The Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified the FAA that an unsafe condition may exist on certain Airbus Model A318, A319, A320, and A321 series airplanes. The DGAC advises that there have been several reports of total loss of all six liquid crystal display (LCD) units for the electronic instrument system (EIS) of a certain EIS2 standard during cruise for a short period of time. The flightcrew used the standby instruments, and the LCD units were eventually recovered. Subsequent investigation revealed that the three display management computers had received erroneous data from one LCD unit. Loss of all LCD units, if not corrected, could result in loss of critical flight information to the flightcrew and the reduced ability of the flightcrew to control the airplane during adverse operating conditions.

Airbus has issued Temporary Revision (TR) 4.02.00/22, dated June 22, 2004, to the A318/319/320/321 Airplane Flight Manual (AFM). The TR provides procedures for the flightcrew to follow in the event of the loss of all LCD units on airplanes equipped with a certain EIS2 standard of electronic instrument system. The DGAC mandated incorporation of the TR and issued French airworthiness directive F-2004-104 R1, dated August 18, 2004, to ensure the continued airworthiness of these airplanes in France.

The DGAC advises that a new EIS2 standard, 4.2, has been developed to address the problems associated with loss of the LCD units. Airbus Service Bulletin A320-31A1220, dated July 2, 2004 (reference Airbus Modification 34571), describes procedures for installing EIS2 standard 4.2, which eliminates the need for the AFM revision described above.

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

Therefore, we are issuing this AD to provide procedures to the flightcrew to restore operation of these LCD units and prevent prolonged loss of critical flight information to the flightcrew and the consequent reduced ability of the flightcrew to control the airplane during adverse flight conditions. This AD requires incorporation of the TR described previously, unless the new EIS2 standard is installed.

The DGAC airworthiness directive mandates changes to the master minimum equipment list (MMEL). But this (FAA) AD will not mandate those MMEL changes because the limits imposed by the FAA-approved MMEL meet or exceed those mandated by the French airworthiness directive.

Although the DGAC airworthiness directive mandates the immediate incorporation of the TR's operational limitations, this (FAA) AD would allow up to 10 days for compliance. We find that a 10-day compliance time will provide the time necessary for operators to accomplish the requirements of this AD without adversely affecting safety.

We consider this AD interim action. The DGAC is considering mandating the new EIS standard on those airplanes. We may consider further rulemaking at that time.

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-2004-19183; Directorate Identifier 2004-NM-158-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.

We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications with you. You can get more information about plain language at http://www/faa.gov/language and http://www.plainlanguage.gov.

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 Direction Ge ne rale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified the FAA that an unsafe condition may exist on certain Airbus Model A330 and A340 series airplanes. The DGAC advises that there have been several reports of total loss of all six liquid crystal display (LCD) units for the electronic instrument system (EIS) of standard EIS2 during cruise for a short period of time. The flightcrew used the standby instruments, and the LCD units were eventually recovered. Subsequent investigation revealed that the three display management computers had received erroneous data from one LCD unit. Loss of all LCD units, if not corrected, could result in loss of critical flight information and the reduced ability of the flightcrew to control the airplane during adverse operating conditions.

Airbus has issued the following temporary revisions (TRs) to the Airbus A330 and A340 airplane flight manuals (AFMs), as applicable:

The TRs provide procedures for the flightcrew to follow in the event of the loss of all LCD units on airplanes equipped with the EIS2 standard of electronic instrument system. The DGAC mandated incorporation of the TRs and issued French airworthiness directive F-2004-117, dated July 21, 2004, to ensure the continued airworthiness of these airplanes in France.

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

Therefore, we are issuing this AD to provide procedures to the flightcrew to restore operation of these LCD units and prevent prolonged loss of critical flight information to the flightcrew and the consequent reduced ability of the flightcrew to control the airplane during adverse flight conditions. This AD requires revising the AFM to incorporate the TRs described previously.

The DGAC airworthiness directive mandates changes to the master minimum equipment list (MMEL). But this (FAA) AD will not mandate those MMEL changes because the limits imposed by the FAA-approved MMEL meet or exceed those mandated by the French airworthiness directive.

Although the DGAC airworthiness directive mandates the immediate incorporation of the TRs' operational limitations, this (FAA) AD would allow up to 10 days for compliance. We find that a 10-day compliance time will provide the time necessary for operators to accomplish the requirements of this AD without adversely affecting safety.

We consider this AD interim action. If final action is later identified, we may consider further rulemaking then.

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-2004-19184; Directorate Identifier 2004-NM-159-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 .

We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications with you. You can get more information about plain language at http://www/faa.gov/language and http://www.plainlanguage.gov .

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.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Boeing Model 707 and 720 series airplanes was published in the Federal Register on February 13, 2004 (69 FR 7174). That action proposed to require an inspection of the main landing gear (MLG) lock support fitting and the wing fillet flap support link for damage, and corrective action, if necessary; and replacement of the bolts and bushings at the joint between the MLG lock support fitting and the wing fillet flap support link.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the one comment received.

One commenter requests to revise “Parts Installation” paragraph (e) of the proposed AD. The commenter suggests including “and no person shall install a bushing other than an aluminum nickel bronze * * *.” The commenter notes that the root cause of the unsafe condition of the proposed AD is corrosion and galling between the bolt and steel bushings.

We agree with the commenter. We inadvertently omitted the bushings from paragraph (e) of the proposed AD. As specified in paragraph (d) of the proposed AD, bolts and bushings are to be replaced with new CRES bolts and Cadmium-plated Al-Ni-Br bushings. The intent of paragraph (e) of the proposed AD was to prevent bolts and bushings other than CRES bolts and Cadmium-plated Al-Ni-Br bushings from being installed. We have revised paragraph (e) of the final rule accordingly.

After careful review of the available data, including the comment noted above, we have determined that air safety and the public interest require the adoption of the rule with the changes previously described. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 230 airplanes of the affected design in the worldwide fleet. We estimate that 42 airplanes of U.S. registry will be affected by this AD, that it will take approximately 14 work hours per airplane to accomplish the required replacement and inspections, and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $38,220, or $910 per airplane.

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

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A final rule AD, FR Doc. 04-21173 that applies to RR RB211-22B, RB211-524, and RB211-535 series turbofan engines, was published in the Federal Register on September 22, 2004 (69 FR 56683). The following correction is needed:

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

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

In accordance with section 513(f)(1) of the act, FDA issued a document on June 15, 2004, classifying the Microgenics CEDIA Sirolimus Assay in class III because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On June 16, 2004, Microgenics Corp. submitted a petition requesting classification of the Microgenics CEDIA Sirolimus Assay under section 513(f)(2) of the act. The manufacturer recommended that the device be classified into class II.

In accordance with 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in 513(a)(1) of the act. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the Microgenics CEDIA Sirolimus Assay can be classified in class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of safety and effectiveness of the device.

The device is assigned the generic name sirolimus test system and is identified as a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.

FDA has identified no direct risks to health related to use of sirolimus test systems. However, FDA has identified improper patient management, which involves failure of the test to perform as indicated or error in interpretation of results, as an indirect risk to health related to use of this device. For example, a falsely low sirolimus measurement could contribute to a decision to raise the sirolimus dose above that which is necessary for therapeutic benefit. This could result in increased risk in the form of thrombocytopenia, leukopenia, anemia, or hyperlipidemia. A falsely high sirolimus measurement could contribute to a decision to decrease the dose below that which is necessary for immunosuppression. This could result in increased risk of rejection of the transplanted organ. Since optimal ranges for sirolimus may vary depending on the metabolite cross-reactivity of the specific assay, as well as on clinical factors, use of assay results to adjust a treatment regimen without consideration of such factors could also lead to improper patient management. Therefore, in addition to the general controls of the act, the device is subject to special controls, identified as the guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.”

The class II special controls guidance document also provides information on how to meet premarket (510(k)) submission requirements for the device, including recommendations on validation of performance characteristics and labeling. FDA believes that following the class II special controls guidance document generally addresses the risks to health identified in the previous paragraph. Therefore, on July 28, 2004, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this classification by adding 21 CFR 862.3840.

Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a sirolimus test system will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurance of safety and effectiveness.

Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness. FDA review of performance characteristics, test methodology, and labeling to satisfy requirements of § 807.87(e), will provide reasonable assurance that acceptable levels of performance for both safety and effectiveness will be addressed before marketing clearance. Thus, persons who intend to market this type of device must submit to FDA a premarket notification containing information on the sirolimus test system they intend to market, before marketing the device.

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

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

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

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $110 million. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

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

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

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

In FR Doc. 04-17699 appearing on page 49960 in the Federal Register of 12 August 2004, the following correction is made to the SUPPLEMENTARY INFORMATION:

On page 49980, first column, third full paragraph (answer to comment 69), the fourth sentence “Furthermore, it is noted that the appellant can file a request for continued prosecution pursuant to § 1.114 and then the appellant would be able to submit an amendment and/or evidence directed to only claims unrelated to the new ground of rejection and have such considered by the examiner.” is corrected to read: “Furthermore, it is noted that the appellant can file a request for continued prosecution pursuant to § 1.114 and then the appellant would be able to submit an amendment and/or evidence also directed to claims unrelated to the new ground of rejection and have such considered by the examiner.”

The Copyright Act grants copyright owners of sound recordings the exclusive right to perform their works publicly by means of digital audio transmissions subject to certain limitations and exceptions. Among the limitations placed on the performance right for sound recordings are certain exemptions and a statutory license that permits certain eligible subscription, nonsubscription, and satellite digital audio radio to perform those sound recordings publicly by means of digital audio transmissions. 17 U.S.C. 114.

Similarly, copyright owners of sound recordings are granted the exclusive right to make copies of their works subject to certain limitations and exceptions. Among the limitations placed on the reproduction right for sound recordings is a statutory license that permits certain eligible subscription, nonsubscription, satellite digital audio, and business establishment services to make ephemeral copies of those sound recordings to facilitate their digital transmission. 17 U.S.C. 112(e).

Both the section 114 and 112 licenses require services to, among other things, report to copyright owners of sound recordings on the use of their works. Both licenses direct the Librarian of Congress to establish regulations to give copyright owners reasonable notice of the use of their works and create and maintain records of use for delivery to copyright owners. 17 U.S.C. 114(f)(4)(A) and 17 U.S.C. 112(e)(4). The purpose of this notice and recordkeeping requirement is to ensure that the royalties collected under the statutory licenses are distributed to the correct recipients.

