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Agricultural Marketing Service, USDA.
Interim final rule with request for comments.
This rule extends the deadline by which raisin handlers must redeem diversion certificates issued under the 2001 raisin diversion program (RDP). The deadline is specified under the Federal marketing order for California raisins (order). The order regulates the handling of raisins produced from grapes grown in California and is administered locally by the Raisin Administrative Committee (RAC). This action gives producers additional time to sell their certificates to handlers and thus be compensated for diverting their 2001 production, which is the intent of the RDP.
Effective December 20, 2001. Comments received by January 3, 2002, will be considered prior to issuance of a final rule.
Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-5698, or e-mail:
Maureen T. Pello, Senior Marketing Specialist, California Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 2202 Monterey Street, suite 102B, Fresno, California 93721; telephone: (559) 487-5901, Fax: (559) 487-5906; or George Kelhart, Technical Advisor, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW STOP 0237, Washington, DC 20250-0237; telephone: (202) 720-2491, Fax: (202) 720-5698.
Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW STOP 0237, Washington, DC 20250-0237; telephone: (202) 720-2491, Fax: (202) 720-5698, or e-mail: Jay.Guerber@usda.gov.
This rule is issued under Marketing Agreement and Order No. 989 (7 CFR part 989), both as amended, regulating the handling of raisins produced from grapes grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule extends the deadline by which handlers may redeem diversion certificates issued under the 2001 RDP for Natural (sun-dried) Seedless (NS) raisins. The deadline is extended from December 17, 2001, to January 18, 2002, and applies only to certificates unsold by producers to handlers as of December 18, 2001. This rule will not preempt any State or local laws, or policies, unless they present an irreconcilable conflict with this rule.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This rule extends the deadline by which handlers may redeem diversion certificates issued under the 2001 NS RDP. The deadline is extended from December 17, 2001, to January 18, 2002, and applies only to certificates unsold by producers as of December 18, 2001. This action gives producers additional time to sell their certificates to handlers and thus be compensated for diverting their 2001 production, which is the intent of the RDP. This action was recommended by the RAC at a meeting on December 11, 2001, by a near unanimous vote of 36 in favor, 2 opposed (believed the RAC should adhere to the current deadline), and 1 abstained.
The order provides authority for volume regulation designed to promote orderly marketing conditions, stabilize prices and supplies, and improve producer returns. When volume regulation is in effect, a certain percentage of the California raisin crop may be sold by handlers to any market (free tonnage) while the remaining percentage must be held by handlers in a reserve pool (reserve) for the account of the RAC. Reserve raisins are disposed of through various programs authorized under the order. For example, reserve raisins may be sold by the RAC to handlers for free use or to replace part of the free tonnage they exported; carried over as a hedge against a short crop the following year; or may be disposed of in other outlets not competitive with those for free tonnage raisins, such as government purchase, distilleries, or animal feed. Net proceeds
The RDP is another program concerning reserve raisins authorized under the order and may be used as a means for controlling overproduction. Authority for the program is provided in § 989.56 of the order. Paragraph (e) of that section provides authority for the RAC to establish, with the approval of USDA, such rules and regulations as may be necessary for the implementation and operation of an RDP. Accordingly, additional procedures and deadlines are specified in § 989.156.
Pursuant to these sections, the RAC must meet by November 30 each crop year to review raisin data, including information on production, supplies, market demand, and inventories. If the RAC determines that the available supply of raisins, including those in the reserve pool, exceeds projected market needs, it can decide to implement a diversion program, and announce the amount of tonnage eligible for diversion during the subsequent crop year. Producers who wish to participate in the RDP must submit an application to the RAC prior to December 20. The RAC conducts a lottery if the tonnage applied for exceeds what has been allotted. RAC staff then notifies producers whether they have been accepted into the program.
Approved producers curtail their production by vine removal or some other means established by the RAC. Such producers receive a certificate the following fall from the RAC which represents the quantity of raisins diverted. Producers sell these certificates to handlers who pay producers for the free tonnage applicable to the diversion certificate minus the established harvest cost for the diverted tonnage. Handlers redeem the certificates by presenting them to the RAC by December 15 (Monday, December 17, 2001, for the 2001 RDP since December 15 fell on a Saturday) and paying an amount equal to the established harvest cost plus payment for receiving, storing, fumigating, handling, and inspecting the tonnage represented on the certificate. The RAC then gives the handler raisins from the prior year's reserve pool in an amount equal to the tonnage represented on the diversion certificate. The new crop year's volume regulation percentages are applied to the diversion tonnage acquired by the handler (as if the handler had bought raisins directly from a producer).
The 2000-01 California NS raisin crop was the largest on record with final deliveries of raisins from producers to handlers totaling 432,616 tons. This compares to the 10-year average of 344,303 tons. With this large crop, 203,330 tons of NS raisins were set aside in a reserve pool. Of that reserve tonnage, 89,076 tons were ultimately allocated to a diversion program. As of December 1, 2001, 70,529 tons of diversion certificates had been acquired by handlers. It was reported at the December 11, 2001, RAC meeting, by RAC staff that the status of about 2,000 tons of 2001 diversion certificates are unknown.
The RAC met on December 11, 2001, and addressed a concern expressed by some producers with the 2001 RDP. Some producers have had trouble selling their 2001 diversion certificates to handlers. There was concern that some certificates may remain unsold and unredeemed by the December 15 deadline (or Monday, December 17, 2001, for the 2001 RDP since December 15 fell on a Saturday). Several reasons were mentioned as to why this was occurring. The California raisin industry as a whole is experiencing a severe economic downturn. Two short crops in 1998 and 1999 along with other factors caused producer prices to drop drastically for the 2000 crop, marking the first time in about 13 years that prices had fallen. The value of handler inventories has likewise fallen which has contributed to handler difficulties in securing financing to purchase diversion certificates from producers. In addition, some handlers do not need any more raisins to meet their market needs. In some instances, producers have tried to negotiate a premium price for their certificates with handlers.
After deliberating various options (discussed in the following section of this rule regarding the Regulatory Flexibility Analysis), the RAC recommended extending the deadline for handlers to redeem 2001 diversion certificates from December 17, 2001, to January 18, 2002. The extension applies only to 2001 certificates unsold by producers as of December 18, 2001. Producers still holding certificates must have the certificates verified and stamped appropriately by the RAC by December 21, 2001, to indicate that such certificates will be valid until January 18, 2002. Handlers may then purchase these certificates from producers and redeem them for 2000-01 crop reserve raisins following prescribed procedures in § 989.156(k). This action will give producers still holding certificates additional time to sell their certificates to handlers, and give handlers additional time to secure financing to purchase the certificates from producers and redeem them with the RAC. Thus, producers will likely be compensated for diverting their 2001 production, which is the intent of the RDP. Section 989.156(k) is changed accordingly for the 2001 RDP only.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.
There are approximately 20 handlers of California raisins who are subject to regulation under the order and approximately 4,500 raisin producers in the regulated area. Small agricultural firms are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less that $5,000,000, and small agricultural producers are defined as those having annual receipts of less than $750,000. Thirteen of the 20 handlers subject to regulation have annual sales estimated to be at least $5,000,000, and the remaining 7 handlers have sales less than $5,000,000. No more than 7 handlers, and a majority of producers, of California raisins may be classified as small entities.
This rule revises § 989.156(k) of the order's rules and regulations regarding the RDP. Under an RDP, producers receive certificates from the RAC for curtailing their production to reduce burdensome supplies. The certificates represent diverted tonnage. Producers sell the certificates to handlers who, in turn, redeem the certificates with the RAC for raisins from the prior year's reserve pool. This rule extends the date whereby handlers may redeem 2001 diversion certificates with the RAC from December 17, 2001, to January 18, 2002, and applies only to certificates unsold by producers to handlers as of December
Regarding the impact of this action on affected entities, producers who curtailed 2001 production and have had trouble selling their diversion certificates to handlers will have additional time to sell their certificates to handlers. Handlers pay producers for the free tonnage applicable to the diversion certificate minus the established harvest cost for the diverted tonnage. For the 2001 RDP, the industry average free tonnage price applied to diversion certificates was $854 per ton, and applicable harvest costs as established by the RAC were $340 per ton. Preliminary volume regulation percentages for the 2001-02 crop were announced by the RAC at 56 percent free and 44 percent reserve. Thus, using these figures, if a producer was issued a certificate for 100 tons of raisins, he/she would be paid $138.24 per ton by the handler, or a total of $13,824 (($854 per ton × 100 tons × .56) minus (100 tons × $340 per ton harvest cost)). Extending the deadline allows producers additional time to sell their certificate and earn some income for not producing a 2001 crop.
Regarding the impact of this action on handlers, handlers experiencing financial difficulty would have additional time to arrange for financing through likely extending lines of credit with financial institutions. Handlers pay producers for the free tonnage applicable to the diversion certificate minus the $340 per ton harvest cost. Handlers redeem the certificates for 2000-01 crop NS reserve raisins and pay the RAC the $340 per ton harvest cost, plus payment for bins ($20 per ton) and for receiving, storing, fumigating, handling (currently totaling $46 per ton) and inspecting (currently $9.00 per ton) the tonnage represented on the certificate (or a total of $415 per ton). In the above example, the handler would redeem the 100-ton certificate with the RAC, pay the RAC $41,500 ($415 per ton × 100 tons), and receive 44 tons (.44 × 100 tons) of raisins from the 2000-01 reserve pool.
In addition, the $41,500 in the above example paid by the handler to the RAC would be allocated to the 2000-01 reserve pool and be used to pay remaining pool expenses or be distributed to 2000-01 reserve pool equity holders (producers). Thus, all such equity holders could potentially benefit from this action.
Several alternatives to the recommended action were considered by the RAC and/or by the RAC's Administrative Issues' Subcommittee. It was proposed that the RAC purchase unsold diversion certificates from producers. However, the order currently provides no authority for this. In addition, there are concerns as to how this would impact future raisin diversion programs, in particular, whether the integrity of the RDP could be maintained.
It was also proposed that a late fee be added to handlers' costs for redeeming diversion certificates after December 17, 2001. However, the order provides no authority for such a late charge. Another option considered was to take no action and adhere to the current deadline. Some industry members believe that there is no guarantee that producers can sell their harvested crop each season, and there should likewise be no “guarantee” that producers can sell their diversion certificates.
There was also consideration of other extension dates besides January 18, 2002. However, after much deliberation, the majority of RAC members believe that extending the deadline to January 18, 2001, was the best solution to this situation. This date will allow the RAC sufficient time before it recommends final volume regulation percentages to ensure that all redeemed diversion certificates are properly reported as 2001 acquisitions by handlers and included in the 2001-02 crop estimate.
This rule imposes no additional reporting or recordkeeping requirements on either small or large raisin handlers. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection requirement referred to in this rule (i.e., the application) has been approved by the Office of Management and Budget (OMB) under OMB Control No. 0581-0178. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. Finally, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
Further, the RAC's meeting on December 11, 2001, and the RAC's Administrative Issues Subcommittee meeting on December 5, 2001, where this action was deliberated were all public meetings widely publicized throughout the raisin industry. All interested persons were invited to attend the meetings and participate in the industry's deliberations. Finally, all interested persons are invited to submit information on the regulatory and information impact of this action on small businesses.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
A 15-day comment period is provided to allow interested persons to respond to this rule. Fifteen days is deemed appropriate because the deadline is extended until January 18, 2002, and comments should be received by USDA prior to that date.
After consideration of all relevant material presented, including the information and recommendation submitted by the RAC and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect, and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the
Grapes, Marketing agreements, Raisins, Reporting and recordkeeping requirements.
7 U.S.C. 601-674.
(k)
Federal Aviation Administration, DOT.
Final rule.
This amendment adopts a new airworthiness directive (AD), that is applicable to Honeywell International Inc. (formerly AlliedSignal Inc. and Textron Lycoming) Models LTS101-600A-2 and LTS101-600A-3 turboshaft engines; and LTP101-600A-1A and LTP101-700A-1A turboprop engines. This amendment requires replacing certain fuel controls that have beryllium-copper bellows with improved fuel controls that incorporate Inconel 718 stainless steel welded bellows. This amendment is prompted by a report of an uncommanded power loss on a Textron Lycoming LTS101 engine due to a corrosion damaged fuel control bellows. The actions specified by this AD are intended to prevent the engine from reducing the fuel flow to minimum flow resulting in an uncommanded power loss.
Effective date January 23, 2002.
The information in this AD may be examined at the Federal Aviation Administration (FAA), New England Region, Office of the Regional Counsel, 12 New England Executive Park, Burlington, MA.
Robert Baitoo, Aerospace Engineer, Los Angeles Aircraft Certification Office, FAA, Transport Airplane Directorate, 3960 Paramount Blvd., Lakewood, CA 90712-4137; telephone (562) 627-5245, fax (562) 627-5210.
A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that is applicable to Honeywell International Inc. (formerly AlliedSignal Inc. and Textron Lycoming) Models LTS101-600A-2 and LTS101-600A-3 turboshaft engines; and LTP101-600A-1A and LTP101-700A-1A turboprop engines was published in the
Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on 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.
The FAA estimates that 40 engines installed on aircraft of U.S. registry would be affected by this proposed AD and that it would take approximately 3 work hours per engine to accomplish the proposed actions. The average labor rate is $60 per work hour. There are no required parts costs. Based on these figures, the total cost effect of the proposed AD on U.S. operators is estimated to be $7,200.
This final rule does not have federalism implications, as defined in Executive Order 13132, because it would 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. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.
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 the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic effect, 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
Air transportation, Aircraft, Aviation safety, Safety.
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is applicable to Honeywell International Inc. (formerly AlliedSignal Inc. and Textron Lycoming) Models LTS101-6000A-2 and LTS101-600A-3 turboshaft engines; and LTP101-600A-1A and LTP101-700A-1A turboprop engines with fuel controls with the following part numbers (P/N's) installed:
This AD applies to each engine identified in the preceding applicability provision, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For engines that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (b) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if the unsafe condition has not been eliminated, the request should include specific proposed actions to address it.
Compliance with this AD is required at the next replacement of the fuel control or within 12 calendar months after the effective date of this AD, whichever occurs first.
To prevent the engine from reducing the fuel flow to minimum flow resulting in an uncommanded power loss:
(a) Remove any fuel control that has one of the P/N's listed in Table 1 of this AD, and replace with a fuel control that does not have one of the part numbers listed in Table 1 of this AD.
(b) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, Los Angles Aircraft Certification Office (LAACO). Operators must submit their request through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, LAACO.
Information concerning the existence of approved alternative methods of compliance with this airworthiness directive, if any, may be obtained from the LAACO.
(c) Special flight permits may be issued in accordance §§ 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the aircraft to a location where the requirements of this AD can be accomplished.
(d) This amendment becomes effective on January 23, 2002.
Federal Aviation Administration, DOT.
Final rule.
This amendment supersedes an existing airworthiness directive (AD), that is applicable to Rolls-Royce Corporation (formerly Allison Engine Company) AE 3007 series turbofan engines. That AD currently requires removal of certain compressor cone shafts from service before exceeding new cyclic life limits and replacement with serviceable parts. This amendment requires increasing the cyclic life limit for certain serial numbers of new compressor cone shafts, part number (P/N) 23070729, that are used on AE3007A1/3 and AE3007A1P engines. This amendment is prompted by recent approved changes in engineering and manufacturing processes for new compressor cone shafts P/N 23070729. The actions specified by this AD are intended to prevent low-cycle fatigue (LCF) failure of cone shafts, which could result in an uncontained engine failure and damage to the airplane.
Effective date January 23, 2002.
The information in this AD may be examined, by appointment, at the Federal Aviation Administration (FAA), New England Region, Office of the Regional Counsel, 12 New England Executive Park, Burlington, MA.
Michael Downs, Aerospace Engineer, Chicago Aircraft Certification Office, FAA, Small Airplane Directorate, 2300 East Devon Avenue, Des Plaines, IL 60018; telephone: (847) 294-7870, fax: (847) 294-7834.
A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 2000-09-05, Amendment 39-11714 (65 FR 26121, May 5, 2000), which is applicable to Rolls-Royce Corporation (formerly Allison Engine Company) AE 3007 series turbofan engines was published
Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on 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 598 Rolls-Royce Corporation (formerly Allison Engine Company) AE 3007 series turbofan engines of the affected design in the worldwide fleet. The FAA estimates that 364 engines installed on airplanes of U.S. registry will be affected by this AD, that it will take approximately 150 work hours per engine to accomplish the required actions, and that the average labor rate is $60 per work hour. Required parts will cost approximately $3,921 per engine. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $4,703,244.
This final rule does not have federalism implications, as defined in Executive Order 13132, because it would 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. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.
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 the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, 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 by contacting the Rules Docket at the location provided under the caption
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is applicable to Rolls-Royce Corporation (formerly Allison Engine Company) models AE 3007A, AE 3007A1, AE 3007A1/1, AE 3007A1/2, AE 3007A1/3, AE 3007A1P, and AE 3007C turbofan engines, with compressor cone shafts, part numbers (P/N's) 23050728 and 23070729, installed. These engines are installed on but not limited to EMBRAER EMB-135 and EMB-145 series and Cessna 750 series airplanes.
This AD applies to each engine identified in the preceding applicability provision, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For engines that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (h) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if the unsafe condition has not been eliminated, the request should include specific proposed actions to address it.
Compliance with this AD is required as indicated, unless already done.
To prevent low-cycle fatigue (LCF) failure of cone shafts, which could result in an uncontained engine failure and damage to the airplane, do the following:
(a) For Rolls-Royce Corporation model AE 3007A engines, remove cone shafts from service prior to accumulating 9,500 cycles-since-new (CSN) and replace with serviceable parts.
(b) For Rolls-Royce Corporation model AE 3007C engines, remove cone shafts from service prior to accumulating 14,500 CSN and replace with serviceable parts.
(c) For Roll-Royce Corporation models AE 3007A1, AE 3007A1/1, and AE 3007A1/2 engines, remove cone shafts from service prior to accumulating 7,500 CSN and replace with serviceable parts.
(d) For Rolls-Royce Corporation model AE 3007A1/3 engines:
(1) With compressor cone shafts P/N 23070729, serial number (SN) MM78599, MM78615, MM78632, MM78650, MM78651, MM78652, MM78653, MM78654, MM78655, MM78656, MM78657, MM78658, MM78659, MM78660, MM78661, MM78662, MM78663, MM78665 or higher, remove cone shafts from service prior to accumulating 9,300 CSN and replace with serviceable parts.
(2) With compressor cone shafts P/N 23050728, or P/N 23070729 having other than the S/N's listed in paragraph (d)(1) of this AD, remove cone shafts from service prior to accumulating 3,500 CSN and replace with serviceable parts.
(e) For Rolls-Royce Corporation AE 3007A1P engines:
(1) With compressor cone shafts P/N 23070729, SN MM78599, MM78615, MM78632, MM78650, MM78651, MM78652, MM78653, MM78654, MM78655, MM78656, MM78657, MM78658, MM78659, MM78660, MM78661, MM78662, MM78663, MM78665 or higher, remove cone shafts from service prior to accumulating 7,300 CSN and replace with serviceable parts.
(2) With compressor cone shafts P/N 23050728, or P/N 23070729 having other than the SN's listed in paragraph (e)(1) of this AD, remove cone shafts from service prior to accumulating 2,400 CSN and replace with serviceable parts.
(f) Paragraphs (a), (b), (c), (d) and (e) of this AD establish new, lower life limits for cone shafts, P/N's 23050728 and 23070729.
(g) Except for the provisions of paragraph (h) of this AD, no cone shafts, P/Ns 23050728 and 23070729, may remain in service exceeding the life limits established in paragraphs (a), (b), (c), (d) and (e) of this AD.
(h) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, Chicago Aircraft Certification Office. Operators must submit their request through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, Chicago Aircraft Certification Office.
Information concerning the existence of approved alternative methods of compliance with this airworthiness directive, if any, may be obtained from the Chicago Aircraft Certification Office.
(i) Special flight permits may be issued in accordance §§ 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the aircraft to a
(j) This amendment becomes effective on January 23, 2002.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is issuing a final rule that establishes the notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States. These regulations implement recent changes in the statutory requirements applicable to certain exports, and also codify recordkeeping requirements for exports of products that cannot be marketed or sold in the United States generally.
This rule is effective March 19, 2002.
Philip L. Chao, Office of Policy, Planning, and Legislation (HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3380.
In the
The FDA Export Reform and Enhancement Act significantly changed and simplified the export requirements for unapproved human drugs, biological products, devices, and animal drugs. For example, before the law was enacted, most exports of unapproved new drugs could only be made to the 21 countries then identified in section 802 of the act, and these exports were subject to numerous restrictions. The FDA Export Reform and Enhancement Act amended section 802 of the act to allow, among other things, the export of unapproved new human drugs to any country in the world if the drug complies with the laws of the importing country and has valid marketing authorization from any of the following countries: Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and the countries in the European Union (EU) and the European Economic Area (EEA) and certain other requirements are met (see section 802(b)(1)(A) of the act). Currently, the EU countries are Austria, Belgium, Denmark, Germany, Greece, Finland, France, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. The EEA countries are the EU countries, Iceland, Liechtenstein, and Norway. (The list of countries will expand automatically if any country accedes to the EU or becomes a member of the EEA.) This provision of section 802 of the act also applies to the export of certain devices that cannot be sold or marketed in the United States.
The FDA Export Reform and Enhancement Act also established recordkeeping and notification requirements. Section 802(g) of the act requires an exporter of a drug or device under section 802(b)(1)(A) of the act to provide a “simple notification” to the agency “identifying the drug or device when the exporter first begins to export such drug or device” to any of the 25 countries identified in section 802(b)(1)(A) of the act. For exports to other, nonlisted countries, section 802(g) of the act requires the exporter to provide a simple notification “identifying the drug or device and the country to which such drug or device is being exported.” This section also requires persons exporting drugs or devices under any provision of section 802 of the act to “maintain records of all drugs or devices exported and the countries to which they were exported.”
Certain aspects of the proposed rule raised numerous issues. As a result, in the
FDA received 18 comments on the proposed rule. In addition, the agency received several comments on the export notification and recordkeeping discussions in its draft export guidance document which was published in the
Most comments focused on specific provisions in the proposed rule. However, others made general comments about FDA's export authority or the need for any regulations or addressed other export issues that were not directly related to the proposed rule. A description of the comments, and FDA's responses, follows.
(Comment 1) Several comments claimed that the proposal was contrary to the letter or intent of the FDA Export Reform and Enhancement Act because it would create “unnecessary,” “cumbersome,” or “burdensome” requirements that would make it more difficult or time-consuming to export products from the United States, place U.S. firms at a competitive disadvantage in global markets, force firms to relocate overseas, or result in lost profits. Some comments said FDA must withdraw the proposal, although others said the agency should significantly revise the proposal to reduce its requirements.
FDA recognizes that the FDA Export Reform and Enhancement Act was designed to facilitate exports of unapproved products from the United States and, through the draft guidance document, proposed rules, and other contacts with individual firms, the agency worked to reduce or eliminate export requirements and facilitate exports. FDA drafted the proposed rule to implement the notification and recordkeeping requirements in section 802 of the act and to establish a single, consistent agency position regarding the types of records it would examine to determine compliance with section
FDA disagrees, therefore, with those comments asserting that the proposed rule was “burdensome” or “unnecessary.” The agency's interest is to implement sections 801(e)(1) and 802 of the act and section 351(h) of the PHS Act in a consistent, uniform manner that will generate notifications and records that will be useful in determining compliance with the act and will have some value both to the exporter and the agency. Furthermore, as discussed later in this document, FDA has, in response to other comments, revised or eliminated various requirements. These changes to the final rule should make it easier for exporters to comply with the act.
(Comment 2) Several comments argued that FDA lacks authority to issue any regulations pertaining to exports. One comment conceded that the act imposes substantive requirements and that FDA can exercise its enforcement authority if a manufacturer violates the export requirements, but argued that FDA does not have “carte blanche” to require exporters to retain records to defend against a possible FDA enforcement action before the agency alleges that a violation has occurred. The comment added that FDA cannot require records as a substantive requirement so that failure to maintain records would be the basis for regulatory action. Another comment asserted that FDA had failed to show that Congress expected FDA to impose new recordkeeping and reporting requirements on industry or how the requirements would be important in fulfilling FDA's statutory obligations.
Another comment simply stated that the act does not require regulations or the recordkeeping described in the proposed rule.
Other comments cited remarks by one legislator to emphasize that no export restrictions would be preferable.
FDA's authority to issue regulations stems from section 701(a) and (b) of the act (21 U.S.C. 371(a) and (b)). Section 701(a) of the act gives the agency authority to issue regulations for the efficient enforcement of the act unless an exception exists, and section 701(b) of the act specifically authorizes the Departments of Health and Human Services (DHHS) and the Treasury to jointly prescribe and for the DHHS to promulgate regulations for the efficient enforcement of section 801 of the act. Given these provisions of the act, FDA clearly has the authority to promulgate regulations concerning exports and to issue regulations for the efficient enforcement of sections 801 and 802 of the act.
Additional discussion of FDA's authority to issue regulations for the efficient enforcement of section 351(h) of the PHS Act is included in the responses to the comments to § 1.101(c) (21 CFR 1.101(c)) (see section II. D below).
Records enable a person to show, and for FDA to verify, that the person has complied with its legal obligations. The FDA Export Reform and Enhancement Act, with very few exceptions, eliminated any need for prior FDA approval of an export, so determining whether a person has complied with the act must depend on an examination of records. If no records can be required, a firm cannot demonstrate that it met all applicable export requirements, and FDA would be unable to verify such compliance.
Further, section 802(g) of the act clearly states, in part, that, “Any exporter of a drug or device
FDA acknowledges that one legislator, in his remarks accompanying the passage of the FDA Export Reform and Enhancement Act, indicated a desire to have no export requirements at all. Nevertheless, the FDA Export Reform and Enhancement Act did contain requirements for exports, and one cannot reasonably argue that Congress, in enacting those requirements, intended them to be ignored, rendered meaningless, or made unenforceable. When interpreting legislation, it is a well-settled principle that, “Absent clear congressional intent to the contrary, we will assume the legislature did not intend to pass vain or meaningless legislation” (
(Comment 3) Two comments argued that the proposal was deficient or had to be withdrawn because FDA had not shown how the proposal protects the public health of U.S. citizens or foreign citizens or benefits consumers.
FDA disagrees with the comments. The rule is intended to implement sections 801(e) and 802(g) of the act and section 351(h) of the PHS Act by describing the types of records that should be kept in order to demonstrate that the export complied with the act and by describing the contents of the simple notification, which must be sent to FDA for certain exports under section 802 of the act. None of these provisions requires a demonstration of the public health benefits for United States or foreign citizens as a prerequisite to rulemaking. Thus, a preamble discussion concerning public health benefits to U.S. citizens or foreign citizens or possible congressional expectations for a regulation is unnecessary.
Nevertheless, the act and, by extension, the final rule indirectly benefits the public health in the United States and in foreign countries. For example, sections 801(e) and 802 of the act permit exports of products that are not approved for use in the United States. (If the products were approved for use and otherwise in compliance with the act's requirements for marketing and sale in the United States, they would not be subject to the export provisions of the act.) Consequently, to the extent that records can show that a product not approved for use in the United States. was, in fact, exported, there would be no U.S. public health concern that a product whose safety or effectiveness has not been established had entered domestic commerce.
As another example, section 351(h) of the PHS Act states, in part, that exports
(Comment 4) One comment said that the present system is “working well” so new regulations are unnecessary. Other comments said the statute was sufficiently clear so no regulations are needed. Another comment asked that foods be excluded from the rule; the comment said, in part, that FDA did not understand the global food market or recognize congressional intent in adopting the FDA Export Reform and Enhancement Act. (The comment also made specific statements against individual provisions in the proposed rule and other claims; FDA addresses those comments elsewhere in this preamble.)
FDA disagrees with the comments. The FDA Export Reform and Enhancement Act affected regulated industries differently. For example, for foods, no significant changes in the export authority occurred, whereas for drugs and devices, the new export provisions offered new authorities for exporting investigational products, products approved by certain foreign countries, and products intended to “fill the pipeline” while awaiting approval in a foreign country.
As another example, before the enactment of the FDA Export Reform and Enhancement Act, unapproved new animal drugs were subject to the export requirements in section 802 of the act, and then-section 801(e) of the act did not permit the exportation of animal drugs that were “unsafe” within the meaning of section 512 of the act (21 U.S.C. 360b). After the enactment of the FDA Export Reform and Enhancement Act, animal drugs are excluded from section 802 of the act and, except for “banned” animal drugs which cannot be exported, now can be exported if they comply with the export requirements in section 801(e)(1) of the act.
Yet, while the new export provisions affected regulated industries differently, certain statutory requirements (such as compliance with section 801(e)(1) of the act) are common to all exports. Other statutory requirements, particularly those in section 802 of the act, are common to drugs and devices, or to drugs, biological products, and devices. In cases where a particular statutory requirement applied to more than one type of product, the agency decided that its interpretation and implementation of that statutory requirement should also be the same, regardless of the product involved. In other words, the rule implementing section 802(g) of the act should be the same for drug exporters as it is for device exporters because both are subject to section 802(g) of the act. Similarly, the requirements in section 801(e)(1) of the act are incorporated by referring to section 802(f) of the act and section 351(h) of the PHS Act, and continue to operate as a freestanding export provision for foods, cosmetics, certain drugs, and devices. The interpretation of section 801(e)(1) of the act should be consistent regardless of the product involved.
So, while the agency's implementation of the export provisions might have been sufficiently clear to some individuals and “working well” for certain industries in certain cases, the absence of a single, consistent interpretation of those statutory provisions created the possibility that different FDA centers would implement the same provisions of the act differently. The agency, therefore, formed a multi-center and multi-office group to develop FDA's policies and interpretations for the FDA Export Reform and Enhancement Act. The draft guidance document (which appeared in the
In short, a rule will help ensure that the export requirements “work well” for all, rather than some, regulated industries and that they work the same way for all regulated industries.
As for the comment requesting that FDA exclude food products from the rule, FDA declines to adopt the comment's suggestion. Section 801(e)(1) of the act clearly and unequivocally applies to food exports, so, absent a compelling reason that would warrant separate or different export regulations for food, FDA declines to exclude food products from the final rule.
(Comment 5) One comment said that the proposed rule contained the “same objectionable provisions” that were in the draft guidance document on exports.
While the agency disagrees with the comment's characterization of the rule, the proposed rule and guidance document contain the same concepts because FDA prepared the draft guidance document and its export-related proposed rules simultaneously. However, the administrative clearance and publication procedures and statutory requirements that apply to guidance documents are much simpler than those that apply to proposed rules. Consequently, the proposed rules appeared several months after FDA had published the draft guidance document in the
(Comment 6) One comment accused the agency of engaging in “regulatory imperialism” that is “neither desired nor needed by other countries” and that the rule reflected what it called “FDA's continued belief that the agency is not simply the public-health agency for the United States, but for the entire world.”
FDA disagrees with the comment. The rule implements parts of sections 801(e)(1) and 802 of the act and section 351(h) of the PHS Act. These provisions do not require, or expect, FDA to be a public health agency “for the entire world,” but the act and section 351(h) of the PHS Act do establish requirements on exports of products that cannot be legally marketed or sold under the act in the United States, and FDA is charged with enforcing the act and section 351 of the PHS Act. The final rule, as stated earlier, creates a single, uniform interpretation for certain export requirements by describing the types of records the agency would examine in order to determine whether a person complied with the law and by describing the content of the notification, if required by the act, to be sent to FDA.
(Comment 7) Two comments involved investigational products. One comment said the proposal would make it more difficult for U.S. firms to conduct foreign clinical trials for drug and biological products. The other comment said the proposal fails to recognize that food samples are often exported for
For clinical investigations involving human drugs and biological products, the FDA Export Reform and Enhancement Act created several avenues for exporting such products. First, if the drug or biological product has been approved for marketing in any of the countries identified in section 802(b)(1) of the act (the so-called “listed countries”), the product may be shipped to any country for any purpose; this would include investigational use, and the export would be subject to the rule's notification and recordkeeping requirements.
Second, if the drug or biological product is exported for investigational use in any listed country and is not approved in any listed country, section 802(c) of the act authorizes its export. These exports are not subject to the notification requirement in section 802(g) of the act, but are subject to section 801(e)(1) of the act and to certain other requirements in section 802 of the act. Most drugs and biological products exported for investigational use would probably be subject to this provision of the act and § 1.101(b) and (g).
Third, the clinical investigation could be conducted under an investigational new drug application (IND). In these cases, only the IND requirements at part 312 (21 CFR part 312) would apply.
