Brucellosis is a contagious disease caused by bacteria of the genus Brucella . The disease mainly affects cattle, bison, and swine, but goats, sheep, horses, and even humans are susceptible. In its principal animal hosts, it causes loss of young through spontaneous abortion or birth of weak offspring, reduced milk production, and infertility. There is no economically feasible treatment for brucellosis in livestock. In humans, brucellosis initially causes flu-like symptoms, but the disease may develop into a variety of chronic conditions, including arthritis. Humans can be treated for brucellosis with antibiotics.

The brucellosis regulations in 9 CFR part 78 (referred to below as the regulations) contain specific provisions for cattle, bison, and swine. Under the regulations, States, herds, and individual animals are classified according to their brucellosis status. Interstate movement requirements for animals are based upon the disease status of the individual animals or the herd or State from which the animal originates.

In an interim rule effective and published in the Federal Register on November 18, 2004 (69 FR 67501-67503, Docket No. 04-103-1), we amended § 78.43 of the regulations by adding Arkansas, Louisiana, and Michigan to the list of validated brucellosis-free States.

Comments on the interim rule were required to be received on or before January 18, 2005. We received one comment by that date, from a private citizen. The commenter stated that all interstate movement of swine should be banned and that if living conditions for swine were raised, swine would be more resistant to diseases such as brucellosis. The commenter further objected to the use of taxpayer funds for the brucellosis program and to the use of the term “depopulated.” As this comment has no bearing on the action taken in the interim rule ( i.e. , the addition of Arkansas, Louisiana, and Michigan to the list of validated swine brucellosis-free States), no changes to the interim rule are indicated.

Therefore, for the reasons given in the interim rule and in this document, we are adopting the interim rule as a final rule without change.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

The Committee has amended section 272.3(a) of its Rules of Procedure to allow members that cannot be present at a meeting in person to participate in the meeting by electronic means, such as by videoconference arrangements, as well as by telephone conference arrangements. The amendment should facilitate the ability of the Committee to act if unusual circumstances, such as a national emergency, prevent the Committee or any of its members from assembling in Washington, DC.

The Committee also has amended sections 272.3(d) and (e) of its Rules of Procedure to reflect the fact that (i) currently only a single Manager is selected to operate the System Open Market Account for the Committee; and (ii) under the Committee's new expedited procedure for the release of Committee minutes, the minutes of a Committee meeting typically will be approved prior to (rather than at) the Committee's next regularly scheduled meeting. In addition, the Committee has updated the references to its internet Web site and to the Federal Reserve Bulletin (which is now published on a quarterly basis) in its Rules Regarding Availability of Information.

Finally, the Committee has modified sections 272.3(b) and 272.4(c) of its Rules of Procedure and sections 271.8(a) and (b) of its Rules Regarding Availability of Information to make the rules gender-neutral. In addition, the Committee has authorized the Secretary of the Committee (with the concurrence of the Committee's General Counsel) to make other technical, non-substantive changes (such as correcting spelling errors or deleting obsolete provisions) to the Committee's rules, regulations and other actions in the future. This delegated authority, which is identical to the authority that the Secretary of the Board has to make technical changes to the Board's rules (12 CFR 265.5(a)(4)), is codified in a new section 272.4(d) of the Rules of Procedure.

In 1947, the Committee directed the Federal Reserve Banks to terminate, effective July 10, 1947, the policy of purchasing all Treasury bills offered to them at a fixed rate of 3/8 percent per annum and to terminate the repurchase option privilege on Treasury bills. This statement, which currently is codified at 12 CFR 281.1, is no longer relevant to the Committee's policies or operations and has been deleted.

The amendments to the Committee's Rules of Procedure and Statements of Policy relate solely to the Committee's internal procedure and practices or constitute general statements of policy. Accordingly, the public notice, public comment and delayed effective date provisions of the Administrative Procedure Act do not apply to these amendments. 1 Because the amendments to the Rules Regarding Availability of Information are technical in nature, the Committee has determined that good cause exists for making these amendments effective immediately, and that public notice and comment on these amendments are impracticable, unnecessary or contrary to the public interest. 2

The FAA proposed to amend 14 CFR part 39 with an AD for certain Boeing Model 707-100, -100B, -300, -300B (including -320B variant), -300C, and -E3A (military) series airplanes; Model 720 and 720B series airplanes; Model 737-100, -200, -200C, -300, -400, and -500 series airplanes; and Model 747 airplanes. That action, published in the Federal Register on August 4, 2004 (69 FR 47031), proposed to require repetitive tests of the overwing fuel fill ports for certain wing tanks; an electrical bonding resistance test between the bulkhead fittings of the engine fuel feed tube and the front spar inside the fuel tank of the wings; other specified actions; and applicable corrective actions if necessary.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments that have been submitted on the proposed AD.

Several commenters support the intent of the proposed AD.

One commenter has no objection to doing the one-time electrical bonding resistance test in paragraph (h) of the proposed AD within the proposed 5-year compliance time. However, the commenter believes there is little or no data to substantiate that the identified unsafe condition exists on Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, other than similar design. The commenter states that the notice of proposed rulemaking (NPRM) is driven by testing done in accordance with SFAR 88 requirements, and according to the NPRM, one Model 747 series airplane was used for the basis of the NPRM. In addition, the commenter states that there is no data to validate testing requirements, since no root-cause has been differentiated between installation problems during manufacture, bonding breakdown, or in-service degradation.

From this comment, we infer that the commenter is requesting that Model 737-100, -200, -200C, -300, -400, and -500 series airplanes be removed from the applicability of this AD. We do not agree. The commenter is correct that a lightning test on a 747 wing fuel tank penetration showed a higher than expected electrical current in the fuel feed tubes inside the fuel tank, and that no tests were conducted on a 737 wing fuel tank penetration. However, the design of the wing fuel tank is identical to that of some Model 707 series airplanes and all Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. Therefore, all these airplanes are subject to the identified unsafe condition. We do not find it necessary to change the final rule in this regard.

Several commenters request that the proposed AD be revised to extend the 5-year compliance time specified in paragraph (h) of the proposed AD. One commenter suggests extending the compliance time to 8 years. Three commenters suggest extending the compliance time to 6 years. One commenter notes that there have not been any reported cases of arcing occurring at the interface between the bulkhead fittings of the engine fuel feed tube and the front spar inside the fuel tank of the wings and between the overwing fuel fill ports and the airplane structure on any of the affected fleet. The same commenter also notes that some of the fleets have been in service over 30 years. Given those facts, that commenter believes an equivalent level of safety can be maintained over the 6-year compliance time. The commenters contend that extending the compliance time will allow affected operators to do the required test during a regularly scheduled maintenance interval while adoption of the proposed compliance time of within 5 years would require operators to schedule special times to do the test, at additional expense.

We do not agree with the request to extend the compliance time specified in paragraph (h) of the final rule. The commenters provide no technical justification for revising the compliance time. The manufacturer has done a risk assessment analysis related to lightning strikes on the Model 707, 737, and 747 fleets and determined that an acceptable level of safety would be provided by a compliance time of five years for accomplishing the actions in the service bulletins (specified as the appropriate source of service information for the final rule). We agree with the manufacturer's assessment. We have determined that the initial compliance time of within five years after the effective date of the AD, as specified in paragraph (h) of the final rule, is appropriate. We do not find it necessary to change the final rule in this regard. However, if anyone wishes to provide technical justification, they may request an approval of an alternative method of compliance (AMOC) from us, in accordance with paragraph (k) of the final rule.

Two commenters request that operator equivalent procedures (OEP) be allowed for draining and gaining access to the fuel tanks. One commenter states that it has established procedures for draining and accessing the fuel tank in accordance with 29 Code of Federal Regulations (CFR) part 1910.146, “Permit Required Confined Space Entry,” and has maintained personnel proficiency by using these procedures.

We agree that OEPs may be allowed for draining and gaining access to the fuel tanks provided those procedures are FAA-accepted procedures. The use of OEPs for draining and gaining access to the fuel tank does not directly affect the means of correcting the unsafe condition. The use of OEPs may also reduce the costs of implementing the AD. Therefore, we have added a new paragraph (j) to the final rule stating: “Operators may use their own FAA-accepted equivalent procedures for draining the fuel tanks and gaining access to the fuel tanks.” We also revised paragraphs (h) and (i) of the final rule by adding “except as provided by paragraph (j) of this AD” and we revised the paragraph numbering following paragraph (j) of the final rule.

One commenter requests to remove the requirement to identify the forward surface of the front spar with the service bulletin number or equivalent as specified in Figures 1 and 2, step 18, of Boeing Alert Service Bulletin 737-28A1174 (cited as an appropriate source of service information in the NPRM). The commenter believes there is no real benefit to this action and that it creates additional exterior markings that must be maintained. The commenter contends that tracking accomplishment of the service bulletin via aircraft records should be sufficient.

We agree with the request to remove the requirement to identify the front spar with the service bulletin number or equivalent. We have determined that it is not necessary to identify the front spar in order to show compliance with this AD, because operators are required to record compliance with ADs in their airplane records. Therefore, we have added a new paragraph (k) in the final rule to explain this difference from the service bulletin.

Two commenters request to revise the proposed AD to allow operators to use equivalent consumable parts instead of the parts specified in Boeing Alert Service Bulletin 737-28A1174. The commenters believe that this provision would reduce the number of AMOC requests.

We do not agree with the requests to allow the use of equivalent consumable parts. No technical justification was provided nor any specifics of what these “equivalent consumable parts” are. We do not find it necessary to change the final rule in this regard. However, if anyone wishes to provide technical justification, they may request an approval of an AMOC from us, in accordance with paragraph (k) of the final rule.

Two commenters requests that we ensure that required parts are available within the 5-year compliance time. No justification was provided.

We do not agree. Most parts for doing the required actions are standard materials, like emery paper, coatings, paints, sealant, etc. The airplane maintenance facilities should have a ready supply of those materials. We have determined that the lead time for obtaining the required parts will not exceed the 5-year compliance time, and that operators should have enough time to coordinate the purchasing of any part or material not on the shelves when they schedule the work associated with the requirements of this AD. Therefore, we do not find it necessary to change the final rule in this regard.

