OPM's final regulations on debarment and suspension of health care providers were published in the Federal Register on February 3, 2003 (68 FR 5470). Subsequently, during the public comment period for OPM's proposed regulations on financial sanctions of health care providers (see the following section of this preamble titled “Financial Sanctions”), an FEHBP carrier commented to our office that the wording of several sections of the debarment and suspension regulations was ambiguous and potentially subject to misinterpretation in regard to the circumstances under which payments could be made to suspended providers.

The carrier's comments focused on §§ 890.1046 through 890.1050 of the regulations, which speak to certain special situations where payments to debarred providers may be permissible. Section 890.1048, regarding providers who are the sole source of health care services in their communities and section 890.1050, authorizing special exceptions to debarments for individual FEHBP enrollees, both contain specific language prohibiting payments to suspended providers in these circumstances. Sections 890.1046, 890.1047, and 890.1049, addressing services provided in emergency situations, institutional health care providers, and claims filed by enrollees who are unaware that their provider has been sanctioned, respectively, are silent regarding the permissibility of payments to suspended providers in those situations. By not specifically identifying the treatment of suspended providers in these three sections, we intended that they be governed by the overall policy stated in § 890.1030(c), that the effect of a suspension is the same as the effect of a debarment. However, we agree with the carrier's observation that the presence of language in §§ 890.1048 and 890.1050 specifically excluding suspended providers from payment under some “special” circumstances may have inadvertently created confusion among both carriers and providers as to our actual intent in situations where the regulatory wording did not specify the rights of suspended providers. Therefore, to avoid possible misinterpretations, we are revising §§ 890.1046, 890.1047, and 890.1049 by adding appropriate language to indicate that suspended providers are eligible to receive FEHBP payments in the special situations addressed by those sections.

The proposed financial sanctions regulations were issued in a notice of proposed rulemaking in the February 10, 2003, Federal Register (68 FR 6649). During the 60-day public comment period, OPM received written comments from an industry association of health insurance plans and oral comments from an FEHBP carrier and from employees. This section of the regulatory preamble addresses all of the comments and explains OPM's rationale for incorporating certain of them in the final rule and declining to implement others.

Most commenters observed that some of the wording in the proposed rule was ambiguous or redundant in addressing (1) the factors used to determine the amounts of penalties and assessments and (2) the procedures for contesting or settling proposed financial sanctions. Upon review, we agree that several sections could be reworded to clarify the intended meaning.

In particular, the proposed § 890.1064(b) appeared to be largely duplicated by § 890.1064(c) and (d), and this redundancy might have fostered some uncertainty as to the relationship between the purposes of financial sanctions and the specific factors that may determine the amount of a sanction against a given provider. In fact, the purposes of financial sanctions are to (1) make OPM whole for any monetary losses and damages associated with a provider's violations and (2) deter future violations by the sanctioned provider and other providers. The procedure for determining amounts in specific cases is intended to effectuate those purposes. Therefore, we have consolidated paragraphs (b), (c), and (d) of § 890.1064 as they appeared in the proposed rule into paragraph (b) as it appears in the final rule, thus eliminating the redundancy and emphasizing the seamless connection between overall regulatory purpose and the amounts of penalties in individual cases. As the result of this consolidation, the proposed paragraph (e) has been redesignated as § 890.1064(c) in the final rule.

Similarly, we have reworded the proposed § 890.1067(c) to clarify that (1) the debarring official may settle or compromise proposed financial sanctions at any stage of the sanctions process prior to issuance of a final decision and (2) such settlements or compromises do not have to be predicated on a provider's filing a contest of the proposed sanctions or making a formal settlement offer.

Several commenters noted that the phrase “intention to contest” in § 890.1068(a) was ambiguous as to the nature of the contact from a provider that would be sufficient to initiate OPM contest procedures. We have rewritten this section in the final rule to make it clear that, in filing a contest, the provider must adhere to the instructions given by the notice of proposed sanctions issued by OPM. If a provider does not file a contest within the timeframe stated in the notice, in a manner that complies with the procedures specified by the notice, OPM may implement the proposed sanctions immediately and without further procedures. However, OPM does not intend to use this provision to deny the opportunity to contest on the grounds of minor “technical” deviations from the instructions in the notice of proposed sanctions. Providers will receive the benefit of any reasonable doubt regarding their adherence to the requirements for filing a contest.

Some commenters also observed that the proposed §§ 890.1070 and 890.1071 were partially redundant and unclear regarding OPM's procedures for conducting and deciding contests. Upon review, we agree that a revision of these sections is warranted. Accordingly, we have consolidated the proposed §§ 890.1070 and 890.1071 into a single § 890.1070 in the final rule. This section sets forth in sequential order the process that the debarring official must apply to deciding contests of proposed financial sanctions and identifies the critical decision points at each stage of this process. To account for the consolidation, we have renumbered proposed §§ 890.1072 and 890.1073 as §§ 890.1071 and 890.1072, respectively, in the final rule.

The association of insurance carriers suggested that the scope of the proposed rule be expanded to provide a mechanism for crediting collected amounts of financial sanctions, deposited in the Employees Health Benefits Fund, to reimburse FEHBP plans for any losses and costs they incur as a result of the provider misconduct on which the financial sanctions are based. In support of this suggestion, the association noted that FEHBP plans may expend substantial amounts when investigating provider violations, and that there is no formula for “compensating plans for [such] losses.” However, FEHBP carriers are reimbursed from the Employees Health Benefits Fund for allowable costs incurred in administering their responsibilities under their FEHBP contracts. The nature and extent of such reimbursement is addressed within the regulatory framework of the Federal Employees Health Benefits Acquisition Regulations, and is subject to annual negotiation between OPM and the carrier. In contrast, the FEHBP sanctions statute is designed solely as an enforcement measure aimed at untrustworthy health care providers, and offers no basis or authority for regulating costs and/or reimbursement policies. Therefore, we have not accepted the carrier association's suggestions.

I certify that this proposed regulation will not have a significant economic impact on a substantial number of small entities, because the financial sanctions are limited to the portion of health care providers' activities involving transactions with the Federal Employees Health Benefits Program.

This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.

The Office of Management and Budget (OMB) has waived the review process required by Executive Order 12866 for this action.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have a retroactive effect. The Act states that the statute is intended to occupy the field of promotion and consumer education involving pork and pork products and of obtaining funds thereof from pork producers and that the regulation of such activity (other than a regulation or requirement relating to a matter of public health or the provision of State or local funds for such activity) that is in addition to or different from the Act may not be imposed by a State.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 1625 of the Act, a person subject to an order may file a petition with the Secretary stating that such order, a provision of such order or an obligation imposed in connection with such order is not in accordance with the law; and requesting a modification of the order or an exemption from the order. Such person is afforded the opportunity for a hearing on the petition. After the hearing, the Secretary would rule on the petition. The Act provides that the district court of the United States in the district in which a person resides or does business has jurisdiction to review the Secretary's determination, if a complaint is filed not later than 20 days after the date such person receives notice of such determination.

This action also was reviewed under the Regulatory Flexibility Act (RFA) (5 United States Code (U.S.C.) 601 et seq. ). The effect of the Order upon small entities initially was discussed in the September 5, 1986, issue of the Federal Register (51 FR 31898). It was determined at that time that the Order would not have a significant effect upon a substantial number of small entities. Many of the estimated 500 importers may be classified as small entities under the Small Business Administration definition (13 CFR 121.201).

This final rule will decrease the amount of assessments on imported pork and pork products subject to assessment by five-hundredths to seven-hundredths of a cent per pound, or as expressed in cents per kilogram, eleven-hundredths to fifteen-hundredths of a cent per kilogram. This decrease is consistent with the decrease in the annual average price of domestic barrows and gilts for calendar year 2002. The average annual market price decreased from $45.87 in 2001 to $37.09 in 2002, a decrease of about 20 percent. Adjusting the assessments on imported pork and pork products will result in an estimated decrease in assessments of approximately $562,000 over a 12-month period. Assessments collected on imported hogs, pork, and pork products for 2002 were $4,250,578. Accordingly, the Administrator of AMS has determined that this action will not have a significant economic impact on a substantial number of small entities.

The Act (7 U.S.C. 4801-4819) approved December 23, 1985, authorized the establishment of a national pork promotion, research, and consumer information program. The program was funded by an initial assessment rate of 0.25 percent of the market value of all porcine animals marketed in the United States and on imported porcine animals with an equivalent assessment on pork and pork products. However, that rate was increased to 0.35 percent in 1991 (56 FR 51635), to 0.45 percent effective September 3, 1995 (60 FR 29963), and then decreased to 0.40 percent effective September 30, 2002 (67 FR 58320). The final Order establishing a pork promotion, research, and consumer information program was published in the September 5, 1986, issue of the Federal Register (51 FR 31898; as corrected, at 51 FR 36383 and amended at 53 FR 1909, 53 FR 30243, 56 FR 4, 56 FR 51635, 60 FR 29963, 61 FR 29002, 62 FR 26205, 63 FR 45936, 64 FR 44643, 66 FR 67071, and 67 FR 58320) and assessments began on November 1, 1986.

The Order requires importers of porcine animals to pay U.S. Customs Service (USCS), upon importation, the assessment of 0.40 percent of the animal's declared value and importers of pork and pork products to pay USCS, upon importation, the assessment of 0.40 percent of the market value of the live porcine animals from which such pork and pork products were produced. This final rule will decrease the assessments on all imported pork and pork products subject to assessment as published in the Federal Register as a final rule September 16, 2002, and effective on September 30, 2002 (67 FR 58320). This decrease is consistent with the decrease in the annual average price of domestic barrows and gilts for calendar year 2002 as calculated by the Department of Agriculture's (Department), AMS, Livestock and Grain Market News (LGMN) Branch. This decrease in assessments will make the equivalent market value of the live porcine animal from which the imported pork and pork products were derived reflect the recent decrease in the market value of domestic porcine animals, thereby promoting comparability between importer and domestic assessments. This final rule will not change the current assessment rate of 0.40 percent of the market value.

The methodology for determining the per pound amounts for imported pork and pork products was described in the Supplementary Information accompanying the Order and published in the September 5, 1986, Federal Register at 51 FR 31901. The weight of imported pork and pork products is converted to a carcass weight equivalent by utilizing conversion factors that are published in the Department's Agricultural Handbook No. 697 “Conversion Factors and Weights and Measures.” These conversion factors take into account the removal of bone, weight lost in cooking or other processing, and the nonpork components of pork products. Secondly, the carcass weight equivalent is converted to a live animal equivalent weight by dividing the carcass weight equivalent by 74 percent, which is the average dressing percentage of porcine animals in the United States as recognized by the industry. Thirdly, the equivalent value of the live porcine animals is determined by multiplying the live animal equivalent weight by an annual average market price for barrows and gilts as calculated by LGMN Branch. Finally, the equivalent value is multiplied by the applicable assessment rate of 0.40 percent due on imported pork and pork products. The end result is expressed in an amount per pound for each type of pork or pork product. To determine the amount per kilogram for pork and pork products subject to assessment under the Act and Order, the cent per pound assessments are multiplied by a metric conversion factor 2.2046 and carried to the sixth decimal.

Since 2001, there has been a change in the way LGMN Branch reports hog prices. Due to the implementation of the Livestock Mandatory Price Reporting program, LGMN no longer report hogs on a live basis because most of the industry buys hogs on a carcass basis. Therefore, the annual average market price for barrows and gilts is now derived from the National Daily Direct Hog Price Report (Slaughtered). To convert this figure to a live basis it must be multiplied by 74 percent, the average dressing percentage of porcine animals.

The formula in the preamble for the Order at 51 FR 31901 contemplated that it would be necessary to recalculate the equivalent live animal value of imported pork and pork products to reflect changes in the rate of assessment or changes in the annual average price of domestic barrows and gilts to maintain equity of assessments between domestic and porcine animals and imported pork and pork products.

The average annual market price decreased from $45.87 per hundredweight in 2001 to $37.09 per hundredweight in 2002, a decrease of about 20 percent. This decrease will result in a corresponding decrease in assessments for all HTS numbers listed in the table in § 1230.110(b), 67 FR 58320; September 16, 2002, of an amount equal to five-hundredths to seven-hundredths of a cent per pound, or as expressed in cents per kilogram, eleven-hundredths to fifteen-hundredths of a cent per kilogram. Based on the most recent available Department of Commerce, Bureau of Census, data on the volume of imported pork and pork products imported during 2002, the decrease in assessment amounts will result in an estimated $562,000 decrease in assessments over a 12-month period. The assessment rate for imported live hogs is not affected by the change in the cents per pound assessment rate for imported pork and pork products.

In addition, this rule deletes two live porcine animal Harmonized Tariff Schedule (HTS) numbers—0103.91.0000 and 0103.92.0000—and adds five new live porcine animal HTS numbers 0103.91.0010, 0103.91.0020, 0103.91.0030, 0103.92.0010, and 0103.92.0090—to the table in § 1230.110(a) to reflect current USCS HTS numbers used for live porcine animals.

