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 all Boeing Model 737-600, 737-700, 737-700C, 737-800, 737-900, 757, and 767 series airplanes was published in the Federal Register on February 24, 2003 (68 FR 8560). That action proposed to require revising the Airplane Flight Manual (AFM) to advise the flightcrew to don oxygen masks as a first and immediate step when a cabin altitude warning occurs.

Interested persons have been afforded an opportunity to participate in the making of this amendment. The FAA has duly considered the comments received.

One commenter concurs with the proposed AD, and several other commenters had no objection to the proposed AD.

One commenter notes that there is no “CABIN ALT” or “CABIN ALTITUDE” warning light in the Boeing Model 737-800 series airplanes that it operates, and for this reason, the commenter suspects that the proposed AD does not apply to its airplanes. The commenter states that the only warning of excessive cabin altitude is the intermittent warning horn. The commenter suggests that the cabin altitude warning system installed on the airplane could be greatly enhanced by a modification that would give the flightcrew a visual warning of improper altitude. The commenter also suggests that the cabin altitude warning should be duplicated in the forward and aft galley areas.

We infer that the commenter is requesting clarification of the applicability and requirements of this proposed AD. We agree that such clarification is needed. Our intent was for this AD to apply to all airplanes listed in the applicability, regardless of the equipment associated with the cabin altitude warning system. We have confirmed with the airplane manufacturer that the Model 737-600, -700, -700C, -800, and -900 series airplanes subject to this AD have a cabin altitude warning horn instead of a warning light. Thus, we have revised Figure 1 of this AD to replace the reference to the illumination of the cabin altitude light with a reference to the sounding of the cabin altitude warning horn.

Further, with regard to the commenter's specific requests to add a cabin warning light on the flight deck and duplicate the cabin altitude warning in the forward and aft galley areas, we acknowledge the concerns of the commenter. While there may be merit to the commenter's suggestions, this AD is not the appropriate context in which to evaluate those suggestions. We have determined that the cabin altitude warning horn is an adequate means to alert the flightcrew to an unsafe condition and provides an acceptable level of safety when combined with the changes to procedures required by this AD. No further change to the AD is necessary in this regard.

One commenter notes that its understanding is that AD 2003-03-15, amendment 39-13039 (68 FR 4892, January 31, 2003), may be revised in the future. (The proposed AD explains that the proposed actions are similar to those in AD 2003-03-15.) The commenter asks us to consider establishing a common compliance time between the proposed AD and any future revision of AD 2003-03-15. The commenter states that it would like to accomplish all AFM changes in a one-time effort to ensure consistency and standardization among its manuals, especially for similar airplane fleets. Related to consistency and standardization, the commenter is also concerned about the variations in operational procedures in the AFM revisions. The commenter states that, while the AFM may differ in format from one model to another, there should not be procedural differences related to responding to a cabin altitude warning.

We acknowledge the commenter's concerns but do not concur with the commenter's request. We find that it is not possible to establish a common compliance time between this AD and a possible future proposed AD, because the timelines for these rulemaking actions are different. We have already proposed this AD and allowed opportunity for the public to comment, but, at this time, we are still considering further rulemaking to revise AD 2003-03-15. In light of the identified unsafe condition, we find that it would be inappropriate to delay issuance of this action indefinitely to wait for development of a proposal to revise AD 2003-03-15.

We also acknowledge the commenter's concerns about ensuring consistency among its AFMs, and we agree that it may be desirable to have the same wording in the AFMs for all models. However, the effort to achieve commonality is compromised by differences in the terminology used to identify similar equipment on different models, and the subtle differences in existing procedures between models. In developing the AFM changes contained in this AD, we limited the scope of changes within each affected AFM to avoid introducing standardized wording that may be incompatible with equipment on the airplane model or may contradict other procedures in the AFM.

No further change to the final rule is necessary in this regard.

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

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. However, for clarity and consistency in this final rule, we have retained the language of the NPRM regarding that material.

After the proposed AD was issued, we reviewed the figures we use to calculate the labor rate to do the required actions. To account for various inflationary costs in the airline industry, we find it appropriate to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The economic impact information, below, has been revised to reflect this increase in the specified hourly labor rate.

There are approximately 3,107 airplanes of the affected design in the worldwide fleet. The FAA estimates that 1,599 airplanes of U.S. registry will be affected by this AD, that it will take approximately 1 work hour per airplane to accomplish the required AFM revision, and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of this AD on U.S. operators is estimated to be $103,935, or $65 per airplane.

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) to include an airworthiness directive (AD) that is applicable to all Airbus Model A330 and A340 series airplanes was published in the Federal Register on April 3, 2003 (68 FR 16225). That action proposed to require revising the Airworthiness Limitations Section of the Instructions for Continued Airworthiness to incorporate life limits for the servo-controls located on the ailerons and replacement of the servo-controls with new servo-controls when they have reached their operational life limits.

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.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. However, for clarity and consistency in this final rule, we have retained the language of the proposed AD regarding that material.

After the proposed AD was issued, we reviewed the figures we use to calculate the labor rate to do the required actions. To account for various inflationary costs in the airline industry, we find it appropriate to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The economic impact information, below, has been revised to reflect this increase in the specified hourly labor rate.

The FAA estimates that 9 Model A330 series airplanes of U.S. registry will be affected by this AD, that it will take approximately 5 work hours per airplane to accomplish the required actions, and that the average labor rate is $65 per work hour. Required parts will be provided to the operators at no cost. Based on these figures, the cost impact of the AD on U.S. operators of Model A330 series airplanes is estimated to be $2,925, or $325 per airplane.

