revisions to Regulation Z and the staff commentary.

The proposed amendment to Regulation Z defining “clear and conspicuous” and the related guidance in the proposed staff commentary are not being adopted in this rulemaking, as discussed below. With respect to the other proposed revisions to Regulation Z and the staff commentary, commenters generally supported the proposed revisions. Accordingly, the final rule and remaining staff interpretations are being adopted substantially as proposed, although some changes have been made for clarity in response to the commenters' suggestions, as discussed below.

Under the consumer financial services and fair lending laws administered by the Board, consumer disclosures generally must be “clear and conspicuous.” Assuming that most institutions already provide consumer disclosures that satisfy the clear and conspicuous standard, the Board's proposals were intended to articulate a more precise standard that could be used as a baseline to determine when an institution may not be meeting the legal standard. Currently, there is little guidance on what that standard means. Moreover, the laws and regulations contain standards that are similar but not identical. Regulation P, which implements the financial privacy provisions of the Gramm-Leach-Bliley Act, articulates more precisely than the other consumer regulations the standard for providing clear and conspicuous disclosures that consumers will notice and understand. Accordingly, the standard and the compliance guidance in Regulation P was used as the model for the December 2003 proposal, which also included compliance guidance in the form of examples of how institutions could satisfy the standard.

Although the Board's effort to establish a more uniform “clear and conspicuous” standard is supported by many commenters, almost all industry commenters strongly oppose the Board's proposal based on Regulation P. They assert that the revisions would establish more burdensome standards that would be costly to implement and expose them to litigation. For example, industry commenters stated that providing “conspicuous” disclosures that are “designed to call attention to the nature and significance of the information in the disclosure” would not be workable for disclosures contained in credit card or deposit account agreements. These commenters asserted that the proposal could mandate fundamental changes in how institutions comply with the “clear and conspicuous” standard.

Consumer advocates generally support the proposals' goals, but they believe the proposals do not set a high enough standard. For example, some consumer advocates said that disclosures in a type size less than 10-point should be deemed too small. Some believe that the proposed guidance is too broad and could be interpreted to allow institutions to include unrelated information amid disclosures that are currently required to be segregated.

The proposed amendment to Regulation Z defining “clear and conspicuous” and the related guidance in the proposed staff commentary are not being adopted in final form in this rulemaking. Board staff is continuing to review the issues raised by the comment letters concerning the clear and conspicuous standard and is considering options to address the commenters' concerns.

In the December 2003 proposal, the Board requested information regarding debt cancellation and debt suspension agreements. Under a debt cancellation agreement or debt suspension agreement, a creditor agrees to cancel, or temporarily suspend, all or part of the borrower's repayment obligation upon the occurrence of a specified event, such as death, disability, or unemployment. About 25 commenters, mostly creditors, insurance companies, consultants, and trade associations, responded to the Board's request for information and views about those products. They generally confirmed that the products are being made available by an increasing number of creditors in connection with many types of credit, on a wide and growing variety of terms.

The Board expressly solicited comment on the need, if any, for additional guidance about the application of TILA and Regulation Z to the sale of debt cancellation and debt suspension products. Most industry commenters generally favored expanding the current rule that allows charges for certain types of optional coverage to be excluded from TILA's finance charge and APR, if certain disclosures are provided. These commenters stated that the exclusion in the current rule should encompass all types of debt cancellation and debt suspension agreements. In contrast, a consumer group favored repeal of the current rule.

Most industry commenters requested that the Board adopt procedures for creditors to follow when seeking to convert borrowers' credit insurance coverage to a debt cancellation or debt suspension agreement. Most commenters stated that creditors should be permitted to use the same procedures used by credit card issuers when notifying consumers of a change in the provider of credit insurance pursuant to § 226.9(f). A few commenters asserted that other applicable laws make the adoption of additional conversion rules or guidance under TILA unnecessary for debt cancellation and debt suspension products.

The Board solicited comment but did not propose any specific revisions to the regulation or commentary concerning debt cancellation or debt suspension agreements. Accordingly, today's final rule does not address these issues. Board staff will continue to gather information about debt cancellation and debt suspension products before determining whether to recommend proposing new rules or guidance.

The Board proposed adding an interpretative rule of construction in § 226.2(b)(5) stating that, wherever the word “amount” is used in Regulation Z and the staff commentary to describe a disclosure requirement, it refers to a numerical amount. Examples illustrating how the interpretative rule of construction for “amount” applies to certain required disclosures were proposed in the staff commentary. The proposed interpretation addresses a recent court decision permitting narrative descriptions of amounts rather than numerical amounts to disclose the payments scheduled to repay a closed-end credit transaction. See Carmichael v. The Payment Center, Inc., 336 F. 3d 636 (7th Cir. 2003); 5 U.S.C. 1638(a)(6); 12 CFR 226.18(g).

A broad interpretation of the term “amount,” suggesting that narrative descriptions may replace numerical amounts, is contrary to TILA's mandate to provide consumers with clear and conspicuous credit disclosures. The Carmichael court's decision could lead to confusing disclosures that are not uniform.

Commenters uniformly supported the proposed rule of construction. Consumer groups expressed concern, however, that the proposed guidance in the staff commentary did not state with sufficient precision when creditors are permitted to disclose a numerical amount other than a dollar amount.

The Board's rule of construction is being adopted as proposed. To address commenters' concerns, comment 2(b)-2 has been revised for clarity. As adopted, comment 2(b)-2 provides that the numerical amount required to be disclosed must be expressed as a dollar amount unless the text of the regulation or commentary indicates otherwise. It also provides examples of when dollar amounts must be disclosed, and when percentages may be disclosed.

Section 125(a) of TILA provides that, in certain credit transactions in which the consumer's principal dwelling secures an extension of credit, the consumer may rescind the transaction within three business days after becoming obligated on the debt (and for open-end plans, after opening or increasing the credit limit on the plan), and in some cases has the right to rescind for up to three years. See 15 U.S.C. 1635(a); 12 CFR 226.15(a)(1). The right of rescission allows consumers time to reexamine their credit contracts and cost disclosures and to reconsider whether to place a lien on their homes. A consumer exercises the right to rescind by notifying the creditor of the rescission by mail, telegram, or other written communication. Creditors must provide consumers with a form to use to exercise the right to rescind, which must include the name and address of the creditor or agent of the creditor to receive the written communication. See § 226.15(b). A consumer's notice is considered given when mailed, when filed for telegraphic transmission, or, if sent by other means, when delivered to the creditor's designated place of business. See § 226.15(a)(2).

Comment 15(a)(2)-1 states that creditors may designate an agent to receive the notification so long as the agent's name and address appear on the rescission form provided to the consumer. The Board proposed to revise the comment to address situations where a creditor fails to provide the required form or to designate an address for sending the notice. The proposal provided that, in such cases, if a consumer sent the notice to someone other than the creditor or assignee—such as a third-party loan servicer acting as the creditor's agent—the consumer's notice of rescission is effective if applicable law deems delivery to that person to be delivery to the creditor or assignee. The comment is being adopted with revisions in response to the public comments.

Commenters generally favored guidance about delivery of a notice of rescission when a creditor has not provided the required form or an address for sending the notice. Consumer groups and industry representatives, including major trade associations, generally agreed that, in such cases, delivering the rescission notice to the loan servicer (the person to whom, or the address to which, payments are sent) should be deemed delivery to the creditor or assignee. In their view, in this circumstance reliance on state law is unnecessary to determine that the loan servicer is the creditor's or assignee's agent. Some industry commenters expressed concern about relying on state law to determine whether delivery to some entity other than the loan servicer might also constitute delivery to the creditor or assignee.

In response to commenters' suggestions, comment 15(a)(2)-1 is being revised to state expressly that where the creditor fails to provide the consumer an address for sending the notification of rescission, the consumer's delivery of notification to the person or address to which the consumer has been directed to send payments constitutes delivery to the creditor or assignee. This bright-line guidance provides clarity for creditors and a practical outcome for consumers. As proposed, however, the comment recognizes the possibility that the creditor or assignee also may have allowed some other entity to serve as its agent for this purpose, which must be determined by the particular circumstances under the applicable state law. Reliance on state law is appropriate to avoid penalizing consumers who were not instructed to send the rescission notice to the loan servicer and who may send the notice to another party acting on behalf of the creditor (for example, an attorney representing the creditor).

Some consumer representatives suggested that the comment be revised to clarify that rescission is effective if the creditor or assignee receives actual notice from any source, for example from legal pleadings. The suggested revision is beyond the scope of the proposal.

When a consumer exercises the right to rescind a mortgage transaction, the consumer is not liable for any finance charges or other charges, and any security interest in the consumer's home becomes void. See 15 U.S.C. 1635(b); § 226.15(d)(1). After the transaction is rescinded, the creditor must tender any money or property given to anyone in connection with the transaction within a specified time frame. The creditor's tender triggers the consumer's duty to return any money or property that the creditor delivered to the consumer. A court may modify these tender procedures. See § 226.15(d)(2)-(4).

