The imported fire ant regulations (contained in 7 CFR 301.81 through 7 CFR 301.81-10 and referred to below as the regulations) quarantine infested States or infested areas within States and restrict the interstate movement of regulated articles to prevent the artificial spread of the imported fire ant.

In an interim rule effective and published in the Federal Register on April 29, 2004 (69 FR 23415-23417, Docket No. 03-109-1), we amended the regulations in § 301.81-3(e) by designating as quarantined areas all or portions of 20 counties in North Carolina.

Comments on the interim rule were required to be received on or before June 28, 2004. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

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

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

Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, filed NADA 141-235 for EXCEDE (ceftiofur crystalline free acid) for Swine Sterile Suspension. The NADA provides for the veterinary prescription use of ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the treatment of SRD associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Haemophilus parasuis , and Streptococcus suis . The application is approved as June 18, 2004, and the regulations are amended in 21 CFR 522.315 and 556.113 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning June 18, 2004.

The agency has determined under 21 CFR 25.33(d)(5) 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.

This rule does not meet the definition of “rule“ in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

This notice finalizes the rule proposed in the Federal Register on July 6, 2001 (66 FR 35567). The Federal Bureau of Investigation (“FBI”) accepted comments on the proposed rule from interested parties until October 22, 2001, and 1,164 comments were received. With the exception of certain changes explained below, the proposed rule is adopted as final.

Significant Comments or Changes:

The Department on July 6, 2001, published a notice of five proposals for changes in the regulations governing the NICS. The changes relate to the amount of time that the NICS retains information about approved firearm transfers in the system's chronological log of background check transactions (“Audit Log”) and the manner in which that information may be used to audit the use and performance of the NICS. The proposed changes sought to balance the Brady Act's mandate that the Department protect legitimate privacy interests of law-abiding firearm transferees and the Department's obligation to enforce the Brady Act and the rest of the Gun Control Act and prevent prohibited persons from receiving firearms.

The comments about each of the five proposals are addressed below.

The majority of the comments received addressed the proposal that would require information relating to allowed firearm transfers, other than the NICS Transaction Number (NTN) and the date the number was assigned, to be destroyed before the beginning of the next day of NICS operations. The NICS regulations currently require destruction of this information within 90 days of the system allowing a transaction. 28 CFR 25.9(b)(1).

Since the closing of the comment period, Congress passed, and the President signed into law, a requirement that addresses the time within which the NICS is required to destroy certain information in the records of allowed transactions. Section 617 of Pub. L. No. 108-199, the Consolidated Appropriations Act, 2004 (or “Omnibus”), requires the NICS to destroy “any identifying information submitted by or on behalf of any person who has been determined not to be prohibited from possessing or receiving a firearm no more than 24 hours after the system advises a Federal firearms licensee that possession or receipt of a firearm by the prospective transferee would not violate subsection (g) or (n) of section 922 of title 18, United States Code, or State law.” Section 617 of the Omnibus bill becomes effective on July 21, 2004, 180 days after January 23, 2004, the date the Omnibus bill was signed into law.

For this reason, proposal #1 has been superseded by a legislative enactment setting a limit on how long the NICS may retain certain information on allowed transactions. The final rule has been revised to conform to the 24-hour record retention provision in the Omnibus bill. However, because many of the comments on proposal #1 raised questions about the effect of the shortened retention period on the operation of the NICS, we discuss those comments below to explain how the NICS will operate under the Omnibus provision and continue to enforce relevant Federal laws effectively.

Commenters questioned whether the FBI could audit system performance adequately when the retention period for most information relating to approved transfers is less than 24 hours. The FBI uses information currently retained in the Audit Log to ensure quality performance from the NICS employees and the operators at the contract Call Centers who take transferee information from Federal Firearms Licensees (“FFLs”). The FBI's procedure for these audits under the existing regulations is to review a sample of decisions (“proceed,” “denied,” and “open”) made by NICS employees and of entries by Call Center operators of transferee information. If an erroneous decision to allow a firearm transfer is detected during the audit, the FBI seeks to rectify the mistake by referring the case to the Bureau of Alcohol, Tobacco, Firearms, and Explosives (“ATF”) for retrieval of the firearm. In addition, retraining may be given to the employees involved or all employees relating to the issues raised by the error to prevent similar mistakes.

Under the Omnibus 24-hour destruction provision, this same auditing function will be performed soon after the transaction is processed by the NICS. This change, from the current review process (which in some instances may be performed as late as 75 days after an initial decision was made) to a process where reviews are performed within 24 hours after an FFL is advised of a “proceed” response (“real time” audits), can be done without any change in the number of transactions audited and the level of confidence underlying the audits. The FBI has determined that, after the proposed change, it can audit the same percentage of employee “proceed” decisions and Call Center entries as it currently reviews. Furthermore, the FBI has determined that, under the new audit procedures, it can attain the same confidence level in the audit results that is achieved under the current post-decision review of proceed records retained for 90 calendar days. The FBI will perform these reviews to accommodate all hours and days of operation. These reviews will include audits of the procedures through which the NICS ensures that aliens who are illegally or unlawfully in the United States or who are non-immigrant aliens do not receive firearms as prohibited by the Gun Control Act. See 18 U.S.C. 922(g)(5). The Department is working toward providing the necessary staffing resources for these “real time” reviews and will coordinate with the FBI to ensure adequate resources for this function.

The Department believes that these “real time” quality assurance audits, performed either before or within a few hours (less than 24 hours, at the outermost) after eligibility decisions are communicated to the FFL, will ensure that the reliability and accuracy of the NICS is maintained. Contemporaneous reviews may prevent a firearm from being erroneously transferred to a prohibited individual. Reviews performed within 24 hours of advising an FFL of a proceed response will, in cases of erroneous proceed decisions discovered by the audit, permit immediate referral of any firearm retrievals to ATF. In addition, the institution of any corrective training promptly after the error will prevent the repetition of errors that might occur where reviews are conducted much later, as they are under the current 90-day retention policy.

One comment observed that because the NICS has cases in which it cannot make a determination within three business days as to whether a potential transferee is disqualified, it cannot both make a determination and evaluate the accuracy of the determination within one business day. These cases, however, are not covered by the Omnibus 24-hour destruction provision. The NICS cannot in some cases reach a final determination within three business days because relevant information is missing from the automated record system and must be obtained from other sources. As discussed below, the final rule defines these cases as “open” responses and allows the NICS to retain information about them until a “proceed” determination is reached or for not more than 90 days, so that if records are returned to the NICS within that time showing that the transfer should have been denied, the case can be referred for a firearm retrieval. When there are no missing records, employees are able to make their determinations quite quickly, usually within a matter of minutes. Reviewing these determinations within 24 hours after they are made is both feasible and preferable to the current system of review.

The FBI also uses information on approved transactions to audit the data processing algorithm that matches system records to the transferee information submitted for the NICS check. These audits will be unaffected by the Omnibus provision because, in 2001, the FBI began performing the algorithm audits daily.

Some commenters contended that the new proposed retention period is inconsistent with the Department's earlier comment that 90 days was “the shortest practicable period of time for retaining records of allowed transfers that would permit the performance of basic security audits of the NICS.” 64 FR 10264. That statement, however, pertains to the process of post-decision reviews currently in effect and not the real-time auditing process that will be implemented under the Omnibus provision.

The current NICS audit process, based on post-decision reviews, is similar to the FBI's audit procedures for its National Crime Information Center (“NCIC”). In auditing the NCIC, the FBI reviews historical data periodically to ensure that law enforcement agencies are accessing the NCIC only for authorized purposes. NCIC users are typically subject to such audits once every three years. There is greater need to audit the NICS promptly, however, because NICS employees are constantly interpreting records, applying state and federal law, and deciding whether persons are eligible to possess or receive a firearm. Five years of operating the NICS have given the FBI sufficient experience in managing the system to implement the real-time quality reviews that will begin once the Omnibus 24-hour destruction requirement becomes effective.

One comment suggested that the new retention period will hamper the ability of the NICS to develop and analyze statistical information about the system's use and performance. The FBI has determined that, although under the new period it may not have as much flexibility in doing so, it will be able to continue to develop needed statistical data about the system's performance under the new retention period by making statistical data runs on a daily basis (before the beginning of the next day of NICS operations) instead of doing so on a weekly or monthly basis.

Another comment questioned the FBI's legal authority to retain more complex statistical data. The Department interprets the provision of the Brady Act requiring the destruction of “all records of the system relating to the person or the transfer,” 18 U.S.C. 922(t)(2)(C), as referring only to records that contain specific information about individual transfers. In addition, as discussed below, the Omnibus provision requires the destruction of “any identifying information submitted by or on behalf of” an approved purchaser. The Department believes, therefore, that the NICS may develop and retain information about the system's performance that does not contain such identifying information. Examples include but are not limited to the gross number of checks processed, the numbers of checks performed for handgun and long gun transfers, and the numbers for the different types of system responses given to FFLs (in the aggregate and by individual FFLs).

The Department interprets section 617 of the Omnibus bill as being consistent with this reading of the Brady Act. Therefore, when the provision becomes effective, the FBI will continue to retain for not more than 90 days non-identifying data associated with transactions such as the FFL number, as well as the NTN and date (which are retained indefinitely), for all transactions in the NICS Audit Log. In addition, when asking an agency for information in connection with a NICS check, the NICS will provide the NTN, which the agency can reference in any response to the NICS. By retaining the FFL and NTN numbers for up to 90 days, the FBI will be able to trace the transaction back to the FFL if prohibiting information is provided by an agency more than 24 hours after the NICS issued a Aproceed@ response. FFLs are required to record the NTN on the Firearms Transaction Record (ATF Form 4473) and must keep those forms for 20 years if the firearm is transferred. 27 CFR 478.129(b). As a result, the FBI will retain the ability to refer the case to ATF for the retrieval of the erroneously transferred firearm and any other firearms illegally possessed by the prohibited person. This practice will ensure that firearm retrievals can continue under the language in the Omnibus bill.

This continued retention of the FFL number is possible because the Department believes that the text of the Omnibus provision only requires the destruction within 24 hours of “identifying information submitted by or on behalf of” the approved purchaser. The statute is most naturally read to equate “identifying information” with information identifying the prospective transferee, rather than information that identifies anyone or anything. The FFL number does not identify the prospective transferee. Additionally, the phrase “identifying information submitted by or on behalf of” a transferee is best read to encompass information in the NICS records provided by the transferee—either directly (“submitted by [the transferee]”), or indirectly through a surrogate, such as the FFL (“submitted on behalf of [the transferee]”). Even though an FFL must submit its FFL number to the NICS before any firearm transfer may be authorized, this number is most naturally characterized not to constitute information “submitted by or on behalf of” a transferee because the transferee plays no role in providing it to the NICS.

To be clear, the Omnibus provision's 24-hour record destruction requirement applies only to transactions in which the NICS has affirmatively determined that possession or receipt of a firearm by the purchaser would not violate 18 U.S.C. 922(g) or (n) or state law and has so “advised” the FFL, i.e. has provided the FFL with a “proceed” response. Section 617 is not applicable to “denied” or “open” transactions. In the case of denied transactions, records are retained indefinitely. Furthermore, as discussed below, the FBI will also continue to be able to retain for up to not more than 90 days (as it does under current law) information on “open” transactions— i.e. , where the NICS has not yet provided a “proceed” or “deny” response because it has not received definitive information about the status of a prospective gun buyer's record ( e.g. , a missing arrest disposition). If prohibiting information is received within 90 days, continued retention of such records will allow the FBI to change an open transaction to a “denied” response and refer the case to ATF for a firearm retrieval if the firearm has been transferred by the FFL (as allowed under the Brady Act when the FFL has not received within three business days a response on whether the transfer is lawful).

Some commenters were concerned that the proposed rule could interfere with the retention of information about proceed transactions by Point of Contact states (“POCs”). Under the existing NICS regulations, 28 CFR 25.9(d), POCs are required to destroy information about allowed transfers that are not part of “a record system created and maintained pursuant to independent state law regarding firearm transactions.” See also 63 FR 58311. The FBI has advised POCs that if they do not have such state authority they must observe the same retention period for allowed transfers as the FBI under § 25.9(b). Thus, POCs that do not have the specified state authority will be required to reduce their retention period to conform to the new period that the FBI will observe, pursuant to the Omnibus provision, upon the effective date of this rule. However, POCs that have state authority to retain this information may continue to do so, and such authority is not affected by this regulatory change.