On December 17, 2003, AMS published in the Federal Register (68 FR 70201) a proposed rule which would decrease the per pound assessment on imported pork and pork products consistent with the decrease in the 2002 average price of domestic barrows and gilts to provide comparability between imported and domestic assessments. The proposal was published with a request for comments by January 16, 2004. No comments were received.

The NCUA published a document in the Federal Register of February 25, 2004 (69 FR 8545), amending § 741.2. The amendatory language included adding new paragraphs (b), (c) and (d). There is no paragraph (d). This amendment removes the reference to paragraph (d).

What events have caused this AD? The Civil Aviation Safety Authority (CASA), which is the airworthiness authority for Australia, recently notified FAA that an unsafe condition may exist on all ASTA Models N22B, N22S, and N24A airplanes. The CASA reports that fatigue tests on the wing strut upper end fitting have shown premature failures and rapid crack growth. Also, fatigue tests on the wing strut lower end fittings, stub wing strut pick up fitting, and stub wing front spar assembly have identified appropriate fatigue lives for the respective parts.

What is the potential impact if FAA took no action? Fatigue loading could result in failure of the wing strut upper end fitting, wing strut lower end fittings, stub wing strut pick up fitting, or stub wing front spar assembly. This failure could lead to reduced structural capability or reduced controllability of the airplane.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all ASTA Models N22B, N22S, and N24A airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on October 24, 2003 (68 FR 60887). The NPRM proposed to require you to repetitively inspect wing fittings for fatigue defects, replace or correct defective wing fittings, and replace the stub wing front spar assembly and wing fitting when fatigue life limits are reached.

Was the public invited to comment? We provided the public the opportunity to participate in the development of this AD. We received no comments on the proposal or on the determination of the cost to the public.

What is FAA's final determination on this issue? We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial corrections. We have determined that these minor corrections:

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

How many airplanes does this AD impact? We estimate that this AD affects 15 airplanes in the U.S. registry.

What is the cost impact of this AD on owners/operators of the affected airplanes?

We estimate the following costs to accomplish the inspection of the wing strut upper end fitting bolt holes:

We estimate the following costs to accomplish the inspection of the stub wing strut pick up fittings:

We estimate the following costs to accomplish any necessary replacements of the wing strut upper end fittings that will be required based on the results of the inspection or on reaching the fatigue life limit. We have no way of determining the number of airplanes that may need the replacement:

We estimate the following costs to accomplish any necessary replacements of the wing strut lower end fittings that will required based on reaching the fatigue life limit. We have no way of determining the number of airplanes that may need the replacement:

We estimate the following costs to accomplish any necessary replacements of the stub wing strut pick up fittings that will be required based on the results of the inspection or on reaching the fatigue life limit. We have no way of determining the number of airplanes that may need the replacement:

We estimate the following costs to accomplish any necessary replacements of the stub wing front spar assembly that will be required based on reaching the fatigue life limit. We have no way of determining the number of airplanes that may need the replacement:

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

Will this AD involve a significant rule or regulatory action? For the reasons discussed above, I certify that this AD:

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

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

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

We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES. Include “AD Docket No. 2003-CE-37-AD” in your request.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 2001-17-28 R1, amendment 39-12510 (66 FR 58924, November 26, 2001), which is applicable to certain Boeing Model 767 series airplanes, was published in the Federal Register on March 3, 2003 (68 FR 9947). For airplanes already subject to the existing AD, the action proposed to require inspecting to determine whether the existing location of a certain wire support standoff is adequate, relocating the wire support standoff if necessary, installing protective sleeving over the wire bundles, and installing wire bundle support clamps if necessary. The action also proposed to expand the applicability of the existing AD to include additional airplanes, and require inspecting the sleeving on certain wire bundles, and accomplishing corrective action if necessary, on those airplanes.

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

Three commenters request that the FAA give credit for actions accomplished in accordance with Boeing Alert Service Bulletin 767-24A0134 (for Model 767-200 and -300 series airplanes), dated March 15, 2001. They state that Revision 1 of the service bulletin specifies no more work is necessary for airplanes changed in accordance with the original issue of the service bulletin.

We agree. We have determined that completion of all the steps in the Accomplishment Instructions of Boeing Alert Service Bulletin 767-24A0134 (for Model 767-200 and -300 series airplanes) or Boeing Alert Service Bulletin 767-24A0135 (for Model 767-400ER series airplanes), both dated March 15, 2001, as applicable, is acceptable for compliance with the corresponding actions specified for Group 1 airplanes in paragraph (b) of this AD. We have added paragraph (c) to this final rule to give credit for accomplishment of previous service bulletins.

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

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

We have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.

There are approximately 839 airplanes of the affected design in the worldwide fleet. We estimate that 325 airplanes of U.S. registry will be affected by this AD.

The inspection that is currently required by AD 2001-17-28 R1 takes approximately 2 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $42,250, or $130 per airplane.

For airplanes in both Groups 1 and 2 as listed in the alert service bulletins, the new actions that are required by this new AD will take approximately 2 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. The cost of required parts will be negligible. Based on these figures, the cost impact of the new requirements of this AD on U.S. operators is estimated to be $42,250, or $130 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain McDonnell Douglas Model DC-9-31 and DC-9-32 airplanes was published in the Federal Register on October 29, 2003 (68 FR 61637). That action proposed to require replacement of certain power relays, and subsequent repetitive cleaning, inspecting, repairing, and testing of certain replaced power relays.

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

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

There are approximately 4 airplanes of the affected design in the worldwide fleet. The FAA estimates that 2 airplanes of U.S. registry will be affected by this AD, that it will take approximately 2 work hours per airplane to accomplish the required inspection, and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $260, or $130 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain McDonnell Douglas Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40, DC-10-40F, MD-10-10F, and MD-10-30F airplanes; and Model MD-11 and MD-11F airplanes was published in the Federal Register on September 18, 2003 (68 FR 54682). That action proposed to require replacement of the left and right number one passenger door bolted lower seal-to-retainer and girt bar view window assemblies with new, double-flush riveted assemblies.

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

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

There are approximately 350 Model DC-10 airplanes, and approximately 195 Model MD-11 and -11F airplanes of the affected design in the worldwide fleet. The FAA estimates that 263 Model DC-10 airplanes and 81 Model MD-11 and -11F airplanes of U.S. registry would be affected by this AD.

The following table shows the estimated cost impact for airplanes affected by this AD:

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Airbus Model A300 B2 and B4 series airplanes; Model A300 B4-600, A300 B4-600R, and A300 F4-600R series airplanes (collectively called A300-600); Model A310 series airplanes; Model A319, A320, and A321 series airplanes; Model A330-301, -321, -322, -341, and -342 airplanes; and Model A340 series airplanes; was published as a supplemental notice of proposed rulemaking (NPRM) in the Federal Register on June 12, 2003 (68 FR 35186). That action proposed to require, among other actions, replacement of certain pitot probes with certain new pitot probes.

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

Several commenters concur with the proposed AD.

One commenter requests that the FAA revise the proposed AD to refer to Airbus Service Bulletin A320-34-1127, Revision 01, dated December 4, 2001, instead of the original issue of that service bulletin. (Paragraph (f) of the supplemental NPRM refers to the original issue of Airbus Service Bulletin A320-34-1127, dated April 24, 1997, as the acceptable source of service information for the accomplishment of the actions in that paragraph.) The commenter notes that the Accomplishment Instructions in Revision 01 have not been revised from those in the original issue; thus, either issue of the service bulletin should be acceptable.

We concur with the commenter's request and have revised paragraph (f) of this final rule to refer to Revision 01 of the service bulletin, and to state that replacement of the pitot probes before the effective date of this AD per the original issue of Airbus Service Bulletin A320-34-1127 is acceptable for compliance with that paragraph. Also, we have revised the applicability statement of this final rule to refer to Revision 01 in addition to the original issue of the service bulletin as the service bulletin associated with Airbus Modification 25998.

Also, we have determined that Airbus has issued the following revised service bulletins, and we have revised “Table 1—Applicability” of this AD to refer to all of these revisions:

• Service Bulletin A300-34-6116, Revision 03, dated June 6, 2003. That service bulletin contains procedures that are essentially the same as those in Revision 02 of the service bulletin, dated May 25, 2000, which paragraph (a)(1) of the supplemental NPRM refers to as an acceptable source of service information for accomplishing the actions in that paragraph on Model A300 B4-600, A300 B4-600R, and A300 F4-600R series airplanes. Accordingly, we have revised paragraph (a)(1) of this final rule to refer to Revision 03 of the service bulletin, while giving credit for actions accomplished previously per the original issue of the service bulletin, dated June 19, 1998; Revision 01, dated August 7, 1998, or Revision 02.

• Airbus Service Bulletin A310-34-2137, Revision 03, dated June 6, 2003. That service bulletin contains procedures that are essentially the same as those in Revision 02 of the service bulletin, dated May 25, 2000, which paragraph (a)(1) of the supplemental NPRM refers to as an acceptable source of service information for accomplishing the actions in that paragraph on Model A310 series airplanes. Accordingly, we have revised paragraph (a)(1) of this final rule to refer to Revision 03 of the service bulletin, while giving credit for actions accomplished previously per Revision 02.

• Service Bulletin A300-32-052, Revision 2, dated September 10, 1981. That service bulletin contains procedures that are essentially the same as those in the original issue of that service bulletin, dated November 15, 1976, which paragraph (d) of the supplemental NPRM refers to as an acceptable source of service information for the actions in that paragraph. Accordingly, we have revised paragraph (d) of this final rule to refer to Revision 2 of the service bulletin, while giving credit for actions accomplished previously per the original issue of the service bulletin.

• Airbus Service Bulletin A300-22-031, Revision 1, dated February 9, 1981. That service bulletin contains procedures that are essentially the same as those in the original issue of that service bulletin, dated June 25, 1979, which paragraph (e) of the supplemental NPRM refers to as an acceptable source of service information for the actions in that paragraph. Accordingly, we have revised paragraph (e) of this final rule to refer to Revision 1 of the service bulletin, while giving credit for actions accomplished previously per the original issue of the service bulletin.

• Service Bulletin A330-34-3038, Revision 01, dated September 14, 2001. That service bulletin contains procedures that are essentially the same as those in the original issue of that service bulletin, dated November 19, 1996, which paragraph (g)(1) of the supplemental NPRM refers to as an acceptable source of service information for the actions in that paragraph. Accordingly, we have revised paragraph (g)(1) of this final rule to refer to Revision 01 of the service bulletin, while giving credit for actions accomplished previously per the original issue of the service bulletin.

• Service Bulletin A330-34-3071, Revision 01, dated May 30, 2001. That service bulletin contains procedures that are essentially the same as those in the original issue of that service bulletin, dated December 11, 1998, which paragraph (g)(2) of the supplemental NPRM refers to as an acceptable source of service information for the actions in that paragraph. Accordingly, we have revised paragraph (g)(2) of this final rule to refer to Revision 01 of the service bulletin, while giving credit for actions accomplished previously per the original issue of the service bulletin.

• Service Bulletin A340-34-4042, Revision 01, dated September 14, 2001. That service bulletin contains procedures that are essentially the same as those in the original issue of that service bulletin, dated November 19, 1996, which paragraph (h)(1) of the supplemental NPRM refers to as an acceptable source of service information for the actions in that paragraph. Accordingly, we have revised paragraph (h)(1) of this final rule to refer to Revision 01 of the service bulletin, while giving credit for actions accomplished previously per the original issue of the service bulletin.

• Service Bulletin A340-34-4079, Revision 06, dated April 1, 2003. That service bulletin contains procedures that are essentially the same as those described in the original issue of the service bulletin, which paragraph (h)(2) of the supplemental NPRM refers to as an appropriate source of service information for the actions required by that paragraph. Accordingly, we have revised paragraph (h)(2) of this final rule to refer to Revision 06 of the service bulletin, while giving credit for actions accomplished previously per the original issue of the service bulletin, dated December 11, 1998; Revision 01, dated May 27, 1999; Revision 02, dated October 6, 1999; Revision 03, dated March 12, 2002; Revision 04, dated June 19, 2002; or Revision 05, dated July 30, 2002.

One commenter requests that paragraph (b) of the supplemental NPRM be revised to state that compliance is required “before or concurrently with the requirements of paragraph (a)(1).” Paragraph (b) of the supplemental NPRM states that compliance is required “before or concurrently with the requirements of paragraph (a)(2).” The commenter correctly notes that paragraph (b) applies to Model A300 B2 and B4 series airplanes, while paragraph (a)(2) refers to Model A300 B4-600R, A310-203, and A310-304 series airplanes. Paragraph (a)(1) applies to Model A300 B2 and B4 series airplanes (among other models).

We concur with the commenter's request. The reference to paragraph (a)(2) in paragraph (b) of the supplemental NPRM was a typographical error. We have corrected this error in paragraph (b) of this final rule.

One commenter requests that we revise the supplemental NPRM to provide credit for accomplishment, during production, of Airbus Modification 2435 in lieu of accomplishment of the actions in Airbus Service Bulletin A300-34-069, Revision 5, dated April 8, 1982, as revised by Airbus A300 Service Bulletin Change Notice 5A, dated February 16, 1987, as would be required by paragraph (b) of the proposed AD. The commenter also requests that we provide credit for accomplishment of earlier revisions of Airbus Service Bulletin A300-34-069.