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.

Currently, there are no Airbus Model A340 series airplanes on the U.S. Register. However, should an affected airplane be imported and placed on the U.S. Register in the future, it will require approximately 5 work hours to accomplish the required actions, at an average labor rate of $65 per work hour. Required parts will be provided to the operators at no cost. Based on these figures, the cost impact of this AD for Model A340 operators will be $325 per airplane.

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.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation Regulations (FAR). The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, and 8260-5. Materials incorporated by reference are available for examination or purchase as stated above.

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

This amendment to part 97 is effective upon publication of each separate SIAP as contained in the transmittal. Some SIAP amendment may have been previously issued by the FAA in a National Flight Data Center (NFDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP amendments may required making them effective in less than 30 days. For the remaining SIAPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs, the TERPS criteria were applied to the condition existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

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

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

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

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes SIAPs. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained in the content of the following FDC/P NOTAMs for each SIAP. The SIAP information in some previously designated FDC/Temporary (FDC/T) NOTAMs is of such duration as to be permanent. With conversion to FDC/P NOTAMs, the respective FDC/T NOTAMs have been canceled.

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

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

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

Until October, 1991 the U.S. Parole Commission carried out its responsibilities through Regional Commissioners and staff located in five regional offices across the country, and National Commissioners and staff located in its headquarters office in Chevy Chase, Maryland. Over the next five years the Commission gradually consolidated its operations into the headquarters office in Maryland as the agency faced the prospect of a reduced caseload of Federal prisoners and parolees due to laws that abolished parole for Federal offenders and limited the life of the Commission. The Commission made some changes in its voting procedures as the agency reduced its size (see 61 FR 55742 (Oct. 29, 1996)). But some procedures that were deemed necessary when regional offices existed were left in place though the rationale for the procedures was diminished. The voting and notice procedures that the Commission is eliminating through this publication fall into this category. The voting procedures, found at 28 CFR 2.24(b)(1) and (2) and 2.28(a)(1), allow a Regional Commissioner to make a modest modification (either an increase or a decrease) to a recommended or established release date without securing the concurring vote of a National Commissioner. Section 2.24(a) also includes a requirement that the prisoner be given notice when his case is transferred by the Regional Commissioner to the National Commissioners for a further vote due to the Regional Commissioner's significant disagreement with the recommendation of an examiner panel. The voting procedures were created as a response to the Regional Commissioners' desire for greater flexibility in decision-making and to avoid the process of securing National Commissioner votes (including shipping case files across the country) when there was only a modest disagreement on a release date. The notice requirement was implemented to ensure that the prisoner was informed of the reason the Commission would not be able to meet the normal 21-day time limit for making a release decision when the case was referred to the National Commissioners. The rationales described above do not have the same force now that the Commissioners are all located in one office in Chevy Chase, Maryland, and case files do not have to be transferred across the country for Commissioner votes. In recent years the Commission has very rarely used the voting procedures of §§ 2.24(b)(1) and (2). The revised rules eliminate the requirement regarding notice of a referral for subsequent voting and provide that the concurrence of two Commissioners is needed to make a decision when the Regional Commissioner disagrees with the examiner panel on the disposition of the case, or when the Regional Commissioner votes to reopen a case under § 2.28(a) and advance a presumptive release date.

Another rule amendment that the Commission is making to correspond to a change in its structure is the amendment to § 2.17. The Commission is amending the procedural rule regarding the voting quorum in original jurisdiction cases to reflect an increase in the agency's authorized membership, and the possibility that the number of Commissioners may change from the present number now holding office (three Commissioners). In section 11231(c) of the National Capital Revitalization and Self-Government Improvement Act of 1997, Pub. L. 105-33, Congress increased the number of persons authorized to serve on the Parole Commission to five, in conjunction with giving the Commission new responsibilities regarding District of Columbia felony offenders. In original jurisdiction cases the Commission's intent is that all decisions, whether made after a hearing or after reviewing a petition for reconsideration, are made by a majority vote of the Commission. The voting requirements in the present rules for original jurisdiction cases are based on a three-member Commission. Therefore, the Commission is changing the original jurisdiction voting requirements to provide that a decision is made on the basis of a majority vote of the Commissioners holding office at the time of the decision.

There are also several procedural rules governing hearing procedures for District of Columbia offenders that have been rendered obsolete by a change in circumstances unrelated to the structure of the Commission. When the Parole Commission took over the task of conducting parole hearings for DC offenders in 1998, as provided by the Revitalization Act, these offenders were incarcerated in correctional facilities of the DC Department of Corrections and the Federal Bureau of Prisons. Because of security and staffing concerns regarding the implementation of parole hearing procedures in DC facilities, the Commission's rules allowed the opportunity for the appearance of a representative and pre-hearing file disclosure for offenders in Bureau custody, but limited or denied these opportunities for offenders in DC custody. Section 11201 of the Revitalization Act required that all DC felony offenders had to be transferred to the custody of the Bureau of Prisons, and this transfer was accomplished by the end of 2001. This transfer has removed the need for different procedures for DC prisoners depending on the identity of the incarcerating authority. Therefore, the Commission is amending the rule at § 2.72 on hearing procedures for DC offenders to remove the difference in procedures regarding the opportunity for representation and pre-hearing file disclosure.