Some commenters suggested that reducing the retention period to less than 24 hours will prevent the identification of unlawful firearm transactions involving straw purchases or the use of false identification. A “straw purchase” occurs when the actual purchaser of a firearm uses another person, the “straw purchaser,” to execute the paperwork necessary to purchase a firearm from an FFL. The straw purchaser violates the law by making a false statement with respect to information required to be kept in the FFL's records. Straw purchases are most often detected by the NICS when an FFL informs a NICS examiner that one person is buying a firearm for another person, such as a friend or family member who recently has been denied. The transactions usually occur on the same operational day and frequently only minutes apart. Under the current regulation (§ 25.9(b)(2)), when such transactions are identified, the proceed information is maintained by the NICS and referred to ATF for investigation where doing so is necessary to pursue an identified case of “misuse of the system.”

The requirement to destroy information about allowed transfers within 24 hours after the FFL has been notified of the approval will not interfere with these cases continuing to come to the attention of the NICS. To conform to the requirement of section 617 of the Omnibus, however, § 25.9(b)(2) has been revised in the final rule to provide that information in the NICS Audit Log, including information not yet destroyed under the 24-hour destruction requirement, that indicates, either on its face or in conjunction with other information, a violation or potential violation of law or regulation may be shared by the FBI with appropriate authorities responsible for investigating, prosecuting, or enforcing such law or regulation. This change is consistent with Routine Use C in the NICS Privacy Act Notice, which provides that: If, during the course of any activity or operation of the system authorized by the regulations governing the system (28 CFR, part 25, subpart A), any record is found by the system which indicates, either on its face or in conjunction with other information, a violation or potential violation of law (whether criminal or civil) and/or regulation, the pertinent record may be disclosed to the appropriate agency/organization/task force (whether Federal, State, local, joint, or tribal) and/or to the appropriate foreign or international agency/organization charged with the responsibility of investigating, prosecuting, and/or enforcing such law or regulation * * *

In addition, the NICS does not destroy records of denials. A NICS employee verifies the potential straw purchase case by referring back to an earlier “denied” response, not an earlier “proceed” response. For that reason, information about allowed transfers in the Audit Log is not used to track lawful transferees to see whether they might be engaged in a straw purchase. Straw purchases by persons with last names different from the ones of persons that later receive the firearm would not be detectable by a review of the Audit Log, regardless of whether the information contained therein is kept for one day or 90 days.

The change required by the Omnibus provision does not affect the ability of law enforcement to detect or prosecute the use of false identification by prospective firearm purchasers. The NICS runs the name and identifying information that the FFL sends to the system based on the identification documents presented by the buyer. The FFL is responsible for examining the identification documents, and the NICS has no means by which it can validate the identification presented. Thus, the change in the retention period of information about allowed transfers has no relevance to the system's ability (or inability) to validate a buyer's identification. One comment suggested that a purchaser using a false identity could be detected by reviewing the Audit Log for a pattern of purchases that could trigger an investigation to uncover possible gun trafficking. The Department's position since the NICS began operating is that such use of the Audit Log is not authorized by the Brady Act and the NICS regulations, both of which prohibit the use of the NICS to establish a system of firearm registration relating to lawful gun purchases; the Audit Log, therefore, is not used to track purchases by lawful gun buyers, even though doing so could potentially identify purchase patterns suggesting possible cases of gun trafficking.

One comment observed that the proposed change would prevent the NICS from referring a “proceed” transaction for a firearm retrieval when a disqualifying record is subsequently entered into the system. The comment indicated that this would allow a prohibited buyer to “beat the clock” and buy a firearm after he or she becomes disqualified but before his or her disqualifying record is entered into the system. The NICS, however, does not currently have a process for automatically comparing new criminal history or other disqualifying information received by the FBI against proceed transactions in the Audit Log. As noted above, under the final rule the system will list as “open” the cases in which the system has hit on a potentially disqualifying record but has not obtained definitive information on whether the person is disqualified. Examples of such cases include transactions where a record is found of an arrest for a disqualifying offense without information about the final disposition or where a record is found of a conviction of a violent misdemeanor without information on whether there is a domestic relationship that would make the offense a disqualifying misdemeanor crime of domestic violence. Records on these open transactions will be kept for not more than 90 days to allow for referral of the case for firearm retrieval in the event disqualifying information is received within that time.

Many commenters argued that the Brady Act and the Firearms Owners' Protection Act require immediate destruction of NICS records upon communicating the proceed decision to the FFL, and that any retention of information on approved transfers violates the provisions of federal law prohibiting the establishment of a federal firearms registry. The United States Court of Appeals for the District of Columbia Circuit rejected this argument in National Rifle Ass'n of America, Inc. v. Reno, 216 F.3d 122 (D.C. Cir. 2000), cert. denied sub nom. National Rifle Ass'n of America, Inc. v. Ashcroft, 533 U.S. 928 (2001). That decision affirmed the Attorney General's discretion to allow the NICS to keep information about allowed firearm transfers for a limited period of time for the limited purpose of conducting audits of the use and performance of the system. See National Rifle Ass'n of America, Inc. v. Reno, 216 F.3d at 137-38, quoting 66 FR 58304 (Oct. 30, 1998). Such discretion perforce extends to the changes effected by this rule, which requires much more prompt destruction of the information than do the regulations it amends. Moreover, by specifying in section 617 of the Omnibus bill the requirement for destroying certain information in records of allowed transfers not more than 24 hours after an FFL is advised of the determination, Congress has specifically authorized retaining these records for up to 24 hours.

Several comments questioned whether records of allowed transfers would be kept beyond the beginning of the next day of NICS operations in computer system backup tapes. The NICS currently maintains complete backups of the last ten calendar days of all data. The Omnibus provision provides no exception to the requirement for the destruction of the identifying information about allowed transactions within 24 hours of advising the FFL of the “proceed” response. The FBI will therefore revise its backup procedures for NICS data to ensure that the relevant data is destroyed within the 24-hour time frame.

Finally, the Department has determined that the regulations should more clearly distinguish between the final rule's use of the term “NICS business day” and the term “business day” as used elsewhere in the regulations. The term “business day” is defined as “a 24-hour day (beginning at 12:01 a.m.) on which state offices are open in the state in which the proposed firearm transaction is to take place.” Ordinarily, this excludes weekends and all holidays on which state offices are closed. In contrast, the FBI NICS Section operates every day of the year during the hours of 8 a.m. to 1 a.m. eastern time, with the exception of Christmas Day. Therefore, in § 25.9(b)(1)(iii), the final rule substitutes the term “NICS operational day” for the term “NICS business day.” “NICS operational day” is defined to mean “the period during which the FBI NICS Operations Center has its daily regular business hours.” In conjunction with this change, the term “NICS Operations Center regular business hours” has been removed from the regulations. This term was defined as 9 a.m. to 2 a.m. eastern time. Shortly after the FBI NICS Operations Center began operating, however, it established business hours of 8 a.m. to 1 a.m. eastern time. The definition of “NICS Operations Center regular business hours” is being removed so that an amendment to the rule is not required in the event of future changes in those hours. The FBI NICS Section will keep POCS and FFLs informed of any changes in its daily regular business hours.

The Department proposed to create Individual FFL Audit Logs upon prior written request from ATF for use in connection with ATF's inspections of FFL records. With the exception of denied transactions, the Individual FFL Audit Logs may contain only non-identifying information for each transaction. All information concerning denied transactions may be included in the Individual FFL Audit Logs. The FBI will create Individual FFL Audit Logs for the transactions processed by the FBI's NICS Operations Center. The Department expects the POC states to work with the FBI and ATF to ensure that such Logs will also be available to ATF for use in its inspections of FFLs in the POC states. The final rule provides: “The FBI will provide POC states the means to provide to the FBI information that will allow the FBI to generate Individual FFL Audit Logs in connection with ATF inspections of FFLs in POC states. POC states that elect not to have the FBI generate Individual FFL Audit Logs for FFLs in their states must develop a means by which the POC will provide such Logs to ATF.”

In the final rule, the Department has dropped the requirement that ATF destroy all records of allowed transfers and open transactions within 90 days of the date on which the Individual FFL Audit Log was created. The Department concluded that the proposed rule's requirement that ATF destroy this information and certify its destruction is not required by law and would create an unnecessary administrative burden. In addition, to give ATF the flexibility to obtain information covering a longer period of transactions for use in its inspections of FFLs, the final rule allows the Individual FFL Audit Logs to contain up to 60 days, as opposed to the proposed 30 days, worth of allowed and open transfer records originating from the inspected FFL.

Several comments on this proposal suggested that giving ATF only the NTN and date of inquiry on allowed transfers limits the utility of these logs in ATF inspections of FFLs. The Department notes that the Individual FFL Audit Logs will allow ATF to review dealer records in several ways that will deter FFL misuse of the NICS. First, by comparing the NTN issued by the NICS to the NTN recorded on the ATF Form 4473, ATF can deter FFLs from falsifying NTNs to conceal the fact that they did not request a NICS check on a transfer and detect any FFLs who have made such falsifications. Second, by comparing the number of NICS checks requested by an FFL during the 60-day period to the number of Forms 4473 that the FFL has for the same period, ATF will be able to ensure that for every NICS check there is a corresponding Form 4473. When there are more NICS checks than there are Forms 4473, ATF will determine whether the FFL was running unauthorized NICS checks unrelated to firearm transfers. When there are fewer NICS checks than there are Forms 4473, ATF can investigate whether the FFL was transferring firearms without the required NICS check. In addition to using the 60 days of data in the Individual FFL Audit logs to detect these discrepancies, ATF can use statistical data that the FBI develops covering a longer period of time on the gross number of checks by the FFL and the gross number of responses by type given by the system (“proceed,” “denied,” or “open”). Since all checks must have a corresponding Form 4473, if such forms are missing, then possible NICS checks for improper purposes may be detected. These reviews by ATF will deter dealers from avoiding NICS checks or running unauthorized NICS checks and violating the right to privacy of persons subject to such checks.

Other comments indicated that limiting the information about allowed transfers in the Individual FFL Audit Logs will prevent ATF from discovering certain types of dealer misuse of the NICS. As noted above, this information will continue to allow ATF to check for fictitious NTNs and discrepancies between the number of checks and the number of Forms 4473. It is true, however, that when the 24-hour destruction requirement in the Omnibus bill is implemented, ATF inspectors will no longer be able to compare the information on the 4473 on proceeded firearm transactions with the information sent to the NICS to determine if an FFL sent the system different information to avoid the background check on the actual buyer. To date, however, ATF has not found such activity to be a problem. ATF believes that, in any event, it will be able to deter FFLs from deliberately sending the NICS information different from what is on the Form 4473 by conducting, as part of its inspections, NICS rechecks on a sample of proceeded transactions to see if the NICS would give the same “proceed” response as of the date of the original transaction. The FBI has also developed a new tool, the NTN validator, which ATF will use to detect fabricated NTNs.

To be sure, the fact that the FBI and ATF were able to conduct comparisons of identifying information from the Form 4473 that was submitted to the NICS may have had some deterrent effect on dealers who would consider abusing the system. The FBI and ATF, however, will create a similar deterrent. As mentioned above, ATF has the authority to run NICS rechecks to see if the NICS returns a “denied” response on a transfer the Form 4473 shows as being allowed. The recheck determines whether the person was prohibited based on records showing the person's status at the time of the original check. The NICS regulations grant ATF authority to conduct NICS rechecks as part of its inspection process under 28 CFR 25.6(j)(2), which permits ATF access to the NICS Index for civil and criminal law enforcement purposes under the Gun Control Act. ATF is also authorized to receive information from other databases checked by the NICS, including the NCIC, the Interstate Identification Index (“III”), and Bureau of Immigration and Customs Enforcement, Department of Homeland Security, databases. Any inconsistency between a proceed on a Form 4473 and a denied response on a recheck would suggest that the dealer had sent the NICS identifying information that differs from that which appears on the Form 4473. Upon the discovery of such a discrepancy, ATF can do a larger sample of rechecks to ascertain if there is a pattern of abuse or initiate an investigation of the FFL if warranted by the facts. Moreover, the rechecks can be done over a much longer period of time than the 60 days of transactions it was anticipated that ATF would review using the information saved and shared under the 90-day retention rule. Using the recheck approach to auditing FFL records of NICS checks increases the probability of irregularities being discovered because ATF can go back a year or more in its recheck sample. The Department has concluded that this recheck process will provide a deterrent to dealers who might consider submitting false information to the NICS, because sanctions for such misuse include suspension of NICS privileges and criminal prosecutions. In addition, under the new rule, the FBI will continue to be able to identify cases in which FFLs, after receiving a denial on a particular purchaser's identifying information, initiate one or more subsequent checks with slight variations of a name, date of birth, or social security number. These cases usually occur shortly after the initial denial or delay and are verified by referring back to the initial denied or open transaction. Finally, traditional law enforcement methods, such as undercover investigations finding cases of dealers submitting false information to the NICS, can lead to prosecutions or license revocations that will deter dealers from engaging in such illegal conduct.