We partially concur with the commenter's request. We have revised paragraph (b) of this final rule to state that “Accomplishment during production of Airbus Modification 2435 is acceptable for compliance.” With regard to providing credit for accomplishment of earlier revisions of Airbus Service Bulletin A300-34-069, we acknowledge that certain earlier revisions of that service bulletin may be acceptable for compliance with corresponding requirements of this AD. However, certain older revisions of service bulletins are unavailable to us; therefore, we are unable to verify whether they are acceptable for compliance. An operator may request approval of an alternative method of compliance with this AD, provided that the operator submits a copy of the revision of the service bulletin for which credit is sought with the request. We have made no further change in this regard.

“Table—Applicability” in the proposed AD has been re-identified as “Table 1—Applicability” in this final rule.

Also, we have revised “Table 1—Applicability” to correct the dates for various revisions of Airbus Service Bulletin A320-34-1170, which were listed incorrectly in the supplemental NPRM.

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

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

Since we issued the supplemental NPRM, we have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.

We estimate that 559 Model A300 B2 and B4 series airplanes; Model A300 B4-600, A300 B4-600R, and A300 F4-600R series airplanes (collectively called A300-600); Model A310 series airplanes; Model A319, A320, and A321 series airplanes; and Model A330-301, -321, -322, -341, and -342 series airplanes; of U.S. registry will be affected by this AD. “Table—Cost Figures” shows the estimated cost figures for certain airplanes affected by this AD. The average labor rate is $65 per work hour.

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

Currently, there are no Airbus Model A340 series airplanes on the U.S. Register. However, should an affected airplane be imported and placed on the U.S. Register in the future, it will require approximately 3 work hours to accomplish the required actions, at an average labor rate of $65 per work hour. The cost of required parts would be $6,000 or $11,100 (depending on airplane configuration). Based on these figures, the cost impact of this AD on a subject Model A340 series airplane would be $6,195 or $11,295 per airplane (depending on airplane configuration).

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain McDonnell Douglas airplane models was published in the Federal Register on July 29, 2003 (68 FR 44491). That action proposed to require a one-time inspection for chafing of wiring in the left-hand tunnel area of the forward cargo compartment, repair if necessary, and coiling and stowing of excess wiring.

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

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

There are approximately 1,116 airplanes of the affected design in the worldwide fleet. The FAA estimates that 655 airplanes of U.S. registry will be affected by this AD, that it will take approximately 3 work hours per airplane to accomplish the required actions, and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $127,725, or $195 per airplane.

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

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

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

The Commission has determined, as part of its oversight responsibilities, to review its rules and guides periodically to seek information about their costs and benefits and their regulatory and economic impact. The information obtained assists the Commission in identifying rules and guides that warrant modification or rescission.

On November 29, 1973, Congress passed the Hobby Protection Act (“Act”), 15 U.S.C. 2101-06. The Act requires manufacturers and importers of “imitation political items”  1 to mark “plainly and permanently” such items with the “calendar year” such items were manufactured. Id. at 2101(a). The Act also requires manufacturers and importers of “imitation numismatic items”  2 to mark “plainly and permanently” such items with the word “copy.” Id. at 2101(b). The Act further directs the Commission to promulgate regulations for determining the “manner and form” that imitation political items and imitation numismatic items are to be permanently marked with the calendar year of manufacture or the word “copy.” Id. at 2101(c) .

Pursuant to the Act, in 1975 the Commission issued rules and regulations under the Hobby Protection Act, 16 CFR part 304. The rule tracks the definitions of terms used in the Act and implements the Act's “plain and permanent” marking requirements by establishing the sizes and dimensions of the letters and numerals to be used, the location of the marking on the item, and how to mark incusable and nonincusable items. 3 In 1988, the rule was amended to provide additional guidance on the minimum size of letters for the word “copy” as a proportion of the diameter of coin reproductions. 4 53 FR 38942 (October 4, 1988).

On March 3, 2003, the Commission published a Federal Register notice (“FRN”) seeking comment on the rule as part of the Commission's ongoing project to review periodically its rules and guides to determine their current effectiveness and impact (68 FR 9856). This FRN sought comment on the costs and benefits of the rule, what changes in the rule would increase its benefits to purchasers and how those changes would affect compliance costs, and whether technological or marketplace changes have affected the rule.

The comments submitted in response to the FRN generally expressed continuing support for the rule, indicating that it has created a level playing field among competitors. The vast majority of comments proposed that the Commission expand the rule to address problems involving the selling (passing off) as originals of reproductions of antiques and collectibles not covered by the Act and rule. 5 The Commission, however, does not have authority under the Act to amend the rule as requested. In addition, existing laws and informational material disseminated by various collecting clubs address many of the concerns raised by these comments.

The Commission received 350 comments in response to its FRN. 6 Approximately 248 comments were letters and e-mails from individual collectors who advocated expanding the rule's coverage to all antiques and collectibles. The vast majority of these were form letters from individual collectors. Of the remainder, eight were from national trade associations and collector groups, 7 three were from hobby publications, 8 and the remaining were from dealers, 9 State and local trade associations and local chapters of national groups, 10 and antique appraisers. 11

The Commission discusses the comments in two sections. In section A, the Commission analyzes the comments relating to political and numismatic products. (“covered products”). In section B, the Commission discusses the comments on expanding the Act and rule to cover all antiques and collectibles.

As previously discussed, the Act and rule's scope are limited to imitation political and numismatic items. The comments uniformly stated that there is a continuing need for the rule and that it has been successful in protecting consumers from the passing off of reproductions of the covered items. 12 In explaining the continuing need for the Act and rule, one commenter stated that the coin collecting hobby is currently experiencing a renaissance, due in large part to the 50 state quarters program that the U.S. Mint launched in 1999. 13 A dealer in political memorabilia on the Internet stated that most collectors of political items feel comfortable for one reason—the Hobby Protection Act. 14

One commenter stated that some manufacturers “skirt” the rule by adding a hallmark or varying the metal so as to claim that the item is not an “exact” replica. 15 The commenter asserted that the consuming public may not be able to discern the immediate difference in metal content in a coin that is in every other respect an exact duplicate of the rare coin. According to the commenter, this problem is exacerbated when the coin is sold in the secondary market, where it is often perceived and sold as a genuine coin. The commenter suggested requiring any replica that duplicates the genuine design elements, legends and denomination markings to be marked “copy” regardless of the replica's metal content. 16

The Commission believes the Act's and rule's definitions of “imitation numismatic item” cover an imitation coin that contains a different metal content from the original item where the imitation item “ purports to be, but in fact is not, an original.” 15 U.S.C. 2106(4); 16 CFR 304.1(d) (emphasis added). Accordingly, such imitation coins should be marked “copy” and this notice should alert those who are not so marking their coins in the mistaken belief that the Act and rule do not apply of their compliance obligation. Moreover, even though the Act and rule address only the marking, and not the marketing, of imitation numismatic or political items, misrepresenting a copy as an original in advertising or marketing constitutes a “deceptive act or practice” under section 5 of the FTC Act, 15 U.S.C. 45. 17

The rule currently requires that the word “copy” be marked on either side of the coin, 16 CFR 304.6(b)(2). Coin World suggested that the word “copy” be incused on both sides of the coin because unscrupulous sellers may take advantage of the fact that manufacturers may have inconspicuously woven the word “copy” into the original design elements of one side of the coin. This may be a particular problem for coins minted prior to 1836. 18 The Commission has concluded that a requirement that “copy” be marked on both sides of an imitation coin is not warranted. With exhibited coins, the potential buyer would normally have the chance to fully view and handle the coin, so the “copy” marking would be seen prior to purchase. Furthermore, as discussed above, if the seller misrepresents a copy as an original in advertising or marketing, such practice would be deceptive in violation of section 5 of the FTC Act, 15 U.S.C. 45.

The vast majority of the 350 comments submitted in response to the Commission's FRN advocated that the Act or rule be expanded to cover antiques and collectibles. In summary, these comments state that reproductions of many types of antiques and collectibles are being passed off as originals, causing harm to collectors and dealers. Many comments also assert that because of improvements in technology, even knowledgeable persons have difficulty distinguishing reproductions from the originals.

Collectors of a wide variety of items proposed expanding the rule. Such commenters included collectors of the following items: Victorian paper weights, 19 casino chips and gambling tokens, 20 custard glass, 21 American Pattern Glass, 22 thimbles, 23 antique fishing lures, 24 glass and porcelain electrical insulation devices related to the communications and power industries, 25 milk bottles and other dairy memorabilia, 26 antique fruit jars, 27 toy trains and related material, 28 and 19th Century homemade dolls.

The comments suggested that many categories of collectibles are subject to being passed off, and provided explanations for the problem. One commenter stated that since the passage of the Act in 1973 there has been a dramatic increase of reproductions in all areas of the antiques and collectibles market. Dealers and collectors alike have been fooled by reproductions they have purchased, believing them to be genuine antiques. The commenter stated that this deception translates into financial losses and builds a sense of mistrust in the antiques market. 29 Numerous commenters stated that because of improvements in manufacturing technology, the quality of reproductions has vastly improved to the point where reproductions are virtually indistinguishable from the originals. 30 One commenter pointed out that some items are even being made from the original molds. 31

Another commenter stated that since the 1998 review of the Act, there has been a tremendous increase in the number of reproductions, imported mainly from the Far East, with forged, fake, or misleading backstamps or other markings and only a paper label indicating the country of origin. The commenter pointed out that the paper labels are routinely removed and the items are then sold in flea markets, antique malls and on the Internet, and are represented as antiques. 32 Similarly, another commenter stated that American import companies contract with foreign factories, most often in China, to make reproductions of vintage American art pottery and art glass with replicas of the original American company marks. The commenter stated that the only indication that the product is a reproduction and/or of foreign origin is a tiny paper sticker that states, “Made in China.” The commenter pointed out that the stickers virtually never make it to the retail market. 33

Several commenters stated that Internet trading makes it impossible to examine an item before purchasing it. 34 One dealer, who has been selling on the Internet for nearly eight years, stated that he is finding an increasing number of customers who are fearful of purchasing reproductions, particularly those who previously have had bad experiences with their Internet purchases. 35 Several commenters stated that Internet sales spread the “fakes” quickly, before dealers and the public can be warned in trade publications. 36 Another commenter reported that the Internet has increased the number of collectors; thus, there has been an increase in buyers who are less informed about reproductions. 37

Although the comments do not present information sufficient to quantify or determine the amount of economic and other harm caused, they suggest several possible adverse effects of the passing off problem. For example, the comments suggest that individual buyers may pay considerably more than a product is worth, that owners of original antiques or collectibles that are heavily reproduced may lose the value of their investment, and that the uncertainty regarding the genuineness of antiques and collectibles may dissuade persons from purchasing originals or from becoming collectors, which also adversely affects businesses that deal in originals.

Most commenters recommended that the Commission require that antique reproductions be clearly and permanently marked “copy.”  38 One commenter stated that permanently marking items as “copy” would eliminate the problem of confusion between the actual antique and the reproduction. That commenter stated that adding “copy” to the product would require only a small adjustment during the manufacturing process. 39 Another commenter argued that the only reason not to permanently mark items as reproductions is if the intent is to co-mingle them with the antiques in order to “fool the public.”  40

The commenters varied in their approaches to the types of additional information that they proposed be disclosed on the items, including requiring manufacturers to mark new items with: the date of manufacture;  41 the manufacturer's name;  42 and/or the place of manufacture. 43 One commenter's solution to temporary paper country-of-origin labels was to embed the country-of-origin and the date permanently into the underside of the product. 44 One dealer suggested that manufacturers who reissue old patterns in exact form and color should be required to use a permanent mark that would identify the date of manufacture. 45

For several reasons, the Commission does not propose to adopt the changes requested by the commenters. First, the Act does not provide the Commission with the legal authority to expand the rule's coverage to all antiques and collectibles. The plain language of the Act encompasses only numismatic and political items and directs the Commission to promulgate rules regarding the marking of these covered products only. 15 U.S.C. 2101. For this reason, the Commission cannot amend the rule to include products not specified in the Act.

Second, the Commission believes that existing Federal and State laws provide remedies for some issues the comments raise. For example, the majority of comments cited imported reproductions as the most significant source of passed off goods. Current U.S. laws and regulations already require country-of-origin markings for goods imported into the United States. Specifically, country-of-origin marking for imports falls under the jurisdiction of the U.S. Bureau of Customs and Border Protection (“CBP”), U.S. Department of Homeland Security, which enforces the Tariff Act of 1930. 19 U.S.C. 1304. U.S. customs laws require each imported article produced abroad to be marked legibly, indelibly, and permanently in a conspicuous place to indicate the country of origin. The Tariff Act also allows the container of an imported good to bear the origin marking rather than the good itself, as long as the good reaches the ultimate purchaser in the container. Under the Tariff Act, a permanent marking is a marking that will remain on the article or container until it reaches the ultimate purchaser, although the marking may be removed by the ultimate purchaser and need not be of a permanence to remain affixed once in his or her possession. 46 This marking may not be removed prior to delivery to the ultimate purchaser, however, and anyone who removes this marking prior to such delivery could be subject to prosecution and criminal penalties.