Fourth, the person could seek permission to export the drug or biological product, without obtaining an IND, under § 312.110. This program, known as the “312 program,” pre-dates the FDA Export Reform and Enhancement Act and allows exports for investigational use.
FDA is preparing a proposed rule that would address exports of drugs and biological products for investigational use and also streamline the requirements for the “312 program.” Additionally, FDA has revised § 1.101(b)(2) and other parts of this rule to simplify the requirements for demonstrating compliance with section 801(e)(1) of the act. These revisions significantly change the records required for demonstrating compliance with section 801(e)(1) of the act and are discussed later in this document.
As for foods exported for investigational or research uses, the act does not contain any special provisions for such products. There is no apparent legal basis to distinguish them from other food exports.
However, section 801(e)(1)(B) of the act only requires that the product intended for export be “not in conflict” with the foreign country's laws. This is considerably different—and far less restrictive than requiring that the exported product be “approved” in the foreign country. Market authorization is relevant only for drugs and devices exported under section 802(b)(1) of the act, because that provision of the act allows exports of unapproved drugs or devices if they have received valid marketing authorization from any listed country, and comply with the other applicable requirements of section 802 of the act. Thus, in the food testing and research and development example cited by the comment, the export would comply with section 801(e)(1)(B) of the act if such activities do not conflict with the laws of the importing country. Additionally, as stated earlier, revised § 1.101(b)(2) greatly simplifies the types of records needed to show that the product is not in conflict with the foreign country's laws.
(Comment 8) One comment objected to notifying FDA at all if a device is International Organization for Standardization (ISO)-9001 certified or has received approval from a notified body so that it may be commercially marketed in the EU. The comment said the Conformite European (CE) mark should exempt the device from notification and said that small countries will find it in their best interests to accept the CE mark as their acceptance standard.
FDA declines to exempt CE-marked or ISO-9001 certified devices from the notification requirement. The act requires notification for drugs and devices exported under section 802(b) of the act. The act does not exempt devices that bear a CE mark or meet ISO-9001 standards from the act's export requirements. The agency notes that such devices may qualify for export under section 801(e)(1) of the act. In such instances, no notification would be required as long as the export complies with section 801(e)(1) of the act.
As for the comment's assertion that small countries should accept the CE mark, such matters are outside the scope of this rule. FDA cannot require other countries to accept a CE mark.
(Comment 9) The preamble to the proposed rule described the requirements in section 802(f) of the act. It noted that the act prohibits exports of a drug or device if the product is the subject of a determination by FDA or by the U.S. Department of Agriculture (USDA) that the probability of reimportation of the exported drug or device would present an imminent hazard to the public health and safety of the United States. The preamble to the proposed rule noted that veterinary biological products are subject to USDA jurisdiction (64 FR 15944, col. 3). One comment requested that FDA remove the reference to veterinary biological products.
The statement in the preamble to the proposed rule accurately described the USDA's jurisdiction. However, the reference to veterinary biological products was inappropriate because sections 801(e)(1) and 802 of the act apply only to FDA-regulated products. No changes to the final rule are necessary, though, because the reference to veterinary biological products appeared only in the preamble to the proposed rule.
(Comment 10) Two comments said the rule failed to address or to distinguish between items that are imported as components or ingredients that are used in products destined for export and products that are manufactured solely for export purposes.
In the
The import for export proposal, however, focused on requirements pertaining to the imported article, whereas this final rule pertains to the notification and recordkeeping requirements for exported products. In other words, the import for export provision in section 801(d) of the act does not relieve “import for export” products from satisfying the export requirements in sections 801(e) and 802 of the act or section 351(h) of the PHS Act. Thus, one should read this final rule in conjunction with the import for export proposal. FDA intends to finalize the import for export proposal in the near future.
Section 1.101(a) would describe the provision's scope as covering notifications and records required for human drug, biological product, device,
(Comment 11) One comment asked if a product meeting all applicable marketing requirements in the United States, but labeled in a foreign language and intended for the same uses as those approved by FDA, would be exempt from the rule.
FDA considers a product which is labeled solely in a foreign language and whose foreign-language labeling has not been approved by FDA (where such FDA approval of labeling is required) to be an unapproved product and subject to the act's approval requirements. FDA approval, in general, includes approval of a product's labeling (see, e.g., sections 505(b)(1)(F), (d)(5), and (d)(7); 512(a)(1)(B), (a)(2)(C), and (b)(1)(F); and 515(c)(1)(F), and (d)(2) of the act (21 U.S.C. 355(b)(1)(F), (d)(5), and (d)(7); 360b(a)(1)(B), (a)(2)(C), and (b)(1)(F); and 360e(c)(1)(F), and (d)(2))). Thus, if FDA has not reviewed or approved the foreign-language label, the product is unapproved and would not be exempt from this rule, even if an identical, FDA-approved product with approved labeling exists.
For information regarding the exportation of products legally marketed in the United States that are accompanied by FDA-approved labeling, please see comment 28.
(Comment 12) One comment objected to the rule's scope, saying that it would cover products that foreign countries might regulate differently from FDA. The comment gave an example of patient [disposal] washcloths, which would be medical devices in the United States, but would be cosmetics in Brazil. The comment said FDA should concern itself with compliance with FDA requirements for domestic shipments.
FDA disagrees with the comment. The most logical interpretation of the act is to have FDA regulate products, and determine whether products are exempt from requirements applicable to products marketed, distributed, or sold in the United States because they qualify for export under sections 801(e) or 802 of the act or section 351(h) of the PHS Act, according to their classification or type in the United States. Thus, a product that would be considered a device in the United States remains a device under the export provisions even though a foreign country might regulate it differently or might not regulate it at all. It would be both inefficient and resource-intensive for exporters and FDA to apply the export requirements based on the product category in which a particular foreign country regulates the product. Moreover, such an approach is inconsistent with the structure of the act's export provisions. The export provisions are a means by which an exporter can ship products that would otherwise be subject to the act's domestic provisions. The purposes underlying the export provisions would be undermined if a product could qualify for export under the rules applicable to the product category of the importing country rather than based on how the product is regulated in the United States.
(Comment 13) One comment said the proposal failed to address specific categories of food products. The comment said that food additives and dietary supplements are “foods” and subject to section 801(e)(1) of the act, but said color additives are not foods, drugs, or any other product mentioned in proposed § 1.101(a). The comment asked if color additives are exempt from the rule.
The act's definitions of “food,” “drug,” and “cosmetic” include components of such products (see section 201(f)(3), (g)(1)(D), and (i)(2) of the act (21 U.S.C. 321(f)(3), (g)(1)(D), and (i)(2)). Section 201(t)(1)(B) of the act, in general, defines a “color additive” as a material that, when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable of imparting color. Most color additives would be components of a food, drug, or cosmetic and, as a result, be subject to the act's export requirements for foods, drugs, or cosmetics. Only those color additives that are not classified as a food, drug, or cosmetic “component” fall outside sections 801(e) and 802 of the act. In such circumstances, if the color additive cannot be legally marketed, distributed, or sold in the United States because it does not comply with the act's requirements for color additives, it may not be exported.
(Comment 14) FDA, on its own initiative, has replaced the word “biologic” or “biologics” with “biological product” or “biological products” throughout the rule. This change has no substantive effect and is intended only to use the term used in the PHS Act for these products.
Section 1.101(b) would establish the recordkeeping requirements for human drugs, biological products, devices, animal drugs, foods, and cosmetics exported under or subject to section 801(e)(1) of the act.
(Comment 15) Several comments challenged FDA's authority to issue any recordkeeping regulations for section 801(e)(1) of the act. Two comments claimed that the act only requires records under section 802(g) of the act, so FDA cannot issue recordkeeping requirements for section 801(e)(1) of the act. One comment added that the proposed recordkeeping requirements went “far beyond” the “simple recordkeeping” requirements specified in the act. Two comments argued that the act did not require records or prescribe what records are to be kept, although one comment acknowledged that companies should keep records to demonstrate compliance with the act. According to these comments, companies have the discretion to keep any records they wish to demonstrate compliance with section 801(e)(1) of the act.
FDA has ample legal authority to require records. Section 701(b) of the act provides the principal legal basis for the recordkeeping requirements in § 1.101(b). Section 1.101(b) reflects the basic export requirements in section 801(e)(1) of the act that apply to all exports under sections 801(e) and 802 of the act, regardless of whether the product is a food, human or animal drug, biological product, device, or cosmetic. The agency drafted this provision to provide a single, consistent interpretation of requirements in section 801(e)(1) of the act to both industry and to the agency's own components. This should result in less confusion and fewer disagreements as to whether a particular document adequately demonstrates compliance with section 801(e)(1) of the act (which would occur if no regulation existed and firms had total discretion over what records to keep). FDA has, however, significantly revised § 1.101(b) in response to the comments (by shortening the recordkeeping period and by clarifying the types of records needed to show that the export meets the foreign purchaser's specifications or does not conflict with foreign laws), and discusses those changes later in this document.
For the records required in § 1.101(e), section 701(a) of the act provides rulemaking authority for the efficient enforcement of the act, and this authority is independent of the recordkeeping requirement in section 802(g) of the act. FDA further notes that, contrary to one comment's claim, section 802(g) of the act does not refer to “simple recordkeeping.” Instead,
(Comment 16) One comment argued that the proposal contains requirements and recommendations that are irrelevant or inappropriate to specific products, such as bulk agricultural commodities. The comment asked FDA to exclude foods from the rule.
FDA declines to exclude foods from the rule. Section 801(e)(1) of the act specifically includes foods, so it is more practical and appropriate to include foods as part of this rule so that the rule applies equally to all products subject to section 801(e)(1) of the act.
Section 801(e)(1) of the act also does not distinguish between types of food, so it would be inappropriate to create exemptions or exceptions for specific food products. FDA has, however, revised some requirements in § 1.101(b) to make it easier to demonstrate compliance with section 801(e)(1) of the act. FDA is unable to respond further to the comment because it did not identify which requirements were supposedly irrelevant or inappropriate or explain why they were irrelevant or inappropriate.
(Comment 17) Proposed § 1.101(b)(1) would require records to be kept at least 5 years after the date of exportation and made available to FDA for review and copying.
Several comments protested that the 5-year period was excessive. One comment claimed that food manufacturers do not even keep records regarding foreign regulatory requirements and that it would be unrealistic and unacceptable to expect them to do so. Two comments suggested that the retention period be 2 years, while another comment suggested that, for drugs, the period be 1 year after the product's expiration date.
The agency has revised the rule to make the record retention period coincide with the CGMP or quality systems (QS) regulations applicable to the product. So, for example, the CGMP record retention period would apply to drug exports, and the QS regulation record retention period would apply to device exports. FDA decided to use CGMP and QS regulation record retention periods because most records described in § 1.101 would be contained in a company's CGMP or QS regulation records. As a result, firms should find it easier to maintain their export records in the same manner and for the same period of time as their CGMP or QS regulation records.
For food and cosmetic exports, the food CGMP regulations do not contain a recordkeeping requirement, and there is no CGMP regulation for cosmetics. Therefore, because the food CGMP and cosmetic regulations do not require records, FDA has revised § 1.101(b)(1) to require records for food and cosmetic exports to be kept for 3 years after the date of exportation. The 3-year period is consistent with the CGMP record retention period for drugs (see 21 CFR 211.180(a)).
As for the comment claiming that food manufacturers do not keep records of foreign regulatory requirements, neither the proposed nor final rules required them to do so. Section 1.101(b)(2) requires records demonstrating that the product does not conflict with the laws of the importing country. The final rule states that such records can consist of either: (1) A letter from an appropriate foreign government agency, department, or body stating that the product has marketing approval from the foreign government or does not conflict with the foreign government’s laws; or (2) a notarized certification by a responsible company official in the United States that the product does not conflict with the importing country’s laws and includes a statement acknowledging that he or she is subject to 18 U.S.C. 1001. Thus, showing that the export does not conflict with the foreign country’s laws does not require a person to keep records regarding foreign regulatory requirements.
(Comment 18) One comment argued that the recordkeeping obligations do not operate until a firm begins to export a product.
FDA disagrees with the comment. Although the rule does not specify when a firm should begin keeping export records, FDA expects firms to begin creating and keeping records before they export a product under sections 801(e) or 802 of the act or section 351(h) of the PHS Act. For example, to show whether the export meets the foreign purchaser's specifications (as required by section 801(e)(1)(A) of the act), an exporter would keep a copy of the incoming purchase order showing which items the foreign purchaser wanted. It would be illogical for the exporter to ask the foreign purchaser to provide a purchase order when the exporter ships or after the exporter has shipped the products to the foreign purchaser or to start keeping such records after he or she has exported the product.
In other words, a prudent firm should know whether exports are permitted or whether the export meets various obligations under the act or the PHS Act before the firm actually exports the product. Yet, even in the absence of this requirement, most firms would have the foreign purchaser's specifications before they export the product because they would want to ensure that they are manufacturing and exporting the correct item and to reassure the foreign purchaser that the exported item meets the purchaser's needs or expectations. Moreover, for purposes of the act, if a product does not comply with the applicable requirements for domestic marketing, distribution, and sale, and the manufacturer lacks evidence that the product is intended for export and meets the requirements of an applicable export exemption (i.e., sections 801 or 802 of the act or section 351(h) of the PHS Act), the product would be subject to enforcement action for violating the act.
To demonstrate that the exported product meets the foreign purchaser's specifications, § 1.101(b)(1) would require records describing or listing the product specifications requested by the foreign purchaser. The proposal indicated such records could include details about the product (e.g., dosage strength, dosage form, purity, quality, operating parameters, composition) and any manufacturing specifications requested by the foreign purchaser (e.g., type of sterilization process to be used, compliance with a particular manufacturing standard).
(Comment 19) Most comments submitted in response to proposed § 1.101(b)(1) interpreted the provision as requiring extremely detailed product specifications and protested the level of detail that they believed the rule required. For example, some comments said that in vitro diagnostic devices are not manufactured to unique specifications and are instead sold to the general laboratory or scientific community. These comments said package inserts describing product specifications, product labeling, or some indication that the in vitro diagnostic device met design criteria should be acceptable.
Other comments said that, for food products or medical devices, contracts or purchase orders between exporters and foreign purchasers should suffice. One comment added that for devices FDA should not require specifications to be in English; the comment said requiring foreign purchasers to draft original specifications in English would be cumbersome and that product labeling is used worldwide as the basis for product performance characteristics.
One comment from a trade association for human drug manufacturers said CGMP records should suffice, but also claimed that the act does not authorize FDA to require any records. In contrast, another comment said that some foreign purchasers have limited requirements and may not require detailed product specifications.
One comment said that recipes, manufacturing specifications, and processes are proprietary information protected under “international agreements” and should not be available to FDA for review and copying. The comment accused FDA of trying to obtain proprietary information with the intent to share such information with foreign entities.
Only one comment stated that the records described in proposed § 1.101(b)(1) would not present any problem. The comment explained that a manufacturer would require a detailed specification for the custom manufacture of any product that is not regularly manufactured or sold in the United States.
FDA believes that many comments misinterpreted the rule. FDA's principal interest is to link a record to a particular export to verify that the exported product met the foreign purchaser's specifications. For example, if the foreign purchaser sought 5,000 bottles of drug X tablets, with each tablet at a 50 milligram (mg) dose, FDA would look for records to show that a particular shipment of drug X to the foreign purchaser consisted of 5,000 bottles of 50 mg of drug X tablets. Records stating only that drug X was shipped to the foreign purchaser would not be satisfactory because they would provide no information regarding the foreign purchaser's specifications or how the export shipment met those specifications.
The final rule does not prescribe any particular degree of detail in the foreign purchaser's specifications. The agency has revised § 1.101(b)(1) to clarify that the records need only contain sufficient detail to match the foreign purchaser's specifications to a particular export. If CGMP records contain information on the foreign purchaser's specifications, they may be sufficient under § 1.101(b)(1).
As for translations, the specifications should be translated, if necessary, to facilitate a determination as to whether the exported product meets the foreign purchaser's specifications. The agency has no preference whether the foreign purchaser or the U.S. manufacturer or exporter does the translation. However, the U.S. manufacturer or exporter should know whether the exported product meets the foreign purchaser's specifications, so it is reasonable to expect that the U.S. manufacturer or exporter would understand the foreign purchaser's specifications and be able to communicate those specifications in English.
FDA disagrees with the comment that claimed that FDA wants to obtain proprietary information in order to transmit that information to foreign entities. Such claims are totally unfounded. FDA is very conscious of its legal obligations to protect trade secrets and confidential commercial information (see section 301(j) of the act (21 U.S.C. 331(j)), 21 CFR part 20) and has regulations governing communications with foreign governments (see 21 CFR 20.89). Those regulations contain several safeguards, such as sponsor consent, to protect any exchanges of confidential commercial information with foreign governments.
(Comment 20) One comment asked how often foreign purchasers must provide product specifications. The comment explained that specifications are only as detailed as necessary to meet the purchaser's needs, so that if the foreign purchaser changes or amends its specifications, the foreign purchaser should be expected to provide an amendment to the U.S. manufacturer. The comment suggested that FDA interpret the rule to require foreign purchasers to provide complete specifications only with the initial order. If the foreign purchaser subsequently changed the specifications, the foreign purchaser would only provide the changes to the manufacturer (rather than a complete set of specifications). The comment added that batch records would be kept in accordance with existing recordkeeping requirements and would be made available during an inspection.
FDA does not expect complete specifications to accompany every order of the same product. For example, if an exporter signs a contract to ship the same item to a foreign purchaser on a monthly basis, the agency would not expect the exporter to obtain complete specifications for each monthly shipment, but would expect the exporter to have specifications that applied to the initial shipment and records showing that subsequent shipments correspond to the same initial specifications. The agency's principal interest is to link records to specific export shipments to verify that a particular exported product met the foreign purchaser's specifications. The level of detail in the specifications may vary between orders, but the agency expects manufacturers to be able to demonstrate that the exported product met the foreign purchaser's specifications.
Proposed § 1.101(b)(2) would require the exporter to maintain documentation that demonstrates that the exported product does not conflict with the importing country's laws. The proposal stated that this would normally consist of a letter from the appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with that country's laws. The proposal would not consider letters or other documents from nongovernmental bodies or persons, such as company officials or attorneys in the foreign country, to be satisfactory for this purpose.
(Comment 21) Many comments objected strongly to proposed § 1.101(b)(2). In general, most comments said it would be difficult, time-consuming, burdensome, or impossible to obtain a letter from a foreign government. Other comments argued that foreign governments might not regulate the exported product so one could not demonstrate that the product was not in conflict with foreign laws or that foreign governments might not be willing to provide a letter due to disinterest, lack of staff, or a desire to protect domestic industry. A few comments suggested that manufacturers should not be responsible for determining whether a product does not conflict with foreign laws, arguing that importers, purchasers, or distributors in the foreign country should bear that responsibility.
Many comments advocated alternative approaches that would eliminate any need for a letter from the foreign government. Most comments favored a certification, declaration, letter, or memo by a company official in the foreign country, a distributor in the foreign country, by a foreign subsidiary, an attorney (either in the United States or in the foreign country), a notified body (if the export were to Europe or Japan), or a foreign government official, or some combination of these firms or persons. These comments often explained that firms are responsible for meeting local requirements and supported the use of certifications or letters from company officials.
One comment suggested using only contractual documents between the exporter and importer. The comment said previous FDA guidance to the grain handling industry used this approach.
Another comment said a copy of a valid import license should be sufficient because these licenses usually require inspection by the foreign government. The comment explained that a manufacturer will not ship a product if its export costs are significant, and it will not ship a product that does not comply with local requirements because the cost of returning the product would be too great.
One comment said a label stating “For export only” should suffice to show that the product does not conflict with the foreign country's laws.
Section 1.101(b)(2) was intended to provide the most reliable indicator that the exported product did not conflict with the foreign country's laws. However, in light of the comments, FDA has revised § 1.101(b)(2) to accept, as an alternative to a letter from the foreign government, a notarized certification from a responsible company official in the United States that the product is not in conflict with the foreign country's laws. The certification must include a statement acknowledging that the responsible company official making the certification is subject to the provisions of 18 U.S.C. 1001. This statutory provision makes it a criminal offense to knowingly and willfully make a false or fraudulent statement, or make or use a false document, in any matter within the jurisdiction of a department or agency of the United States. This statutory provision also makes it a criminal offense to knowingly and willfully falsify, conceal, or cover up by any trick, scheme, or device a material fact in any matter within the jurisdiction of a department or agency of the United States. This revision should address the concerns expressed in most comments and eliminate any potential delays or obstacles in demonstrating compliance with section 801(e)(1)(B) of the act. FDA reserves the authority to request additional documentation demonstrating that the export is not in conflict with the foreign country's laws if questions arise regarding a certification.
FDA declines to amend the rule to accept contracts as evidence that an export is not in conflict with a foreign country's laws. While parties entering contracts usually intend to execute legally binding obligations, they do not necessarily take into account whether the export complies with foreign laws.
(Comment 22) A few comments disputed FDA's authority to require a letter from a foreign government. They noted that a particular legislator considered such a requirement to be objectionable or simply declared that FDA exceeded its legal authority.
As stated earlier, FDA has revised § 1.101(b)(2) to accept certifications from company officials as an alternative to a letter from a foreign government agency.
Additionally, as discussed earlier, FDA has ample legal authority under section 701 of the act to issue regulations for the efficient enforcement of the act.
(Comment 23) One comment interpreted § 1.101(b)(2) as being satisfied if the foreign country had issued an approval letter or published some document indicating that the product was approved.
Copies of approval letters or other government-issued documents indicating government approval are acceptable to show that the product is not in conflict with the foreign country's laws, but, as stated earlier, the final rule also allows firms to provide a certification from a responsible company official that the product is not in conflict with the foreign country's laws. FDA reiterates that section 801(e)(1)(B) of the act does not require the foreign government to “approve” the exported product for commercial marketing; it only requires that the export “not be in conflict” with the foreign country's laws.
Market authorization from a foreign government is relevant under section 802(b)(1) of the act, which authorizes the export of drugs and devices that have received marketing authorization from a listed country. However, the final rule does not contain any detailed provisions pertaining to the market authorization aspect of section 802(b)(1) of the act.
(Comment 24) Proposed § 1.101(b)(2) also would require the letter from the foreign government to be in English or for the person exporting the article to have an English-language translation. One comment objected to the English-language translation requirement. The comment said World Trade Organization (WTO) notification processes do not require translations and that, for exported food products, English-language translations are not always available or necessary.
Section 1.101(b)(2) accepts certifications from company officials in the United States to show that the export does not conflict with the importing country's laws, and the final rule requires the certification to be in English or for an English-language translation to be available. This should not be objectionable because a U.S. exporter is likely to have a responsible official capable of writing a certification in English.
FDA is not persuaded that WTO notification processes are relevant to the rule because this rule concerns compliance with U.S. law by U.S. companies. Section 801(e)(1)(B) of the act requires the exported food, drug, device, or cosmetic to not be in conflict with the laws of the country to which it is intended for export, and § 1.101(b)(2) describes how a U.S. firm demonstrates compliance with section 801(e)(1)(B) of the act.
(Comment 25) One comment said proposed § 1.101(b)(2) would adversely affect clinical trials conducted outside the United States by affecting the supplies of exported drugs for investigational use.
Because FDA has revised § 1.101(b)(2) to accept certifications as an alternative to a letter from a foreign government, the agency does not anticipate any significant problems or delays in executing the certifications, so there should be no adverse impact on exporting drugs for investigational use. Additionally, FDA intends to issue a proposed rule concerning exports of investigational new drugs. The proposal would describe some new regulatory approaches for exporting investigational new drugs and would streamline existing requirements for such exports.
Proposed § 1.101(b)(3) would require the records to include copies of any labels or labeling statements, placed on the shipping packages, that show that the packages are intended for export. The proposal indicated that statements such as “For export only” may be sufficient for this purpose.
(Comment 26) Two comments said that raw or processed agricultural commodities cannot be labeled. The comments said that FDA should accept a statement on the bill of lading, export declaration, or other shipping document. One comment suggested that the label, alone, should be sufficient and that FDA should not require firms to show that the export does not conflict with the foreign country's laws.
FDA agrees and has revised the rule to permit the statement to be attached to a bill of lading, export declaration, or other document accompanying the exported product if the product, as it is ordinarily shipped, cannot be labeled.
As for the comment's statement that FDA should not require firms to show that an export does not conflict with a foreign country's laws, FDA points out that section 801(e)(1)(B) of the act expressly requires that a food, drug, device, or cosmetic intended for export to be “not in conflict with the laws of
Proposed § 1.101(b)(4) would require records showing that the product is not sold or offered for sale in the United States. The preamble to the proposal said that these records could pertain to the product, its labeling, and similar products sold in the United States. The idea was to show that the exported product, when compared to those sold in the United States, was different from products sold domestically.
(Comment 27) Several comments objected to the proposed requirement, arguing that the act does not require any records or labeling to show that the exported product is not sold or offered for sale in the United States.
In contrast, other comments stated that it is difficult to assemble records to “prove a negative,” namely that a particular product is not sold or offered for sale in the United States, particularly when a company does not sell a similar product in the United States or only exports products. Some comments suggested that FDA accept copies of shipping records, product labeling, price lists or catalogs, product listings submitted to FDA, or certifications from the exporter. Most comments recommended that the labeling statement in § 1.101(b)(3)—that the product is “For export only”—be acceptable, although some would add a product label stating, “Not for sale in the United States.” Two comments said records relating to the production, destruction, and export of products or showing how exported products are segregated from those sold in the United States should be acceptable.
After further consideration, FDA agrees that it would be difficult and impractical to require records of products sold domestically, product labels, or similar information in order to demonstrate that a particular export is “not sold” in the United States. The agency has revised the rule to state that production and shipping records relating to the exported product will be sufficient and that promotional material will be helpful in determining whether a product is “offered for sale” in the United States. The agency notes that information concerning products sold or offered for sale in the United States that are similar to an exported product may be used by the agency in determining compliance with section 801(e)(1) of the act. The final rule does not require an exporter to retain records concerning similar products sold or offered for sale in the United States, but other provisions in the act may require such records to be retained.
(Comment 28) FDA interpreted section 801(e)(1)(D) of the act as requiring exported products to be different from products sold in the United States. One comment questioned FDA's interpretation. The comment said that section 801(e)(1)(D) of the act is only intended to prevent diversion of products into domestic commerce. The comment argued that preventing the sale of foreign-market versions of products sold in the United States “perversely” establishes a more restrictive regime for products sold in the United States than products not sold or offered for sale in the United States.
Two comments disagreed with FDA's position as it pertains to multiple batches of the same product. (In the draft guidance document, FDA indicated that section 801(e)(1)(D) of the act would not be met if a manufacturer made five batches of the same drug and sought to sell some batches in the United States and to export the others; the draft guidance document indicated that the U.S. sales would show that the product is, in fact, sold in the United States contrary to section 801(e)(1)(D) of the act.) The comments argued that section 801(e)(1)(D) of the act should be interpreted as applying only to specific products that are or were sold or offered for sale in the United States, so products that are intended for export may, in fact, be exported even though the same product or different batches of the product are sold in the United States.
After considering the comment, FDA is clarifying its interpretation of section 801(e)(1)(D) of the act. If the product is legally sold in the United States, and the same product is intended for export for the same approved use and is accompanied by the FDA-approved labeling, FDA may consider the product to be sold or offered for sale in the United States. In most circumstances, the product would not have to meet the requirements of section 801(e)(1) of the act because the product to be exported is the same product that can be legally sold in the United States and does not need to qualify for an exemption from the act's requirements. By stating that the product is “accompanied” by the FDA-approved label, FDA does not require the FDA-approved label to be affixed to each exported product, but the agency does expect the FDA-approved label to be included in the export shipment. The agency recognizes that no interest would be served by requiring firms to attach FDA-approved labels to exported products if those labels would have to be removed or altered for the product to be sold in a foreign country.
In contrast, if the product to be exported involves a use that is not approved in the United States, or is labeled solely in a foreign language and whose foreign language labeling has not been approved by FDA, then the product is “unapproved” and falls within the act's export provisions. In these cases (as we stated in our response to comment 11 earlier), the product must comply with section 801(e)(1)(D) of the act, and FDA would not consider the product to be sold or offered for sale in the United States within the meaning of section 801(e)(1)(D) of the act.
As for batches of the same product, FDA is clarifying its position to state that batches of a product that are segregated from products intended for domestic commerce or produced on manufacturing lines that are dedicated to export markets, may meet the requirement in section 801(e)(1)(D) of the act as long as the batch intended for export differs from the domestic product. (For example, the product intended for export is not made under the same CGMPs that apply to the product marketed in the United States.)
FDA will revise its guidance document on the FDA Export Reform and Enhancement Act to reflect these positions.
Proposed § 1.101(c) would establish recordkeeping requirements, in addition to those required under § 1.101(b), for partially processed biological products exported under section 351(h) of the PHS Act.
(Comment 29) One comment would delete all recordkeeping requirements for partially processed biological products. The comment said that proposed § 1.101(b)'s recordkeeping requirements are based on section 802(g) of the act, but that provision is inapplicable to partially processed biological products.
FDA disagrees with the comment. FDA licenses biological products under the authority of section 351 of the PHS Act. The PHS Act requires that biological products be licensed and be
(1) is not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
(2) is not intended for sale in the United States; and
(3) is intended for further manufacture into final dosage form outside the United States, shall be subject to no restriction on the export of the product under this chapter or the Federal Food, Drug, and Cosmetic Act * * * if the product is manufactured, processed, packaged, and held in conformity with current good manufacturing practice requirements or meets international manufacturing standards as certified by an international standards organization recognized by the Secretary and meets the requirements of section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act * * *.
Furthermore, it would be both unfair and illogical to interpret section 801(e)(1) of the act in a manner that would impose more requirements on persons who export foods, drugs, devices, and cosmetics, and comparatively fewer (if any) requirements on persons who export partially processed biological products.
The act and the PHS Act authorize additional recordkeeping requirements to demonstrate compliance with the other requirements for the export of partially processed biological products under section 351(h) of the PHS Act. Partially processed biological products are drugs under the act, and section 351(h) of the PHS Act allows such products to be exempt from both the PHS Act and from the act if certain requirements are met. The rule's recordkeeping requirements for exports under section 351(h) of the PHS Act will allow FDA to determine efficiently whether the terms of the exemption have been met and whether any violations of the act exist, which would be the case if the export does not comply with the exemption in section 351(h) of the PHS Act. The issuance of these regulations, therefore, is authorized under section 701(a) of the act, which gives FDA the authority to issue regulations for the efficient enforcement of the act.
Recordkeeping requirements to implement section 351(h) of the PHS Act are also authorized by section 361 of the PHS Act (42 U.S.C. 264). Under that section, FDA may make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases between the States. Because of their nature, partially processed biological products pose a potential risk of transmitting diseases because they may not have been treated to inactivate infectious agents or other harmful agents. FDA has determined that it may appropriately and effectively regulate partially processed biological products intended for export, and the risks associated with their movement in interstate commerce, by imposing recordkeeping requirements specific to exports under section 351(h) of the PHS Act.
FDA has, however, rewritten § 1.101(c)(2) through (c)(4) to adopt parallel sentence structure. These changes are intended to make the rule easier to read and have no substantive impact on the rule.
(Comment 30) Proposed § 1.101(c)(1) would require persons exporting a partially processed biological product under section 351(h) of the PHS Act to maintain records demonstrating that the product for export is a partially processed biological product, that is, “not in a form applicable to the prevention, treatment, or cure of disease or injuries of man.”
One comment said it would be impractical to create records to show that a product is a partially processed biological product. The comment said that a partially processed biological product “is just that, a partially processed biologic.”
FDA disagrees with the comment. Before Congress enacted the FDA Export Reform and Enhancement Act, FDA interpreted the term “partially processed biologic” in section 351(h) of the PHS Act as including products that require purification, inactivation, fractionation, or significant chemical modification before the partially processed biological product can be used in making a final product. To demonstrate that a product was a partially processed biological product, a firm provided either an explanation or documentation explaining the need to purify, inactivate, fractionate, or chemically modify the partially processed biological product before it could be used in a final product.
While the FDA Export Reform and Enhancement Act eliminated the need to submit an export application to FDA, it did not alter the term “partially processed biologic” or suggest any changes to FDA's interpretation of the term. Consequently, FDA expects firms to have records demonstrating that the product intended for export is, indeed, a partially processed biological product that is eligible for export under section 351(h) of the PHS Act. Those records may consist of an explanation or documentation explaining the need to purify, inactivate, fractionate, or chemically modify the partially processed biological product before it could be used in a final product.