The Copyright Office announced interim regulations on March 11, 2004, specifying notice and recordkeeping requirements for use of sound recordings under the section 112 and 114 licenses.  1 See 69 FR 11515 (March 11, 2004). However, those interim regulations are prospective and do not address the notice and recordkeeping requirements for the period from October 28, 1998 (the date the statutory licenses other than the license for preexisting subscription services first became available) through March 31, 2004 (the “historic period”).

Previously, the Office had published a notice of inquiry seeking comment on what records of use are to be prescribed for uses of sound recordings during the historic period, a period during which many services had maintained few or, in many instances, no records of such use. 68 FR 58054 (October 8, 2003). The Office received a number of comments and, on July 13, 2004, the Office published a notice of proposed rulemaking proposing rules to address the historic period that were based upon the comments it had received in response to the notice of inquiry. 69 FR 42007 (July13, 2004). Because few, if any, records of prior use had been maintained to date and those that do exist would be of little or no use in forming the basis for distribution of royalties for the historic period, the Office concluded that there was little likelihood of obtaining any useful and meaningful data by requiring services to report information from the historic period. Instead of requiring such retroactive reports, the Office followed the suggestion of several commenters and proposed to adopt rules providing that a proxy be used in lieu of reporting requirements for the historic period. The proxy that emerged as the one most favored by the commenters was the data already provided by the preexisting subscription services to SoundExchange, Inc. 2 under the regulations announced in 1998 and now codified at 37 CFR 270.2 for transmissions made under section 114(f).

The Office proposed to adopt regulations specifying that the records of use submitted by the preexisting subscription services during the period between October 28, 1998, and March 31, 2004, shall be considered the records of use for all services operating under the section 112(e) and section 114 licenses and that no additional records need be filed by the nonsubscription services, the satellite digital radio audio services, business establishment services or new types of subscription services.

Three comments were submitted to the Office in response to the notice of proposed rulemaking. SoundExchange, Inc., a nonprofit organization jointly controlled by representatives of copyright owners and performers on whose behalf it receives and disburses section 114 statutory royalties, expressed its support for the proposed rule as “the best solution for a bad situation”- i.e ., a situation in which services using the statutory license had not been required to retain data on use of sound recordings. The National Association of Broadcasters, many of whose members operate under the statutory license, also expressed its support for the proposed rule.

RLI submitted a comment in which it took no position on the use of data from the preexisting subscription services as a proxy. However, RLI asserted that contrary to the Office's understanding, a number of copyright owners and performers had designated RLI as their designated agent to distribute statutory royalties. RLI therefore urged that the records of use submitted by the preexisting subscription services to SoundExchange be provided to RLI as well so that RLI could use those records in its distribution of royalties to copyright owners and performers who have designated it as their designated agent. RLI further requested that the regulations provide that RLI receive such records directly from the preexisting subscription services rather than from SoundExchange.

In light of the support in the comments for adoption of the reports already submitted by the preexisting subscription services as a proxy for reports from nonsubscription services, the satellite digital radio audio services, business establishment services or new types of subscription services, the Office has decided to adopt the proposed rule as a final rule.

However, RLI's assertion that it is entitled to receive the preexisting subscription services' reports requires a modification of the proposed rule. Whether RLI has or has not properly been designated by any copyright owners or performers is not an issue that can be resolved in this rulemaking proceeding; nor is there any need to resolve that issue. It will suffice to provide in the regulation that if RLI has been properly designated by any copyright owners or performers, 3 SoundExchange must provide copies of the preexisting subscription services' reports to that designated agent. The Office rejects as impractical RLI's request that the preexisting subscription services be required to send those reports directly to RLI. The reports in question, which cover the period from October 28, 1998, through March 31, 2004, have already been submitted to SoundExchange (or its predecessor, the Recording Industry Association of America) over a period of several years under the existing notice and recordkeeping regulations for preexisting subscription services. It would be an unfair burden on the preexisting subscription services to require them now to serve additional copies of those reports (copies of which they have not necessarily retained) on RLI, especially when all the reports are now in the possession of SoundExchange, which necessarily will have retained those reports to assist in distribution of royalties.

Throughout this document, “we,” “us” and “our” refer to EPA.

On April 16, 2003 (68 FR 18546), we published a limited approval and limited disapproval of MCESD Rule 331 as adopted locally on April 7, 1999 and submitted by the State on August 4, 1999. We based our limited disapproval action on certain deficiencies in the submittal. This disapproval action started a sanctions clock for imposition of offset sanctions 18 months after April 16, 2003 and highway sanctions 6 months later, pursuant to section 179 of the Clean Air Act (CAA) and our regulations at 40 CFR 52.31.

On April 21, 2004, MCESD adopted revisions to Rule 331 that were intended to correct the deficiencies identified in our limited disapproval action. On July 28, 2004, the State submitted these revisions to EPA. In the Proposed Rules section of today's Federal Register , we have proposed approval of this submittal because we believe it corrects the deficiencies identified in our April 16, 2003 disapproval action. Based on today's proposed approval, we are taking this final rulemaking action, effective on publication, to stay and/or defer imposition of sanctions that were triggered by our April 16, 2003 limited disapproval.

EPA is providing the public with an opportunity to comment on this stay/deferral of sanctions. If comments are submitted that change our assessment described in this final determination and the proposed full approval of revised MCESD Rule 331, we intend to take subsequent final action to reimpose sanctions pursuant to 40 CFR 51.31(d). If no comments are submitted that change our assessment, then all sanctions and sanction clocks will be permanently terminated on the effective date of a final rule approval.

We are making an interim final determination to stay and/or defer CAA section 179 sanctions associated with MCESD Rule 331 based on our concurrent proposal to approve the State's SIP revision as correcting deficiencies that initiated sanctions.

Because EPA has preliminarily determined that the State has corrected the deficiencies identified in EPA's limited disapproval action, relief from sanctions should be provided as quickly as possible. Therefore, EPA is invoking the good cause exception under the Administrative Procedure Act (APA) in not providing an opportunity for comment before this action takes effect (5 U.S.C. 553(b)(3)). However, by this action EPA is providing the public with a chance to comment on EPA's determination after the effective date, and EPA will consider any comments received in determining whether to reverse such action.

EPA believes that notice-and-comment rulemaking before the effective date of this action is impracticable and contrary to the public interest. EPA has reviewed the State's submittal and, through its proposed action, is indicating that it is more likely than not that the State has corrected the deficiencies that started the sanctions clocks. Therefore, it is not in the public interest to initially impose sanctions or to keep applied sanctions in place when the State has most likely done all it can to correct the deficiencies that triggered the sanctions clocks. Moreover, it would be impracticable to go through notice-and-comment rulemaking on a finding that the State has corrected the deficiencies prior to the rulemaking approving the State's submittal. Therefore, EPA believes that it is necessary to use the interim final rulemaking process to stay and/or defer sanctions while EPA completes its rulemaking process on the approvability of the State's submittal. Moreover, with respect to the effective date of this action, EPA is invoking the good cause exception to the 30-day notice requirement of the APA because the purpose of this notice is to relieve a restriction (5 U.S.C. 553(d)(1)).

This action stays and/or defers federal sanctions and imposes no additional requirements.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget.

This action is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action.

The administrator certifies that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

This rule does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action does not have Federalism implications because it does 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This rule is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply to this rule because it imposes no standards.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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 to Congress and the Comptroller General. However, section 808 provides that any rule for which the issuing agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the agency promulgating the rule determines. 5 U.S.C. 808(2). EPA has made such a good cause finding, including the reasons therefor, and established an effective date of September 30, 2004. 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 the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 29, 2004. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purpose of judicial review nor does it extend the time within which petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

Do not submit this information to EPA through Regional Materials in EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date, and page number).

• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

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• Describe any assumptions and provide any technical information and/or data that you used.

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• Provide specific examples to illustrate your concerns, and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• Make sure to submit your comments by the comment period deadline identified.

In this action, we are approving a revised maintenance plan for the Longmont CO attainment/maintenance area that is designed to keep the area in attainment for CO through 2015, and we're approving revised transportation conformity motor vehicle emissions budgets (MVEB). We approved the original CO redesignation to attainment and maintenance plan for the Longmont area on September 24, 1999 ( see 64 FR 51694).

The original Longmont CO maintenance plan that we approved on September 24, 1999 (hereafter September 24, 1999 maintenance plan) utilized the then applicable EPA mobile sources emission factor model, MOBILE5a. On January 18, 2002, we issued policy guidance for States and local areas to use to develop SIP revisions using the new, updated version of the model, MOBILE6. The policy guidance was entitled “Policy Guidance on the Use of MOBILE6 for SIP Development and Transportation Conformity” (hereafter, January 18, 2002 MOBILE6 policy). On November 12, 2002, EPA's Office of Transportation and Air Quality (OTAQ) issued an updated version of the MOBILE6 model, MOBILE6.2, and notified Federal, State, and local agency users of the model's availability. MOBILE6.2 contained additional updates for air toxics and particulate matter. However, the CO emission factors were essentially the same as in the MOBILE6 version of the model.

For the years analyzed in the September 24, 1999 maintenance plan (1993, 2005, 2010, and 2015), the State revised and updated the mobile sources CO emissions using MOBILE6.2. With the revised maintenance plan, the State also provided emissions data for 2006. The State recalculated the CO MVEB for 2010 through 2014 and applied a selected amount of the available safety margin to the 2010 through 2014 transportation conformity MVEB. The State recalculated the CO MVEB for 2015 and beyond and also applied a selected amount of the available safety margin to the 2015 and beyond transportation conformity MVEB. We have determined that all the revisions noted above are Federally-approvable, as described further below.

Section 110(k) of the CAA addresses our actions on submissions of revisions to a SIP. The CAA requires States to observe certain procedural requirements in developing SIP revisions for submittal to us. Section 110(a)(2) of the CAA requires that each SIP revision be adopted after reasonable notice and public hearing. This must occur prior to the revision being submitted by a State to us.

The Colorado Air Quality Control Commission (AQCC) held a public hearing for the revised Longmont Carbon Monoxide (CO) Maintenance Plan December 18, 2003. The AQCC adopted the revised maintenance plan directly after the hearing. This SIP revision became State effective on March 1, 2004, and was submitted by the Governor to us on April 12, 2004.

We have evaluated the Governor's submittal for the revised maintenance plan and have determined that the State met the requirements for reasonable notice and public hearing under section 110(a)(2) of the CAA. We reviewed these SIP materials for conformance with the completeness criteria in 40 CFR part 51, Appendix V and determined that the submittal was administratively and technically complete. The Governor was advised of our completeness determination through a letter from Robert E. Roberts, Regional Administrator, dated June 17, 2004.