The Commission staff has brought the foreign origin marking concerns raised in this proceeding to the CBP's attention because its regulations govern several of the problems discussed in the comments. For example, numerous commenters stated that certain country-of-origin labels are being deliberately removed before reaching the “ultimate purchaser.” The CBP urges persons with information regarding the violative removal of required country-of-origin markings to write to: Commercial Enforcement Branch, Office of Field Operations, U.S. Bureau of Customs and Border Protection, 1300 Pennsylvania Ave., NW., Washington, DC 20229, or to call CBP's toll free Commercial Fraud Hotline, 1-800-BE-ALERT. The CBP staff suggest consumers provide them with as much of the following information as possible: The port to which the questionable merchandise was shipped; the importers' names and/or the repurchasers' names; the kind of merchandise at issue; and any information regarding the alleged deliberate removal of the paper country-of-origin label.

Further, intentionally passing off reproductions as antiques can be prosecuted as criminal fraud or as civil fraud in a lawsuit by a buyer. 47 Additionally, the Lanham Act provides injured persons with a private right of action against certain false or misleading representations regarding goods or false designation of origin, e.g. , reproductions being passed off as original items. 15 U.S.C. 1125. Further, a pattern or practice of significant affirmative misrepresentations or failure to disclose material information relating to reproductions passed off as originals may violate the FTC Act. 48

In addition to the deliberate removal of country-of-origin labels, many commenters suggested that the lack of truly permanent country-of-origin labels on reproductions can result in these reproductions inadvertently being passed off as originals in the secondary market. This could be addressed, at least in part, through greater enforcement of labeling requirements to the initial seller and through educational remedies.

The record indicates that there are many non-legal resources available to educate consumers about antiques and collectibles and thus reduce consumers' susceptibility to the practice of passing off. For example, several newsletters and hobby newspapers regularly warn and advise buyers of antiques and collectibles about reproductions of specific items and classes of items. 49 The comments also indicate that there are collector clubs for many categories of collectibles that provide members with similar information. 50 The Commission staff will continue to explore whether there is a role for the Commission in these efforts to increase consumer awareness.

The comments uniformly favor retention of the rule and state that there is a continuing need for the rule with regard to currently covered products, i.e. , imitation numismatic and political items; that the rule benefits consumers and the industry; that the rule does not impose substantial economic burdens; and that the benefits of the rule outweigh the minimal costs it imposes.

Although many comments recommended that the rule be expanded to cover all antiques and collectibles, the Commission does not have the authority under the Act to expand the rule in this manner. Furthermore, there are a variety of legal and non-legal resources that address many of the issues raised by the commenters favoring expansion of the rule's coverage. Accordingly, the Commission has determined to retain the current Rule and is terminating this review.

Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada J0K 1H0, filed ANADA 200-307 that provides for use of Penicillin G Potassium, USP, in the drinking water of turkeys for the treatment of erysipelas caused by Erysipelothrix rhusiopathiae . Vétoquinol N.-A., Inc.'s Penicillin G Potassium, USP, is approved as a generic copy of Fort Dodge Animal Health's Penicillin G Potassium, USP, approved under NADA 55-060. The ANADA is approved as of January 29, 2004, and the regulations are amended in 21 CFR 520.1696b 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.

The agency has determined under 21 CFR 25.33(a)(1) 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.

Alpharma Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141-223 for use of CLINACOX (diclazuril) and 3-NITRO (roxarsone) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for broiler chickens. The NADA is approved as of January 27, 2004, and the regulations are amended in 21 CFR 558.198 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.

The agency has determined under 21 CFR 25.33(a)(2) 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.

Pursuant to 5 U.S.C. 553, a notice of proposed rulemaking (NPRM) was not published for this rule. Good cause exists for not publishing an NPRM and for making this regulation effective in less than 30 days after Federal Register publication. It has come to the attention of the Coast Guard that vessels cannot safely pass the barge that is to conduct fendering repairs on the Belt Parkway Bridge. Repairs on the bridge fendering are scheduled to begin by February 2, 2004. Therefore, in order to ensure safe passage of vessels through the Belt Parkway Bridge, this regulation needs to be effective less than 30 days after publication in the Federal Register .

The Belt Parkway Bridge repairs were determined necessary as a result of a recent bridge allision. Waterway closures in the vicinity of and beneath the bridge are needed because repair equipment and construction materials will be in the vicinity of the bridge. Delaying this work for sufficient time to conduct a public notice rulemaking and advanced publication would be contrary to the public interest for safety purposes.

This rule is necessary to ensure the continued safe navigation under and through the Belt Parkway Bridge during fender repair operations. While repair operations are underway, a working barge will dramatically limit the ability of vessels to transit the waterway. However, the working barge will move on demand given one-hour notice by way of VHF CH 13.

The Captain of the Port anticipates minimal negative impact on vessel traffic due to this emergency repair work given the above schedule and ability to pass with notice.

This rule establishes a safety zone on all waters of Paerdegat Basin 50-yards upstream and downstream of the Belt Parkway Bridge. The safety zone is in effect between 8 a.m. on February 23, 2004 through March 26, 2004 at 8 p.m. At all times, mariners can safely transit into, and out of, Paerdegat Basin, through the Belt Parkway Bridge, when a minimum of one-hour advance notice is given to the onscene vessel operator on VHF CH 13 between 7 a.m. and 3:30 p.m. Monday through Friday. The area will be opened for vessel transits after the stated working hours and on weekends. Public notifications will be made prior to the effective period via the Local Notice to Mariners, Marine Information and electronic mail Broadcasts, and on the Internet at http://www.harborops.com.

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 following: Mariners utilizing Paerdegat Basin were notified of this closure and the one-hour delay of passage. Mariners held no objection based on the fact that they can safely transit into, and out of, Paerdegat Basin when a minimum of one-hour advance notice is given to the onscene vessel operator between 7 a.m. and 3:30 p.m. Monday through Friday during the brief repair period. Also, the area will be opened for vessel transits after working hours and on weekends. The local maritime community and public will be notified in advance of any work with regard to the closures by way the Local Notice to Mariners, marine information and electronic mail broadcasts; and on the internet at http://www.harborops.com.

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 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 (Pub. L. 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 would 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 business 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).

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

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those costs. This rule would not impose an unfunded mandate.

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.

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.

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

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

Throughout this document wherever “we,” “us,” or “our” are used we mean the EPA.

The Environmental Protection Agency (EPA) is approving the sections 111(d)/129 State Plan submitted by the Louisiana Department of Environmental Quality (LDEQ) on February 18, 2003. The State Plan establishes emission limits, monitoring, operating, and recordkeeping requirements for commercial and industrial solid waste incinerator (CISWI) units for which construction commenced on or before November 30, 1999. This State Plan implements and enforces provisions at least as protective as the Federal Emission Guidelines (EGs) applicable to existing CISWIs. The State Plan becomes federally enforceable upon EPA's approval.

Section 111(d) of the Clean Air Act (CAA) requires that “designated” pollutants, regulated under standards of performance for new stationary sources by section 111(b) of the CAA, must also be controlled at existing sources in the same source category to a level stipulated in an emission guideline (EG) document. Section 129 of the CAA specifically addresses solid waste combustion and emissions controls based on what is commonly referred to as “maximum achievable control technology” (MACT). Section 129 requires EPA to promulgate a MACT based emission guidelines document for CISWI units, and then requires states to develop plans that implement the EG requirements.

The CISWI EG under 40 CFR part 60, subpart DDDD, establishes emission and operating requirements under the authority of the sections 111(d) and 129 of the CAA. States must also include in their State Plans other elements, such as inventories, legal authority, and public participation documentation, to demonstrate their ability to enforce the State Plans. These requirements must be incorporated into a State plan that is “at least as protective” as the EG, and is federally enforceable upon approval by EPA. The procedures for adoption and submittal of State plans are codified in 40 CFR part 60, subpart B.

When burned, commercial and industrial solid wastes emit various air pollutants, including hydrochloric acid, dioxin/furan, toxic metals (lead, cadmium, and mercury) and particulate matter. Mercury is highly hazardous and is of particular concern because it persists in the environment and bioaccumulates through the food web. Serious developmental and adult effects in humans, primarily damage to the nervous system, have been associated with exposures to mercury. Harmful effects in wildlife have also been reported; these include nervous system damage and behavioral and reproductive deficits. Human and wildlife exposure to mercury occur mainly through eating of fish. When inhaled, mercury vapor attacks also the lung tissue and is a cumulative poison. Short-term exposure to mercury in certain forms can cause hallucinations and impair consciousness. Long-term exposure to mercury in certain forms can affect the central nervous system and cause kidney damage.

Exposure to particulate matter can aggravate existing respiratory and cardiovascular disease and increase risk of premature death. Hydrochloric acid is a clear colorless gas. Chronic exposure to hydrochloric acid has been reported to cause gastritis, chronic bronchitis, dermatitis, and photosensitization. Acute exposure to high levels of chlorine in humans may result in chest pain, vomiting, toxic pneumonitis, pulmonary edema, and death. At lower levels, chlorine is a potent irritant to the eyes, the upper respiratory tract, and lungs.

Exposure to dioxin and furan can cause skin disorders, cancer, and reproductive effects such as endometriosis. These pollutants can also affect the immune system.

The EPA proposed the EGs in the Federal Register on November 30, 1999. 64 FR 67092. On December 1, 2000, EPA finalized the EGs. 65 FR 75338. The EGs are also found at 40 CFR part 60, subpart DDDD.

EGs are not federally enforceable. Section 129(b)(2) of the CAA requires States to submit State Plans to EPA for approval. Each State must show that its State Plan will carry out and enforce the EGs. State Plans must be at least as protective as the EGs, and they become federally enforceable upon EPA's approval. The procedures for adopting and submitting State Plans are in 40 CFR part 60, subpart B.

The State of Louisiana submitted its sections 111(d)/129 State Plan to EPA for approval on February 18, 2003. The State adopted the EG requirements of 40 CFR part 60, subpart DDDD by incorporation by reference (IBR) into the Louisiana Administrative Code (LAC 33:III.3003.B.6) on October 20, 2002. The State Plan also included a demonstration of the State's legal authority to carry out the plan, inventory of sources and emissions, evidence of a public hearing on the State Plan, and provisions for submission of progress reports to EPA.

EPA has evaluated the CISWI State Plan submitted by Louisiana for consistency with the Act, EPA guidelines and policy. EPA has determined that Louisiana's State Plan meets all requirements and therefore, EPA is approving Louisiana's Plan to implement and enforce the EGs as it applies to existing CISWIs.

EPA's approval of Louisiana's State Plan is based on our findings that:

(1) LDEQ provided adequate public notice of public hearings for the proposed rulemaking that allows Louisiana to carry out and enforce provisions that are at least as protective as the EGs for CISWIs; and

(2) LDEQ demonstrated legal authority to: adopt emission standards and compliance schedules applicable to the designated facilities; enforce applicable laws, regulations, standards and compliance schedules; seek injunctive relief; obtain information necessary to determine compliance; require recordkeeping; conduct inspections and tests; require the use of monitors; require emission reports of owners and operators; and make emission data publicly available.

A detailed discussion of EPA's evaluation of the State Plan is included in the technical support document (TSD) located in the public rulemaking file for this action and available from the EPA contact listed in the Public Participation section of this document.

All CISWIs that commenced construction on or before November 30, 1999, must comply with these requirements.

The following incinerator source categories are exempt from the Federal requirements for CISWIs:

(1) Pathological waste incineration units;

(2) Agricultural waste incineration units;

(3) Municipal waste combustion units;

(4) Hospital/medical/infectious waste incineration units;

(5) Small power production facilities;

(6) Cogeneration facilities;

(7) Hazardous waste combustion units;

(8) Materials recovery units;

(9) Air curtain incinerators;

(10) Cyclonic barrel burners;

(11) Rack, part, and drum reclamation units;

(12) Cement kilns;

(13) Sewage sludge incinerators;

(14) Chemical recovery units; and

(15) Laboratory analysis units.

Please refer to 40 CFR 60.2555 for specific definitions of these incinerator source categories, and any recordkeeping or other requirements that still may need to be met.

If a CISWI cannot achieve compliance within one year of the effective date of EPA approval of the State Plan, the operator must agree to meet certain increments of progress until it achieves compliance. Section VI of the State Plan details the increments of progress for the affected CISWI. All existing CISWI units in the State of Louisiana must comply with these requirements by December 1, 2005.

Any existing CISWI that fails to meet the requirements by December 1, 2005, must shut down. The unit will not be allowed to start up until the owner/operator installs the controls necessary to meet the requirements on the date the unit restarts operation.

EPA is publishing this approval action without prior proposal because the Agency views this as a noncontroversial action and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the State Plan should relevant adverse comments be filed. If EPA receives no significant, material, and adverse comments by April 2, 2004, this action will be effective on May 3, 2004.