(Comment 31) Proposed § 1.101(c)(4) would require a firm to maintain copies of all labeling that accompanies the partially processed biological product for export, such as a container label with the statement, “Caution: For Further Manufacturing Use Only,” and any package insert and to make such copies and package inserts available to FDA during an inspection.
One comment said the proposed requirement was unauthorized under the act and the PHS Act. The comment said that manufacturers should not have to keep copies of all labeling that accompanies an exported product.
FDA disagrees with the comment. The requirement to maintain copies of all product labeling is consistent with CGMP requirements. For example, as part of the batch product and control record requirements for drugs, 21 CFR 211.188(b)(8) requires retention of complete labeling control records, including specimens or copies of all labeling used in batch products. Section 351(h) of the PHS Act expressly requires that exported partially processed
The requirement to maintain copies of all product labeling is also consistent with the requirement in section 351(h)(2) of the PHS Act that a partially processed biological product intended for export not be “intended for sale in the United States” and the requirement in section 351(h)(3) of the PHS Act that the exported product be “intended for further manufacture into final dosage form outside the United States.” Without copies of all labeling, FDA would be unable to determine that the product is labeled in a manner consistent with these requirements. Section 1.101(c)(4) provides a practical approach for implementing sections 351(h)(2) and (h)(3) of the PHS Act because the labeling will help show that the product is not intended for sale in the United States, while the suggested cautionary statement will help demonstrate that the product is intended for further manufacture outside the United States. This cautionary statement is consistent with the statement required on other products intended for further manufacture, such as source plasma (see 21 CFR 640.70(a)(2)), and is also consistent with FDA's authority under section 361(h) of the PHS Act to make and enforce regulations to prevent the introduction, transmission, or spread of communicable disease.
Although FDA suggests the inclusion of the statement, “Caution: For Further Manufacturing Use Only,” on the label of exported partially processed biological products, the proposed rule did not mandate the use of that particular statement. The agency included a cautionary statement to give exporters specific information on label statements that may be sufficient to show that the product is intended for further manufacturing into a final dosage form outside the United States, as required by section 351(h)(3) of the PHS Act. The final rule, at § 1.101(c)(4), clarifies that exporters may use other records demonstrating that the exported partially processed biological product is intended for further manufacturing into a final dosage form outside the United States.
(Comment 32) One comment interpreted this provision as requiring valid marketing authorization for the partially processed biological product and stated that the act does not require valid marketing authorization for such products. The comment said that firms might export partially processed biological products for research purposes, for use in clinical evaluations, or for product evaluation before marketing. The comment suggested that an attestation by a company official in the foreign country suffice in place of valid marketing authorization.
The comment misinterprets the rule. Section 1.101(b)(2) and section 801(e)(1)(B) of the act only require that the product not be in conflict with the foreign country's laws. FDA does not interpret this to mean that the exported product must have valid marketing authorization in the foreign country to which it is being exported. FDA recognizes that some countries lack affirmative approval mechanisms for certain products and that some countries do not “approve” certain products, particularly products used for research or investigational purposes.
For biological products that may be regulated as devices (and devices generally), the Center for Devices and Radiological Health (CDRH) has information on countries that are nonresponsive to inquiries seeking permission either to market or to conduct clinical tests on devices. Because regulatory conditions pertaining to devices are rapidly changing in many countries, FDA recommends that firms first attempt to obtain authorization from an appropriate government official. If a firm is unsuccessful in establishing communications with a government official and/or obtaining any type of written authorization, or denial of authorization, from a foreign government, it may contact the Division of Program Operations, CDRH, for guidance.
FDA also reiterates that the final rule, as revised, accepts a certification from a responsible company official in the United States that the product does not conflict with the importing foreign country's laws.
Proposed § 1.101(d) would establish the notification requirements for drugs, biological products, and devices exported under section 802 of the act. In brief, proposed § 1.101(d)(1) would require exporters to provide written notification to the agency that identifies the article's name, identifies its generic name if the article is a drug or the article's type if the product is a device, describes the product's strength and dosage form (if the product is a drug or biological product) or the product's model number (if the product is a device), and identifies the country that is to receive the exported article.
The proposed rule acknowledged that, for exports to listed countries under section 802(b)(1) of the act, section 802(g) of the act requires the notification to identify only the drug, biological product, or device being exported, and does not expressly require the notification to identify the country to which the drug, biological product, or device is being exported. (In contrast, for drugs, biological products, or devices exported to nonlisted countries under section 802 of the act, section 802(g) of the act requires both identification of the exported product and the country to which the product is being exported.) Nevertheless, proposed § 1.101(d) would require that all export notifications under section 802(g) of the act identify the product and the importing country. FDA explained that it took this action because section 802(a)(2) of the act requires FDA to notify the “appropriate public health official” in the foreign country receiving an exported drug, biological product, or device if FDA disapproves a marketing application for the drug, biological product, or device, and section 802(f) of the act requires FDA to consult with the “appropriate public health official in the affected country” in the event that an exported drug, biological product, or device presents an imminent hazard to the public health. FDA further noted that similar consultation obligations exist if the product's labeling is not in accordance with the requirements and conditions for use in the country in which the drug, biological product, or device has valid marketing authorization and the country to which the drug, biological product, or device is being exported or if the drug, biological product, or device is not promoted in accordance with the labeling requirements of section 802(f) of the act. Thus, to facilitate these notifications and consultations with foreign officials (particularly in the event that FDA disapproves a drug, biological product, or device that has been exported, or the exported product presents an imminent hazard to the public health of the
(Comment 33) Many comments strongly objected to identifying a listed country. Most stated that the act did not require the notification to identify listed countries. Some comments dismissed FDA's rationale regarding its statutory obligation to consult foreign government officials as unlikely to occur or dismissed it without explanation. One comment described the proposed requirement to require notifications to identify the listed country as “casting a wide net to catch a few guppies at tremendous cost to the other fish,” and said FDA could conduct an inspection of the firm to obtain the information on the listed countries receiving an exported product. Another comment said that identifying a listed country would mean that FDA is questioning the foreign country's judgment. Others implied that identifying a listed country would be burdensome or would complicate export notifications.
A few comments said firms could voluntarily disclose the identity of the listed country in the notification, but could not be required to do so. One comment suggested that the notification state that the foreign country has provided valid marketing authorization, without identifying the listed country. Only one comment agreed with FDA's rationale to have the notifications identify all countries, including listed countries.
FDA agrees that, if it had to consult a foreign government as required by the act, it could inspect a firm's export records to determine whether listed countries received a particular export. This approach, however, would be much more time-consuming and costly both for the industry and the agency because FDA would have to schedule the inspection, the firm would have to locate and assemble export records, and FDA would have to examine those records before it learned the listed country's identity. Consultation with the listed country, as required by the act, would be delayed, and this could present public health concerns if the agency's obligation to consult the foreign government was due to an imminent hazard finding or if FDA disapproved the product because it was not safe or effective.
The agency also notes that export declarations required by the Bureau of the Census for certain exports and submitted to the U.S. Customs Service identify the ultimate consignee, by name and address, and, depending on the form used, the foreign port of unloading or intermediate consignees (see 15 CFR 30.7 (“Information Required on Shipper's Export Declarations”)). Assuming that firms use these export declarations, it would seem that identifying a listed country would be less burdensome or less problematic than identifying consignees by name and address. It is also difficult to see how requesting identification of a listed country in a notification sent to FDA, when the export declaration given to the U.S. Customs Service identifies the consignee and foreign port, can be characterized as “questioning” the judgment of a foreign country.
Nevertheless, given the distinction drawn in the statute and objections to this provision, FDA has revised § 1.101(d) to require identification of unlisted countries only. Firms may voluntarily identify a listed country in a notification, but are not required to do so. If a firm chooses to withhold the identification of a listed country, FDA suggests, but does not require, the firm to state in its notification that the export went to a listed country. (This will enable FDA to determine quickly that the firm did not neglect to identify an unlisted country.) If the statutory obligation to consult with a country receiving an exported product is triggered, FDA will conduct an inspection of the exporting firm to identify which listed countries it must contact.
(Comment 34) One comment said that approved products that are exported should not be the subject of an export notification, even if the product is exported for an unapproved use. The comment said that requiring notifications for these products would be inconsistent with Congressional intent to relieve manufacturers of export obligations and would be beyond FDA's jurisdiction. The comment said that foreign health authorities are “fully empowered to approve labeling and/or indications that they deem appropriate.”
The comment is only partially correct. Approved products that are exported for their approved indications and are otherwise in compliance with the act's requirements for marketing, distribution, and sale in the United States are not subject to the export requirements in section 802 of the act. For these exports, no notification is necessary.
However, exports of an “approved” product for an unapproved use are subject to section 802 of the act. For example, section 802 of the act applies to drugs that require approval under section 505 of the act (21 U.S.C. 355) “before such drug * * * may be introduced or delivered for introduction into interstate commerce.” The act defines “interstate commerce,” in part, as “commerce between any State or Territory and any place outside thereof.'' Exports fall within the definition of “interstate commerce” because the shipment originates in a State and is destined to a “place outside.” Additionally, contrary to the comment's suggestion, the exported drug is not “approved” by FDA because the intended use in the foreign country was not the subject of a FDA-approved application. To phrase this another way, FDA's approval processes includes approval of the drug's indications for use, so the fact that the agency may have approved the drug for other uses does not relieve the manufacturer from compliance with section 505 of the act when unapproved uses are concerned.
The agency notes that, as an alternative to section 802 of the act, such exports may be permitted under section 801(f) of the act. Exports under section 801(f) of the act must comply with the requirements in section 801(e)(1) and (f) of the act, but do not require notification to FDA. If a product can be exported under either section 802 or 801(f) of the act, the exporter has the option of determining which export authority to use.
(Comment 35) The proposed rule would require persons exporting a product in anticipation of market authorization in a listed country under section 802(d) of the act to comply with the notification requirements in proposed § 1.101(d)(1). The preamble to the proposed rule explained that this requirement would be consistent with an interpretation of section 802(g) of the act that considers the nexus between section 802(b)(1) and (d) of the act. Section 802(g) of the act requires exporters of drugs, biological products, and devices to provide a simple notification to the agency when they export a product to a listed country or to an unlisted country under section 802(b)(1) of the act. Section 802(b)(1) of the act permits exports when the drug, biological product, or device has valid marketing authorization in a listed country, whereas section 802(d) of the act permits exports to a listed country in anticipation of market authorization. FDA stated that a literal interpretation of section 802(g) of the act would not require an exporter to notify FDA when it shipped a product to a listed country in anticipation of market authorization, but would instead require the exporter to notify FDA when the exporter shipped the same product to the same country once it has marketing
Many comments objected to requiring a notification for exports under section 802(d) of the act, stating that the act did not authorize such notifications. Some said that FDA could not justify requiring such notification on the grounds that it would be more efficient or simpler. One comment viewed the proposed notification requirement as a prohibition on exports that would delay the availability of products. Another comment interpreted the rule as requiring two notifications—one for exports in anticipation of market authorization, and a second when the product received marketing authorization.
Only one comment agreed with the proposal, but reiterated that a subsequent notification once the product received marketing authorization should not be required.
FDA has revised the final rule to limit notifications to products exported under section 802(b) of the act. In other words, no notification is required if the export is made in anticipation of market authorization under section 802(d) of the act. A person who exports a product in anticipation of market authorization, and later receives marketing authorization, would only submit the notification to FDA when the first export occurs to a particular foreign country following marketing authorization in that country.
(Comment 36) One comment said that section 802(d) of the act permits anyone to export a product in anticipation of market authorization, regardless of who applied for market authorization.
Section 802(d) of the act is commonly referred to as allowing firms to “fill the pipeline” so that a product will be available immediately upon market authorization by a foreign country. If the comment's interpretation of section 802(d) of the act were correct, any firm could export the product so long as one firm was seeking market authorization. In other words, under the comment's interpretation, if firm A were seeking market authorization to sell a drug called X, firms B, C, and D could export drug X to the same foreign country under the guise of ``anticipating'' market authorization. The comment's interpretation of section 802(d) of the act also would place little weight on the term “anticipation” of market authorization. Arguably, if a firm has not applied for market authorization, it cannot be characterized as “anticipating” market authorization. The inclusion of the word “anticipation” in section 802(d) of the act suggests that the firm exporting the drug or device is, in fact, the entity that is seeking market authorization or would be capable of distributing that drug or device upon marketing authorization.
Consequently, FDA interprets section 802(d) of the act as follows. If the foreign country's product approval process is specific to an application (i.e., to have marketing authorization, a firm must submit an application, and the application must be approved), then a firm seeking to invoke section 802(d) of the act to export a drug or device to a foreign country must be seeking market authorization in that foreign country.
If, however, the foreign country's product approval process would allow multiple products on the market upon market authorization (i.e., once marketing authorization occurs, any person can market a drug or device that meets the conditions of that marketing authorization), then a firm seeking to invoke section 802(d) of the act to export a drug or device to such a foreign country does not have to be the firm that sought marketing authorization in that foreign country.
This interpretation of section 802(d) of the act acknowledges both the marketing authorization process in a foreign country and gives appropriate weight to the words “in anticipation of market authorization.”
(Comment 37) Proposed § 1.101(d)(1) would require a notification to identify the exported product by name. If the exported product were a drug or biological product, the proposal would require the notification to provide a generic name and a description of the product's strength and dosage form. If the exported drug were a device, the proposal would require the notification to identify the type of device and to provide its model number.
One comment stated that, because FDA is generally not able to examine sales and marketing information, it would be appropriate for the notification to contain information on the product, classification, lot code or unique identifying number, country of exportation, and whether or not the product was accepted.
FDA declines to revise the rule as suggested by the comment. The product-specific information described in § 1.101(d)(1) should be sufficient to identify a particular export. Firms are free to provide information on a lot code or a unique identifying number, but the final rule does not require this. Furthermore, because the act presumes that the United States is the country from which the product is exported and because section 801(e)(1)(B) of the act requires the exported product to be “not in conflict” with the foreign country's laws, FDA declines to require firms to identify the country of exportation or to state whether the product was “accepted.”
(Comment 38) FDA, on its own initiative, has revised § 1.101(d)(1)(ii) to replace “generic name” with “abbreviated or proper name.” In proposing to require the export notification to contain the product's “name” and its “generic name,” FDA intended to require persons exporting a human drug to identify the product by its trade name and its abbreviated chemical name and to require persons exporting a biological product to identify the product by its trade name and its proper name. However, the term “generic name” created some confusion within FDA as to whether FDA was specifically interested in generic drug products. Consequently, FDA has revised § 1.101(d)(1)(i) to require the notification to identify the product's trade name while § 1.101(d)(1)(ii) now requires the notification to contain the exported product's “abbreviated or proper name.” The agency has made a similar change to § 1.101(e)(1)(i) and (e)(1)(ii).
The agency has also inserted language referring to biological products in § 1.101(d)(1) to clarify that investigational biological products may be exported under section 802(c) of the act and that biological products may be exported in anticipation of marketing authorization under section 802(d) of the act.
(Comment 39) A few comments addressed the frequency of export notifications. Two comments said notifications should be required only for the first export of a product. The comments stated that subsequent exports should not result in notifications, although the comments were unclear whether the subsequent export could be to a different country than the initial export.
Section 802(g) of the act requires an exporter of a drug or device to provide
In the other scenario, when the export is to an unlisted country, section 802(g) of the act requires the exporter to provide the simple notification when it first begins to export the drug or device to that unlisted country, and the notification must identify the unlisted country. The act, therefore, requires a simple notification whenever the exporter first ships a drug or device to an unlisted country. Thus, to use the same illustration, if company X, under section 802(b) of the act, wants to export a drug to unlisted country D, company X must provide a simple notification that identifies the drug being exported and must also identify unlisted country D. Subsequent exports of the same drug to unlisted country D would not require company X to send a simple notification to FDA. However, if company X later wants to export the same drug to unlisted country E under section 802(b) of the act, company X must provide another simple notification to FDA, and the simple notification must identify the drug being exported and unlisted country E.
(Comment 40) In the preamble to the proposed rule, FDA invited comment on possible alternatives to this notification requirement that would satisfy the consultation, notification, and recordkeeping obligations and requirements in section 802 of the act. The agency was especially interested in alternatives that would reduce the paperwork burden, such as electronic submissions and recordkeeping or periodic notifications (e.g., monthly, quarterly), and the details of such alternatives.
One comment suggested that FDA accept export notifications that covered more than one country. Another comment suggested that FDA accept notifications on an annual basis, or no more often than a biannual basis, that the notifications be submitted in tabular form and submitted directly, if not electronically, to FDA. One comment suggested that FDA develop an interactive website so exporters could “fill in the blanks.” Another comment suggested using Operational and Administrative System for Import Support (OASIS) system entries as notifications under section 802(g) of the act and would have annual reports submitted by exporters serve as confirmation of the export; the comment said that the notifications described in the proposed rule would add significant costs to manufacturers.
FDA appreciates the comments' suggestions. The agency does not object if a simple notification covers more than one country; nothing in the act or these regulations prevents firms from identifying more than one country in a simple notification. Furthermore, if the foreign purchaser's specifications change after the first shipment, and the new specifications result in a drug or device that is not significantly different from the first exported drug or device, an exporter may, but is not required to, provide a new notification. For example, assume that company X is exporting an electronic device to listed country A. Later, the foreign purchaser revises its product specifications to change the voltage requirements for the device. The revised product specifications call for an electronic device that is substantially similar to the original electronic device, so FDA would not require another notification.
In contrast, if company X is exporting a combination drug to listed country A, and the foreign purchaser revises its product specifications to substitute a different active ingredient, the drug to be exported has changed significantly, and FDA would expect the exporter to provide a new simple notification to cover the changed drug product when the exporter “first begins” to export the changed drug product.
As for electronic submissions and other technology, FDA intends to explore options for facilitating notification to FDA, but is unable to create an interactive, web-based system at this time. The agency is also unable to adapt the OASIS system to cover notifications because the OASIS system focuses on imports, not exports, and is operationally separate from FDA's administrative oversight of exports.
As for annual or semiannual submissions, the agency considered these options, but section 802(g) of the act appears to contemplate more timely notifications. The act requires notifications when the exporter “first begins” to export the drug or device under section 802(b)(1) of the act, so the most logical interpretation of the phrase “first begins” would mean that exporters must provide the notification to FDA when they actually export the drug or device.
(Comment 41) FDA, on its own initiative, has revised the address for export notifications involving biological products and devices regulated by the Center for Biologics Evaluation and Research. The final rule replaces “Office of Compliance” with “Office of Compliance and Biologics Quality.” This change reflects the current office name.
Proposed 1.101(e) would establish additional recordkeeping requirements for exported drugs, biological products, and devices subject to section 802(g) of the act. These records would include, but not be limited to: (1) Records concerning the product's name, (2) the product's generic name if the product is a drug or a biological product or the type of device if the product is a device, (3) a description of its strength and dosage form and the product's lot or control number (if the product is a drug or biological product) or the product's model number (if the product is a device), (4) the consignee's name and address, and (5) the date on which the product was exported and the quantity of product exported.
(Comment 42) Several comments objected to most or all of the proposed recordkeeping requirements. Some comments argued that manufacturers already keep CGMP records and that none of the information sought in proposed § 1.101(e) is required or even authorized by law. Another comment said the proposed recordkeeping requirement was “excessive” because it required too many documents be kept. Another comment said FDA should only require companies to keep records of exports to countries where they directly export drugs; if the drugs were subsequently exported elsewhere by the importing company, the importing company would be responsible for records of shipments to third countries.
One comment sought clarification, asking if the records required by § 1.101(e) are distinct from the quality system regulation records required for devices under 21 CFR part 820.
Section 802(g) of the act clearly states that, “Any exporter of a drug or device shall maintain records of all drugs or
Moreover, persons exporting drugs or devices, particularly persons who manufacture the exported drug or device, should already possess the information sought in § 1.101(e). For example, § 1.101(e)(1)(i) requires records containing the product's name. Most prudent exporters know the names of the products being exported. Section 1.101(e)(1)(ii) and (e)(1)(iii) requires records to contain more specific information about the drug or device, such as the drug's strength and dosage form or the type of device and its model number. A manufacturer who is exporting products should know the product's abbreviated name or proper name, strength, dosage form, and lot or control number (if the product is a drug or biological product) or the type of device and model number (if the product is a device), because this information is related to CGMPs for the product (see, e.g., 21 CFR 211.100 (written procedures for production and process control), 211.110 (sampling and testing of in-process materials and drug products), 820.70 (production and process controls for devices), and 820.160 (requiring device manufacturers to maintain distribution records which include or refer to the location of the consignee's name and address, the identification and quantity of devices shipped, the date shipped, and control numbers used). Additionally, section 802(f)(1) of the act prohibits exportation of a drug or device, under section 802 of the act, if the drug or device is not manufactured, processed, packaged, and held in substantial conformity with CGMP requirements. Thus, an exporter who is in substantial conformity with CGMPs should already possess the information described in § 1.101(e)(1)(ii) and (e)(1)(iii). Finally, § 1.101(e)(1)(iv) and (e)(1)(v) require the records to include the consignee's name and address, the date on which the product was exported, and the quantity of product exported. Presumably, an exporter knows where it is sending a product, when it ships the product, and how much was shipped.
FDA emphasizes that § 1.101(e) does not require exporters to keep duplicate sets of records—one for export purposes and another for CGMP purposes—nor does it require exporters to create new records if the exporter keeps the information described in § 1.101(e) elsewhere. The records sought by § 1.101(e) may be part of the exporter's CGMP or QS regulation records.
Furthermore, to give exporters additional flexibility in meeting this requirement, FDA has amended § 1.101(e)(2) to state that the records may be kept at the site from which the products were exported “or manufactured.” This change will accommodate firms who manufacture products for export and are responsible for the product's exportation, but who send the product to another location for packaging or other operations before exportation occurs.
(Comment 43) Two comments asked FDA to clarify what it wanted regarding a consignee's name and address. The comments explained that devices are often exported to distribution centers, and so the comment suggested that distribution centers should be acceptable as consignees. Other comments said FDA cannot require any records identifying a consignee. The comments asserted that the act does not require or even authorize FDA to require such information.
FDA does not object if a distribution center in a foreign country is listed as a “consignee” under this rule. Identification of the consignee's name and address is intended to help FDA in the event that it has to consult foreign government officials regarding an exported product. The consignee's name and address will inform government agencies where the exported drug or device was first sent and will help speed efforts to recover or to prevent the distribution of potentially hazardous products.
As for those comments objecting to identifying a consignee, FDA's general rulemaking authority in section 701(a) of the act provides sufficient statutory authority to require these records. FDA also believes that exporters would retain records identifying the consignee, by name and address, as part of their normal business practices because, presumably, the consignee ordered the drugs or devices and must pay for and receive the exported product. FDA further notes that export declarations submitted to the U.S. Customs Service must identify ultimate consignees by name and address, and, depending on the form used, may even identify intermediate consignees. Thus, exporters should have information regarding a consignee's name and address.
(Comment 44) Proposed § 1.101(e)(2) would require exporters to keep records at the site from which the products were exported and to maintain those records for at least 5 years after the date of exportation.
Several comments objected to the 5-year period. Two comments advocated a 2-year period in order to be consistent with the QS regulation requirements. One comment suggested retaining records for 3 years after the product's expiration date. Another comment criticized the agency for not providing a rationale for the 5-year period; this comment said that 5-year period might be too long in some situations, but not long enough in others, and said the time period was inappropriate without some rationale and a link to the act.
The records required in § 1.101(e) are similar, if not identical to, some records that are kept for CGMP or QS regulation purposes. To make recordkeeping easier for firms, FDA has revised the rule to state that these records must be retained in accordance with the record retention period for CGMP or QS regulation records. FDA reiterates that firms may use their CGMP or QS regulation records for dual purposes (i.e., to demonstrate compliance with CGMP or QS regulation requirements and to demonstrate compliance with the export regulations in § 1.101) and do not have to keep dual sets of records.
(Comment 45) One comment said that proposed § 1.101(e) did not apply to investigational new drugs exported under section 802(c) of the act, but said that companies maintain records on such exports due to other obligations, such as CGMP requirements.
FDA disagrees with the comment's interpretation. The relevant portion of section 802(g) of the act states that “any exporter of a drug or device” shall maintain records; this differs from the other sentences in section 802(g) of the act which refer to exporters of drugs or devices exported under section 802(b)(1)(A) of the act. As a result, § 1.101(e) does apply to exports of investigational drugs under section 802(c) of the act.
Several comments addressed issues concerning implementation of the rule or other export matters.
(Comment 46) One comment asked how the rule relates to other export documents issued by FDA. Another comment said interpreting sections 801 and 802 of the act is complicated by the lack of clear implementing regulations; the comment said it is difficult to determine which requirements apply to a given product and asked FDA to
FDA prepared four agency wide documents to implement the FDA Export Reform and Enhancement Act. The agency developed a draft guidance document describing its interpretation of the export provisions; the guidance document is not binding on regulated industries or on FDA. For binding requirements, FDA prepared three regulations: (1) A rule to implement the “import for export” requirements in section 801(d) of the act, (2) a rule pertaining to export notifications and recordkeeping (which is presented here), and (3) a rule pertaining to exports of investigational new drugs (which FDA intends to publish in the
Other export-related documents issued by FDA include a rule on investigational device exports (now codified at § 812.18(b) (21 CFR 812.18(b))) and a Compliance Policy Guide, CPG 7150.01, “Certification for Exports,” on export certificates.
FDA agrees that implementing sections 801 and 802 of the act is difficult because the statutory requirements apply to different products in different ways. For example, most human drugs are subject to the export requirements in sections 802 and 801(e)(1) of the act, but insulin and antibiotics for human use and animal drugs are only exported under section 801(e) of the act. Most devices can be exported under section 801(e) or section 802 of the act, and either choice carries its own set of requirements. FDA prepared the guidance document in an effort to sort out the various requirements for each product and drafted the regulations to create binding requirements where such requirements were necessary. The agency decided against drafting a single rule because there was little overlap or commonality between subjects. For example, the import for export requirements are not relevant for exports of investigational new drugs, so a single rule would have been inappropriate and confusing.
(Comment 47) One comment asked FDA to phase-in the rule to minimize its impact on commerce.
The final rule is effective March 19, 2002. This should give firms sufficient time to comply with the rule.
(Comment 48) One comment said FDA should conduct educational seminars or programs, in conjunction with the U.S. Customs Service and with the support of various trade associations, or do a televised program whose agenda is developed by industry and Federal agencies.
FDA has, in the past, participated in conferences and educational programs that have discussed export matters, and individual centers have prepared guidance documents and other materials on selected topics. For example, CDRH has prepared a videotape on export issues. The agency intends to continue its participation in educational conferences and programs to the extent that its resources permit.
(Comment 49) One comment would revise § 1.101 to require only a simple notification for drugs and devices exported for investigational use. The comment said that drugs and biological products that are exported for investigational use and are the subject of an IND are regulated more strictly than drugs and biological products that are exported for investigational use without an IND. The comment said that FDA authorization is needed under § 312.110, but drugs that are exported without an IND only require a simple notification to FDA. Consequently, the comment would revise the export provisions in both parts 312 and 812 (21 CFR part 812) to require only simple notifications for drugs and devices exported for investigational use.
The agency declines to revise § 1.101 as suggested by the comment. Section 802(g) of the act only requires simple notifications for exports under section 802(b)(1) of the act. FDA expects most exports of drugs or devices for investigational use in a listed country will fall under section 802(c) of the act; this means that exports of investigational drugs or devices to a listed country do not require a person to provide a simple notification to FDA. If, however, a firm exports a drug or device for investigational use under section 802(b)(1) of the act, the firm will have to provide a simple notification to FDA.
Additionally, as stated earlier, FDA intends to publish a proposed rule in the
(Comment 50) The draft guidance document discussed FDA's position on transshipment of investigational drugs and devices (the shipment of an export from one country to a second country, followed by the shipment of the same product from the second country to a third country) (see 63 FR 62219 at 32228). The draft guidance document interpreted section 802(c) of the act as not allowing transshipment from a listed country to an unlisted country because the act does not suggest that the listed countries are mere transfer points or conduits for investigational drugs and devices destined for unlisted countries and because allowing transshipment from listed to unlisted countries would undermine the statutory limitation on investigational drug and device exports to listed countries. The proposed rule on export notifications and recordkeeping was silent on this issue.
Nevertheless, two comments submitted to the proposed rule (instead of the draft guidance document) objected to FDA's position on transshipment. The comments argued that shipments between listed and unlisted countries are matters covered by foreign law and that FDA's interpretation would restrict a firm's ability to conduct clinical trials outside the United States or otherwise defeat congressional intent and deprive foreign governments of the “right” to determine whether subsequent exports should be made.
The issue of transshipment of investigational drugs and devices is not relevant to the final rule. Nevertheless, the unrestricted transshipment of investigational drugs and devices from listed to unlisted countries would undermine the express limitation in section 802(c) of the act. Section 802(c) of the act allows exports of drugs and devices “intended for investigational use in any [listed] country * * * in accordance with the laws of that country.” The key statutory phrase is that the drug or device must be intended for investigational use in a listed country. In a transshipment scenario, the drug or device is intended for investigational use in an unlisted country, and this would be contrary to section 802(c) of the act.
However, if the investigation in the unlisted country is subject to the laws and regulations of the listed country—in other words, if persons in the listed country remain responsible for the conduct of the clinical trial and the investigation complies with the listed country's laws—shipment to an unlisted country is not contrary to the act. To illustrate how this works, assume that an investigational new drug is exported
If, however, the investigational drug is simply shipped to a warehouse in country LC and then shipped to country X, without anyone in country LC being responsible for the investigation or having the investigation remain subject to country LC's laws, then the export would not comply with section 802(c) of the act. The statutory requirements in section 802(c) of the act would not be met because the investigational use was never intended to be in the listed country and is not subject to country LC's laws.
The agency has determined under 21 CFR 25.30(h) 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.
The proposed rule estimated the costs associated with submitting notifications to FDA and maintaining records. FDA based its estimates on the number of notifications received by FDA in 1996 or 1997 (depending on the last year for which complete figures were available at the time of the proposed rule) and consultations with industry sources (64 FR 15944 at 15946). The Office of Management and Budget (OMB), in reviewing FDA's Paperwork Reduction Act documents, neither approved nor rejected FDA's request for approval of a new information collection. Instead, OMB stated that it had concerns regarding the burden and utility of the collection which shall be assessed in light of public comments received. FDA received several comments on the agency's estimates.
(Comment 51) For the recordkeeping requirements for human drugs, biological products, animal drugs, devices, foods, and cosmetics exported under or subject to section 801(e)(1) of the act, FDA estimated that there would be an average of 318 recordkeepers per year, at a annual frequency of 2.8 records per respondent, at 1 hour per record. One comment said that FDA “grossly underestimated” the recordkeeping burden because the rule presents significant burdens on food manufacturers and creates “an entirely new recordkeeping bureaucracy for exporters of food products.” The comment stated that translating letters alone will take more than 1 hour per product.
FDA disagrees with the comment. Section 801(e)(1) of the act is not a new statutory requirement, particularly when applied to food exports, so it does not present a new or significant burden on food manufacturers or create “an entirely new recordkeeping bureaucracy.” Additionally, the final rule reduces any burden on exporters by revising certain requirements; for example, the final rule clarifies that the foreign purchaser's specifications should provide sufficient detail to be linked to a particular export and that a responsible company official may certify that the export does not conflict with the importing country's laws.
While FDA concedes that § 1.101(b) does, in one instance, seek English-language translations of foreign documents, presumably a prudent U.S. company would translate foreign-language documents as part of its ordinary business practice, if only to ensure that the foreign-language document is what it purports to be or that the U.S. company truly understands the contents of the foreign-language document or that the U.S. company would be able to translate the foreign-language document into English.
As for the burden hour estimate for § 1.101(b), FDA, as explained below, has increased the burden hour estimate to 24 hours per record.
(Comment 52) The preamble to the proposed rule estimated the total information collection burden to be 2,659 hours and that no capital costs or operating and maintenance costs would result.