EPA has reviewed the State's revised maintenance plan for the Longmont attainment/maintenance area and believes that approval is warranted. The following are the key aspects of this revision along with our evaluation of each:

(a) The State has revised the Longmont maintenance plan and has air quality data that show continuous attainment of the CO NAAQS.

As described in 40 CFR 50.8, the national primary ambient air quality standard for carbon monoxide is 9 parts per million (10 milligrams per cubic meter) for an 8-hour average concentration not to be exceeded more than once per year. 40 CFR 50.8 continues by stating that the levels of CO in the ambient air shall be measured by a reference method based on 40 CFR part 50, Appendix C and designated in accordance with 40 CFR part 53 or an equivalent method designated in accordance with 40 CFR part 53. The September 24, 1999 maintenance plan relied on ambient air quality data from 1989 through 1996. In our consideration of the revised Longmont CO maintenance plan, submitted by the Governor on April 12, 2004, we reviewed ambient air quality data from 1993 through 2003 and the first calendar quarter of 2004. The Longmont area shows continuous attainment of the CO NAAQS from 1993 to present. All of the above-referenced air quality data are archived in our Aerometric Information and Retrieval System (AIRS).

(b) Using the MOBILE6.2 emission factor model, the State revised the attainment year inventory (1993), prior projected years (2005, 2010, and 2015) inventories and a new projected year (2006) emission inventory.

The revised maintenance plan that the Governor submitted on April 12, 2004 includes comprehensive inventories of CO emissions for the Longmont area. These inventories include emissions from stationary point sources, area sources, non-road mobile sources, and on-road mobile sources. More detailed descriptions of the revised 1993 attainment year inventory, the revised 2005, 2010, and 2015 projected inventories, and the new projected 2006 inventory, are documented in the maintenance plan in section 2 entitled “Emission Inventories and Maintenance Demonstration” and in the State's Technical Support Document (TSD). The State's submittal contains emission inventory information that was prepared in accordance with EPA guidance. Summary emission figures from the 1993 attainment year and the projected years are provided in Table IV.-1 below.

The revised mobile source emissions show the largest change from the September 24, 1999 maintenance plan and this is primarily due to the use of MOBILE6.2 instead of MOBILE5a. The MOBILE6.2 modeling information is contained in the State's TSD (see “Mobile Source Emission Inventories,” page 6) and on a compact disk we prepared (a copy is available upon request). The State's TSD information is also available on a compact disk that may be requested from the State or it can be downloaded directly from the State's Web site at http://apcd.state.co.us/documents/techdocs.html. The TSD compact disk contains much of the modeling data, input-output files, fleet makeup, MOBILE6.2 input parameters, and other information and is included with the docket for this action. Other revisions to the mobile sources category resulted from revised vehicle miles traveled (VMT) estimates that were provided to the State from the Denver Regional Council of Governments (DRCOG), which is the metropolitan planning organization (MPO) for the Longmont area. In summary, the revised maintenance plan and State TSD contain detailed emission inventory information that was prepared in accordance with EPA guidance and is acceptable to EPA.

(c) The State revised the maintenance demonstration used in the September 24, 1999 Longmont maintenance plan.

As noted above, the State used the MOBILE6.2 model to revise the Longmont CO maintenance plan. Our January 18, 2002, MOBILE6 policy allows areas to revise their motor vehicle emission inventories and transportation conformity MVEBs using the MOBILE6 model without needing to revise the entire SIP or completing additional modeling if: (1) The SIP continues to demonstrate attainment or maintenance when the MOBILE5-based motor vehicle emission inventories are replaced with MOBILE6 base year and attainment/maintenance year inventories; and (2) the State can document that the growth and control strategy assumptions for non-motor vehicle emission sources continue to be valid and minor updates do not change the overall conclusion of the SIP. Our January 18, 2002 MOBILE6 policy also speaks specifically to CO maintenance plans on page 10 of the policy. The first paragraph on page 10 of the policy states “* * * if a carbon monoxide (CO) maintenance plan relied on either a relative or absolute demonstration, the first criterion could be satisfied by documenting that the relative emission reductions between the base year and the maintenance year are the same or greater using MOBILE6 as compared to MOBILE5.”

The State could have used the streamlined approach described in our January 18, 2002 MOBILE6 policy to update the Longmont CO MVEB. However, the Governor's April 12, 2004 SIP submittal instead contained a completely revised maintenance plan and maintenance demonstration for the Longmont area. That is, all emission source categories (point, area, non-road, and mobile) were updated using the latest versions of applicable models (including MOBILE6.2), transportation data sets, emissions data, emission factors, population figures, and other demographic information. We have determined that this fully revised maintenance plan SIP submittal exceeds the requirements of our January 18, 2002 MOBILE6 policy and, therefore, our January 18, 2002 MOBILE6 policy is not relevant to our approval of the revised maintenance plan and its MVEB.

As discussed above, the State prepared revised emission inventories for the years 1993, 2005, 2006, and 2010, and 2015. The results of these calculations are presented in Table 1 “Longmont Carbon Monoxide Maintenance Plan Emission Inventories” on page 4 of the revised Longmont maintenance plan and are also summarized in our Table IV.-1 above. The State has demonstrated that with the use of MOBILE6.2, mobile source emissions show a continuous decline from 1993 to 2015 and that the total CO emissions, from all source categories, projected for each future year (2005, 2006, 2010, and 2015) are all below the 1993 attainment year level of CO emissions. Therefore, we have determined that the revised maintenance plan continues to demonstrate maintenance of the CO NAAQS from 1993 to 2015 and is approvable.

(d) Monitoring Network and Verification of Continued Attainment: Continued attainment of the CO NAAQS in the Longmont area depends, in part, on the State's efforts to track indicators throughout the maintenance period. This requirement is met in section 5. “Monitoring Network/Verification of Continued Attainment” of the revised Longmont CO maintenance plan. In section 5., the State commits to continue the operation of the CO monitor in the Longmont area and to annually review this monitoring network and make changes as appropriate to meet the requirements of 40 CFR part 58.

Also, in section 6.A, the State commits to track mobile sources' CO emissions (which are the largest component of the inventories) through the ongoing regional transportation planning process that is done by DRCOG. Since regular revisions to Longmont's transportation improvement programs must go through a transportation conformity finding, the State will use this process to periodically review the Vehicle Miles Traveled (VMT) and mobile source emissions projections used in the revised maintenance plan. This regional transportation process is conducted by DRCOG in coordination with the State's Air Pollution Control Division (APCD), the AQCC, and EPA.

Based on the above, we are approving these commitments as satisfying the relevant requirements. We note that our final rulemaking approval renders the State's commitments federally enforceable. These commitments are also the same as we approved in the original maintenance plan.

(e) Contingency Plan: Section 175A(d) of the CAA requires that a maintenance plan include contingency provisions. To meet this requirement, the State has identified appropriate contingency measures along with a schedule for the development and implementation of such measures.

As stated in section 6 of the revised maintenance plan, the contingency measures for the Longmont area will be triggered by a violation of the CO NAAQS. (However, the maintenance plan does note that an exceedance of the CO NAAQS may initiate a voluntary, local process by the City of Longmont, DRCOG, and APCD to identify and evaluate potential contingency measures.)

The City of Longmont and DRCOG, in conjunction with the APCD and AQCC, will initiate a subcommittee process to begin evaluating potential contingency measures no more than 60 days after being notified by the APCD that a violation of the CO NAAQS has occurred. The subcommittee will present recommendations within 120 days of notification and the recommended contingency measures will be presented to the AQCC within 180 days of notification. The AQCC will then hold a public hearing to consider the recommended contingency measures, along with any other contingency measures that the AQCC believes may be appropriate to effectively address the violation of the CO NAAQS. The necessary contingency measures will be adopted and implemented within one year after the violation occurs.

The potential contingency measures that are identified in section 6.C of the revised Longmont CO maintenance plan include: (1) An enhanced vehicle inspection and maintenance program as described in AQCC Regulation No. 11 as it existed prior to the modifications adopted by the AQCC on January 10, 2000; (2) a 3.1% oxygenated gasoline program from November 8 through February 7, with a 2.0% oxygen content required from November 1 through November 7; and (3) nonattainment New Source Review (NSR) permitting requirements.

Based on the above, we find that the contingency measures provided in the State's revised Longmont CO maintenance plan are sufficient and continue to meet the requirements of section 175A(d) of the CAA.

(f) Subsequent Maintenance Plan Revisions: In accordance with section 175A(b) of the CAA, Colorado committed to submit a revised maintenance plan eight years after our approval of the original redesignation. This provision for revising the maintenance plan is contained in section 7 of the revised Longmont CO maintenance plan. In section 7, the State commits to submit a revised maintenance plan in 2007 to correspond with our initial approval of the original maintenance plan on September 24, 1999 (64 FR 51694).

Based on our review of the components of the revised Longmont CO maintenance plan, as discussed in our items IV.(a) through IV.(f) above, we have concluded that the State has met the necessary requirements in order for us to fully approve the revised Longmont CO maintenance plan.

One key provision of our conformity regulation requires a demonstration that emissions from the transportation plan and Transportation Improvement Program are consistent with the emissions budget(s) in the SIP (40 CFR 93.118 and 93.124). The emissions budget is defined as the level of mobile source emissions relied upon in the attainment or maintenance demonstration to maintain compliance with the NAAQS in the nonattainment or maintenance area. The rule's requirements and EPA's policy on emissions budgets are found in the preamble to the November 24, 1993 transportation conformity rule (58 FR 62193-62196) and in the sections of the rule referenced above.

With respect to maintenance plans, our conformity regulation requires that MVEB(s) must be established for the last year of the maintenance plan and may be established for any other years deemed appropriate (40 CFR 93.118). For transportation plan analysis years after the last year of the maintenance plan (in this case 2015), a conformity determination must show that emissions are less than or equal to the maintenance plan's motor vehicle emissions budget(s) for the last year of the implementation plan. EPA's conformity regulation (40 CFR 93.124) also allows the implementation plan to quantify explicitly the amount by which motor vehicle emissions could be higher while still demonstrating compliance with the maintenance requirement. The implementation plan can then allocate some or all of this additional “safety margin” to the emissions budget(s) for transportation conformity purposes.