If EPA receives significant, material, and adverse comments by the above date, the Agency will withdraw this action before the effective date by publishing a subsequent document in the Federal Register. EPA will address all public comments received in a subsequent final rule based on the parallel proposed rule published in today's Federal Register. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time.

EPA is committed to ensuring public access to the information that is used to inform the Agency's decisions regarding the environment and human health and to ensuring that the public has an opportunity to participate in the Agency's decision process. The official public rulemaking file consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. The public rulemaking file does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute, although such information is a part of the administrative record for this action. The public rulemaking file is the collection of materials that is available for public viewing at the Regional Office. The administrative record is the collection of material used to inform the Agency's decision on this rulemaking action.

1. An official public rulemaking file available for inspection at the Regional Office. The Regional Office has established an official public rulemaking file for this action under NM-40-2-7445a. The public rulemaking file is available for viewing at the Air Planning Section, U.S. Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. EPA requests that, if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section two working days in advance to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4 p.m. excluding Federal holidays.

2. Copies of the State submittal. Copies of the State submittal is also available for public inspection during official business hours, by appointment at the Louisiana Department of Environmental Quality, Air Quality Division, 7290 Bluebonnet Boulevard, Baton Rouge, Louisiana 70810.

3. Electronic access. You may access this Federal Register document electronically through the Regulation.gov Web site located at http://www.regulations.gov where you can find, review, and submit comments on Federal rules that are open for comment and have been published in the Federal Register.

The E Government Act of 2002 states that “to the extent practicable” agencies shall accept electronic comments and establish electronic dockets. Also, President Bush's management plan for government includes a government- wide electronic rulemaking system. The first phase of the eRulemaking initiative was the development of a Federal portal that displays all Federal Register notices and proposed rules open for comment. The URL for this site is http://www.regulations.gov. The site also provides the public with the ability to submit electronic comments that then can be transferred to the Agency responsible for the rule.

EPA's policy is to make all comments it receives, whether submitted electronically or on paper, available for public viewing at the Regional Office as EPA receives them and without change. However, those portions of a comment that contain properly identified and claimed CBI or other information whose disclosure is restricted by statute will be excluded from the public rulemaking file. The entire comment, including publicly restricted information, will be included in the administrative record for this action.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in section I.D, below. Do not use e-mail to submit CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment, and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the public rulemaking file, and may be made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. E-mail. Comments may be sent by electronic mail (e-mail) to boyce.kenneth@epa.gov, Attention “Public comment on proposed rulemaking LA-66-1-7598.” In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

ii. Regulations.gov. As an alternative to email, you may submit comments electronically to EPA by using the Federal Web-based portal that displays all Federal Register notices and proposed rules open for comment. To use this method, access the Regulations.gov Web site at http://www.regulations.gov, then select “Environmental Protection Agency” at the top of the page and click on the “Go” button. The list of current EPA actions available for comment will be displayed. Select the appropriate action and please follow the online instructions for submitting comments. Unlike EPA's email system, the Regulations.gov Web site is an “anonymous” system, which means EPA will not know your identity, e-mail address, or other contact information, unless you provide it in the text of your comment.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in section I.C.2, directly below. These electronic submissions will be accepted in WordPerfect, Word, or ASCII file format. You should avoid the use of special characters and any form of encryption.

2. By mail. Send your comments to: Kenneth Boyce, Air Planning Section (6PD-L), Multimedia Planning and Permitting Division, U.S. Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. Please include the text “Public comment on proposed rulemaking LA-66- 1-7598” in the subject line of the first page of your comments.

3. By hand delivery or courier. Deliver your written comments or comments on a disk or CD ROM to: Kenneth Boyce, Air Planning Section (6PD-L), Multimedia Planning and Permitting Division, U.S. Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733, Attention “Public comment on proposed rulemaking LA-66- 1-7598”. Such deliveries are only accepted during official hours of business, which are Monday through Friday, 8:30 a.m. to 4 p.m., excluding Federal holidays.

For comments submitted to the Agency by mail or hand delivery, in either paper or electronic format, you may assert a business confidentiality claim covering confidential business information (CBI) included in your comment by clearly marking any part or all of the information as CBI at the time the comment is submitted to EPA. CBI should be submitted separately, if possible, to facilitate handling by EPA. Submit one complete version of the comment that includes the properly labeled CBI for EPA's official docket and one copy that does not contain the CBI to be included in the public docket. If you submit CBI on a disk or CD ROM, mark the on the outside of the disk or the CD ROM that it contains CBI and then identify the CBI within the disk or CD ROM. Also submit a non-CBI version if possible. Information which is properly labeled as CBI and submitted by mail or hand deliver will be disclosed only in accordance with procedures set forth in 40 CFR part 2. For comments submitted by EPA's e-mail system or through Regulations.gov, no CBI claim may be asserted. Do not submit CBI to Regulations.gov or via EPA's e-mail system. Any claim of CBI will be waived for comments received through Regulations.gov or EPA's e-mail system. For further advice on submitting CBI to the Agency, contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice.

It is important to note that the comments you provide to EPA will be publicly disclosed in a rulemaking docket or on the internet. The comments are made available for public viewing as EPA receives them and without change. Any personal information you choose to include in your comment will be included in the docket. However, EPA will exclude from the public docket any information labeled confidential business information (CBI), copyrighted material or other information restricted from disclosure by statute.

Comments submitted via Regulations.gov will not collect any personal information, e-mail addresses, or contact information unless they are included in the body of the comment. Comments submitted via Regulations.gov will be submitted anonymously unless you include personal information in the body of the comment. Please be advised that EPA cannot contact you for any necessary clarification if technical difficulties arise unless your contact information is included in the body of comments submitted through Regulations.gov. However, EPA's e-mail system is not an anonymous system. Email addresses are automatically captured by EPA's e-mail system and included as part of your comment that is placed in the public rulemaking docket.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at your estimate.

5. Provide specific examples to illustrate your concerns.

6. Offer alternatives.

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

8. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

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 State plan 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 State plan submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a State plan submission, to use VCS in place of a State plan submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 3, 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 not limited to:

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0403. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone numberis (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://ecfr.gpoaccess.gov/ cgi/t/text/text-idx?sid= 694b82a50366afdfc121f3c76cc00405& c=ecfr&tpl=/ecfrbrowse/ Title40/40cfrv21_02.tpl , a beta site currently under development.

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

In the Federal Register of August 6, 2003 (68 FR 46613) (FRL-7316-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(e), as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (2E6383) by Morse Enterprises, Limited, Inc., Brickell East Floor Ten, 151 South East 15 Road, Miami, Florida. This notice included a summary of the petition prepared by the petitioner Morse Enterprises. One commenter requested information on the identity and mechanism of action of the active ingredient, which is provided and/or addressed in this rule.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Yeast Extract Hydrolysate from Saccharomyces cerevisiae .

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

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

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

An acute oral study was conducted with the end use product KeyPlex 350 at the limit value of 5 g/kg, a single high dose required by the Agency's testing guidelines to determine whether any adverse effects are noted at this extremely elevated exposure level. No deaths or adverse effects occurred during this test, placing this product in Toxicity Category IV (the least toxic) via the oral route of exposure. A primary dermal irritation study has shown KeyPlex 350 to be very slightly irritating to non-irritating, placing the product in Toxicity Category IV (again, the least toxic) for skin irritation. An eye irritation study indicated that the product is slightly irritating to rabbit eyes, placing the product in Toxicity Category III for primary eye irritation. There have been no reported incidents of hypersensitivity to Yeast Extract Hydrolysate from Saccharomyces cerevisiae in individuals exposed during the manufacture or use of this product, which has been used as a plant micronutrient product for over 20 years. Nevertheless, to comply with the Agency's requirements under FIFRA section 6(a)(2), any incident of hypersensitivity associated with the use of this pesticide must be reported to the Agency.

All other acute and subchronic toxicity studies were waived based upon all or some combination of the following rationales: First, no effects were observed in an acute oral study on the end use product, KeyPlex 350 containing 0.063% Yeast Extract Hydrolysate from Saccharomyces cerevisiae , at the limit value of 5 g/kg. Yeast Extract Hydrolysate from Saccharomyces cerevisiae is made from Brewer's (Baker's) yeast extract, which is the water soluble portion of autolyzed yeast ( Saccharomyces cerevisiae ), and contains protein, peptides, free amino acids, vitamins, minerals and trace elements. Brewer's yeast extract is already widely used as a flavor enhancer for soups, soy sauce, sausage, fruits, etc., and is also used as a nutritional supplement, since it is rich in B-vitamins. Brewer's yeast extracts are used in hundreds of food products at levels up to 2.0%, as consumed, which is approximately 32 times higher than levels of Yeast Extract Hydrolysate from Saccharomyces cerevisiae found in the end use product (0.063%). Third, Brewer's yeast extract is affirmed as “generally recognized as safe”, or GRAS (21 CFR 184.1983), which means that it may be applied to food as a direct additive. Fourth, all inerts used in the end use product KeyPlex 350 are either already exempted from the requirement of a tolerance under 40 CFR 180.1001 (c) or (d), or common fertilizer ingredients cleared by FDA as direct food additives (GRAS). Fifth, KeyPlex 350 containing 0.063% Yeast Extract Hydrolysate from Saccharomyces cerevisiae has been sold as a plant micronutrient product for over 20 years, with no adverse effects ever reported. Sixth, label directions allow a minuscule amount (a maximum of 7.1 milliliters) of Yeast Extract Hydrolysate from Saccharomyces cerevisiae to be applied per acre per year, and the literature indicates that the components of yeast hydrolysate degrade rapidly in the environment. Finally, Yeast Extract Hydrolysate from Saccharomyces cerevisiae has a non-toxic mode of action by eliciting a systemic acquired resistance response in plants, and has no direct antimicrobial effect on plant disease organisms.

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

Yeast Extract Hydrolysate from Saccharomyces cerevisiae is already cleared for use in food products at concentrations greater than that found in the end use product KeyPlex 350. Additional dietary exposure to Yeast Extract Hydrolysate from Saccharomyces cerevisiae resulting from labeled uses is unlikely to occur because of extremely low use rates and rapid degradation in the field. Further, the lack of demonstrable toxicity in acute studies and the long history of safe use as a component of food products support the establishment of an exemption from the requirement of a tolerance for Yeast Extract Hydrolysate from Saccharomyces cerevisiae .

1. Food . The use of KeyPlex 350 is not expected to result in any increase in dietary exposure to Yeast Extract Hydrolysate from Saccharomyces cerevisiae against the background of Brewer's yeast extract normally consumed in the diet. Yeast Extract Hydrolysate from Saccharomyces cerevisiae is made by hydrolyzing Brewer's yeast extract, which is the water soluble portion of autolyzed yeast ( Saccharomyces cerevisiae ) and contains protein, peptides, free amino acids, vitamins, minerals and trace elements. Brewer's yeast extract is classified as Generally Recognized as Safe (GRAS) under 21 CFR 184.1983 and is used as a flavor enhancer for soups, soy sauce, sausage, fruits, and other food products at concentrations in the range of 0.1%-2.0%, as consumed, which is significantly higher than the levels found in the end use product KeyPlex 350 (0.063%). Brewer's yeast is also used as a human nutritional supplement since it is rich in B-vitamins. Further, all inerts in the formulation of KeyPlex 350 are either already exempted from the requirement of a tolerance under 40 CFR 180.1001 (c) or (d), or common fertilizer ingredients cleared by FDA as direct food additives (GRAS). Finally, when used according to label directions, an extremely small amount (a total of 7.1 milliliters) of Yeast Extract Hydrolysate from Saccharomyces cerevisiae may be applied per acre per year, and the literature indicates that the components of yeast hydrolysate are rapidly degraded in the environment.

2. Drinking water exposure . Brewer's yeast extract, the starting material for the manufacture of Yeast Extract Hydrolysate from Saccharomyces cerevisiae , is classified as GRAS under 21 CFR 184.1983. Further, the other ingredients used in the production of Yeast Extract Hydrolysate from Saccharomyces cerevisiae are either already exempted from the requirement of a tolerance under 40 CFR 180.1001 (c) or (d), or common fertilizer ingredients cleared by FDA as direct food additives (GRAS). The concentration of Yeast Extract Hydrolysate from Saccharomyces cerevisiae allowable in food products is significantly higher than that found in the end use product KeyPlex 350. Finally, because KeyPlex 350 is applied at extremely low rates and rapidly degrades in the environment, it poses no concern as a drinking water contaminant.

With the sole exception of turf uses, the label use sites are commercial agricultural and horticultural, as opposed to domestic settings. In addition, KeyPlex 350 is applied at extremely low rates and rapidly degrades after application. As a result, the approved uses of KeyPlex 350 for field crops and commercial application to turf and ornamentals will not likely result in exposures in residences, schools or day care institutions to Yeast Extract Hydrolysate from Saccharomyces cerevisiae . Thus non-occupational exposure to the general population is expected to be minimal to non-existent.

1. Dermal exposure . KeyPlex 350 is classified as a Toxicity Category IV product, the least toxic category,with regard to dermal irritation. This combined with the lack of toxicity via the oral route, suggests that risks due to dermal exposure are of no concern.