Under the proposal, comment 15(d)(4)-1 was revised to state expressly that the sequence of procedures under § 226.15(d)(2) and (3), or a modification of those procedures by a court, does not affect consumers substantive right to rescind. Thus, where the consumer's right to rescind is contested by the creditor, a court would normally determine whether the consumer has a right to rescind and determine the amounts owed before establishing the procedures for the parties to tender any money or property.

Commenters generally supported the proposed revision. Nevertheless, a few industry representatives and consumer groups asked Board staff to address an issue not raised in the proposal. These industry representatives requested revisions to the commentary to support court decisions that affirmed the court's authority to impose equitable conditions to ensure that consumers meet their financial obligations before the creditor's security interest is declared void. Consumer groups requested revisions that would support other court decisions holding that the voiding of the security interest under TILA's rescission provision is automatic and independent of the consumer's ability to tender money or property.

Comment 15(d)(4)-1 is adopted as proposed, with some modifications for clarity, and does not address the additional issue raised by the commenters. The comment clarifies only that the sequence of procedures under § 226.15(d)(2) and (3), or a court's modification of those procedures under § 226.15(d)(4), does not affect consumers' substantive right to rescind and to have the loan amount reduced, which may be necessary before the consumer is able to establish how the consumer will refinance or otherwise repay the loan.

18(c) Itemization of Amount Financed.

A technical revision is made to comment 18(c)(1)(iii)-1, to conform a citation to footnote 41 of Regulation Z. No substantive change is intended.

19(b) Certain Variable-Rate Transactions.

Section 226.19(b) applies to all closed-end variable-rate transactions that are secured by the consumer's principal dwelling and have a term greater than one year. Guidance about the applicability of § 226.19 to construction loans was published in comment 19(b)-1. 54 FR 9422, March 7, 1989. That guidance has been inadvertently appended to comment 19(b)(1)-1 in the Code of Federal Regulations. The two comments are restated in their correct form for reprinting in the Code of Federal Regulations. No substantive change is intended.

23(a) Consumer's Right to Rescind.

For the reasons discussed above, comment 23(a)(2)-1 is revised to state the rule for effective delivery of a rescission notice when the creditor fails to provide the required form or designate an address for sending the notice. ( See SUPPLEMENTARY INFORMATION to comment 15(a)(2)-1.)

23(d) Effects of Rescission.

For the reasons discussed above, comment 23(d)(4)-1 is revised to state expressly that the sequence of procedures under § 226.23(d)(2) and (3), or a modification of those procedures by a court under § 226.23(d)(4), does not affect consumers' substantive right to rescind and to have the loan amount adjusted accordingly, which may be necessary before consumers are able to establish how they will refinance or otherwise repay the loan. ( See supplementary information to comment 15(d)(4)-1.)

In March 2001, the Board revised § 226.27 to permit creditors to provide disclosures in languages other than English as long as disclosures in English are available to consumers who request them. 66 FR 1739, March 30, 2001. Technical revisions are made to comment 27-1, and comment 27-2 is deleted to conform the commentary to § 226.27, as amended. No substantive change is intended.

32(a) Coverage.

Rules for certain closed-end mortgage loans in § 226.32 are triggered, in part, by the amount of “points and fees” payable by the consumer at or before loan closing and by the “total loan amount.” See § 226.32(a)(1)(ii). Comment 32(a)(1)(ii)-1, which was added in 1996, provides examples for calculating the “total loan amount.” 61 FR 14952, April 4, 1996. A technical revision is made to comment 32(a)(1)(ii)-1, to correct a dollar amount given in one of the examples. No substantive change is intended.

In accordance with section 3(a) of the Regulatory Flexibility Act, the Board has reviewed the amendment to Regulation Z. The amendment adds an interpretative rule of construction to state that the word “amount” represents a numerical amount throughout Regulation Z. In addition, revisions to the staff commentary provide guidance on consumers' exercise of the right to rescind certain home-secured loans. The amendment does not have any significant impact on small entities.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506; 5 CFR 1320 Appendix A.1), the Board reviewed the rule under the authority delegated to the Board by the Office of Management and Budget. The Federal Reserve may not conduct or sponsor, and an organization is not required to respond to, this information collection unless it displays a currently valid OMB control number. The OMB control number is 7100-0199.

The collection of information that is revised by this rulemaking is found in 12 CFR part 226. This collection is mandatory (15 U.S.C. 1601 et seq. ) to evidence compliance with the requirements of TILA and Regulation Z. The respondents and recordkeepers are for-profit financial institutions, including small businesses. Institutions are required to retain records for twenty-four months. This regulation applies to all types of creditors, not just state member banks; however, under Paperwork Reduction Act regulations, the Federal Reserve accounts for the burden of the paperwork associated with the regulation only for state member banks. Other agencies account for the paperwork burden on their respective constituencies under this regulation.

The revisions provide that the term “amount” represents a numerical amount throughout Regulation Z. The revisions to the staff commentary also provide guidance on consumers' exercise of rescission for certain home-secured loans. These revisions are not expected to increase the paperwork burden of creditors.

With respect to state member banks, there are 1,312 respondents and recordkeepers. Current annual burden under Regulation Z is estimated to be 618,398 hours.

Because the records would be maintained at state member banks and the notices are not provided to the Federal Reserve, no issue of confidentiality arises under the Freedom of Information Act.

The Board has a continuing interest in the public's opinion of the Federal Reserve's collections of information. At any time, comments regarding the burden estimated, or any other aspect of this collection of information, including suggestions for reducing the burden estimate, may be sent to the Office of Management and Budget, Paperwork Reduction Project (7100-0199), Washington, DC 20503, with copies of such comments sent to Cynthia Ayouch, Federal Reserve Board Clearance Officer, Division of Research and Statistics, Mail Stop 41, Board of Governors of the Federal Reserve System, Washington, DC 20551.

The Civil Aviation Safety Authority (CASA), which is the airworthiness authority for Australia, recently notified FAA that an unsafe condition may exist on all AeroSpace Technologies of Australia Pty Ltd N22 and N24 series airplanes. The CASA received a number of reports of airplanes with cracks around the rivet heads on the rear bulkhead frame. The cracks could result in failure of the fuselage rear bulkhead and consequent loss of airplane control.

If not detected and corrected, cracks in the rear fuselage frame could cause the fuselage rear bulkhead to fail. This failure could result in loss of airplane control.

We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all AeroSpace Technologies of Australia Pty Ltd Model N22B, N22S, and N24A airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on December 29, 2003 (68 FR 74874). The NPRM proposed to require you to inspect the rear fuselage bulkhead of aircraft for cracks and make required repairs and/or modifications.

We provided the public the opportunity to participate in developing this AD. We received no comments on the proposal 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 except for the changes discussed above and minor editorial corrections. We have determined that these changes and minor corrections:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

On July 10, 2002, the FAA published a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's AD system. This regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. This material previously was included in each individual AD. Since this material is included in 14 CFR part 39, we will not include it in future AD actions.

We estimate that this AD affects 14 airplanes in the U.S. registry.

We estimate the following costs to accomplish the inspection:

We estimate the following costs to accomplish any necessary repairs that will be required based on the results of the inspection. We have no way of determining the number of airplanes that may need these repairs:

We estimate the following costs to accomplish the modification.

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 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 summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES. Include “AD Docket No. 2000-CE-43-AD” in your request.

This amendment adopts a new AD for Sikorsky Model S-76 A, B, and C helicopters with dual channel autopilot and dual inverters installed. This action requires, before further flight, determining if the No. 1 inverter is wired to the DC essential bus, and if it is, modifying the wiring or installing a placard that limits the maximum IMC airspeed to 120 knots indicated airspeed (KIAS) as well as annotating the Operating Limitations section of the RFM to reflect this limit. Also, this action requires, within 30 days, for those helicopters with the No. 1 inverter wired to the DC essential bus, modifying the electrical wiring so that the No. 1 inverter, which powers the co-pilot's Automatic Flight Control System (AFCS) computer, is wired to the No. 2 DC primary bus and also modifying the electrical wiring so that the No. 2 inverter, which powers the pilot's AFCS computer, is wired to the DC essential bus. If installed, removing the placard and the RFM annotation is allowed after modifying the electrical wiring. This amendment is prompted by three incidents in which a No. 2 generator had an intermittent malfunction and both autopilots disengaged. The actions specified in this AD are intended to prevent both autopilots from disengaging following a No. 2 DC generator failure, and subsequent loss of control of the helicopter during IMC operations.

The FAA has reviewed Sikorsky Alert Service Bulletin (ASB) No. 76-24-14A, Revision A, dated October 9, 2003, which describes procedures for performing a test to determine if the No. 1 inverter is wired to the DC essential bus, and provides the required wiring modification to relocate the source for the No. 2 Inverter to the DC essential bus and to relocate the No. 1 Inverter to the No. 2 DC bus, if required. The ASB also provides for a temporary airspeed limitation of 120 knots indicated airspeed during IMC operations until the required wiring modification is completed.