Boeing Alert Service Bulletin A3505, dated November 1, 2001, affects, among other airplane models, Model “707-320B” series airplanes, which are a variant of Model 707-300B series airplanes. This service bulletin does not affect other Model 707-300B series airplanes. Whereas, Boeing Service Bulletin 3513, dated November 6, 2003, affects, among other airplane models, Model “707-300B” series airplanes, including Model 707-320B variant. For clarification purposes, we have revised the final rule to refer to both models as Model “707-300B (-320 variant)” or “707-300B (including -320 variant),” as applicable.

We have revised the Cost Impact section of the final rule by adding the applicable service bulletin for the listed airplane models.

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

This AD will affect about 4,303 airplanes worldwide. The average labor rate per hour is $65. The following table provides the estimated costs for U.S. operators to comply with this AD.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

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

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

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

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

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

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

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

The FAA proposed to amend 14 CFR part 39 with an AD for certain Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. That action, published in the Federal Register on December 7, 2004 (69 FR 70571), proposed to require doing repetitive inspections for fractures and cracks of the links of the aileron power control unit (PCU); replacing any fractured/cracked link; and doing applicable related investigative and corrective actions, if necessary.

We provided the public the opportunity to participate in the development of this AD. We have considered the one comment that was submitted on the proposed AD. The commenter supports the proposed AD.

We have carefully reviewed the available data, including the comment that has been submitted, and determined that air safety and the public interest require adopting the AD as proposed.

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

This AD will affect about 697 airplanes of U.S. registry. The required inspection will take about 1 work hour per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $45,305, or $65 per airplane, per inspection cycle.

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

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

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

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

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

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

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

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

We have received a report indicating that all four cockpit flight panel displays went blank simultaneously during flight, then recovered without any flightcrew action after approximately 74 seconds, on a Gulfstream Model GV-SP series airplane. Two similar incidents occurred on the ground. An engineering investigation revealed a software problem on the Honeywell Primus Epic system, which can cause a temporary loss of data from the cockpit display units. Loss of the cockpit display units will result in a reduction of the flightcrew's situational awareness, and possible loss of control of the airplane. The engineering investigation also revealed noise interference on the avionics standard communication bus (ASCB), which is a part of the Honeywell Primus Epic system. Noise interference, if not corrected, can possibly interfere with the display recovery after a blanking event, and consequently extend the time that the cockpit displays remain blank.

We determined that since the Honeywell Primus Epic system also is installed on Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ 170 series airplanes, those airplanes are subject to an unsafe condition similar to that addressed in this AD. In light of that determination, we issued AD 2004-26-12, amendment 39-13924 (69 FR 78300, December 30, 2004), to address that unsafe condition on that airplane model. We may consider additional rulemaking on other airplane models having the Honeywell Primus Epic system that also exhibit a similar unsafe condition.

We have reviewed Gulfstream G500 Alert Customer Bulletin 2, dated October 27, 2004; and Gulfstream G550 Alert Customer Bulletin 2, dated October 27, 2004. The customer bulletins describe procedures for inspecting the ASCB for any noise interference and contacting the manufacturer if any noise interference indications are found during the inspection.

We have also reviewed Gulfstream G500 Airplane Flight Manual (AFM) GAC-AC-G500-OPS-0001, Revision 7, dated December 28, 2004; and Gulfstream G550 AFM GAC-AC-G550-OPS-0001, Revision 9, dated December 28, 2004. The AFM revisions describe procedures to recover the cockpit display units in the event that all four cockpit display units go blank during flight. Additionally, these AFM revisions describe procedures to ensure that the flightcrew is aware that dispatch of any flight with any of the following display units inoperative is prohibited: the integrated standby flight display (SFD), very high frequency (VHF) 1, very high frequency omnidirectional range (VOR) 1, or air traffic control (ATC) 1. The AFM revisions also describe procedures to advise the flightcrew that, during the use of Taxi/Before Takeoff, Descent, and Before Landing checklists, the briefings (takeoff and approach) should include the possibility of the loss of all cockpit display units and the subsequent transition to the use of the standby instruments.

In addition, we have reviewed Gulfstream G500 Aircraft Service Change 902; and Gulfstream G550 Aircraft Service Change 902; both dated December 30, 2004. The aircraft service changes describe procedures to install software updates to the Honeywell Primus Epic systems and for submitting the service reply card, and specify concurrent accomplishment of Gulfstream G500 Aircraft Service Change 043, dated December 30, 2004; and Gulfstream G550 Aircraft Service Change 043, dated December 30, 2004; as applicable. Gulfstream G500 Aircraft Service Change 043 and Gulfstream G550 Aircraft Service Change 043 describe procedures for installing hardware upgrades to the Honeywell Primus Epic systems. The hardware upgrades include upgrading and retrofitting display controllers, display units, a display driver unit, and a data management unit in addition to replacing an existing circuit breaker with a new circuit breaker. Installing the software update and the hardware upgrade will allow removal of certain AFM revisions and will end the repetitive inspections of the ASCB.

Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition.

The unsafe condition described previously is likely to exist or develop on other airplanes of the same type design. Therefore, we are issuing this AD to prevent a software error from blanking the cockpit display units, which will result in a reduction of the flightcrew's situational awareness, and possibly loss of control of the airplane. We are also issuing this AD to address noise interference in the avionics standard communication bus (ASCB), which can interfere with the display recovery after a blanking event and consequently extend the time that the displays remain blank. In addition, we are issuing this AD to ensure that the flightcrew is advised of the procedures necessary to address blank cockpit display units, and to ensure that adequate standby instrument systems are available to safely complete the flight.

This AD requires doing the actions specified in the service information described previously, except as discussed under “Differences Between the AD and the Customer Bulletins.”

Operators should note that, although the Accomplishment Instructions of the referenced customer bulletins describe procedures for submitting a sheet recording compliance with the customer bulletin, this AD will not require those actions. The FAA does not need this information from operators.

Operators should note that, although the Modification Instructions of the referenced aircraft service changes describe procedures for submitting a service reply card, this AD will not require those actions. The FAA does not need this information from operators.

Although the customer bulletins specify that operators may contact the manufacturer for disposition if any noise interference indications are found during the inspection of the ASCB, this AD requires operators to repair the ASCB according to a method approved by the FAA.

The customer bulletins specify a one time inspection; however, they do note that a recurring inspection will be added to the applicable airplane maintenance manual (AMM). The recurring inspection interval in the applicable AMM is specified as 60 days, the same as this AD.

The customer bulletins state that a certain number of Gulfstream Model GV-SP series airplanes with specific serial numbers are affected. This AD also specifies certain additional airplanes with serial numbers that are not stated in the customer bulletin. These additional airplanes may also be subject to the unsafe condition.

As indicated in Note 1 of this AD, operators may accomplish the AFM revisions required by this AD by inserting a copy of Gulfstream G500 AFM GAC-AC-G500-OPS-0001, Revision 7, dated December 28, 2004, or Gulfstream G550 AFM GAC-AC-G550-OPS-0001, Revision 9, dated December 28, 2004, into the applicable AFM. Future general revisions to the AFM must contain the identical procedures specified in the applicable sections of the AFM revisions required by this AD.

An unsafe condition exists that requires the immediate adoption of this AD; therefore, providing notice and opportunity for public comment before the AD is issued is impracticable, and good cause exists to make this AD effective in less than 30 days.

This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any relevant written data, views, or arguments regarding this AD. Send your comments to an address listed under ADDRESSES. Include “Docket No. FAA-2005-20280; Directorate Identifier 2004-NM-254-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD. We will consider all comments received by the closing date and may amend the AD in light of those comments.

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

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

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

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

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

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

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

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

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

The FAA proposed to amend 14 CFR Part 39 with an AD for all Saab Model SAAB SF340A and SAAB 340B series airplanes. That action, published in the Federal Register on October 27, 2004 (69 FR 62625), proposed to require a one-time inspection to determine the part and serial numbers of certain engine vibration isolators (mounts) and the cure dates of certain molded assemblies incorporated in those engine mounts; and related corrective actions if necessary.

We provided the public the opportunity to participate in the development of this AD. We have considered the comment that has been submitted on the proposed AD.

The commenter requests that the proposed AD be withdrawn. The commenter states that delamination of a bonded canister (molded assembly) is readily apparent and would have been detected during the scheduled inspections recommended in the Saab maintenance program. The commenter also mentions that the molded assemblies have a life limit of 5,000 flight hours, at which point those assemblies are removed from the airplane. The commenter notes that by the time the proposed AD is issued, almost three years would have passed since the affected molded assemblies were put into service. The commenter remarks that it is unlikely that any affected molded assembly remaining in the field would not have already been identified and removed from service during the regularly scheduled maintenance inspection program. The commenter states that, for the reasons mentioned above, the FAA needs to consider the timing of the proposed AD. The commenter suggests that, at this late date, the unsafe condition regarding the removal of molded assemblies subject to delamination would have resolved itself.

We do not agree with the commenter's request to withdraw this AD. The procedures specified in a service bulletin are not mandatory. Therefore, we must issue an AD to ensure that the identified unsafe condition is properly addressed. Even if the current U.S.-registered fleet is in compliance with the requirements of this AD, the issuance of the rule is still necessary to ensure that any affected airplane that is imported and placed on the U.S. register in the future will be required to be in compliance as well. We also want to ensure that, if the subject molded assemblies are currently in an operator's spare parts inventory, the actions required by this AD are performed. In addition, as provided by paragraph (e) of this AD, operators who have already done all of the actions required by this AD are already in compliance with this AD, and no further action is required by them. Furthermore, the requirements of this AD include a general visual inspection for chafing of the nacelle structure and fire sensor loop. This inspection is necessary because chafing of the nacelle structure and fire sensor loop is part of the unsafe condition addressed by this AD. We must ensure that operators did this inspection and did not just replace the engine mounts. Also, the airworthiness authority for the state of design issued an airworthiness directive mandating the same actions required by this AD. No change has been made to this AD regarding this issue.