The Commission is amending the rule at 28 CFR 2.14 to provide that, for a prisoner who has had his initial hearing prior to the parole eligibility date and who must continue to serve the minimum term of his sentence before reaching parole eligibility, such a prisoner has the opportunity for an interim hearing nine months prior to the parole eligibility date. This amendment simplifies the Commission's present rule and ensures that such a prisoner is afforded the chance for an advancement of a presumptive release date to a parole effective date that coincides with the parole eligibility date, if the prisoner shows superior program achievement or other clearly exceptional circumstances that warrant a change in the previous decision.

The Commission is revising the rule at 28 CFR 2.49 to insert instructions on determining the type of revocation hearing that must be held when a Federal parolee has an unadjudicated violation charge that may be determinative of revocation and/or reparole, and the parolee wants an adverse witness present at the hearing for confrontation and cross-examination on the contested charge. These instructions are presently found in the rules regarding revocation proceedings for DC parolees and supervised releasees, and the addition of the instructions in § 2.49 (with other editorial changes in § 2.49 and § 2.102) ensures that there is consistency in the application of agency policy on the place of a revocation hearing for all offenders under the Commission's jurisdiction.

The Commission is also making a number of corrections to the rules. In reviewing the rules on agency action following a hearing, the Commission discovered that a provision in § 2.13(c) on issuing the notice of the Commission's decision within 21 days of the hearing had been erroneously eliminated as a result of an amendment to § 2.13 promulgated in 1994. The Commission is correcting this error by restoring the notice provision, with an amendment conforming to the elimination of the requirement regarding notice of a referral to the National Commissioners. The Commission is also restoring part of an instruction regarding the scoring of Item A of the salient factor score, a component of the paroling policy guidelines (28 CFR 2.20). This part of the instruction on counting a prior instance of criminal conduct when the offender's case was diverted from a final criminal conviction was erroneously omitted when the Commission revised the salient factor scoring manual in November, 2002. Other obvious errors in the paroling policy guidelines that have been corrected are the omission of a reference to conduct causing “serious bodily injury” in the rating of property destruction offenses, the insertion of an instruction for rating a kidnaping offense in the instructions for rating an assault offense, and the repetition of an instruction in a general note on holding an offender accountable for the criminal acts of his co-conspirators.

Finally, the Commission is making editorial changes to a number of rules in order to use up-to-date terms ( e.g. , substituting “Executive Hearing Examiner” for “administrative hearing examiner” or “community corrections center” for “community treatment center”). As a result of a recodification of the District of Columbia Code, almost all the citations to the DC Code in the present rules are to statutes that have been renumbered. The new rules provide citations to the revised statutes. The Commission is also amending the rule for offenders sentenced under the DC Youth Rehabilitation Act to clarify the group of youth offenders who are eligible for parole given the delayed enactment of the DC Sentencing Reform Emergency Amendment Act of 2000.

These final rules will be applied to all cases as of the effective date of the rules.

The U.S. Parole Commission has determined that this final rule does not constitute a significant rule within the meaning of Executive Order 12866. The final rule will not have a significant economic impact upon a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 605(b), and is deemed by the Commission to be a rule of agency practice that does not substantially affect the rights or obligations of non-agency parties pursuant to section 804(3)(c) of the Congressional Review Act.

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

A temporary safety zone is necessary to ensure the safety of participants and spectators from the hazards associated with an air and water show. All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on scene patrol personnel. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Chicago or his designated on scene representative. The Captain of the Port Chicago's designated on scene representative will be the Patrol Commander. The Captain of the Port or his designated on scene representative may be contacted via VHF Channel 16.

The safety zone will encompass all waters and adjacent shoreline of Lake Michigan bounded by the arc of a circle with a radius of 5 nautical miles with its center in approximate position 41°37′25″ N, 087°15′42″ W (off of Miller Beach Ogden Dunes). These coordinates are based upon North American Datum 1983 (NAD 1983).

This temporary rule is not a significant regulatory action under section 3(f) of Executive Order 12866 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 proposal to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

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

The Coast Guard certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601-612) that this temporary final rule will not have a significant economic impact on a substantial number of small entities.

In accordance with Section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), the Coast Guard offered to assist small entities in understanding this rule so that they can better evaluate its effectiveness and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions, call 1-888-REG-FAIR (1-888-734-3247).

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

The Coast Guard has analyzed this rule under Executive Order 13132, Federalism, and has determined that this rule does not have implications under that Order.

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 this preamble.

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

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

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

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

We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.lC, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

This final rule adjusts our fees in accordance with the applicable provisions of title 35, United States Code, as amended by the Consolidated Appropriations Act, Fiscal Year 2000 (which incorporated the Intellectual Property and Communications Omnibus Reform Act of 1999) (Pub. L. 106-113). This final rule also adjusts, by a corresponding amount, a few patent fees (37 CFR 1.17(e), (r), (s), and (t)) that track statutory fees (either 37 CFR 1.16(a) or 1.17(m)).

Legislation has been introduced in the Congress that would alter our fees. Customers should be aware that legislative changes to our fees would supersede this final rule. If such changes occur, we will make corresponding rule changes by publication in the Federal Register . Customers may wish to refer to our official website at www.uspto.gov for the most current fee amounts. Official notices of any fee changes will appear in the Federal Register and the Official Gazette of the United States Patent and Trademark Office.

A proposed rule notice was published at 68 FR 23092 on April 30, 2003, which requested comments by May 30, 2003. No comments were received.

Patent fees are authorized by 35 U.S.C. 41, 119, 120, 132(b) and 376. For fees paid under 35 U.S.C. 41(a) and (b) and 132(b), independent inventors, small business concerns, and nonprofit organizations who meet the requirements of 35 U.S.C. 41(h)(1) are entitled to a fifty-percent reduction.