This unsafe condition is likely to exist or develop on other helicopters of the same type design. Therefore, this AD is being issued to prevent both autopilots from disengaging following a No. 2 DC generator failure, and subsequent loss of control of the helicopter during IMC operations. This action requires, before further flight, determining if the No. 1 inverter is wired to the DC essential bus, and if it is, modifying the wiring or installing a placard that limits the maximum IMC airspeed to 120 KIAS as well as annotating the Operating Limitations section of the RFM to reflect this limit. Also, this action requires, within 30 days, for those helicopters with the No. 1 inverter wired to the DC essential bus, modifying the electrical wiring so that the No. 1 inverter, which powers the co-pilot's AFCS computer, is wired to the No. 2 DC primary bus and also modifying the electrical wiring so that the No. 2 inverter, which powers the pilot's AFCS computer, is wired to the DC essential bus. If installed, removing the placard and the RFM annotation is allowed after modifying the electrical wiring. The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the controllability of the helicopter. Therefore, the previously described airspeed limitation reduction is required before further flight, and this AD must be issued immediately.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

The FAA estimates that this AD will affect 105 helicopters. The operational test will take approximately 1 work hour to accomplish and the wiring modification will take approximately 2 work hours to accomplish at an average labor rate of $65 per work hour. The materials required to perform the modification consists of 2 wire sleeve markers whose cost is negligible. Based on these figures, we estimate the total cost impact of the AD on U.S. operators to be $18,525 assuming that all 105 helicopters will be tested and about 90 helicopters will need the modification.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2003-SW-45-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, recently notified the FAA that an unsafe condition may exist on certain Bombardier Model CL-600-2C10 (Regional Jet Series 700 & 701) and CL-600-2D24 (Regional Jet Series 900) series airplanes. TCCA advises that there have been two instances of longitudinal cracks found in the primary fuel ejector on affected airplanes. This condition, if not corrected, could result in fuel leakage from the wing tanks into the center tank, which could cause engine shutdown during flight.

Bombardier has issued the following Temporary Revisions (TRs) to the Airplane Flight Manuals (AFM), Document CSP B-012 (for Model CL-600-2C10 (Regional Jet Series 700 & 701) series airplanes) and CSP C-012 (for Model CL-600-2D24 (Regional Jet Series 900) series airplanes):

• CRJ Regional Jet (Bombardier) TR RJ 700/52-2, dated December 19, 2003, to the Bombardier Model CL-600-2C10 AFM, Document CSP B-012.

• CRJ Regional Jet (Bombardier) TR RJ 900/10-1, dated December 19, 2003, to the Bombardier Model CL-600-2D24 AFM, Document CSP C-012.

These TRs describe revisions to the Abnormal Procedures section of the AFM to advise the flightcrew to monitor the fuel quantity in the center fuel tank throughout the flight.

Bombardier has also issued CRJ 700/900 Regional Jet Alert Service Bulletin 670BA-28-025, Revision A, dated December 15, 2003. This service bulletin describes procedures for performing repetitive tests to detect fuel leaking between the wing tanks and the center tank. The leak test involves filling the wing fuel tanks with a specified quantity of fuel, and monitoring the amount of fuel increase in the center tank over time. The service bulletin describes procedures for sending the results of the leak test to the Bombardier Technical Help Desk.

If the amount of fuel increase in the center fuel tank is more than 150 pounds (68 Kgs), the service bulletin describes procedures for further related investigative and corrective actions. The related investigative action is performing a visual inspection of the center tank (including the ejectors and fuel system components) to determine the source of the leak. When the source of the leak is found, the corrective action is replacing any cracked or damaged part with a new part. The service bulletin also includes directions for faxing the results of inspections to Bombardier, and for sending all replaced parts to Bombardier.

TCCA classified these TRs, and this service bulletin as mandatory and issued Canadian airworthiness directive CF-2004-04, dated February 12, 2004, to ensure the continued airworthiness of these airplanes in Canada.

For airplanes having serial number 10005 through 10065 inclusive, the service bulletin states that, prior to the leak test, flexible hoses and brackets must be installed in the fuel feed system in accordance with Bombardier CRJ 700 Regional Jet Service Bulletin 670BA-28-008, Revision C, dated January 23, 2003. These installations are intended to address conditions that can result in fuel line and coupling damage, and leakage due to the combined effects of installation misalignment and vibration.

These airplane models are manufactured in Canada and are 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, TCCA has kept us informed of the situation described above. We have examined the findings of TCCA, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD is being issued to revise the AFM to advise the flightcrew to monitor the fuel quantity in the center fuel tank throughout the flight. This AD also requires repetitive leak tests of the center fuel tank; a detailed inspection if a leak is detected; and repair, if necessary. For certain airplanes, this AD also requires installation of flexible hoses and brackets in the fuel feed system. The actions are required to be accomplished in accordance with the service information described previously, except as discussed below.

Although Service Bulletin 670BA-28-025, Revision A, and the Canadian airworthiness directive specify a “visual inspection” to determine the source of any leakage found during the leak test, this AD requires a “detailed inspection.” A definition of “detailed inspection” is included in Note 2 of this AD.

Where the Canadian airworthiness directive refers to airplanes that have accumulated a certain number of flight hours “since new,” this AD uses the words “since the date of issuance of the original Airworthiness Certificate or the date of issuance of the Export Certificate of Airworthiness, whichever occurs first.” This decision is based on our determination that the words “since new” may be interpreted differently by different operators. We find that the terminology included in this AD is generally understood within the industry and records will always exist that establish these dates with certainty.

The Canadian airworthiness directive allows for leak tests to be performed in accordance with CRJ 700/900 Regional Jet (Bombardier) Alert Service Bulletin 670BA-28-025, original issue, dated December 12, 2003; or CRJ 700/900 Regional Jet (Bombardier) Alert Service Bulletin 670BA-28-025, Revision A, dated December 15, 2003. However, this AD would require actions to be accomplished in accordance with Revision A. Revision A contains significant changes to procedures and compliance times.

Although Service Bulletin 670BA-28-025, Revision A, and the Canadian airworthiness directive include sending reports of certain findings to the manufacturer, this AD does not include those requirements.

Although Service Bulletin 670BA-28-025, Revision A includes instructions for sending all damaged parts to the manufacturer, this AD does not include that requirement.

This is considered to be interim action until final action is identified, at which time the FAA may consider further rulemaking.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification ( e.g. , reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2004-NM-41-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 2001-26-24, amendment 39-12590 (67 FR 497, January 4, 2002), which is applicable to certain McDonnell Douglas Model DC-9 series airplanes, was published in the Federal Register on December 8, 2003 (68 FR 68304). The action proposed to continue to require replacing the transformer ballast assembly in the pilot's console with a new, improved ballast assembly. The action also proposed to expand the applicability of the existing AD to include additional airplanes. In addition, the action proposed to provide an optional method for accomplishing the requirements of the existing AD.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has revised the applicability of the proposed AD to specify certain model designations (Model DC-9-21, -41, and -51) as published in the most recent type certificate data sheet for the affected models. These model designations are identical to those specified in the referenced service bulletin.

We have also revised the applicability of the proposed AD to correct a typographical error that resulted in a duplicate reference to Model DC-9-33F instead of Model DC-9-32F. We intended the applicability of the proposed AD to include the same Model airplanes as those listed in Boeing Alert Service Bulletin DC9-33A114, Revision 03, dated January 16, 2003, which was cited in the applicability statement of the proposed AD for determining the specific affected airplanes. Therefore, we have revised references to the applicability throughout the final rule to include Model DC-9-32F airplanes.

After careful review of the available data, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes previously described. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 575 airplanes of the affected design in the worldwide fleet. The FAA estimates that 477 airplanes of U.S. registry will be affected by this AD.

The replacement that is currently required by AD 2001-26-24 and provided as an option in this AD takes approximately 1 work hour per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts cost approximately between $1,379 and $1,860 per airplane. Based on these figures, the cost impact of the replacement on U.S. operators is estimated to be between $688,788 and $918,225, or between $1,444 and $1,925 per airplane.

The new optional modification that is provided by this AD will take approximately 2 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts will cost approximately $4,472 per airplane. Based on these figures, the cost impact of the new optional modification provided by this AD on U.S. operators is estimated to be $4,602 per airplane.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (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. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to a certain McDonnell Douglas Model DC-9-15 airplane was published in the Federal Register on October 2, 2003 (68 FR 56794). That action proposed to require an inspection to detect chafing or overheat damage of the electrical wires located at fuselage station Y=110.000 bulkhead of the lower nose left tunnel; and corrective actions, if necessary. That action also proposed to require replacing the external power ground stud with a new ground stud using new attaching parts, torquing new attachments, and installing a nameplate.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that 1 Model DC-9-15 airplane, having fuselage number 0097, of U.S. registry will be affected by this AD, that it will take approximately 2 work hours to accomplish the required actions, and that the average labor rate is $65 per work hour. Required parts will cost approximately $35. Based on these figures, the cost impact of the AD on the U.S. operator is estimated to be $165.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (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. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 99-09-13, amendment 39-11146 (64 FR 20146, April 26, 1999), which is applicable to certain Boeing Model 757-200 series airplanes, was published in the Federal Register on December 22, 2003 (68 FR 71051). The action proposed to continue to require modifications to the attachment installation of the forward lavatory. The action also proposed to add airplanes to the applicability of the existing AD.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 694 airplanes of the affected design in the worldwide fleet. The FAA estimates that 355 airplanes of U.S. registry will be affected by this AD.