We have added a new paragraph (g), Parts Installation, in this AD to clarify that, prior to the installation of an engine vibration mount on an airplane, the part and serial number of the engine vibration mount, and the cure date of the molded assembly incorporated in the engine mount must be determined, and any applicable corrective action accomplished before further flight, in accordance with the requirements of paragraph (f) of this AD. Although this was our intent in the proposed AD, the Parts Installation paragraph was inadvertently omitted from the proposed AD. The subsequent paragraphs in this AD have been reidentified accordingly.

Also, for clarification purposes, certain terminology in the proposed AD has been changed in this AD. The phrase “molded assembly engine mounts (isolators)” has been changed to “engine vibration isolators (mounts).” The term “bonded canister assemblies” has been changed to “molded assemblies.”

We have carefully reviewed the available data, including the comment that has been submitted, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

This AD affects about 170 airplanes of U.S. registry. The required actions will take about 2 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of this AD for U.S. operators is $22,100 or $130 per airplane.

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

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

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

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

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

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

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

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

On May 23, 2003, the Department published an interim rule (68 FR 28129; Public Notice 4368) detailing the implementation of the SEVIS monitoring system. The Department published this interim rule with a request for comments. There were no comments received and the Department is now making final the interim rule.

The Department is amending its regulations at 22 CFR 41.61 and 41.62 regarding students and exchange visitors by adding the requirement that authorized consular officials verify the provenance of SEVIS-generated forms I-20 or DS-2019 against SEVIS data in the Consular Consolidated Database CCD. It is also amending its regulations by adding the requirement that authorized consular officials verify the payment of any applicable SEVIS fee, and to make Border Commuter Students (F-3 and M-3) subject to SEVIS requirements. No F-1, F-2, F-3, M-1, M-2, M-3, J-1 or J-2 visas may be issued unless an authorized consular official has verified the provenance of the student or exchange visitor acceptance documentation against SEVIS data in the CCD, or via direct access to SEVIS.

The Department is publishing this rule as a final rule, after a 60-day provision for post-promulgation public comments and review, based on the “good cause” exceptions set forth at 5 U.S.C. 553(b)(3)(B) and 553(d)(3).

The Department of State, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign based companies in domestic and import markets.

This rule will not result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector and it will not significantly or uniquely affect small governments.

The Department of State does not consider this rule to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. In addition, the Department is exempt from Executive Order 12866 except to the extent that it is promulgating regulations in conjunction with a domestic agency that are significant regulatory actions. The Department has nevertheless reviewed the regulation to ensure its consistency with the regulatory philosophy and principles set forth in that Executive Order.

This regulation will not 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. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement.

The final rule does not impose information collection requirements under the provisions of the Paperwork Reduction Act, 44 U.S.C., chapter 35.

The interim rule amended the Departments' regulations at 22 CFR part 41. In view of the foregoing, the Department does not feel it necessary to amend the regulations as published in the interim rule, and the interim rule is being incorporated herein as a final rule.

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

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

In addition to using EDOCKET (http://www.epa.gov/edocket/) , 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

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 tolerances for residues of acibenzolar- S -methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid- S -methyl ester, in or on onion, dry bulb and onion, green at 0.05 parts per million (ppm). These tolerances will expire and are revoked on June 30, 2007. 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.

Iris yellow spot virus is a new and expanding pest problem. Onion thrips transmit the virus which cause leaf and flower stalk lesions, as well as smaller sized bulbs. Production seed can also be infected. Economic consequences can be significant due to yield losses. The virus also reduces bulb size causing reduction in grade. EPA has authorized under FIFRA section 18 the use of acibenzolar- S -methyl on onion, dry bulb and onion, green, for control of iris yellow spot virus in Colorado. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of acibenzolar- S -methyl in or on onion, dry bulb and onion, green. 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 these tolerances will expire and are revoked on June 30, 2007, 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 onion, dry bulb and onion, green 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 these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether acibenzolar- S -methyl meets EPA's registration requirements for use on onion, dry bulb and onion, green or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of acibenzolar- S -methyl by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than Colorado 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 acibenzolar- S -methyl, 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 acibenzolar- S -methyl and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for residues of acibenzolar- S -methyl in or on onion, dry bulb and onion, green at 0.05 ppm. EPA's assessment of the dietary exposures and risks associated with establishing these tolerances follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. The toxicology database for acibenzolar- S -methyl is incomplete. Subchronic neurotoxicity, developmental neurotoxicity and an additional mutagenicity study (Ames study) are required. EPA has 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 acibenzolar- S - methyl are fully discussed in a final rule published in the Federal Register on August 18, 2000 (65 FR 50438)(FRL-6737-6) that established tolerances for residues of acibenzolar- S -methyl in or on bananas, Brassica (cole) leafy vegetables, fruiting vegetables, leafy vegetables and spinach. Please refer to that document for a complete discussion of the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. No NOAEL for developmental toxicity was observed in the rat developmental study for acibenzolar- S -methyl. Because no NOAEL was observed, an additional 3X uncertainty factor is being applied to the 100X uncertainty factor to account for intra- and inter-species variability, resulting in a 300X UF for toxicological endpoints derived from this study.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for acibenzolar- S -methyl used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.561) for the residues of acibenzolar- S -methyl, in or on a variety of raw agricultural commodities including bananas, Brassica (cole) leafy vegetables, fruiting vegetables, leafy vegetables, spinach and tomato paste. Risk assessments were conducted by EPA to assess dietary exposures from acibenzolar- S -methyl 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 one day or single exposure. Probabilistic (i.e., Monte Carlo) acute dietary risk assessments were conducted for acibenzolar- S -methyl using the Dietary Exposure Evaluation Model (DEEM-FCID, Version 2.03), which uses food consumption data from the USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998 and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: For onions, the recommended tolerance level of 0.05 ppm was used and the assumption of 100% crop treated was made. DEEM default processing factors were used for dried onion, dried banana, dried plantain, and dried tomato. Empirical processing factors were used for tomato paste (7.1), tomato puree (2.9), and tomato juice (1.0). Blended commodities were treated differently than nonblended and partially blended commodities. Foods were classified as blended, partially blended, or nonblended. For blended commodities, the mean field trial values were used as a point estimate for expected residues. A value of ½ the limit of quantitation( LOQ) was used for samples that contained less than LOQ residues. Maximum percent crop treated (PCT) estimates were used as residue adjustment factors. The blended commodities included dried bananas, dried plantains, dried bell peppers, dried nonbell peppers, dried tomatoes, tomato paste, and tomato puree. For nonblended and partially blended commodities, the distributions of the field trial data were used. Again, a value of ½ LOQ was used for samples that contained less than LOQ residues. Maximum PCT estimates were used for brocolli, cabbage, cauliflower, celery, head lettuce, leaf lettuce, spinach, peppers, and tomatoes.

ii. Chronic exposure .In conducting this chronic dietary risk assessment the DEEM-FCID, Version 2.03, which uses food consumption data from the USDA's CSFII from 1994-1996 and 1998 and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: tolerance level residues for all crops and 100% crop treated were used.

iii. Cancer . Acibenzolar- S -methyl has been classified as not likely to be carcinogenic to humans. Therefore, a quantitative exposure assessment was not conducted to assess cancer risk.

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

Section 408(b)(2)(F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on PCT.

In assessing chronic risk, EPA did not use PCT data. In assessing acute risk, The Agency used PCT information as follows: for onions the assumption of 100% crop treated was made. The following maximum PCT estimates were used: 1% of broccoli, 1% of cabbage, 1% of cauliflower, 1% celery, 12% head lettuce, 12% leaf lettuce, 1% peppers, 15% spinach and 1% tomatoes. For all other commodities it was assumed 100% of the crop was treated.

EPA believes that the PCT information described above for acibenzolar- S -methyl on leafy vegetables, fruiting vegetables and brassica (cole) leafy vegetables is reliable and has a valid basis. The PCT information is based on reliable estimates of the potential market for acibenzolar- S -methyl and the petitioner's estimate of the market share it expects to capture. EPA believes the estimates do not underestimate the percent of these crops that may be treated.

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

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 SCI-GROW (screening concentration in ground water), which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 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 acibenzolar- S -methyl they are further discussed in the aggregate risk sections below.

Based on the PRZM/EXAMS and SCI-GROW models the EECs of acibenzolar- S -methyl for acute exposures are estimated to be 7.9 parts per billion (ppb) for surface water and 0.02 ppb for ground water. The EECs for chronic exposures are estimated to be 0.49 ppb for surface water and 0.02 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). Acibenzolar- S -methyl 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.”

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

1. In general . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA's risk assessments either directly through use of a margin of exposure (MOE) analysis or through using UFs (safety) in calculating a dose level that poses no appreciable risk to humans.

2. Developmental toxicity studies . In a prenatal developmental study in rats the maternal NOAEL is 200 mg/kg/day and the LOAEL is 400 mg/kg/day based on hemorrhagic perineal discharge. A developmental NOAEL was not identified. The LOAEL is 10 mg/kg/day (lowest dose tested) based on umbilical hernia.

In a prenatal developmental study in rabbits the maternal NOAEL is 50 mg/kg/day and the LOAEL is 300 mg/kg/day based on mortality, clinical signs of toxicity, decreased maternal body weight and food consumption. The developmental NOAEL is 300 mg/kg/day and the LOAEL is 600 mg/kg/day based on a marginal increase in vertebral anomalies.

3. Reproductive toxicity study . In a reproduction and fertility study, the parental/systemic NOAEL is 11 to 31 mg/kg/day and the LOAEL is 105 to 288 mg/kg/day based on increased weights and hemosiderosis of the spleen. The reproductive NOAEL is 223 to 604 mg/kg/day and the LOAEL is greater than 223 to 604 mg/kg/day based on no effects. The offspring NOAEL is 11 to 31 mg/kg/day and the LOAEL is 105 to 288 mg/kg/day based on reduced pup body weight gains and lower pup body weights during lactation.