Other comments argued that the Brady Act does not allow the FBI to retain information about the FFL identification number (“FFL identifier”) or to transfer any information on allowed transfers or open transactions to ATF. The comments asserted that the FBI can only keep the NTN and date (without the associated FFL identifier) and may only share that information with ATF when there is a bona fide criminal investigation. As noted above, the Department's authority to retain information on allowed transfers, including the FFL identifier number, in the Audit Log for a limited time was upheld in National Rifle Ass'n of America, Inc. v. Reno , 216 F.3d 122 (D.C. Cir. 2000), cert. denied sub nom. National Rifle Ass'n of America, Inc. v. Ashcroft , 533 U.S. 928 (2001). Also, for the reasons specified above, the Department believes that the record-destruction requirement in the Omnibus bill only applies to the identifying information submitted by or on behalf of the prospective purchaser. Sharing FFL identifiers with ATF in connection with its inspections of FFLs facilitates authorized audits of FFLs' use of the NICS.

Initially, the purpose of this proposal was to create a separate category of transactions called “unresolved.” In the final rule, however, the name of the category is changed from “unresolved” to “open.” “Open” transactions are those non-canceled transactions where the FFL has not yet been notified of the final determination. In such cases, additional information is needed before the NICS examiner can verify whether a “hit” in the database demonstrates that the prospective purchaser is disqualified from receiving a firearm under state or federal law. Under the final rule, the NICS will be able to maintain records of open transactions until either (1) a final determination on the transaction is reached and has been communicated to the FFL resulting in the transaction status being changed to a “proceed” (24-hour destruction) or a “denied” (indefinite retention) status, or (2) 90 days elapse from the date of inquiry.

Currently, approximately 74 percent of all transactions are completed immediately and approximately 92 percent are completed while the FFL is still on the telephone with the FBI NICS Section. Therefore, open transactions represent a very small percentage of all calls to the NICS. Creating an “open” category clarifies that the NICS can retain, as discussed above, the identifying information on such transactions beyond the 24-hour retention period for “proceed” transactions so that employees can complete research and analysis necessary to achieve an accurate determination. If the transaction's status is changed to “denied” within 90 days, the NICS would be able to refer the matter to ATF for a possible firearm retrieval and retain the transaction information indefinitely.

Several commenters raised the concern that the creation of a new “open” category would change the statutory mandate in the Brady Act that allows an FFL to transfer a firearm if the NICS has not determined, within three business days, that the transaction is prohibited by law. However, the new category of “open” would not affect an FFL's ability to transfer or withhold a firearm after three business days, but would simply allow the NICS to keep accurate records of the precise status of NICS transactions. With this new category of “open” transactions, the NICS will more accurately reflect the status of all transactions in the system, track changes in their status, and update its records accordingly.

The definition of “Delay” has been amended to clarify that it means the response given to the FFL indicating that the transaction is in an “Open” status and that more research is required prior to a NICS “Proceed” or “Denied” response.

Finally, several comments stated that the open category would be unnecessary if the record systems checked by the NICS had complete information. The Department agrees that all levels of government must continue to improve the completeness of disposition information in the criminal history record system so that such information can be available to the NICS without the need for further research. As record completeness improves, the number of open transactions should decrease. The Department is addressing the problem of missing dispositions by making the closing of such gaps a priority use of the funding available to the states under the National Criminal History Improvement Program (“NCHIP”). It is expected, however, that achieving improved completeness will take additional time, and that there will continue to be a need for the NICS to have an “open” category for the foreseeable future.

Under current § 25.6(h), POC states are encouraged, but not required, to transmit to the FBI determinations that a background check indicates a firearm transfer is denied. Unfortunately, most POC states currently do not transmit this information to the NICS. In order to provide the NICS with complete information about POC transactions, the Notice of Proposed Rulemaking contemplated that POC states would be required to transmit all determination information on all POC determinations—approved, open, and denied—as soon as it is available.

A number of POC states and interest groups commented that a requirement to transmit information about all determinations would overly and unduly burden the POC states and the NICS. In addition, they stated that POC denial information is the most valuable and necessary for the NICS to collect. The 24-hour destruction requirement in the Omnibus, however, makes it just as important that the NICS have notice of when a POC transaction is open, because otherwise it will have to assume the transaction has been approved and destroy the transaction information within 24 hours of the initial check. This result will mean that the NICS may not have information about the transaction even though the POC has not finished its review of or made a final determination concerning the open transaction. In turn, this would cause certain inefficiencies in the completion of POC checks, in some cases requiring the POC to run an open transaction a second time where the information about the initial check has been destroyed because the FBI is forced to assume the transaction has been proceeded.

In light of these comments and the requirement of the Omnibus provision, the Department has changed the final rule to provide that POC states must transmit electronic NICS transaction determination messages to the FBI for the following transactions: (1) Open transactions that are not resolved before the end of the operational day on which the check is requested; (2) denied transactions; (3) transactions reported to NICS as open and later changed to proceed; and (4) denied transactions that have been overturned. The FBI will provide POCs with an electronic message capability to transmit this information.

These electronic messages shall be provided to the NICS immediately upon communication of the POC determination to the FFL. For open transactions, the electronic messages shall be communicated no later than the end of the operational day on which the check was initiated. The FBI will assume that POC transactions that are not identified as denied or open have received a proceed response and will accordingly destroy certain information from those NICS records within 24 hours.

The FBI has already provided and will continue to provide the POCs guidance and support on the system requirements for providing the NICS the required information about transaction status. In addition, the 2004 Program Announcement for the National Criminal History Improvement Program (NCHIP), available on the website of the Bureau of Justice Statistics, provides that NCHIP funds are available to POC states “to implement programming or operational changes in records management necessary to comply” with new NICS requirements for POC participation resulting from the Omnibus bill.

Receiving information about POC denials will enable the FBI to refer all denials, not just those made by the FBI NICS Operations Center, to ATF for investigation. Receiving notification of open POC transactions will allow the FBI to retain information about the POC transaction for up to 90 days, or until the transaction's status is changed to proceed before the expiration of 90 days, in the same way the FBI will retain information about open transactions handled by the FBI NICS Section.

Several commenters were concerned that the new POC requirement might interfere with state record-retention rules. These issues are addressed by the current requirement in the NICS regulations regarding record retention by POC states. Specifically, 28 CFR 25.9(d) states:

(d) The following records of state and local law enforcement units serving as POCs will be subject to the Brady Act's requirements for destruction:

(1) All inquiry and response messages (regardless of media) relating to the initiation and result of a check of the NICS that allows a transfer that are not part of a record system created and maintained pursuant to independent state law regarding firearms transactions; and

(2) All other records relating to the person or the transfer created as a result of a NICS check that are not part of a record system created and maintained pursuant to independent state law regarding firearms transactions.

The Department gave the following explanation of this section in the Federal Register when the initial NICS regulations were published on October 30, 1998: “Sections 25.9(d)(1) and (2) of the final rule were revised to make it clear that the referenced state records of allowed transfers would not be subject to the Brady Act record destruction requirement if they are part of a record system created and maintained pursuant to independent state law regarding firearms transfers. The reason for this clarification is to avoid interfering with state regulation of firearms. If a state is performing a gun eligibility check under state law, and state law requires or allows the retention of the records of those checks, the state's retention of records of the concurrent performance of a NICS check would not add any more information about gun ownership than the state already retains under its own law.” 63 FR 58304. The Department does not believe that the Omnibus 24-hour record destruction provision affects this part of the NICS regulation. The Omnibus provision simply reduces the record retention time for records subject to the Brady Act's record destruction requirement; it does not expand the records that are subject to the destruction requirement.

As noted above, however, POC states that do not have a state law regarding firearms transactions that requires or allows the retention of the records of gun eligibility checks must comply with the same record destruction schedule observed by the FBI. Therefore, to ensure that the Department observes the requirements of the Omnibus bill, beginning July 21, 2004, such POC states must destroy records relating to allowed transfers, in accordance with 28 CFR 25.9(d), no more than 24 hours after advising FFLs of proceed determinations. Otherwise, NICS transactions in those states will have to be processed by the FBI to ensure compliance with the Omnibus provision.

The final rule would permit lawful transferees to request that the NICS maintain information about themselves in a Voluntary Appeal File, a separate computer file that will be checked by the NICS, so that the NICS will not erroneously deny a firearm transfer in the future. Persons who may request that the NICS maintain information about them to facilitate future firearms transactions include lawful purchasers who have been delayed or denied a firearm transfer because they have a name and date of birth similar to that of a prohibited person. The NICS has the authority to maintain such information in order to reduce the number of requests it receives for the reasons underlying a delay or denial of a firearm transfer and the number of unnecessary appeals. Doing so will enhance the service that NICS provides to FFLs and lawful firearm transferees and help fulfill the Brady Act's goal of providing an “instant” background check where possible.

This provision would also avoid erroneous denials or extended delays on NICS checks of persons who were convicted but have had their rights restored or have obtained from ATF relief from the firearm disability. Some commenters noted that some states provide that the firearm privileges of certain convicted persons are automatically restored after the passage of a set period of time. The commenters asserted that use of the Voluntary Appeal File should not be available to persons receiving the restoration of their rights because possession of a firearm by such persons presents a threat to public safety. Under certain conditions, however, the Gun Control Act allows individuals with otherwise disqualifying convictions to possess and receive firearms if their civil rights have been restored. See 18 U.S.C. 921(a)(20) and 921(a)(33)(B)(ii). The NICS is required by law to recognize such restorations of rights when determining a person's eligibility to obtain a firearm. The Department, therefore, declines to impose the suggested limitation on the use of the Voluntary Appeal File.

At the suggestion of the FBI, the Department amends this provision to clarify that the FBI may remove a person from the Voluntary Appeal File when the FBI finds that a disqualifying record has been created after the date of the person's entry into the file. Thus, the following sentence is added to the end of the new § 25.10(g): “If the FBI finds a disqualifying record on the individual after his or her entry into the Voluntary Appeal File, the FBI may remove the individual's information from the file.” The Department is also correcting an error in the last sentence of this section of the proposed rule, which used the term “Voluntary Audit Log” instead of “Voluntary Appeal File.” That sentence in the final rule reads: “However, the FBI shall not be prohibited from retaining such information contained in the Voluntary Appeal File as long as needed to pursue cases of identified misuse of the system.”

One comment raised procedural objections concerning the delays in the effective date of the 90-day retention rule published in January 2001. The Department provided explanations for the postponement of the effective date when those actions were taken. See 66 FR 12854 (Mar. 1, 2001); 66 FR 22898 (May 3, 2001). Criticisms of those delays are irrelevant to the lawfulness of the process by which the current rule is being promulgated.

For the reasons specified below, the effective date for this rule is July 20, 2004, the date of its signature. No later than July 21, 2004, the FBI will implement the 24-hour destruction requirement in the Omnibus provision, together with the associated changes to the NICS quality review process, and the creation of the “open” category under proposal #3.

While the authority to provide ATF with Individual FFL Audit Logs under proposal #2 and to establish a Voluntary Appeals File under proposal #5 is effective as of July 20, 2004, the FBI will not be able to implement those system enhancements immediately. The FBI will implement those enhancements as soon after the effective date as practicable.

No later than July 21, 2004, the FBI will establish the capacity for POCs to send to the NICS an electronic message on the status of the specified transactions as provided in proposal # 4. Due to programming and other changes that have to be made for certain states to send the POC determination messages, some POCs will not be able to take advantage of this capacity on July 21, 2004. All POCs must, however, continue to work with the FBI to satisfy the final rule's POC determination message requirement.

The Department finds “good cause” for exempting this rule from the provision of the Administrative Procedure Act providing for a delayed effective date. 5 U.S.C. 553(d). Consistent with section 617 of the Omnibus bill, this rule must be in place by July 21, 2004 to ensure continued funding for the NICS system. Because it would be contrary to the public interest to have any interruption in this program, which protects the public by making it unlawful for felons and other prohibited persons from receiving or possessing firearms, this rule took effect July 20, 2004, upon signature.

The Attorney General, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this final rule and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. Although many FFLs are small businesses, they are not subject to any additional burdens under the plan adopted to audit their use of the NICS. In addition, the rule will not have any impact on an FFL's ability to contact the NICS, nor will it result in any delay in receiving responses from the NICS.

The Department of Justice has drafted this final rule in light of Executive Order 12866, section 1(b), Principles of Regulation. The Department of Justice has determined that this rule is a “significant regulatory action” under section 3(f) of Executive Order 12866, and accordingly it has been reviewed by the Office of Management and Budget (“OMB”).