Several comments said FDA underestimated the total and that firms would incur new costs. Two trade associations, representing device manufacturers and drug manufacturers, indicated that the estimated information collection burden and costs for a single firm would be significant. For example, one device firm was said to market its products in 90 countries and in approximately 600 different packaging and labeling configurations. According to the comment, to meet the proposed recordkeeping requirements, the firm would need new records for at least 500 configurations, at $30 per hour and 4 hours per record (for a total update cost of $60,000) and recordkeeping costs would be $100 per hour for 500 records, or an additional $50,000. For new products, estimated record preparation costs would be $30 per hour x 4 hours x 84 products (or $10,080) and recordkeeping costs of $8,400. As another example, a trade association representing the drug industry interpreted the rule as requiring detailed records on product specifications and translations. The comment said that one drug company estimated that it spends 160 employee hours of “regulatory time” and 80 person hours of “legal time” alone to obtain documentation necessary to export to a single multicenter trial in Latin America and Eastern Europe. (The comment did not explain what “regulatory time” or “legal time” are.) The comment did not provide an estimate of the information collection burden because it said that FDA's requirements were open-ended; instead, it declared FDA's estimates to be “unrealistic.” Two comments also said that drug companies would need to spend $50,000 to $100,000 in capital costs alone to upgrade their computers to comply with the proposed requirements.
FDA reiterates that its estimates were based on the number of export notifications FDA has received and on information provided by industry sources. Those industry sources varied in terms of the amount of time required to maintain a record or to submit a notification, and none indicated that computer upgrades would be necessary. The averages must be compared against the estimates provided in the comments, which are based on information from a single company.
The agency also disagrees, in part, with the estimates provided by a single device firm. In general, devices may be exported under section 801(e) or 802 of the act. The agency reiterates that, for devices, the requirements in section 801(e)(1) of the act are not new; consequently, if the devices are exported under section 801(e) of the act, the comment's claim that hundreds of “new” records would be required cannot be accurate unless the firm has not been retaining any documents to show its compliance with section 801(e)(1) of the act. In contrast, if the firm is exporting devices under section 802(b) of the act, section 802(g) of the act would require the firm to submit a notification to FDA. Yet FDA's export notification records do not reveal a significant number of device exports or a significant number attributable to one firm. The average number of export notifications received was 244 per year. This average covers both drug and device firms and is far lower than the
Nevertheless, FDA has increased the recordkeeping burden hour estimate for § 1.101(b) from 2 hours to 24 hours. This estimate exceeds the 4-hour estimate submitted by the device firm and is consistent with a comment (described below in comment 53) from a drug company.
FDA declines to adopt the 240-hour figure provided by a drug company for exports of a drug for investigational use because FDA cannot determine what activities are covered by the comment's estimate or whether the comment's estimate even involves activities that are covered by the rule. For example, the comment stated that it devoted considerable time assembling documents to export drugs to a single multicenter trial in Latin America and Eastern Europe. The comment's reference to Latin America and Eastern Europe suggests that the firm is not exporting the drugs under section 802(c) of the act because section 802(c) of the act pertains solely to exports of investigational new drugs and devices to listed countries, and Latin American and Eastern European countries are not listed countries. So, to export a drug for investigational use, the firm must be exporting the investigational new drugs under an IND or under § 312.110, or the exported drugs have marketing authorization from a listed country. (It is possible that the firm could export an investigational new drug under section 802(b)(1) of the act if the drug received market authorization from a listed country, but the comment did not indicate that the investigational new drug has such market authorization.) Yet this final rule does not address exports under an IND or § 312.110, and therefore, if the firm's comment is relevant to this rule, the firm would have to be exporting drugs that have marketing authorization from a listed country and using those drugs for investigational use in Latin America and Eastern Europe. Assuming this to be the case, the changes in the final rule, such as accepting a certification from a responsible company official in place of a letter from a foreign government and clarifying FDA's expectations regarding a foreign purchaser's specifications, should reduce the firm's information collection burden.
(Comment 53) One comment said that FDA underestimated the rule's financial impact. The comment explained that, for a single firm, “notifications” for section 801(e) of the act (which FDA presumes to be “records” because section 801(e)(1) of the act does not require notification) will result in five files and five records per year and require 24 to 32 hours for each export file. For notifications under section 802(g) of the act, there will be 10 files and 7 records per year, at 0.75 hours per export notification and 16 hours per export file. For partially processed biological products, the comment claimed its averages as 18 files and 5 records per year, at 16 hours per export file.
FDA has increased the burden hour estimate for records under § 1.101(b) to 24 hours per record. The agency declines to use the higher estimate of 32 hours because the final rule simplifies the types of records that are required to show compliance with section 801(e)(1) of the act. For example, the final rule accepts a company official's notarized certification that the exported product is not in conflict with the foreign country's laws, whereas the proposed rule would have required a letter from a foreign government official.
FDA did not revise the estimates for § 1.101(d). Although the comment suggests that the average number of notifications is greater than 2.4 per respondent, the comment's claimed average of five notifications per year may be accurate for that particular firm and may not be applicable to all firms exporting products. FDA based its estimate on the total number of notifications received and the total number of firms submitting notifications. FDA further notes that its estimate of 1 burden hour per notification is actually greater than the comment's estimate of 0.75 burden hours per notification. The comment's average time may reflect that firm's efficiency in processing notices, and FDA will not assume that all firms are as efficient.
As for partially processed biological products, although the comment suggests that the average number of notifications is greater than 2.4 per respondent, the comment's claimed average of five notifications per year may be accurate for that particular firm and may not be applicable to all firms exporting products. FDA based its estimate on the total number of notifications received and the total number of firms submitting notifications. The agency is, however, increasing the burden hour estimate for § 1.101(e) from 2 to 16 hours as suggested by the comment.
This final rule contains information collection requirements which are subject to review by OMB under the Paperwork Reduction Act of 1995. The title, description, and respondent description of the information collection requirements are shown below, with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The estimates are based on the number of notifications received by the relevant FDA centers in 1996 or 1997 (depending on the last year for which figures were available) as well as consultations with and comments from industry sources.
As required by section 3507(d) of the Paperwork Reduction Act of 1995, FDA has submitted a copy of this rule to OMB for its review of these previously approved information collection requirements.
FDA has examined the impacts of this rule under Executive Order 12866 and the Regulatory Flexibility Act (Public Law 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize new benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes this rule is consistent with the regulatory philosophy and the principles identified in the Executive order. In addition, OMB has decided that the rule is a significant regulatory action as defined in the Executive order.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The rule establishes the notification and recordkeeping requirements for persons exporting various FDA-regulated products under sections 801(e) and 802 of the act and section 351(h) of the PHS Act. The notification and recordkeeping requirements are minimal and involve information that should already be in an exporter's possession (such as the name of the product being exported, a description of the product being exported, and the date of exportation). Thus, FDA certifies that this rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501
The agency has determined that the final rule is not a significant action as defined in the Unfunded Mandates Reform Act, and will not have an effect on the economy that exceeds $100 million in any one year.
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.
1. The authority citation for 21 CFR part 1 is revised to read as follows:
15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.
(a)
(b)
(1) Records demonstrating that the product meets the foreign purchaser's specifications: The records must contain sufficient information to match the foreign purchaser's specifications to a particular export;
(2) Records demonstrating that the product does not conflict with the laws of the importing country: This may consist of either a letter from an appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with that country's laws, or a notarized certification by a responsible company official in the United States that the product does not conflict with the laws of the importing country and that includes a statement acknowledging that he or she is subject to the provisions of 18 U.S.C. 1001;
(3) Records demonstrating that the product is labeled on the outside of the shipping package that it is intended for export: This may consist of copies of any labels or labeling statements, such as “For export only,” that are placed on
(4) Records demonstrating that the product is not sold or offered for sale in the United States: This may consist of production and shipping records for the exported product and promotional materials.
(c)
(1) Records demonstrating that the product for export is a partially processed biological product and not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
(2) Records demonstrating that the partially processed biological product was manufactured in conformity with current good manufacturing practice requirements;
(3) Records demonstrating the distribution of the exported partially processed biological products; and
(4) Copies of all labeling that accompanies the exported partially processed biological product and other records demonstrating that the exported partially processed biological product is intended for further manufacture into a final dosage form outside the United States; this may include a container label with the statement, “Caution: For Further Manufacturing Use Only” and any package insert.
(d)
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's abbreviated or proper name or, if the product is a device, the type of device;
(iii) If the product is a drug or biological product, a description of the product's strength and dosage form or, if the product is a device, the product's model number; and
(iv) If the export is to a country not listed in section 802(b)(1) of the act, the country that is to receive the exported article. The notification may, but is not required to, identify countries listed in section 802(b)(1) of the act or state that the export is intended for a listed country without identifying the listed country.
(2) The notification shall be sent to the following addresses:
(i) For biological products and devices regulated by the Center for Biologics Evaluation and Research—Division of Case Management (HFM-610), Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, rm. 200N, Rockville, MD 20852-1448;
(ii) For human drug products—Division of Labeling and Nonprescription Drug Compliance (HFD-310), Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855-2737;
(iii) For devices—Division of Program Operations (HFZ-305), Center for Devices and Radiological Health, Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850.
(e)
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's abbreviated or proper name or, if the product is a device, the type of device;
(iii) If the product is a drug or biological product, a description of its strength and dosage form and the product's lot or control number or, if the product is a device, the product's model number;
(iv) The consignee's name and address; and
(v) The date on which the product was exported and the quantity of product exported.
(2) These records shall be kept at the site from which the products were exported or manufactured, and be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product. The records shall be made available to FDA, upon request, during an inspection for review and copying by FDA.
Environmental Protection Agency (EPA).
Direct final rule.
EPA is approving a revision to the state of Kansas' section 111(d) plan for controlling emissions from existing hospital/medical/infectious waste incinerators. The state revised its existing plan to establish increments of progress and a new compliance date for two HMIWI sources. Approval of the revised state plan will ensure that these requirements are Federally enforceable.
This direct final rule will be effective February 19, 2002. unless EPA receives adverse comments by January 18, 2002. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the
Comments may be mailed to Wayne Kaiser, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101.
Copies of documents relative to this action are available for public inspection during normal business
Wayne Kaiser at (913) 551-7603.
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
Information regarding this action is presented in the following order:
Section 111(d) of the Clean Air Act (CAA) requires states to submit plans to control certain pollutants (designated pollutants) at existing facilities (designated facilities) whenever standards of performance have been established under section 111(b) for new sources of the same type, and EPA has established emission guidelines (EG) for such existing sources. A designated pollutant is any pollutant for which no air quality criteria have been issued, and which is not included on a list published under section 108(a) or section 112(b)(1)(A) of the CAA, but emissions of which are subject to a standard of performance for new stationary sources.
Standards and guidelines for new and existing HMIWIs were promulgated under the authority of sections 111 and 129 of the CAA on September 15, 1997 (62 FR 48374). These standards are 40 CFR part 60, subpart Ec for new sources, and 40 CFR part 60, subpart Ce for existing sources.
The subpart Ce EG is not a direct Federal regulation but is a “guideline” for states to use in regulating existing HMIWIs. The EG requires states to submit for EPA approval a section 111(d) state plan containing air emission regulations and compliance schedules for existing HMIWIs.
We originally approved the state's HMIWI 111(d) plan on July 14, 2000 (65 FR 43702), and it became effective on September 12, 2000. Sources were required to be in compliance within one year of the effective date of EPA approval of the state plan, i.e., September 12, 2001, or in any case no later than September 15, 2002. Sources may petition the state for a compliance date extension beyond September 12, 2001, if they are planning to install air pollution control equipment and if they commit to an increment of progress schedule. The final compliance date cannot extend beyond September 15, 2002, however.
Two HMIWIs in Kansas, one each located in Johnson and Wyandotte Counties, requested that they be granted until September 15, 2002, or an additional year, to come into compliance. Both sources justified the need for additional time in order to install air pollution control equipment and related operating and monitoring equipment. The state has approved these requests.
The state has included increments of progress dates in the sources' compliance schedules. Dates have been established for: award of contracts, commence on-site construction, complete initial startup, calibration and adjustment, conduct required performance testing, and demonstrate final compliance. The final compliance date is September 15, 2002.
These compliance extensions constitute a revision to the compliance date that was contained in the approved 111(d) plan. Thus, the state has submitted the new compliance schedules for these two sources to us for approval as an amendment to its 111(d) plan.
This action will ensure consistency between the state plan and the approved Federal plan, and ensure Federal enforceability of the approved state plan.
We are approving these revisions to the state's HMIWI 111(d) plan. We are processing this action as a final action because the revisions make routine changes to the existing plan which are noncontroversial. Therefore, we do not anticipate any adverse comments. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves a state action as meeting Federal requirements and imposes no additional requirements. 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
In reviewing state plan submissions, our role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), we have no authority to disapprove state submissions for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews state submissions, to use VCS in place of state submissions that otherwise satisfy the provisions of the CAA. 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, we have taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in
The Congressional Review Act, 5 U.S.C. section 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 19, 2002. 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).)
Environmental protection, Air pollution control, Carbon monoxide, Hydrocarbons, Intergovernmental relations, Lead, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
42 U.S.C. 7401
(d) Amended plan for the control of air emissions from hospital/medical/infectious waste incinerators submitted by the Kansas Department of Health and Environment on October 25, 2001. This plan revision establishes a final compliance date of September 15, 2002, for two incinerators in Johnson and Wyandotte Counties, Kansas. The effective date of the amended plan is February 19, 2002.
Environmental Protection Agency (EPA).
Final rule; technical correction.
EPA issued a final rule in the
This regulation is effective December 19, 2001. Objections and request for hearings, identified by docket control number OPP-301179A, must be received by EPA on or before February 19, 2002.
Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method provided in Adverse comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit II. of the
By mail: Libby Pemberton, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9364; e-mail address: pemberton.libby@epa.gov.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
A final rule to establish time-limited tolerances for combined residues of sethoxydim and its metabolites containing the 2-cyclohexen-1-one moiety (calculated as the herbicide) on various commodities was published in the
This final rule implements a technical correction to the CFR, and it does not otherwise impose or amend any requirements. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346a, 371.
(b) * * *
Veterans' Employment and Training Service, Department of Labor.
Interim final rule; request for comments.
The Veterans' Employment and Training Service (VETS) is amending its regulations implementing the VETS-100 reporting requirement. This amendment revises the final rule that was published on October 11, 2001 (66 FR 51998), and that went into effect on November 13, 2001, to withdraw from the rule the specification for how Federal contractors filing the report were to calculate the maximum and minimum number of employees. The basic requirement to report the maximum and minimum number of employees remains.
Comments should be sent to Norman Lance, Chief, Investigations and Compliance Division, VETS, by regular mail at the U.S. Department of Labor, Veterans' Employment and Training Service, Federal Contractor Program FRN-Comments—Interim Final Rule, Federal Contractor Program Office, 6101 Stevenson Avenue, Alexandria, VA 22304, or by e-mail at
Norm Lance, Chief, Investigations and Compliance Division, VETS, at (202) 693-4731 or by e-mail at
The Veterans Employment Opportunities Act (VEOA) was signed into law in October 1998. The statute extended the affirmative action and reporting responsibilities of Federal contractors and subcontractors. Among other changes, the VEOA added the requirement that contractors and subcontractors report the maximum number and the minimum number of persons they employed during the reporting period to the Secretary of Labor.
On October 5, 2000, VETS published a Notice of Proposed Rulemaking (65 FR 59684) to implement the provisions of the VEOA, including the requirement for reporting the minimum and maximum number of employees. The Notice of Proposed Rulemaking did not contain guidance on how covered contractors were to determine the minimum and maximum number of employees. One commenter asked for clarification about how to determine the minimum and maximum number of employees. The commenter asserted that there could be continuous changes in employment levels at a company and that it was unclear exactly when the minimum and maximum number of employees had to be determined. To respond to the concerns of the commenter, VETS clarified the regulation language by adding the following language to the final rule:
The minimum and maximum number of employees reportable at each hiring location during the period covered by the report must be determined as follows: Contractors must review payroll records for each of the pay periods included in the report. The minimum number of employees is the total number of employees paid in the payroll period in which the contractor had the fewest number of employees. The maximum number of employees is the total number of employees paid in the payroll period in which the contractor had the greatest number of employees.
This new language was inserted in section 61-250.10(a)(3), and also in section 61-250.11 under the paragraph entitled “Maximum and minimum number of employees.” (66 FR 52004-52005, October 11, 2001).
It has been brought to the attention of VETS that the revised language might have inadvertently increased the record keeping burden on some contractors. VETS has learned that it might be difficult to match up payroll periods, employees, and physical VETS-100 reporting locations in the way contemplated by the final rule. For example, some companies use separate payrolls and pay dates for nonexempt and exempt employees within a single establishment. Other companies maintain separate payrolls and pay dates for bargaining unit employees and nonbargaining unit employees. Some companies temporarily remove employees who are on short-term leaves of absence from their payrolls. These absent employees, however, still may be considered “active” employees for purposes of the VETS-100 report.
To permit contractors flexibility in how they determine the maximum and minimum number of employees, VETS is making two amendments to part 61-250. In each place in which the instructions quoted above were placed in the rule, the instructions now are being withdrawn. Accordingly, contractors will be required to report the maximum and minimum number of
However, VETS expressly requests comments on the methods contractors intend to use to calculate the minimum and maximum number of employees. VETS plans on publishing this information, either in regulatory format or as guidance to contractors, for future reporting cycles.
Section 61-250.10(a)(3). The language quoted above that specified how contractors were to determine the maximum number and minimum number of employees is withdrawn. Contractors are still obligated to provide a count of the maximum and minimum number of employees. However, contractors may use any reasonable method for calculating and determining the maximum number and minimum number of employees during the reporting period.
The language quoted above, which appears as a paragraph entitled “Maximum and minimum number of employees” under section 250.11, is withdrawn. All other instructions in this section on how to prepare the VETS-100 report remain intact.
The Department of Labor has determined that this Interim Final Rule is not economically significant as defined in the Regulatory Flexibility Act. However, this rule has been reviewed by the Office of Management and Budget under Executive Order 12866. This rule will not: (1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency, or otherwise interfere, with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866. Therefore, a regulatory impact analysis is unnecessary.
This Interim Final Rule is not a major rule for purposes of the Congressional Review Act.
Executive Order 12875—This Interim Final Rule does not create an unfunded Federal Mandate upon any State, local, or tribal government.
Unfunded Mandate Reform Act of 1995—This Interim Final Rule does not include any Federal mandate that may result in increased expenditures by State, local and tribal governments in the aggregate of $100 million or more, or increased expenditures by the private sector of $100 million or more.
These regulations have been reviewed in accordance with Executive Order 13132 regarding Federalism. This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, the requirements of section 6 of Executive Order 13132 do not apply to this rule.
This Interim Final Rule does not substantially change the existing obligations of Federal contractors or subcontractors. The Department of Labor certifies that the rule will not have a significant economic impact on a substantial number of small business entities. Therefore, no regulatory flexibility analysis is required.
The inclusion of guidelines in the October 11, 2001, final rule on how to determine the minimum and maximum number of employees may have inadvertently resulted in greater burden than that reflected in the rule. By removing the portion of the rule that specified how the minimum and maximum number of employees was to be computed, this Interim Final Rule restores the burden to that reflected in the final rule.
The Department of Labor has determined that it is unnecessary and contrary to the public interest to publish a Notice of Proposed Rulemaking (NPRM) regarding this amendment. This Interim Final Rule will prevent covered contractors from having to comply with a possibly significant and inadvertent increase in their recordkeeping burdens. The portion of the October 11 rule that is being removed simply provided information on how the maximum and minimum number of employees was to be computed; removing that information nevertheless retains unchanged the fundamental statutory requirement that contractors report their maximum and minimum employment.
For the above-listed reasons, the Department of Labor finds that publishing an NPRM, and providing a period for notice and comment, before implementing this Interim Final Rule is unnecessary and contrary to the public interest, and therefore pursuant to 5 U.S.C. 553(b)(B) good cause exists for publishing these regulations as an Interim Final Rule. Furthermore, the Department finds that the above-listed reasons also constitute good cause under 5 U.S.C. 553(d)(3) for waiving the customary requirement to delay the effective date of a regulation for 30 days following its publication. Therefore, this Interim Final Rule is effective immediately upon publication.
Government contracts, Reporting and recordkeeping requirements, Veterans.
38 U.S.C. 4212(d).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Interim final rule; announcement of a fishing capacity reduction program and solicitation for bids from participants.
NMFS issues this interim final rule to establish a voluntary fishing capacity reduction program (FCRP) for the Northeast multispecies fishery that permanently removes multispecies limited access fishing permits. Permit holders who would like to participate may submit bids, which will be ranked based on the amount of the bid and an estimate of the fishing capacity represented by the permit. The intent of this program is to obtain the maximum sustained reduction in fishing capacity at the least cost. As this is a limited access fishery, the capacity removed by the program cannot be replaced. It is being implemented by an interim final rule to allow public comments, in particular on its related Environmental Assessment and on the determination under the Regulatory Flexibility Act that this action will not have a significant economic impact on a substantial number of small entities.
Effective January 18, 2002. NMFS will accept bids through February 19, 2002. Comments must be received on or before January 18, 2002.
Written comments should be sent to National Marine Fisheries Service, 1 Blackburn Drive, Gloucester, MA 01930, Attn: Jack Terrill. Comments involving the reporting burden estimates or any other aspects of the collection-of-information requirements contained in this interim final rule should be sent to both Jack Terrill and to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, D.C. 20503 (ATTN: NOAA Desk Officer). Copies of the Environmental Assessment may be obtained from Jack Terrill, Fishery Administrator, National Marine Fisheries Service, 1 Blackburn Drive, Gloucester, MA 01930.
Jack Terrill, Fishery Administrator, (Jack.Terrill@noaa.gov) 978-281-9136 or Daniel Morris, Special Projects Officer, (Daniel.Morris@noaa.gov) 978-281-9237. This
On July 13, 2000, the President signed the Military Construction Appropriations Act for FY 2001 (Act) (Pub.L. 106-246), which authorized a $10 million emergency supplemental appropriation for disaster assistance for the Northeast multispecies fishery. The funds are intended to compensate industry permittees who choose to participate in a program aimed at reducing the permitted fishing capacity in the multispecies fishery. NMFS published a notice of the proposed program, solicited comments on the proposal, and announced nine public meetings throughout New England at 66 FR 17668, April 3, 2001. NMFS received 21 written comments, one of which was signed by 88 people. The nine public meetings were attended by approximately 130 people; NMFS responds to the comments below. Further background for this program is provided in the April 3, 2001,
In general, commenters expressed support for the proposed program, which would compensate holders of limited access multispecies permits for the voluntary surrender of their permits. Separate from this FCRP, capacity reduction in the multispecies fishery is under consideration by the New England Fishery Management Council (Council) and is closely related to many other initiatives, including gear and time/area restrictions, aimed at promoting the recovery of depressed groundfish stocks. During the public meetings related to the FCRP, NMFS received many comments regarding measures under consideration by the Council. These comments have been shared with Council staff. Except where the comments are relevant to this FCRP, issues related to the Council’s activities are not addressed in the following paragraphs.
The statutory language establishing the FCRP requires that NMFS implement the program in a timely manner, and NMFS has attempted to do that. NMFS acknowledges that the uncertainty regarding the capacity reduction measures in Amendment 13 and the timing thereof may make it difficult for some permittees to determine whether or not to participate in the FCRP and at what level to set their bids.
Funds received through participation in the FCRP may be considered taxable income. The type of income and the tax rate would be determined by the participant’s tax situation, and it would be the responsibility of the program participant to seek appropriate tax
The purpose of the program is not to remove individuals or corporations from the fishery; it is to remove excess capacity as it is represented by limited-access multispecies permits. Unlike vessel buyout programs in the past, the FCRP established by this rule will compensate fishers for surrendering only their limited access Northeast multispecies permits. NMFS does not intend to restrict FCRP participants from working in the multispecies fishery or any other fishery in the future. Besides, restrictions on future fishing by FCRP participants would be extremely difficult to detect and enforce. The variations are many and would be very difficult to track. It is clear, however, that the multispecies fishing histories associated with the permits surrendered under this FCRP are prohibited from being used or referenced for qualification in any future multispecies permitting program. Though at this time no such programs are foreseen, NMFS will maintain records of FCRP participants to enforce this stipulation of the program. Whether or not the FCRP participant resumes working in the fishery, a permit and the capacity it represents will have been removed from the finite pool of capacity forever; thus meeting the goal of the FCRP.
Some commenters stated that Charter/Party vessels should be excluded from the program. Because there is an open access category for Charter/Party vessels, these vessels could surrender a limited access permit, and then acquire an open access permit and remain in the fishery. Thus, the surrender of the permit, they claimed, would have no net effect on capacity.
The FCRP aims to reduce commercial fishing capacity in the multispecies fishery. A vessel owner may currently hold both a multispecies limited access permit and an open access Charter/Party permit, and surrender of the former would be consistent with the goals of this program. Open access Charter/Party vessels are restricted by gear (two hooks per angler) and passenger capacity and are prohibited from selling any catch. While new fishing effort under the Charter/Party permit category may slightly confound the benefits of the FCRP, the restrictions on the Charter/Party category should minimize the net effect of effort re-entry. NMFS does not intend to restrict vessels with Charter/Party permits from participation in the FCRP, nor does NMFS intend to change the access status of the Charter/Party permit category.
NMFS concurs that the funds, once awarded, should not be restricted in how they are subsequently used. Vessel upgrades are limited by existing regulations.
Though participation in the FCRP is open to any limited-access multispecies permit holder, the most likely participants are those for whom the permit represents little opportunity to land regulated groundfish. The permits of fishers who are working in other fisheries or who have moved out of the industry altogether are likely to represent the least utility and are more likely to be surrendered under the FCRP. Because most FCRP participants have already moved out of the multispecies fishery and into other activities, the program is not likely to result in a measurable shift of fishing effort. In the long term, the surrender of the Federal multispecies permit limits the FCRP participant’s future fishing options, should the permittee someday wish to alter or diversify his/her fishing activity. Effort that might have returned to the multispecies fishery will be applied in another activity. The likelihood and timing of such an occurrence is impossible to predict.
Finally, because the program allows participants to retain all state and Federal permits other than the one surrendered, it is likely vessels will continue to be used. It remains the responsibility of the vessel owners to dispose of unused property in accordance with local, state, and Federal regulations; if a vessel has fallen into disuse, it is conceivable that some of the proceeds from the FCRP may actually help a boat owner comply with disposal regulations.
Participation in the FCRP is strictly voluntary. A community that wants to maintain Federal multispecies permits among its local fleet should consider coordinating its members’ participation (or non-participation) in the program. At present, Federal multispecies permits in
NMFS has considered alternatives to the final FCRP that would take into account recency of use in the multispecies fishery or other fisheries. NMFS considered bid-ranking processes and bid-capping equations that gave greater credit or value to permits that have logged landings since 1994. However, recency of use as it relates to ease or likelihood of reactivation is a variable that NMFS cannot quantify with confidence and consistency sufficiently enough to effectively inform program priorities. This FCRP takes a very long view of the fishery and assumes that over time all the permits will have a roughly equal probability of being reactivated, and the value of permits should not be weighted with respect to recency of use.
Furthermore, NMFS believes that the FCRP should be implemented without any suggestion that fishers must either use their permits, surrender them, or have them withdrawn for non-use. Any reliance by NMFS on recency of use as a factor for valuing permits may be perceived as contrary to this principle and may even prompt permit holders to reenter the fishery. Participation in the FCRP is voluntary.
The statutory language that established the FCRP requires that NMFS compensate fishers for the permanent revocation of their limited access multispecies fishing permits.
NMFS has considered this idea, but has declined to implement it for several reasons. The baselines and DAS associated with the permits range rather widely and affect the value of the permits accordingly. A fixed rate, set by NMFS, would be an appropriate value for only a small subset of the permits, and either would be too small to interest one segment of the fishery or would overpay the other. Permit holders are more likely than NMFS to have a good idea of what their permit is worth to them, and the reverse bid process as exercised in the vessel buyout programs of the past has been considered successful.
It is correct that to qualify for a Category C or D limited access monkfish permit vessel owners were required to have a multispecies or scallop limited access permit and certain levels of monkfish landings. If a fisher (who does not also hold a scallop permit) surrenders the qualifying multispecies permit under the FCRP, the monkfish permit would not be invalidated, but would be moved into a different limited access category (C to A, and D to B), and would be subject to the regulations of the new category. Holders of monkfish permits should be familiar with these requirements when deciding whether to participate in the FCRP.
The goal of the FCRP is to remove the greatest amount of fishing capacity from the Northeast multispecies fishery in the most cost effective manner. In support of this goal, and assuming that the bids submitted to the FCRP will exceed the funds that are available, NMFS must rank the bids with respect to relative vessel capacity. In other words, NMFS must rank and accept bids based on the least cost per unit of capacity.
NMFS considered two methods for ranking bids under the proposed FCRP, using capacity estimates derived through data envelopment analysis (DEA) or a simplified relative capacity indicator based upon linear calculation of permit baseline characteristics. Each is described in detail in the April 3, 2001,
NMFS received many comments regarding the proposed bid ranking methods. In general, the public preferred the idea of the simplified method, as it seemed more direct and easier to understand than the DEA method. However, commenters failed to give consistent guidance about weighting factors for the simplified method and the relative importance of the various baseline characteristics. Vessel designs and fishing strategies vary widely throughout the region and no simple equation could be developed
For the FCRP, NMFS has elected to employ the DEA model. Using DEA, NMFS will prepare an estimate of all potential bidders’ vessel capacity to harvest multispecies. This estimate of daily fishing capacity (EFC) would be an inference, based on capacity estimates for similarly configured vessels that are actively working in the fishery. This is the method that is gaining national and international acceptance as the best estimate of fishing capacity and is used by NMFS in reports on fishing capacity to Congress.
Applications to participate in the FCRP will be scored by dividing the bid by the product of the vessel’s daily estimated capacity and its allocated DAS [Score = bid ÷ (EFC x DAS)]. The lowest score would represent the least cost per unit capacity and would be ranked highest. Scores would then be listed and selected in ascending order.
Most of the limited access multispecies permits are under a fleet DAS management scheme and are presently authorized 88 DAS. Less than 10 percent of the permits are in an Individual DAS category and may be authorized more than 88 DAS per year. Multiplying the EFC by the allocated DAS will reflect the additional fishing opportunity represented by these permits. Permits in limited access Category C, Small Boat Exemptions, are associated with vessels 30 ft (9.1 m) or less in length overall (LOA) and have unlimited DAS. To weight these bids appropriately, NMFS will use the category’s fleet average number of DAS per year. If bids are received from holders of permits in this category, NMFS will analyze vessel trip reports to determine the 3 consecutive years with the highest used DAS per year per vessel, and from these 3 years will determine the average DAS per year for Category C permits.
From the July of 1998 through June 1999, NMFS initiated the Baseline Audit Program for multispecies and scallop limited access permit categories. NMFS contacted permittees who had not undergone a vessel replacement and asked them to verify and/or correct the permit baseline information in NMFS’ records. For the purpose of the FCRP, NMFS considers information on file to be the final numbers used for vessel baseline. The audit program did not include all CPH status permits. Some CPH baselines have been verified, but some have not. If owners of CPH status permits without verified baselines want to participate in the FCRP, NMFS will work with the applicant to establish or verify the vessel baseline in a manner consistent with the baseline audit program. For all other FCRP participants, NMFS intends to use the baseline information on file on the date of publication for the FCRP.
This FCRP allows permit holders to set their bids at any dollar amount, and a competitive bid ranking process will be used to determine which bids represent the better value for the Government and thus will be accepted first. The competitive nature of the process is the first incentive for permit holders to make reasonable bids. If bids are received for permits from two similarly configured vessels with equal DAS allocation, the lower bid will be the higher ranked of the two and will have a greater chance of being accepted. Therefore, permit holders should submit bids that are reasonable.
Some participants at the public meetings asked if NMFS intends to set a maximum limit on bids and asked if NMFS will award funds to permit holders as long as funds are available, even if the bids are unreasonably high. Commenters noted that NMFS may receive bids that greatly exceed accepted values of permits and, if funds remain available, NMFS may need to justify acceptance or non-acceptance of such bids.
The setting of bids should depend on the value and risks the permit holder associates with the business opportunity represented by the permit. As one suggestion of the reasonableness of bids, NMFS has examined the classified advertisements in industry magazines and newspapers. While permits, technically, are not transferable, in the private sector Federal fishing permits are commonly exchanged for money through paper transactions for vessel transfers. Over the last year, classified listings in national and regional publications reflected values for suites of Federal permits including the limited access Northeast multispecies permits from $10,000 to $65,000. The amount advertised varied with respect to the vessel’s baseline and the number of additional permits included in the sale. While by no means a complete survey of the value of limited access permits, the examples from the industry publications may assist permit holders in the development of their bids and may indicate to NMFS the reasonableness of bids.