4. Prenatal and postnatal sensitivity. The Agency concluded that there is concern for the increased susceptibility of infants and children to exposure to acibenzolar- S -methyl based on the developmental toxicity study in rats where treatment-related developmental malformations, anomalies and variations were observed at doses equal to or below the NOAEL for maternal toxicity.

5. Conclusion . The toxicology database for acibenzolar- S -methyl is incomplete. Subchronic neurotoxicity, developmental neurotoxicity and an additional mutagenicity study (Ames study) are required. When assessing acute and chronic dietary exposures, the Agency concluded that the FQPA safety factor should be retained at 10X for the female, 13 to 50 years old, population subgroup (the only population subgroup of concern for acute exposures). The Agency recognizes that the fetal effects occurring in the rat developmental study are of significant toxicological concern and that a developmental neurotoxicity study has been required to further define the neurotoxic potential observed in this study. However, the Agency concluded that a safety factor of 10X is adequate in this case since:

i. The Agency has accounted for the concern that these fetal effects occurred at the lowest dose tested (no developmental NOAEL established) by the requirement of an additional uncertainty factor of 3X when this endpoint is used for risk assessment.

ii. These fetal effects were only observed in one species (in the rat but not in the rabbit).

iii. These fetal effects were not observed in the 2-generation reproduction study.

iv. The exposure databases are well characterized and the exposure assessments will not likely underestimate the exposure resulting from the use of acibenzolar- S -methyl.

a. A quantitative increase in susceptibility of fetuses (compared to dams) in the rat developmental toxicity study (developmental malformations occurred at a dose level which was considerably below the NOAEL for maternal toxicity).

b. A concern that the treatment-related developmental malformations (umbilical hernia) observed in rat fetuses occurred at the lowest dose tested (NOAEL was not established) in the rat developmental toxicity study.

c. The requirement for a developmental neurotoxicity study in rats based on the occurrence of treatment-related effects in nervous system tissues in the rat developmental study.

The data provided no indication of increased susceptibility of rabbit fetuses following in utero exposure or of rat fetuses/pups following pre-/postnatal exposures. In these studies, developmental/offspring effects were observed only at or above treatment levels which produced maternal/parental toxicity. When assessing chronic dietary exposure, the Agency concluded that the safety factor can be reduced to 3X for the general population, including infants and children (with the exception of the aforementioned female 13 to 50 population subgroup) since the concern for increased susceptibility seen after in utero exposure in the developmental study has no bearing on chronic exposure scenarios for persons other than Females 13 to 50. However, since there still remains a data gap for a developmental neurotoxicity study in rats the safety factor was only reduced to 3X.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking 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 residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + chronic non-dietary, non-occupational exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes with reasonable certainty that exposures to acibenzolar- S -methyl in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of acibenzolar- S -methyl on drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure (at the 99.9th percentile of exposure), from food to acibenzolar- S -methyl will occupy 61% of the aPAD for females 13 to 49 years, the only population subgroup of concern for acute dietary exposure (i.e., no significant acute effects relevant to other subgroups were identified in acute toxicity studies for acibenzolar- S -methyl). In addition, despite the potential for acute dietary exposure to acibenzolar- S -methyl in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of acibenzolar- S -methyl in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in Table 2 of this unit:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to acibenzolar- S -methyl from food will utilize 6% of the cPAD for the U.S. population, 3% of the cPAD for all infants less than 1 year old, 12% of the cPAD for children 1 to 2 years old, the children's subpopulation at greatest exposure and 49% of the cPAD for females 13 to 50 years, the subpopulation at greatest risk. There are no residential uses for acibenzolar- S -methyl that result in chronic residential exposure to acibenzolar- S -methyl. In addition, despite the potential for chronic dietary exposure to acibenzolar- S -methyl in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of acibenzolar- S -methyl in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of this unit:

3. Short-term and Intermediate-term risks . Short-term and intermediate-term aggregate exposure take into account non-dietary, and non-occupational plus chronic exposure to food and water (considered to be a background exposure level). Acibenzolar- S -methyl is not registered for use on any sites that would result in residential exposure; therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed.

4. Aggregate cancer risk for U.S. population . Acibenzolar- S -methyl has been classified as not likely to be carcinogenic to humans; therefore, acibenzolar- S -methyl is expected to pose at most a negligible cancer risk.

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

An adequate enforcement methodology (AG-671A) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no maximum residue limits for acibenzolar- S -methyl that have been established by Codex or in Canada or Mexico; therefore, no compatibility issues exist with Codex in regard to the proposed U.S. tolerances discussed in this review.

Therefore, the tolerances are established for residues of acibenzolar- S -methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid- S -methyl ester, in or on onion, dry bulb and onion, green at 0.05 ppm.

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-2004-0214 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 April 18, 2005.

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 (1900L), 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 Suite 350, 1099 14 th St., NW., Washington, DC 20005. 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 (202) 564-6255.

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A.1., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by the docket ID number OPP-2004-0214, 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 ADDRESSES . 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 time-limited tolerances under section 408 of the FFDCA. 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 FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerances 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 .

In addition to using EDOCKET (http://www.epa.gov/edocket/) , 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 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.gpo/opptsfrs/home/guidelin.htm/.

In the Federal Register of August 18, 2004 (69 FR 51301) (FRL-7364-5), 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 2F6487) by Monsanto Company, 600 13th Street, NW., Suite 600, Washington, DC 20005. The petition requested that 40 CFR 180.364 be amended by establishing a tolerance for residues of the herbicide glyphosate, N-phosphonomethyl glycine, in or on alfalfa, seed at 0.5 parts per million (ppm). That notice included a summary of the petition prepared by Monsanto Company, the registrant. There was one comment received in response to this notice of filing from B. Sachau, 15 Elm Street, Florham, NJ 07932. The commentor objected to allowing any tolerance, waiver, or exemption for glyphosate. The commentor also objected to animal testing and stated that a more reliable method of testing should be developed. This comment is further discussed and addressed in the Final Rule which published in the Federal Register of November 10, 2004 (69 FR 65081) (FRL-7683-9).

During the course of the review the Agency decided to correct the company address to read: Monsanto Company, 1300 I St., NW., Suite 450 East, Washington DC 20005.

The Agency is also correcting the proposed tolerance expression to agree with the current expression by including references to the salts. Therefore, the tolerance expression is corrected to read: A tolerance is established for residues of glyphosate, (N-(phosphonomethyl)glycine, resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate in or on alfalfa, seed at 0.5 parts per million (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 glyphosate, (N-(phosphonomethyl)glycine, resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate on alfalfa, seed at 0.5 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance were discussed in the Final Rule published in the Federal Register of November 10, 2004 (69 FR 65081) which established tolerances for residues of glyphosate in or on cotton, gin byproducts and cotton, undelinted seed. Based on the risk assessments discussed in the above notice, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregrate exposure to glyphosate residues.

Adequate analytical methods are available for the enforcement of tolerances for glyphosate in plant and livestock commodities. These methods include gas liquid chromatography (GLC) (Method I in Pesticides Analytical Manual (PAM II)) and high performance liquid chromatography (HPLC) with fluorometric detection. Use of GLC is discouraged due to the lengthliness of the experimental procedure. The HPLC procedure has undergone successful Agency validation and was recommended for inclusion into PAM II. A gas chromatography spectrometry (GC/MS) for glyphosate in crops has also been validated by EPA.

These methods may be requested from Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft Meade, MD 20755-5350; telephone number (410) 305-2905; e-mail address: residuemethods@epa.gov.

Codex and Mexican maximum residue levels (MRLS) are established for residues of glyphosate per se and Canadian MRLs are established for the combined residues of glyphosate and aminomethylphosphonic acid (AMPA) on a variety of raw agricultural commodities.

Currently no Codex, Mexican, or Canadian MRLs are established for alfalfa, seed.

There are no conditions of registration for the establishment of tolerances on alfalfa, seed.

Therefore, the tolerance is established for residues of glyphosate, N-(phosphonomethyl)glycine, resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate, in or on alfalfa, seed at 0.5 ppm.

Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of 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 FFDCA, as was provided in the old sections 408 and 409 of 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-2005-0021 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 April 18, 2005.

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 (1900L), 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 Suite 350, 1099 14th St., NW., Washington, DC 20005. 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 (202) 564-6255.

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by docket ID number OPP-2005-0021 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 ADDRESSES . 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 a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

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

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

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

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

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

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

In addition to using EDOCKET (http://www.epa.gov/edocket/) , 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 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/.

In the Federal Register of August 25, 2004 (69 FR 52256) (FRL-7372-4), 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 3F4268) by E. I. DuPont de Nemours and Company, Laurel Run, Wilmington, DE 19880-0038. The petition requested that 40 CFR 180.441(a)(1) be amended by establishing a tolerance for residues of the herbicide quizalofop (2-[4-(6-chloroquinoxalin-2-yl oxy)phenoxy]propanoic acid) and quizalofop ethyl (ethyl-2-[4-(6-chloroquinqaxalin-2-yl oxy)phenoxy]propanoate), all expressed as quizalofop ethyl (DuPont Assure II) in or on the raw agricultural commodities, dry beans at 0.4 parts per million (ppm); dry bean straw at 3.0 ppm; succulent beans at 0.25 ppm; succulent bean forage at 3.0 ppm; dry peas at 0.25; dry pea straw at 3.0 ppm; succulent peas at 0.3 ppm; succulent pea forage at 3.0 ppm; sugar beet root at 0.1 ppm; sugar beet top at 0.5 ppm; and § 180.441(a)(3) by establishing a permanent tolerance for sugar beet molasses at 0.2 ppm. These proposed tolerances replace the time-limited tolerances listed in § 180.441(a)(4). That notice included a summary of the petition prepared by E.I. Dupont de Nemours and Company, the registrant. There was one comment received in response to this notice of filing. The commenter objected to all approvals of this chemical. The commenter further opposed all exemptions, waivers, residues on food and in soil/water or any plant. The commenter also objected to testing on cows, rabbits, and dogs and to the residues in milk. This comment will be further discussed in Unit V. of this document.