This final rule 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. The states are not required to act as POCs for the NICS, but do so voluntarily. The FBI consults with the state POCs on a regular basis about NICS operational issues and has held annual User conferences where POC questions and concerns are addressed. In addition, several POCs made comments on the current proposed rule and the rule has been modified to be more flexible in light of the concerns expressed by the POCs. For these reasons, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

This final rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This final rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000 or more, a major increase in costs or prices, or have significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Information collection associated with this regulation will be submitted to the Office of Management and Budget for review under the provisions of the Paperwork Reduction Act of 1995. The OMB control number for this collection is 1110-0035.

The proposed rule would have made a condition of state participation in the system as a POC the requirement to transmit all determination information to the NICS as soon as it is available to the state, including determinations that a firearm transfer may proceed, is denied, or the check is open. While the Department did not receive any comments specifically addressing the Paperwork Reduction Act, the FBI did receive comments from POC states addressing the burden and utility of the proposed information collection. As noted above, as a result of these comments, the final rule eliminates the requirement that POCs provide transaction status information to the FBI on approximately 74 percent of the transactions, i.e. no information need be submitted for transactions in which POCs provide a “proceed” response to an FFL during the operational day on which the check was requested. The rule does require POCs to submit transaction status information on: (1) Open transactions that are not resolved before the end of the operational day the check is requested; (2) denied transactions; (3) transactions reported to NICS as open and later changed to proceed; and (4) denied transactions that have been overturned. As a result of this change in the final rule, POCs will only be required to submit information on approximately twenty-six percent of determinations.

The number of respondents that will be affected by this information collection will be 18, the number of states that act as POCs for the NICS (states that do NICS checks only in connection with the issuance of firearm permits are not considered POCs for these purposes). The FBI estimates that it will require one minute for each POC state to send to the NICS the required information in each POC determination message. Collectively, the POCs conduct approximately 4 million NICS checks per year. Assuming a 74 percent immediate proceed rate, the POCs will have to send electronic messages with the details of the transaction in only 26 percent of their determinations. Thus, it is estimated that the total public burden (in hours) associated with this collection from the estimated 19 respondents is 17,333 hours in the first year.

(4) Creation and Use of Individual FFL Audit Logs. Upon written request from ATF containing the name and license number of the FFL and the proposed date of inspection of the named FFL by ATF, the FBI may extract information from the NICS Audit Log and create an Individual FFL Audit Log for transactions originating at the named FFL for a limited period of time. An Individual FFL Audit Log shall contain all information on denied transactions, and, with respect to all other transactions, only non-identifying information from the transaction. In no instance shall an Individual FFL Audit Log contain more than 60 days worth of allowed or open transaction records originating at the FFL. The FBI will provide POC states the means to provide to the FBI information that will allow the FBI to generate Individual FFL Audit Logs in connection with ATF inspections of FFLs in POC states. POC states that elect not to have the FBI generate Individual FFL Audit Logs for FFLs in their states must develop a means by which the POC will provide such Logs to ATF.

On June 18, 2004, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations, Mystic River, Massachusetts, in the Federal Register (69 FR 34099). The Coast Guard provided a 20-day comment period to the public to comment on the proposed rule. We received one comment letter in response to the notice of proposed rulemaking. No public hearing was requested and none was held.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds good cause exists for making this rule effective less than 30 days after publication in the Federal Register because this final rule needs to be in effect on July 26, 2004, in order to provide the necessary safeguards in the interest of national security and public safety during the week the Democratic National Convention (DNC) will be convened in Boston, Massachusetts.

The S99 (Alford Street) Bridge, mile 1.4, across The Mystic River has a vertical clearance in the closed position of 7 feet at mean high water and 16 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR 117.609.

The bridge owner, the City of Boston, requested that the S99 (Alford Street) Bridge remain closed to vessel traffic during the Democratic National Convention (DNC) from 7 a.m. on July 26, 2004 through 7 a.m. on July 30, 2004. Vessels that can pass under the draw without a bridge opening may do so at all times.

During the DNC several primary vehicular traffic routes, including I-93, and the North Station commuter rail station will be closed for security purposes.

Route 99 has been designated as the alternate detour route to accommodate much of the detoured vehicular traffic and buses transporting commuter rail passengers into and through Boston during the week the DNC is underway. Rail commuters that normally transit to North Station will be bussed into Boston utilizing Route 99 as a detour route.

The bridge owner requested that the S99 (Alford Street) Bridge remain closed to help facilitate the expected heavy vehicular traffic in the interest of public safety.

This proposed change temporarily amends 33 CFR 117.609 by suspending paragraph (a) and adding a new temporary paragraph (c) effective from July 26, 2004 through July 30, 2004.

Under this temporary final rule, effective from 7 a.m. on July 26, 2004 through 7 a.m. on July 30, 2004, the S99 (Alford Street) Bridge shall open on signal only between 4 a.m. and 5 a.m., daily.

The Coast Guard received one comment letter in response to the notice of proposed rulemaking.

The comment letter was from the Mystic Wellington Yacht Club, which is located upstream from the S99 (Alford Street) Bridge. The yacht club's letter stated that the members of the yacht club did not pose a threat to the public and that it would impose a hardship because members would not be able to pass through the bridge.

The bridge is not being closed due to waterborne threats. The bridge is being closed to facilitate the anticipated heavy vehicular traffic during the week of the DNC. Route 99 has been designated as a detour route for the displaced vehicular traffic and buses ferrying commuter rail passengers to Boston. The closure of the S99 (Alford Street) Bridge will help facilitate the movement of detoured vehicular traffic traveling Route 99 as a result of the closure of the Amtrak commuter rail station in Boston and the closure of the I-93 highway during the week the DNC will hold it's convention.

The Coast Guard determined, as a result of the comment received, to allow the S99 (Alford Street) Bridge to open on signal each day between 4 a.m. and 5 a.m. to facilitate marine traffic that can't pass under the draw in the closed position.

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).

This conclusion is based on the fact that most vessel traffic on the Mystic River can pass under the bridge without a bridge opening at various stages of the tide the bridge shall open on signal between 4 a.m. and 5 a.m., daily during the effective period, for vessels that cannot transit underneath.

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

The Coast Guard certifies under 5 U.S.C. 605(b), that this rule will not have a significant economic impact on a substantial number of small entities.

This conclusion is based on the fact that most vessel traffic on the Mystic River can pass under the bridge without a bridge opening at various stages of the tide the bridge shall open on signal between 4 a.m. and 5 a.m., daily during the effective period, for vessels that cannot transit underneath.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

No small entities requested Coast Guard assistance and none was given.

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

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

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

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by 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 concern 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 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 M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction, from further environmental documentation. It has been determined that this final rule does not significantly impact the environment.

The normal vertical clearance under the Marine Parkway Bridge in the full open position is 152 feet at mean high water and 156 feet at mean low water. The existing regulations are listed at 33 CFR 117.795(a).

The bridge owner, MTA Bridges and Tunnels Authority, requested a temporary deviation from the Drawbridge Operation Regulations to facilitate necessary maintenance repairs at the bridge.

During the bridge repairs safety netting will be suspended under the bridge towers preventing the bridge from fully opening and therefore reducing the vertical clearance during bridge openings by (50) fifty feet.

The normal maximum vertical clearance under the bridge in the full open position is 156 feet at mean low water and 152 feet at mean high water. A review of the bridge opening logs and opening requests revealed that the bridge normally does not open more than (90) ninety feet for the passage of vessel traffic. As a result none of the normal waterway users should be affected by this vertical clearance reduction.

Under this temporary deviation the Marine Parkway Bridge, mile 3.0, across Jamaica Bay, shall open for vessel traffic only up to a maximum of 106 feet at mean low water and 102 feet at mean high water from August 16, 2004, through October 10, 2004.

This deviation from the operating regulations is authorized under 33 CFR 117.35, and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.

The NJTRO Bridge has a vertical clearance in the closed position of 8 feet at mean high water and 13 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR 117.747.

The bridge owner, New Jersey Transit Rail Operations (NJTRO), requested a temporary deviation from the drawbridge operation regulations to facilitate necessary scheduled bridge maintenance. The bridge must remain in the closed position during the performance of these repairs.

Therefore, under this temporary deviation the NJTRO Bridge may remain in the closed position from 10 p.m. on July 30, 2004, through 10 a.m. on July 31, 2004.

An alternate date, in case of inclement weather, shall be from 10 p.m. on August 6, 2004, through 10 a.m. on August 7, 2004.

This deviation from the operating regulations is authorized under 33 CFR 117.35, and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.

The Coast Guard did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Information on the fireworks display was not supplied to the Coast Guard in sufficient time to draft and publish an NPRM. Any delay encountered in this regulation's effective date would be contrary to public interest since the safety zone is needed to prevent traffic from transiting a portion of Boston Harbor, Massachusetts during the fireworks event and to provide for the safety of life on navigable waters. Additionally, the zone will have a negligible impact on vessel transits due to the fact that vessels will be limited from the area for only one hour, and vessels can still transit in other areas in the majority of Boston Harbor during the event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Any delay encountered in this regulation's effective date would be contrary to public interest since the safety zone is needed to prevent traffic from transiting a portion of Boston Harbor, Massachusetts during the fireworks event and to provide for the safety of life on navigable waters. Additionally, the zone should have a negligible impact on vessel transits due to the fact that vessels will be limited from the area for only one hour, and vessels can still transit in other areas in the majority of Boston Harbor during the event.

This regulation establishes a safety zone in Boston Inner Harbor within a 400-yard radius of the fireworks barge located at position 42°22.263″ N, 071°02.956″ W. The safety zone is in effect from 10 p.m. until 11 p.m. on July 26, 2004.

The zone restricts movement within this portion of Boston Inner Harbor and is needed to protect the maritime public from the dangers posed by a fireworks display. Marine traffic may transit safely outside of the safety zone during the effective periods. The Captain of the Port anticipates minimal negative impact on vessel traffic due to this event. Public notifications will be made prior to the effective period via safety marine information broadcasts and local notice to mariners.

The Coast Guard is establishing a temporary safety zone for the Democratic Governors Association Fireworks Display on July 26, 2004 in Boston, MA, temporarily closing all waters of Boston Inner Harbor within a 400-yard radius of the fireworks barge located at approximate position 42°22.263″ N, 071°02.956″ W. This action is necessary to protect the public from hazards posed by a fireworks display. The safety zone prohibits entry into or movement within this portion of Boston Inner Harbor during the closure period.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS).

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

Although this regulation prevents traffic from transiting a portion of Boston Inner Harbor during the effective period, the affects of this regulation will not be significant for several reasons: that vessels will be restricted from the area for only a minimal time period, vessels may safely transit outside of the safety zone, and advance notifications which will be made to the local maritime community by safety marine information broadcasts and local notice to mariners.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Boston Inner Harbor on July 26, 2004. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: vessel traffic can safely pass outside of the safety zone during the effective period, the period is limited in duration, and advance notifications will be made to the local maritime community by safety marine information broadcasts and local notice to mariners.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule will have a significant economic impact on it, please submit a comment ( see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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 does not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule does 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 Execute Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

The Coast Guard 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 pose 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, paragraph (34)(g), of the Instruction, from further environmental documentation.

A draft “Environmental Analysis Check List” and a draft “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES . Comments on this section will be considered before we make the final decision on whether the rule should be categorically excluded from further environmental review.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Information on the fireworks display was not supplied to the Coast Guard in sufficient time to draft and publish an NPRM. Any delay encountered in this regulation's effective date would be contrary to public interest since the safety zone is needed to prevent traffic from transiting a portion of Boston Harbor, Massachusetts during the fireworks event and to provide for the safety of life on navigable waters. Additionally, the zone will have a negligible impact on vessel transits due to the fact that vessels will only be limited from the area for 1.5 hours, and vessels can still transit in other areas in the majority of Boston Harbor during the event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Any delay encountered in this regulation's effective date would be contrary to public interest since the safety zone is needed to prevent traffic from transiting a portion of Boston Harbor, Massachusetts during the fireworks event and to provide for the safety of life on navigable waters. Additionally, the zone should have a negligible impact on vessel transits due to the fact that vessels will only be limited from the area for 1.5 hours, and vessels can still transit in other areas in the majority of Boston Harbor during the event.

This regulation establishes a safety zone in Boston Inner Harbor within a 400-yard radius of the fireworks barge located at position 42°21.616 N, 071°02.717 W. The safety zone will be in effect from 10:30 p.m. on July 25, 2004, until 12 a.m. on July 26, 2004.

The zone restricts movement within this portion of Boston Inner Harbor and is needed to protect the maritime public from the dangers posed by a fireworks display. Marine traffic can transit safely outside of the safety zone during the effective period. The Captain of the Port anticipates minimal negative impact on vessel traffic due to this event. Public notifications will be made prior to the effective period via safety marine information broadcasts and local notice to mariners.