NMFS also has developed a method to set a quantitative limit on the bid:capacity ratio. While this method will not set a maximum dollar amount on bids, it should encourage FCRP participants to set reasonable bids and should help identify and disqualify those bids that do not represent a good value for the Government. As noted above, applications will be ranked by dividing the bid amount by the product of EFC and the allocated (or average, for Category C) DAS. The resulting scores will be listed in ascending order. The median value, 50th percentile of the scores, will be multiplied by a capping factor of 1.5 to establish the maximum score value that NMFS will accept. Because this quantitative limit is a relative value determined by bids received and the distribution of the bid:capacity ratios, it cannot be determined beforehand. The use of this quantitative cap should further influence FCRP participants to set bids that are not unreasonably high.
The use of this relative cap has its limits, and NMFS may use the aforementioned qualitative measures of reasonableness (private sector purchase prices) to validate the results of the capping method. As noted, for the quantitative limit calculation, NMFS intends to use the 50th percentile of the scores and a capping factor of 1.5. These values were developed through an analysis of the results of the two Northeast multispecies vessel buyout programs during the late 1990's. If the distribution of scores in this FCRP is significantly different from the distribution of the vessel buyout ranking factors, or if all the bids received are exceptionally high, the quantitative method will not be an appropriate measure of reasonableness. NMFS maintains the discretion to accept or reject bids based on the combination of these measures of reasonableness, as well as the professional judgement of NMFS’ staff and advisors.
This interim final rule serves as notification of the program to all holders of Northeast multispecies limited access fishing permits. In addition to this official notification, NMFS will send letters to all holders of current limited access multispecies permits and CPH status announcing the program and soliciting bids. The letter will include
1. NMFS intends to consider applications to the FCRP only from holders of Federal multispecies permits in a limited access category or CPH status. Valid multispecies limited access permits are those limited access permits held by vessels meeting the eligibility requirements and maintained by annual renewal per 50 CFR 648.4(a)(1)(i). To be valid for the purposes of the FCRP, a permit must be free of all permit sanctions, pending or otherwise, at the time that the bid is submitted, and at the time of closing.
2. A permit holder must be an individual who is a citizen or national of the United States; or a corporation, partnership, association (non-profit or otherwise), trust, or other nongovernmental entity; if such an entity is a citizen of the United States within the meaning of section 802 of the Shipping Act, 1916, as amended (46 U.S.C. App. 802).
a. Federal Government employees, including full-time, part-time, and intermittent personnel, and Fishery Management Council employees and members (or corporations owned by members) are not eligible to participate in the program.
b. Holders of permits that are the subject of outstanding and/or pending investigations, charges, and penalties are not eligible to participate in the program.
c. Vessel owners whose permitted vessel exceeds the permit baseline and authorized upgrades, per 50 CFR 648.4 (a)(i)(F), are not eligible to participate in the program.
3. When two or more parties share interest in the permit, the bidder must affirm in writing that he/she represents the other parties.
1. Permit holders are limited to one bid per permit. Permit holders who intend to participate in the FCRP must submit their bids using the materials provided by NMFS. Bids must be postmarked before February 19, 2002. NMFS will not accept bids received late, or by fax or e-mail.
2. Bidders must ensure that all written matter is legible. Bid amounts must be written out numerically and in longhand (as one would do on a bank check).
3. Bidders must verify their Northeast multispecies permits, and the histories associated with the permits.
4. Bidders electing to offer permits in addition to the Northeast multispecies permit should identify the additional permit in the space provided on the bid submission form. Offering of additional limited access permits will not affect a bid’s ranking or the amount of the compensation to be paid, but may be used by NMFS as a tiebreaker.
After the bidding period closes, NMFS will rank the bids, as follows:
The bid is the dollar amount submitted by the applicant on the application materials.
Each bid received will be divided by the product of its respective EFC and allocated DAS to get the bid ranking score. For Category C permits, NMFS will use an average DAS determined as detailed in section III above. The lowest score will represent the least cost to the Government per unit of fishing capacity. NMFS will accept bids by beginning with the permit represented by the lowest score and will proceed in ascending order until all the funds are committed or until the cap for FCRP efficiency or other reasonableness measures are met. See also Section IV.
In the event that the scoring results in a tie, NMFS will give preference to the permit that represents the greatest fishing capacity. If the tie is between two permits representing equal capacity, NMFS will give preference to the participant offering to surrender additional limited access permits.
1. NMFS, Northeast Region, will contact permit holders as soon as possible with the results of the bid ranking and will arrange for disbursal of the funds. The method of payment used will depend on the amount of the awards.
2. Permits and associated permit history will be considered invalid upon the permit holder’s receipt of notification that the bid has been accepted in the FCRP. Such history will be invalidated from use to qualify for any future permitting programs in this fishery.
3. Applicants whose bids are accepted must complete and submit the following forms, which will be provided by NMFS, prior to disbursal of funds:
a. SF-3881, “ACH Vendor/Miscellaneous Payment Enrollment Form”
b. W-9, “Request for Taxpayer Identification Number and Certification”
c. CD-511, “Certification Regarding Debarment, Suspension, and Other Responsibility Matters: Drug-Free Workplace Requirements and Lobbying”
The Department of Commerce (“Department”) Pre-Award Notification Requirements for Grants and Cooperative Agreements contained in the
1. The delinquent account is paid in full;
2. A negotiated repayment schedule is established and at least one payment is received; or
3. Other arrangements satisfactory to the Department are made.
G. Release of Public Information. Information on the removed permits, accepted bids, and associated vessel may be released publicly after awards are made.
The Assistant Administrator for Fisheries (AA), NMFS, has determined that this interim final rule is consistent with the Military Construction Appropriations Act for FY 2001 (Pub.L. 106-246) and the Interjurisdictional Fisheries Act of 1986.
This interim final rule has been determined to be not significant for purposes of E.O. 12866.
Applications under this program are subject to E.O. 12372, “Intergovernmental Review of Federal Programs”.
NMFS prepared an environmental assessment (EA) for this action and the AA concluded that there will be no significant impact on the human environment as a result of this interim final rule. A copy of the EA is available from NMFS (see
This interim final rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA). The collection of this information has been approved by OMB under control number 0648-0376. Public reporting burden for preparation of the grant application is estimated to be one hour per response including the time for reviewing instructions, gathering and maintaining records, and completing and reviewing the collection of information. An additional two hour reporting burden is estimated for those applicants who are accepted by NMFS including time for submission of invalidated permits. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to NMFS (See
Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this interim final rule would not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (RFA). Although the economic impacts on small entities are not immediately quantifiable, as the mix of accepted bids can only be determined after bidding is complete, NMFS does not expect that this action would have a significant economic impact on a substantial number of small entities. As participation in the FCRP is voluntary, it is unlikely that entities would participate unless they accrued some benefit. Moreover, the retirement of permits, active and latent, is expected to benefit those fishermen remaining in the fishery, though the extent of that benefit is unclear at this time. As a result, a regulatory flexibility analysis was not prepared.
16 U.S.C. 4107.
Environmental Protection Agency (EPA).
Proposed rule.
EPA proposes to approve a revision to the state of Kansas' section 111(d) plan for controlling emissions from existing hospital/medical/infectious waste incinerators.
In the final rules section of the
Comments on this proposed action must be received in writing by January 18, 2002.
Comments may be mailed to Wayne Kaiser, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101.
Wayne Kaiser at (913) 551-7603.
See the information provided in the direct final rule which is located in the rules section of the
Office of Inspector General (OIG), HHS.
Notice of intent to develop regulations.
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
To assure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 19, 2002.
Please mail or deliver your written comments to the following address: Office of Inspector General, Department of Health and Human Services, Attention: OIG-61-N, Room 5246, Cohen Building, 330 Independence Avenue, SW., Washington, DC 20201.
We do not accept comments by facsimile (FAX) transmission. In commenting, please refer to file code OIG-61-N. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 5541 of the Office of Inspector General at 330 Independence Avenue, SW., Washington, DC, on Monday through Friday of each week from 8:00 a.m. to 4:30 p.m.
Joel Schaer, (202) 619-0089, OIG Regulations Officer.
Section 1128B(b) of the Social Security Act (the Act) (42 U.S.C. 1320a-7b(b)) provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive remuneration in order to induce or reward business reimbursable under the Federal health care programs. The offense is classified as a felony and is punishable by fines of up to $25,000 and imprisonment for up to 5 years. The OIG may also propose the imposition of civil money penalties, in accordance with section 1128A(a)(7) of the Act (42 U.S.C. 1320a-7a), or exclusions from the Federal health care programs, in accordance with section 1128(b)(7) of the Act (42 U.S.C. 1320a-7(b)(7)).
Since the statute on its face is so broad, concern has been expressed for many years that some relatively innocuous commercial arrangements may be subject to criminal prosecution or administrative sanction. In response to the above concern, the Medicare and Medicaid Patient and Program Protection Act of 1987, section 14 of Public Law 100-93, specifically required the development and promulgation of regulations, the so-called “safe harbor” provisions, specifying various payment and business practices which, although potentially capable of inducing referrals of business reimbursable under the Federal health care programs, would not be treated as criminal offenses under the anti-kickback statute and would not serve as a basis for administrative sanctions. The OIG safe harbor provisions have been developed “to limit the reach of the statute somewhat by permitting certain non-abusive arrangements, while encouraging beneficial and innocuous arrangements” (56 FR 35952, July 29, 1991). Health care providers and others may voluntarily seek to comply with these provisions so that they have the assurance that their business practices are not subject to any enforcement
The OIG has also periodically issued Special Fraud Alerts to give continuing guidance to health care providers with respect to practices the OIG finds potentially fraudulent or abusive. The Special Fraud Alerts encourage industry compliance by giving providers guidance that can be applied to their own businesses. The OIG Special Fraud Alerts are intended for extensive distribution directly to the health care provider community, as well as those charged with administering the Federal health care programs.
Section 205 of Public Law 104-191 requires the Department to develop and publish an annual notice in the
In developing safe harbors for a criminal statute, the OIG is required to engage in a thorough review of the range of factual circumstances that may fall within the proposed safe harbor subject area so as to uncover potential opportunities for fraud and abuse. Only then can the OIG determine, in consultation with the Department of Justice, whether it can effectively develop regulatory limitations and controls that will permit beneficial and innocuous arrangements within a subject area while, at the same time, protecting the Federal health care programs and their beneficiaries from abusive practices.
In accordance with the requirements of section 205 of Public Law 104-191, the OIG last published a
In accordance with section 205, we will consider a number of factors in reviewing proposals for new or modified safe harbor provisions, such as the extent to which the proposals would effect an increase or decrease in—
• Access to health care services;
• The quality of care services;
• Patient freedom of choice among health care providers;
• Competition among health care providers;
• The cost to Federal health care programs;
• The potential overutilization of the health care services; and
• The ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.
In addition, we will also take into consideration other factors, including, for example, the existence (or nonexistence) of any potential financial benefit to health care professionals or providers that may vary based on their decisions whether to (1) order a health care item or service, or (2) arrange for a referral of health care items or services to a particular practitioner or provider.
In determining whether to issue additional Special Fraud Alerts, we will also consider whether, and to what extent, the practices that would be identified in a new Special Fraud Alert may result in any of the consequences set forth above, as well as the volume and frequency of the conduct that would be identified in the Special Fraud Alerts.
A detailed explanation of justifications for, or empirical data supporting, a suggestion for a safe harbor or Special Fraud Alert would be helpful and should, if possible, be included in any response to this solicitation.
Agricultural Marketing Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces the intention of the Agricultural Marketing Service (AMS) to request an extension for and revision to a currently approved information collection in support of the Regulations Governing the Voluntary Grading of Shell Eggs.
Comments on this notice must be received by February 19, 2002.
Contact Shields Jones, Standardization Branch, Poultry Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Avenue, SW., STOP 0259, Washington, DC 20050-0259, (202) 720-3506.
To provide programs and services, section 203(h) of the AMA directs and authorizes USDA to inspect; certify and identify; and identify the grade, class, quality, quantity, and condition of agricultural products under such rules and regulations as prescribed, including assessment and collection of fees for the cost of the service.
The regulations in 7 CFR part 56 provide a voluntary program for grading shell eggs on the basis of U.S. standards, grades, and weight classes. In addition, the shell egg industry and users of the products have requested that other types of voluntary services be developed and provided under these regulations; e.g., contract and specification acceptance services and certification of quantity. This voluntary grading service is available on a resident basis or on an as-needed basis. A fee for service is paid by the user.
Since this is a voluntary program, respondents need to request or apply for the specific service they wish, and in doing so, they provide information. Since the AMA requires that the cost of service be assessed and collected, information is collected to establish the Agency's cost.
The information collection requirements in this request are essential to carry out the intent of the AMA, to provide the respondents the type of service they request, and to administer the program.
The information collected is used only by authorized representatives of USDA (AMS, Poultry Programs' national staff; regional directors and their staffs; Federal-State supervisors and their staffs; and resident Federal-State graders, which includes State agencies). The information is used to administer and to conduct and carry out the grading services requested by the respondents. The Agency is the primary user of the information. Information is also used by each authorized State agency which has a cooperative agreement with AMS.
Copies of this information collection can be obtained from Shields Jones, Standardization Branch, on (202) 720-3506.
Send comments regarding, but not limited to, the following: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; or (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, to: David Bowden, Jr., Chief, Standardization Branch, Poultry Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave., SW., Stop 0259, Washington, DC 20250-0259. All comments received will be available for public inspection during regular business hours at the same address.
All responses to this notice will be summarized and included in the request for the Office of Management and Budget approval. All comments will also become a matter of public record.
Forest Service, USDA.
Notice of past meeting.
The Sierra County Resource Advisory Committee (RAC) met for the
The meeting was held November 26, 2001 from 3:15 p.m. to 6:15 p.m.
The meeting was held at the Downieville Community Hall, Downieville, CA.
Ann Westling, Committee Coordinator, USDA, Tahoe National Forest, 631 Coyote St, Nevada City, CA, 95959, (530) 478-6205, E-mail:
Agenda items covered included: (1) An Overview of Payments to States Act, Pub. L. 106-393 was provided; (2) Organizational guidelines for the Sierra County RAC were developed by group; (3) Planning processes for projects in Sierra County were discussed; (4) Preliminary project ideas were presented; (7) Public comment was not taken as no members of the public were still in attendance toward the end of the meeting. The meeting was open to the public.
Forest Service, USDA.
Notice of meeting.
The Sierra County Resource Advisory Committee (RAC) will meet on January 14, 2002, in Sierraville, California. The purpose of the meeting is to discuss issues relating to implementing the
The meeting will be held January 4, 2002 from 1:30 p.m. to 4:30 p.m. If a storm or other difficulty presents itself, a backup meeting date is scheduled for January 28, 2001, at the same time and location.
The meeting will be held at the Sierraville Ranger Station conference room, 317 S. Lincoln (Hwy 89), Sierraville, CA.
Ann Westling, Committee Coordinator, USDA, Tahoe National Forest, 631 Coyote St, Nevada City, CA, 95959, (530) 478-6205, e-mail:
Agenda items to be covered include: (1) Welcome and introductions; (2) Review of previous meeting, meeting minutes, and Pub. L. 106-393; (3) Presentation on National Fire Plan and other funding sources; (4) Discussion and decision on criteria for Sierra County RAC projects; (5) Presentation of project ideas; and (6) Preliminary ranking of project ideas. The meeting is open to the public. Public input opportunity will be provided during each agenda item and individuals will have the opportunity to address the Committee at that time.
Forest Service, USDA.
Notice.
The intended effect of this action is to comply with 36 CFR part 219 section 219.35(e) which directs that within 1 year of November 9, 2000, the Regional Forester must withdraw the Regional Guide. When a Regional Guide is withdrawn, the Regional Forester must identify any decisions in the Regional Guide that are to be transferred to a regional supplement of the Forest Service directive system (36 CFR 200.4) or to one or more plans and give notice in the
This action will be effective November 9, 2001.
Arthur Briggs, Director of Planning; Southwestern Region; 333 Broadway SE, Albuquerque, NM. Phone: (505) 842-3292.
This action accomplishes the withdrawal of the Regional Guide for the Southwestern Region. An analysis of the direction contained in the Regional Guide shows that all its applicable direction is either: (1) Already incorporated into Forest Plans, Forest Service directives, statutes or regulations; or (2) contains guidance that does not need to be brought forward as direction to facilitate forest planning. No further action is needed to complete the withdrawal of the Regional Guide for the Southwestern Region.
Import Administration, International Trade Administration, Department of Commerce.
Notice of initiation of antidumping and countervailing duty administrative reviews.
The Department of Commerce (the Department) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with November anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews.
December 19, 2001.
Holly A. Kuga, Office of AD/CVD Enforcement, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230, telephone: (202) 482-4737.
The Department has received timely requests, in accordance with 19 CFR 351.213(b)(2001), for administrative reviews of various antidumping and countervailing duty orders and findings with November anniversary dates.
In accordance with section 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than November 30, 2002.
During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under section 351.211 or a determination under section 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.
Interested parties must submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305.
These initiations and this notice are in accordance with section 751(a) of the Tariff Act of 1930, as amended (19 U.S.C. 1675(a)), and 19 CFR 351.221(c)(1)(i).
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce is extending the time limits of the final results of the antidumping duty administrative review on extruded rubber thread from Malaysia. The review covers three producers/exporters of the subject merchandise to the United
December 19, 2001.
Irina Itkin or Elizabeth Eastwood, Office of AD/CVD Enforcement, Import Administration, International Trade Administration, U.S. Department of Commerce, at (202) 482-0656 or (202) 482-3874, respectively.
This extension is in accordance with section 751(a)(3)(A) of Tariff Act of 1930, as amended by the Uruguay Round Agreements Act, and 19 CFR 351.213(h)(2).
In notice document 01-30170, appearing on page 63218 in the issue of Wednesday, December 5, 2001, make the following correction:
On page 63218, in the third column, first full paragraph, “Order Date: December 8, 2001.” should read “Order Date: December 8, 2000.”
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of intent to prepare an Environmental Assessment (EA); request for written comments.
NMFS announces its intention to prepare an EA, in accordance with the National Environmental Policy Act, to assess the impacts of issuing a subsistence quota for bowhead whales to the AEWC for the years 2003 through 2007. NMFS solicits comments and information to facilitate this analysis.
Comments and information must be postmarked by January 31, 2002.
Written comments should be sent to Chief, Marine Mammal Division (F/PR2), Office of Protected Resources, National Marine Fisheries Service, 13th Floor, 1315 East-West Hwy, Silver Spring, MD 20910. Please mark the outside of the envelope with “Comments on Bowhead Whale Analysis.” Comments will not be accepted if submitted via e-mail or Internet.
Emily Hanson Menashes, NMFS Office of Protected Resources, 301-713-2322.
At its 1997 annual meeting, the International Whaling Commission (IWC) approved a 5-year quota for the aboriginal take of the Western arctic stock of bowhead whales. The quota allows for a combined total of up to 280 whales to be landed in the years 1998 through 2002 by Alaskan and Russian natives. For each of these years, the number of bowhead whales struck shall not exceed 67, except that any unused portion of a strike quota from any year shall be carried forward and added to the strike quota of any subsequent year, provided that no more than 15 strikes shall be added to the strike quota for any one year.
The basis for the quota was a joint request by the Russian Federation and the United States, showing that the needs of both countries' Native groups could be met with an annual average of 56 landed bowhead whales (or a total of 255 for the Alaska Eskimos and 25 for the Chukotka people over the 5-year period). The annual strike limits and quotas for whales are determined at the beginning of each year after consultation with the Russian government.
At the 52nd annual meeting of the IWC, held in June and July of 2000, the IWC Scientific Committee proposed a structure for block quotas for the bowhead whale aboriginal subsistence hunt to be used as part of the Scientific Committee's proposed revisions to the Aboriginal Whaling Management Plan. This structure calls for five-year blocks with an inter-annual carry-over allowance of up to 50 percent of unused strikes, including strikes from the previous quota block (IWC/52/AS7). The Commission agreed with the proposal from the Scientific Committee in the context of trials.
At the 53rd IWC annual meeting, held in July of 2001, the Commission agreed with the Scientific Committee's recommendations with respect to carry-over. The Scientific Committee also noted that if, under a recommended Strike Limit Algorithm, current aboriginal subsistence need is met, then a revised Schedule paragraph might specify a block strike limit quota with an annual cap on strikes. The Scientific Committee also reiterated its 1999 advice for the Bering-Chukchi-Beaufort Seas stock of bowhead whales, i.e., that it is very likely that a catch limit of 102 whales or less would be consistent with the requirements of the Schedule (IWC/53/4, Report of the Scientific Committee).
Alaska Eskimos have been taking bowhead whales for at least 2,000 years. Alaska Native subsistence hunters take less than one percent of the population of bowhead whales per year. Since 1977, the number of takes has ranged between 14 and 77 per year, depending in part on changes in management strategy and in part on higher estimates of bowhead whale abundance in recent years (NMFS Alaska Marine Mammal Stock Assessments, 2000).
The IWC's 54th annual meeting is scheduled for May of 2002. NMFS is preparing an EA on issuing a quota to the AEWC for a subsistence hunt on bowhead whales for the years 2003 through 2007 in the event that the IWC renews a 5-year aboriginal subsistence quota for bowhead whales. NMFS will evaluate the following four alternatives:
Alternative 1—Grant the AEWC a quota that meets the documented need of Alaskan Eskimos for 255 landed whales over 5 years (2003 through 2007), with an annual strike quota of 67
Alternative 2—Grant the AEWC a quota that meets the documented need of Alaskan Eskimos for 255 landed whales over 5 years (2003 through 2007), with an annual strike quota of 67 bowhead whales per year, where no more than 15 unused strikes are added to the strike quota for any one year.
Alternative 3—Grant the AEWC a quota that meets the documented need of Alaskan Eskimos for 255 landed whales over 5 years (2003 through 2007), with an annual strike quota of 67 bowhead whales per year, where, for unused strikes, up to 50 percent of the annual strike limit is added to the strike quota for any one year.
Alternative 4 (No Action)—Do not grant the AEWC a quota.
To ensure that the review is comprehensive and based on the best available information, NMFS is soliciting information and comments from any interested party concerning issuing a bowhead whale quota to the AEWC of 255 landed whales over 5 years (2003 through 2007). NMFS is particularly interested in information on the affected environment or environmental consequences of issuing a quota. It is requested that data, information, and comments be accompanied by (1) supporting documentation, and (2) the name, address, and affiliation of person submitting data. Following publication of the draft EA, NMFS will solicit additional public input.
Department of the Air Force, DoD.
Notice of meeting.
Pursuant to Public Law 92-463, notice is hereby given of forthcoming meetings of the Federal Advisory Committee for the End-to-End Review of the U.S. Nuclear Command and Control System (NCCS). The purpose of these meetings is to conduct a comprehensive and independent review of the NCCS positive measures to assure authorized use of nuclear weapons when directed by the President while assuring against unauthorized or inadvertent use. This meeting will be closed to the public.
January 29, 2002.
NSS, Skyline 3, Suite 500, 5201 Leesburg Pike, Falls Church, VA 22041.
Mr. William L. Jones, U.S. Nuclear Command and Control System Support Staff (NSS), Skyline 3, 5201 Leesburg Pike, Suite 500, Falls Church, Virginia 22041, (703) 681-8681.
President's Commission on Excellence in Special Education, Department of Education.
Notice of a public meeting.
This meeting describes the schedule and agenda of a forthcoming meeting of the President's Commission on Excellence in Special Education (Commission). Notice of this meeting is required under section 10(a)(2) of the Federal Advisory Committee Act in order to notify the public of their opportunity to attend. The Commission's meeting notice is subject to the final appropriation of the Labor, HHS, and Education 2002 budget and may change if this budget is not enacted prior to January 15, 2002.
Tuesday, January 15, 2002, from 8:30 a.m.-7 p.m.
The Commission meeting will be held in Washington, DC. Exact location of hearing is not yet determined because of delays in finalizing meeting logistics.
C. Todd Jones, Executive Director, at 202-208-1312 (telephone) or Troy R. Justesen, Deputy Executive Director, at 202-219-0704 (telephone), (202) 208-1953 (fax),
The Commission is established under Executive Order 13227 (October 2, 2001) to collect information and study issues related to Federal, State, and local special education programs with the goal of recommending policies for improving the educational performance of students with disabilities. In furtherance of its duties, the Commission shall invite experts and members of the public to provide information and guidance. The Commission shall prepare and submit a report to the President outlining its findings and recommendations.
The Commission will discuss current and future activities. Specifically, the Commission will focus on planning future Commission meetings and hearings to be held in location across the nation.
Individuals requiring accommo- dations such as interpreting services, assistive listening devices, materials in alternative formats should notify Troy R. Justesen, at (202) 219-704, no later than January 8, 2002. We will attempt to meet requests after this date, but cannot guarantee availability of the requested accommodation. The meeting site will be accessible to individuals with mobility impairments, including those who use wheelchairs.
Records of all Commission proceedings are available for public inspection at the President's Commission on Excellence in Special Education, 80 F Street, NW., Suite 408; Washington, DC 20208 from 9 a.m. to 5 p.m. (EST).
Take notice that on November 30, 2001, Central Vermont Public Service Corporation (CVPS) tendered for filing a letter stating that CVPS will not file a Forecast 2002 Cost Report for FERC Electric Tariff, Original Volume No. 4, since there are no customers expected to take such service.
Any person desiring to be heard or to protest such filing should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). All such motions and protests should be filed on or before December 21, 2001. Protests will be considered by the Commission to determine the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. Copies of this filing are on file with the Commission and are available for public inspection. This filing may also be viewed on the Commission's Web site at
Take notice that on November 30, 2001, Central Vermont Public Service Corporation (CVPS) tendered for filing a letter stating that CVPS will not file a Forecast 2002 Cost Report for FERC Electric Tariff, Original Volume No. 3. No customers will take Tariff No. 3 transmission service during 2002 because such service was terminated effective December 31, 1999. CVPS provides transmission service under its FERC Electric Tariff, First Revised Volume No. 7.
Any person desiring to be heard or to protest such filing should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). All such motions and protests should be filed on or before December 21, 2001. Protests will be considered by the Commission to determine the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. Copies of this filing are on file with the Commission and are available for public inspection. This filing may also be viewed on the Commission's web site at
Take notice that on December 6, 2001, Duke Power (Duke), a division of Duke Energy Corporation, tendered for filing a Service Agreement under Duke's Wholesale Market-Based Rate Tariff Providing for Sales of Capacity, Energy, or Ancillary Services and Resale of Transmission Rights between Duke and Williams Energy Marketing and Trading Company. Duke requests that the proposed Service Agreement be permitted to become effective on November 12, 2001. Duke states that this filing is in accordance with part 35 of the Commission's Regulations, and that a copy has been served on the North Carolina Utilities Commission.
Any person desiring to be heard or to protest such filing should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). All such motions and protests should be filed on or before December 27, 2001. Protests will be considered by the Commission to determine the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. Copies of this filing are on file with the Commission and are available for public inspection. This filing may also be viewed on the Commission's Web site at
Take notice that on December 7, 2001, Nevada Power Company (NPC) filed with the Federal Energy Regulatory Commission (Commission) a complaint requesting that the Commission mitigate unjust and unreasonable prices in sales contracts between NPC and Allegheny Energy Supply Company, LLC (Allegheny) entered into in the last half of 2000 and the first half of 2002 for delivery after January 1, 2002.
NPC requests that the Commission set a refund effective date of 60 days from the date of filing of its complaint.
Copies of NPC's filing were served on Allegheny and the Public Utilities Commission of Nevada.
NPC has requested privileged treatment of certain information in the complaint and has filed privileged and public copies of the complaint, a request for privileged treatment, and a protective agreement.
Any person desiring to be heard or to protest this filing should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). All such motions or protests must be filed on or before December 27, 2001. Protests will be considered by the Commission in determining the
Pleasants Energy, LLC (Pleasants Energy), an indirect wholly-owned subsidiary of Dominion Energy, Inc. filed with the Commission, in the above-docketed proceeding, a proposed market-based rate tariff under which Pleasants Energy will engage in the sales of capacity, energy, and/or ancillary services and the resale of transmission rights. Pleasants Energy also requested certain waivers and authorizations. In particular, Pleasants Energy requested that the Commission grant blanket approval under 18 CFR Part 34 of all future issuances of securities and assumptions of liabilities by Pleasants Energy. On December 6, 2001, the Commission issued an order that accepted the tariff for sales of capacity and energy at market-based rates (Order), in the above-docketed proceeding.
The Commission's December 6, 2001 Order granted Pleasants Energy's request for blanket approval under Part 34, subject to the conditions found in Appendix A in Ordering Paragraphs (2), (3), and (5):
(2) Within 30 days of the date of this order, any person desiring to be heard or to protest the Commission's blanket approval of issuances of securities or assumptions of liabilities by Pleasants Energy should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with rules 211 and 214 of the Commission's rules of practice and procedure, 18 CFR 385.211 and 385.214.
(3) Absent a request to be heard within the period set forth in Ordering Paragraph (2) above, Pleasants Energy is hereby authorized to issue securities and assume obligations and liabilities as guarantor, indorser, surety or otherwise in respect of any security of another person; provided that such issue or assumption is for some lawful object within the corporate purposes of Pleasants Energy, compatible with the public interest, and reasonably necessary or appropriate for such purposes.
(5) The Commission reserves the right to modify this order to require a further showing that neither public nor private interests will be adversely affected by continued Commission approval of Pleasants Energy's issuances of securities or assumptions of liabilities. . . .
Notice is hereby given that the deadline for filing motions to intervene or protests, as set forth above, is January 7, 2002.
Copies of the full text of the Order are available from the Commission's Public Reference Branch, 888 First Street, NE., Washington, DC 20426. The Order may also be viewed on the on the Web at
Take notice that on November 30, 2001, Williston Basin Interstate Pipeline Company (Williston Basin), P.O. Box 5601, Bismarck, North Dakota 58506-5601, filed in Docket No. CP02-36-000 an Abbreviated Application pursuant to Section 7(b) of the Natural Gas Act (NGA) and Sections 157.7 and 157.18 of the Commission's Regulations for an order authorizing Williston Basin to abandon the transportation of natural gas volumes for Shell Western E&P, Inc. (Shell) pursuant to Rate Schedule T-5 and authorizing Williston Basin to abandon Rate Schedule T-5 of its FERC Gas Tariff, Second Revised Volume No. 1 (Tariff), in its entirety, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The application may be viewed on the web at www.ferc.fed.us/online/rims.htm. Call (202) 208-2222 for assistance.
Williston Basin states that the Rate Schedule T-5 Service Agreement with Shell expires by the terms of the agreement on December 1, 2001 and no service has been provided to Shell pursuant to this Service Agreement since March 1998. Williston Basin also states that pursuant to Docket No. CP85-534-000, Rate Schedule T-5 was available only to six specific producers. Williston Basin has previously filed for and received authorization, pursuant to Section 7(b) of the NGA, to abandon service to the other five specific producers. With the termination of the Service Agreement with Shell on December 1, 2001, service under Rate Schedule T-5 will no longer be available to any party and Williston Basin has no further need for Rate Schedule T-5.
Any person desiring to be heard or to make any protest with reference to said application should file with the Federal Energy Regulatory Commission, Washington, DC 20426, a motion to intervene or a protest in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the Natural Gas Act (18 CFR 157.10). All such motions to intervene or protests should be filed on or before January 3, 2002. All protests filed with the Commission will be considered by it in determining the appropriate action to be taken but will not serve to make the protestants parties to the proceeding. Any person wishing to become a party to a proceeding or to participate as a party in any hearing therein must file a motion to intervene in accordance with the Commission's Rules.
Take notice that the following filings have been made with the Commission:
Take notice that on November 30, 2001, Pacific Gas and Electric Company (PG&E) and PG&E Corporation (Parent) on behalf of its subsidiaries, Electric Generation LLC, ETrans LLC and GTrans LLC (collectively, the Applicants) filed with the Federal Energy Regulatory Commission an application pursuant to section 203 of the Federal Power Act (FPA) and related declaratory orders under sections 201 and 305 of the FPA and section 12 of the Natural Gas Act for authorization of a disposition of jurisdictional facilities. PG&E is a debtor pursuant to Title 11 of the U.S. Code. In accordance with the plan of reorganization pending before the bankruptcy court, Applicants request approval for various transactions required for a reorganization of PG&E that will result in the corporate unbundling of certain of PG&E's operations and spin-off of PG&E (as a retail gas and electric distribution company) from Parent. The application includes a request for privileged treatment of confidential information. A copy of the related filings will be posted on PG&E's Web site at
Take notice that on December 5, 2001, Mirant Americas Energy Marketing, LP (MAEM) tendered for filing with the Federal Energy Regulatory Commission (Commission) a revised triennial market power analysis in compliance with the November 20, 2001, Commission Order. AEP Power Marketing, Inc. 97 FERC 61,219 (2001).