Section 41(f) of title 35, United States Code, provides that fees established under 35 U.S.C. 41(a) and (b) may be adjusted on October 1, 1992, and every year thereafter, to reflect fluctuations in the CPI over the previous twelve months.

Section 41(d) of title 35, United States Code, authorizes the Director to establish fees for all other processing, services, or materials related to patents to recover the average cost of providing these services or materials, except for the fees for recording a document affecting title, for each photocopy, for each black and white copy of a patent, and for standard library service.

Section 41(g) of title 35, United States Code, provides that new fee amounts established by the Director under section 41 may take effect thirty days after notice in the Federal Register and the Official Gazette of the United States Patent and Trademark Office.

The patent statutory fees established by 35 U.S.C. 41(a) and (b) will be adjusted on October 1, 2003, to reflect fluctuations occurring during the twelve-month period from October 1, 2002, through September 30, 2003, in the Consumer Price Index for All Urban Consumers (CPI-U). The Office of Management and Budget has advised us that in calculating these fluctuations, we should use CPI-U data as determined by the Secretary of Labor. In accordance with previous fee-setting methodology, we base this fee adjustment on the Administration's projected CPI-U for the twelve-month period ending September 30, 2003, which is 2.08 percent. Based on this projected CPI-U, patent statutory fees will be adjusted by 2.08 percent.

Certain patent processing fees established under 35 U.S.C. 41(d), 119, 120, 132(b), 376, and Public Law 103-465 (the Uruguay Round Agreements Act) will be adjusted to reflect fluctuations in the CPI.

The fee amounts were rounded by applying standard arithmetic rules so that the amounts rounded will be convenient to the user. Fees for other than a small entity of $100 or more were rounded to the nearest $10. Fees of less than $100 were rounded to an even number so that any comparable small entity fee will be a whole number.

Any fee amount that is paid on or after the effective date of the fee adjustment will be subject to the new fees then in effect. The amount of the fee to be paid will be determined by the time of filing. The time of filing will be determined either according to the date of receipt in our office or the date reflected on a proper Certificate of Mailing or Transmission, where such a certificate is authorized under 37 CFR 1.8. Use of a Certificate of Mailing or Transmission is not authorized for items that are specifically excluded from the provisions of § 1.8. Items for which a Certificate of Mailing or Transmission under § 1.8 are not authorized include, for example, filing of Continued Prosecution Applications (CPAs) under § 1.53(d) and other national and international applications for patents. See 37 CFR 1.8(a)(2).

Patent-related correspondence delivered by the “Express Mail Post Office to Addressee” service of the United States Postal Service (USPS) is considered filed or received in our office on the date of deposit with the USPS. See 37 CFR 1.10(a)(1). The date of deposit with the USPS is shown by the “date-in” on the “Express Mail” mailing label or other official USPS notation.

To ensure clarity in the implementation of the new fees, a discussion of specific sections is set forth below.

Section 1.16, paragraphs (a), (b), (d), and (f) through (i), are revised to adjust fees established therein to reflect fluctuations in the CPI.

Section 1.17, paragraphs (a)(2) through (a)(5), (b) through (e), (m), and (r) through (t), are revised to adjust fees established therein to reflect fluctuations in the CPI.

Section 1.18, paragraphs (a) through (c), are revised to adjust fees established therein to reflect fluctuations in the CPI.

Section 1.20, paragraphs (e) through (g), are revised to adjust fees established therein to reflect fluctuations in the CPI.

Section 1.492, paragraphs (a)(1) through (a)(3), (a)(5), (b), and (d), are revised to adjust fees established therein to reflect fluctuations in the CPI.

This final rule contains no information collection requirements within the meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. This final rule has been determined to be not significant for purposes of Executive Order 12866. This final rule does not contain policies with Federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (August 4, 1999).

The Deputy General Counsel for General Law of the United States Patent and Trademark Office has certified to the Chief Counsel for Advocacy, Small Business Administration, that the final rule change will not have a significant economic impact on a substantial number of small entities (Regulatory Flexibility Act, 5 U.S.C. 605(b)). The final rule change increases fees to reflect the change in the CPI as authorized by 35 U.S.C. 41(f). Further, the principal impact of the major patent fees has already been taken into account in 35 U.S.C. 41(h)(1), which provides small entities with a fifty-percent reduction in the major patent fees. We received roughly 111,000 patent applications (approximately 33 percent of total patent applications) last year from small entities. Since the average small entity fee will increase by less than $10, with a minimum increase of $1 and a maximum increase of $35, there will not be a significant economic impact on a substantial number of small entities due to this final rule change.

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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-2003-0138. The official public docket is intended to serve as a repository for materials (i.e.,documents and other information) submitted to the Agency in connection with this action and/or relied upon by the Agency in taking 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 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. To the extent that a particular document is not located in the official public docket, consult the person listed under FOR FURTHER INFORMATION CONTACT.

The legacy docket for this case is OPP-2003-0020, which was set up in connection with the Notice of Filing of this pesticide petition, 8E5001. It contains the Federal Register Notice dated February 14, 2003, (68 FR 7554), which was published to announce this petition, other relevant Federal Register documents associated with the exemption from temporary tolerance which preceded this permanent exemption from tolerance, and comments received in response to the publication of this petition.