2. Inhalation exposure . KeyPlex 350 is classified as a Toxicity Category IV product, the least toxic category, via the oral route, and will not likely pose any risk via inhalation.

Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to consider the cumulative effect of exposure to Yeast Extract Hydrolysate from Saccharomyces cerevisiae and to other substances that have a common mode of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. Because of the lack of toxicity, lack of information indicating that any toxic effects, if they existed, would be cumulative with any other compounds, extremely low use rates, and common occurrence in hundreds of food products, the Agency does not expect any cumulative or incremental effects from exposure to residues of this product when used as directed on the label.

Key Plex 350 has an oral LD 50 greater than 5 g/kg, placing the product in Toxicity Category IV, the least toxic category. Further, Brewer's yeast extract, from which Yeast Extract Hydrolysate from Saccharomyces cerevisiae is derived, is a common component of hundreds of food products and is used as a human nutritional supplement because of its high B-vitamin content. Therefore, EPA concludes that there is a reasonable certainty that no harm to the United States population in general, and to infants and children, specifically, will result from aggregate exposure to residues of Yeast Extract Hydrolysate from Saccharomyces cerevisiae . This includes all anticipated dietary exposures and all other exposures for which there is reliable information. Accordingly, exempting Yeast Extract Hydrolysate from Saccharomyces cerevisiae from the requirement of a tolerance is considered safe and pose no risk. FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional ten-fold margin of exposure (safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless EPA determines that a different margin of exposure (safety) will be safe for infants and children. Margins of exposure (safety) are often referred to as uncertainty (safety) factors. Here, based on all the available information and for all the reasons already set forth above in this final rule, the Agency finds that there are no threshold effects of concern to infants, children, and adults when Yeast Extract Hydrolysate from Saccharomyces cerevisiae is used as labeled, and that the provision requiring an additional margin of safety is not necessary to protect infants and children. As a result, EPA has not used a margin of exposure (safety) approach to assess the safety of Yeast Extract Hydrolysate from Saccharomyces cerevisiae .

EPA is required under the FFDCA as amended by FQPA to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there is no scientific basis for including, as part of the program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, Yeast Extract Hydrolysate from Saccharomyces cerevisiae may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption. Based on available data, no endocrine system-related effects have been identified with consumption of Yeast Extract Hydrolysate from Saccharomyces cerevisiae . To date, there is no evidence to suggest that Yeast Extract Hydrolysate from Saccharomyces cerevisiae affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

The Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation for the reasons enumerated in this preamble, including Yeast Extract Hydrolysate from Saccharomyces cerevisiae's lack of toxicity. Accordingly, the Agency has concluded that an analytical method is not needed for enforcement purposes for Yeast Extract Hydrolysate from Saccharomyces cerevisiae residues.

There is currently no CODEX Maximum Residue Limit set for food use of this active ingredient.

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2004-0003. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?sid =baa35b6058a65d5fafe66e7269d4d215&c=ecfr&tpl =/ecfrbrowse/Title40/40cfrv21_02.tpl , a beta site currently under development.

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

In the Federal Register of July 16, 2003 (68 FR 42026) (FRL-7317-4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 3E6567) by CP Kelco, 8355 Aero Dr., San Diego, CA 92123-1718. This notice included a summary of the petition prepared by CP Kelco. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of gellan gum (CAS No. 71010-52-1).

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

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

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability, and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by gellan gum are discussed in this unit. The information submitted in support of this petition included the review and evaluation of 14 toxicity studies performed using gellan gum by the Joint Expert Committee on Food Additives (JECFA) which is an international expert scientific committee that is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). Gellan gum is also approved as a food additive in 21 CFR 172.665.

Gellan gum is produced through the fermentation of Pseudomonas elodea (a non-pathogenic bacteria). Gellan gum is a water-soluble polysaccharide that is composed of repeating units, which are called monosaccharides. These four units are one molecule of rhamnose (a sugar found in various plants), one molecule of glucuronic acid (an oxidized glucose molecule), and two molecules of glucose (a component of sucrose, which is common sugar). Gellan gum has a molecular weight greater than 70,000 with 95% above 500,000.

According to the CP Kelco website ( http://www.cpkelco.com ) gellan gum would typically be used in icings and frostings, jams and jellies, jellied candies such as gummy bears, and various fruit and bakery fillings. As the name indicates, when dissolved in water, gellan gum acts as a thickening or gelling agent, and can produce textures in the final product that vary from hard, non-elastic, brittle gels to fluid gels.

In 1990, gellan gum was evaluated by the JECFA. As part of their evaluation, they reviewed studies related to the absorption, distribution, and excretion of gellan gum (in rats). They also reviewed the following types of toxicological studies: Acute toxicity (in rats), short-term studies (in rats and monkeys), long-term/carcinogenicity (in mice, rats, and dogs), reproductive (in rats), and teratology (developmental) studies (in pregnant rats). The results of these reviews were discussed in the petitioner's July 16, 2003, Notice of Filing. The petitioner accurately and adequately stated the reviews performed by JECFA; therefore, the Agency has not reprinted them in their entirety in this final rule.

Selected summary information includes the following:

• Gellan gum was shown to be poorly absorbed and did not cause any deaths in rats which received a single large dose (5 gram (g) per kilogram (kg) of body weight) in the diet or by gavage.

• Short-term (90-day) exposure of rats to gellan gum at levels up to 60 g/kg in the diet did not cause any adverse effects.

• In a 28-day study in prepubertal monkeys, no overt signs of toxicity were observed at the highest-dose level of 3 g/kg of body weight per day.

• In reproduction and teratogenicity studies in rats in which gellan gum was given at dose levels up to 50 g/kg in the diet, there was no evidence of interference with the reproductive process, and no embryotoxic or developmental effects were observed.

• Gellan gum was also shown to be non-genotoxic in a battery of standard short-term tests.

• In a study in dogs, which were treated for 1 year at dose levels up to 60 g/kg in the diet, there were no adverse effects that could be attributed to chronic exposure to gellan gum.

• In long-term carcinogenicity studies, gellan gum did not induce any adverse effects in mice or rats at the highest-dose levels of 30 g/kg and 50 g/kg in the diet, respectively.

The Agency notes that the dose levels used in these animal studies were in g/kg body weight not milligrams (mg)/kg as in most of the studies reviewed and evaluated by the Agency.

There was also a limited study on tolerance to gellan gum in humans. Results indicated that oral doses of up to 200 mg/kg of body weight administered over a 23-day period did not elicit any adverse reactions, although faecal bulking effects were observed in most humans.

In its conclusions, the JECFA Committee indicated that the potential laxative effect (at high intakes of gellan gum) should be taken into account when used as a food additive. The JECFA Committee also allocated an ADI (average daily intake) of “not specified” to gellan gum, which means that a specific limit on the average daily intake of gellan gum was not needed.

Gellan gum is approved by the Food and Drug Administration (FDA) as a direct food additive when added to foods as a stabilizer or thickener according to good manufacturing practices when used according to the following conditions (21 CFR 172.665):

• The additive is a high molecular weight polysaccharide gum produced from Pseudomonas elodea by a pure culture fermentation process and purified by recovery with isopropyl alcohol.

• The strain of Pseudomonas elodea is non-pathogenic and non-toxic in man and animals.

• The additive is produced by a process that renders it free of viable cells of Pseudomonas elodea.

The evaluations performed by WHO and FDA indicate a substance of lower toxicity. The only concern that has been indicated for gellan gum as indicated by the JECFA Committee was a possible laxative effect which occurs only at high intakes of gellan gum. This laxative effect likely occurs as a result the body's limited ability to absorb gellan gum.

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

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

1. Food . Gellan gum has been safely used as a food additive for over 10 years in various food formulations. Foods which can commonly contain gellan gum include frostings, gelatins, puddings, fillings, jams, milk products, fruit juices, and soft candy. CP Kelco supplied to the Agency, the direct use levels (expressed as percent) of gellan gum in a variety of food formulations. The typical amount of gellan gum used as a food additive does not exceed 0.5% of the processed food.

Given the use of gellan gum as a thickening or jelling agent, there is a “built in” limitation as to the amount needed. Too much gellan gum would over-thicken, making the pudding or jam too stiff for the intended use. According to information provided by CP Kelco, the maximum percent of gellan gum in a food formulation to achieve the desired thickening or jelling effect would be less than 2%.

Gellan gum has a molecular weight which is greater than 70,000 with 95% above 500,000. Such large substances are not easily absorbed, as demonstrated by the rat metabolism study which indicated poor absorption. The constituents of gellan gum are naturally occurring materials (sugar monosaccharides) that, in fact, are found in living organisms.

Gellan gum is approved for use as a direct food additive by FDA. To the best of the Agency's knowledge gellan gum has been used for over 10 years as a stabilizer and thickener—as a gelling agent in foods without any reported incidence. The Agency estimated an annual U.S. population exposure for gellan gum using the annual production information provided by CP Kelco (100,000 kg) and a U.S. population estimate of approximately 290,809,777 as of July 1, 2003, from the U.S. census website ( http://eire.census.gov/popest/data/national/popbriefing.php ). The Agency estimated annual exposure of gellan gum to the U.S. population is approximately 0.94 mg/person/day.

The amount of gellan gum that could occur in food as a result of its use as an inert ingredient in a pesticide product should not significantly increase the amount of gellan gum in the food supply above those amounts currently permitted by FDA. Furthermore, it is unlikely that the manner which gellan gum is used in pesticide formulations will differ significantly from it's use as a direct food additive due to “built in” limitations based on the desired thickening or gelling effect.

2. Drinking water exposure . Gellan gum is composed of repeating monosaccharides. When mixed with water, gellan gum acts as a thickener, thus producing a viscous solution. Eventually, the material will degrade to the constituent monosaccharides: Two glucose molecules, one glucuronic molecule, and one rhamnose molecule. The rate at which this occurs will depend on the size of the “bead” that forms when dissolved in water. While physical/chemical degradation processes (such as hydrolysis) would occur, it is more likely that gellan gum would be degraded via microbial degradation. Due to the lower toxicity of the degradates, the naturally occurring sugars, there are no concerns for exposure to gellan gum in drinking water.

The Agency believes that the potential for the use of gellan gum in and around the home exists.

1. Dermal exposure . Based on the high molecular weight of gellan gum, it is not likely to be absorbed through the skin.

2. Inhalation exposure . Based on the fact that gellan gum is a polysaccharide which would degrade into naturally occurring sugars, it is not likely to cause any adverse effects when inhaled. The resulting molecules are normally found in living organisms (including humans) and would be metabolized normally.

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

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to gellan gum and any other substances, and gellan gum does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that gellan gum has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/ .

Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. The JEFCA committee has evaluated reproductive and teratogenicity (developmental) toxicity studies in rats in which gellan gum was given at dose levels up to 50 g/kg in the diet and found no indication of increased susceptibility. Based on the WHO/JECFA evaluation of gellan gum, EPA has not used a safety factor analysis to assess the risk of gellan gum. For the same reasons the additional tenfold safety factor is unnecessary.

The JECFA Committee reviewed and evaluated 14 toxicity studies and as a result of their review and evaluation, JECFA determined an ADI (Acceptable Daily Intake) of “not specified.” The only concern was for the potential laxative effect at high intakes. FDA has also approved the use of gellan gum as a direct food additive when used as a stabilizer and thickening agent (21 CFR 172.665).

Based on the available information which includes an Agency estimated-daily exposure of 0.94 mg/kg/day, toxicity studies conducted in g/kg body weight rather than mg/kg body weight (with few to no effects), evaluations by both FDA and WHO/JEFCA, and the high molecular weight of gellan gum, the EPA finds that exempting gellan gum (CAS No. 71010-52-1) from the requirement of a tolerance will be safe.

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

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

There are no existing tolerances or tolerance exemptions for gellan gum.

Gellan gum is used as a food additive in many countries. The Agency is not aware of any country requiring a tolerance for gellan gum nor have any CODEX Maximum Residue Levels (MRL's) been established for any food crops at this time.

The Agency established 40 CFR 180.950 (see the rationale in the proposed rule published January 15, 2002 (67 FR 1925) (FRL-6807-8)) to collect the tolerance exemptions for those substances classified as List 4A, i.e., minimal risk substances. As part of evaluating an inert ingredient and establishing the tolerance exemption, the Agency determines the chemical's list classification. The results of the review and evaluation performed by WHO/JECFA as well as FDA's approval of gellan gum as a direct food additive, indicate a substance of lower toxicity. Therefore, gellan gum (CAS No. 71010-52-1) is to be classified as a List 4A inert ingredient.

Based on the information in the official public docket, summarized in this preamble, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of gellan gum (CAS No. 71010-52-1). Accordingly, EPA finds that exempting gellan gum from the requirement of a tolerance will be safe.