The Coast Guard is establishing a temporary safety zone for the Time Warner Cable Fireworks Display on July 25, 2004 in Boston, MA, temporarily closing all waters of Boston Inner Harbor within a 400 yard radius of the fireworks barge located at approximate position 42°21.616 N, 071°02.717 W. This action is necessary to protect the public from hazards posed by a fireworks display. The safety zone prohibits entry into or movement within this portion of Boston Inner Harbor during the closure period.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS).

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

Although this regulation prevents traffic from transiting a portion of Boston Inner Harbor during the effective period, the affects of this regulation will not be significant for several reasons: that vessels will be restricted from the area for a minimal time period; vessels may safely transit outside of the safety zone; and advance notifications will be made to the local maritime community by safety marine information broadcasts and local notice to mariners.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Boston Inner Harbor on July 25, 2004. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: vessel traffic can safely pass outside of the safety zone during the effective period, the period is limited in duration, and advance notifications which will be made to the local maritime community by safety marine information broadcasts and local notice to mariners.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule will have a significant economic impact on it, please submit a comment ( see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule will economically affect it.

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 does not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

The Coast Guard 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 pose 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, paragraph (34)(g), of the Instruction, from further environmental documentation.

A draft “Environmental Analysis Check List” and a draft “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES. Comments on this section will be considered before we make the final decision on whether the rule should be categorically excluded from further environmental review.

On May 21, 2004, we published a notice of proposed rulemaking (NPRM) entitled “Security Zones; Democratic National Convention, Boston, MA” in the Federal Register (69 FR 29246). We received one electronically submitted comment regarding the proposed rule. No public meeting was requested, and none was held.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . This rule is needed to protect former presidents and their spouses, the Democratic nominee for president and vice president, their spouses, and particular U.S. Congressmen from potential acts of terrorism or subversive acts during the Democratic National Convention (DNC). Any delay encountered in this rule's effective date would be contrary to public interest and public safety.

In light of terrorist attacks on New York City and Washington, DC on September 11, 2001, and the continuing concern for future terrorist and or subversive acts against the United States, especially at events where a large number of persons are likely to congregate, the Coast Guard is establishing temporary security zones in certain waters of the Charles River in the vicinity of the FleetCenter/North Station, certain waters of Boston Inner Harbor in the vicinity of Logan International Airport, and surrounding VIP designated vessels identified by the COTP Boston, Massachusetts during the DNC. The DNC has been designated a National Special Security Event (NSSE) and will occur between July 26, 2004, and July 29, 2004, at the FleetCenter/North Station facilities, in Boston, Massachusetts. Security measures for this event, including security zones proposed herein, are necessary from July 24,2004 to July 31, 2004, and are needed to safeguard maritime transportation infrastructure, the public, and designated protectees, and to safeguard designated VIP vessels carrying protectees, from potential acts of violence or terrorism during DNC activities. The planning for these security zones has been conducted in conjunction with, and as a result of requests from, the United States Secret Service (USSS), the lead federal agency for the DNC, and the Capitol Police. This rule will temporarily close sections of the Charles River in the vicinity of the FleetCenter/North Station, certain Boston Inner Harbor water areas along the perimeter of Logan International Airport, and surrounding designated VIP vessels identified by the COTP Boston, Massachusetts, to be in need of Coast Guard escort for security reasons while they are transiting the COTP Boston, Massachusetts zone, at specified times from July 24, 2004, to July 31, 2004.

For purposes of this rulemaking, designated VIP vessels include any vessels designated by the Coast Guard COTP Boston, Massachusetts to be in need of Coast Guard escort in the COTP Boston, Massachusetts zone, based on a request from the USSS or the Capitol Police. Any VIP designated vessel may contain protectees. “Protectees” for the purposes of the USSS include the President of the United States and former presidents and their spouses, the Democratic nominee for president, and the Democratic nominee for vice president and their spouses. “Protectees” for the purposes of the Capitol Police include particular U.S. Congressmen. One or more Coast Guard Cutters or small boats will escort designated VIP vessels deemed in need of escort protection.

The Captain of the Port Boston, Massachusetts will notify the maritime community of the periods during which the security zones will be enforced. Broadcast notifications will be made to the maritime community advising them of the boundaries of the zones.

No person or vessel may enter or remain in the prescribed security zones at any time without permission of the Captain of the Port. Each person or vessel in a security zone must obey any direction or order of the COTP, or the designated Coast Guard on-scene representative. The COTP may take possession and control of any vessel in a security zone and/or remove any person, vessel, article or thing from a security zone. No person may board, take or place any article or thing on board any vessel or waterfront facility in a security zone without permission of the COTP. Any violation of any security zone described herein, is punishable by, among others, civil penalties (not to exceed $32,500 per violation, where each day of a continuing violation is a separate violation), criminal penalties (imprisonment for not more than 6 years and a fine for not more than $250,000 for an individual and $500,000 for an organization), in rem liability against the offending vessel and license sanctions. This rule is established under the authority contained in 50 U.S.C. 191, and 33 U.S.C. 1226 and 1231.

As part of the Diplomatic Security and Antiterrorism Act of 1986 (Pub. L. 99-399), Congress amended section 7 of the Ports and Waterways Safety Act (PWSA), 33 U.S.C. 1226, to allow the Coast Guard to take actions, including the establishment of security zones, to prevent or respond to acts of terrorism against individuals, vessels, or public or commercial structures. Moreover, the Coast Guard has authority to establish security zones pursuant to the Act of June 15, 1917, as amended by the Magnuson Act of August 9, 1950 (50 U.S.C. 191 et seq. )(the “Magnuson Act”) and implementing regulations promulgated by the President in subparts 6.01 and 6.04 of part 6 of title 33 of the Code of Federal Regulations.

One electronically filed comment was received regarding the proposed regulation. The content of the comment was three-fold. It recognized the need to establish restrictions during the DNC period based on the significance of the event and the current threat environment, and commended the proposed rule for appropriately balancing security needs with waterway use. It recommended further outreach efforts, and lastly suggested the rule could be improved by providing additional clarification to waterway users regarding application of the restrictions. The specific questions posed and responses follow:

To address outreach, both the Coast Guard and the USSS have undergone extensive outreach efforts to ensure affected waterway users would be informed of DNC related waterway restrictions. Information on proposed restrictions was provided at Boston Port Operators Group meetings on February 18, March 17, and April 21, at two specific industry stakeholder meetings on March 30 and 31, and at a harbormasters and salvors meeting on May 27, 2004.

Meetings were also held at the Watertown Yacht Club and the Jubilee Yacht Club, which included representatives from numerous clubs in the Boston and surrounding areas. Further, an informational brochure outlining the proposed security zones was distributed at these meetings, to other local boating and yacht clubs, to the Massachusetts Bay Yacht Association, and at local boat shows by the Coast Guard Auxiliary. The informational brochure is also posted on the Marine Safety Office Boston internet Web site found at http://uscg.mil/d1/units/msobos/.

The Coast Guard and the USSS will continue notifications by distribution of the final rule (once published) to maritime stakeholders and by marine information broadcasts. Below are the seven specific questions posed in the comment:

(1) How far in advance of transit during the week of the Convention must commercial, regular users of the security zone seek pre-approval of such transit?

Pre-approval is defined as permission given prior to the start of DNC security operations by the Captain of the Port Boston to transit through a security zone. The process by which commercial entities could gain pre-approval to transit DNC security zones began in September of 2003 when the USSS identified affected commercial operators and began negotiations regarding potential waterway restrictions. Shortly thereafter the Coast Guard Captain of the Port Boston joined in the outreach effort and assisted the USSS in further identification of affected commercial operators as the actual parameters of the proposed security zones took shape. Information on proposed restrictions and requests for affected commercial entities were provided at Boston Port Operators Group meetings on February 18, March 17, and April 21, at two specific industry stakeholder meetings on March 30 and 31, and a harbormasters and salvors meeting on May 27, 2004. At this point, the Coast Guard expects that any pre-approval requests should have already been submitted to the USSS or the Coast Guard. Once the security zones go into effect, only pre-approved transits and those requested due to emergency situations will be allowed. We have revised the text of paragraph (b)(2) or the regulation to clarify this point.

(2) How extensive will the pre-transit sweep by law enforcement be?

The pre-transit sweep will be as extensive as deemed necessary by law enforcement presence for the safety and security of the port during the Democratic National Convention.

(3) What is a “commercial vessel” for purposes of the regulation?

A commercial vessel is considered any vessel engaged in “commercial service”. Commercial service includes any type of trade or business involving the transportation of goods or individuals, except service performed by a combatant vessel as stated in 46 U.S.C. 2101(5).

(4) What pattern of use constitutes a “regular route” for purposes of the regulation?

A “regular route” for the purposes of this regulation means transits that are based on a pre-set schedule which has been established ahead of time, and where such transits have been occurring in the specified areas as part of an ongoing business over the past several months or years.

(5) What are the purposes of the pre-transit sweep?

The purpose of the pre-transit sweep is to ensure the safety and security of the persons on board the vessel, law enforcement personnel, and for the safety and security of the port.

(6) Upon what grounds, if any, could on-scene Coast Guard personnel refuse passage rights to commercial users whose route was pre-approved by the COTP?

Any act, behavior, or situation deemed unsafe or a threat to security by on-scene law enforcement personnel who are authorized by the COTP to enforce the safety and security zones could result in refusal of passage.

(7) Is there any appeal procedure for those who apply in advance to the COTP for permission to pass through a security zone, but are denied clearance?

Comments or correspondence may be directed to the office listed under ADDRESSES and will be reviewed. However, the COTP has final authority and the right to deny permission or revoke prior permission when deemed necessary for the safety and security of the public or the Boston COTP zone.

This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

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

Although this proposed regulation will temporarily prevent traffic from transiting a portion of the Charles River, Boston Inner Harbor and surrounding certain VIP designated vessels during the specified effective periods, the effects of this regulation will be minimized based on several factors. Vessels that historically have conducted daily business in the area of the Charles River security zone will be allowed to transit, as long as transits have been prearranged as discussed, thereby preventing disruption to their normal business. The potential delays associated with vessels being swept and escorted through the zone will be minimal. The Logan Airport DNC security zone mirrors an existing state security zone, and therefore users of these waters will not encounter restrictions significantly different from those already in existence. The temporary security zones surrounding VIP designated vessels are included in this rule as a precautionary measure should they become necessary. At this time, no VIP designated vessel security zones are scheduled. If they are deemed necessary during the event and are subsequently enacted, these zones are limited in scope, enough so that vessels may transit safely outside of the zones and still make use of the waterway. Additionally, VIP designated vessels will be advised to operate in such a manner as to avoid restricting the main shipping channels from use by large commercial vessels that require the depth of water to operate safely. Lastly, advance notice to waterways users has been, and will continue to be, made via outreach meetings, informational brochures, safety marine information broadcasts, and local notice to mariners.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in these security zones during this event. However, this proposed rule will not have a significant economic impact on a substantial number of small entities due to: transit accommodations that are being made for regular commercial operators within the Charles River and Logan Airport DNC zones; the minimal time that vessels will be restricted from the area of the zones; vessels being able to pass safely around the zones; vessels having to wait only a short time for the VIP designated vessels to pass if they cannot safely pass outside the zones; and the advance notifications which will be made to the local maritime community by marine information broadcasts.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Chief Petty Officer Daniel Dugery Waterways Safety and Response. Marine Safety Office Boston, (617) 223-3000.

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

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

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

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

This rule will not affect 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, paragraph (34)(g), of the Instruction, from further environmental documentation. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(3), the Coast Guard finds that good cause exists for not publishing an NPRM. Due to the late notification of the dates of this bridge demolition using explosives, publishing an NPRM would be impracticable. Publishing an NPRM would be contrary to the public interest because immediate action is needed to protect mariners from the hazards associated with this bridge demolition. Publishing an NPRM would also be unnecessary since the Raritan River safety zone will have minimal impact on the waterway for the following reasons: the New Jersey Department of Transportation (NJDOT) has been in contact with facilities upstream from the bridge during the construction of the adjacent, new, Route 35 bridge, who are well aware of the construction project and the expected delays associated with demolition of the old Route 35 bridge, the zone is only expected to be enforced for 1 hour during the seven planned blasts. Additionally, vessels will not be precluded from mooring at or getting underway from recreational piers in the vicinity of the zone.

For the same reasons, the Coast Guard further finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register pursuant to 5 U.S.C. 553(d)(3).

This rule is necessary to protect the life and property of the maritime public from the hazards posed from the Route 35 bridge demolition using explosives. The safety zone will be enforced for 1 hour during seven planned blasts. However, vessels may be given permission to transit the zone once the blasting has been completed for the day. Additionally, vessels will not be precluded from mooring at or getting underway from recreational piers in the immediate area outside the zone.