Section 4 “Transportation Conformity and Mobile Source Carbon Monoxide Emission Budgets” of the revised Longmont CO maintenance plan briefly describes the applicable transportation conformity requirements, provides MVEB calculations, identifies “safety margin,” and indicates that the City of Longmont and DRCOG elected to apply the identified “safety margin” to the MVEB for 2010 through 2014 and 2015 and beyond.

In section 4 of the revised maintenance plan, the State evaluated two MVEBs; a budget for 2015 (the last year of the maintenance plan) and beyond and a budget applicable to the years 2010 through 2014. For the 2015 MVEB, the State subtracted the total estimated 2015 emissions (from all sources) of 36.36 Tons Per Day (TPD) from the 1993 attainment year total emissions of 52.71 TPD. This produced a “safety margin” of 16.35 TPD. The State then reduced this “safety margin” by one TPD. The identified “safety margin” of 15.35 TPD for 2015 was then added to the estimated 2015 mobile sources emissions, 25.99 TPD, to produce a 2015 MVEB of 41 TPD. For the 2010 through 2014 MVEB, the State subtracted the total estimated 2010 emissions (from all sources) of 38.17 TPD from the 1993 attainment year total emissions of 52.71 TPD. This produced a “safety margin” of 14.54 TPD. The State then reduced this “safety margin” by one TPD. The identified “safety margin” of 13.54 TPD for 2010 was then added to the estimated 2010 mobile sources emissions, 28.01 TPD, to produce a 2010 through 2014 MVEB of 41 TPD. These MVEBs were identified in the first sentence of paragraph two of section 4 of the revised maintenance plan which states, “The Longmont attainment/maintenance area mobile source emission budgets are 41 tons/day for 2010 through 2014 and 41 tons/day for 2015 and beyond.” Based on this choice, and in order for a positive conformity determination to be made, transportation plan analyses for years 2010 through 2014 must show that motor vehicle emissions will be less than or equal to the 2010 through 2014 MVEB of 41 TPD of CO and transportation plan analyses for years 2015 and beyond must show that motor vehicle emissions will be less than or equal to the 2015 MVEB of 41 TPD of CO. The revised maintenance plan also states that the previously approved CO MVEB of 16.76 TPD for 2015 and beyond (see 64 FR 51694, September 24, 1999) is removed from the SIP and is replaced by the new MVEBs of 41 TPD for the years 2010 through 2014 and 41 TPD for 2015 and beyond. Therefore, we are approving the transportation conformity MVEBs of 41 TPD of CO for 2010 through 2014 and 41 TPD of CO for 2015 and beyond for the Longmont attainment/maintenance area.

Section 110(l) of the CAA states that a SIP revision cannot be approved if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress towards attainment of a NAAQS or any other applicable requirement of the CAA. The revised Longmont CO maintenance plan will not interfere with attainment, reasonable further progress, or any other applicable requirement of the CAA.

In this action, EPA is approving the revised Longmont CO maintenance plan, that was submitted by the Governor on April 12, 2004, and the revised transportation conformity motor vehicle CO emission budgets for the years 2010 through 2014 and 2015 and beyond.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the “Proposed Rules” section of today's Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective November 29, 2004 without further notice unless the Agency receives adverse comments by November 1, 2004. If the EPA receives adverse comments, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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 the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 29, 2004. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Today's rule regulates the use of HCFC-141b as a foam blowing agent used in the manufacture of rigid polyurethane/polyisocyanurate foam products. Businesses that currently might be using HCFC-141b, or might want to use it in the future, include:

You may be potentially affected by this action if you are a person or company involved with agricultural biotechnology, that may develop and market plant-incorporated protectants. Potentially affected entities may include, but are not limited to:

• Seed companies (NAICS code 111)

• Pesticide manufacturers (NAICS code 32532)

• Establishments involved in research and development in the life sciences (NAICS code 54171)

• Colleges, universities, and professional schools (NAICS code 611310).

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 174 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

In the Federal Register of August 11, 2004 (69 FR 48870) (FRL-7673-2), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 3F6785) by DowAgro Sciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. The petition requested that 40 CFR part 174 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of Bacillus thuringiensis var. aizawai strain PS811 (Cry1F insecticidal protein) and the genetic material necessary for its production in cotton when used as a plant-incorporated protectant.

This notice included a summary of the petition prepared by the petitioner DowAgro Sciences, LLC. Comments were received by The National Cotton Council and cotton grower groups. All comments were in support of this tolerance exemption.

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

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

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

Data have been submitted to the Agency demonstrating the lack of mammalian toxicity at high levels of exposure to the pure Cry1F protein. These data demonstrate the safety of the Cry1F protein at levels well above maximum possible exposure levels that are reasonably anticipated in the crops. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial Bacillus thuringiensis products from which this plant-incorporated protectant was derived. See 40 CFR 158.740(b)(2)(i). For microbial products, further toxicity testing and residue data are triggered by significant acute effects in studies such as the mouse oral toxicity study to verify the observed effects and clarify the source of these effects (Tier II and Tier III). The acute oral toxicity data submitted support the prediction that the Cry1F protein would be non-toxic to humans. Thus, although Cry1F expression level data were required for an environmental fate and effects assessment, residue chemistry data were not required for a human health effects assessment of the subject plant-incorporated protectant ingredients because of the lack of mammalian toxicity.

Male and female mice (5 of each) were dosed with 15% (w/v) of the test substance, which consisted of Bacillus thuringiensis var. aizawai Cry1F protein at a net concentration of 11.4%. Two doses were administered approximately an hour apart to achieve the dose totaling 33.7 milliliter/kilogram body weight (mL/kg bwt). Outward clinical signs and body weights were observed and recorded throughout the 14-day study. Gross necropsies performed at the end of the study indicated no findings of toxicity. No mortality or clinical signs were noted during the study. A lethal dose (LD) 50 was estimated at > 5,050 milligram (mg)/kg bwt of this microbially produced test material. The actual dose administered contained 576 mg Cry1F protein/kg bwt. At this dose, no LD 50 was demonstrated as no toxicity was observed. Cry1F maize seeds contain 0.0017 to 0.0034 mg of Cry1F/gram of cotton kernel tissue. When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, Roy D., et al., Toxicological Considerations for Protein Components of Biological Pesticide Products , Regulatory Toxicology and Pharmacology 15L, 3-9 (1992). Therefore, since no effects were shown to be caused by the plant-pesticides, even at relatively high dose levels, the Cry1F protein is not considered toxic. Further, amino acid sequence comparisons showed no similarity between Cry1F protein to known toxic proteins available in public protein databases. Finally, regarding toxicity to the immune system, the acute oral toxicity data submitted support the prediction that the Cry1F protein would be non-toxic to humans.

Since Cry1F is a protein, allergenic sensitivities were considered. Current scientific knowledge suggests that common food allergens tend to be resistant to degradation by heat, acid, and proteases, and may be glycosylated and present at high concentrations in the food. Data has been submitted which demonstrates that the Cry1F protein is rapidly degraded by gastric fluid in vitro and is non-glycosylated. In a solution of Cry1F: Pepsin at a molar ratio of 1:100, complete degradation of Cry1F to amino acids and small peptides occurred in 5 minutes. A heat lability study demonstrated the loss of bioactivity of Cry1F protein to neonate tobacco budworm larvae after 30 minutes at 75 °C. This indicates that the protein is highly susceptible to digestion in the human digestive tract and that the potential for adverse health effects from chronic exposure is virtually nonexistent. Furthermore, studies submitted to EPA done in laboratory animals have not indicated any potential for allergic reactions to Bacillus thuringiensis or its components, including the endotoxin of the crystal protein. Additionally, a comparison of amino acid sequences of known allergens uncovered no evidence of any homology with Cry1F, even at the level of 8 contiguous amino acids residues. Accordingly, the potential for the Cry1F protein to be a food allergen is minimal.

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:

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

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

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

• Industry (NAICS 32532), e.g., Pesticide Manufacturing, 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 November 21, 2003 (68 FR 65708) (FRL-7333-7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3E6676) by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268. This notice included a summary of the petition prepared by Dow AgroSciences, the petitioner.

The petition requested that 40 CFR 180.469 be amended by establishing time-limited tolerances for residues of the herbicide safener dichlormid, ( N,N -diallyl-2,2-dichloroacetamide or Acetamide, 2,2-dichloro- N,N -di-2-propenyl-) (CAS Reg. No. 37764 -25-3), in or on sweet corn commodities at 0.05 parts per million (ppm). There were no comments received in response to the notice of filing.

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....“

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 and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for residues of dichlormid on sweet corn commodities at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the time-limited tolerances follows.

In 1999, the Agency prepared a risk assessment which was used as the basis for establishing time-limited tolerances for residues of dichlormid in or on field and pop corn commodities. A final rule for these time-limited tolerances published in the Federal Register of March 27, 2000 (65 FR 16143) (FRL-6498-7). Based on that risk assessment, EPA concluded at that time that all of the risks were below the Agency's level of concern and there was a reasonable certainty that no harm would result to the general population, and to infants and children from aggregate exposure to residues of dichlormid on corn commodities.

No additional toxicity data has been reviewed and evaluated by the Agency since that time. For a complete description of the toxicological profile and endpoints, the uncertainty factors, the exposure assessment which included dietary exposure for both food and drinking water, the safety factor for infants and children, and aggregate risk for dichlormid, see the final rule of March 27, 2000.

In response to the new petition, to establish time-limited tolerances for sweet corn commodities, the Agency has prepared a new assessment that evaluates the acute and chronic dietary and drinking water risks from exposure to dichlormid in or on field, pop and sweet corn commodities. The drinking water exposure estimates are the same as those in the March 27, 2000 Final Rule. Since, no other assessments or evaluations are needed for assessing the risk of dichlormid, only the acute and chronic scenarios are discussed in Unit III. below.

1. Dietary exposure from food and feed uses. Time-limited tolerances (expiring December 31, 2005) are established in 40 CFR 180.469 for residues of dichlormid, in or on field and pop corn commodities. Risk assessments were conducted by EPA to assess dietary exposures from dichlormid in or on field, pop and sweet corn commodities 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.

In conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: The acute dietary risk analyses incorporated tolerance level residues and assumed 100% of the corn commodities were treated with dichlormid.

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 dietary risk analyses incorporated tolerance level residues and assumed 100% of the corn commodities had been treated with dichlormid.