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. 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. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of February 14, 2003 (68 FR 7554) (FRL-7289-9), 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 8E5001) by Interregional Research Project Number 4 (IR-4), New Jersey Agricultural Experiment Station, Technology Center of New Jersey, 681 U. S. Highway #1 South, North Brunswick, NJ 08902-3390, on behalf of the Arizona Cotton Research and Protection Council, 3721 East Wier Avenue, Phoenix, AZ 85040-2933. This notice included a summary of the petition prepared by the petitioner, IR-4, on behalf of the Arizona Cotton Research and Protection Council. In response to the notice of filing of this petition, comments in favor of the use of the pesticide were received from cotton growers, processors and ginners, mainly from Arizona and Texas.

The petition requested that 40 CFR 180.1206 be amended by establishing an exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on cotton and its food/feed commodities.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement of 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.

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.

Aspergillus flavus AF36 (also referred to as AF36) is a non-aflatoxin-producing or atoxigenic strain of Aspergillus flavus , whose species are ubiquitous around the world. Some members of the genus Aspergillus produce mycotoxins, such as aflatoxin, a potent carcinogen produced by toxigenic strains of A. flavus . Other members of the genus Aspergillus have been domesticated for commercial use, such as Aspergillus niger for production of enzymes (e.g., alpha-galactosidase found in beano, a dietary supplement) and Aspergillus oryzae for production of soy sauce. The subject strain of this final rule, Aspergillus flavus AF36, is characterized as an atoxigenic strain by its lack of production of aflatoxin. It is not vegetatively compatible with the toxigenic strains of A. flavus , a feature which limits cross-over potential to, and, thus, further proliferation of, the toxigenic strains. Starter cultures, selected on the basis of the vegetative incompatibility with aflatoxin-producing strains, are to be monitored by standard thin layer chromatography (TLC) procedures, and visualization via scanning fluorescence densitometry scanning [Master Record Identification Number (MRID) 44626101; BPPD Data Evaluation Report of Analysis of Samples, dated March 29, 1999 (hereinafter referred to as “BPPD review - March 29, 1999”); BPPD Review of Supplementary Information dated May 14, 1999 (hereinafter referred to as “BPPD review - May 14, 1999”)]. In this manner, the applicant proposes to maintain batches free of aflatoxin contamination during production. Batches contaminated with aflatoxin, or human pathogens, or unintentional ingredients above regulatory levels are to be destroyed. Thus, use of AF36 is not likely to add to the environmental burden of the aflatoxin-producing strains of A. flavus .

The pesticide is proposed for a single prebloom application once a year to cotton fields to displace the aflatoxin-producing strains of Aspergillus flavus from cotton. Sterilized wheat seeds, colonized with Aspergillus flavus AF36, are to be applied at 10 lb of end-use product (EP) (equivalent to the low rate of less than 0.01 lb active ingredient (ai) per acre). Within 3 days of application of the pesticide, the fields are furrow irrigated to promote germination of AF36, which apparently colonizes the cotton crop and soil, before the aflatoxin-producing strains of A. flavus proliferate. This competitive exclusion of the aflatoxin-producing strains does not increase the total Aspergillus population in the environment above background levels as demonstrated in soil and air monitoring studies. [MRIDs 45307201, 45307202; BPPD Review of Soil and Air Monitoring Studies and Product Performance Testing (Efficacy), dated May 15, 2003 (hereinafter referred to as “BPPD Review - May 15, 2003”)]. The displacement of the toxigenic strain of Aspergillus flavus by AF36 may reduce aflatoxin contamination of cotton seed.

The toxicology and pathogenicity data generated by the petitioner in support of this tolerance exemption, and reviewed by the Agency, are summarized below. The following discussion of the evaluations of the submitted studies and information indicates that exposure to the pesticide is not likely to be greater than that which occurs normally to other ubiquitous A. flavus strains. Submitted data also indicate no toxicity or infectivity of AF36 in test mammalian systems. More detailed analyses of these studies can be found in the specific Agency reviews of the studies that are cited below.

1. Acute oral toxicity/pathogenicity (OPPTS Harmonized Guideline 885.3050; MRID 43972403) . Agency evaluation of submitted acute oral study indicates no toxicity/infectivity effects of the pesticide. Five male, and five female Sprague Dawley rats were treated orally with the microbial pesticide (500 milligrams/milliliter (mg/mL) or 6.3 x 10 3 cfu/mL) by gavage. No clinical signs or abnormalities were noted during the study, and the pesticide was considered to be neither toxic nor infective following oral administration of a single dose. The acute oral test resulted in a Toxicity Category IV classification with a lethal dose (LD) 50 greater than 5,000 milligrams/kilogram (mg/kg) body weight [MRID 43972403; BPPD Data Evaluation Report, Acute Oral Toxicity Study in Rats, dated April 23, 1996 (hereinafter referred to as “BPPD Review - April 23, 1996”)].

2. Acute pulmonary toxicity/pathogenicity (OPPTS Harmonized Guideline 885.3150; MRID 45798201). The Agency required an intratracheal pulmonary infectivity/pathogenicity study. This test involves intratracheal instillation of the test material and post mortem examination of lungs and other organs for clearance.

Three studies were submitted in support of the mammalian acute infectivity/pathogenicity pulmonary guideline: A range finding study and two complete acute pulmonary studies. The dose-range study concluded that 10 8 cfu/rat would be a suitable test dose level for the acute pulmonary studies [MRID 45739101; BPPD Data Evaluation Report, dated April 02, 2003a (hereinafter referred to as “BPPD Review - April 02, 2003a”)]. In the first acute pulmonary study, conducted with Tween 80 as a surfactant in the test material, 26 male and 26 female Sprague Dawley rats (approximately 8 to 10 weeks old) each were dosed with a single intratracheal dose of 1.2 mL/kg at 5.30 x 10 8 cfu/mL (or 1.28 to 1.63 x 10 8 cfu/animal). Results from this study indicated that the test organism was neither infective nor pathogenic, in spite of rat mortality, which is believed to have been due to a severe acute inflammatory response to the Tween 80 [MRID 45798101; BPPD Data Evaluation Report, dated April 02, 2003a (hereinafter referred to as “BPPD Review - April 02, 2003b”)].