This rule establishes a temporary safety zone in all waters of the Raritan River within 500 yards of the old Route 35 Bridge. The safety zone will be enforced for 1 hour during seven separate blasts planned between July 7, and September 30, 2004. However, vessels may be given permission to transit the zone once the blasting has been completed for the day. The safety zone will prevent vessels from transiting this portion of the Raritan River and is needed to protect the maritime public from the hazards associated with this bridge demolition using explosives. Vessels will not be precluded from mooring at or getting underway from recreational piers in the vicinity of the zone. Public notifications will be made prior to the event via the Local Notice to Mariners and Marine Information Broadcasts.

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).

This finding is based on: the minimal time that vessels will be restricted from the zone; the NJDOT has been in contact with facilities upstream from the bridge during the construction of the adjacent, new Route 35 Bridge, who are aware of the construction project and the expected delays associated with demolition of the old Route 35 Bridge, the zone is only expected to be enforced for 1 hour during seven planned blasts. Additionally, vessels will not be precluded from mooring at or getting underway from recreational piers in the vicinity of the zone. Advance notifications will be made to the local maritime community by the Local Notice to Mariners and marine information broadcasts.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of the affected waterway during the time this zone is enforced.

This safety zone will not have a significant economic impact on a substantial number of small entities for reasons enumerated under the “Regulatory Evaluation” section.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this temporary rule so that we can better evaluate its effects on them and participate in the rulemaking. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Lieutenant Commander W. Morton, Waterways Oversight Branch, Coast Guard Activities New York at (718) 354-4191.

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

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

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

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule 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 considered the environmental impact of this rule and concluded that under figure 2-1, paragraph 34(g), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation. This rule fits paragraph 34(g) as it establishes an emergency safety zone. A “Categorical Exclusion Determination” will be available in the docket for inspection or copying where indicated under ADDRESSES.

On January 16, 2004, we published a notice of proposed rulemaking (NPRM) entitled “Security Zone: Coronado Bay Bridge, San Diego, CA” in the Federal Register (69 FR 2554). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. COTP San Diego issued a temporary final rule (TFR) for this security zone that was effective November 7, 2003, to May 1, 2004 (68 FR 67946, December 5, 2003). No comments or letters were received as a result of the TFR.

Since the September 11, 2001, terrorist attacks on the World Trade Center in New York, the Pentagon in Arlington, Virginia and Flight 93, the Federal Bureau of Investigation (FBI) has issued several warnings concerning the potential for additional terrorist attacks within the United States. In addition, the ongoing hostilities in Afghanistan and the conflict in Iraq have made it prudent for U.S. ports to be on a higher state of alert because Al-Qaeda and other organizations have declared an ongoing intention to conduct armed attacks on U.S. interests worldwide.

The threat of maritime attacks is real as evidenced by the October 2002 attack of a tank vessel off the coast of Yemen and the continuing threat to U.S. assets as described in the President's finding in Executive Order 13273 of August 21, 2002 (67 FR 56215, September 3, 2002), that the security of the U.S. is endangered as evidenced by the September 11, 2001, attacks and that such disturbances continue to endanger the international relations of the United States. See also Continuation of the National Emergency with Respect to Certain Terrorist Attacks, (67 FR 58317, September 13, 2002); Continuation of the National Emergency With Respect To Persons Who Commit, Threaten To Commit, Or Support Terrorism (67 FR 59447, September 20, 2002). Additionally, a Maritime Advisory was issued to: Operators of U.S. Flag and Effective U.S. controlled Vessels and other Maritime Interests, detailing the current threat of attack, MARAD 02-07 (October 10, 2002).

In its effort to thwart terrorist activity, the Coast Guard has increased safety and security measures on U.S. ports and waterways. As part of the Diplomatic Security and Antiterrorism Act of 1986 (Pub. L. 99-399), Congress amended section 7 of the Ports and Waterways Safety Act (PWSA), 33 U.S.C. 1226, to allow the Coast Guard to take actions, including the establishment of security and safety zones, to prevent or respond to acts of terrorism against individuals, vessels, or public or commercial structures. The Coast Guard also has authority to establish security zones pursuant to the Act of June 15, 1917, as amended by the Magnuson Act of August 9, 1950 (50 U.S.C. 191 et seq. ) and implementing regulations promulgated by the President in subparts 6.01 and 6.04 of part 6 of title 33 of the Code of Federal Regulations.

In this particular rulemaking, to address the aforementioned security concerns and to take steps to prevent the catastrophic impact that a terrorist attack against the Coronado Bridge would have on the public interest, the Coast Guard proposes to establish security zones around the Coronado Bridge. These security zones would help the Coast Guard to prevent vessels or persons from engaging in terrorist actions against these bridges. Due to these heightened security concerns and the catastrophic impact a terrorist attack on these bridges would have on the public transportation system and surrounding areas and communities, security zones are prudent for these structures.

U.S. Coast Guard personnel will enforce this security zone. The Coast Guard may be assisted by other Federal, State, county, municipal or private agencies, including the Coast Guard Auxiliary. Vessels or persons violating this section will be subject to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192. Pursuant to 33 U.S.C. 1232, any violation of the security zones described herein, is punishable by civil penalties (not to exceed $32,500 per violation, where each day of a continuing violation is a separate violation), criminal penalties (imprisonment up to 6 years and a maximum fine of $250,000), and in rem liability against the offending vessel. Any person who violates this section using a dangerous weapon, or who engages in conduct that causes bodily injury or fear of imminent bodily injury to any officer authorized to enforce this regulation, will also face imprisonment up to 12 years. Vessels or persons violating this section are also subject to the penalties set forth in 50 U.S.C. 192: seizure and forfeiture of the vessel to the United States, a maximum criminal fine of $10,000, and imprisonment up to 10 years, and a civil penalty of not more than $25,000 for each day of a continuing violation.

This regulation is promulgated under the authority of 33 U.S.C. 1225 in addition to the authority contained in 50 U.S.C. 191 and 33 U.S.C. 1231.

We received no comments on our proposed rule. Therefore, our final rule remains the same as our proposed rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

The anticipated economic impact of this rule is so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is deemed unnecessary. Although the rule restricts access to portions of the navigable waterways around the bridge, the effect of this regulation will not be significant because: (i) The zones would encompass only a small portion of the waterway; (ii) vessels would be able to pass safely around the zones; and (iii) vessels would be allowed to enter these zones on a case-by-case basis with permission of the Captain of the Port, or his designated representative.

The sizes of the security zones are the minimum necessary to provide adequate protection for the bridges, vessels operating in the vicinity, their crew and passengers, adjoining areas and the public. The entities most likely to be affected are commercial vessels transiting the main ship channel en route the southern San Diego Bay and Chula Vista ports and pleasure craft engaged in recreational activities and sightseeing.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. The security zones would not have a significant economic impact on a substantial number of small entities for several reasons: small vessel traffic could pass safely around the security zones and vessels engaged in recreational activities, sightseeing and commercial fishing would have ample transit area outside of the security zones to engage in these activities. Small entities and the maritime public would be advised of these security zones via public notice to mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding this rule.

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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.

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, paragraph (34)(g) of the Instruction, from further environmental documentation because we are establishing a security zone.

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

Table 1 lists the rules we are approving with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board (CARB).

On October 10, 2003, these rule submittals were found to meet the completeness criteria in 40 CFR part 51 appendix V, which must be met before formal EPA review.

We approved versions of these rules into the SIP on the dates listed: MBUAPCD Rule 101, May 16, 2000 and SBCAPCD Rule 102, October 7, 1999.

Monterey Rule 101 is amended by adding two new definitions: “Emergency Generators and Water Pumps” and “Owner/Operator.”

Santa Barbara Rule 102 is amended by adding a new definition for “common operations” to indicate that the emissions from all marine vessels and cargo carriers servicing or associated with a stationary source shall be considered emissions from the stationary source while operating within the air basin. The amended rule defines the geographic area to be California Coastal Waters adjacent to the APCD. This is consistent with the approach used by other coastal APCDs.

The TSD has more information about these rules.

These rules describe administrative provisions and definitions that support emission controls found in other local agency requirements. In combination with the other requirements, these rules must be enforceable ( see section 110(a) of the Act) and must not relax existing requirements ( see sections 110(l) and 193). EPA policy that we used to help evaluate enforceability requirements consistently includes the Bluebook (“Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988) and the Little Bluebook (“Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001).

We believe these rules are consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by August 23, 2004, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on September 21, 2004. This will incorporate these rules into the federally enforceable SIP.

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. section 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. section 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 September 21, 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).)

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 notlimited to:

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

• Animal production (NAICS 112), e.g., ranchers and 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/ .

In the Federal Register of December 10, 2003 (68 FR 68806) (FRL-7330-8), EPA issued a proposed rule to revoke certain tolerances and tolerance exemptions for residues of the fungicide and insecticide dinocap; insecticides combustion product gas, ethion, formetanate hydrochloride, nicotine-containing compounds, polyoxyethylene, and tartar emetic; herbicides chlorpropham, cyanazine, and tridiphane; fungicides bitertanol, 1,1,1-trichloroethane, and triforine; and the plant regulators cloprop and 4,6-dinitro-o-cresol. Also, the December 10 2003 proposal provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under the FFDCA standards.

This final rule revokes certain tolerances and tolerance exemptions for residues of insecticides combustion product gas, ethion, formetanate hydrochloride, nicotine-containing compounds, polyoxyethylene, and tartar emetic; herbicides chlorpropham, cyanazine, and tridiphane; fungicides 1,1,1-trichloroethane and triforine; and the plant regulators cloprop and 4,6-dinitro-o-cresol because these specific tolerances and exemptions correspond to uses no longer current or registered under FIFRA in the United States. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. It is EPA's general practice to revoke those tolerances and tolerance exemptions for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance or tolerance exemption to cover residues in or on imported commodities or domestic commodities legally treated.

Concerning the Reregistration Eligibility Decisions (REDs) for chlorpropham and ethion and the Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision (TRED) for chlorpropham mentioned in this rule, printed copies of the REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490-9198; fax number: 1-513-489-8695; Internet address: http://www.epa.gov/ncepihom/ , and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800-553-6847 or 703-605-6000; Internet address: http://www.ntis.gov/ . Electronic copies of REDs and TREDs are available on the internet at http://www.epa.gov/pesticides/reregistration/status.htm .

EPA has historically expressed a concern that retention of tolerances that are not necessary to cover residues in or on legally treated foods has the potential to encourage misuse of pesticides within the United States. Thus, it is EPA's policy to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated.

Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed in Unit II.A. if one of these conditions applies, as follows:

1. Prior to EPA's issuance of a section 408(f) order requesting additional data or issuance of a section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained.

2. EPA independently verifies that the tolerance is no longer needed.

3. The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under FQPA.

This final rule does not revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained. In response to the proposal published in the Federal Register of December 10, 2003 (68 FR 68806), EPA received comments as follows:

Comments . A private citizen from New Jersey expressed concern with pesticide use in general and the public's exposure in their daily lives. On December 10, 2003, the individual stated that there should be zero tolerance for all the chemicals mentioned in 40 CFR part 180.

Agency response . The private citizens's comment did not take issue with the Agency's conclusion that certain tolerances which were no longer needed should be revoked. It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States.

1. Bitertanol . EPA received a comment from Bayer CropScience, who requested on January 15, 2004, that EPA not revoke the tolerance for bitertanol on bananas. Bayer acknowledged that while some previously submitted data may not meet current guideline requirements, it would support the tolerance on banana for import purposes with data.

Agency response. Because in a comment to the proposed rule, Bayer CropScience expressed a need for the retention of the banana tolerance for import purposes and intent to support the tolerance with data, EPA will not revoke the tolerance in 40 CFR 180.457 for residues of beta-([1,1'-biphenyl]-4-yloxy)-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol, also called bitertanol, in or on banana (whole) at this time. EPA published a guidance on pesticide import tolerances and residue data for imported food in the Federal Register of June 1, 2000 (65 FR 35069) (FRL-6559-3). When the submitted data have been reviewed, EPA will re-evaluate that tolerance under FFDCA. If data adequate to support a safety finding are lacking, EPA intends to revoke the tolerance on banana in 40 CFR 180.457.

2. Cloprop . EPA received a comment from the Pineapple Growers Association of Hawaii (PGAH) who requested on January 9, 2004, and again on January 23, 2004, that the tolerance for the use of cloprop on pineapples not be revoked for 3 years in order to allow for the exhaustion of existing stocks of cloprop.

Agency response . On September 21, 2001, EPA amended its authorization of a specific emergency exemption under section 18 of FIFRA for application of cloprop on pineapple in Hawaii until August 2, 2002. There are no active registrations for use of cloprop on pineapples and therefore, the pineapple tolerance is no longer needed. However, due to PGAH's comment on existing stocks, EPA is changing the revocation date of the tolerance in 40 CFR 180.325 for residues of 2-(m-chlorophenoxy) propionic acid, called cloprop, from application of the acid or of 2-(m-chlorophenoxy) propionamide in or on pineapple to February 1, 2007, which EPA believes allows sufficient time for existing stocks to be used and cloprop-treated pineapples to clear the channels of trade.