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

For ground water, the Agency used its SCI-GROW (Screening Concentration in Ground Water) screening model and environmental fate data to determine the Estimated Environmental Concentration (EEC) of dichlormid in ground water. SCI-GROW is an empirical model based upon actual ground water monitoring data collected for the registration of a number of pesticides that serve as benchmarks for the model. The current version of SCI-GROW appears to provide realistic estimates of pesticide concentrations in shallow, highly vulnerable ground water sites (i.e., sites with sandy soils and depth to ground water of 10 to 20 feet). The SCI-GROW ground water screening concentration is 0.046 ppb.

The Agency used the Generic Estimated Environmental Concentration (GENEEC) to estimate pesticide concentrations in surface water. GENEEC simulates a 1 hectare by 2 meter deep edge-of-the-field farm pond which receives pesticide runoff from a treated 10 hectare field. GENEEC can substantially overestimate true pesticide concentrations in drinking water. It has certain limitations and is not the ideal tool for use in drinking water risk assessments. However, it can be used in screening calculations and does provide an upper bound on the concentration of true drinking water concentrations.

Using GENEEC and available environmental fate data, EPA calculated the following Tier 1 EECs for dichlormid:

• Peak (Acute) EEC: 27.29 ppb

• Average (Chronic) EEC 26.93 ppb

Interim Agency policy allows the average (chronic) GENEEC value to be divided by 3 to obtain a value of 8.98 ppb for use in chronic risk assessment calculations.

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 EECs from these models to quantify drinking water exposure and risk as a percent of reference dose (%RfD) or percent of population adjusted dose (%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 dichlormid they are further discussed in Unit III.D.

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). Dichlormid is not approved for use on any sites that would result in residential exposure.

4. Cumulative Effects. 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 dichlormid. Dichlormid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that dichlormid has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/ .

1. In general . Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the 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 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. Conclusion. The additional FQPA safety factor of 10X is retained for acute risks since: (1) There is qualitative evidence of increased susceptibility in the rabbit developmental study; and (2) the toxicity database is incomplete. There are data gaps for the 2-generation reproduction study in rats, and acute and subchronic neurotoxicity studies. The additional FQPA safety factor of 30X is applied for chronic risks for the reasons discussed above for acute risks and for the data gap for the chronic toxicity study in dogs.

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. 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 + 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 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. For dichlormid, a DWLOC was calculated for the acute and chronic scenarios for the U.S. population and for the most highly exposed population subgroup.

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 the pesticide 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 residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Using the exposure assumptions previously discussed for acute exposure, the acute dietary exposure from food to dichlormid will occupy 3% of the aPAD for the U.S. population, and 9% of the aPAD for non-nursing infants < 1 year old. In addition, there is potential for acute dietary exposure to dichlormid in drinking water. Since the modeled groundwater and surface water concentrations are less than the DWLOCs, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 1:

2. Chronic risk. Using the exposure assumptions previously described for chronic exposure, EPA has concluded that exposure to dichlormid from food will utilize 5% of the cPAD for the U.S. population, and 11% of the cPAD for children 1-6 years old. In addition, there is potential for chronic dietary exposure to dichlormid drinking water. Since the modeled groundwater and surface water concentrations are less than the DWLOCs, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 2:

3. Conclusion. 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 residues of the herbicide safener dichlormid, ( N,N -diallyl-2,2-dichloroacetamide or Acetamide, 2,2-dichloro- N,N -di-2-propenyl-) (CAS Reg. No. 37764 -25-3).

FQPA requires the Agency to develop a screening program to determine whether certain substances (including all pesticides and inerts or 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...” The Agency 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 the inert ingredient dichlormid for endocrine effects may be required.

Adequate enforcement methodology (gas chromatography with a nitrogen selective detector) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, Public Information and Record Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov .

There is neither a Codex proposal, nor Canadian or Mexican limits for residues of dichlormid in corn commodities.

There are several data gaps which needed to be addressed before permanent tolerances can be established. The following studies have been submitted for Agency review and evaluation (1) 2-Generation Reproduction Study-Rat, (2) General Metabolism (3) Acute Neurotoxicity (4) Subchronic Neurotoxicity, (5) Crop Field Trials, and (6) Rotational Crop (Confined). The Agency will review and evaluate these studies, and then prepare a new risk assessment.

The data gaps are not as extensive as it would seem. For the crop field trials, both pre-and post-emergent data using dichlormid have been provided. The additional field trials are to fulfill the guideline requirements. To account for the incomplete toxicological database, the Agency retained an additional 10X safety factor for infants and children as to acute risk and an additional 30X safety factor as to chronic risk.

Therefore, time-limited tolerances expiring December 31, 2005, are established for residues of the herbicide safener dichlormid, ( N,N -diallyl-2,2-dichloroacetamide or Acetamide, 2,2-dichloro- N,N -di-2-propenyl-) (CAS Reg. No. 37764-25-3) in or on sweet corn commodities 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), 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-2004-0318 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 November 29, 2004.

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

Mail your written request to: Office of the Hearing Clerk (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 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 . Send us your copies, identified by docket ID number OPP-2004-0318, using one of the following methods:

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

•  Agency Website : http://www.epa.gov/edocket/ . EDOCKET, EPA's electronic public docket and comment system, is EPA's preferred method for receiving electronic copies. Follow the on-line instructions for submitting materials to the docket.

•  E-mail : 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.

•  Mail : 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.

•  Hand Delivery : In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES .

Do not include any CBI in the copy you submit for the public docket.

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 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 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 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 May 7, 2003 (68 FR 24463) (FRL-7305-7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1F06305) by ISK Biosciences Corporation, Concord, OH. That notice included a summary of the petition prepared by ISK Biosciences Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing tolerances for combined residues of the fungicide cyazofamid, 4-chloro-2-cyano- N,N -dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonamide and its metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in or on cucurbit vegetables (Group 9) at 0.10 parts per million (ppm), potato at 0.01 ppm, tomato at 0.20 ppm, and grape wine at 1.0 ppm.

Following review of the residue and metabolism data, EPA has made several minor changes to the proposed tolerances. For cucurbits and potatoes, EPA expanded the tolerance expression to cover both cyazofamid and its metabolite CCIM, which is also a residue of concern. This expansion of the tolerance expression necessitated a raising of the tolerance level for potatoes from 0.01 ppm to 0.02 ppm. No change in the tolerance values was needed for tomatoes. Finally, residue and processing data for grape wine showed that residues might slightly exceed 1.0 ppm; accordingly, the tolerance for grape wine was raised to 1.5 ppm.

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 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 cyazofamid on cucurbits at 0.10 ppm, potatoes at 0.01 ppm, tomatoes at 0.2 ppm, and wine grape 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 cyazofamid are discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. 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 cyazofamid used for human risk assessment is shown in Table 2 of this unit:

1. Dietary exposure from food and feed uses . Permanent and temporary tolerances for residues of cyazofamid and its metabolites are not currently established. Risk assessments were conducted by EPA to assess dietary exposures from the proposed uses of cyazofamid on food and feed crops 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 TM ) and Lifeline TM , which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: As an acute dietary endpoint was not identified for the general population including infants and children, the acute dietary analysis was performed for the population subgroup females 13 to 49 years old only. The assumptions of this dietary exposure assessment are tolerance level residues and 100% crop-treated.

At the 95th percentile of exposure, the Tier 1 acute DEEM-FCID TM and Lifeline TM analysis gave the results listed in Table 3. For the acute analysis, the exposure at the 95th percentile for Females 13 to 49 years old is 0.003769 mg/kg/day for DEEM-FCID TM or 0.004013 mg/kg/day for LifelineT, which utilizes < 1% of the acute PAD for cyazofamid for both DEEM-FCID TM and Lifeline TM . The results of the Lifeline TM and DEEM-FCID TM analyses are fully consistent.

A summary of the acute dietary exposure estimates for cyazofamid and its metabolote CCIM used for human risk assessment are shown in Table 3 of this unit:

ii. Chronic exposure . In conducting the chronic dietary risk assessment EPA used the DEEM-FCID TM and Lifeline TM , which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The assumptions of this dietary exposure assessment are tolerance level residues and 100% crop-treated.

The Tier 1 chronic DEEM-FCID TM and Lifeline TM analysis gave the results listed in Table 4. For the chronic analysis, the most highly exposed population subgroup and the highest risk estimate was for Children 1 to 2 years old. The chronic exposures for Children 1 to 2 years old are 0.004778 mg/kg/day for DEEM-FCID TM ) or 0.004529 mg/kg/day for Lifeline TM ), which utilize < 1.0% (for both DEEM-FCID TM and Lifeline TM ) of the chronic PAD for cyazofamid. The results of the Lifeline TM and DEEM-FCID TM analyses are fully consistent.

A summary of the chronic dietary exposure estimates for cyazofamid used for human risk assessment is shown in Table 4 of this unit:

iii. Cancer . A cancer dietary assessment was not conducted because cyazofamid has been classified as “not likely to be carcinogenic to humans”.

iv. Anticipated residue and percent crop treated (PCT) information . The Agency did not use anticicated residue estimates and PCT information in the cyazofamid dietary exposure assessment.

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

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentration in Groudwater (SCI-GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include 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 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 percent of the reference dose (%RfD) or percent of the population adjusted dose (%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.

Based on the FIRST and SCI-GROW models, the EECs of cyazofamid and its metabolites for acute exposures are estimated to be 6.436 parts per billion (ppb) for surface water and 0.002680 ppb for ground water. The EECs for chronic exposure is estimated to be 0.495 ppb for surface water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Cyazofamid 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 cyazofamid and any other substances and cyazofamid 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 cyazofamid 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 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 . There are no concerns or residual uncertainties for pre- and or postnatal toxicity.

3. Conclusion . EPA determined that the 10X safety factor to protect infants and children should be removed i.e. , reduced to 1X. The FQPA factor is removed because:

i. In the prenatal developmental toxicity study in rabbits, there was no indication of increased susceptibility (qualitative or quantitative) of rabbit fetuses to in utero exposure to cyazofamid. No maternal or developmental effects were seen at any dose up to the limit dose of 1,000 mg/kg/day.

ii. In the prenatal developmental toxicity study in rabbits, there was no indication of increased susceptibility (qualitative or quantitative) of rabbit fetuses to in utero exposure to cyazofamid. No maternal or developmental effects were seen at any dose up to the limit dose of 1,000 mg/kg/day.

iii. In the two-generation reproduction study, the highest dose tested ( > 1,000 mg/kg/day) did not cause maternal systemic toxicity nor did it elicit reproductive or offspring toxicity.

iv. The Agency concluded that the concern is low for the quantitative susceptibility seen in the rat developmental toxicity study and there are no residual uncertainties because:

a. The developmental effect is well identified with clear NOAEL/LOAEL.

b. The developmental effect (increased bent ribs) is a variation rather than a malformation.

c. The developmental effect is seen only at the limit dose of 1,000 mg/kg/day.

d. This endpoint is used to establish the acute RfD for Females 13-49 years old.

e. The overall toxicity profile indicates that cyazofamid is not a very toxic compound.

v. There were no indications of pre- or postnatal toxicity and no residual uncertainties from the rabbit developmental study or the rat two generation reproduction study.

vi. The exposure assessments are Tier 1, conservative, high-end assessments and will not underestimate the potential dietary (food and water) exposures.

vii. There are no proposed residential uses.