It will take approximately 4 work hours per airplane to accomplish the required modification, at an average labor rate of $65 per work hour. Required parts will cost approximately $100 per airplane. Based on these figures, the cost impact of the required modification on U.S. operators is estimated to be $127,800, or $360 per airplane.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. The manufacturer may cover the cost of replacement parts associated with this AD, subject to warranty conditions. Manufacturer warranty remedies may also be available for labor costs associated with this AD. As a result, the costs attributable to the AD may be less than stated above.

The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (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. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 78-01-16, amendment 39-3117 (43 FR 1300, January 9, 1978), which is applicable to certain McDonnell Douglas Model DC-9-10, DC-9-20, DC-9-30, DC-9-40, and DC-9-50 series airplanes, was published as a supplemental notice of proposed rulemaking (NPRM) in the Federal Register on December 22, 2003 (68 FR 71040). That action proposed to continue to require repetitive ultrasonic or magnetic particle inspections to detect cracking of the engine pylon aft upper spar straps (caps); and if necessary, replacement of the strap with a new strap, or modification of the engine pylon rear spar straps, which constitutes terminating action for the repetitive inspections. The action also proposed to require new, improved repetitive ultrasonic inspections, and corrective actions if necessary. The action also proposed to require, among other items, a terminating action for the repetitive inspection requirements and to add airplanes to the applicability.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 577 Model DC-9-10, DC-9-20, DC-9-30, DC-9-40, and DC-9-50 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 350 airplanes of U.S. registry will be affected by this AD.

The ultrasonic inspection that is currently required by AD 78-01-16, and retained in this AD, takes approximately 3 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of this currently required action on U.S. operators is estimated to be $195 per airplane, per inspection cycle.

The new ultrasonic inspection that is required by this AD will take approximately 4 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the new ultrasonic inspection required by this AD on U.S. operators is estimated to be $260 per airplane, per inspection cycle.

The new modification of the rear spar upper strap (cap) that is required by this AD will take between approximately 349 and 412 work hours to accomplish (depending on the configuration of the affected airplane), at an average labor rate of $65 per work hour. The cost of required parts will be between approximately $1,865 and $7,947 per airplane. Based on these figures, the cost impact of the new modification required by this AD on U.S. operators is estimated to be between $24,550 and $34,727 per airplane.

For certain airplanes, the repetitive visual inspections of the upper rear spar (cap) for bearing migration and correct pin staking will take approximately 20 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of that inspection required by this AD on U.S. operators is estimated to be $1,300 per airplane, per inspection cycle.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

Should an operator elect to accomplish the optional magnetic particle inspection that will be provided by this AD action, it will take approximately 7 work hours to accomplish it, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of this action on U.S. operators will be $455 per airplane, per inspection cycle.

The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (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. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

(r) This amendment becomes effective on May 5, 2004.

This final rule amends the NASA Grant and Cooperative Agreement Handbook to incorporate a format and numbering scheme to identify announcements for NASA's grants and cooperative agreements. This 12 character number consists of the following: Two alpha digits for the Agency (NN); one alpha digit for the Center; two numeric digits for the fiscal year; six alpha and numeric digits for either the purchase request or the issuing organization's code and action number; and one alpha digit for the type of announcement.

The NASA Grant and Cooperative Agreement Handbook does not currently include a format and numbering scheme for announcements of grants and cooperative agreements. Each NASA Center has its own procedures for numbering announcements. This change will bring consistency to the procedures for numbering announcements, and ensure these procedures are consistent with the data fields of NASA's Integrated Financial Management (IFM) system. The Grant and Cooperative Agreement Handbook will be amended to include a cross-reference to NFS 1804.7102, “Numbering Scheme for Solicitations”.

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. , because the changes modify existing internal operational practices.

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

On June 6, 2002 (67 FR 38869), the Commission published amendments to its rules governing the registration of intermediaries in the futures industry (“2002 Release”). Specifically, the rules facilitated changing the Commission's paper-based registration system to an online registration system and permitted floor brokers with temporary licenses to act in the capacity of a fully registered floor broker. After the incorporation of these changes to Rule 3.12  1 , the amended rule, as published, deleted two subsections of Rule 3.12.

The final regulations as published in the Code of Federal Regulations omit two paragraphs that were in previous versions of Rule 3.12: 17 CFR 3.12(f)(3) and (4). 2 The Commission did not intend to delete these paragraphs, as evidenced by the fact that the 2002 Release contains five asterisks following paragraph (f)(2) of Rule 3.12 as printed therein. Nevertheless, the 2003 edition of the Code of Federal Regulations omits paragraphs 17 CFR 3.12(f)(3) and (4).

Section 3.12(f)(3) requires persons associated with more than one sponsor to file fingerprints on a fingerprint card with the National Futures Association. 17 CFR 3.12(f)(4) states that an associated person (“AP”) of a futures commission merchant or introducing broker (“IB”) that directs managed accounts to commodity trading advisors (“CTA”), which are carried by the AP's FCM or IB, are deemed to be APs of the FCM or IB, but not the CTA. Sections 3.12(f)(3) and 3.12(f)(4) were originally in Rule 3.12 before the Commission published the 2002 Release. 3

As published, Rule 3.12 is missing two important subsections, which these corrections add.

The FHWA published a document in the Federal Register of February 27, 2004 (69 FR 9470) with an incorrect paragraph designation in § 970.208. The FHWA is correcting this typographical error in the lettering sequence of the paragraph.

On March 1, 2004, a temporary deviation for the operation of the Black Bayou Pontoon Bridge across the Gulf Intracoastal Waterway, mile 237.5 west of Harvey Lock, in Calcasieu Parish, LA was published in the Federal Register (69 FR 9549). The temporary deviation allowed the bridge to remain in the closed-to-navigation position from 7 a.m. until 11 a.m. and from 1 p.m. until 5 p.m. Monday through Friday from March 17, 2004, through April 14, 2004. The Louisiana Department of Transportation and Development (LDOTD) has now requested a two-week extension to the temporary deviation in order to complete the repairs. The extension of the temporary deviation is necessary to ensure the complete repair of the fender system for the safety of the bridge. The extension of the temporary deviation will allow the bridge to remain in the closed-to-navigation position from 7 a.m. until 11 a.m. and from 1 p.m. until 5 p.m. Monday through Friday until April 28, 2004.

As the bridge has no vertical clearance in the closed-to-navigation position, vessels will not be able to transit through the bridge sight when the bridge is closed. Navigation at the site of the bridge consists mainly of tows with barges and some recreational pleasure craft. Due to prior experience, as well as coordination with waterway users, it has been determined that this closure will not have a significant effect on these vessels. The bridge normally opens to pass navigation an average of 878 times per month. The bridge opens on signal as required by 33 CFR 117.5. The bridge will be able to open for emergencies during the closure period with proper notice. Alternate routes are not available.

In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible. This deviation from the operating regulations is authorized under 33 CFR 117.35.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Publishing an NPRM was impracticable and contrary to the public interest, because the rule was needed to allow the contractor to provide for worker safety while repairing the bridge. Also, since this rule provides for bridge openings during the majority of the day, during daytime hours, when the area is most heavily traveled, vessel traffic will not be unduly disrupted during the repair process. Two temporary final rules were previously published (68 FR 47462 and 68 FR 57614), that requested a similar schedule though occurring on different dates. The contractor contacted the Coast Guard on January 27, 2004 and requested the date change due to various delays outside the contractor's control.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after Federal Register publication. The contractor submitted a letter on January 27, 2004, requesting an extension and change to the bridge's operating schedule to effect repairs, due to delays beyond their control. Accordingly, there was insufficient time remaining to either publish an NPRM or delay the effective date of the rule. This temporary rule provides for a reduction in bridge openings to allow the contractor to safely repair the bridge while providing for the reasonable needs of navigation during daylight hours.

The Main Street Bridge, mile 24.7, St. Johns River at Jacksonville, Duval County, Florida, has a vertical clearance of 40 feet at mean high water and a horizontal clearance of 350 feet between the fender systems. The existing operating regulation in 33 CFR 117.325(a) requires the bridge to open on signal except that, from 7 a.m. to 8:30 a.m. and 4:30 p.m. to 6 p.m., Monday through Saturday, except Federal holidays, the draw need not open for the passage of vessels. The draw opens at any time for vessels in an emergency involving life or property.

Royal Bridge, Inc., contractors, notified the Coast Guard on January 27, 2004, that work on the vertical lift bridge was delayed by events outside their control and that an additional temporary schedule change was needed to complete the project. They also requested an extra 2 hours per day for the closure period (6 p.m. to 6 a.m.). Finally, due to worker safety issues, there will be a 5-foot reduction in vertical clearance for scaffolding. This rule is necessary to provide for worker safety during repairs to the bridge and does not significantly hinder navigation, as openings will be provided throughout the remainder of the day when the transit area is most heavily traveled.

Under this temporary rule, the bridge need not open from 6 p.m. until 6 a.m., March 31, 2004, to May 31, 2004. This action is necessary for worker safety during repairs to the bridge and does not significantly hinder navigation.