3. Dinocap . EPA received a comment from Dow AgroSciences, who requested on February 2, 2004, that EPA not revoke the tolerances for dinocap on apple and grape because it would support the tolerances on apple and grape for import purposes. Also, Dow AgroSciences noted that it had previously indicated such an intention which EPA included in a notice regarding the availability of the RED for dinocap published in the Federal Register of September 17, 2003 (68 FR 54449) (FRL-7321-8). In addition, Dow AgroSciences stated it would work with EPA to achieve compliance with the Agency's guidance on import tolerances and its data requirements.

Agency response . Because in a comment to the proposed rule, Dow AgroSciences expressed a need for the retention of the apple and grape tolerances for import purposes and intent to support the tolerances with data, EPA will not revoke the tolerances in 40 CFR 180.341 for combined residues that is a mixture of 2,4-dinitro-6-octylphenyl crotonate and 2,6-dinitro-4-octylphenyl crotonate, called dinocap, in or on apple and grape at this time. EPA published a guidance on pesticide import tolerances and residue data for imported food in the Federal Register of June 1, 2000 (65 FR 35069). When the submitted data have been reviewed, EPA will re-evaluate the tolerances under FFDCA. If data adequate to support a safety finding are lacking, EPA intends to revoke the tolerances on apple and grape in 40 CFR 180.341. In this final rule, the Agency will revise the text for tolerances in 40 CFR 180.341 paragraph (a) into tabular form.

No comments were received by the Agency concerning the following.

4. Chlorpropham . In the 1996 RED for chlorpropham, EPA required environmental fate and ecological effects data to maintain the spinach registration, which was registered as a Special Local Need under FIFRA 24(c) and was not being supported by the primary registrants of technical chlorpropham. In February 2002, EPA canceled the last Special Local Need registration, but allowed use until December 31, 2002. On July 19, 2002, EPA reassessed the spinach tolerance in a TRED for chlorpropham. That reassessment decision was a recommendation to revoke the spinach tolerance because there are no active registrations and therefore, the tolerance is no longer needed. The Agency believes that there has been sufficient time for chlorpropham-treated spinach to clear the channels of trade. Therefore, EPA is revoking the interim tolerance in 40 CFR 180.319 regarding isopropyl m-chlorocarbanilate (CIPC), called chlorpropham, for residues in or on spinach.

5. Combustion product gas . EPA is revoking the tolerance exemption in 40 CFR 180.1051 for residues of the gas produced by the controlled combustion in air of butane, propane, or natural gas in or on all food commodities (except fresh meat) when used after harvest in modified atmospheres for stored product with prescribed conditions. The Agency is revoking the tolerance exemption because no active U.S. registrations have existed since 1993 and therefore, the tolerance exemption is no longer needed.

6. Cyanazine . In November 1994, EPA initiated a Special Review of cyanazine based on concerns that cyanazine may pose a risk of inducing cancer in humans from dietary, occupational, and residential exposure. In the Federal Register of July 25, 1996 (61 FR 39023) (FRL-5385-7), EPA announced a final determination to terminate the cyanazine Special Review. In the same notice, EPA accepted requests for the voluntary cancellation of cyanazine registrations effective December 31, 1999, and ordered the cancellations to take effect on January 1 2000, authorized sale and distribution of such products in the channels of trade in accordance with their labels through September 30, 2002, and prohibited the use of cyanazine products after December 31, 2002. EPA issued an order confirming the cyanazine cancellation on January 6, 2000 (65 FR 771) (FRL-6486-7).

EPA proposed to revoke the tolerances for cyanazine on April 23, 1999 (64 FR 19961) (FRL-6076-4). Only one significant comment was received in response to that document. Griffin L.L.C. requested that EPA not revoke the tolerances for cyanazine and due to Griffin's interest in maintaining those tolerances as import tolerances, the Agency did not take action on cyanazine at that time (July 21, 1999, 64 FR 39078) (FRL-6093-9). However, in a letter to the Agency dated August 24, 1999, Griffin L.L.C. stated that it no longer needs EPA to maintain import tolerances for cyanazine. The Agency believes that there has been sufficient time for cyanazine-treated commodities to clear the channels of trade. Therefore, EPA is revoking the tolerances in 40 CFR 180.307 for residues of the herbicide 2-[[4-chloro-6-(ethylamino)-s-triazin-2-yl]amino]-2-methylpropionitrile, called cyanazine, in or on corn, forage; corn, fresh, kernel plus cob with husks removed; corn, grain; corn, stover; cotton, undelinted seed; sorghum, forage; sorghum, grain; sorghum, grain, stover; wheat, forage; wheat, grain; and wheat, straw.

7. 4,6-Dinitro-o-cresol . EPA is revoking the tolerance in 40 CFR 180.344 for residues 4,6-dinitro-o-cresol (DNOC) and its sodium salt in or on apple from application to apple trees at the blossom stage because no active U.S. registrations have existed for its associated commodity use since 1993 and therefore, the tolerance is no longer needed.

8. Ethion . On July 31, 2002 (67 FR 49606) (FRL-7191-4), EPA published a final rule in the Federal Register which revoked ethion tolerances on citrus fruit, dried citrus pulp, and certain animal commodities with expiration/revocation dates of October 1, 2008. The Agency acknowledged that citrus and animal feed (citrus, dried pulp) with legal residues of ethion can take several years to clear channels of trade from ethion's last legal use date of December 31, 2004.

In the July 2002 final rule, EPA did not act on the cattle and milk fat tolerances for ethion because of an existing cattle ear tag product. On October 16, 2002 (67 FR 63909) (FRL-7276-6), EPA published a notice in the Federal Register under section 6(f)(1) of FIFRA announcing its receipt of a request from the registrant for cancellation of the last cattle ear tag product for ethion. EPA approved the registrant's request for voluntary cancellation and on June 4 2003, issued a cancellation order with an effective date of May 31, 2003, i.e., the order allowed the basic registrant to distribute and sell existing stocks of the canceled product until May 31, 2003. Therefore, EPA is revoking tolerances in 40 CFR 180.173 for residues of the insecticide ethion (O,O,O',O'-tetraethyl S,S'-methylene bisphosphorodithioate) including its oxygen analog (S-[[(diethoxyphosphinothioyl) thio]methyl] O,O-diethyl phosphorothioate) in or on cattle, fat; cattle, meat byproducts; cattle, meat (fat basis); and milk fat (reflecting (n) residues in milk), each with an expiration/revocation date of October 1, 2008. These dates are consistent with the expiration/revocation date concerning the ethion tolerance on dried citrus pulp, an animal feed. In addition and in accordance with the 2001 Registration Eligibility Decision (RED) for ethion, EPA is not only revoking the cattle tolerances, but also decreasing them based on an available ruminant feeding study to 0.2 parts per million (ppm) during the period before they expire on October 1, 2008. In the RED, EPA found that these revised tolerances are safe in accordance with section 408 of the FFDCA. A copy of the ethion RED is available at http://www.epa.gov/edocket/ by searching for docket ID number OPP-2003-0265 concerning the proposed rule of (December 10, 2003, 68 FR 68806) (FRL-7330-8). The ethion RED is also available at http://www.epa.gov/pesticides/reregistration/status.htm/ . See the ethion RED Part IV(C)(1)(b): Tolerance Summary.

Also, in the 2001 RED for ethion, EPA recommended that the citrus tolerances should be revoked, but also be raised during the period before they expire (from 10.0 to 25.0 ppm for dehydrated pulp and from 2.0 to 5.0 ppm for citrus fruits) based on the available citrus field trial and processing data. In the RED, EPA found that these revised tolerances are safe in accordance with section 408 of the FFDCA. (See the ethion RED Part IV(C)(1)(b): Tolerance Summary). Therefore, in 40 CFR 180.173, while the citrus, dried pulp and fruit, citrus tolerances will continue to expire on October 1, 2008, the Agency is increasing the tolerances for citrus, dried pulp (10 ppm) and fruit, citrus (2.0 ppm) during the period before they expire to 25.0 and 5.0 ppm, respectively.

In addition, to conform to current Agency practice, EPA is revising the commodity terminologies in 40 CFR 180.173 for “fruit, citrus” to “fruit, citrus, group 10”; and “milk fat (reflecting (n) residues in milk)” to “milk, fat, reflecting negligible residues in milk.”

9. Formetanate hydrochloride . EPA had initiated negotiations with the registrant for formetanate hydrochloride due to Agency concerns. As one measure to reduce concerns, the registrant agreed to delete the product use on plums and prunes, which appear to benefit little from use of the product. Pursuant to section 6(f) of FIFRA, EPA received the request for voluntary amendments to delete the aforementioned uses from the registrations. On February 8, 2000, a 6(f)(1) notice of receipt of the request by the registrant was published in the Federal Register (65 FR 6208) (FRL-6489-6). EPA granted the registrant's request to waive the 180-day comment period, but the Agency provided a 30-day public comment period, and granted the requested amendments to delete those uses from registration labels on May 31, 2000. Except for the purpose of relabeling, the Agency had prohibited sale and distribution by the registrant after December 1, 1999, and by persons other than the registrant, including existing stocks, after June 1, 2000, of products labeled for use on plums and prunes.

Because there are no active registrations for use of formetanate hydrochloride on plums and prunes, the tolerances are no longer needed. Therefore, EPA is revoking the tolerances in 40 CFR 180.276(a)(1) for residues of the insecticide formetanate hydrochloride in or on plum, prune, fresh and in 40 CFR 180.276(a)(2) for residues of the insecticide formetanate hydrochloride in or on dried prunes.

10. Nicotine-containing compounds . On December 6, 2002 (67 FR 72673) (FRL-7281-5), EPA published a notice in the Federal Register under section 6(f)(1) of FIFRA announcing its receipt of a request from the registrant to amend a registration for a product whose active ingredient is a nicotine-containing compound and delete greenhouse food crops uses, including cucumber, lettuce, and tomato. (These were the last active food use registrations for nicotine-containing compounds). EPA approved the registrants' requests for voluntary deletion of these uses and allowed a period of 18 months for the registrant to sell and distribute existing stocks until December 4, 2004. The Agency believes that there is sufficient time for end users to exhaust those existing stocks and treated commodities to clear the channels of trade by December 4, 2005. Therefore, EPA is revoking the tolerances in 40 CFR 180.167 for residues of nicotine-containing compounds in or on cucumber, lettuce, and tomato with expiration/revocation dates of December 4, 2005.

11. Polyoxyethylene . EPA is revoking the tolerance exemptions in 40 CFR 180.1078 for residues of poly(oxy-1,2-ethanediyl), alpha-isooctadyl-omega-hydroxy, also called polyoxyethylene, in or on fish, shellfish, irrigated crops, meat, milk, poultry, and eggs because no active U.S. registrations have existed since 1990 and therefore, the tolerance exemptions are no longer needed.

12. Tartar emetic . EPA is revoking the tolerances in 40 CFR 180.179 for residues, calculated as combined antimony trioxide, in or on fruit, citrus; grape, and onion because no active U.S. registrations have existed for their associated commodity uses since 1992.

13. 1,1,1-Trichloroethane . EPA is revoking the tolerance exemption in 40 CFR 180.1012 for residues of 1,1,1-trichloroethane when used in the postharvest fumigation of citrus fruits because no active U.S. registrations have existed since 1989 and therefore, the tolerance exemption is no longer needed

14. Tridiphane . On September 26, 2001 (66 FR 49184) (FRL-6802-1), EPA published a notice in the Federal Register under section 6(f)(1) of FIFRA announcing its receipt of a request from the registrant for cancellation of the last active tridiphane product registration. EPA approved the registrants' request for voluntary cancellation and issued a cancellation order with an effective date of April 5, 2002, which allowed the registrant to sell and distribute existing stocks of the canceled product until July 17, 2002. The Agency believes that there has been sufficient time for end users to exhaust those existing stocks and for treated commodities to clear the channels of trade. Therefore, EPA is revoking the tolerances in 40 CFR 180.424 for residues of 2-(3,5-dichlorophenyl)-2-(2,2,2-trichloroethyl)-oxirane, called tridiphane, in or on corn, grain, field; corn, forage; and corn, stover.