Take notice that on December 6, 2001, the Midwest Independent Transmission System Operator, Inc. (the Midwest ISO) tendered for filing with the Federal Energy Regulatory Commission (Commission) revisions to its Open Access Transmission tariff (OATT), FERC Electric Tariff, First Revised Volume No. 1. The proposed revisions to the Midwest ISO OATT are intended to correct inconsistencies and to clarify certain provisions.
The Midwest ISO seeks an effective date of the later of December 19, 2001 or the date the Midwest ISO begins providing service under its OATT.
The Midwest ISO also seeks waiver of the Commission's regulations 18 CFR 385.2010 (2001) with respect to service on all parties on the official service list in this proceeding. Midwest ISO has electronically served a copy of this filing, with attachments, upon all Midwest ISO Members, Member representatives of Transmission Owners and Non-Transmission Owners, the Midwest ISO Advisory Committee participants, Policy Subcommittee participants, as well as all state commissions within the region. In addition, the filing has been electronically posted on the Midwest ISO's Web site at
On December 7, 2001, NorthWestern Energy Marketing, LLC, a limited liability corporation organized under the laws of the State of Delaware, filed its response to the December 3, 2001 request of Michael A. Coleman, Director of the Division of Tariffs and Rates-West at the Federal Energy Regulatory Commission (Commission) for the following in the above-referenced proceeding: (1) Confirmation and clarification that NEM requests authorization to make sales of ancillary services utilizing an Internet-based OASIS like site and (2) inclusion in NEM's proposed FERC Electric Rate Schedule No. 1 a provision for refunds in certain circumstances.
Take notice that on December 7, 2001, Southwestern Public Service Company (Southwestern) tendered for filing a First Revised Rate Schedule for Central Valley Electric Cooperative, Inc. (Central Valley) to comply with Order 614 and amend the Exhibit A delivery point listing for service to Central Valley to add a new delivery point.
Take notice that on December 7, 2001, the California Independent System Operator Corporation (ISO) tendered for filing an errata to its 2002 Grid Management Charge filed on November 2, 2001. The purpose of the errata is to allow for the Quarterly Adjustment to the ISO's 2002 revenue requirement to reflect anticipated cost savings, or to reflect unanticipated collections of fines and penalties. This provision was intended to be submitted with the November 2, 2001 filing but was omitted due to an oversight. The ISO is requesting that the errata be treated the same as if it was submitted on November 2, 2001 and be made effective January 1, 2002.
The ISO states that this filing has been served on the Public Utilities Commission of California, the California Energy Commission, the California Electricity Oversight Board, and upon all parties with effective Scheduling Coordinator Service Agreements under the ISO Tariff.
Take notice that on December 4, 2001, Southwest Power Pool, Inc. (SPP) submitted for filing two executed service agreements for Firm Point-to-Point Transmission Service with Southwestern Power Administration (Transmission Customer).
SPP requests an effective date of June 1, 2002 for these service agreements. A copy of this filing was served on the Transmission Customer.
Take notice that on December 4, 2001, PPL Montana, LLC (PPL Montana) filed with the Commission an executed service agreement under PPL Montana's FERC Electric Tariff, Original Volume No. 3 between PPL Montana and Enron Power Marketing, Inc. (EPMI).
PPL Montana requests that the Commission grant a waiver so as to permit the service agreement to become effective on September 1, 2001. PPL Montana states that it has served a copy of this filing on EPMI.
Take notice that on December 4, 2001, the Holt Company of Ohio (Holt) submitted for filing with the Federal Energy Regulatory Commission (Commission) an Umbrella Service Agreement for Short-Term Sales between Holt and American Municipal Power-Ohio (AMP-Ohio). The Umbrella Service Agreement between Holt and AMP-Ohio sets out the general commercial terms and conditions pursuant to which Holt makes sales of electric energy and capacity to AMP-Ohio.
Take notice that on December 4, 2001, Troup Electric Membership Corporation (Troup), a non-profit electric distribution cooperative filed a petition for authority to sell power at market-based rates, acceptance of its proposed rate schedule and certain waivers.
Troup requests an effective date for its proposed rate schedule that would be 60 days from the date of the filing of its petition or the date of the order accepting Troup's rate schedule for filing.
Take notice that on December 5, 2001, American Transmission Company LLC (ATCLLC) tendered for filing an executed Distribution-Transmission Interconnection Agreement between ATCLLC and City of Kaukauna.
ATCLLC requests an effective date of June 25, 2001.
Take notice that on December 5, 2001, Southern Company Services, Inc. (SCS), acting on behalf of Alabama Power Company, Georgia Power Company, Gulf Power Company, Mississippi Power Company, and Savannah Electric and Power Company (collectively Southern Companies), filed a Notice of Cancellation of three (3) transmission service agreements under the Open Access Transmission Tariff of Southern Companies (Tariff) (FERC Electric Tariff, Fourth Revised Volume No. 5). These three cancellations include: (1) A non-firm point-to-point transmission service agreement under the Tariff between SCS, as agent for Southern Companies, and Avista Energy, Inc.; (2) a firm point-to-point service agreement under the Tariff between SCS, as agent for Southern Companies, and Avista Energy, Inc.; and (3) a conditional and experimental firm point-to-point transmission service agreement under the Tariff between SCS, as agent for Southern Companies, and Coral Power, LLC.
Take notice that on December 5, 2001, Pacific Gas and Electric Company (PG&E) tendered for filing a new Grid Management Charge Pass-Through Tariff (GMC P-TT) This filing seeks to recover the costs proposed in the California Independent System Operator Corporation's (ISO) GMC filing in Docket No. ER02-250-000 on November 1, 2001.
PG&E requests an effective date of January 1, 2002 or the date the Commission makes effective the ISO's filing in Docket No. ER02-250-000.
Copies of this filing have been served upon the California Public Utilities Commission, all affected customers and the ISO.
Take notice that on December 5, 2001, PPL EnergyPlus, LLC (PPL EnergyPlus) filed with the Federal Energy Regulatory Commission (Commission) revisions to its Rate Schedule FERC No. 9, a long-term power sales agreement between PPL EnergyPlus and PPL Electric Utilities Corporation (PPL Electric).
PPL EnergyPlus requests that the Commission grant a waiver so as to permit the revised agreement to become effective on January 1, 2002. PPL EnergyPlus states that it has served a copy of this filing upon PPL Electric.
Take notice that on December 5, 2001, PPL EnergyPlus, LLC (PPL EnergyPlus) filed with the Federal Energy Regulatory Commission (Commission) revisions to its First Revised Rate Schedule FERC No. 4, a long-term power sales agreement between PPL EnergyPlus and PPL Electric Utilities Corporation (PPL Electric).
PPL EnergyPlus requests that the Commission grant a waiver so as to permit the revised agreement to become effective on January 1, 2002. PPL EnergyPlus states that it has served a copy of this filing upon PPL Electric.
Take notice that on December 5, 2001, PPL Montana, LLC (PPL Montana) filed a notice of cancellation of a transaction confirmation between PPL Montana and Enron Power Marketing, Inc. (EPMI).
Notice of the cancellation has been served upon EPMI.
E. Any person desiring to be heard or to protest such filing should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). All such motions or protests should be filed on or before the comment date. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a motion to intervene. Copies of this filing are on file with the Commission and are available for public
Take notice that the following hydroelectric applications have been filed with the Commission and are available for public inspection:
a.
b.
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d.
e.
f.
g.
h.
i. All documents (original and eight copies) should be filed with: Linwood A. Watson, Jr., Acting Secretary, Federal Energy Regulatory Commission, 888 First Street, NE, Washington DC 20426. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
j.
The transfer applications were filed within five years of the expiration of the licenses for Project Nos. 233, 1354, 2107, 2661, and 2687, which are subject of pending relicense applications. In Hydroelectric Relicensing Regulations Under the Federal Power Act (54 F.R. 23,756; FERC Stats. and Regs., Regs. Preambles 1986-1990 30,854 at p. 31,437), the Commission declined to forbid all license transfers during the last five years of an existing license, and instead indicated that it would scrutinize all such transfer requests to determine if the transfer's primary purpose was to give the transferee an advantage in relicensing (id. at p. 31,438 n. 318).
Several of the transfer applications also contain separate requests for approval of the substitution of the transferee for the transferor as the applicant in the pending relicensing applications filed by PG&E in Project Nos. 233-081, 1354-005, 2107-010, 2661-012, and 2687-014.
k. Copies of these filings are on file with the Commission and are available for public inspection. The filings may also be viewed on the web at http://www.ferc.gov using the “RIMS” link, select “Docket#” and follow the instructions (call (202) 208-2222 for assistance). Copies are also available for inspection and reproduction at the addresses in item f above.
l. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. An additional copy must be sent to the Director, Division of Hydropower Administration and Compliance, Federal Energy Regulatory Commission, at the above-mentioned address. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
All documents (original and eight copies) should be filed with: Linwood A. Watson, Jr., Acting Secretary, Federal Energy Regulatory Commission, 888 First Street, NE, Washington DC 20426. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
k.
l. Copies of this filing are on file with the Commission and are available for public inspection. This filing may also be viewed on the Web at
m.
n.
o.
p.
q. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
r.
s.
t.
On September 24, 2001, the Federal Energy Regulatory Commission (Commission) issued a notice for the Prairie du Sac Project (FERC No. 11162-002) proposing to establish a restricted service list for the purpose of developing and executing a Programmatic Agreement (PA) for managing properties included in or eligible for inclusion in the National Register of Historic Places. The Prairie du Sac Project is located in Sauk and Columbia Counties in central Wisconsin. Wisconsin Power and Light Company is the prospective licensee.
Rule 2010 of the Commission's Rules of Practice and Procedure provides that, to eliminate unnecessary expense or improve administrative efficiency, the Secretary may establish a restricted service list for a particular phase or issue in a proceeding.
Add “Larry Garvin, Executive Director of Heritage Preservation, Ho-Chunk Nation of Wisconsin, P.O. Box 667, Black River Falls, WI 54615”.
Pursuant to the Federal Advisory Committee Act, Public Law 92-463, notice is hereby given that the Executive Committee (EC) of the US EPA Science Advisory Board (SAB) will conduct a public teleconference meeting on Friday, January 11, 2002 from 11 am to 1:30 pm Eastern Daylight Time. The meeting will be coordinated through a conference call connection in Room 6013 in the USEPA, Ariel Rios Building, 1200 Pennsylvania Ave, NW, Washington, DC 20004. The public is encouraged to attend the meeting in the conference room noted above. However, the public may also attend through a telephonic link, to the extent that lines are available. Additional instructions about how to participate in the conference call can be obtained by calling Ms. Diana Pozun (202-564-4544) or e-mail at
(b) Although not confirmed at the time this FR Notice was prepared, the EC may also review a draft Commentary from the SAB's Environmental Economics Advisory Committee (EEAC) on the topic:
Please check with Diana Pozun (see contact information below) prior to the meeting to determine if any other reports will be on the agenda as last minute changes can take place.
It is the policy of the EPA Science Advisory Board to accept written public comments of any length, and to accommodate oral public comments whenever possible. The EPA Science Advisory Board expects that public statements presented at its meetings will not be repetitive of previously submitted oral or written statements.
Environmental Protection Agency (EPA).
Notice.
This notice announces Agency approval of applications submitted by Makhteshim-Agan of North America, Inc., 551 Fifth Avenue, Suite 1100, New York, NY 10176, to conditionally register the pesticide products Rimon Technical and Rimon 10 EC containing Novaluron a new active ingredient not included in any previously registered products pursuant to the provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.
By mail: Suku Oonnithan, Insecticide-Rodenticide Branch, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 605-0368; and e-mail address: oonnithan.suku@epa.gov.
You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
To access a fact sheet which provides more detail on this registration, go to the Home Page for the Office of Pesticide Programs at http://www.epa.gov/pesticides/, and select “fact sheet.”
2.
In accordance with section 3(c)(2) of FIFRA, a copy of the approved label, the list of data references, the data and other scientific information used to support registration, except for material specifically protected by section 10 of FIFRA, are available for public inspection in the Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal Mall #2, Arlington, VA (703) 305-5805. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave., NW., Washington, DC 20460. Such requests should: Identify the product name and registration number and specify the data or information desired.
A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161.
A conditional registration may be granted under section 3(c)(7)(C) of FIFRA for a new active ingredient where certain data are lacking, on condition that such data are received by the end of the conditional registration period and do not meet or exceed the risk criteria set forth in 40 CFR 154.7; that use of the pesticide during the conditional registration period will not cause unreasonable adverse effects; and that use of the pesticide is in the public interest. The Agency has considered the available data on the risks associated with the proposed use of novaluron, and information on social, economic, and environmental benefits to be derived from such use. Specifically, the Agency has considered the nature and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of novaluron during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is, in the public interest.
Consistent with section 3(c)(7)(C) of FIFRA, the Agency has determined that these conditional registrations are in the public interest. Use of the pesticides are of significance to the user community, and appropriate labeling, use directions, and other measures have been taken to ensure that use of the pesticides will not result in unreasonable adverse effects to man and the environment.
EPA issued a notice, published in the
Rimon Technical, EPA registration number 11678-57, is used for the manufacturing of end-use product formulations. Rimon 10 EC, EPA registration number 66222-35, is used for the control of insect pests on container grown ornamentals in greenhouses. Both products were approved on September 25, 2001.
Environmental protection, Pesticides and pest.
Environmental Protection Agency (EPA).
Notice.
This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain
Comments, identified by docket control number PF-1037, must be received on or before January 18, 2002.
Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the
By mail: Anne Ball, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-8717; e-mail address: ball.anne@epa.gov.
You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1037 in the subject line on the first page of your response.
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Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI 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. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under
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 copies of 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 the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this notice.
7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the
EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.
Environmental protection, Agricultural commodities, Biopesticides, Feed additives, Food additives, Pesticides and pests, Pollution prevention, Reporting and recordkeeping requirements.
The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.
EPA has received a pesticide petition [1G6307] from Growth Products Ltd. , PO Box 1259, White Plains, NY 10602, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a temporary tolerance for the microbial pesticide
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Growth Products Ltd. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Growth Products Ltd. and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.
Companion Liquid Biological Fungicide 00.03%
1.
2.
Toxicological data on the active ingredient had been previously accepted to support the current exemption from the requirement of a tolerance for residues for seed treatment of agricultural commodities See 40 CFR 180.1111). These studies include an acute oral toxicity/pathogenicity study in the rat, an acute dermal toxicity study in the rabbit, an acute pulmonary toxicity/pathogenicity study in the rat, an acute intravenous toxicity/pathogenicity study in the rat and a primary eye irritation study in the rabbit. EPA found from a review of these studies that the active ingredient was not toxic to test animals when administered via the oral, dermal, intravenous, or pulmonary routes of exposure. The active ingredient was not infective or pathogenic to test animals when administered via the oral, pulmonary, and intravenous routes. No reports of hypersensitivity had been reported from personnel working with this organism.
Toxicological data on the end-use product Companion Liquid Biological Fungicide had been previously accepted to support a registration for non-food greenhouse use. An acute oral toxicity study showed no toxicity at a dose of 5,000 milligrams/kilograms (mg/kg) in rats (Toxicity category IV), a primary eye irritation study showed mild irritation at a dose of 0.1 milliliters (mL) in rabbits (Toxicity Category IV), and a primary dermal irritation study showed moderate dermal irritation at a dose of 0.5 mL in rabbits (Toxicity Category III). The results of the above studies indicate that there are no significant human health risks associated with the active ingredient or end use product.
1.
ii.
2.
Personal protective equipment (PPE) mitigates the possibility of exposure for applicators and handlers of the proposed products, when used in agricultural settings.
It is not expected that, when used as proposed, products containing
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2.
To date there is no evidence to suggest that
There is an existing EPA tolerance in 40 CFR 180.1111:
A codex Alimentarium Commission Maximum Residue Level (MRL) is not required for
Environmental Protection Agency (EPA).
Notice.
This notice announces receipt of an application 56228-EUP-O from the Animal and Plant Health Inspection Service, U.S. Department of Agriculture (USDA/APHIS) requesting an experimental use permit (EUP) for the use of sodium cyanide in M-44 Cyanide Capsules in M-44 spring-loaded ejectors to control coyotes (
Comments, identified by docket control number OPP-50891, must be received on or before January 18, 2002.
Comments and data may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the
By mail: William W. Jacobs, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-6406; and e-mail address: jacobs.bill@epa.gov.
This action is directed to the public in general. This action may, however, be of interest to those interested in programs for protecting native wildlife species of declining numbers before they are imperiled to such an extent that they are listed as threatened or endangered species. All predacidal uses of sodium cyanide were canceled in 1972. Since that time, use of the compound in M-44 capsules has been reinstated for controlling canids that prey on livestock, that prey on threatened or endangered species, or that are vectors of comminicable diseases. Use of M-44s to protect wildlife that are not yet listed as threatened or endangered has not been directly authorized. The proposed research program is intended to explore the feasibility of use of M-44s to protect sage grouse and Gunnison sage grouse and to obtain new evidence regarding the units' utility and safety when used in that capacity. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-50891 in the subject line on the first page of your response.
1.
2.
3.
Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI 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. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under
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 copies of 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 the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the notice.
7. Make sure to submit your comments by the deadline in this document.
8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
In cooperation with State wildlife agencies in Idaho, Utah, and Colorado, USDA/APHIS “intends to determine whether integrated predation management including the use of M-44s is more effective for sage grouse (
The proposed research originally was to take place in sage grouse habitat in Wayne and Garfield Counties, Utah, and in Owyhee County, Butte County, and Oneida County, Idaho. The Gunnison sage grouse reportedly occurs in the proposed study site in San Juan County, Utah. According to the application, the Gunnison (
Predator management using M-44s and non-pesticidal methods is to be effected in an area of Gunnison sage grouse habitat in San Juan County, Utah. Control operations are to be conducted and monitored by USDA/APHIS personnel. Recruitment of Gunnison sage grouse is to be monitored in the managed areas by the Utah Division of Wildlife Resources. The Colorado Division of Wildlife is to monitor recruitment of Gunnison sage grouse in a neighboring area of Colorado where there is to be “no formal predator control program.”
Recruitment of sage grouse also is proposed to be monitored in areas subject to predator control in Wayne and Garfield Counties, Utah, and in Owyhee, Oneida, and Butte Counties, Idaho. At the Wayne, Garfield, Owyhee, and Oneida sites, two sage grouse breeding areas are to be protected by predator control methods other than M-44s while two other areas are to be protected by those same methods plus M-44s. At the Butte site, only non-chemical methods are to be used. At all sites, numbers of target and nontarget species taken by each method are to be recorded along with “the amount of time spent in the application of each management method.” Artificial nests consisting of three brown chicken eggs placed under a sage bush are to be monitored at some sites. At two Idaho sites, fates of some sage grouse are to be monitored using radio telemetry.
Following the review of the USDA/APHIS application and any comments and data received in response to this notice, EPA will decide whether to issue or deny the EUP request for this EUP program, and if issued, the conditions under which it is to be conducted. Any issuance of an EUP will be announced in the
Under 40 CFR 172.11(a), EPA is required to publish in the
Environmental protection, Experimental use permits.
Environmental Protection Agency (EPA).
Notice.
This notice announces receipt of an application 71065-EUP-E from Growth Products Limited requesting an experimental use permit (EUP) for the fungicide
Comments, identified by docket control number OPP-50887, must be received on or before January 18, 2002.
Comments and data may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the
By mail: Anne Ball, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-8717; e-mail address: ball.anne@epa.gov.
This action is directed to the public in general. This action may, however, be of interest to those persons who are or may be required to conduct testing of microbial substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-50887 in the subject line on the first page of your response.
1.
2.
3.
Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI 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. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under
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 copies of 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 the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the notice.
7. Make sure to submit your comments by the deadline in this document.
8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
Growth Products Ltd., P.O. Box 1259, White Plains, NY 10602 has requested an EUP for the microbial pesticide Companion
The proposed experimental program is to cover a total of 200 acres in 5 states, as follows: California, Florida, New York, North Dakota, and Washington. The rate of application of the pesticide is to be: for field crops, 32 oz. per acre in sufficient water to ensure full coverage; for soil drench application, 16 oz. in 100 gallons of water for cell/plug production; and 1 oz. per 30 gallons of water for closed systems (ebb and flow) and hydroponics.
Proposed crop treatment sites include apples, broccoli, celery, citrus, cotton, grapes (raisin, table and wine), herbs and spices, lettuce (iceberg and leaf), melons, onions, potatoes, strawberries, sunflower, tobacco, and tomatoes. Disease severity and intensity will be observed, as well as measurements of root growth in both length and mass, leaf color, and tissue analysis of nutrient levels, all of which are indicators of healthy plants.
Ground methods of application are proposed, including soil drench application by injection into irrigation systems, and closed systems (ebb and flow) and hydroponics by incorporation into closed continuous recirculation systems.
Following the review of the Growth Products Limited application and any comments and data received in response to this notice, EPA will decide whether to issue or deny the EUP request for this EUP program, and if issued, the conditions under which it is to be conducted. Any issuance of an EUP will be announced in the
The Agency's authority for taking this action is under 40 CFR part 172, subpart A.
Environmental protection, Experimental use permits.
Environmental Protection Agency.
Extension of public comment period for EPA Staff White Paper that explores a number of options for addressing boutique fuels in the longer term.
In the November 14, 2001
Julia Macallister, Office of Air Quality and Transportation, (734) 214-4131, or by E-mail at
Environmental Protection Agency (EPA).
Notice of availability.
The Agency seeks public comment on a draft Pesticide Registration (PR) Notice titled “Guidelines for Expedited Review of Experimental Use Permits (EUPs) for Conventional Pesticides.” This draft Notice provides criteria that, if met, can result in a greater number of food use EUPs being issued on an expedited basis for conventional pesticides. EUP applications submitted that meet all of the criteria identified in the Notice will be expedited through the Agency's review process and registrants will not need to utilize their priority slots. The Notice applies to all applicants for EUPs for non-antimicrobial, conventional pesticides. The Notice does not apply to biological pesticides because these pesticides present different risk factors and because the Agency has not heard that the lack of biological pesticide EUPs is an issue.
Comments, identified by docket control number OPP-00755, must be received on or before February 19, 2002.
Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the
Rachel Holloman, Registration Division (7505C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-7193; fax number: (703) 305-6920; e-mail address: holloman.rachel@epa.gov.
This action is directed to the public in general. This action may be of particular interest to those persons who apply for EUPs for conventional pesticides or are required to submit data to EPA to register pesticides or to establish tolerances for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as well as to growers and grower groups. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this Notice, consult the person listed under
1.
2.
3.
You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00755 in the subject line on the first page of your response.
1.
2.
3.
Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI 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. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under
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 copies of 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 the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the notice.
7. Make sure to submit your comments by the deadline in this notice.
8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
The purpose of the proposed PR Notice is to provide criteria that, if met, can result in a greater number of food use EUPs being issued on an expedited basis for conventional pesticides.
Before issuing a new EUP, the Agency must review a subset of the toxicity and exposure data that would otherwise be required for full registration under FIFRA and make several statutory findings. When food is to be treated and allowed to enter domestic commerce under the EUP, EPA must determine (under FFDCA) that “there is a reasonable certainty of no harm” from aggregate exposures to the pesticide, including exposures resulting from use under the EUP. Prior to the passage of
1. The Agency is proposing certain acreage limitations based upon a determination that crops treated on these limited acreages would have a marginal impact on both acute and chronic dietary risk. The criteria have been developed in such a way that, if the criteria are satisfied, the Agency can easily determine, based upon existing Agency assessments, that the requisite FIFRA and FFDCA safety findings can be met. How might the Agency expand these limitations, while utilizing existing risk assessments, to ensure that the statutory findings are satisfied? Should the Agency consider a sliding scale of acres per total acres planted of a minor crop? If so, what should that scale be to cover all of the diverse micro-climates, soils, growing seasons and cropping practices for the various commodities across the United States?
2. The Agency is proposing no more than 100 acres per watershed using the U.S. Geological Survey's (USGS) watershed definition as one of the “risk criteria” in this proposal. What might EPA consider as other options, to ensure that this criteria is not too confusing and/or too limiting for certain commodity grower industries and/or in certain states so as not to eliminate the possibility of conducting larger scale EUPs under this program?
3. The Agency has proposed several active ingredient criteria for this program, choosing to initially limit the program to those active ingredients which need evaluation prior to registration to ensure growers that the products are effective alternatives to already registered products they know. Along with those criteria, the Agency has proposed other criteria for this program that, if met, could result in a greater number of food use EUPs being issued on an expedited basis. What other criteria might the Agency consider (i.e., “minor crop priorities” being added to the active ingredient criteria), and why?
4. What else, if anything, might the Agency consider incorporating into the proposed program to ensure that the field efficacy and crop tolerance data for minor crops, needed by registrants to add minor crop uses to their labels after tolerances are granted, are provided?
5. What other conventional chemicals might the Agency consider adding to the proposed “eligible pesticides” listing up front (besides those that will be considered, if submitted, on a case-by-case basis)?
The PR Notice discussed in this notice is intended to provide guidance to EPA personnel and decision-makers and to pesticide registrants. This notice is not binding on either EPA or pesticide registrants, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation.
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice; request for public comment.
In accordance with the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended by the Superfund Amendments and Reauthorization Act of 1986 (CERCLA), 42 U.S.C. 9600
In exchange for the settlement, 10th Street Land Management has agreed to pay EPA $408,000 in cash that will be placed in a special account for use at the Site. In addition, 10th Street Land Management has agreed to maintain the asphalt cap.
For thirty (30) calendar days following the date of publication of this notice, EPA will receive written comments relating to the proposed settlement. If requested prior to the expiration of this public comment period, EPA will provide an opportunity for a public meeting in the affected area. EPA's response to any comments received will be available for public inspection at the U.S. Environmental Protection Agency, 75 Hawthorne Street, San Francisco, CA 94105.
Comments must be submitted on or before January 18, 2002.
The proposed Prospective Purchaser Agreement and additional background documents relating to the settlement are available for public inspection at the U.S. Environmental Protection Agency, 75 Hawthorne Street, San Francisco, CA 94105. A copy of the proposed settlement may be obtained from William Keener, Assistant Regional Counsel (ORC-1), Office of Regional Counsel, U.S. EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105. Comments should reference “10th Street Land Management PPA, Lorentz Barrel &
William Keener, Assistant Regional Counsel (ORC-1), Office of Regional Counsel, U.S. EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105; phone: (415) 972-3940; fax: (415) 947-3570; e-mail:
Environmental Protection Agency.
Notice of proposed
Under Section 122(g)(4) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the Environmental Protection Agency (EPA) has offered a
Written comments may be submitted to Mr. Ray Strickland at the above address within 30 days of the date of publication.
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's approval of applications for test marketing exemption (TME) under section 5(h)(1) of the Toxic Substances Control Act (TSCA) and 40 CFR 720.38. EPA has designated these applications as TME-02-01, TME-02-02, and TME-02-03. The test marketing conditions are described in the TME applications and in this notice.
Approval of these TMEs are effective December 12, 2001. Written comments will be received until January 3, 2002.
Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit III. of the
This action is directed in particular to the chemical manufacturer and/or importer who submitted the TMEs to EPA. This action may, however, be of interest to the public in general. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
A.
B.
The notice of receipt was published late in the 45-day review period; however, an opportunity to submit comments is being offered at this time.
A.
B.
C.
Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI 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. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person identified under
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 copies of 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 the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the proposed rule or collection activity.
7. Make sure to submit your comments by the deadline in this document.
8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
Section 5(h)(1) of TSCA and 40 CFR 720.38 authorizes EPA to exempt persons from premanufacture notification (PMN) requirements (under TSCA section 5(a)(1)(A) and 40 CFR Part 720) and permit them to manufacture or import new chemical substances for test marketing purposes, if the Agency finds that the manufacture, processing, distribution in commerce, use, and disposal of the substances for test marketing purposes will not present an unreasonable risk of injury to health or the environment. EPA may impose restrictions on test marketing activities and may modify or revoke a test marketing exemption upon receipt of new information which casts significant doubt on its finding that the test marketing activity will not present an unreasonable risk of injury.
EPA has approved the above-referenced TMEs. EPA has determined that test marketing the new chemical substances, under the conditions set out in the TME applications and in this notice, will not present any unreasonable risk of injury to health or the environment.
The test market time period, production volume, number of customers, and use must not exceed specifications in the applications and this notice. All other conditions and restrictions described in the applications and in this notice must also be met.
TME-02-02: Butyl acylate, polymer with styrene and methylamino chloride compounds, lactic acid salt.
TME-02-03: Butyl acylate, polymer with styrene and methylamino chloride compounds, nitric acid salt.
The following additional restrictions apply to these TMEs. A bill of lading accompanying each shipment must state that the use of these substances are restricted to that approved in the TMEs. In addition, the applicant shall maintain the following records until 5 years after the date they are created, and shall make them available for inspection or copying in accordance with section 11 of TSCA:
1. Records of the quantity of each TME substance produced and the date of manufacture.
2. Records of dates of the shipments to each customer and the quantities supplied in each shipment.
3. Copies of the bill of lading that accompanies each shipment of the TME substances.
EPA identified concerns for potential lung toxicity to workers and environmental toxicity to aquatic organisms. However, these concerns were adequately mitigated because of expected low exposures to workers, lack of releases to surface water, and reduction of aquatic toxicity in the presence of total organic carbon. Therefore, EPA has determined that these test marketing activities will not present an unreasonable risk of injury to human health or the environment.
Environmental protection, Test marketing exemptions.
Environmental Protection Agency.
Notice of proposed reissuance of a general permit.
This general permit was originally effective on April 7, 1997, and expires on April 9, 2002. EPA proposes to reissue this general permit with minor changes based on updated information relating to the impact of such mining activity on the environment. EPA is proposing to automatically extend coverage under this general permit, when final, to those facilities covered by the previous permit which submit a Notice of Intent (NOI) prior to April 9, 2002.
Interested persons may submit comments on the proposed reissuance of the GP to EPA, Region 10 at the address below. Comments must be received by February 4, 2002.
Comments on the proposed General Permit should be sent to Director, Office of Water; USEPA Region 10; 1200 Sixth Avenue, OW-135; Seattle, Washington 98101.
Copies of the Proposed General Permit and Fact Sheet are available upon request. Requests may be made to Audrey Washington at (206) 553-0523 or to Cindi Godsey at (907) 271-6561 or electronically mailed to:
Export-Import Bank of the United States (Ex-Im Bank).
Notice and request for comments.
Under the provisions of the Paperwork Reduction Act of 1945, the Export-Import Bank of the United States is submitting to the Office of Management and Budget (OMB) a request to review and approve a revised exporter and banker survey. The purpose of the survey is to fulfill a statutory mandate (the Export-Import Bank Act of 1945, as amended, 12 U.S.C. 635) which directs Ex-Im Bank to report annually to the U.S. Congress any action taken toward providing export credit programs that are competitive with those offered by official foreign export credit agencies. The Act further stipulates that the annual report on competitiveness should include the results of a survey of U.S. exporters and U.S. commercial lending institutions which provide export credit to determine their experience in meeting financial competition from other countries whose exporters compete with U.S. exporters.
Accordingly, Ex-Im Bank is requesting that the proposed survey (EIB No. 00-02) be sent to approximately 50 respondents, split equally between bankers and exporters. The revised survey is similar to the previous survey, as it asks bankers and exporters to evaluate the competitiveness of Ex-Im Bank's programs vis-á-vis foreign export credit agencies. However, it has been modified in order to account for newer policies and to capture enough information to provide a better analysis of our competitiveness. In addition,the survey will be administered electronically via email, with recipients encouraged to respond electronically as well.
Written comments should be received on or before January 18, 2002.
Direct all written comments or requests for additional information to David Rostker, Office of Management and Budget, Information and Regulatory Affairs, Room 10102, New Executive Office Building, Washington, D.C. 20503, (202) 395-3897.
Carlista D. Robinson, Export-Import Bank of the U.S., 811 Vermont Avenue, NW., Washington, DC 20571 (202) 565-3351.
With respect to the proposed collection of information, Ex-Im Bank invites comments as to:
Federal Communications Commission.
Notice; solicitation of comments.