In the second acute pulmonary study, which was a repetition of the first acute pulmonary test, but was conducted without Tween 80, 25 male and 25 female Sprague Dawley rats (approximately 8 to 10 weeks old) each received a single intratracheal dose of approximately 1.2 mL/kg. Mortality of 4 rats by day 2 appeared to be attributable to an initial dosing effect. The rest of the test animals showed an initial response, followed by a rapid recovery indicating no toxicity. Although some surviving rats lost weight intermittently, all surviving rats gained weight prior to scheduled sacrifice. No clinical signs that were considered to be due to the test organism were observed in the test rats. Organs were examined post mortem as previously described. Aspergillus flavus AF36 was detected in the lungs with clearance by day 8 after dosing. No test organisms were detected in any samples from the shelf control or inactivated test organism treated rats. Based on the presented/submitted data, including the clearance data, the test organism, Aspergillus flavus AF36, was considered not toxic, infective, or pathogenic to the rat pulmonary system. The study is acceptable.

3. Acute inhalation (OPPTS Harmonized Guideline 152-32). The inert is sterilized wheat seeds, comprising approximately 99% of this pesticidal product. It acts as a matrix and nutrient source for the germinating AF36. Because this constitutes the majority of the pesticide and does not contain respirable particles of less than 10 microns, an inhalation study was not required pursuant to 40 CFR 158.740(c). In addition, based on the results obtained through the acute pulmonary toxicity/pathogenicity studies summarized immediately above, AF36 is considered not toxic, infective, or pathogenic to the rat pulmonary system. On the basis of this study and the nature of the inert ingredients present, the pesticide was considered Toxicity Category III for acute inhalation effects. [MRID 45798201; BPPD Data Evaluation Report, dated April 02, 2003c (hereinafter referred to as “BPPD Review - April 02, 2003c”)].

4. Hypersensitivity incidents (OPPTS Harmonized Guideline 152-37; MRID 45739104). The registrant submitted information (MRID 45739104) to demonstrate the lack of hypersensitivity to workers who have been exposed during the manufacture, application, and use of the pesticide in the research and experimental phases. No adverse hypersensitivity reaction to AF36 was recorded or reported by a state council or six companies during use for 3 or 6 years [MRID 45739104; BPPD Data Evaluation Report, dated April 02, 2003d (hereinafter referred to as “BPPD Review - April 02, 2003d”)]. However, to comply with the Agency's requirements under section 6(a)(2), any incident of hypersensitivity associated with the use of this pesticide must be reported to the Agency.

5. Data waivers. Data waivers were requested for the following studies:

i. Acute dermal toxicity/pathogenicity (OPPTS Harmonized Guideline 885.3100)

ii. Primary dermal irritation (OPPTS Harmonized Guideline 870.2500)

iii. Primary eye irritation (OPPTS Harmonized Guideline 870.2400)

iv. Intravenous, intracerebral, intraperitoneal injection (OPPTS Harmonized Guideline 885.3200)

v. Hypersensitivity study (40 CFR 152-36)

vi. Immune response (40 CFR 152-38)

With regards to the dermal and eye irritation guideline tests, it was impractical to apply the end-use product, sterilized wheat seeds inoculated with Aspergillus flavus AF36, as test material. Furthermore, non-occupational dermal and eye exposures, or exposures via any of the routes in Unit III.5.i.—vi., are not likely to be above naturally-occurring background levels for the following reasons.

First, Aspergillus flavus , a saprophytic fungus, is a normal constituent of the microflora in air and soil. The naturally occurring soil and plant colonizer is also found on living and dead plant material throughout the world. Aflatoxin-producing strains of Aspergillus flavus are particularly prominent in hot, dry climates supplemented with irrigation and are ubiquitous components of the natural Arizona desert ecosystem. Quantities of A. flavus typically increase during crop production and the fungus occurs widely on crop debris left in the soil. Shortly after application, AF36 germinates, apparently displaces the aflatoxin-producing strains from cotton and the soil, and spore levels return to normal background, without increase of total A. flavus . This was demonstrated in soil and air monitoring studies submitted over multiple years of experimental usage [BPPD Review - May 15, 2003]. Thus exposures to AF36 are not likely to increase above those normally associated with the naturally occurring A. flavus background levels.

Second, the application rate is low, being less than 0.01 lb active ingredient per acre, and agricultural sites are treated, thus minimizing non-occupational and residential exposure. The proposed label rate is less than 0.01 pound of active ingredient in 10 pounds end-use product, or approximately 1.34 x 10 7 colony forming units (cfu) per acre.

Finally, drift is not expected during application based on the large granular nature of the pesticide (i.e., sterilized inoculated wheat seeds). In addition, only one prebloom application is made, and cultivation is not recommended after application. Thus, once again, the potential for non-occupational dermal and residential exposure is unlikely.

The acute oral toxicological study demonstrated an LD 50 of greater than 5,000 mg/kg with no toxicity/infectivity effects, and demonstrable clearance from organs examined post mortem [MRID 43972403; BPPD Review - April 23, 1996]. This rationale supported the request to waive the acute intraperitoneal study.