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. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). The Coast Guard expects the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. This rule will impact vessels greater than 35 feet in height because of the reduction in vertical clearance. This rule, however, will only affect a small percentage of vessel traffic through the bridge, because of limited nighttime navigation at this location, and openings are available during daylight hours.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities, because the regulations will affect only a limited amount of marine traffic and will still provide for navigation needs by opening on signal from 6:01 a.m. to 5:59 p.m.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this temporary 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 (Public Law 104-121), we want to assist small entities in understanding this temporary rule so that they can better evaluate its effects on them and comment if necessary. If this temporary rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in FOR FURTHER INFORMATION CONTACT .

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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 would not result in such an expenditure, we do discuss the effects of this rule elsewhere in the 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 would not create an environmental risk to health or risk to safety that might 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. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.1D, 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 (32)(e), of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (32)(e), of the Instruction, an “Environmental Analysis Checklist” and a “Categorical Exclusion Determination” are not required for this rule.

The safety zones in 33 CFR 165.1315 were established to provide for the safety of vessels in the vicinity of annual fireworks displays on the Willamette River, the Columbia River and the Coos River. Entry into these zones is prohibited during the following enforcement periods unless authorized by the Captain of the Port or his designee:

• The safety zone for the Cinco de Mayo Fireworks Display will be enforced May 7, 2004, from 9:30 p.m. until 10 p.m.

• The safety zone for the Portland Rose Festival Fireworks Display will be enforced June 30, 2004, from 9:50 p.m. until 10:30 p.m.

• The safety zone for the Tri-City Chamber of Commerce Fireworks Display will be enforced July 4, 2004, from 10 p.m. until 10:30 p.m.

• The safety zone for the Cedco Inc. Fireworks Display will be enforced July 3, 2004, from 10 p.m. until 10:30 p.m.

• The safety zone for the Astoria 4th of July Fireworks Display will be enforced July 4, 2004, from 10 p.m. until 10:30 p.m.

• The safety zone for the Oregon Food Bank Blues Festival will be enforced July 4, 2004, from 10 p.m. until 10:30 p.m.

• The safety zone for the Oregon Symphony Concert Fireworks Display will be enforced September 2, 2004, from 9 p.m. until 9:30 p.m.

• The safety zone for the Vancouver Celebrate America Fireworks Display will be enforced October 17, 2004, from 9 p.m. until 9:20 p.m.

The Captain of the Port may be assisted by other Federal, State, or local agencies in enforcing these security zones.

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)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0281. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://gpoaccess.gov/ecfr/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of May 9, 2003 (68 FR 25026) (FRL-7306-3), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(e), as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 1F6288) by Jeneil Biosurfactant Company, 400 N. Dekora Woods Boulevard, Saukville, Wisconsin 53080. This notice included a summary of the petition prepared by the petitioner Jeneil Biosurfactant Company. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of rhamnolipid biosurfactant.

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

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

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

Rhamnolipid biosurfactant (pc code 110029, CAS number 147858-26-2) has the CAS name decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-[alpha]-L-mannopyranosyl)-[alpha]-L-mannopyranosyl]oxy]-, 1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-[alpha]-L-mannopyranosyl)oxy]decanoate. The basic composition of the active ingredient consists of a well-known carbohydrate (rhamnose sugar) and fatty acid (hydroxydecanoic acid). The active ingredient is a mixture of two types of rhamnolipid molecules, R1 (RLL) and R2 (RRLL) at a ratio of R2:R1 = 0.7 - 2.0. Chemical name of the rhamnolipid molecules is as follows: Molecule 1 (defined as R1 or RLL): Decanoic acid, 3-[(6-deoxy-[alpha]-L-mannopyranosyl) oxy]-, 1-(carboxymethyl) octyl ester; and molecule 2 (defined as R2 or RRLL): Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-[alpha]-L-mannopyranosyl)-[alpha]-L-mannopyranosyl] oxy]-, 1-(carboxymethyl) octyl ester.

Adequate mammalian toxicology data are available and support registration of the product containing the active ingredient rhamnolipid biosurfactant. Rhamnolipid molecules are simple glycolipids consisting of a carbohydrate (rhamnose) ring and a fatty acid (hydroxydecanoic acid) tail. Individually, these molecules are not toxic. Rhamnose is a comparatively rare sugar approved by FDA as a food additive, and fatty acids are ubiquitous in animals and plants and are a major energy source in the body. Consequently, the breakdown products of rhamnolipids are of little toxicological concern. The mode of action of rhamnolipid biosurfactants is a physical action on the plant pathogen, rather than a toxic action. Rhamnolipid biosurfactant products are currently in use as emulsifiers, dispersants, wetting agents, and agricultural adjuvants. There have been no reports of adverse effects from any uses of rhamnolipid biosurfactants to date. The information submitted indicates there is already widespread exposure to rhamnose sugar, fatty acids, and rhamolipid biosurfactants without any reported adverse effects to human health. The acute toxicity studies, in conjunction with data or other information obtained from the open literature and the expected low exposure to humans, demonstrate that no risks to human health are expected from the pesticidal use of rhamnolipid biosurfactant.

1. Acute oral toxicity (OPPTS Harmonized Guidline 870.1100; 152-10; MRID 45376702). Male and female rats (5 per sex) were dosed once with 5,000 milligrams/kilograms (mg/kg) and observed for 14 days. The acute oral lethal dose (LD) 50 was > 5,000 mg/kg. The study was acceptable and placed the test material in Toxicity Category IV.

2. Acute dermal toxicity (OPPTS Harmonized Guidline 870.1200; 152-11; MRID 45376703). Male and female rats (5 per sex) were dosed with 5,000 mg/kg for 24 hours and observed for 14 days The acute dermal LD 50 was > 5,000 mg/kg. The study was acceptable and placed the test material in Toxicity Category IV.

3. Acute inhalation toxicity (OPPTS Harmonized Guidline 870.1300; 152-12, MRID 45376704). Male and female rats (5 per sex) were exposed whole-body to a gravimetric concentration of 2.05 mg/liter (L) 9.5% rhamnolipid biosurfactant in water for 4 hours, and observed for 14 days. The lethal concentration (LC) 50 was > 2.05 mg product/L (0.20 mg active ingredient (a.i.)/L). The study was acceptable and placed the test material in Toxicity Category IV.

Other acute toxicology data also reviewed in support of the rhamnolipd biosurfactant registration include the following.

1. Primary eye irritation (OPPTS Harmonized Guidline 870.2400; 152-13; MRID 45376705).

2. Primary eye irritation (OPPTS Harmonized Guidline 870.2400; 152-13; MRID 45376706).

3. Primary eye irritation (OPPTS Harmonized Guidline 870.2400; 152-13; MRID 45376707).

4. Primary dermal irritation (OPPTS Harmonized Guidline 870.2500; 152-14; MRID 45376708).

A data waiver was requested for the following study, and granted by the Agency. Although no study was conducted by the registrant, acceptable information/data was submitted to support the data waiver request.

Dermal sensitization (OPPTS Harmonized Guidline 870.2600; 152-15).

The requested waiver was granted by the Agency based on the fact that rhamnolipid biosurfactant is not related to any known mutagens and does not belong to a chemical class of compounds containing known mutagens. Rhamnolipid biosurfactant consists of rhamnose sugar and hydroxydecanoic acid, both of which have food-related uses.

Requested waivers for 90-day oral toxicity and immunotoxicity were granted by the Agency based on the physical mode of action of the active ingredient; the lack of acute oral, dermal, and inhalation toxicity; and the innocuous nature of the potential breakdown products of rhamnolipid biosurfactants.

Repeated-dose studies are conditionally required if the potential for adverse chronic effects are indicated based on: (1) The subchronic effect levels established in Tier I subchronic oral, inhalation, or dermal studies, (2) the pesticide use pattern, or (3) the frequency and the level of repeated human exposure that is expected. Oncogenicity studies are required only if the active ingredient or any of its metabolites, degradation products, or impurities produce in Tier I studies any morphologic effects in any organ that potentially could lead to neoplastic changes. None of the results of the submitted studies triggered the need for chronic exposure or oncogenicity testing.

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

1. Food . There is a great likelihood of exposure in the normal human diet to rhamnolipid biosurfactant's components for most, if not all individuals, including infants and children. Rhamnolipid biosurfactant constituents, rhamnose sugar and fatty acid, are normal parts of the human diet. To date, there have been no known reports of any hypersensitivity incidents from users of the surfactant. Even if exposure increased due to pesticidal use of rhamnolipid biosurfactant, given the low toxicity of the components (or of the surfactant) and the widespread dietary exposure to the components, the Agency believes the risk associated with dietary exposure to the biosurfactant by the oral route would be low to non-existent.

2. Drinking water exposure . Because rhamnolipid biosurfactant has low acute mammalian toxicity, the constituent rhamnose sugar is a food additive, and constituent fatty acids are ubiquitous in plant and animals, no risk is anticipated should exposure occur through drinking water.