Under section 408(g) of FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2004-0003 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before May 4, 2004.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit X.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2004-0003, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

The NFS at 1817.204(e)(i) currently states that the five-year limitation (basic plus option periods) applies to all NASA contracts regardless of type. This has been interpreted to mean that the limitation does not apply to agreements such as basic ordering agreements and blanket purchase agreements. This interpretation is not consistent with the intent of the limitation and does not support NASA's efforts to maximize opportunities for competition. This final rule clarifies that the limitation is applicable to all award instruments. This change to the NFS is being issued as a final rule since it does not have a significant effect beyond the internal operating procedures of NASA. Comments may be submitted to the above address.

This final rule does not constitute a significant revision within the meaning of FAR 1.501 and Public Law 98-577, and publication for public comment is not required. However, NASA will consider comments from small entities concerning the affected NFS Part 1817 in accordance with 5 U.S.C. 610.

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

The Anti Car Theft Act of 1992, Pub. L. 102-519, amended the law relating to the partsmarking of major component parts on designated high-theft vehicle lines and other motor vehicles. The Anti Car Theft Act amended the definition of “passenger motor vehicle” in 49 U.S.C. 33101(10) to include a “multipurpose passenger vehicle or light duty truck when that vehicle or truck is rated at not more than 6,000 pounds gross vehicle weight.” Since “passenger motor vehicle” was previously defined to include passenger cars only, the effect of the Anti Car Theft Act is that certain multipurpose passenger vehicle (MPV) and light-duty truck (LDT) lines may be determined to be high-theft vehicles subject to the Federal motor vehicle theft prevention standard (49 CFR part 541).

The purpose of the theft prevention standard is to reduce the incidence of motor vehicle theft by facilitating the tracing and recovery of parts from stolen vehicles. The standard seeks to facilitate such tracing by requiring that vehicle identification numbers (VINs), VIN derivative numbers, or other symbols be placed on major component vehicle parts. The theft prevention standard requires motor vehicle manufacturers to inscribe or affix VINs onto covered original equipment major component parts, and to inscribe or affix a symbol identifying the manufacturer and a common symbol identifying the replacement component parts for those original equipment parts, on all vehicle lines selected as high-theft.

The Anti Car Theft Act also amended 49 U.S.C. 33103 to require NHTSA to promulgate a parts-marking standard applicable to major parts installed by manufacturers of “passenger motor vehicles (other than light duty trucks) in not more than one-half of the lines not designated under 49 U.S.C. 33104 as high-theft lines.” NHTSA lists each of the selected lines not designated under 49 U.S.C. 33104 as high-theft lines in Appendix B to part 541. Since § 33103 did not specify marking of replacement parts for below-median lines, the agency does not require marking of replacement parts for these lines. NHTSA published a final rule amending 49 CFR part 541 to include the definitions of MPV and LDT, and major component parts. [See 59 FR 64164, December 13, 1994].

49 U.S.C. 33104(a)(3) specifies that NHTSA shall select high-theft vehicle lines, with the agreement of the manufacturer, if possible. Section 33104(d) provides that once a line has been designated as likely high-theft, it remains subject to the theft prevention standard unless that line is exempted under § 33106. Section 33106 provides that a manufacturer may petition to have a high-theft line exempted from the requirements of § 33104, if the line is equipped with an antitheft device as standard equipment. The exemption is granted if NHTSA determines that the antitheft device is likely to be as effective as compliance with the theft prevention standard in reducing and deterring motor vehicle thefts.

The agency annually publishes the names of the lines which were previously listed as high-theft, and the lines which are being listed for the first time and will be subject to the theft prevention standard beginning in a given model year in Appendix A to part 541. It also identifies in Appendix A-I to part 541 those lines that are exempted from the theft prevention standard for a given model year under § 33104. Additionally, this listing identifies those lines (except light-duty trucks) in Appendix B to part 541 that have theft rates below the 1990/1991 median theft rate but are subject to the requirements of this standard under § 33103.

On July 2, 2003, the final listing of high-theft lines for the MY 2004 vehicle lines was published in the Federal Register (68 FR 39471). The final listing identified two vehicle lines, the Toyota Scion xA and Scion xB that were listed for the first time and became subject to the theft prevention standard beginning with the 2004 model year.

For MY 2005, there were no new vehicle lines identified as likely to be high-theft lines, in accordance with the procedures published in 49 CFR part 542.

The vehicle lines listed as being subject to the parts-marking standard have previously been designated as high-theft lines in accordance with the procedures set forth in 49 CFR Part 542. Under these procedures, manufacturers evaluate new vehicle lines to conclude whether those new lines are likely to be high theft. The manufacturer submits these evaluations and conclusions to the agency, which makes an independent evaluation; and, on a preliminary basis, determines whether the new line should be subject to the parts-marking requirements. NHTSA informs the manufacturer in writing of its evaluations and determinations, together with the factual information considered by the agency in making them. The manufacturer may request the agency to reconsider the preliminary determinations. Within 60 days of the receipt of these requests, the agency makes its final determination. NHTSA informs the manufacturer by letter of these determinations and its response to the request for reconsideration. If there is no request for reconsideration, the agency's determination becomes final 45 days after sending the letter with the preliminary determination. Each of the new lines on the high-theft list has been the subject of a final determination under either 49 U.S.C. 33103 or 33104.

The list of lines that have been exempted by the agency from the parts-marking requirements of Part 541 includes a high-theft line newly exempted in full beginning with MY 2005. The vehicle line newly exempted in full is the DaimlerChrysler Corporation's (DaimlerChrysler) Town and Country MPV. The agency granted DaimlerChrysler's petition for an exemption of its Town and Country MPV from the parts-marking requirements of the Federal Motor Vehicle Theft Prevention Standard beginning with the 2005 model year (68 FR 46676, August 6, 2003). Subsequent to publishing the 2004 final rule, the agency granted BMW of North America, Inc.'s petition for an exemption of its Carline 6 from the parts-marking requirements beginning with the 2004 model year (68 FR 69127, December 11, 2003). Accordingly, the listing has been amended to reflect that two lines previously designated as high-theft lines have been deleted from Appendix A and added to Appendix A-I. The vehicle lines listed as being exempt from the standard have previously been exempted in accordance with the procedures of 49 CFR Part 543 and 49 U.S.C. 33106.

Similarly, the low-theft lines listed as being subject to the parts-marking standard have previously been designated in accordance with the procedures set forth in 49 U.S.C. 33103.

Therefore, NHTSA finds for good cause that notice and opportunity for comment on these listings are unnecessary. Further, public comment on the listing of selections and exemptions is not contemplated by 49 U.S.C. Chapter 331.

For the same reasons, since this revised listing only informs the public of previous agency actions and does not impose additional obligations on any party, NHTSA finds for good cause that the amendment made by this notice should be effective as soon as it is published in the Federal Register .

NHTSA has analyzed this rule and determined that it is not “significant” within the meaning of the Department of Transportation's regulatory policies and procedures. The agency has also considered this notice under Executive Order 12866. As already noted, the selections in this final rule have previously been made in accordance with the provisions of 49 U.S.C. 33104, and the manufacturers of the selected lines have already been informed that those lines are subject to the requirements of 49 CFR Part 541 for MY 2005. Further, this listing does not actually exempt lines from the requirements of 49 CFR Part 541; it only informs the general public of all such previously granted exemptions. Since the only purpose of this final listing is to inform the public of actions for MY 2005 that the agency has already taken, a full regulatory evaluation has not been prepared.

The agency has also considered the effects of this listing under the Regulatory Flexibility Act. I hereby certify that this rule will not have a significant economic impact on a substantial number of small entities. As noted above, the effect of this final rule is simply to inform the public of those lines that are already subject to the requirements of 49 CFR Part 541 for MY 2005. The agency believes that the listing of this information will not have any economic impact on small entities.

In accordance with the National Environmental Policy Act of 1969, the agency has considered the environmental impacts of this rule, and determined that it will not have any significant impact on the quality of the human environment.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this final rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Assessment.

This final rule does not have a retroactive effect. In accordance with section 33118 when the Theft Prevention Standard is in effect, a State or political subdivision of a State may not have a different motor vehicle theft prevention standard for a motor vehicle or major replacement part. 49 U.S.C. 33117 provides that judicial review of this rule may be obtained pursuant to 49 U.S.C. 32909. Section 32909 does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.

The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, cero, cobia, little tunny, dolphin, and, in the Gulf of Mexico only, bluefish) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act by regulations at 50 CFR part 622.

Based on the Councils' recommended total allowable catch and the allocation ratios in the FMP, on August 2, 2000, (65 FR 41015, July 3, 2000) NMFS implemented a commercial quota of 3.87 million lb (1.76 million kg) for the Atlantic migratory group of Spanish mackerel. For the southern zone, NMFS specified an adjusted quota of 3.62 million lb (1.64 million kg) calculated to allow continued harvest at a set rate for the remainder of the fishing year in accordance with 50 CFR 622.44(b)(2). In accordance with 50 CFR 622.44(b)(1)(ii)(C), after 75 percent of the adjusted quota of Atlantic group Spanish mackerel from the southern zone is taken until 100 percent of the adjusted quota is taken, Spanish mackerel in or from the EEZ in the southern zone may be possessed on board or landed from a permitted vessel in amounts not exceeding 1,500 lb (680 kg) per day. The southern zone for Atlantic migratory group Spanish mackerel extends from 30°42′45.6″ N. lat., which is a line directly east from the Georgia/Florida boundary, to 25° 20.4′ N. lat., which is a line directly east from the Miami-Dade/Monroe County, FL, boundary.

NMFS has determined that 75 percent of the adjusted quota for Atlantic group Spanish mackerel from the southern zone has been taken. Accordingly, the 1,500 lb (680 kg) per day commercial trip limit applies to Spanish mackerel in or from the EEZ in the southern zone effective 6 a.m., local time, March 1, 2004, through March 31, 2004, unless changed by further notification in the Federal Register .

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(3)(B), as such prior notice and opportunity for public comment is unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself already has been subject to notice and comment, and all that remains is to notify the public of the trip limit reduction. Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action in order to protect the fishery since the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment will require time and would potentially result in a harvest well in excess of the established quota.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.

The regulations for the sea scallop fishery for the 2003 fishing year (March 1, 2003 - February 29, 2004) include, among other measures, an area access program to govern the fishery within the Hudson Canyon Sea Scallop Access Area (Hudson Canyon Area). Details about the development of this program were provided in the proposed rule for this action, and are not repeated here. The program establishes an overall total allowable catch (TAC) for the area, limits the number of trips that can be taken into the area, establishes a scallop trip limit, and establishes a minimum number of days-at-sea (DAS) that will be deducted for each access trip from the vessel's DAS allocation. The New England Fishery Management Council (Council) adopted Amendment 10 to the FMP in September 2003, and submitted it for review by the Secretary of Commerce (Secretary) on December 19, 2003. Among the measures proposed in Amendment 10 is a continuation of an area access program for the Hudson Canyon Area, with some revisions to the program. Amendment 10 has been made available to the public for comment through March 15, 2004, with the Notice of Availability published on January 16, 2004 (69 FR 2561).

The Council's December 2003 submission of Amendment 10 means that it will not be possible to implement the action, if approved, by the start of the fishing year on March 1, 2004. Thus, the existing Hudson Canyon area access program will expire at the end of the fishing year (February 29, 2004) and, on March 1, 2004, the Hudson Canyon Area will open to fishing without an area access program. Absent another regulatory action, the DAS allocations currently specified in the FMP will go into effect for limited access scallop vessels on March 1, 2004: 34, 14, and 3 DAS for full-time, part-time, and occasional vessels, respectively. Amendment 10 would, if approved, allocate an additional eight, three, and one DAS for use by full-time, part-time, and occasional vessels, respectively, in areas other than those under area management. Amendment 10 would also, if approved, specifically allocate 48, 12, and 12 DAS for use by full-time, part-time, and occasional vessels, respectively, within the Hudson Canyon Area, under an area access program.

Without this emergency action, the fishing that occurs in the Hudson Canyon Area between March 1 and the implementation of Amendment 10 (if approved) would inflict fishing mortality on the resource in addition to that proposed for the Hudson Canyon Access Area in Amendment 10. The additive impacts of this fishing could result in localized overfishing in the Hudson Canyon Area. Should Amendment 10 be disapproved, this final emergency action will allow controlled harvests from the Hudson Canyon Area, consistent with the status of the Hudson Canyon Area resource as analyzed in Amendment 10. This action will allow the resource within the Hudson Canyon Area to be harvested at appropriate levels, and will allow limited access vessels to fish at a level nearer to the mortality objectives for the stock.

Without continued controls on scallop fishing in the Hudson Canyon Area, NMFS is concerned about the impact of fishing on the scallop resource in this area, even with the reduced allocation of DAS. The area was initially closed to protect concentrations of juvenile scallops, which have since grown to harvestable size. For the past 3 fishing years, fishing has been allowed, but with controls. Amendment 10 proposes to maintain controls on effort and catch that would prevent the areas from being overfished. A lapse in controls may result in high fishing effort and mortality, which may be detrimental to the health of the scallop resource in the area. In fact, the reduced DAS allocations that will otherwise take effect on March 1, 2004, may serve as an incentive for some vessels to fish within the Hudson Canyon Area rather than elsewhere, and fishing effort could concentrate in the area. Controls within the area over the past few years have maintained catch rates that may be higher than those in other areas. In addition, the Hudson Canyon Area is a relatively short distance from ports in the Mid-Atlantic, and vessel owners may choose to fish in the Hudson Canyon Area to minimize the DAS used to cover steaming time to more distant fishing areas.