In a Public Notice in this proceeding released on December 11, 2001, the Common Carrier Bureau sought comment on the IT&E Overseas, Inc. Petition for Designation as an Eligible Telecommunications Carrier in the territory of Guam.
Comments are due on or before January 18, 2002. Reply comments are due on or before February 4, 2002.
See
Richard D. Smith or Anita Cheng, Attorney, or Sheryl Todd, Management Analyst, Common Carrier Bureau, Accounting Policy Division, (202) 418-7400 TTY: (202) 418-0484.
On December 6, 2001, IT&E Overseas, Inc. (IT&E) filed with the Commission a petition under section 214(e)(6) seeking designation as an eligible telecommunications carrier (ETC) to receive Federal universal service support for service offered in Guam. Specifically, IT&E contends that the Public Utilities Commission of Guam (Guam Commission) has provided an affirmative statement that it does not regulate commercial mobile radio service (CMRS) carriers, IT&E meets all the statutory and regulatory prerequisites for ETC designation, and designating IT&E as an ETC will serve the public interest. The Common Carrier Bureau seeks comment on the IT&E petition, including the requested service area.
The petitioner must provide copies of its petition to the Guam Commission at the time of filing with the Commission. The Commission will also send a copy of this Notice to the Guam Commission by overnight express mail to ensure that the Guam Commission is notified of the notice and comment period.
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, interested parties may file comments as follows: Comments are due January 18, 2002 and reply comments are due February 4, 2002. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS) or by filing paper copies.
Parties also must send three paper copies of their filing to Sheryl Todd, Accounting Policy Division, Common Carrier Bureau, Federal Communications Commission, 445 Twelfth Street, SW., Room 5-B540, Washington, DC 20554. In addition, commenters must send diskette copies to the Commission's copy contractor, Qualex International, Portals II, 445 Twelfth Street, SW., Room CY-B402, Washington, DC 20554.
Pursuant to § 1.1206 of the Commission's rules, this proceeding will be conducted as a permit-but-disclose proceeding in which
The Commission hereby gives notice of the filing of the following agreement(s) under the Shipping Act of 1984. Interested parties can review or obtain copies of agreements at the Washington, DC offices of the Commission, 800 North Capitol Street, NW., Room 940. Interested parties may submit comments on an agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within 10 days of the date this notice appears in the
By Order of the Federal Maritime Commission.
Notice is given that the Commission, on December 11, 2001, served an Order to Show Cause (“Order”) on Cargo Carriers Ltd., Commonwealth Shipping Ltd., Martyn C. Merritt and Mary Anne Merritt.
Cargo Carriers Ltd. is a licensed ocean transportation intermediary (“OTI”) that operates as a non-vessel-operating common carrier and ocean freight forwarder (FMC Organization No. 13507). It appears that Cargo Carriers Ltd.'s 1999 OTI license application contains false information concerning its qualifying individual and the sharing of office space with a company controlled by Mary Anne Merritt.
Commonwealth Shipping Ltd. holds itself out to the public as an ocean
The Order directs Cargo Carriers Ltd. to show cause why the Commission should not order the revocation of its ocean transportation intermediary license for providing materially false or misleading statements to the Commission; and to show cause why the Commission should not order the cancellation of its non-vessel-operating common carrier tariff if its license is revoked. The Order also directs Commonwealth Shipping Ltd. show cause why the Commission should not order the cancellation of its tariff holding itself out to the public as an ocean common carrier because it does not operate as an ocean common carrier. The Order further directs Cargo Carriers Ltd., Commonwealth Shipping Ltd., Martyn C. Merritt and Mary Anne Merritt show cause why the Commission should not order Cargo Carriers Ltd., Commonwealth Shipping Ltd., Martyn C. Merritt and Mary Anne Merritt to cease and desist from future violations of the Shipping Act of 1984.
The full text of the Order may be viewed on the Commission's homepage at
Any person having an interest and desiring to intervene in this proceeding shall file a petition for leave to intervene no later than December 31, 2001 in accordance with 46 CFR 502.72.
The Federal Maritime Commission hereby gives notice that the following Ocean Transportation Intermediary licenses have been revoked pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. app. 1718) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, effective on the corresponding date shown below:
In the
Federal Maritime Commission.
Notice.
Notice is hereby given of the names of the members of the Performance Review Board.
Harriette H. Charbonneau, Director of Human Resources, Federal Maritime Commission, 800 North Capitol Street, NW., Washington, DC 20573.
Sec. 4314(c) (1) through (5) of title 5, U.S.C., requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more performance review boards. The board shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointing authority relative to the performance of the senior executive.
The Members of the Performance Review Board Are:
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 11, 2002.
Board of Governors of the Federal Reserve System, December 13, 2001.
Administration on Aging, HHS.
The Administration on Aging (AoA), Department of Health and Human Services, In compliance with the Paperwork Reduction Act (Pub. L. 96-511), is submitting to the Office of Management and Budget for clearance and approval an information collection instrument, entitled Program Evaluation Data Collection Protocols and Tools for the Alzheimer's Disease Demonstration Grants to States Program.
Administration on Aging, HHS.
The Administration on Aging (AoA), Department of Health and Human Services, in compliance with the Paperwork Reduction Act (Public Law 96-511), is submitting to the Office of Management and Budget for clearance and approval an information collection instrument, entitled Performance (Progress) Reports for Alzheimer's Disease Demonstration Grants to States Program Grantees.
The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2002 funds for a cooperative agreement program for the surveillance, research, and prevention of birth defects. The purpose of this program is to aid in the surveillance, research, and prevention of birth defects.
Assistance will be provided only to the International Centre for Birth Defects (ICBD). No other applications are solicited.
Located in Rome, Italy, ICBD was established in 1989 as an organization devoted to the prevention of birth defects through surveillance, training, and epidemiologic research. ICBD accomplishes this by serving as the headquarters for the International Clearinghouse for Birth Defects Monitoring Programs. The Clearinghouse is a non-governmental organization comprised of 32 member programs representing 34 countries in Europe, the Americas, Japan, China, South Africa, and Australia. The Clearinghouse's mission is to prevent birth defects through the exchange of information, enabling collaborative research, and consultation and assistance. Specifically, the Clearinghouse:
1. Responds to possible or suspected clusters of congenital malformations with information, monitoring systems, and personnel so that member countries are alerted and preventive action may be taken. This is the primary and most enduring goal of the Clearinghouse;
2. Enables collaborative epidemiological research based on birth defect surveillance data obtained from the member programs. Joint studies with the member programs have attempted to provide an understanding of endemic occurrence as well as temporal and/or geographical clusters of malformations; and
3. Provides expert consultation and assistance.
Title 2 of the United States Code, section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
Approximately $150,000 is available in FY 2002 to fund this award. It is expected that the award will begin on or about April 1, 2002, and will be made for a 12-month budget period within a project period of up to three years. Funding estimates may change.
Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.
Funds may be utilized only for the purpose and for the activities described and approved in the final award.
1. All requests for funds contained in the budget shall be stated in U.S. dollars. Once an award is made, CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.
a. Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services. Equipment may be purchased if deemed necessary to accomplish program objectives, however, prior approval by CDC officials must be requested in writing.
b. The costs that are generally allowable in grants to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: Indirect costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the United States or to international organizations regardless of their location.
c. The applicant may contract with other organizations under this program. However, the applicant must perform a substantial portion of the activities including program management and operations, and delivery of prevention services for which funds are required.
This and other CDC announcements can be found on the CDC home page Internet address
To obtain business management technical assistance, contact: Angelia D. Hill, Grants Management Specialist, International Grants and Contracts Branch, Procurement and Grants Office, Centers for Disease Control and
Program technical assistance may be obtained from: J. David Erickson, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway NE., Atlanta, GA 30341-3724, Telephone: (770) 488-7161, E-mail address:
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the National Center for Environmental Health (NCEH) of the Centers for Disease Control and Prevention (CDC) announces the following committee meeting.
Opportunities will be provided during the meeting for oral comments. Depending on the time available and the number of requests, it may be necessary to limit the time of each presenter.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of hearing.
This notice announces an administrative hearing to reconsider the decision to disapprove Missouri SPA 92-33 on January 23, 2002, at 10 a.m., Richard Bolling Federal Building; Plaza Room 664; 601 East Twelfth Street; Kansas City, Missouri 64106-2808.
Requests to participate in the hearing as a party must be received by the presiding officer by January 3, 2002.
Kathleen Scully-Hayes, Office of Hearings, Centers for Medicare & Medicaid Services, Suite L 2520 Lord Baltimore Drive, Baltimore, Maryland 21244-2670, Telephone: (410) 786-2055.
This notice announces an administrative hearing to reconsider our decision to disapprove Missouri SPA 92-33.
Section 1116 of the Social Security Act (the Act) and 42 CFR part 430 establish HHS procedures that provide an administrative hearing for reconsideration of a disapproval of a State plan or plan amendment. The Centers for Medicare & Medicaid Services (CMS) is required to publish a copy of the notice to a state Medicaid agency that informs the agency of the time and place of the hearing and the issues to be considered. If we subsequently notify the agency of additional issues that will be considered at the hearing, we will also publish that notice. Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as
The issue is whether the provisions of section 1923(f)(1)(A) of the Act and regulations at 42 CFR 447.296(b)(6) would permit the State to increase disproportionate share hospital (DSH) payments under this State plan amendment submitted after September 30, 1991. Missouri submitted SPA 92-33 on November 18, 1991, as part of SPA 91-50. This amendment would provide for an additional payment to 10 DSH hospitals that have the highest Medicaid utilization in the State and had a high volume of nursery and neonatal care days.
Under the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991 (Pub. L. 102-234), which added section 1923(f)(l)(A) of the Act and the Federal regulation at 42 CFR 447.296(b)(6), the State cannot increase DSH payments to hospitals based on amendments submitted after September 30, 1991, for payments made during the period January 1, 1992, through September 30, 1992, except in very limited circumstances. The reason for this moratorium on DSH payments was so CMS could determine a state's base DSH allotments for an annual period beginning in Federal fiscal year 1993.
The additional DSH payment included in this amendment is not within the statutory exception for payments under certain SPAs submitted to the Secretary between September 30, 1991, and November 26, 1991. This exception applies only to an amendment that designates only DSHs with a Medicaid or low-income utilization percentage at or above the statewide arithmetic mean. In
While the additional DSH payment meets the timing criteria for this exception (it was submitted on November 18, 1991, as part of SPA 91-50), it was not intended to limit the State's overall definition of DSHs to those with a Medicaid or low-income utilization percentage at or below the statewide arithmetic mean. This provision did not concern the designation of DSHs at all, but only concerned the payment rate for some already designated hospitals. It provided for a 10-percent additional payment to certain hospitals otherwise designated and receiving DSH payments. Therefore, CMS found this exception not to apply, and disapproved Missouri SPA 92-33.
The notice to Missouri announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows:
I am responding to your request for reconsideration of the decision to disapprove Missouri State Plan Amendment (SPA) 92-33.
The issue is whether the provisions of section 1923(f)(1)(A) of the Social Security Act (the Act) and regulations at 42 CFR 447.296(b)(6) would permit the State to increase disproportionate share hospital (DSH) payments under this State plan amendment submitted after September 30, 1991. Missouri submitted SPA 92-33 on November 18, 1991, as part of SPA 91-50. This amendment would provide for an additional payment to 10 DSH hospitals that have the highest Medicaid utilization in the State and had a high volume of nursery and neonatal care days.
Under the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991 (Pub. L. 102-234), which added section 1923 (f)(l)(A) of the Act and the Federal regulation at 42 CFR 447.296(b)(6), the State cannot increase DSH payments to hospitals based on amendments submitted after September 30, 1991, for payments made during the period January 1, 1992, through September 30, 1992, except in very limited circumstances. The reason for this moratorium on DSH payments was so CMS could determine a state's base DSH allotments for an annual period beginning in Federal fiscal year 1993.
The additional DSH payment included in this amendment is not within the statutory exception for payments under certain SPAs submitted to the Secretary between September 30, 1991, and November 26, 1991. This exception applies only to an amendment that designates only DSHs with a Medicaid or low-income utilization percentage at or above the statewide arithmetic mean. In regulations at 42 CFR 447.296(b), the Secretary has interpreted this exception to apply only when the amendment is intended to limit the state's overall definition of DSH to those specified hospitals.
While the proposed amendment meets the timing criteria for this exception (it was submitted on November 18, 1991, as part of SPA 91-50), it does not meet the substantive criteria for this exception. The proposed amendment does not limit the State's overall definition of DSHs to those with a Medicaid or low-income utilization percentage at or below the statewide arithmetic mean. This provision did not concern the designation of DSHs at all, but only concerned the payment rate for some already designated hospitals. It provided for a 10-percent additional payment to certain hospitals otherwise designated and receiving DSH payments. Therefore, CMS found this exception not to apply, and disapproved Missouri SPA 92-33.
I am scheduling a hearing on your request for reconsideration to be held on January 23, 2002, at 10:00 a.m.; Richard Bolling Federal Building; Plaza Room 664; 601 East Twelfth Street; Kansas City, Missouri 64106-2808.
If this date is not acceptable, we would be glad to set another date that is mutually agreeable to the parties. The hearing will be governed by the procedures prescribed at 42 CFR, Part 430.
I am designating Ms. Kathleen Scully-Hayes as the presiding officer. If these arrangements present any problems, please contact the presiding officer. In order to facilitate any communication which may be necessary between the parties to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. The presiding officer may be reached at (410) 786-2055.
Centers for Medicare & Medicaid Services (CMS), (HHS).
Notice of hearing.
This notice announces an administrative hearing to reconsider the decision to disapprove Missouri State Plan Amendment 91-50, on January 23, 2002, at 10:00 a.m., at the Richard Bolling Federal Building; Plaza Room 664; 601 East Twelfth Street; Kansas City, Missouri 64106-2808.
Requests to participate in the hearing as a party must be received by the presiding officer by January 3, 2002.
Kathleen Scully-Hayes, Office of Hearings, CMS, Suite L, 2520 Lord Baltimore Drive, Baltimore, Maryland 21244-2670, Telephone: (410)-786-2055.
This notice announces an administrative hearing to reconsider the decision to disapprove Missouri State Plan Amendment (SPA) 91-50.
Section 1116 of the Social Security Act (the Act) and 42 CFR part 430 establish Department procedures that provide an administrative hearing for reconsideration of a disapproval of a State plan or plan amendment. The Centers for Medicare & Medicaid (CMS) is required to publish a copy of the notice to a state Medicaid agency that informs the agency of the time and place of the hearing and the issues to be considered. If we subsequently notify the agency of additional issues that will be considered at the hearing, we will also publish that notice.
Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as
The issue is whether this amendment proposed a retroactive effective date that is not consistent with law for an additional disproportionate share hospital (DSH) payment to the 10 highest Medicaid utilization hospitals in the State that had a high volume of nursery and neonatal care days. This SPA was submitted on November 18, 1991, with a proposed effective date of October 21, 1991.
Under the Medicaid Voluntary Contribution and Provider Specific Tax
This proposed amendment is not within the statutory exception for payments under certain SPAs submitted to the Secretary between September 30, 1991, and November 26, 1991. This exception applies only to an amendment that designates only DSHs with a Medicaid or low-income utilization percentage at or above the statewide arithmetic mean. In regulations at 42 CFR 447.296(b), the Secretary has interpreted this exception to apply only when the amendment is intended to limit the state's overall definition of DSH to those specified hospitals.
While this proposed amendment meets the timing criteria for this exception, as it was submitted on November 18, 1991, it does not meet the substantive criteria for this exception. The proposed amendment does not limit the State's overall definition of DSH to those with a Medicaid or low-income utilization percentage at or below the statewide arithmetic mean. This proposed amendment did not concern the designation of DSHs, but only concerned the payment rate for some already designated hospitals. This proposed amendment provided for a 10-percent additional payment to certain hospitals otherwise designated and receiving DSH payments. Therefore, CMS found that this exception did not apply and disapproved Missouri SPA 91-50.
The notice to Missouri announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows:
I am responding to your request for reconsideration of the decision to disapprove Missouri State Plan Amendment (SPA) 91-50, which was submitted on November 18, 1991.
The issue is whether this amendment proposed a retroactive effective date that is not consistent with law for an additional disproportionate share hospital (DSH) payment to the 10 highest Medicaid utilization hospitals in the State that had a high volume of nursery and neonatal care days. The proposed effective date of the SPA is October 21, 1991.
Under the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991 (Public Law 102-234), which added section 1923(f)(1)(A) of the Social Security Act (the Act) and the Federal regulation at 42 CFR 447.296(b)(6), the State cannot increase DSH payments to hospitals based on amendments submitted after September 30, 1991, for payments made during the period January 1, 1992, through September 30, 1992, except in very limited circumstances. The reason for this moratorium on DSH payments was so the Centers for Medicare & Medicaid Services (CMS), could determine a state's base DSH allotments for an annual period beginning in Federal fiscal year 1993.
This proposed amendment is not within the statutory exception for payments under certain SPAs submitted to the Secretary between September 30, 1991, and November 26, 1991. This exception applies only to an amendment that designates only DSHs with a Medicaid or low-income utilization percentage at or above the statewide arithmetic mean. In regulations at 42 CFR 447.296(b), the Secretary has interpreted this exception to apply only when the amendment is intended to limit the state's overall definition of DSH to those specified hospitals.
While this proposed amendment meets the timing criteria for this exception, as it was submitted on November 18, 1991, it does not meet the substantive criteria for this exception. The proposed amendment does not limit the State's overall definition of DSH to those with a Medicaid or low-income utilization percentage at or below the statewide arithmetic mean. This proposed amendment did not concern the designation of DSHs, but only concerned the payment rate for some already designated hospitals. This proposed amendment provided for a 10-percent additional payment to certain hospitals otherwise designated and receiving DSH payments. Therefore, CMS found that this exception did not apply and disapproved Missouri SPA 91-50.
I am scheduling a hearing on your request for reconsideration to be held on January 23, 2002, at 10:00 a.m.; Richard Bolling Federal Building; Plaza Room 664; 601 East Twelfth Street; Kansas City, Missouri 64106-2808. If this date is not acceptable, we would be glad to set another date that is mutually agreeable to the parties. The hearing will be governed by the procedures prescribed at 42 CFR, Part 430.
I am designating Ms. Kathleen Scully-Hayes as the presiding officer. If these arrangements present any problems, please contact the presiding officer. In order to facilitate any communication which may be necessary between the parties to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. The presiding officer may be reached at (410) 786-2055.
Fish and Wildlife Service, Interior.
Notice of emergency exemption issuance.
The following applicant has been issued a scientific research permit to conduct certain activities with an endangered species pursuant to section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Linda Belluomini, Permits Biologist at 503-231-2063.
The Washington Department of Fish and Wildlife has been authorized via permit number TE-050644, by the U.S. Fish and Wildlife Service's Pacific Region to capture individuals from the Columbia Basin distinct population segment (DPS) of the pygmy rabbit (Brachylagus idahoensis) for a captive propagation program. We issued this permit for the purpose of enhancing the propagation and survival of the Columbia Basin pygmy rabbit. The 30-day public comment period required by the Endangered Species Act (Act) was waived in accordance with section 10(c) of the Act upon a determination that an emergency affecting the health and life of specimens of Columbia Basin pygmy rabbits exists, and that no reasonable alternative is available to the applicant.
The Columbia Basin pygmy rabbit DPS has undergone dramatic annual declines since 1998, and the entire wild portion of this population now consists of fewer than 50 individuals from just 1 known colony on State land in Douglas County, Washington. As part of a captive breeding program, initiated by the Washington Department of Fish and Wildlife (WDFW) during the spring of 2001, an additional 14 individuals from this population are being held in
Delay in the WDFW's planned activities due to the 30-day public comment period could jeopardize the success of the captive breeding program and, ultimately, the long-term security of the Columbia Basin pygmy rabbit. Individuals within the wild portion of this population may experience significant mortality due to increased susceptibility to predation and inclement weather with the onset of winter, and additional animals may not be available for capture later in the season. Even if this population does not undergo further decline this winter, any wild individuals will likely have weakened body conditions and be more susceptible to capture-related stress and mortality if captured later in the season. Capture operations in midwinter may also be compromised by seasonal precipitation and/or low temperatures. Finally, capturing any additional animals later in the season will give them less time to acclimate to the holding facilities, and they may be unavailable for breeding efforts planned for early spring 2002.
Fish and Wildlife Service, Interior.
Notice of receipt of application.
The following applicant has applied for a permit to conduct certain activities with endangered species. This notice is provided pursuant to section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531,
The applicant requests an amendment to his permit for scientific take activities of listed species in Region 3 to add the following species for scientific purposes and the enhancement of propagation or survival of the species in the wild, in accordance with listing, recovery outlines, recovery plans and/or other Service work for the species: Canada lynx (
Written data or comments should be submitted to the Regional Director, U.S. Fish and Wildlife Service, Ecological Services, 1 Federal Drive, Fort Snelling, Minnesota 55111-4056, and must be received within 30 days of the date of this publication.
Documents and other information submitted with this application are available for review by any party who submits a written request for a copy of such documents to the following office within 30 days of the date of publication of this notice: Mr. Peter Fasbender, U.S. Fish and Wildlife Service, Ecological Services, 1 Federal Drive, Fort Snelling, Minnesota 55111-4056. Telephone: (612) 713-5343; Fax: (612) 713-5292; E-mail:
Fish and Wildlife Service, Interior.
Notice of receipt of application.
The following applicant has applied for a permit amendment to conduct certain activities with endangered species. This notice is provided pursuant to section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531,
The applicant requests a permit to take (collect) the following species: Indiana bat (
Written data or comments should be submitted to the Regional Director, U.S. Fish and Wildlife Service, Ecological Services Operations, 1 Federal Drive, Fort Snelling, Minnesota 55111-4056, and must be received within 30 days of the date of this publication.
Documents and other information submitted with this application are available for review by any party who submits a written request for a copy of such documents to the following office within 30 days of the date of publication of this notice: U.S. Fish and Wildlife Service, Ecological Services Operations, 1 Federal Drive, Fort Snelling, Minnesota 55111-4056. Telephone: (612) 713-5343; Fax: (612) 713-5292.
Fish and Wildlife Service, Interior.
Notice of meetings; extension of comment period.
The U.S. Fish and Wildlife Service (Service or we) invites public participation in public meetings associated with the comment period for a Draft Environmental Impact Statement (DEIS) on double-crested cormorant management. The DEIS has been prepared under the authority of the National Environmental Policy Act and the Migratory Bird Treaty Act and analyzes the potential environmental impacts of several management alternatives to address conflicts associated with double-crested cormorants. This notice describes the proposed action and the other five management alternatives analyzed in the DEIS; identifies the locations, dates, and times of public meetings; and identifies the Service official to whom comments may be directed.
Written comments regarding the DEIS should be submitted by February 28, 2002, to the address below. Dates and times for ten public meetings are listed in the table under
Requests for copies of the DEIS should be mailed to Chief, Division of Migratory Bird Management, U.S. Fish and Wildlife Service, 4401 N. Fairfax Dr., Room 634, Arlington, VA 22203. Written comments on the DEIS can be sent by the following two methods:
(1) By mail to the above address; or
(2) By email to:
Please include your name and mailing address in all comments submitted; anonymous comments will not be considered. The public meetings will be held at the locations listed in the table under
Jon Andrew, Division of Migratory Bird Management, (703) 358-1714.
On November 8, 1999, we published a notice of intent in the
All comments received, including names and addresses, will become part of the public record. The public may inspect comments during normal business hours in Room 634, Arlington Square Building, 4401 N. Fairfax Drive, Arlington, Virginia. Such requests will be handled in accordance with the Freedom of Information Act and the Council on Environmental Quality's National Environmental Policy Act regulations (40 CFR 1506.6(f)). Individual respondents may request that we withhold their name and/or home address from the record, which we will honor to the extent allowable by law. If a respondent wishes us to withhold his/her name and/or address, this must be stated prominently at the beginning of the document.
The DEIS describes and evaluates six alternatives for the purposes of reducing conflicts associated with cormorants, enhancing the flexibility of natural resource agencies to deal with cormorant conflicts, and ensuring the health and viability of cormorant populations. Alternatives, including the proposed action, were analyzed with regard to their potential impacts on cormorant populations, fish, other birds, vegetation, federally listed threatened and endangered species, water quality and human health, economic impacts (including aquaculture and sport fishing-related economies), fish hatcheries and environmental justice, property losses, and existence and aesthetic values. We analyzed the anticipated environmental effects of the following management alternatives: (1) Continue current cormorant management practices (No Action); (2) implement only non-lethal management techniques; (3) expand current cormorant damage management practices; (4) establish a new Depredation Order to address public resource conflicts (PROPOSED ACTION); (5) reduce regional cormorant populations; and (6) establish frameworks for a cormorant hunting season.
The proposed action would establish a Public Resource Depredation Order that allows State, Federal, and Tribal land management agencies to manage cormorants that are injurious to public resources such as fisheries, vegetation, and other wildlife species. Thus, control actions could take place without a federal permit on the agency's lands and waters or nearby private lands and waters (with appropriate landowner permission). Agencies that conduct control activities under the Public Resource Depredation Order would be subject to reporting and monitoring requirements, overseen by the Service. Additionally, under the proposed action, the current Aquaculture Depredation Order would be expanded to allow control of cormorants by wildlife damage professionals at winter roost sites; and Director's Order 27, restricting the use of depredation permits at public fish cultural facilities, would be revoked.
Ten public meetings will be held at the locations and times listed below:
International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) issued by the presiding administrative law judge (ALJ) in the above-captioned investigation granting a motion to add Martec Access Products, Inc. as a respondent.
Michael Liberman, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-3115. Copies of the ALJ's ID and all other nonconfidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-2000. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on July 16, 2001, based on a complaint filed by The Chamberlain Group, Inc. against six entities: Linear Corporation, Napoleon Spring Works, Inc., Lynx Industries, Inc., Innovative Home Products, Inc., Wayne-Dalton Corporation, and Guardian Access Corporation. 66 FR 37704 (2001). Computime Limited was later added as a respondent. The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States, the sale for importation, and/or the sale within the United States after importation of certain garage door operators by reason of infringement of certain claims of complainant's U.S. Letters Patents Nos. Re. 35,364 and Re. 36,703.
On September 21, 2001, complainant filed a motion for leave to amend the complaint and notice of investigation to add Martec Access Products, Inc. as a respondent. On October 2, 2001, the Commission investigative attorney filed a response in support of complainant's motion to amend. On October 15, 2001, respondent Wayne-Dalton Corporation (“Wayne-Dalton”) filed a motion to strike complainant's motion to amend. On October 25, 2001, complainant filed a response to Wayne-Dalton's motion to strike complainant's motion to amend. On October 31, 2001, Wayne-Dalton filed a motion for leave to reply to complainant's response to Wayne-Dalton's motion.
On November 26, 2001, the ALJ granted complainant's motion to amend in the subject ID. On the same day the ALJ denied respondent's motion to strike.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in § 210.42 of the Commission's rules of practice and procedure (19 CFR 210.42).
By order of the Commission.
International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ's”) initial determination (“ID”) granting a motion to amend the complaint in the above-captioned investigation to add license agreements and licensees.
Mary Elizabeth Jones, Esq., Office of the General Counsel, U.S. International Trade Commission, telephone (202) 205-3106. Copies of the subject ID and all other nonconfidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone 202-205-2000. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TTD terminal on 202-205-1810. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on March 16, 2001, based on a complaint by Gemstar-TV Guide International, Inc. of Pasadena, California, and StarSight Telecast, Inc. of Fremont, California, alleging violations of section 337 of the Tariff Act of 1930 in the importation into the
On August 7, 2001, complainants Gemstar-TV Guide International, Inc. and StarSight Telecast, Inc. moved to amend the complaint to add license agreements and licensees. No party opposed the motion to amend.
On August 23, 2001, the presiding ALJ issued an ID (Order No. 24) granting the motion. No petitions for review of the ID were filed.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and Commission rule 210.42, 19 CFR 210.42.
By order of the Commission.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment Standards Administration is soliciting comments concerning the following information collections: (1) Pre-Hearing Statement (LS-18); (2) Overpayment Recovery Questionnaire (OWCP-20); (3) Claim for Continuance of Compensation (CA-12).
Written comments must be submitted to the office listed in the addressee section below by February 19, 2002.
Ms. Patricia A. Forkel, U.S. Department of Labor, 200 Constitution Ave., NW., Room S-3201, Washington, DC 20210, telephone (202) 693-0339 (this is not a toll-free number), fax (202) 693-1451, E-mail:
The Office of Workers' Compensation Programs administers the Longshore and Harbor Workers' Compensation Act. The Act provides benefits to workers injured in maritime employment on the navigable waters of the United States or in an adjoining area customarily used by an employer in loading, unloading, repairing, or building a vessel. Title 20, CFR 702.217 provides for the referral of claims under the Longshore Act for formal hearings. This section provides that, before a case is transferred to the Office of Administrative Law Judges, the district director shall furnish each of the parties or their representatives with a copy of a pre-hearing statement form. Each party shall, within 21 days of receipt, complete it and return it to the district director. Upon receipt, the district director shall transmit the form to the Office of the Chief Administrative Law Judge.
The Department of Labor is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department of Labor seeks the approval of the extension of this information collection in order to carry out its responsibility to prepare cases for formal hearings under the Act.
Both the Federal Coal Mine Health and Safety Act (30 U.S.C. 923(b) and 20 CFR 725.544(c) and the Federal Employees' Compensation Act (5 U.S.C. 8129(b) and 20 CFR 10.320-10.324) provide for the recovery, waiver, compromise, or termination of overpayment of benefits to beneficiaries. The OWCP-20 collects information used to ascertain the financial condition of the beneficiary who has been overpaid to determine if the concealment or improper transfer of assets, and to identify and consider present and potential income and current assets for enforced collection proceedings. The form also provides a means for the beneficiary to explain why he/she is not at fault for the overpayment.
The Department of Labor is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who
The Department of Labor seeks the extension of approval for this information collection in order to carry out its responsibility under the law to resolve overpayments under the Acts.
Under 5 U.S.C. 8133, Federal Employees' Compensation Act, and 20 CFR 10.410, eligible dependents of deceased Federal employees receive compensation benefits on account of the employee's death. The OWCP monitors death benefits for criteria which qualify the beneficiary as the employee's dependent under law. The CA-12 is designated for this purpose.
The Department of Labor is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment Standards Administration is soliciting comments concerning the following information collection: OFCCP Reporting and Recordkeeping Requirements: Supply and Service.
Written comments must be submitted to the office listed in the addressee section below by December 19, 2001.
Please submit comments to Ms. Patricia A. Forkel, U. S. Department of Labor, 200 Constitution Ave., NW., Room S-3201, Washington, DC 20210, telephone (202) 693-0339 fax (202) 693-1451, EMail pforkel@fenix2.dol-esa.gov. For questions concerning this information collection request, please contact Mr. James Melvin, U. S. Department of Labor, Office of Federal Contract Compliance Programs, telephone (202) 693-0102.
The Office of Federal Contract Compliance is responsible for the administration of equal opportunity programs prohibiting employment discrimination and requiring affirmative action and applies to Federal contractors and subcontractors. OFCCP administers three programs: Executive Order 11246, as amended; Section 503 of the Rehabilitation Act of 1973, as amended; and the affirmative action provisions of the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended, (VEVRAA), 38 USC 4212. This information collection contains all recordkeeping and reporting requirements which are derived from the implementing regulations found at Title 41 of the Code of Federal Regulations, chapter 60.
The Department of Labor is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated,
The Department of Labor (DOL) is seeking an extension of this information collection in order to substantiate compliance with nondiscrimination and affirmative action requirements monitored by OFCCP.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Occupational Safety and Health Administration (OSHA), Labor.
Request for comment.
OSHA solicits comment concerning its proposal to increase the existing burden-hour estimates for, and to extend OMB approval of, the information-collection requirements of the Electrical Standards for Construction (29 CFR part 1926, subpart K).
Submit written comments on or before February 19, 2002.
Submit written comments to the Docket Office, Docket No. ICR-1218-0130(2002), OSHA, U.S. Department of Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-2350. Commenters may transmit written comments of 10 pages or less by facsimile to (202) 693-1648.
Theda Kenney, Directorate of Safety Standards Programs, OSHA, U.S. Department of Labor, Room N-3621, 200 Constitution Avenue, N.W., Washington, DC 20210; telephone (202) 693-2444. A copy of the Agency's Information-Collection Request (ICR) supporting the need for the information collections specified by the Electrical Standards for Construction is available for inspection and copying in the Docket Office, or by requesting a copy from Theda Kenney at (202)693-2044 or Todd Owen at (202)693-2444. For electronic copies of the ICR, contact OSHA on the Internet at
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (i.e., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information-collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA-95) (44 U.S.C. 3506(c)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are understandable, and OSHA's estimate of the information-collection burden is correct.