15. Triforine . On December 24, 1997 (62 FR 67365) (FRL-5761-8), EPA published a notice in the Federal Register under section 6(f)(1) of FIFRA announcing its receipt of a request from the registrant to amend a triforine product registration and delete certain triforine uses, including almonds, apples, apricots, asparagus, blueberries, cherries, cranberries, nectarines, plums, and prunes. EPA approved the registrants' requests for voluntary deletion of these uses and allowed a period of 18 months for the registrant to sell and distribute existing stocks (until approximately the end of 1999). Also, on July 31, 1998 (63 FR 41145) (FRL-6015-8), EPA published a notice in the Federal Register which announced cancellation of a triforine registration for non-payment of 1998 maintenance fee and issuance of a cancellation order which permitted the registrant to sell and distribute existing stocks of the canceled product until January 15, 1999.

The Agency believes that end users had sufficient time to exhaust those existing stocks and for treated commodities to have cleared the channels of trade. Therefore, EPA is revoking the tolerances in 40 CFR 180.382(a) for residues of triforine in or on almond, hulls; almond; apple; apricot; bell pepper; blueberry; cantaloupe; cherry; cranberry; cucumber; eggplant; hop, dried cone; hop, spent; nectarine; peach; plum; prune, fresh; strawberry; and watermelon; and in 40 CFR 180.382(c) for residues of triforine in or on asparagus because no active U.S. registrations exist which cover those commodities and therefore, the tolerances are no longer needed.

It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.

With the exception of certain tolerances for cloprop, ethion, and nicotine-containing compounds for which EPA is revoking tolerances/exemptions with specific expiration/revocation dates, the Agency is modifying certain ethion tolerances before they expire and revoking tolerances/exemptions, and revising commodity terminologies effective on October 21, 2004. EPA is delaying the effectiveness of these modifications and revocations for 90 days following publication of this final rule to ensure that all affected parties receive notice of EPA's actions. For this final rule, tolerances that were revoked because registered uses did not exist concerned uses which have been canceled for more than a year. Therefore, commodities containing these pesticide residues should have cleared the channels of trade. EPA is revoking specific tolerances/exemptions with expiration/revocation dates of February 1, 2007 for cloprop, October 1, 2008 for ethion, and December 4, 2005 for nicotine-containing compounds.

The Mental Health Parity Act of 1996 (MHPA) was enacted on September 26, 1996 (Pub. L. 104-204). MHPA amended the Public Health Service Act (PHS Act) and the Employee Retirement Income Security Act of 1974 (ERISA) to provide for parity in the application of annual and lifetime dollar limits on mental health benefits with dollar limits on medical/surgical benefits. Provisions implementing MHPA were later added to the Internal Revenue Code of 1986 (Code) under the Taxpayer Relief Act of 1997 (Pub. L. 105-34).

The provisions of MHPA are set forth in Title XXVII of the PHS Act, Part 7 of Subtitle B of Title I of ERISA, and Chapter 100 of Subtitle K of the Code. The Secretaries of Health and Human Services, Labor, and the Treasury share jurisdiction over the MHPA provisions. These provisions are substantially similar, except as follows:

• The MHPA provisions in the PHS Act generally apply to health insurance issuers that offer health insurance coverage in connection with group health plans and to certain State and local governmental plans. States, in the first instance, enforce the PHS Act for issuers. Only if a State does not substantially enforce the MHPA provisions under its insurance laws will the Department of Health and Human Services enforce the provisions, through the imposition of civil money penalties. Moreover, no enforcement action may be taken by the Secretary of Health and Human Services against any group health plan except certain State and local governmental plans.

• The MHPA provisions in ERISA generally apply to all group health plans other than governmental plans, church plans, and certain other plans. These provisions also apply to health insurance issuers that offer health insurance coverage in connection with those group health plans. Generally, the Secretary of Labor enforces the MHPA provisions in ERISA, except that no enforcement action may be taken by the Secretary against issuers. However, individuals may generally pursue actions against issuers under ERISA and, in some circumstances, under State law.

• The MHPA provisions in the Code generally apply to all group health plans other than governmental plans, but they do not apply to health insurance issuers. A taxpayer that fails to comply with these provisions may be subject to an excise tax under section 4980D of the Code.

The MHPA provisions are set forth in section 2705 of the PHS Act, section 712 of ERISA, and section 9812 of the Code. MHPA applies to a group health plan (or health insurance coverage offered by issuers in connection with a group health plan) that provides both medical/surgical benefits and mental health benefits. MHPA's original text included a sunset provision specifying that MHPA's provisions would not apply to benefits for services furnished on or after September 30, 2001. On December 22, 1997, the Departments of Health and Human Services, Labor, and the Treasury issued interim final regulations under MHPA in the Federal Register (62 FR 66931). The interim final regulations included this statutory sunset date.

On January 10, 2002, President Bush signed H.R. 3061 (Pub. L. 107-116), the 2002 Appropriations Act for the Departments of Labor, Health and Human Services, and Education (“Appropriations Act”). (During the 107th Congress, legislation was passed by the Senate to amend and expand the substantive provisions of MHPA. This legislation was offered as an amendment to the provisions of H.R. 3061. The Conference Report accompanying the underlying provisions of H.R. 3061 states that instead of the amendment proposed by the Senate, the amendment to MHPA contained in H.R. 3061 extends the original sunset date of MHPA, so that MHPA's provisions will not apply to benefits for services furnished on or after December 31, 2002, H.R. Rep. 107-342, at 170 (2001)). This legislation extended MHPA's original sunset date under the PHS Act, ERISA, and the Code, so that MHPA's provisions in all three statutes would not sunset until December 31, 2002.

On March 9, 2002, President Bush signed H.R. 3090 (Pub. L. 107-147), the Job Creation and Worker Assistance Act of 2002 (“Job Creation Act”). That legislation amended section 9812 of the Code (the mental health parity provisions), but did not amend the corresponding MHPA provisions in the PHS Act or ERISA. The Job Creation Act extended the sunset date under the Code to December 31, 2003.

On December 2, 2002, President Bush signed H.R. 5716 (Pub. L. 107-313), the Mental Health Parity Reauthorization Act of 2002. This legislation further extended MHPA's sunset date under the PHS Act and ERISA so that MHPA's provisions would apply to any services furnished before December 31, 2003.

As a result of those pieces of legislation, the Department published conforming changes to the interim final mental health parity regulations, conforming the regulatory sunset date to the new statutory sunset date. The Department also made conforming changes extending the duration of the increased cost exemption to be consistent with the new sunset date (68 FR 38206, June 27, 2003).

On December 19, 2003, President Bush signed S. 1929 (Pub. L. 108-197), the Mental Health Parity Reauthorization Act of 2003. That legislation further extends MHPA's sunset date under the PHS Act and ERISA so that MHPA's provisions apply to any services furnished before December 31, 2004. This statutory amendment has not altered MHPA's scope. It continues to apply to a group health plan (or health insurance coverage offered by issuers in connection with a group health plan) that provides both medical/surgical benefits and mental health benefits. (The parity requirements under MHPA, the interim regulations, and the amendment to the interim regulations do not apply to any group health plan (or health insurance coverage offered in connection with a group health plan) for any plan year of a small employer. The term “small employer” is defined as an employer who employed an average of at least 2 but not more than 50 employees on business days during the preceding calendar year and who employs at least 2 employees on the first day of the plan year.) As a result of this statutory amendment, and to assist employers, plan sponsors, health insurance issuers, and workers, the Department is publishing this amendment to the interim final regulations, conforming the regulatory sunset date to the new statutory sunset date. The Department is making the effective date of this amendment to the interim final regulations effective as of August 23, 2004. Since the extension of this sunset date is essentially self-implementing, this amendment to the MHPA regulations is published on an interim final basis under section 2792 of the PHS Act.

This amendment to the interim final regulations is adopted under the authority contained in sections 2701 through 2763, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as added by HIPAA (Pub. L. 104-191), and amended by MHPA (Pub. L. 104-204, as amended by Pub. L. 107-116, Pub. L. 107-313, and Pub. L. 108-197).

This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.

We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.

Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). According to the terms of the Executive Order, it has been determined that this action is not a “significant regulatory action” within the meaning of the Executive Order. Rather, it is an amendment to the 1997 interim final regulations that makes no substantive changes to those regulations, and merely extends the regulatory sunset date to conform to the new statutory sunset date added by Public Law 108-197. Because it is not a major rule, we are not required to perform an assessment of the costs and savings.

The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and we certify, that this rule will not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and we certify, that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This rule will have no consequential effect on the governments mentioned or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it publishes a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed this final rule and have determined that it will not have a substantial effect on State or local governments.

We have reviewed this rule and determined that, under the provisions of Public Law 104-121, the Contract with America Act, it is not a major rule.

Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) added a new title XXVII to the Public Health Service (PHS) Act to establish various reforms to the group and individual health insurance markets. The group market reforms are contained under Part A of title XXVII, which includes, among other things, guaranteed availability of coverage to small group market employers and renewability of coverage in the small and large group markets; limitations on pre-existing condition exclusion periods; special enrollment periods under certain circumstances; and prohibition of discrimination against individual participants and beneficiaries based on health status.

Part A of title XXVII was amended by the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA), the Mental Health Parity Act of 1996 (MHPA), and the Women's Health and Cancer Rights Act of 1998 (WHCRA), which added new sections 2704, 2705 and 2706 (subpart 2 of Part A of title XXVII), respectively. NMHPA provides protections for mothers and newborn children for hospital stays following childbirth. MHPA, which applies to group health plans sponsored by employers with more than 50 employees, provides for parity between annual and lifetime dollar limits applicable to mental health benefits, and annual and lifetime dollar limits applicable to medical and surgical benefits. Originally, the MHPA sunset date was September 30, 2001, but subsequent legislation (Pub. L. 107-116 and Pub. L. 107-313) respectively extended the sunset date to December 31, 2002, and December 31, 2003. WHCRA requires group health plans that provide medical and surgical benefits for mastectomies to cover, among other things, reconstructive surgery and prostheses following a mastectomy.

Section 2721(b)(2) of the PHS Act, as added by HIPAA and implemented at 45 CFR 146.180, permits non-Federal governmental employers to elect to exempt self-funded portions of their group health plans (that is, benefits not provided through health insurance coverage) from most of the requirements of title XXVII of the PHS Act. (This practice is sometimes referred to as “opting out of HIPAA.”) However, health plans cannot be exempted from certification and disclosure of creditable coverage requirements under section 2701(e) of the PHS Act.

On July 26, 2002, we published in the Federal Register (67 FR 48802) an interim final rule with comment period, “Technical Change to Requirements for the Group Health Insurance Market; Non-Federal Governmental Plans Exempt From HIPAA Title I Requirements” that amended existing exemption election requirements at § 146.180 that apply to self-funded non-Federal governmental plans. In the interim final rule with comment period, we clarified the conditions under which plan sponsors may exempt these plans from most of the requirements of title XXVII of the PHS Act, provided guidance on the procedures, limitations, and documentation associated with exemption elections, revised the exemption election requirements to reinforce beneficiary protections, and made a technical correction to § 146.150 “Guaranteed availability of coverage for employees in the small group market.”

We refer the reader to the July 26, 2002, interim final rule with comment period for greater detail.

We received no public comments on the July 26, 2002, interim final rule.

The provisions of this final rule are identical to the provisions of the July 26, 2002, interim final rule with comment period.

Under the Paperwork Reduction Act (PRA) of 1995, we are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We received no comments.

The reporting and disclosure requirements referenced under § 146.180(b), (g), and (h) are currently approved under OMB number 0938-0702 (HIPAA Group Market Information Collection Requirements).

Under paragraph (e) of § 146.180, CMS may require that additional information be submitted after receiving an election to opt out. The burden of this requirement is the time it takes to gather and submit the additional information. This type of information collection is exempt from the requirements of the PRA under section 1320.4 as it is a collection of information during the conduct of an administrative action.

As required by section 3504(h) of the PRA, we have submitted a copy of this document to OMB for its review of these information collection requirements.

If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following:

We have examined the impacts of this final rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.

Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This final rule is not economically significant and is not a major rule.

The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year. Individuals and States are not included in the definition of a small entity. This final rule will have no significant impact on small businesses.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This final rule does not impose unfunded mandates on State, local, or tribal governments.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. We have determined that this final rule does not significantly affect the rights, roles, and responsibilities of State or local governments.

The July 26, 2002, interim final rule with comment period was reviewed by the Office of Management and Budget (OMB) in accordance with provisions of Executive Order 12866.

Section 648.21 (f)(2) requires the Regional Administrator to subtract any overages of Loligo squid commercial quota landed during Quarter I from the allocation for Quarter III. Accordingly, the Regional Administrator, based on dealer reports and other available information, has determined that there was a 5.6 percent overage in Quarter I Loligo squid directed fishery. Therefore, the quota for the directed fishery for Loligo squid in Quarter III is reduced from 6,435,130 lb (2,918.9 mt) to 5,733,152 lb (2,600.5 mt). The regulations governing the Atlantic mackerel, squid, and butterfish fisheries require notification to the public of this adjustment.