This emergency action under section 305(c) of the Magnuson-Stevens Act is justified under and consistent with NOAA emergency rule guidelines published at 62 FR 44421 (August 21, 1997). These guidelines provide that a Magnuson-Stevens Act emergency action is justified in extremely urgent or special circumstances where substantial harm to or disruption of the resource, fishery or community will be caused in the time it would take to follow standard rulemaking procedures. It was not reasonably foreseeable that Amendment 10 would not be implemented by March 1, 2004, at the time when it was in development, otherwise, NMFS would have initiated another type of action, such as a Secretarial amendment or framework adjustment. Therefore, the only procedure available to the agency for implementing these measures is a section 305(c) emergency action. As discussed above, failure to implement this emergency action will result in serious conservation and economic problems for the fishery. NMFS published a proposed emergency rule on February 4, 2004 (69 FR 5307) and requested public comment. Comments and responses are addressed in this final rule.

The final measures for the emergency action are summarized below:

Continuation of the existing notification and enrollment requirements of the current Hudson Canyon Controlled Access Area program, including twice hourly vessel monitoring system (VMS) polling;

Continuation of the existing observer program established for the current Hudson Canyon Controlled Access Area program;

Continuation of the existing VMS catch reporting requirements;

Continuation of the existing requirement for vessels taking a controlled area access trip to utilize twine top mesh with a minimum size of 10 inches (25.4 cm) to reduce finfish bycatch, primarily of flatfish;

An additional allocation of 48 DAS for full-time limited access scallop vessels to conduct four trips within the Hudson Canyon Area only;

An additional allocation of 12 DAS for part-time and occasional limited access vessels to conduct one trip within the Hudson Canyon area only;

Allocation of DAS in trip-length blocks of 12 days, with each vessel making an Access Area trip to be charged 12 DAS for each trip, regardless of actual trip length;

Establishment of a trip possession limit for limited access vessels fishing under DAS of 18,000 lb (8,165 kg) (consistent with a 1,500-lb (680-kg) per day catch rate);

Establishment of a 400 lb (181-kg) possession limit for General category vessels fishing in the Hudson Canyon Area (this measure will make the possession limit for these vessels consistent with the existing possession limit in open fishing areas).

Four sets of comments were submitted in response to the proposed rule for the emergency action from the Council, the Fishery Survival Fund (FSF) and two members of the public.

Comment 1: One individual urged NMFS to keep the Hudson Canyon Area closed and immediately establish other marine sanctuary areas so that fish stocks do not continue to be decimated.

Response: NMFS considered closing the Hudson Canyon Access Area as an alternative to the emergency action. However, closure of this area was deemed to be unwarranted given the analyses for this action and in Amendment 10 that indicate that controlled harvest of the area should be maintained for an additional 2 years, beginning in 2004. Moreover, it would be inappropriate to establish marine sanctuaries in an emergency action given the narrow scope of such an action.

Comment 2: One individual commented that quotas are already too high, even in this alleged emergency. The emergency rule should cut all such quotas by 50 percent and 10 percent every year thereafter.

Response: NMFS assumes that the commenter is referring to DAS allocations. NMFS disagrees with the comment. The scallop resource condition actually warrants a higher level of harvest than would occur without any action. The DAS schedule in the current regulations would achieve a fishing mortality level well below the target prescribed for the scallop fishery.

Comment 3: One individual commented that NMFS should establish email communication for comments on NMFS actions.

Response: NMFS now requires that all actions soliciting public comment include email addresses for electronic commenting (E-comments).

Comment 4: The Council is concerned that vessels will charge into the Hudson Canyon Area to fish all four trips using 3.5-inch (8.9-cm) rings, particularly in areas where small scallops occur. Amendment 10 proposes to require vessels fishing the Hudson Canyon Area to use gear with larger rings and to protect small scallops in the southwest corner of the Hudson Canyon Area by including this portion of the area as part of a closed area. The Council states that the allocation of four trips in Amendment 10 was calculated to produce optimum yield with 4-inch (10.2-cm) rings, and that an allocation as high as four trips may not be appropriate if vessels using 3.5-inch (8.9-cm) rings utilize the majority of the four trip allocation. The Council therefore recommends that the emergency action allocate no more than one Hudson Canyon Area trip per limited access vessel.

Response: The comment implies that Amendment 10 will definitely be implemented prior to expiration of the emergency action. However, NMFS has not determined that Amendment 10 will be approved, and allocating only one trip would be overly restrictive if Amendment 10 is not approved. While 4-inch (10.2-cm) rings may provide for long-term benefits according to the analyses included in Amendment 10, NMFS does not expect these benefits to come to light in this action which is limited in duration. Therefore, given the impracticability of establishing a new gear requirement in the limited timeframe of this emergency action, NMFS has determined that maintaining the 3.5-inch (8.9-cm) ring size requirement is appropriate for this limited action.

Comment 5: The Council is concerned about opening the Hudson Canyon Area to access by vessels using general category permits or limited access vessels fishing under general category rules. The Council states that the intent of Amendment 10 was to allow access by general category vessels in the future when new controlled access areas are reopened, and to allow for them to land 400 lb (181.44 kg) of scallops. However, the comment notes that the Council intended to develop additional management measures including mandatory vessel monitoring systems, mandatory observers on selected trips, and a 2-percent TAC set-aside to cap the number of general category trips into reopened areas. The comment states that, because none of these measures are available for Hudson Canyon Area access, the Council did not intend to allow general category access. The Council, therefore, recommends that the emergency action continue the existing 100-lb (45.36-kg) scallop possession limit for vessels fishing under general category rules within the Hudson Canyon Access Area.

Response: Based on historical information of general category activity in the fishery, there is no evidence that the impacts of fishing activity by general category vessels operating with a 400 lb (181.44 kg) possession limit will jeopardize the scallop resource within the Hudson Canyon Access Area in the context of this temporary, limited action. Moreover, allowing a 400-lb (181.44-kg) possession limit for general category vessels and limited access vessels fishing outside of the DAS program will reduce the enforceability concerns associated with having different possession limits for general category vessels fishing inside and outside of the Hudson Canyon Access Area. NMFS's review of the Amendment 10 document does not clearly support the Council intent described in their comment above. NMFS urges the Council to provide more details about the record supporting this comment so the intent can be properly reflected in any final action on Amendment 10, if approved.

Comment 6: The Council commented that, although the Amendment 10 analysis shows substantial abundance of small scallops in the Elephant Trunk area, the Council agrees that the benefits derived from closing the area on March 1, 2004, until implementation of Amendment 10, if approved, are reduced with a 34 DAS allocation for full-time vessels. If Amendment 10 is delayed more than anticipated, or higher DAS allocations are available, however, the Council recommends reconsideration of the decision to let the Elephant Trunk area remain open.

Response: NMFS agrees that, if Amendment 10 is approved, the benefits of a short-term closure of the Elephant Trunk may be negligible. NMFS did not consider closure of the area as an alternative because conducting the necessary analysis may have delayed the action beyond March 1, 2004, and defeating the benefits of proceeding with an emergency action.

Comment 7: One individual commented that the closure of the Hudson Canyon Access Area is based on Amendment 7 to the FMP, which established the closure. The commenter stated that Amendment 7 is not based on science and ignored relevant science and environmental conditions.

Response: NMFS disagrees. While Amendment 7 originally established the 3-year closure of the Hudson Canyon Area, this emergency action will continue a controlled access program for the Hudson Canyon Access Area based on several years of controlled harvest strategies. The management actions that established area access all were based on the best available scientific information.

Comment 8: The FSF commented in support of the emergency action but requested that NMFS consider a provision or policy to address trips terminated early due to unforseen circumstances (i.e., the broken trip provision). The FSF also urged NMFS to consider a closure of the Elephant Trunk area to scallop fishing to protect the large concentration of small scallops in the area.

Response: Because of the limited scope of this action, it is not possible to address the broken trip issue at this time. NMFS could not consider the broken trip provision that is proposed in Amendment 10 because the provision would require a collection of information that has not been approved by the Office of Management and Budget (OMB). As in prior years, NMFS will consider broken trips on a case by case basis. If Amendment 10 is approved, all relevant implementation issues associated with the broken trip provision would be considered.

NMFS did not consider closure of the Elephant Trunk for the reasons explained in the response to Comment 6.

The regulatory text in § 648.14, paragraphs (30) and (31) has been changed to clarify the prohibition relative to scallop possession limits.

A formal section 7 consultation under the Endangered Species Act was initiated for the Atlantic sea scallop fishery on November 21, 2003, and subsequently included consideration of the measures included in this emergency action. In a biological opinion dated February 23, 2004, the Regional Administrator determined that fishing activities conducted under the emergency rule are not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of critical habitat.

As explained in greater detail elsewhere in the preamble to this final rule, the Assistant Administrator for Fisheries, NOAA, finds that the need to implement these measures in a timely manner to avoid excessive localized fishing mortality in the Hudson Canyon Access Area, constitutes good cause under the authority contained in 5 U.S.C. 553(d)(3), to waive the 30-day delay in effective date. Without the emergency rule, the Hudson Canyon Area will open to fishing without an area access program on March 1, 2004. This area was initially closed to protect concentrations of juvenile scallops, which have since grown to harvestable size. However, for the past 3 years, fishing in this area has been allowed, but with controls. A lapse in controls may result in high fishing effort and mortaility, which may be detrimental to the health of the scallop resource in the area. This emergency rule should prevent a derby style fishery from occurrring in the Hudson Canyon Area.

This action is authorized by 50 CFR part 648 and has been determined to be not significant for purposes of Executive Order 12866.

Included in this final rule is the Final Regulatory Flexibility Analysis (FRFA) prepared pursuant to 5 U.S.C. 604(a). The FRFA incorporates the discussion that follows, the comments and responses to the proposed rule, and the IRFA and other analyses completed in support of this action. A copy of the IRFA is available from the Regional Administrator (see ADDRESSES ).

A description of the reasons why this action is being considered, and the objectives of and legal basis for this action, is contained in the preamble to the proposed rule and is not repeated here.

Four sets of comments were submitted on the proposed rule, but none contained comments on the economic impacts of this rule.

The measures implemented by this emergency action could impact any commercial vessel issued a Federal sea scallop vessel permit. All of these vessels are considered small business entities for purposes of the FRFA because they all grossed less than $3.5 million according to the dealer reports for the 2001 and 2002 fishing years. Therefore, the analysis of impacts on vessels in the environmental assessment and other supporting documents for this action are relevant to this FRFA. There are two main components of the scallop fleet: Vessels eligible to participate in the limited access sector of the fleet and vessels that participate in the open access General Category sector of the fleet. Limited access vessels are issued permits to fish for scallops on a Full-time, Part-time or Occasional basis. In 2001, there were 252 Full-time permits, 38 Part-time permits, and 20 Occasional permits. In 2002, there were 270 Full-time permits, 31 part time permits, and 19 Occasional permits. Because the fishing year ends on the last day of February of each year, 2003 vessel permit information was incomplete at the time the Amendment 10 analysis was completed. Much of the economic impacts analysis is based on the 2001 and 2002 fishing years; 2001 and 2002 were the last 2 years with complete permit information. According to the most recent vessel permit records for 2003, there were 278 Full-time limited access vessels, 32 Part-time limited access vessels, and 16 Occasional vessels. In addition, there were 2,293, 2,493, and 2,257 vessels issued permits to fish in the General Category in 2001, 2002, and 2003, respectively. Annual scallop revenue for the limited access sector averaged from $615,000 to $665,600 for Full-time vessels, $194,790 to $209,750 for Part-time vessels, and $14,400 to $42,500 for Occasional vessels during the 2001 and 2002 fishing years. Total revenues per vessel, including revenues from species other than scallops, exceeded these amounts, but were less than $3.5 million per vessel.

This action does not contain any new collection-of-information, reporting, recordkeeping, or other compliance requirements.

The alternatives to the final action are the no action alternative and closure of the Hudson Canyon Access Area to scallop fishing. Neither the no-action nor the closure alternative would minimize the economic impacts on small entities. Under both non-preferred alternatives, lower overall DAS allocations would similarly constrain landings and revenues. For both the no-action and the closure alternatives, DAS allocations of 34, 14, and 3 DAS for full-time, part-time, and occasional vessels would reduce annual revenues to approximately $110 million from $158 million, compared to the final action. For the no-action alternative, the harvest of larger, more valuable scallops from the Hudson Canyon Access Area would not offset the revenue losses because lower overall DAS allocations would constrain landings.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule, or group of related rules, for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a small entity compliance guide will be sent to all holders of permits issued for the Atlantic sea scallop fishery. In addition, copies of this final rule and guide (i.e., permit holder letter) are available from the Regional Administrator (see ADDRESSES ) and may be found at the following web site: http://www.nmfs.gov/ro/doc/nero.html .