A hypersensitivity study was waived since hypersensitivity incidents were not reported from maximally exposed workers and researchers during the research and experimental phases associated with the use of the active ingredient, A. flavus AF36 [BPPD Review - April 02, 2003d]. Nevertheless, reports of hypersensitivity incidents associated with the use of the pesticide are still required to comply with FIFRA section 6(a)(2) requirements.

Submitted toxicity/pathogenicity studies in the rodent (required for microbial pesticides) also indicate that following oral and pulmonary routes of exposure [BPPD Review - April 23, 1996; BPPD Review - April 02, 2003c], the immune system is still intact and able to process and clear the active ingredient. Thus, the request to waive the immune response study was granted.

On the basis of the foregoing rationales, and there being no documented problems associated with the non-aflatoxin producing strain, Aspergillus flavus AF36, data waivers for the studies listed in Unit III.5.i.—vi., were granted to the applicant for the proposed use of Aspergillus flavus AF36 on cotton.

6. Subchronic, chronic toxicity and oncogenicity, and residue. Based on the data generated in accordance with the Tier I data requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III data requirements were not triggered and, therefore, not required in connection with this action. In addition, because the Tier II and Tier III data requirements were not required, the residue data requirements set forth in 40 CFR 158.740(b) also were not required.

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).

There is a potential for aggregate exposure of adult humans, infants and children to the microbe because of the ubiquitous distribution of Aspergillus fungal strains in the environment. The Agency has considered the incremental exposure and risk associated with the proposed application of this strain of Aspergillus flavus , AF36, as summarized below, and concludes that use of AF36 is not likely to add an incremental risk above that posed by the normal exposure of adults, infants and children to Aspergillus flavus strains present in the environment. In fact, use of the pesticide, AF36, may decrease potential environmental aflatoxin exposure to exposed populations.

1. Food . Based on submitted studies, the end-use product, Aspergillus flavus AF36, demonstrates low acute oral toxicity category IV potential [BPPD Review - April 23, 1996]. No toxicity endpoints were indicated to justify setting a numerical tolerance for the fungal active ingredient, Aspergillus flavus AF36. An LD 50 greater than 5,000 mg/kg body weight, in the acute oral studies discussed above, indicates that consumption of food commodities treated with AF36 poses no incremental risk via dietary exposure. Indeed, the submitted data indicate no toxicity or infectivity of AF36 in the acute oral test mammalian systems.

Cotton itself is not a food commodity. Residues of A. flavus AF36, the microbial active ingredient, are not likely to survive the heating and pressure associated with the processing of cottonseed into cottonseed meal. Moreover, A. flavus AF36 will not separate into the edible fraction, cotton seed oil. Thus, potential transfer of residues of A. flavus AF36 to edible cotton food/feed commodities is not expected. Consequently, human dietary exposure to A. flavus AF36 via cottonseed oil, or by secondary transfer of A. flavus AF36 residues to meat and milk via cottonseed meal, is not expected. Therefore, the Agency has determined that dietary exposure to A. flavus AF36 is not likely to result in any undue health effects and risk.

While the Agency has concluded that AF36 is not likely to add to the dietary burden, any potential contribution by AF36 to aflatoxin contamination was also considered, for a conservative estimate of the health effects of this pesticide. This is because aflatoxin is considered a public health hazard (see Unit VII.D.) and AF36 is proposed as a biocontrol agent for aflatoxin-producing strains of A. flavus . Even if AF36 does not control aflatoxin levels in the treated cotton food/feed commodities, a safety net exists in the screening of cotton and its by-products for aflatoxin prior to their introduction into the channels of commerce. For instance, FDA does not allow cotton seed products containing aflatoxin above 20 parts per billion (ppb) to be used in dairy rations or above 300 ppb to be used for feeding beef cattle. As previously stated, the registrant claims that quality control and selection procedures will not allow aflatoxin production in the starter cultures for pesticide manufacture [BPPD review - March 29, 1999; BPPD review - May 14, 1999]. Any batches with aflatoxin are to be destroyed. For these reasons, the Agency has determined that use of AF36 will not add to the dietary burden of aflatoxin, but is rather more likely to ameliorate aflatoxin levels in treated cotton food/feed commodities. Therefore, dietary exposure to aflatoxin, as a result of AF36 use, is not likely to be greater, and may even be less, than that which currently exists.

2. Drinking water exposure . Exposure to AF36 via drinking water is not likely to be greater than current/existing exposures to A. flavus strains. Potential risks via exposure to drinking water or runoff are adequately mitigated by, among other things, percolation through soil. Thus, exposure via drinking water from the proposed use of this non-aflatoxin-producing strain of Aspergillus flavus is not likely to pose any incremental risk to adult humans, infants and children. In fact, displacement of the toxigenic strains of A. flavus by AF36 may decrease exposure and risk to the toxigenic strains of A. flavus in the environment.

1. Dermal exposure . The potential for non-occupational dermal exposure to AF36 is unlikely because the potential use sites, are commercial and agricultural, and because of the granular nature of the pesticide, which minimizes spray drift. As discussed earlier (see Unit III.), lack of hypersensitivity incidents, low application rates, and return of levels of Aspergillus flavus to background shortly after germination, poses minimal risk to populations via dermal, non-occupational exposure. Thus, dermal non-occupational exposure to the non-aflatoxin strain is not likely to be greater than the existing exposure to A. flavus at current levels.

2. Inhalation exposure . For the reasons stated immediately above, non-occupational inhalation exposure to AF36 is not expected to be greater than that which currently exists for A. flavus strains.

Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to consider the cumulative effect of exposure to Aspergillus flavus AF36 and to other substances that have a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. Aspergillus flavus AF36 does not appear to be toxic or pathogenic to humans. There is no indication that the fungus A. flavus AF36 shares any common mechanisms of toxicity with other registered pesticides. In addition, there are no other registered pesticide products containing Aspergillus flavus AF36, and other A. flavus strains abound naturally in the environment. Moreover, the displacement of the toxigenic strain of A. flavus by AF36 may reduce aflatoxin contamination of cottonseed. Based on the low toxicity potential of AF36, the fact that it is non-aflatoxigenic, and the safety net already in place to monitor for aflatoxin, no cumulative or incremental effect is expected from the use of AF36 on cotton.

There is reasonable certainty that no harm will result from aggregate exposures to residues of A. flavus AF36, in its use as an antifungal agent, to the U. S. population, including infants and children. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed previously, there appears to be no potential for harm, from this fungus in its use as an antifungal agent via dietary exposure since the organism is non-toxic and non-pathogenic to animals and humans. The Agency has arrived at this conclusion based on the very low levels of mammalian toxicity for acute oral and pulmonary effects with no toxicity or infectivity at the doses tested (see Unit III above). Moreover, non-occupational inhalation or dermal exposure is not expected above background levels (see Unit V).

FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional ten-fold margin of exposure (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 exposure (safety) will be safe for infants and children. Margins of exposure (safety) are often referred to as uncertainty (safety) factors. In this instance, based on all the available information, the Agency concludes that the fungus, A. flavus AF36, is non-toxic to mammals, including infants and children. Because there are no threshold effects of concern to infants, children and adults when A. flavus AF36 is used as labeled, the provision requiring an additional margin of safety does not apply. As a result, EPA has not used a margin of exposure (safety) approach to assess the safety of A. flavus AF36.

EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen-and thyroid systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority, to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

The Agency is not requiring information on the endocrine effects of this active ingredient, Aspergillus flavus AF36, at this time. The Agency has considered, among other relevant factors, available information concerning whether the microorganism may have an effect in humans similar to an effect produced by a naturally occurring estrogen or other endocrine effects. There is no known metabolite that acts as an “endocrine disrupter” produced by this microorganism. The submitted toxicity/infectivity or pathogenicity studies in the rodent (required for microbial pesticides) indicate that, following oral and pulmonary routes of exposure, the immune system is still intact and able to process and clear the active ingredient (see Unit III.). In addition, based on the low potential exposure level associated with the proposed single, seasonal, prebloom application of the pesticide, the Agency expects no adverse effects to the endocrine or immune systems.

The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation. Accordingly, the Agency has concluded that for an exemption from tolerance, analytical methods are not needed for enforcement purposes for residues of Aspergillus flavus AF36 on treated cotton. Nonetheless, and for purposes of clarification, analytical methods are still required for product characterization, quality control, and quality assurance for manufacturing purposes [BPPD review - March 29, 1999; BPPD review - May 14, 1999]. Vegetative compatibility tests are used to screen starter cultures to identify the non-aflatoxin-producing Aspergillus flavus AF36 strain. Starter cultures of AF36 are also selected on the basis of the lack of aflatoxin as monitored by standard thin layer chromatography (tlc) procedures and visualization via scanning fluorescence densitometry scanning. Other appropriate methods are required for quality control to assure product characterization, the control of human pathogens and other unintentional metabolites or ingredients within regulatory limits, and to ascertain storage stability and viability of the pesticidal active ingredient.

There is no Codex maximum residue level for residues of Aspergillus flavus AF36.

PR Notice 2002-1 lists aflatoxin as a public health hazard, for which product performance or efficacy data are required according to 40 CFR 158.202(i). To demonstrate that this pesticide may reduce aflatoxin-producing strains and does not increase A. flavus populations above background levels, the applicant provided product performance or efficacy data from multiple years of soil and air monitoring studies.

Aflatoxin, one of the most potent human carcinogens, is the metabolite of concern produced by the target pest, aflatoxin-producing strains of Aspergillus flavus . As such, the Agency considers aflatoxin a public health hazard. In the soils of cotton-producing areas of Arizona and south Texas, especially in the dry regions, the toxigenic strains are prominent. Few alternatives, if any, exist to displace aflatoxin-producing A. flavus strains from cotton and other crops. Decontamination of crops via ammoniation is costly, not available universally, and decreases the value of the crop. Other methods to reduce aflatoxin formation include manipulation of harvest date, costly irrigation practices, and different methods of harvesting and storage practices.

Efficacy data submitted to the Agency include monitoring of soil and air levels of the toxigenic and non-aflatoxin-producing strains of A. flavus AF36 in the field and on the crops. Results from the environmental expression and population monitoring studies, during the experimental program, demonstrate that a single seasonal application of AF36 on cotton fields may incite significant changes in the incidence of toxigenic A. flavus strains resident in the agroecosystem, without altering the overall quantity of A. flavus . Soil and air population counts of A. flavus from treated fields were associated with concomitant decreases in incidences of toxigenic A. flavus , for many of the treated areas [BPPD review - May 15, 2003]. Reducing the aflatoxin-producing populations of fungi, and the concomitant reduction of aflatoxin, a potent carcinogen, is in the public interest.

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-2003-0138 in the subject line on the first page of your submission. All objections and hearing requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 12, 2003.

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 IX.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-2003-0138, 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 from the tolerance requirement 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).