During the course of the review it was determined that the commodity listing in the notice of filing was not consistent with current terminology. Therefore, these corrections are being made at this time. The proposed commodity language for 40 CFR 180.441(a)(1) is beans, dry at 0.4 ppm; bean, succulent at 0.25 ppm; beet, sugar, roots at 0.1 ppm; beet, sugar, tops at 0.5 ppm; cowpea, forage at 3.0 ppm; cowpea, hay at 3.0 ppm; pea, dry at 0.25 ppm; pea, field, hay at 3.0 ppm; pea, field vines at 3.0 ppm; and pea, succulent at 0.3 ppm. The commodities dry bean straw, succulent bean forage, dry pea straw, and succulent pea forage are replaced by the commodities cowpea, hay; cowpea, forage; pea. field, hay; and pea, field, vines; respectively. Similarly, the proposed commodity language for § 180.441(a)(3) is beet, sugar, molasses. These tolerances replace the time-limited tolerances listed in § 180.441(a)(4).

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 combined residues of quizalofop (2-[4-(6- chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid) and quizalofop ethyl (ethyl-2-[4-(6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoate), all expressed as quizalofop-ethyl in or on the agricultural commodities beans, dry at 0.4 ppm; bean, succulent at 0.25 ppm; beet, sugar, roots at 0.1 ppm; beet, sugar, tops at 0.5 ppm; cowpea, forage at 3.0 ppm; cowpea, hay at 3.0 ppm; pea, dry at 0.25 ppm; pea, field, hay at 3.0 ppm; pea, field vines at 3.0 ppm; and pea, succulent at 0.3 ppm and quizalofop-p-ethyl ester (ethyl (R)-(2-(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoate) and its acid metabolite quizalofop-p (R-(2-(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid)), and the S enantiomers of both the ester and the acid, all expressed as quizalofop-p-ethyl ester in or on the commodity beet, sugar, molasses at 0.2 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 quizalofop-ethyl as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of June 16, 1998 (63 FR 32753) (FRL-5793-5).

The dose at which NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

Three other types of safety or uncertainty factors may be used: “Traditional UF”; the “special FQPA safety factor”; and the “default FQPA safety factor.” By the term “traditional UF”, EPA is referring to those additional UFs used prior to FQPA passage to account for database deficiencies. These traditional UFs have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term “special FQPA safety factor” refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The “default FQPA safety factor” is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional UF or a special FQPA safety factor).

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (aRfD or cRfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional UFs deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic population adjusted dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 x 10 -5 ), one in a million (1 x 10 -6 ), or one in ten million (1 x 10 -7 ). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer =point of departure/exposures) is calculated.

A summary of the toxicological endpoints for quizalofop-ethyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of June 16, 1998 (63 FR 32753) (FRL-5793-5).

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.441) for the combined residues of quizalofop-ethyl, quizalofop-p-ethyl and associated metabolites, in or on a variety of raw agricultural commodities. Tolerances are established under § 180.441(a)(2) for quizalofop, quizalofop-ethyl, and quizalofop methyl (methyl 2-[4-(6-oxy)phenoxy]propanoate) all expressed as quizalofop-ethyl in or on meat, fat, and meat by products of cattle, goat, hog, horse, poultry, and sheep; milk and milk fat; and egg. Risk assessments were conducted by EPA to assess dietary exposures from quizalofop ethyl 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. There were no effects observed in the toxicology data base that could be attributable to a single dose (exposure). Therefore an acute dietary exposure analysis was not performed.

ii. Chronic exposure . In conducting the chronic dietary risk assessment EPA used the Dietary Exposure Evaluation Model (DEEM TM ) software with the Food Commodity Intake Database (FCID), which incorporates food consumption data as reported by respondents in the United States Department of Agriculture (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: Tolerance level residues, DEEM TM default factors, and 100% crop treated. Data on percent of the crop treated or anticipated residues were not used.

iii. Cancer . EPA concluded that the pesticidal use of quizalofop-ethyl is not classifiable as to human carcinogenicity. Therefore, a quantitative cancer exposure assessment was not performed. Refer to Unit II.B.4. in the Federal Register of June 16, 1998 (63 FR 32753) (FRL-5793-5) for a detailed discussion.

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

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 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 incorporates an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop (PC) area factor as an adjustment to account for the maximum PC 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 screen for sorting out pesticides for which it is unlikely that drinking water concentrations would 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), which are the model estimates of a pesticide's concentration in water. EECs derived from these models are used 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 quizalofop-ethyl, they are further discussed in Unit III.E.

Based on the GENEEC and SCI-GROW models, the EECs of quizalofop-ethyl for chronic exposures are estimated to be 8.08 ppb for surface water and 0.15 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).

Quizalofop-ethyl is not registered for use on any sites that would result in residential exposure.

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

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to quizalofop-ethyl and any other substances and quizalofop-ethyl 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 quizalofop-ethyl 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 OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/ .

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety (MOS) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . The histopathology data for F2 weanlings in the 2-generation reproductive toxicity study suggested an increased sensitivity to the offspring. In that study, an increase in the incidence of eosinophilic changes in the liver were noted in the F2 weanlings, and the offspring no observed effect level (NOEL) was less than the parental systemic NOEL. However, the significance of these observations in the 2-generation reproductive toxicity study is rendered questionable due to: (i) The changes in the weanling liver were not well characterized; (ii) the biological significance of this endpoint was not known; (iii) the precise dose of test substance to 21-day old weanlings cannot be determined with any accuracy, but it is likely to exceed that of the adults; (iv) this endpoint (eosinophilic changes), in adults, would not be considered appropriate for use in regulation of a chemical because of the questionable biological significance of this effect; and, (v) previous toxicological studies show the liver as the target organ in rats. No particular significance to the offspring is attributed to the liver effects. Developmental toxicity studies showed no increased sensitivity in pups as compared to maternal animals following in utero exposures to rats and rabbits.

3. Conclusion . There is a complete toxicity data base for quizalofop-ethyl and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The impact of quizalofop-ethyl on the nervous system has not been specifically evaluated in neurotoxicity studies. A developmental neurotoxicity study is not required for quizalofop-ethyl based on the following: (i) Quizalofop-ethyl does not appear to be a neurotoxic chemical; (ii) no-treatment-related effects on brain weight or histopathology (non-perfused) of the nervous system was observed in studies that measured these endpoints; (iii) no evidence of developmental anomalites of the fetal nervous system were observed in either rats or rabbits, at maternally toxic oral doses up to 300 and 600 mg/kg/day, respectively, and; (iv) no evidence of an effect on functional development was observed in a postnatal segment of the developmental toxicity study in rats. EPA determined that the 10X SF to protect infants and children should be removed. The FQPA factor is removed because the toxicology data base is complete; a developmental neurotoxicity study is not required; developmental toxicity studies showed no increased sensitivity in fetuses as compared to maternal animals following in utero exposures in rats and rabbits; and a 2-generation reproduction study showed no increased sensitivity in pups as compared to adults.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against EECs. DWLOC values are not regulatory standards for drinking 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 residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure milligrams/kilogram/day (mg/kg/day) = cPAD - (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA's Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Quizalofop-ethyl is not expected to pose an acute risk because no toxicological endpoints attributable to a single exposure (dose) were identified in the toxicology data base.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to quizalofop-ethyl from food will utilize 3.0% of the cPAD for the U.S. population, 3.4% of the cPAD for all infants ( < 1 year old), and 9.6% of the cPAD for children 1-2 years old. There are no residential uses for quizalofop-ethyl that result in chronic residential exposure to quizalofop-ethyl. In addition, there is potential for chronic dietary exposure to quizalofop-ethyl in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 1.

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

Quizalofop-ethyl is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

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

Quizalofop-ethyl is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

5. Aggregate cancer risk for U.S. population . Quizalofop-ethyl is classified as “not classifiable as to human cancer potential.” The Agency believes that any cancer risk posed by quizalofop-ethyl is negligible and there is reasonable certainty that no harm will result form exposure to residue of quizalofop-ethyl. Refer to the Federal Register of June 16, 1998 (63 FR 32753) (FRL-5793-5) for a detailed discussion.

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

Adequate analytical methodology (high pressure liquid chromatography (HPLC) using either an ultraviolet or fluorescence detector is available for enforcement purposes in Vol II of the Food and Drug Administration (FDA) Pesticide Analytical Method (PAM II, Method I).

Since there are no Mexican or Canadian Maximum Residue Levels, compatibility is not a problem at this time. Compatibility cannot be achieved with the Canadian negligible residue type limit of 0.1 ppm, since data supporting United States use patterns had findings of real residues above 0.1 ppm.

There are no conditions of registration for establishment of tolerances on the commodities bean, dry; bean, succulent; cowpea, forage; cowpea, hay; beet, sugar, molasses; beet, sugar, roots; beet, sugar, tops; pea, dry; pea, field, hay; pea, field, vines; and pea, succulent.

One comment was received in response to the notice of filing. The commenter objected to all approvals of any kind for this pesticide and objected to all exemptions, waivers, residues on food, milk, or on soil/water or any plants. The commenter also objected to animal testing on cows, rabbits, or dogs, because animal testing constitutes animal abuse and stated that it should be stopped. The commenter also stated that more modern less abusive methods should be used.

The comment contained no scientific data or evidence to rebut the Agency's conclusion that there is a reasonable certainty that no harm will result from the aggregate exposure to quizalofop-ethyl, including all anticipated dietary exposure and all other exposures for which there is reliable information.