The potential for non-dietary exposure to rhamnolipid biosurfactnt residues for the general population, including infants and children, is unlikely because potential use sites are horticultural and agricultural crops. Rhamnolipid biosurfactant's constituent carbohydrate (rhamnose sugar) and fatty acid (hydroxydecanoic acid) are not considered toxic; rhamnose sugar is a food additive and fatty acids, ubiquitous in plants and animals, are a major energy source in the body. Rhamnolipid biosurfactant's toxicity has been determined to be very low through the oral, dermal and inhalation routes. Therefore, while there exists a great likelihood of prior exposure to rhamnolipid biosurfactant's components, any risk from increased exposure due to the proposed product would be negligible.

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.”

EPA does not have, at this time, available data to determine whether rhamnolipid biosurfactant has a common mechanism of toxicity with other substances. 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 rhamnolipid biosurfactant and any other substances and rhamnolipid biosurfactant 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 rhamnolipid biosurfactant 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. U.S. population . The Agency has determined that there is reasonable certainty that no harm will result from aggregate exposure to residues of rhamnolipid biosurfactant to the U.S. population. This includes all anticipated dietary exposures and other non-occupational exposures for which there is reliable information. The Agency arrived at this conclusion based on the anticipated low exposure estimates from its pesticidal use; the low mammalian toxicity of rhamnolipid biosurfactant; and the already widespread human exposure to rhamolipid biosurfactant constituents, rhamnose sugar and hexadecanoic acid, without any reported adverse effects to human health.

2. Infants and children . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of exposure for infants and children in the case of threshold effects unless the Agency determines, based on reliable data, that a different margin is safe. Margins of exposure are referred to as uncertainty or safety factors, and are used to account for potential prenatal and postnatal toxicity and any lack of completeness of the data base. Based on all the reliable available information the Agency reviewed on rhamnolipid biosurfactant, including that showing a lack of threshold effects, the Agency concluded that the additional margin of safety is not necessary to protect infants and children and that not adding any additional margin of safety will be safe for infants and children.

The Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation for the reasons stated above, including low toxicity and low exposure from the pesticidal use of rhamnolipid biosurfactant. For the same reasons, the Agency concludes that an analytical method is not required for enforcement purposes for rhamnolipid biosurfactant.

There are no CODEX maximum residue levels for rhamnolipid biosurfactant.

Based on the toxicology information/data submitted and other information available to the Agency, there is a reasonable certainty that no harm will result from aggregate exposure of residues of rhamnolipid biosurfactant to the U.S. population, including infants and children, under reasonably foreseeable circumstances, when the biochemical pesticide is used in accordance with good agricultural practices. This includes all anticipated dietary exposures and all other non-occupational exposures for which there is reliable information. The Agency has arrived at this conclusion based on the information/data submitted (and publically available) demonstrating no toxicity. As a result, EPA is establishing an exemption from the tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of rhamnolipid biosurfactant in or on all food commodities.

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. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0281 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 June 1, 2004.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov , or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit X.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0281, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 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 the FFDCA, such as the exemption 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 the 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 .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2004-0052. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://ecfr.gpoaccess.gov/ecfr/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for residues of the fungicide zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide), in or on ginseng at 0.06 parts per million (ppm). This tolerance will expire and is revoked on December 31, 2006. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18-related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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

Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

Leaf and stem blight are diseases caused by pathogens for Alternaria and Phytophthora . If left unchecked, their damage to growing ginseng is seen in root rot, premature defoliation, and loss in root yields (ginseng is a root crop). Total yield loss is likely. The ginseng industry maintains that the alternative pesticide and cultural control means are insufficient. Although there are, in fact, pesticides that are labeled for these problems on ginseng, the alternatives are not effective or have a resistance issue in regards to the pathogens. Azoxystrobin was also labeled under section 3 for ginseng in 2000, however, its use is limited to six treatments per season, in order to preserve its efficacy. EPA has authorized under FIFRA section 18 the use of zoxamide on ginseng for control of Alternaria and Phytophthora in Michigan and Wisconsin. After having reviewed the submission, EPA concurs that emergency conditions exist for these States.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of zoxamide in or on ginseng. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance will expire and is revoked on December 31, 2006, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on ginseng after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether zoxamide meets EPA's registration requirements for use on ginseng or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of zoxamide by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than Michigan and Wisconsin to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for zoxamide, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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 the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of zoxamide and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for residues of zoxamide in or on ginseng at 0.06 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

Tolerances have been established for residues of zoxamide in or on grapes, potatoes, tomatoes and the cucurbit vegetable group 9 (40 CFR 180.567). 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. A summary of the toxicological dose and endpoints for zoxamide for use in human risk assessment is discussed in Unit III.A. of the Federal Register of April 11, 2001 (66 FR 18725) (FRL-6774-8).

Briefly, an endpoint for acute dietary exposures was not identified since no effects were observed in oral toxicity studies that could be attributable to a single dose. For chronic dietary exposures, the chronic reference dose (cRfD) is 0.48 milligrams/kilogram/day (mg/kg/day). The FQPA safety factor was removed (i.e., reduced to 1x) for zoxamide, because there is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure; a developmental neurotoxicity study conducted with zoxamide is not required. Therefore, the chronic population adjusted dose (cPAD) is 0.48 mg/kg/day. 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). Zoxamide is not registered for use on any sites that would result in residential exposure. Therefore, short-term and intermediate-term aggregate risks were not assessed. Zoxamide has been classified as not likely to be carcinogenic to humans. Therefore, the only exposure scenario the Agency assessed is for chronic (non-cancer) exposures to zoxamide.

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.567) for the combined residues of zoxamide and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) in or on potatoes, tomatoes and the cucurbit vegetable group 9 and for only residues of zoxamide on grapes. Risk assessments were conducted by EPA to assess dietary exposures from zoxamide in food as follows:

i. Acute exposure . Acute dietary 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 acute dietary endpoint was identified since no effects were observed in oral toxicity studies that could be attributable to a single dose. Therefore, acute dietary risk assessments were not performed.

ii. Chronic exposure . In conducting this chronic dietary risk assessment, the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDT, Version 1.3) analysis evaluated the individual food consumption 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: Published and proposed tolerances level residues were used. Default processing factors and 100% crop treated were assumed for all commodities.

iii. Cancer . Zoxamide has been classified as not likely to be carcinogenic to humans. Therefore, risk assessments to estimate risk from cancer were not performed.

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

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and screening concentration in ground water (SCI-GROW), which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a Tier I model) before using PRZM/EXAMS (a Tier II model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to zoxamide, they are further discussed in the aggregate risk sections below.

Based on the PRZM/EXAMS and SCI-GROW models, the EECs of zoxamide for chronic exposures are estimated to be 21.8 parts per billion (ppb) for surface water and 2.1 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). Zoxamide is not registered for use on any sites that would result in residential exposure.

4. Cumulative exposure to 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.”

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

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2004-0035. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of November 26, 2003 (68 FR 66422) (FRL-7332-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(e), as amended by FQPA (Public Law 104 -170), announcing the filing of a pesticide tolerance petition (3F6756) by Syngenta Seeds, Incorporated, P.O. Box 12257, 3054 Cornwallis Road, Research Triangle Park, NC 27709-2257. This notice included a summary of the petition prepared by the petitioner Syngenta Seeds, Incorporated. Comments were received from grower groups, and the National Cotton Council supporting this petition.

The petition requested that 40 CFR 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Bacillus thuringiensis VIP3A Insect Control Protein as Expressed in Event COT102 and the genetic material necessary for its production.

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

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)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0415. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.gpoaccess.gov/ecfr/ , a beta site currently under development.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of October 22, 2003 (68 FR 60371) (FRL-7328-4), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F4888) by Monsanto Company, 800 North Lindberg Blvd., St. Louis, Missouri 63167. This notice included a summary of the petition prepared by the petitioner Monsanto. There were two comments received in response to the notice of filing. One comment was from a private citizen who opposed the granting of the tolerance exemption and felt the EPA was not fulfilling its duty of protecting public health and the environment.

The second comment was from Valent BioSciences Corporation, a producer of microbial Bacillus thuringiensis pesticide products. Valent maintained that the basis of the safety assessment for the Cry3Bb1 protein is the expression of Cry proteins in Bacillus thuringiensis microbial pesticides that have been safely used for over 40 years. The commenter contends that the strain of B. thuringiensis subspecies kumamotoensis has never been registered as a microbial pesticide and therefore Cry3Bb1 does not deserve to benefit from the implied 40 years of safe use argument.

The commenter also states that any new strain of B.thuringiensis , such as B. thuringiensis subspecies kumamotoensis , would be required to demonstrate safety through new data on mammalian toxicology and pathogenicity for non-target organisms.

The commenter also raised questions concerning whether the fact that the Cry3Bb1 protein subject to the tolerance determination is a variant of the natural Cry3Bb1 endotoxin that has been engineered specifically to enhance activity against the corn rootworm larvae means that the binding characteristics have been altered.

The results of toxicity tests indicate a toxicity category III designation. The commenter is concerned about these toxicity results reflecting negatively on the currently registered microbial Bt use.

Finally, the commenter is concerned whether the validated ELISA method for detecting Cry3Bb1 protein would distinguish the variant from the natural toxins.

In response to the first commentor, EPA takes seriously its duty to protect human health and the environment. Specifically, under the FFDCA, EPA must make a finding that there is a reasonable certainty of no harm from the granting of the proposed tolerance exemption. EPA is making such a finding and herein sets forth the bases for this finding.