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 (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 the 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, OPP concludes with reasonable certainty that exposures to the pesticide 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 residues of the pesticide in 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 from food to cyazofamid will occupy < 1% of the aPAD for females 13 years and older. In addition, there is potential for acute dietary exposure to cyazofamid in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in Table 5 of this unit:

2. Chronic risk . The chronic dietary exposure analyses in this assessment for cyazofamid result in dietary risk (food only) estimates that are below the Agency's level of concern for chronic dietary (food only) exposure. For the chronic analysis, the most highly exposed population subgroup and the highest risk estimate was for children 1 to 2 years old. The chronic exposures for children 1 to 2 years old are 0.004778 mg/kg/day for DEEM-FCID TM or 0.004529 mg/kg/day for Lifeline TM , which utilize < 1.0% (for both DEEM-FCID TM and Lifeline TM ) of the chronic PAD for cyazofamid. EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 6 of this unit:

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).

Cyazofamid 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).

Cyazofamid 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 . The Agency classified cyazofamid as “not likely to be carcinogenic to humans.” Thus, cyazofamid is not expected to pose a risk.

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 cyazofamid residues.

The Food and Drug Administration's (FDA's) Multi-Residue Protocol D (without cleanup) is the acceptable enforcement method in crops. The petitioner should provide the Agency with a single modified method for all crops with the inclusion of the minor variations for crops as needed.

There are currently no Codex, Canadian, or Mexican MRL's or tolerances for cyazofamid on cucurbits, tomato, potato, and wine. Therefore, international harmonization is not an issue for this petition.

The following confirmatory data are needed for wheat. Data are listed below by guideline series.

1. Harmonized guideline 860.1300—Nature of the residue. The metabolism studies conducted on plants (grapes, potatoes, and tomatoes) and livestock (goats and hen) as well as the confined rotational crop study are deemed tentatively acceptable. To fully upgrade each study, the petitioner is required to provide information pertaining to dates of sample collection, extraction, and final analysis. This information is required for each study to determine actual sample storage intervals.

The metabolic profiles in crop matrices (grape, wine; potato and tomato) determined at the beginning and at the end of the analytical phase were not provided. Representative chromatograms of the radiolabeled residues taken before and after storage under frozen conditions should be submitted. In the future, additional metabolism data might be required if uses on additional crops are requested.

2. Harmonized guideline 860.1340—Residue analytical methods. The petitioner has provided the proposed enforcement method entitled, “Analytical Method for IKF-916 and CCIM in Tomato Samples” as an attachment to the ILV of the method. The Agency finds that the Residue Analytical Methods used for data collection may be used as a single analyte confirmatory method. However, the petitioner should provide the Agency with a single modified method for all crops with the inclusion of the minor variations for crops as needed. The FDA's Multi-Residue Protocol D (without cleanup) is the acceptable enforcement method in crops.

3. Harmonized guideline 860.1380—Storage stability. Storage stability data for 18 months on the representative commodities of the cucurbit group should be submitted to support the storage intervals and conditions of the crop field trials.

4. Harmonized guideline 860.1850—Confined Accumulation in rotational Crops. The submitted study is tentatively deemed adequate to satisfy data requirements for a confined rotational crop study pending submission of information pertaining to extraction and analysis dates of samples from the 31-day PBI. These dates are required to determine the actual sample storage intervals and need for additional storage stability data. The supporting storage stability data from the current submission indicate that the parent and its metabolites CCIM and CCBA are relatively stable in fortified samples of carrot roots, lettuce, and wheat forage stored frozen for up to 4 months. The identities of the parent, CCIM, CCIM-AM, and sugars are deemed adequately identified pending submission of representative TLC or data from TLC analyses.

5. Other data . Historical control data for dog toxicity studies.

Therefore, tolerances are established for the combined residues of cyazofamid, 4-chloro-2-cyano- N,N -dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in or on cucurbit vegetables (Group 9) at 0.10 ppm, potato at 0.02 ppm, tomato at 0.20 ppm, and grape, wine at 1.5 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-2004-0211 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 November 29, 2004.

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

Mail your written request to: Office of the Hearing Clerk (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 Street, NW., Suite 350, Washington, DC. 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-2004-0211 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)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

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/.

In the Federal Register of December 20, 2000 (65 FR 79834) (FRL-6751-9), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (6E4757) by Firmenich, P.O. 5880, Princeton, NJ 08543.

Firmenich requested that octanal, also known as caprylic aldehyde, or 1-octanal, be approved for use as an inert ingredient in pesticide formulations applied to growing crops, RACs after harvest, or to animals at an amount that was not to exceed 0.2% of the formulated product. This notice included a summary of the petition prepared by the petitioner Firmenich.

The petition requested that 40 CFR 180.1001, (c) and (e), newly re-designated as § 180.910 and § 180.930 April 28, 2004 (69 FR 23113) (FRL-7335-4), be amended by establishing an exemption from the requirement of a tolerance for residues of octanal, (CAS Registration No. 124-13-0). There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which 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.

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 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 octanal are discussed in this unit.

Table 1 below summarizes the toxicological aspects of octanal (C 8 aldehyde), and its surrogates, heptanal (C 7 aldehyde) and nonanal (C 9 aldehyde). All three chemicals belong to a group of short-chained linear (unbranched) aliphatic acyclic aldehydes. Based on their structural similarities, and the fact that studies indicate that these aldehydes are biochemically similar, toxicity data can be used almost interchangeably as surrogate data for these three substances. These aliphatic aldehydes are oxidized in the body to form the corresponding fatty acids. Thus, the corresponding fatty acids, octanoic and nonanoic acid, which are essentially metabolites of the original aldehyde can also be used as surrogate data. The Agency used the surrogate data from heptanal, nonanal, octanoic acid, and nonanoic acid as discussed in table 1 below, to supplement the available information on octanal.

Toxicity for octanal was assessed, in part, by a process called structure-activity relationship (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.

Octanal is absorbed via all routes. It is expected that oxidation of the aldehyde group to a carboxylic acid group would occur. There is concern for irritation to all tissues, especially at a high percentage in a product. There is uncertain concern for dermal sensitization based on analogs, and developmental toxicity based on aldehydes.

Octanal is a member of a class of chemicals (aldehydes) which are metabolized in the body to the corresponding fatty acids. The mammalian body has a demonstrated pathway to process octanal. Octanal is metabolized to octanoic acid.

There are developmental studies on octanoic acid performed as part of two investigations on the developmental effects of valproic acid. Unlike octanoic acid which is an eight carbon chain linear (unbranched) aliphatic acid that exhibits low toxicity, valproic acid is an eight carbon (branched chain) aliphatic acid. Valproic acid is teratogenic in humans and rodents. Based on results of these investigations, however, octanoic acid was not even included in the list of chemicals that were considered to have caused developmental effects.

The toxicity data from octanoic acid, was used to assess the toxicity of octanal. Even though as a group the st aliphatic aldehydes and acids, which include octanoic acid and octanal, can exhibit developmental toxicity, the toxicity data for octanoic acid indicate that developmental effects were seen only at very high doses (1,125 milligrams/kiligram/day (mg/kg/day)). Also there was no evidence of reproductive toxicity for octanoic acid, even at very high doses (2,050 mg/kg/day).

The petitioner has accepted the Agency's limitation of 0.2% octanal in the formulated pesticide product. At this low percentage in the formulated products the residues from the use of octanal as an inert ingredient will be much lower than the amounts which can possibly cause developmental or reproductive toxicity.

The SAR also indicated concerns for dermal sensitization, and irritation to mucous membranes. These concerns can be appropriately addressed through labeling and the use of protective equipment.

In examining aggregate exposure, FFDCA section 408 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).

Octanal has been used in foodstuffs as a flavoring agent since the 1900's. The FDA has approved octanal for use as a direct food additive as a flavoring agent (21 CFR 172.515-Synthetic flavoring substances and adjuvants) and it is sponsored by EPA and the Flavor and Fragrance High Production Volume Consortia as a high production volume chemical. The Joint FAO/WHO (Food and Agriculture Organization/World Health Organization) Expert Committee on Food Additives concluded that linear aliphatic alcohols, aldehydes, and acids, which include octanal and octanoic acid, are ubiquitous in nature. In fact, low molecular weight alcohols and acids such as octanal and octanoic acid have been detected in almost every known fruit and vegetable. Given the natural occurrence, there is a background (naturally occurring) level of exposure to octanal that cannot be regulated, and cannot be decreased.

At its twenty-eighth meeting (1984), the Expert Committee established a group ADI (Acceptable Daily Intake) of 0-0.1 mg/kg bwt for octanal and nonanal singly or in combination. The Agency interprets this as an ADI of 0-0.1 mg/kg bwt for octanal alone. The use of octanal and octanoic acid was re-evaluated by the Expert Committee in 1998 (http://www.inchem.org/documents/jecfa/jecmono/v040je10.htm) as part of a group of flavoring agents. Using 1987 production volumes and other available information, JECFA estimated the exposure to octanal from use as a flavoring agent to be 0.0015 mg/kg bwt and for octanoic acid to be 0.011 mg/kg bwt. The available data indicates that consumption of octanal and octanoic acid as naturally occurring in fruit and vegetables is much greater than consumption as a flavoring agent. Exposure resulting from the use of octanal in only herbicide formulations at less than 0.2 % in the formulated product is anticipated to be much smaller than either the ADI, the naturally occurring background level of exposure, or exposure from its use as a flavoring agent.

2. Drinking water exposure . Due to its rapid volatilization octanal's half life in rivers is 2 hours and in lakes is 5 days. Because of this high volatility there would be only very low drinking water exposure and consequently no concern for risk to human health.

Octanal is used as a fragrance for soaps, detergents, and perfumes. Because it constitutes such a low percentage of the formulation exposure is likely to be minimal.