OPPTS Harmonized Guideline--Health Effects Guidelines (Series 870) recommend that dog or rabbit be used for various acute, subchronic, and longer term chronic, carcinogenic, developmental, and reproductive studies. Residue Chemistry Guidelines (Series 860) recommend that a cow be used for certain feeding studies. Information derived from these tests indicate the presence of possible hazards or residues from exposure to the test substance. Currently, there are no in vitro studies that can address the questions that these studies answer. The Agency is currently working with the Interagency Coordinating Committee on the Validation or Alternate Methods to investigate alternative in vitro methods.

Therefore, permanent tolerances are established for combined residues of quizalofop (2-[4-(6-chloroquinoxalin-2-yl)oxy)phenoxy)-propanoic acid) and quizalofop ethyl (ethyl-2-[4-(6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoate), all expressed as quizalofop ethyl in or on bean, dry at 0.4 ppm; bean, succulent at 0.25; beet, sugar, roots at 0.1 ppm; beet, sugar, tops at 0.5 ppm; cowpea, forage at 3.0 ppm; cowpea, hay at 3.0 ppm; pea, dry at 0.25 ppm; pea, field, hay at 3.0 ppm; pea, field, vines at 3.0 ppm; and pea, succulent at 0.3 ppm (40 CFR 180.441(a)(1)). Also, 40 CFR 180.441(a)(3) is amended by establishing a permanent tolerance for the combined residues of quizalofop-p-ethyl ester (ethyl (R)-(2-(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoate)) and its acid metabolite quizalofop-p R-(2-(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid), and the S enantiomers of both the ester and the acid, all expressed as quizalofop-p-ethyl ester is established for beet, sugar, molasses at 0.2 ppm. These tolerances replace the ones listed in 40 CFR 180.441(a)(4).

Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of 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 FFDCA, as was provided in the old sections 408 and 409 of 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-2004-0324 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 April 18, 2005.

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 (1900L), 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 Suite 350, 1099 14th St., NW., Washington, DC 20005. 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 (202) 564-6255.

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by docket ID number OPP-2004-0324, 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 ADDRESSES . 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 a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

(3) * * *

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

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

In addition to using EDOCKET at http://www.epa.gov/edocket/ , 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

In the Federal Register of October 23, 2002 (67 FR 65115) (FRL-7276-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 2E6503) by Grain Processing Corporation, 1600 Oregon St, Muscatine, Iowa 52761 and SPI Polyols, 321 Cherry Lane, New Castle, Delaware 19720.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of hydrogenated starch hydrolysate (CAS Reg. No. 68425-17-2). Hydrogenated starch hydrolysate is intended to be used as an inert ingredient in pesticide products. That notice included a summary of the petition prepared by the petitioner. One comment was submitted. The Agency's response to this comment is in Unit X.

Section 408(b)(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(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. . . .”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of the pesticide chemical. 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.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Syrups, hydrolyzed starch, hydrogenated (also known as hydrogenated starch hydrolyzate or HSH) is a generic term for various hydrogenated syrups. These are also known by the terms sugar alcohols, polyhydric alcohols, or polyols. According to the Food and Drug Administration (FDA), sugar alcohols are “not technically considered artificial sweeteners, . . . are slightly lower in calories than sugar and do not promote tooth decay or cause a sudden increase in blood glucose. They include sorbitol, xylitol, lactitol, mannitol, and maltitol and are used mainly to sweeten sugar-free candies, cookies, and chewing gums.”

Syrups, hydrolyzed starch, hydrogenated (CAS Reg. No. 68425-17-2) are typically prepared by hydrolyzing a starch (such as corn starch) and then hydrogenating the hydrolysis product. Starch is a polymer composed of repeating glucose units that are linked by glucosidic bonds. Hydrolysis is the process by which these bonds are broken. Given that starch is a complex polysaccharide, hydrolysis of a starch yields a complex mixture of various chemicals, that retain the basic configuration of saccharides, but can have different functional groups. This complex mixture is then hydrogenated. Both the starting material (the type of starch), and the method of hydrolysis (heat, acid and/or enzymatic) can impact the hydrolyzed starch product that would then be hydrogenated.

Syrups, hydrolyzed starch, hydrogenated contain various amounts of maltitol, sorbitol and higher order polyols or polysaccharides. Higher-order polyols can be considered to be somewhat polymerized. Syrups, hydrolyzed starch, hydrogenated do not contribute nutrition to the human diet, are often used in reduced-calorie products, and by many are considered useful in the diets of persons with diabetes.

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. The nature of the toxic effects caused by syrups, hydrolyzed starch, hydrogenated are discussed in this unit.

The Joint Expert Committee on Food Additives (JECFA) is an international expert scientific committee that is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). In Food Additive Series 20, JECFA conducted a review of hydrogenated glucose syrups (see http://www.inchem.org/documents/jecfa/jecmono/v020je13.htm) . JECFA defined these syrups as follows: “Hydrogenated glucose syrups (HGS) are a mixture of polymers of glucose obtained from starch by hydrolysis which, upon hydrogenation, results in chemical reduction of the end-group glucose molecule to sorbitol. HGS consists primarily of maltitol and sorbitol, with lower portions of hydrogenated oligo- and polysaccharides.” The toxicity data base included metabolism studies; several mutagenicity studies; a multigeneration reproduction toxicity study; a developmental study; and various acute, short-term, and long-term toxicity studies. JECFA's conclusions are extracted directly from that document:

• HGS or its major component maltitol produced significantly lower blood-glucose levels and more stable insulin levels than glucose or sucrose due to slow metabolism of maltitol.

• The results from the in vitro assays, with and without metabolic activation, suggest that HGS does not induce a mutagenic, clastogenic, genotoxic, or neoplastic transformation response. No in vivo clastogenic effects were observed.

• Acute and short-term animal studies indicate that HGS is not toxic after single or repeated oral administration of large doses. In rats, no evidence of toxic effects of prolonged feeding of up to 15-20% of the diet was observed. A 90-day study in dogs showed no evidence of adverse effects, except for diarrhea, at a level of 4.95 grams/kilogram body weight per day (g/kg bwt day).

• A multigeneration reproduction study in rats, in which HGS was administered in drinking water as an 18% aqueous solution, did not reveal any toxicologically significant effects.

In humans, an effect of concern for all polyols is a laxative effect. Available information indicates that a laxative effect can occur at intake levels of 30-50 g/day.

WHO/JECFA also reviewed an oral long-term toxicity/carcinogenic study in the rat conducted with a test substance that was approximately 87% maltitol. No adverse effects were observed in the toxicity study. A slightly increased incidence of mammary gland adenocarcinomas was observed in female rats at the two highest dose levels. However, based on historical control data, these increases were not considered to be related to treatment (see http://www.inchem.org/documents/jecfa/jecmono/v32je08.htm) .

In 1998, JECFA conducted another review of Maltitol Syrup (see http://www.inchem.org/documents/jecfa/jecmono/v040je07.htm) . This evaluation examined the metabolic fate of maltitol and higher-order polyols using both in vitro and in vivo studies. The results indicated that the higher-order polyols were readily hydrolyzed to glucose and maltitol. Glucose would be readily absorbed by the mammalian body; however, the rate of absorption is slower than that of directly ingested glucose. Maltitol would be further degraded through fermentation by intestinal flora. The amounts of maltitol that are absorbed are quickly excreted in the urine with little evidence of metabolism.

JECFA's review of several animal toxicity studies indicated that no treatment-related toxicity was seen in rats or dogs fed a typical syrups, hydrolyzed starch, hydrogenated product at dose levels of 18 and 43 g/kg bwt day, respectively, for 90 days.

In 1999, JECFA conducted a review of the food additive polyglycitol syrup (see http://www.inchem.org/documents/jecfa/jecmono/v042je13.htm) . In this review, JECFA stated that their previous evaluation of maltitol syrup was applicable to polyglycitol syrup. Maltitol syrup differs from polyglycitol syrup only in the relative proportions of sorbitol, maltitol and higher-order polyols. For this 1999 review, a short-term toxicity study in rats given material with a high-order polyol content of 78% was reviewed.

Doses of a polyglycitol syrup, equal to 13 g/kg bwt per day, in the diets of rats for 13 weeks, “was not associated with adverse effects. The only effects observed--increased weight of the empty caecum and increased urinary calcium excretion in the absence of elevated serum calcium--were considered to be the consequence of the accumulation of poorly absorbed material in the caecum and to be of no toxicological significance.”

On the basis of the information reviewed at both the 1998 and the 1999 meetings, JECFA allocated a group acceptable daily intake (ADI) of “not specified” to materials conforming to the specifications for polyglycitol syrup and maltitol syrup. Thus, based on its review of the available data, polyglycitol syrups do not, in the opinion of JECFA, represent a hazard to health and the establishment of an acceptable daily intake (a specific limit on the average daily intake) expressed in numerical form is not needed.

In an acute oral toxicity study, using a test substance described only as an hydrogenated starch hydrolyzate, the lethal dose (LD) 50 was > 2,500 mg/kg (Toxicity Category III).

Syrups, hydrolyzed starch, hydrogenated is a generic term for a range of chemical substances that contain various sugar alcohols (sorbitol, maltitiol, and higher-order polyols) in varying proportions. WHO/JECFA has over a period of some years reviewed an extensive toxicity data base. The studies were conducted using similar mixtures of sugar alcohols. Generally, the studies did not reveal any toxicologically significant effects even at dose levels in the grams per kilogram body weight per day range. The human body has a demonstrated ability to metabolize this type of substance. The most noted effect in humans is a potential laxative effect.

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).

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

1. Food . To the best of the Agency's knowledge, products similar to syrups, hydrolyzed starch, hydrogenated have been used in food manufacture for approximately 20 years. In the food processing industry, these syrups are used as sweetening (flavoring) agents, humectants, texturizers, stabilizers, bulking agents and surface-finishing agents. According to information on the internet, various syrups, hydrolyzed starch, hydrogenated products are used in the manufacture of sugar-free soft and hard candies, and chewing gum. The SPI Polyol website advocates for use of its products in hard candies at levels up to 40%.