Regarding the comments from Valent BioScience, the basis of the Cry3Bb1 tolerance determination is toxicology data that has been generated separately from any registered microbial B. thuringiensis . While EPA acknowledges that it has made reference to the safe use of microbial formulations in both the 2000 reassessment of the B. thuringiensis -based PIPs and several registered PIPs, all of these PIP proteins have had extensive mammalian safety data generated for the expressed protein itself. Therefore, Monsanto's reference in the notice of filing to the safe use of microbial B. thuringiensis , while cogent to the safety assessment as useful generic information on previous exposure to the Cry proteins, is not the basis of the safety finding to support a tolerance exemption.

The fact that all three variants of Cry3Bb1 protein [see Unit. III.] have been tested for toxicity and allergenicity indicate that the safety of these three variants at least, is similar for mammalian species. The indication of these test results is that minor modifications due to protein engineering for enhanced target activity does not necessarily alter non-target toxicity for mammalian species. This supposition does not mean that all protein engineering modifications would result in equally benign results for non-target species. No insecticidal activity was seen in specific insect species, including six species of coleopteran and two species of lepidopteran pests with the variant Cry3Bb1 protein suggesting that the host range activity is limited. There are also results from bioassays with two of the variant Cry3Bb1 proteins against two sensitive coleopteran species ( Leptinotarsa decemlineata and Diabrotica virgifera ) that indicates that there are not significant changes in the activity between the two variants.

The category III designation for the results of the acute oral toxicity test using purified Cry3Bb1 toxin do not represent any change from the results that would be seen with microbial preparations. The category classification is due to the limitation of dose volume for the test animal rather than any sign of toxicity in the test or concern for possible exposure. The oral tests were done with purified protein doses that are orders of magnitude higher than would be seen in any microbial B. thuringiensis products. Actual exposure to Cry proteins in PIP products are not expected to represent any hazard of oral toxicity given the results seen in these tests.

Regarding the analytical method, there are features of the assay procedures that could lessen the likelihood of recognizing a microbial source of Cry3Bb1 δ-endotoxin. The microbial B. thuringiensis products are known to be rapidly weathered away by environmental conditions like rain and UV radiation lessening the possibility of a microbial product being present. In addition, if a positive result was obtained for the presence of Cry3Bb1 protein in an unexpected source, the test could be confirmed by washing the suspect crop then retesting. Any surface contamination by residues from treatment with a B. thuringiensis product would be removed. Any subsequent positive finding should be a true Cry3Bb1 detection since it would represent an internal tissue detection which could be reasonably assumed to result only from plant expression of the Cry3Bb1 gene.

The petition requested that 40 CFR part 180 be amended by establishing an temporary exemption from the requirement of a tolerance for residues of Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn.

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

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

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

Data have been submitted demonstrating the lack of mammalian toxicity at high levels of exposure to the pure Cry3Bb1 proteins. These data demonstrate the safety of the products at levels well above maximum possible exposure levels that are reasonably anticipated in the crops. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial Bacillus thuringiensis products from which this plant-incorporated protectant was derived (See 40 CFR 158.740(b)(2)(i)). For microbial products, further toxicity testing and residue data are triggered by significant acute effects in studies such as the mouse oral toxicity study, to verify the observed effects and clarify the source of these effects (Tiers II and III).

Three acute oral studies were submitted for Cry3Bb1 proteins. These studies were done with three variants of the Cry3Bb1 protein engineered with either four or five internal amino acid sequence changes to enhance activity against the corn rootworm. The acute oral toxicity data submitted support the prediction that the Cry3Bb1 protein would be non-toxic to humans. Male and female mice (10 of each) were dosed with 36, 396, or 3,780 milligrams/kilograms bodyweight (mg/kg bwt) of Cry3Bb1 protein for one variant. The mice were dosed with 38.7, 419, or 2,980 mg/kg bwt of Cry3Bb1 protein for the second variant. The mice were dosed with 300, 900, or 2,700 mg/kg bwt of Cry3Bb1 protein for the third variant. In one study, two animals in the high dose group died within a day of dosing. These animals both had signs of trauma probably due to dose administration (i.e., lung perforation or severe discoloration of lung, stomach, brain and small intestine). No clinical signs were observed in the surviving animals and body weight gains were recorded throughout the 14-day study for the remaining animals. Gross necropsies performed at the end of the study indicated no findings of toxicity attributed to exposure to the test substance in any of the three studies. No other mortality or clinical signs attributed to the test substance were noted during either study.

When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, Roy D., et al. “Toxicological Considerations for Protein Components of Biological Pesticide Products,” Regulatory Toxicology and Pharmacology 15, 3-9 (1992)). Therefore, since no effects were shown to be caused by the plant-incorporated protectants, even at relatively high dose levels, the Cry3Bb1 proteins are not considered toxic. Further, amino acid sequence comparisons showed no similarity between Cry3Bb1 proteins to known toxic proteins available in public protein data bases.

Since Cry3Bb1 are proteins, allergenic sensitivities were considered. Current scientific knowledge suggests that common food allergens tend to be resistant to degradation by heat, acid, and proteases, may be glycosylated and present at high concentrations in the food.

Data have been submitted that demonstrate that the Cry3Bb1 protein is rapidly degraded by gastric fluid in vitro . In a solution of simulated gastric fluid (pH 1.2 - U.S. Pharmacopeia), complete degradation of detectable Cry3Bb1 protein occurred within 30 seconds. Insect bioassay data indicated that the protein loss insecticidal activity within 2 minutes of incubation in SGF. Incubation in simulated intestinal fluid resulted in a ~59 kDa protein digestion product. A comparison of amino acid sequences of known allergens uncovered no evidence of any homology with Cry3Bb1, even at the level of 8 contiguous amino acids residues.

The potential for the Cry3Bb1 proteins to be food allergens is minimal. Regarding toxicity to the immune system, the acute oral toxicity data submitted support the prediction that the Cry3Bb1 proteins would be non-toxic to humans. As noted above, toxic proteins typically act as acute toxins with low dose levels. Therefore, since no effects were shown to be caused by the plant-incorporated protectants, even at relatively high dose levels, the Cry3Bb1 proteins are not considered toxic.

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

The Agency has considered available information on the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. These considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the plant-incorporated protectant chemical residue, and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the plant-incorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. Oral exposure, at very low levels, may occur from ingestion of processed corn products and, potentially, drinking water. However a lack of mammalian toxicity and the digestibility of the plant-incorporated protectants have been demonstrated. The use sites for the Cry3Bb1 proteins are all agricultural for control of insects. Therefore, exposure via residential or lawn use to infants and children is not expected. Even if negligible exposure should occur, the Agency concludes that such exposure would present no risk due to the lack of toxicity demonstrated for the Cry3Bb1 proteins.

Pursuant to section 408(b)(2)(D)(v) of FFDCA, EPA has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity to these plant-incorporated protectants, we conclude that there are no cumulative effects for the Cry3Bb1 proteins.

The data submitted and cited regarding potential health effects for the Cry3Bb1 proteins include the characterization of the expressed Cry3Bb1 protein in corn, as well as the acute oral toxicity, and in vitro digestibility of the proteins. The results of these studies were determined applicable to evaluate human risk and the validity, completeness, and reliability of the available data from the studies were considered.

Adequate information was submitted to show that the Cry3Bb1 test material derived from microbial cultures was biochemically and, functionally similar to the protein produced by the plant-incorporated protectant ingredients in corn. Production of microbially produced protein was chosen in order to obtain sufficient material for testing.

The acute oral toxicity data submitted supports the prediction that the Cry3Bb1 proteins would be non-toxic to humans. When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, Roy D., et al. “Toxicological Considerations for Protein Components of Biological Pesticide Products,” Regulatory Toxicology and Pharmacology 15, 3-9 (1992)). Since no effects were shown to be caused by Cry3Bb1, even at relatively high dose levels (3,780 mg Cry3Bb1/kg bwt), the Cry3Bb1 proteins are not considered toxic. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial Bacillus thuringiensis products from which this plant-incorporated protectant was derived. See 40 CFR 158.740(b)(2)(i). For microbial products, further toxicity testing and residue data are triggered by significant acute effects in studies such as the mouse oral toxicity study to verify the observed effects and clarify the source of these effects (Tiers II and III).

Cry3Bb1 residue chemistry data were not required for a human health effects assessment of the subject plant-incorporated protectant ingredients because of the lack of mammalian toxicity.

Both available information concerning the dietary consumption patterns of consumers (and major identifiable subgroups of consumers including infants and children); and safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives, are generally recognized as appropriate for the use of animal experimentation data were not evaluated. The lack of mammalian toxicity at high levels of exposure to the Cry3Bb1 proteins demonstrate the safety of the product at levels well above possible maximum exposure levels anticipated in the crop.

The genetic material necessary for the production of the plant-incorporated protectant active ingredients are the nucleic acids (DNA, RNA) which comprise genetic material encoding these proteins and their regulatory regions. The genetic material (DNA, RNA) necessary for the production of Cry3Bb1 proteins in corn have been exempted under the blanket exemption for all nucleic acids (40 CFR 174.175).