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 the above chemical substances and any other substances. Octanal 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 this chemical substance 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 10-fold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data unless EPA concludes that a different margin of safety will be safe for infants and children. For octanal, based on an understanding of the metabolic pathway, the expected low oral toxicity, the available toxicity data which indicates low toxicity, and especially considering the developmental toxicity no observed adverse effect level of 1,125 mg/kg/day for octanoic acid, a metabolite of octanal, EPA has not used a safety factor analysis to assess the risk. For the same reasons a 10-fold safety factor is unnecessary.

Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of octanal, and that under reasonably forseeable circumstances aggregate exposure to octanal will pose no appreciable risk to human health. Accordingly, EPA finds that exempting octanal (CAS Registration No. 124-13- 0) from the requirement of a tolerance will be safe.

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 octanal 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 tolerance exemptions for octanal.

The Agency is not aware of any country requiring a tolerance for octanal nor have any CODEX Maximum Residue Levels been established for any food crops at this time.

The mammalian body has a demonstrated pathway to process octanal. Octanal is metabolized to the corresponding fatty acid, octanoic acid, so there are no concerns for dietary exposure. Given that the petitioner will use octanal at levels not to exceed 0.2% of the formulation, and its metabolic transformation to octanoic acid, its use as an inert ingredient would not significantly increase the levels of octanal in the food supply, and should result in human exposure far below any dose level that could possibly produce an adverse effect

Based on the information discussed in this preamble, the expected low oral toxicity, and the developmental toxicity data for the metabolite (octanoic acid), EPA concludes that there is reasonable certainty of no harm from aggregate exposure to residues of 1-octanal. Therefore, EPA is establishing a tolerance exemption for 1-octanal (CAS Reg. No. 124-13- 0) with a limitation in the pesticide formulation of not more than 0.2%.

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 of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 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 Identification (ID) number OPP-2004-0298 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 November 29, 2004.

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

Mail your written request to: Office of the Hearing Clerk (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 IX.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by docket ID number OPP-2004-0298, 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. 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 FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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 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 a tolerance for residues of the herbicide mesotrione, 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in or on cranberry at 0.01 parts per million (ppm). This tolerance will expire and is revoked on December 31, 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.

The States claim that emergency situations have occurred due to new pests that have been introduced into cranberry producing areas. Oregon and Washington have both declared crisis exemptions under FIFRA section 18 for the use of mesotrione on cranberry for control of several broadleaf weeds. EPA concurs that emergency conditions exist for these States.

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

Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether mesotrione meets EPA's registration requirements for use on cranberry or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of mesotrione by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than Oregon and Washington 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 mesotrione, contact the Agency's Registration Division at the address provided 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 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/ .

In response to the original pesticide petition (PP OE6177) submitted in 2000 by Eden Bioscience, EPA established tolerance exemptions for sodium thiosulfate also known as thiosulfuric acid, disodium salt, anhydrous, (CAS Reg. No. 7772-98-7) or sodium thiosulfate pentahydrate also known as thiosulfuric acid disodium salt, pentahydrate, (CAS Reg. No. 10102-17-7). The exemptions as established specified that the percent of sodium thiosulfate was not to exceed 6% of the formulated product. For a discussion of the information submitted and the results of the Agency's review and evaluation, see the Federal Register of December 21, 2001 (66 FR 65850) (FRL-6811-6).

In the Federal Register of November 26, 2003 (68 FR 66416) (FRL-7333-8), EPA issued a notice pursuant to section 408(d)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP OE6177) by Eden Bioscience, 3830 Monte Villa Parkway, Bothell, Washington, 98021-6942. This notice included a summary of the petition prepared by the petitioner Eden Bioscience.

The petition requested that the existing exemption in 40 CFR 180.1001, newly re-designated as 180.910, be amended by removing the 6% in the formulation limitation for residues of sodium thiosulfate (CAS Reg No.10102-17-7). There were no comments received in response to the notice of filing.

The petition was amended by Eden Bioscience Corporation because recent research indicates that higher levels of sodium thiosulfate than the currently allowed 6% are needed in certain situations, such as the use of very high water volumes with products containing a low percentage of active ingredient. Therefore, Eden Bioscience proposed to amend the existing exemption to permit the use of sodium thiosulfate in a pesticide formulated product as an inert ingredient with no numerical limitation when used on growing crops or on raw agricultural commodities after harvest.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which 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.

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 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 sodium thiosulfate are discussed in this unit.

In support of the sodium thiosulfate petition submitted in 2000, the petitioner submitted mutagenicity information obtained from open literature, an acute oral toxicity study, and FDA's review and evaluation of the developmental studies conducted in the mouse, rat, hamster, and rabbit. There was no indication of any effect on maternal or fetal survival, or in incidences of visceral or skeletal abnormalities. There was no effect on genotoxicity, or mutagenicity for sodium thiosulfate. The Agency's review and evaluation of all submitted information was cited in the final rule published in the Federal Register of December 21, 2001, (66 FR 65850). No new or additional information was submitted to the Agency as a result of the amendment to the petition.

In examining aggregate exposure, FFDCA section 408 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 evaluated the use of sodium thiosulfate as an inert ingredient in addition to its use as a GRAS (Generally Recognized As Safe) substance as part of the previous action. A complete discussion on the possible dietary, and other non-occupational exposures is contained in the final rule published in the Federal Register of December 21, 2001, (66 FR 65850).

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; greehouse, 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 .

To be deleted from the NPL is: the Love Canal Superfund site, City of Niagara Falls, Niagara County, New York. A Notice of Intent to Delete for the Love Canal site was published in the Federal Register on March 17, 2004. The closing date for comments on the Notice of Intent to Delete was April 16, 2004.

EPA received comments, including the two major comments discussed below, on the proposed deletion and addressed these comments in a Responsiveness Summary. Several commenters expressed concern that the wastes that were originally disposed of in the Love Canal landfill have not been removed. The containment, leachate collection, and treatment and monitoring remedy at the Site was selected consistent with the requirements of the Federal Superfund law. Excavation and removal of hazardous materials from landfills can potentially create more contaminant exposure to human health and the environment than a containment remedy. Moreover the large volumes of contaminated soils from an excavated landfill must be treated and redisposed of at other secure hazardous waste facilities, requiring either utilization of limited existing landfill capacity or the creation of new landfills to accommodate the excavated waste from old landfills. The excavated landfill requires filling with clean backfill materials and still must be subject to engineering controls due to residual contamination that could not practicably be removed. For these reasons, EPA developed a presumptive remedy for large landfills consisting of containment through capping and leachate collection and treatment. The Love Canal site remedy is a permanent remedy that is consistent with the requirements of the Superfund law. Several commenters were also concerned that the deletion of the Love Canal site from the NPL would imply that EPA will not have any further involvement at the Love Canal site and that, if there were to be a need for further Superfund response at the Love Canal site, such a response could not be provided since the Love Canal site would no longer be on the NPL. EPA confirmed in the Responsiveness Summary that its responsibility for the Love Canal site does not cease after the deletion from the NPL.

The NCP (40 CFR 300.425 (e)) states that a site that is deleted from the NPL is eligible for further fund-financed remedial actions should future conditions warrant such action. A Superfund site can be deleted from the NPL when one of the following criteria, as identified in the NCP (40 CFR 300.425(e)), is met. These criteria are as follows: (1) Responsible or other parties have implemented all appropriate response actions required; (2) all appropriate Fund-financed response under CERCLA has been implemented and no further response action by responsible parties is appropriate; or, (3) the remedial investigation has shown that the release poses no significant threat to human health or the environment, and therefore, taking remedial measures is not appropriate. In the case of the Love Canal site, the first two criteria have been met. The third criterion is not applicable, since remedial measures were taken.

All of the comments received and EPA's responses are contained in the Responsiveness Summary, a copy of which is available at the EPA Public Information Office, Niagara Falls, New York at (716) 285-8842. The Responsiveness Summary is also available in the Administrative Record File, located in the EPA Regional Office.

As part of EPA's policy for Superfund sites where the remedy will result in substances remaining on-site above health-based levels that would allow for unrestricted use or unlimited exposure, EPA conducts five-year reviews to confirm that the remedy continues to adequately protect human health and the environment. In the case of the Love Canal site, the institutional controls in place do not allow for unrestricted use or unlimited exposure. In September 2003, EPA issued the first five-year review report for the Love Canal site operations. NYSDEC provided technical oversight for the preparation of EPA's five-year review report and concurred with EPA's findings that the containment and barrier drain system were working properly. EPA concludes that the Site does not pose a significant threat to public health or the environment.

EPA identifies sites that appear to present a significant risk to public health or the environment, and it maintains the NPL as the list of those sites. As described in § 300.425(e)(3) of the NCP, any site or portion thereof deleted from the NPL remains eligible for remedial actions in the unlikely event that conditions at the site warrant such action in the future. Deletion of a site from the NPL does not affect potentially responsible party liability or impede agency efforts to recover costs associated with response efforts.

The Department of the Interior published a final rule in the Federal Register on October 21, 2002, revising its regulations implementing the FOIA, 43 CFR Part 2. Four offices under the OHA were inadvertently omitted in Appendix A and the addresses for OHA's reading rooms located in Arlington, Virginia, and the Minnesota State Office, as well as the telephone number for the New Mexico State Office, were incorrect. The Arizona, Montana, North Dakota, and South Dakota State Offices have been added to Appendix A and the above-cited addresses and telephone number have now been corrected. Appendix A also has been updated to reflect other changes in the contact information that have occurred since October 21, 2002.

When the regulations were published in October 2002, the reference to OMB Circular A-110 in § 2.25 was inadvertently omitted. A correction has been made to clarify that, in accordance with OMB Circular A-110, the requirements of § 2.25 apply only to grants and Federal assistance awarded to institutions of higher education, public and private hospitals, and other quasi-public and private nonprofit organizations. They do not apply to those entities covered by OMB Circular A-102.

In addition, in § 2.22(b)(2), the requirement that bureaus notify requesters of their appeal rights when referring documents located in DOI's files to another agency for a release determination was inadvertently omitted. Section 2.22(b)(2) has been revised to include this requirement. Also, in § 2.17(c), the table summarizing the chargeable fees for each category of requester is being reprinted for clarity. Editorial changes have been made in §§ 2.18 and 2.23 to correct the references cited and typographical errors.