Given the widespread occurrence of all the various hydrogenated syrups or sugar alcohols in the existing food supply, the amount of syrups, hydrolyzed starch, hydrogenate in the food supply that could result from use in a pesticide product would not be expected to significantly increase the existing amounts in the food supply. The EPA-regulated uses as an inert ingredient in a pesticide product would be considerably less than all of the existing food additive non-nutritive sweetener uses.

2. Drinking water exposure . According to information on the internet, various syrups, hydrolyzed starch, hydrogenated products are soluble in water. It is expected that dissolving these chemicals in water would result in a thick syrupy solution depending on the percent of the syrups, hydrolyzed starch, hydrogenated in solution.

The Agency has used a surrogate chemical, sorbitol, to model the behavior of syrups, hydrolyzed starch, hydrogenated in the environment. Degradation via chemical reactions without the participation of organisms, or abiotic degradation of these chemicals would not be expected to be an important fate process. Chemicals such as syrups, hydrolyzed starch, hydrogenated will tend to have very low sorption coefficients; thus, migration to ground water and surface water via dissolution in water is highly likely. Volatilization from water would be minimal. Biodegradation is expected to be rapid. Degradation will proceed to mineralization, the formation of carbon dioxide and water, in a matter of hours to days thus mitigating the likelihood of leaching and runoff in substantial quantities to sources of drinking water.

Syrups, hydrolyzed starch, hydrogenated are also used in dental products since they do not contribute to tooth decay.

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

Unlike other pesticide chemicals 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 syrups, hydrolyzed starch, hydrogenated and any other substances, and syrups, hydrolyzed starch, hydrogenated 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 syrups, hydrolyzed starch, hydrogenated 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/ .

FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. The JEFCA committee has evaluated a multigeneration reproductive toxicity study in rats in which HGS (hydrogenated glucose syrup), a substance very similar to syrups, hydrolyzed starch, hydrogenated was administered in drinking water as an 18% aqueous solution. JECFA's review and evaluation did not reveal any toxicologically significant effects, and found no indication of increased susceptibility. Based on the reviews and evaluations conducted by WHO/JECFA, EPA has not used a safety factor analysis to assess the risk of syrups, hydrolyzed starch, hydrogenated. For the same reasons the additional tenfold safety factor is unnecessary.

The JECFA Committee reviewed and evaluated over a period of some years toxicity studies performed on various sugar alcohol chemicals. As a result of their review and evaluation, JECFA determined an ADI (Acceptable Daily Intake) of “not specified.” The only concern was for the potential laxative effect at high intakes. Based on the available information, EPA finds that exempting syrups, hydrolyzed starch, hydrogenated (CAS Reg. No. 68425-17-2) from the requirement of a tolerance will be safe for the general population including infants and children.

FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect. . . .” EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing syrups, hydrolyzed starch, hydrogenated for endocrine effects may be required.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

There are no existing tolerances or tolerance exemptions for syrups, hydrolyzed starch, hydrogenated.

Various syrups, hydrolyzed starch, hydrogenated are used as food additives in several countries. The Agency is not aware of any country requiring a tolerance for syrups, hydrolyzed starch, hydrogenated nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

The Agency established 40 CFR 180.950 (see the rationale in the proposed rule published January 15, 2002 (67 FR 1925) (FRL-6807-8)) to collect the tolerance exemptions for those substances classified as List 4A, i.e., minimal risk substances. As part of evaluating an inert ingredient and establishing the tolerance exemption, the Agency determines the chemical's list classification. The results of the reviews and evaluations performed by WHO/JECFA indicate a substance of lower toxicity. Therefore, syrups, hydrolyzed starch, hydrogenated (CAS Reg. No. 68425-17-2) is to be classified as a List 4A inert ingredient.

One comment was received from the Corn Allergy Support Group requesting that the Agency not grant the tolerance exemption for syrups, hydrolyzed starch, hydrogenated. The commenter believes that syrups, hydrolyzed starch, hydrogenated can cause severe allergic reactions in those individuals who are allergic to corn. It is certainly possible for an individual to be allergic to any food. However, most food allergy experts agree that the most common food allergens are: Peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat. According to the Food Allergy and Anaphylaxis Network (see http://www.foodallergy.org/allergens.html ) these eight allergens account for 90% of all food-allergic reactions.

Generally, an allergic response occurs as a result of the body's reaction to protein. In 2001, the Agency evaluated in a White Paper the presence of protein in several of the processed foods derived from corn (see http://www.epa.gov/oscpmont/sap/2001/july/wetmilling.pdf ). Corn can be milled by a dry milling or a wet milling process. The dry milling process produces flour, cornmeal, grits, corn bran and feed mixtures. The wet milling process uses a series of chemical reactions to produce corn syrup, corn oil and cornstarch. The steps that occur in the wet milling process are: Steeping, germ separation, fine grinding, starch separation, syrup conversion, and fermentation.

Given that corn starch can be used as the starting material for syrups, hydrolyzed starch, hydrogenated, the following parts of the discussion of the starch separation process as extracted from the White Paper are relevant here: “Mill starch is passed through a centrifuge which allows for the gluten to be spun out. . . . At this point, the starch has only approximately one to two percent of protein remaining. The starch is diluted 8 to 14 times, rediluted and washed again. . . to remove the last trace of protein and produce high quality starch (usually greater than 99.5% pure).” The starch is then converted to corn syrup via various refinement steps that are similar to the heat, acid and/or enzymatic processes using in producing syrups, hydrolyzed starch, hydrogenated.

Data in the White Paper demonstrate that while some very low levels of protein are present in the cornstarch, no detectable levels are present in corn syrup.

Given the similarities of the starting materials and the processes used, the Agency believes that the above data can be used to demonstrate the absence of protein in syrups, hydrolyzed starch, hydrogenated.

In response to the comment received, Grain Processing Corporation, the petitioner, submitted an opinion paper prepared by Dr. Steve L. Taylor of the Food Allergy Research & Resource Program at the University of Nebraska. The opinion paper dated February 9, 2000, is titled, Allergenicity of Corn-Derived Maltodextrin and Corn Starch . The abstract of Dr. Taylor's opinion is as follows:

Given the above data and an analysis of the information provided, EPA believes that there is a reasonable certainty that the tolerance exemption for syrups, hydrolyzed starch, hydrogenated would not contribute to allergic individuals' exposure to allergens. The protein that would provoke the allergic reaction is no longer present.

Based on the reviews and evaluations performed by JECFA which included the establishment of an acceptable daily intake (ADI) of “not specified” for polyglycitol syrups, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of syrups, hydrolyzed starch, hydrogenated. Accordingly, EPA finds that exempting syrups, hydrolyzed starch, hydrogenated (CAS Reg. No. 68425-17-2) from the requirement of a tolerance will be safe.

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 FFDCA 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-2005-0026 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 April 18, 2005.

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 (1900L), 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 Suite 350, 1099 14th St., NW., Washington, DC 20005. 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 (202) 564-6255.

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit XI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by docket ID number OPP-2005-0026, 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 ADDRESSES . 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 .

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

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

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

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

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

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

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), 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.gpo/opptsfrs/home/guidelin.htm/ .

In the Federal Register of December 31, 2003 (68 FR 75504) (FRL-7334-2), 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 1F6342) by Arvesta Corporation, 100 First St., Suite 1700, San Francisco, CA 94105. The petition requested that 40 CFR 180.586 be amended by establishing a tolerance for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on pome fruit at 1.0 parts per million (ppm). That notice included a summary of the petition prepared by Arvesta Corporation, the registrant. There were no comments received in response to the notice of filing.

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

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of 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 clothianidin on pome fruit at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by clothianidin as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of May 30, 2003 (68 FR 32390) (FRL-7306-8).

The dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

Three other types of safety or uncertainty factors may be used: “Traditional uncertainty factors;” the “special FQPA safety factor;” and the “default FQPA safety factor.” By the term “traditional uncertainty factor,” EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term “special FQPA safety factor” refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The “default FQPA safety factor” is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10x to account for interspecies differences and 10x for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 x 10 - 5 ), one in a million (1 x 10 - 6 ), or one in ten million (1 x 10 - 7 ). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated.

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

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.586) for the residues of clothianidin, in or on a variety of raw agricultural commodities. Tolerances for clothianidin are established on canola, field corn, pop corn, sweet corn, and milk. Since clothianidin is a major metabolite of thiamethoxam, which has many registered uses and several pending uses, residues of clothianidin that would theoretically result from the metabolism of thiamethoxam are included in the analysis. Risk assessments were conducted by EPA to assess dietary exposures from clothianidin 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. In conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID T ), which incorporates food consumption data as reported by respondents in the United States Department of Agriculture (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 acute exposure assessments: The acute analysis is a conservative assessment that was based on tolerance level residues and the assumption of 100% crop treated (PCT) for established and proposed clothianidin uses. For the commodities that have both thiamethoxam tolerances and established or proposed clothianidin tolerances (i.e., sweet corn, field corn, pop corn, canola, milk, and pome fruit), the proposed clothianidin tolerances are added to the residues that could result from use of thiamethoxam. The assumptions made for the acute exposure assessments for thiamethoxam are discussed in the Federal Register of January 5, 2005 (70 FR 708) (FRL-7689-7). The general U.S. population and all population subgroups have exposure and risk estimates which are below EPA's LOC (i.e., the aPADs are all below 100%). The most highly exposed population subgroup is infants less than 1 year old, which utilizes 80% of the aPAD.

ii. Chronic exposure . In conducting the chronic dietary risk assessment EPA used the DEEM-FCID TM , which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The chronic analysis is a relatively conservative assessment that was based on tolerance level residues and the assumption of 100% CT for established and proposed clothianidin uses, with the exception of anticipated residues (AR) for apples and pears. For the commodities that have both thiamethoxam tolerances and established or proposed clothianidin tolerances (i.e., sweet corn, field corn, pop corn, canola, and milk), the proposed clothianidin tolerances are added to the residues that could result from use of thiamethoxam. For apples and pears, the highest average field trial (HAFT) levels from the residue field trials were added to the residues that could result from use of thiamethoxam. The assumptions made for the chronic exposure assessments for thiamethoxam are discussed in the Federal Register of January 5, 2005 (70 FR 708) (FRL-7689-7). The general U.S. population and all population subgroups have exposure and risk estimates which are below EPA's LOC (i.e., the cPADs are all below 100%). The most highly exposed population subgroup is children 1 to 2 years of age, which utilizes 15% of the cPAD.

iii. Cancer . EPA has determined that clothianidin is not likely to be a human carcinogen. As a result, a quantitative cancer dietary exposure analysis was not performed.

iv. Anticipated residue and PCT information . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E) of FFDCA, EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

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

In addition to using EDOCKET at (http://www.epa.gov/edocket/) , 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

In the Federal Register of November 15, 2001 (66 FR 57450) (FRL-6808-6), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 1E6257) by The C.P. Hall Company, 311 S. Wacker, Suite 4700, Chicago, IL 60606, now doing business as CPH Services. The petition requested that 40 CFR part 180 be amended by establishing exemptions from the requirement of a tolerance for residues of N,N-dimethyloctanamide (CAS Reg. No. 1118-92-9) and N,N-dimethyldecanamide (CAS Reg. No. 14433-76-2) when used as inert ingredients as an emulsifier, solvent, and cosolvent in pesticide formulations applied only to growing crops at less than 15% of the total formulation by weight. That notice included a summary of the petition prepared by the petitioner.