Section 408(b)(2)(C) of FFDCA provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity.

In addition, section 408(b)(2)(C) of FFDCA also provides that EPA shall apply an additional ten-fold 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 unless EPA determines that a different margin of safety will be safe for infants and children.

In this instance, based on all the available information, the Agency concludes that there is a finding of no toxicity for the Cry3Bb1 proteins and the genetic material necessary for their production. Thus, there are no threshold effects of concern and, as a result, the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply.

There is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to the Cry3Bb1 proteins and the genetic material necessary for their production. This includes all anticipated dietary exposures and all other exposures for which there is reliable information.

The Agency has arrived at this conclusion because, as discussed above, no toxicity to mammals has been observed for the plant-incorporated protectants.

The pesticidal active ingredients are proteins, derived from sources that are not known to exert an influence on the endocrine system. Therefore, the Agency is not requiring information on the endocrine effects of these plant-incorporated protectants at this time.

Validated methods for extraction and direct ELISA analysis of Cry3Bb1 in corn grain have been submitted and found acceptable by the Agency.

No Codex maximum residue levels exists for the plant-incorporated protectants Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn.

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. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0415 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 June 1, 2004.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov , or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0415, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 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 the FFDCA, such as the exemption 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 the 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 manufacture. Potentially affected categories and entities may include, but are not limited to

• Crop production (NAICS, 111)

• Animal production (NAICS, 112)

• Food manufacturing (NAICS, 311)

• Pesticide manufacturing (NAICS, 32532).

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2004-0007. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of October 9, 2002 (67 FR 62971) (FRL-7196-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 2G6494) by Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. This notice included a summary of the petition prepared by the petitioner Dow AgroSciences, LLC. Comments were received in response to the notice of filing. These comments were from grower groups, state agencies, and academia. All comments were in support of the registration of Dow AgroSciences' stacked gene plant-incorporated protectant.

A one year experimental use permit was issued on April 15, 2003 for CryIAc/CryIF in cotton. On April 30, 2003 (68 FR 23073) (FRL-7302-4), a temporary exemption from the requirement of a tolerance (40 CFR 180.1227) was granted for Bacillus thuringiensis var. Aizawai strain PS811 CryIF insecticidal protein in cotton. This tolerance exemption will expire on May 1, 2004. Dow AgroSciences, petitioned the Agency for an amended/extension for the CryIAc/CryIF EUP and the related temporary exemption from the requirement of a tolerance for the 2004-2005 planting season.

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

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

You may be 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 worker; 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, 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2004-0029. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of October 10, 1997 (62 FR 52998) (FRL-5748-5), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), as amended by the FQPA (Public Law 104-170) announcing the filing of a pesticide tolerance petition, petition number 7F4888, by Monsanto Company, 700 Chesterfield Parkway, North, St. Louis, MO 63198. This notice included a summary of the petition prepared by the petitioner Monsanto Company. There were no comments received in response to the notice of filing. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its production in cotton.

In the Federal Register of May 11, 2001 (66 FR 92) (FRL-6781-6, EPA issued a final rule pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(e), as amended by the FQPA, by establishing a temporary exemption from the requirement of a tolerance for Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its production in cotton when applied/used as a plant-incorporated protectant. Since that time, EPA has completed the full commercial registration. Therefore, on its own initiative, EPA is amending the temporary exemption from the requirement of a tolerance for Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its production in cotton when applied/used as a plant-incorporated protectant (§180.1215) to change the exemption from a temporary exemption to a permanent exemption.

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

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

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 .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2004-0089. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm /.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of December 31, 2002 (67 FR 79918) (FRL-7285-6), 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 1F6296) by Valent U.S.A. Corporation, 1333 North California Boulevard, Suite 600, Walnut Creek, California 94596-8025. That notice included a summary of the petition prepared by Valent U.S.A. Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.568 be amended by establishing a tolerance for residues of the herbicide, flumioxazin (2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2 H -1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1 H -isoindole-1,3(2 H )-dione) in or on cotton at 0.02 parts per million (ppm) and cotton gin byproducts at 0.60 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 the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

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 flumioxazin on cottonseed at 0.02 ppm and cotton gin byproducts at 0.60 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. The nature of the toxic effects caused by flumioxazin are discussed in Table 1 of this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

In 1993, the Commission substituted Channel 251A for Channel 221A at Dawson, Georgia. See 58 FR 36375 (July 7, 1993). Channel 251A is not currently listed in the FM Table of Allotments, Section 73.202(b) under Georgia for the community of Dawson.

The Code of Federal Regulations must be corrected to add Channel 251A and remove Channel 221A at Dawson, Georgia.

On January 23, 2004 (69 FR 3257), the Federal Register published a final rule in the above captioned proceeding. On page 3266, instruction 14 of the rules amended § 101.63 by revising paragraphs (a) and (b). In revising paragraph (b), the instructions neglected to redesignate then existing paragraphs (b), (c), (d), and (e), as paragraphs (c), (d), (e), and (f), respectively. This document corrects § 101.63. Instruction 16 of the rules amended § 101.107(a) by revising the table. The instruction neglected to reflect revisions to the footnotes of the table that were published in the Federal Register on January 31, 2003 (68 FR 4956). This document corrects footnote 9 published on January 23, 2004 (69 FR 3266) and also renumbers it to read as footnote 8.

As published, the final regulations contain errors which may prove to be misleading and need to be clarified.

Each year, NASA's financial statements are audited in accordance with generally accepted government auditing standards. NASA must maintain adequate controls to reasonably assure that property, plant and equipment and materials are presented fairly in its financial statements. Since contractors maintain NASA's official records for its assets in their possession, NASA uses the data contained in contractor reports for annual financial statements and property management. This final rule provides policies and procedures related to obsolete property, contractor validation of 1018 data, and proper reporting of software to which NASA has title. This change will provide for consistent reporting of NASA property by contractors. It also reflects the need to change the date of submission for annual property reports from October 31st to October 15th. No public comments were received. The interim rule is converted to a final rule without change.

This final rule is not a significant regulatory action, and therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This final rule is not a major rule under 5 U.S.C. 804.

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small businesses within the meaning of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because it clarifies existing property reporting policies and procedures contractors must follow when accounting for and reporting assets.

The Paperwork Reduction Act does not apply because the changes to the NFS do not impose new recordkeeping or information collection requirements which require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2004 TAC of Pacific cod allocated to catcher processor vessels using pot gear in the BSAI was established as a directed fishing allowance of 2,003 metric tons by the 2004 final harvest specifications for groundfish in the BSAI (69 FR 9242, February 27, 2004), for the period 1200 hrs, A.l.t., January 1, 2004, through 1200 hrs, A.l.t., June 10, 2004. See § 679.20(c)(3)(iii), § 679.20(c)(5), and § 679.20(a)(7)(i)(A) and (C).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS, has determined that the A season apportionment of the 2004 TAC of Pacific cod allocated as a directed fishing allowance to catcher processor vessels using pot gear in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher processor vessels using pot gear in the BSAI.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent the Agency from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific cod specified for catcher processor vessels using pot gear in the BSAI.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2004 final harvest specifications for groundfish of the BSAI (69 FR 9242, February 27, 2004), established the Pacific cod TAC allocated to catcher/processor vessels using trawl gear in the BSAI for the period 1200 hrs, A.l.t., January 1, 2004, through 1200 hrs, A.l.t., April 1, 2004, as 23,422 metric tons. See § 679.20(c)(3)(iii), § 679.20(c)(5), and § 679.20(a)(7)(i)(A) and (C). In accordance with § 679.20(d)(1)(iii), the directed fishery for Pacific cod by catcher/processor vessels using trawl gear was closed effective 1200 hrs, A.l.t., March 14, 2004 (69 FR 12569, March 17, 2004) because it was determined that the A season allocation of the 2004 Pacific cod TAC specified for catcher/processor vessels using trawl gear had been caught.

NMFS has determined that as of March 20, 2004, the remaining amount of the A season allocation of the 2004 Pacific cod TAC for catcher/processor vessels using trawl gear is 2,000 metric tons. Therefore, NMFS is terminating the previous closure and is reopening directed fishing for Pacific cod by catcher/processor vessels using trawl gear in the BSAI effective 1200 hrs, A.l.t., March 28, 2004.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent the Agency from responding to the most recent fisheries data in a timely fashion and would delay the reopening of the fishery for the remaining A season allocation of Pacific cod TAC specified for catcher/processor vessels using trawl gear in the BSAI.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2004 final harvest specification for groundfish of the BSAI (69 FR 9242, February 27, 2004), allocated an Atka mackerel A season allowance in the Central Aleutian District of the BSAI of 14,384 metric tons (mt).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the A season allowance of the 2004 TAC specified for Atka mackerel in the Central Aleutian District will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 14,084 mt, and is setting aside the remaining 300 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance will be reached. Consequently, NMFS is prohibiting directed fishing for Atka mackerel in the Central Aleutian District of the BSAI.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent the Agency from responding to the most recent fisheries data in a timely fashion and would delay the closure of the fisheries under the A season allowance of the 2004 TAC of Atka mackerel specified for the Central Aleutian District of the BSAI.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.