This rule updates the Code of Federal Regulations to include accurate information about how to file requests under the FOIA. Because this rule corrects errors and omissions from the rule as originally published, and because this rule makes no substantive changes to the existing requirements, publishing a proposed rule and requesting public comments would delay public access to accurate information. Likewise, delaying the effective date would postpone public access to accurate information without serving any higher purpose. For these reasons, we find that:

(1) Notice and public comment on these corrections are impracticable, unnecessary, and contrary to the public interest. As allowed by 5 U.S.C. 553(b), we are not publishing a proposed rule.

(2) Good cause exists for making this rule effective immediately upon publication under 5 U.S.C. 553(d)(3).

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the National Flood Insurance Program, 42 U.S.C. 4001 et seq. ; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59 et seq. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the Federal Register .

In addition, the Federal Emergency Management Agency has identified the special flood hazard areas in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in the identified special flood hazard area of communities not participating in the NFIP and identified for more than a year, on the Federal Emergency Management Agency's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives a 6-month, 90-day, and 30-day notification addressed to the Chief Executive Officer that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications have been made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless they take remedial action.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, October 26, 1987, 3 CFR, 1987 Comp.; p. 252.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778, October 25, 1991, 56 FR 55195, 3 CFR, 1991 Comp.; p. 309.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under both 5 U.S.C. 553(b)(A) and (b)(B), the Coast Guard finds that this rule is exempt from notice and comment rulemaking requirements because some of these changes involve agency organization and practices, and all of these changes are non-substantive. This rule consists only of corrections and editorial, organizational, and conforming amendments. These changes will have no substantive effect on the public; therefore, it is unnecessary to publish an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same reasons, good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

Each year titles 46 and 49 of the Code of Federal Regulations are updated on October 1. This rule, which becomes effective September 30, 2004, corrects organization names and addresses, revises authority citations for certain parts to reflect our move to the Department of Homeland Security (DHS) in March 2003, and makes other technical and editorial corrections throughout titles 46 and 49. This rule does not change any substantive requirements of existing regulations.

In the following paragraphs, we describe revisions that are not self-explanatory name, address or spelling corrections, gender-neutral changes, or updates to references/cites:

a. 46 CFR 10.205, 10.901, 10.903, 12.10-9, and 12.13-1. These sections contain a date or dates that no longer apply. Any date that has passed and no longer affects the rule has been removed.

b. 46 CFR 10.306, 10.811, and 12.02-29. The time periods for these sections have passed, or their subject matter is no longer relevant. These sections have served their purpose and are no longer valid. They are removed and reserved.

c. 46 CFR 13.113, 13.115, and 13.117. These sections contain grandfather provisions (for tankerman certified under prior regulations) that have expired. These sections have served their purpose, and they no longer apply to anyone. They are removed and reserved.

d. 46 CFR 15.1030. We added an interpretive note to the end of this section. Including this interpretive note in the CFR serves as an important reminder for those who are subject to it as well as those who are tasked with enforcing this regulation. The note first appeared in a Notice of Interpretation published in the Federal Register (USCG-2000-7742, 65 FR 49284, 11 Aug. 2000). We did not receive any formal comments (pro or con) when this notice was published.

e. 46 CFR 15.1105. Paragraph (d) is deleted as it has served its purpose. The passage of time has made this paragraph obsolete.

f. 46 CFR 28.575. This change allows one to use the formula with either English units or metric units.

g. 46 CFR 54.15 and 116.438. Errors in conversion of units are corrected.

h. 46 CFR 175.400. An erroneous conversion from cubic meters to cubic feet is corrected.

i. A number of sections throughout title 46 contain collection of information numbers changed by the transfer of the Coast Guard from the Department of Transportation (DOT) to the Department of Homeland Security (DHS). The old DOT series numbers (2115-) are replaced by the new DHS series numbers (1625-).

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. As this rule involves internal agency practices and procedures and non-substantive changes, it will not impose any costs on the public.

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

This rule will have no substantive effect on the regulated public. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraphs (34)(a) and (b), of the Instruction from further environmental documentation because this rule involves editorial, procedural, and internal agency functions. An “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

By partnership agreement dated February 1, 2002, between the SBA and DoD, the SBA delegated to DoD its authority to enter into contracts under Section 8(a) of the Small Business Act (15 U.S.C. 637(a)). The expiration date of the partnership agreement has been extended from September 30, 2004, to September 30, 2005. This final rule amends DFARS 219.800 to reflect the extension.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

This rule will not have a significant cost or administrative impact on contractors or offerors, or a significant effect beyond the internal operating procedures of DoD. Therefore, publication for public comment is not required. However, DoD will consider comments from small entities concerning the affected DFARS subpart in accordance with 5 U.S.C. 610. Such comments should cite DFARS Case 2004-D015.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

Congress included a two-sentence provision in the Office of Management and Budget's (OMB) appropriation for fiscal year 1999 directing OMB to amend Section _.36 of OMB Circular A-110 to “require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act.” The provision also provided for a reasonable fee to cover the costs incurred in responding to a request. OMB Circular A-110 applies to grants and cooperative agreements to institutions of higher education, hospitals, and other non-profit institutions, from all Federal agencies.

OMB finalized the revision on September 30, 1999 (64 FR 54926, October 8, 1999). OMB published guidance to Federal agencies for adopting the revisions (65 FR 14405) on March 16, 2000, as an interim final rule. DOT adopted the guidance as an interim final rule in the same document. DOT now adopts the revisions as a final rule.

DOT did not receive any comments on the interim final rule. Consequently, the Department is adopting the interim final rule without change.

This is a significant regulatory action under Executive Order 12866 and the Department of Transportation's Regulatory Policies and Procedures, because it adopts as a final rule an earlier regulatory action which had been listed as significant.

The Regulatory Flexibility Act requires that, for each rule with a “significant economic impact on a substantial number of small entities,” an analysis must be prepared describing the rule's impact on small entities and identifying any significant alternatives to the rule that would minimize the economic impact on small entities. DOT certifies that this final rule will not have a significant impact on a substantial number of small entities. This rule concerns the information that Federally-funded researchers must provide in response to Freedom of Information Act requests.

The Unfunded Mandates Act requires agencies to prepare several analytic statements before proposing any rule that may result in annual expenditures of $100 million by State, local, Indian Tribal governments or the private sector. Since this final rule will not result in expenditures of this magnitude, DOT certifies that such statements are not necessary. This final rule will not impose additional reporting or recordkeeping requirements subject to the Paperwork Reduction Act.

Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable Federal motor vehicle safety standards shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable Federal motor vehicle safety standards. Where there is no substantially similar U.S.-certified motor vehicle, 49 U.S.C. 30141(a)(1)(B) permits a nonconforming motor vehicle to be admitted into the United States if its safety features comply with, or are capable of being altered to comply with, all applicable Federal motor vehicle safety standards based on destructive test data or such other evidence as the Secretary of Transportation decides to be adequate.

Under 49 U.S.C. 30141(a)(1), import eligibility decisions may be made “on the initiative of the Secretary of Transportation or on petition of a manufacturer or importer registered under [49 U.S.C. 30141(c)].” The Secretary's authority to make these decisions has been delegated to NHTSA. The agency publishes notice of eligibility decisions as they are made.

Under 49 U.S.C. 30141(b)(2), a list of all vehicles for which import eligibility decisions have been made must be published annually in the Federal Register . On October 1, 1996, NHTSA added the list as an appendix to 49 CFR Part 593, the regulations that establish procedures for import eligibility decisions (61 FR 51242). As described in the notice, NHTSA took that action to ensure that the list is more widely disseminated to government personnel who oversee vehicle imports and to interested members of the public. See 61 FR 51242-43. In the notice, NHTSA expressed its intention to annually revise the list as published in the appendix to include any additional vehicles decided by the agency to be eligible for importation since the list was last published. See 61 FR 51243. The agency stated that issuance of the document announcing these revisions will fulfill the annual publication requirements of 49 U.S.C. 30141(b)(2). Ibid .

This is a summary compilation of decisions on import eligibility that have already been made and does not involve new decisions. This action was not reviewed under E.O. 12866. This action is not “significant” within the meaning of the Department of Transportation's regulatory policies and procedures.

In accordance with the Regulatory Flexibility Act, NHTSA has evaluated the effects of this action on small entities. Because this action does not impose any regulatory requirements, but merely furnishes information by revising the list in the Code of Federal Regulations of vehicles for which import eligibility decisions have been made, it has no economic impact. Based upon this evaluation, I certify that this action will not have a significant economic impact on a substantial number of small entities. Accordingly, the agency has not prepared a regulatory flexibility analysis.

Executive Order 13132 on “Federalism” requires NHTSA 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.” Executive Order 13132 defines the term “policies that have federalism implications” 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.” Under Executive Order 13132, NHTSA may not issue a regulation that has federalism implication, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or NHTSA consults with State and local officials early in the process of developing the proposed regulation.

The amendments adopted in this rule 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 as specified in Executive Order 13132. Thus, the requirements of section 6 of the Executive Order do not apply to this rulemaking action.

The agency has considered the environmental implications of this rule in accordance with the National Environmental Policy Act of 1969 and determined that it will not significantly affect the human environment.

In accordance with the Paperwork Reduction Act of 1980, as amended, the agency notes that there are no information collection requirements associated with this rulemaking action.

This rule will not have any retroactive or preemptive effect. Judicial review of this rule may be obtained pursuant to 5 U.S.C. 702. That section does not require that a petition for reconsideration be filed prior to seeking judicial review.

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with the base year of 1995). Because this final rule will not require the expenditure of any financial resources, no Unfunded Mandates assessment has been prepared.

Executive Order 13045 applies to any rule that (1) is determined to be “economically significant” as defined under E.O. 12866, and (2) concerns an environmental, health, or safety risk that NHTSA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, we must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned rule is preferable to other potentially effective and reasonably feasible alternatives considered by us. This rulemaking is not economically significant.

NHTSA finds that prior notice and opportunity for comment are unnecessary under 5 U.S.C. 553(b)(3)(B) because this action does not impose any regulatory requirements, but merely revises the list of vehicles not originally manufactured to conform to the Federal motor vehicle safety standards that NHTSA has decided to be eligible for importation into the United States to include all vehicles for which such decisions have been made since the last list was prepared in September of 2003.

In addition, so that the list of vehicles for which import eligibility decisions have been made may be included in the next edition of 49 CFR parts 400 to 999, which is due for revision on October 1, 2004, good cause exists to dispense with the requirement in 5 U.S.C. 553(d) for the effective date of the rule to be delayed for at least 30 days following its publication.