In 2003, EPA received an amendment to the pending PP 1E6257. Subsequent to the publication of that notice of filing, the petitioner requested to amend the pending pesticide petition to remove the 15% limitation on the percentage of N,N-dimethyloctanamide and N,N-dimethyldecanamide used in formulated products. There were no other changes to the information presented by the petitioner in the 2001 notice. The amended notice was published in the Federal Register of November 19, 2003 (68 FR 65279) (FRL-7332-6). There were no comments received in response to either of the notices of filing.

Section 408(b)(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(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....”

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.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

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. The nature of the toxic effects caused by N,N-dimethyloctanamide and N,N-dimethyldecanamide are discussed in this unit.

The petitioner has also submitted information to the Agency as part of the High Production Volume Challenge Program. According to that information, N,N-dimethyldecanamide (CAS No. 14433-76-2) is produced commercially in a purified form (98%) as Hallcomid M-10. N,N-dimethyloctanamide (CAS No. 1118-92-9) and N,N-dimethyldecanamide are produced as a commercial mixture, Hallcomid M-8-10, containing 50-65% N,N-dimethyloctanamide, 37-50% of N,N-dimethyldecanamide, 0-5% N,N-dimethylhexanamide, and 0-2% N,N-dimethyldodecanamide.

The test substance for all of the studies reviewed by the Agency was identified as Hallcomid M-8-10. Thus, both the N,N-dimethyloctanamide and N,N-dimethyldecanamide were present in the test substance. Given that the octanamide and decanamide differ only in the carbon length (C8 versus C10) of the alkyl chain, the two chemicals can be considered as surrogates for each other.

The acute toxicity profile is presented in Table 1. below:

The petitioner submitted oral subchronic studies in the rat and dog, a rat inhalation study, and developmental toxicity studies in the rat and rabbit. The results of the Agency's review of these studies are in Table 2. below:

Toxicity for N,N-dimethyloctanamide and several structurally-related analogs was assessed, in part, by a process called SAR. In this process, the chemical's structural similarity to other chemicals (for which data are available) is used to determine toxicity. For human health, this process, can be used to assess absorption and metabolism, mutagenicity, carcinogenicity, developmental and reproductive effects, neurotoxicity, systemic effects, immunotoxicity, and sensitization and irritation. This is a qualitative assessment using terms such as good, not likely, poor, moderate, or high. Since N,N-dimethyldecanamide is of a chain length intermediate between N,N-dimethyloctanamide and the analogs assessed, the SAR conclusions also apply to N,N-dimethyloctanamide.

The SAR conclusions were as follows: Absorption would be poor via all routes of exposure. Thus, no significant effects are expected. The SAR did indicate concerns that one of the analogs might be an irritant. These concerns can be appropriately addressed through labeling and the use of protective equipment.

The acute toxicity data indicated that N,N-dimethyloctanamide and N,N-dimethyldecanamide are eye and dermal irritants.

Subchronic toxicity studies revealed no significant treatment related effects for N,N-dimethyloctanamide and N,N-dimethyldecanamide. In the 6-week oral gavage study in dogs, there were no significant differences between treated and control groups. During a 90-day oral toxicity study in rats, N,N- dimethyloctanamide and N,N-dimethyldecanamide did not produce any significant effects on mortality, clinical signs, food consumption, hematology, or gross pathology. In the 5-day inhalation study, test animals exhibited signs of respiratory tract irritation. However, this respiratory irritant effect occurred only at high inhalation doses.

N,N-dimethyloctanamide and N,N-dimethyldecanamide showed no evidence of mutagenicity, or chromosome aberration, and did not show any signs of developmental toxicity in the study in rabbits at dose levels up to 1,000 mg/kg/day. In a rat developmental toxicity study there was a decrease in weight gain in the high dose group, which could possibly be explained by a decrease in food consumption. It is noted that the SAR did not identify any developmental or reproductive concerns.

There is a consistent pattern of NOAELs of 100 mg/kg/day or greater in both subchronic toxicity studies and the maternal NOAELs in the developmental toxicity studies. But, the effects noted were not clinically or toxicologically relevant especially when compared to the control groups. These effects were mainly decreased weight gain in all species tested, but this occurred in such a small number of animals that it was not even statistically significant. Also, there was a corresponding decrease in food consumption. Additionally, it is noted that the spacing between the NOAELs and LOAELs is large.

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).

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Both N,N-dimethyloctanamide and N,N-dimethyldecanamide are sponsored under the High Production Volume Challenge Program. This is indicative of over 1 million pounds of N,N-dimethyloctanamide and N,N-dimethyldecanamide either produced or imported per year. Information indicates that N,N-dimethyloctanamide and N,N-dimethyldecanamide are used in personal care products and in paints.

The Agency has used various screening-level models to estimate some of the existing levels of exposure and those that could occur as a result of establishing this tolerance exemption. To assure protectiveness, the estimates in Table 4. below are deliberately intended to over-estimate exposure.

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

Unlike other pesticide chemicals 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 N,N-dimethyloctanamide and N,N-dimethyldecanamide and any other substances. N,N-dimethyloctanamide and N,N-dimethyldecanamide do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that N,N-dimethyloctanamide and N,N-dimethyldecanamide have 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 (OPP) 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/ .

FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data unless EPA concludes that a different margin of safety will be safe for infants and children. The Agency has reviewed the results of two developmental toxicity studies conducted using N,N-dimethyloctanamide and N,N-dimethyldecanamide. Based on the observed insignificant clinical toxic effects such as decreased weight gain due to decreased food intake, and the fact that developmental signs were observed only at very high doses, EPA has not used a safety factor analysis to assess the risk. For the same reasons a tenfold safety factor is unnecessary.

The Agency has reviewed and evaluated a toxicity database of 15 studies conducted using N,N-dimethyloctanamide and N,N-dimethyldecanamide. Studies indicate that N,N-dimethyloctanamide and N,N-dimethyldecanamide have a low systemic toxicity via oral exposure and are not mutagenic. Developmental effects were observed only at very high doses. The SAR assessments did not indicate any concerns for carcinogenicity, developmental, or reproductive effects. Based on the available information on toxicity and exposure, EPA finds that exempting N,N-dimethyloctanamide and N,N-dimethyldecanamide from the requirement of a tolerance will be safe for the general population including infants and children.

FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect. . .” EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing N,N-dimethyloctanamide and N,N-dimethyldecanamide for endocrine effects may be required.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

There are no existing tolerances or tolerance exemptions for N,N-dimethyloctanamide and N,N-dimethyldecanamide.

The Agency is not aware of any country requiring a tolerance for N,N-dimethyloctanamide and N,N-dimethyldecanamide nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of N,N-dimethyloctanamide or octanamide, N,N-dimethyl (CAS Reg. No. 1118-92-9), and N,N-dimethyldecanamide or decanamide, N,N-dimethyl (CAS Reg. No. 14433-76-2). Accordingly, EPA finds that exempting octanamide, N,N-dimethyl (CAS Reg. No. 1118-92-9) and decanamide, N,N-dimethyl (CAS Reg. No. 14433-76-2) from the requirement of a tolerance will be safe.

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 FFDCA 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-2005-0031 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 April 18, 2005.

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 (1900L), 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 Suite 350, 1099 14 th St., NW., Washington, DC 20005. 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 (202) 564-6255.

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit XI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by docket ID number OPP-2005-0031, 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 ADDRESSES . 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).

NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management 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 2005 Pacific cod interim TAC allocated to catcher vessels 60 feet (18.3 m) LOA and longer using pot gear in the BSAI is 8,380 metric tons as established by the 2005 interim harvest specifications for groundfish in the BSAI (69 FR 76870, December 23, 2004). See § 679.20(c)(2)(ii)(A), § 679.20(c)(5), and § 679.20(a)(7)(i)(A) and (C)(1)(iv).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS, has determined that the 2005 Pacific cod interim TAC allocated to catcher vessels using pot gear in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels 60 feet (18.3 m) LOA and longer using pot gear in the BSAI. Vessels less than 60 feet (18.3 m) LOA using pot gear in the BSAI may continue to participate in the directed fishery for Pacific cod under a separate Pacific cod allocation to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

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 NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the fisheries under the 2005 Pacific cod interim TAC specified for catcher 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 GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (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 pollock interim TAC for Statistical Area 630 of the GOA is 3,091 metric tons (mt) as established by the interim harvest specifications for groundfish of the GOA (69 FR 74455, December 14, 2004).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the pollock interim TAC in Statistical Area 630 will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 2,891 mt, and is setting aside the remaining 200 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 has been reached. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 630 of the GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

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 NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of pollock in Statistical Area 630 of the GOA.

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.