The Electrical Standards for Construction contain a number of paperwork requirements. The following sections describe these requirements in detail.
Under the AEGC program, the employer must test all cord sets, receptacles that are not part of the permanent wiring of the building or structure, and cord- and plug-connected equipment that require grounding. Accordingly, employers must test each equipment-grounding connector for continuity and ensure that it is electrically continuous, and test each receptacle and attachment cap or plug for correct attachment of the equipment-grounding conductor, and ensure that the conductor connects to the proper terminal. Employers are to perform these tests before: First using the equipment; returning the equipment to service following repair; and using equipment after any incident that the employer reasonably suspects damaged equipment. In addition, an employer must conduct testing at least every three months, except for fixed cord sets and receptacles not exposed to damage, which employees must test at least every six months. Employers must also record the tests, including the identity of each receptacle, cord set, and cord- and plug-connected equipment that passed the test, and the previous testing date or the interval covered by the last test. The employer is to maintain these records using logs, color coding, or other effective means until replaced by the next record, and make them available at the job site for inspection by OSHA compliance officers and affected employees.
The purpose of the AEGC program is to detect and correct faults in grounding conductors before a high-voltage accident occurs. Grounding conductors often fail because of the rough use they receive at construction sites, and such failure results in improperly grounded equipment; employees who then use the improperly grounded equipment are at risk for death or injury caused by high-voltage electrical shock. The written program identifies the equipment that the competent person must inspect and test, and delineates the procedures they are to use while inspecting and testing the equipment for grounding faults. Making the written program available for review and copying by OSHA compliance officers and affected employees ensures that the program covers the required equipment currently used at the work site, and that the competent person is following appropriate procedures during inspection and testing. Recording the tests results informs OSHA compliance officers and affected employees that the competent person tested the required equipment, and whether or not this equipment is safe to use.
• Section 1926.403(i)(2)(iii). Mark the entrances to rooms and other guarded locations containing exposed live parts with conspicuous warning signs that forbid unqualified employees from entering.
• Section 1926.403(i)(2)(iii). Post warning signs if unauthorized employees may come in contact with live parts.
• Section 1926.405(h). Mark termination enclosures for portable cables over 600 volts (nominal) with a high-voltage hazard warning.
• Section 1926.408(a)(2)(iii). Provide a means to completely isolate equipment for inspection and repairs. Accordingly, employers must ensure that means of isolation not designed to interrupt the load current of the circuit either are capable of interlocking with a circuit interrupter or they must post a sign warning against opening the means under load.
• Section 1926.408(a)(3)(i). Provide a metallic structure on mobile or portable equipment for enclosing the terminals of the power cables, and mark the structure with a sign warning that the structure contains energized parts.
• Section 1926.416(a)(3). Before starting work, determine whether or not an employee, tool, or machine may come into physical or electrical contact with an energized electric power circuit, whether exposed or concealed. If so, the employer must post and maintain proper warning signs where such circuits exist, and advise employees of the location of such circuits, the hazards involved, and the protective measures they are to take.
These warning signs and marks alert unqualified and unauthorized employees to the presence of electrical hazards, and notify electricians of the need to exercise caution and to take other measures to protect themselves when they are near electrical hazards. Therefore, these paperwork requirements prevent death and serious injury among these employees that may result from inadvertent contact with high-voltage electrical hazards.
The required tags warn others not to reenergize, or activate the controls to, circuits and equipment on which an employee is working. Accordingly, the tags prevent death and serious injury to these employees caused by high-voltage electrical shock, or by operation of the equipment.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information-collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information-collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information-collection and -transmission techniques.
OSHA is proposing to increase the existing burden-hour estimate for, and to extend OMB's approval of, the paperwork requirements specified by the Electrical Standards for Construction. The Agency is proposing to increase the total burden-hour estimate from 53,001 hours to 84,803 hours, an increase of 31,802 hours. This
John L. Henshaw, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506), and Secretary of Labor's Order No. 3-2000 (62 FR 50017).
Signed at Washington, DC, on December 14, 2001.
Occupational Safety and Health Administration (OSHA), Labor.
Maritime Advisory Committee for Occupational Safety and Health: Notice of meeting.
The Maritime Advisory Committee for Occupational Safety and Health (MACOSH), established under section 7 of the Occupational Safety and Health Act of 1970 to advise the Secretary of Labor on issues relating to occupational safety and health programs, policies, and standards for the maritime industries in the United States, will meet in Baltimore, Maryland.
MACOSH will meet on February 20 and 21, 2002, from 8:30 a.m. until approximately 5 p.m.
The Committee will meet at the Baltimore Marriott Waterfront Hotel, 800 Aliceanna Street, Baltimore, Maryland. Mail comments, views, or statements in response to this notice to Joseph V. Daddura, Acting Director, Office of Maritime Safety Standards, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution Avenue, NW., Washington, DC 20210. Telephone (202) 693-2086; fax: (202) 693-1663.
Joseph V. Daddura, Acting Director, Office of Maritime Safety Standards, OSHA: Telephone (202) 693-2086.
All interested persons are invited to attend the public meetings of MACOSH at the time and place indicated above. Individuals with disabilities wishing to attend should contact Theda Kenney at (202) 693-2222 no later than February 1, 2002, to obtain appropriate accommodations.
This meeting will include discussion of the following subjects: MACOSH input on OSHA priorities, vertical tandem lifts in the longshoring industry, an update on the NIOSH diesel exhaust epidemiology study, an NFPA update on the changes to NFPA 306 “Control of Gas hazards on Vessels,” discussion of common issues with OSHA Advisory Committee on Construction Safety and Health, and MACOSH work group reports.
Written data, views, or comments for consideration by MACOSH on the various agenda items listed above may be submitted, preferably with copies, to Joseph V. Daddura at the address listed above. Submissions received by February 1, 2002, will be provided to the members of the committee and will be included in the record of the meeting.
Requests to make oral presentations to the Committee may be granted if time permits. Anyone wishing to make an oral presentation to the Committee on any of the agenda items noted above should notify Joseph V. Daddura by February 1, 2002. The request should state the amount of time desired, the capacity in which the person will appear, and a brief outline of the content of the presentation.
This notice issued under the authority of sections 6(b)(1) and 7(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655, 656), the Federal Advisory Committee Act (5 U.S.C. App. 2), and 29 CFR part 1912.
The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an amendment to Facility Operating License No. DPR-20, held by Nuclear Management Company, LLC (NMC or the licensee), for operation of the Palisades Plant, located in Van Buren County, Michigan, and the NRC is issuing this environmental assessment and finding of no significant impact.
The proposed amendment would change the limiting conditions for operation (LCOs), surveillance requirements (SRs), and design features in the Technical Specifications (TSs) to provide more flexible fuel loading constraints for the Palisades fuel storage racks and accommodate future core designs. The changes affect TS Sections 3.7.15, “Spent Fuel Pool (SFP) Boron Concentration,” 3.7.16, “Spent Fuel Assembly Storage,” and 4.3, “Design Features—Fuel Storage.” Allowed uranium enrichments for storage would be increased. Enrichment limits for storage racks for unirradiated fuel (currently limited to fuel assemblies having a maximum average planar uranium-235 (U-235) enrichment of 4.20 weight percent) would be increased
The proposed action is in accordance with the application dated March 2, 2001, as supplemented by letters dated March 29 and September 14, 2001. Although the initial application for a license amendment was tendered by Consumers Energy Company (CEC), CEC has subsequently been succeeded by NMC as the licensed operator of Palisades. By letter dated May 17, 2001, NMC requested that the Commission continue to process and disposition licensing actions previously docketed and requested by CEC.
The proposed action to change the fuel enrichment and burnup combinations acceptable for storage in Region II racks is needed to allow flexibility in fuel placement within the pool. This flexibility is needed because recent fuel assembly enrichments at Palisades have been above the current 3.27 weight percent enrichment limit for Region II racks specified in TS 4.3.1.2. Thus, currently, these assemblies can only be stored in Region I racks that have limited unused storage capacity. This proposed action is also needed to eliminate reliance upon programs (periodic “blackness” testing) designed to detect degradation and ensure the integrity of fixed Boroflex poison material in the Region II fuel racks for reactivity control. Since the licensee's criticality calculations for this proposed change do not credit the Boroflex material, periodic blackness testing can be discontinued.
The proposed action to increase fuel storage enrichment limits allows the licensee the flexibility to pursue increased reload fuel enrichments needed to optimize fuel cycle costs.
The NRC has completed its evaluation of the potential radiological consequences for both normal and accident conditions associated with the proposed allowed storage of fuel with increased enrichment and SFP criticality calculations supporting the proposed changes. Radiological consequences are only indirectly affected by increasing fuel enrichment. The radiological consequences are primarily a function of operating power and burnup. By increasing fuel enrichment, the same power level can be produced for a longer period of time before refueling. Therefore, the proposed allowed storage of fuel with increased enrichment in the SFP would have no effect on authorized operating power levels, but would result in increasing the burnup levels that can be practically achieved. The proposed license amendment to change the TSs would not affect the allowed maximum burnup for Palisades. The licensee determines this limit using approved fuel assembly and core design methodology stated in the Palisades Final Safety Analysis Report (FSAR), as periodically updated. The evaluation of the radiological consequences resulting from fuel handling accidents (and other accident and transient conditions) would not change since the maximum allowed fuel burnup remains unchanged. The licensee will continue to evaluate reload core designs on a cycle-by-cycle basis as part of its reload safety evaluation process to confirm that the cycle core design adheres to the limits that exist in the accident analyses and TSs and, thus, ensure that each reactor operating cycle will be acceptable.
The applicability of TS LCO 3.7.15 would be changed from “When fuel assemblies are stored in the SFP and a verification of the stored assemblies has not been performed” to “When fuel assemblies are stored in the Spent Fuel Pool.” The NRC staff finds this to be a more restrictive change with no environmental impact.
Required Action A.2.2 for LCO 3.7.15 would be deleted because verification alone would not restore the plant to analyzed conditions. Required Action A.2.1 would be renumbered as “A.2.”
The intent of the existing LCO 3.7.15 is to protect against criticality during a fuel handling accident or misloading event. The licensee's criticality analyses supporting the proposed action credit boron for normal storage as well as for accident scenarios. Therefore, the applicability of LCO 3.7.15 would be extended to all times when fuel assemblies are stored in the Palisades fuel pool and Action A.2.2 would be eliminated.
The change in applicability effectively increases the minimum SRs for spent fuel boron since samples now must be taken even if loading has been verified. Since administrative procedures at Palisades currently require these samples at least weekly, this change would have no effect upon plant operations and would not result in a change to individual or cumulative occupational radiation exposure limits. Similarly, the changed surveillance
The enrichment allowed in TS 4.3.1.3.a would be changed from “Fuel assemblies having a maximum average planar U
Since the storage racks for new (unirradiated) fuel are not used to store irradiated fuel, radiological consequences associated with changes in storage limitations are largely limited by the prevention of inadvertent criticality. The licensee's criticality analyses supporting this license amendment request show that the k
Storage of higher enriched fresh fuel assemblies in the storage racks for unirradiated fuel, under specific loading patterns, has no effect on nonradiological effluent releases.
The enrichment allowed in TS 4.3.1.1.a for fuel assemblies in Region I fuel storage racks would be changed from “having a maximum enrichment of 4.40 weight percent” to “having a maximum planar average U-235 enrichment of 4.95 weight percent.” In TS 4.3.1.1.d, the existing requirement that the Region I fuel storage racks be designed and maintained with:
“New or irradiated fuel assemblies.”
The licensee's criticality analyses supporting this license amendment request show that the 95/95 k
In itself, increasing the enrichment level allowed for storage in the Region I fuel pool racks has no effect on possible radiological or nonradiological effluent releases. Since the licensee's criticality design calculations show that K
Therefore, the proposed TS changes associated with Region I fuel pool storage have no significant adverse radiological impact. These changes also have no adverse nonradiological impact.
The licensee proposes the following TS changes regarding the storage of fuel assemblies in Region II of the fuel pool:
LCO 3.7.16 currently requires that “The combination of initial enrichment and burnup of each fuel assembly stored in Region II shall be within the requirements of Table 3.7.16-1.” This would be changed to require that “The combination of initial enrichment, burnup, and decay time of each irradiated fuel assembly stored in Region II shall be within the requirements of Table 3.7.16-1.” Thus, this change would add the decay time of each assembly as an additional requirement for storage in Region II. Similarly, the associated SR (SR 3.7.16.1) to “Verify by administrative means that the initial enrichment and burnup of each spent fuel assembly stored in Region II is in accordance with Table 3.7.16-1” would be changed to
The licensee's criticality analyses, which are the basis for this license amendment request, show that the 95/95 K
Boron is already present in the Palisades SFP. Likewise, the fuel stored in the pool is burned to levels dictated by core design constraints. Fuel assemblies experience radioactive decay while they are stored. These characteristics of the fuel would not be changed by the proposed amendment. Therefore, crediting the reactivity effects associated with boron, burnup, and decay in the design-basis criticality calculations has no effect upon possible radiological or nonradiological effluent releases. Since the criticality design calculations show that K
In general, the proposed burnup and enrichment combinations that are acceptable for storage in the Region II racks require higher burnups for a given enrichment than those present in the current TS Table 3.7.16-1. This increase in allowed minimum burnup does not affect radiological consequences since the actual fuel burnup is dictated by core design constraints and may be significantly higher than that required for storage in Region II fuel storage racks (up to 58,900 MWD/MTU assembly average for recent Palisades reload fuel, as discussed in FSAR Section 3.2.3, Nuclear Limits). In general, higher burnup has a limited effect on the short-lived isotope inventory in the fuel due to the development of an equilibrium condition between production and decay. Instead, extended burnups increase the fraction of the short-lived isotopes that migrate into the fuel-clad gap region (see, for example, NUREG/CR-5009, “Assessment of the Use of Extended Burnup Fuel in Light Water Power Reactors,” prepared for the U.S. Nuclear Regulatory Commission by Pacific Northwest). With increasing burnup, there is no decrease in fuel rod integrity or the probability of fuel failures during normal operations, as long as actual burnup does not exceed the vendor-approved values. However, with the increased short-lived activity in the clad-gap region, increased burnup could result in increased activity being released into the reactor coolant under normal operation if fuel failures were to occur. Maximum fuel burnup limits are not being changed by this proposed amendment.
On the basis of the above assessment, the NRC staff concludes that the proposed TS changes regarding the storage of new and irradiated fuel, including fuel with increased allowed enrichment (up to 4.95 weight percent), will not have a significant adverse environmental effect.
The proposed action will not significantly increase the probability or consequences of accidents, no changes are being made in the types of effluents that may be released off site, and there is no significant increase in occupational or public radiation exposure. Therefore, there are no significant radiological environmental impacts associated with the proposed action.
With regard to potential nonradiological impacts, the proposed action does not have a potential to affect any historic sites. It does not affect nonradiological plant effluents and has no other environmental impact. Therefore, there are no significant nonradiological environmental impacts associated with the proposed action
Accordingly, the NRC staff concludes that there are no significant environmental impacts associated with the proposed action.
As an alternative to the proposed action, the NRC staff considered denial of the proposed action (i.e., the “no-action” alternative). Denial of the application would result in no change in current environmental impacts. The environmental impacts of the proposed action and the alternative action are similar.
The action does not involve the use of any different resource than those previously considered in the Final Environmental Statement for Palisades dated June 1972, as supplemented.
On December 12, 2001, the NRC staff consulted with the Michigan State official, Mary Ann Elzerman, regarding the environmental impact of the proposed action. The State official agreed with the NRC staff's proposed issuance of this Environmental Assessment and Finding of No Significant Impact.
On the basis of the environmental assessment, the NRC concludes that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, the NRC has determined not to prepare an environmental impact statement for the proposed action.
Further details with respect to the proposed action may be found in the licensee's application dated March 2, 2001, as supplemented by letters dated March 29 and September 14, 2001.
For the Nuclear Regulatory Commission.
The U.S. Nuclear Regulatory Commission (the Commission) is considering issuance of an amendment to Facility Operating License No. DPR-16, issued to AmerGen Energy Company, LLC (AmerGen or the licensee), for operation of the Oyster Creek Nuclear Generating Station, located in Ocean County, New Jersey.
The proposed action is a one-time exemption from the requirements of Title 10 of the
10 CFR part 50, Appendix E, Items IV.F.2.b and c require each licensee at each site to conduct an exercise of its onsite and offsite emergency plan every 2 years. Federal agencies (the Nuclear Regulatory Commission for the onsite exercise portion and the Federal Emergency Management Agency for the offsite exercise portion) observe these exercises and evaluate the performance of the licensee and State and local authorities having a role under the emergency plan.
The licensee had initially planned to conduct an exercise of its onsite and offsite emergency plan on October 16, 2001, within the required 2-year interval. However, AmerGen has decided to postpone the exercise as a result of the ongoing national security threat in the United States, and the response, recovery, and other continuing offsite agency activities associated with the September 11, 2001, attacks on the World Trade Center.
The Commission has completed its evaluation of the proposed action and concludes that the proposed action involves an administrative activity (a scheduler change in conducting an exercise) unrelated to plant operations.
The proposed action will not increase the probability or consequences of accidents. No changes are being made in the types of any effluents that may be released offsite, and there is no significant increase in occupational or public radiation exposure. Therefore, there are no significant radiological environmental impacts associated with the proposed action.
With regard to potential non-radiological impacts, the proposed action does not involve any historic sites. It does not affect non-radiological plant effluents and has no other environmental impact. Therefore, there are no significant non-radiological environmental impacts associated with the proposed action.
Accordingly, the Commission concludes that there are no significant environmental impacts associated with the proposed action.
As an alternative to the proposed action, the staff considered denial of the proposed action (
This action does not involve the use of any resources not previously considered in the Final Environmental Statement dated December 1974 for the Oyster Creek Nuclear Generating Station.
In accordance with its stated policy, on November 8, 2001, the staff consulted with the New Jersey State official, Rich Pinney of the New Jersey Department of Environment and Natural Resources, regarding the environmental impact of the proposed action. The State official had no comments. In addition, by letter dated September 27, 2001, the Federal Emergency Management Agency indicated support for rescheduling the exercise.
On the basis of the environmental assessment, the Commission concludes that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, the Commission has determined not to prepare an environmental impact statement for the proposed action.
For further details with respect to the proposed action, see the licensee's letter dated October 8, 2001, which is available for public inspection at the Commission's Public Document Room, located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the ADAMS Public Library component on the NRC Web site,
For the Nuclear Regulatory Commission.
The Florida Power and Light Company (the licensee) is the holder of Facility Operating License Nos. DPR-31 and DPR-41, which authorize operation of the Turkey Point Plant, Units 3 and 4. The licenses provide, among other things, that the facilities are subject to all rules, regulations, and orders of the U.S. Nuclear Regulatory Commission (NRC, the Commission) now or hereafter in effect.
The facility consists of two pressurized water reactors located in Miami-Dade County in Florida.
By letter dated October 23, 2000, Florida Power and Light, the licensee for Turkey Point Plant, requested, among other things, an exemption from certain requirements of 10 CFR 50.44; 10 CFR part 50, Appendix A, General Design Criterion 41, 42, and 43; and 10 CFR part 50, Appendix E, section VI; related to the hydrogen control system (i.e., recombiners, hydrogen monitors, and post-accident containment vent system). The proposed exemption would remove the above requirements from the Turkey Point Plant design basis. The staff has reviewed the information provided and concludes that the requested exemption for the hydrogen recombiners and the post-accident containment vent system are justified. The staff will act on the exemption request for the containment hydrogen monitors, the requested modification to the revised Confirmatory Order issued on October 5, 2000, and the revision to the Technical Specifications related to the post-accident containment vent system and the hydrogen monitors by separate correspondence.
The post-accident containment vent system is provided to facilitate controlled venting through adding air (Service Air backed by Instrument Air) to the reactor containment and venting air from the containment to effectively maintain hydrogen concentration below 4.0 volume percent. Regulatory requirements for the hydrogen control system are specified in 10 CFR 50.44 and 10 CFR part 50, Appendix A, (General Design Criteria 41, 42, and 43). Additional staff guidance is provided in Regulatory Guide (RG) 1.7. Staff review and acceptance criteria are specified in Section 6.2.5 of the Standard Review Plan.
Pursuant to 10 CFR 50.12, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR part 50, when (1) the exemptions are authorized by law, will not present an undue risk to public health or safety, and are consistent with the common defense and security; and (2) when special circumstances are present.
For this exemption, these special circumstances include consideration that the quantity of hydrogen prescribed by 10 CFR 50.44(d) and RG 1.7 which necessitated the need for hydrogen recombiners and the post-accident containment vent system would be bounded by the hydrogen generated during a severe accident. As shown in the attached safety evaluation, the staff has found that the relative importance of hydrogen combustion for large, dry containments with respect to containment failure is quite low. This finding supports the argument that the hydrogen recombiners are not risk significant from a containment integrity perspective and that the risk associated with hydrogen combustion is not from design basis accidents but from severe accidents. Studies have shown that the majority of risk to the public is from accident sequences that lead to containment failure or bypass, and that the contribution to risk from accident sequences involving hydrogen combustion is actually quite small for large, dry containments such as Turkey Point's. This is true despite the fact that the hydrogen produced in these events is substantially larger than the hydrogen production postulated by 10 CFR 50.44(d) and RG 1.7. Hydrogen combustion sequences that could lead to early containment failure typically involve up to 75 percent core metal-water reaction. Hydrogen combustion sequences that could lead to late containment failure involve additional sources of hydrogen due to the interaction of corium and the concrete basemat after vessel breach. Although the recombiners and the post-accident containment vent system are effective in maintaining the RG 1.7 hydrogen concentration below the lower flammability limit of 4.0 volume percent (for a design basis loss-of-coolant accident (LOCA)), they are overwhelmed by the larger quantities of hydrogen associated with severe accidents that would typically be released over a much shorter time period (e.g., 2 hours). However, NUREG/CR-4551 states that hydrogen combustion in the period before containment failure is considered to present no threat to large, dry containments. Table A.4-5 of NUREG/CR-4551 shows that the contribution of hydrogen combustion to late containment failure is also very small. Therefore, the relative importance of hydrogen combustion for large, dry containments with respect to containment failure has been shown to be quite low.
The recombiners can, however, prevent a subsequent hydrogen burn, if needed, due to radiolytic decomposition of water and corrosion in the long term. Analysis performed in accordance with the methodology of RG 1.7 shows that the hydrogen concentration will not reach 4.0 volume percent for 15 days after initiation of a design basis LOCA. Additionally, as described in the attached safety evaluation, hydrogen concentrations on the order of 6.0 volume percent or less are bounded by hydrogen generated during a severe accident and would not be a threat to containment integrity since there is ample time between burns to reduce elevated containment temperatures using the installed containment heat removal systems. The Turkey Point Individual Plant Examination (IPE) concluded that containment survival is almost certain following hydrogen combustion when the Reactor Building Cooling Units and the Reactor Building Spray System are operating.
The underlying purpose of 10 CFR 50.44 is to show that, following a LOCA, an uncontrolled hydrogen-oxygen recombination would not take place, or that the plant could withstand the consequences of uncontrolled hydrogen-oxygen recombination without loss of safety function. Based on the analysis, which includes the staff's evaluation of the risk from hydrogen combustion, resolution of Generic Issue 121, “Hydrogen Control for PWR [pressurized-water reactor] Dry Containments,” and the Turkey Point IPE, the plant could withstand the consequences of uncontrolled hydrogen-oxygen recombination without loss of safety function and without credit for the hydrogen recombiners for not only the design basis case, but the more limiting severe accident with up to 100 percent metal-water reaction. Therefore, the requirements for hydrogen recombiners as part of the Turkey Point design basis are unnecessary and their removal from the design basis is justified. Additionally, elimination of the hydrogen recombiners from the Emergency Operating Procedures (EOPs)
The staff examined the licensee's rationale that supports the exemption request and concluded that the exemption requested for the recombiners and the post-accident containment vent system is justified as stated in the supporting safety evaluation. Additionally, elimination of the hydrogen recombiners and the post-accident containment vent system from the EOPs would be a simplification and a safety benefit. Consequently, pursuant to 10 CFR 50.12(a)(2)(ii), application of the regulation is not necessary to achieve the underlying purpose of the rule.
The safety evaluation may be examined, and/or copied for a fee at the NRC's Public Document Room, located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the ADAMS Public Library component on the NRC Web site, http://www.nrc.gov (the Public Reading Room).
Accordingly, the Commission has determined that, pursuant to 10 CFR 50.12(a), the exemption pertaining to the recombiners and the post-accident containment vent system is authorized by law, will not present an undue risk to the public health and safety, and is consistent with the common defense and security. Also, pursuant to 10 CFR 50.12(a)(2)(ii), special circumstances are present. Therefore, the Commission hereby grants Florida Power and Light Company an exemption from the requirements for the recombiners and the post-accident containment vent system as stated in 10 CFR 50.44 and 10 CFR part 50, Appendix A, General Design Criteria 41, 42 and 43 for the Turkey Point Plant, Units 3 and 4.
Pursuant to 10 CFR 51.32, the Commission has determined that the granting of this exemption will not have a significant effect on the quality of the human environment (66 FR 59266).
This exemption is effective upon issuance.
For the Nuclear Regulatory Commission.
The Advisory Committee on Nuclear Waste (ACNW) will hold its 131st meeting on January 8-10, 2002, at 11545 Rockville Pike, Rockville, Maryland, Room T-2B3.
The entire meeting will be open to public attendance.
The schedule for this meeting is as follows:
A.
B.
C.
• ACRS/ACNW November 14, 2001 Joint Subcommittee Meeting on Risk-Informed Regulation in NMSS
• Annual Research Report to the Commission
• Proposed Rule on Probability of an Unlikely Event
D.
E.
F.
G.
H.
I.
J.
K.
Procedures for the conduct of and participation in ACNW meetings were published in the
Further information regarding topics to be discussed, whether the meeting has been canceled or rescheduled, the Chairman's ruling on requests for the opportunity to present oral statements and the time allotted therefore can be obtained by contacting Mr. Howard J. Larson.
ACNW meeting notices, meeting transcripts, and letter reports are now available for downloading or viewing on the internet at
Videoteleconferencing service is available for observing open sessions of ACNW meetings. Those wishing to use this service for observing ACNW meetings should contact Mr. Theron Brown, ACNW Audiovisual Technician (301/415-8066), between 7:30 a.m. and 3:45 p.m. EST at least 10 days before the meeting to ensure the availability of this service.
Individuals or organizations requesting this service will be responsible for telephone line charges and for providing the equipment and facilities that they use to establish the videoteleconferencing link. The availability of videoteleconferencing services is not guaranteed.
The ACNW meeting dates for Calendar Year 2002 are provided below:
The ACRS Subcommittee on Materials and Metallurgy will hold a meeting on January 15-16, 2002, Room T-2B3, 11545 Rockville Pike, Rockville, Maryland.
The entire meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will review the preliminary results of the Fracture Analysis of Vessels: Oak Ridge (FAVOR) code calculation associated with the Reevaluation of the Technical Basis for the Pressurized Thermal Shock Rule Screening Criterion Project. The purpose of this meeting is to gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the full Committee.
Oral statements may be presented by members of the public with the concurrence of the Subcommittee Chairman; written statements will be accepted and made available to the Committee. Electronic recordings will be permitted only during those portions of the meeting that are open to the public, and questions may be asked only by members of the Subcommittee, its consultants, and staff. Persons desiring to make oral statements should notify the cognizant ACRS staff engineer named below five days prior to the meeting, if possible, so that appropriate arrangements can be made.
During the initial portion of the meeting, the Subcommittee, along with any of its consultants who may be present, may exchange preliminary views regarding matters to be considered during the balance of the meeting.
The Subcommittee will then hear presentations by and hold discussions with representatives of the NRC staff, and other interested persons regarding this review.
Further information regarding topics to be discussed, whether the meeting has been canceled or rescheduled, and the Chairman's ruling on requests for the opportunity to present oral statements and the time allotted therefor, can be obtained by contacting the cognizant ACRS staff engineer, Mr. Noel F. Dudley (telephone 301/415-6888) between 7 a.m. and 3:45 p.m. (EST). Persons planning to attend this meeting are urged to contact the above named individual one or two working days prior to the meeting to be advised of any potential changes to the agenda, etc., that may have occurred.
Nuclear Regulatory Commission.
Notice of New System of Records.
The Nuclear Regulatory Commission (NRC) is providing notice of the establishment of a new system of records, NRC-12, Child Care Tuition Assistance Program Records.
The new system of records will become effective without further notice on January 28, 2002 unless comments received on or before that date cause a contrary decision.
Send comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: Rulemakings and Adjudications staff. Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:30 a.m. and 4:15 p.m. on Federal workdays. Copies of comments received may be examined at either the NRC Public Document Room, One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland, or the NRC's Agencywide Documents Access and Management System (ADAMS). Comments are also available at the NRC's rulemaking Web site at
Sandra S. Northern, Privacy Program Officer, FOIA/Privacy Act Team, Web, Publishing, and Distribution Services Division, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-6879; e-mail:
The establishment of this new system of records, NRC-12, Child Care Tuition Assistance Program Records, will allow the NRC to collect and maintain family income data from NRC employees for the purpose of determining their eligibility for child care subsidies, and the amounts of the subsidies. It will also maintain information from the employee's child care provider(s) for verification purposes, e.g., that the provider is licensed. Data will be
A report on the proposed new system of records is being sent to the Office of Management and Budget (OMB), the Committee on Governmental Affairs of the U.S. Senate, and the Committee on Government Reform of the U.S. House of Representatives as required by the Privacy Act and OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals.”
According, the NRC proposes to add NRC-12 to read as follows:
Child Care Tuition Assistance Program Records
Office of Human Resources, NRC, Two White Flint North, 11545 Rockville Pike, Rockville, Maryland.
NRC employees who voluntarily apply for child care tuition assistance.
These records include application forms for child care tuition assistance containing personal information, including employee (parent) name, social security number, grade, home and work telephone numbers, home and work addresses, total family income, names of children on whose behalf the parent is applying for tuition assistance, child's date of birth; information on child care providers used, including name, address, provider license number and State where issued, tuition cost, and provider tax identification number; and copies of IRS Form 1040 and 1040A for verification purposes.
Public Law 107-67, section 630 and Executive Order 9397.
In addition to the disclosures permitted under subsection (b) of the Privacy Act, the NRC may disclose information contained in this system of records without the consent of the subject individual if the disclosure is compatible with the purpose for which the record was collected under the following routine uses:
a. To the Office of Personnel Management to provide statistical reports;
b. For any of the routine uses specified in the Prefatory Statement of General Routine Uses.
Information may be collected on paper or electronically and may be stored as paper forms or on computers.
Information may be retrieved by employee name or social security number.
When not in use by an authorized person, paper records are stored in lockable file cabinets and computer records are protected by the use of passwords.
The records in this system are currently unscheduled and must be retained until the National Archives and Records Administration (NARA) approves a records disposition schedule for this material.
Director, Office of Human Resources, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
Individuals seeking to determine whether this system of records contains information pertaining to themselves should write to the Freedom of Information Act and Privacy Act (FOIA/PA) Officer, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and comply with the procedures contained in NRC's Privacy Act regulations, 10 CFR part 9.
Same as “Notification procedure.”
Same as “Notification procedure.”
Information in this system of records is obtained from NRC employees who apply for child care tuition assistance. Furnishing of the information is voluntary.
For the Nuclear Regulatory Commission.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”),
The Exchange proposes to amend the Exchange's rules to establish a fee schedule for transactions in Nasdaq/National Market securities (“Nasdaq/NM Securities”) and to establish a revenue sharing program to reflect recent developments in competitive business strategy. The text of the proposed rule change is available at the principal offices of the CSE and at the Commission.
In its filing with the Commission, the CSE included statements concerning the purpose of, and the basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified
The Exchange is proposing two amendments to the Exchange Rules governing transaction fees and market data revenue credits in keeping with recent trends in the securities industry.
The first amendment adds subsection (2) to CSE Rule 11.10(A)(e), (“Crosses and Meets”). Proposed subsection (2) establishes a fee schedule for transactions in Nasdaq/NM Securities.
The second amendment creates in incentive for CSE members to trade Nasdaq/NM Securities on the Exchange and will be codified as CSE Rule 11.10(A)(l) (“Tape ‘C’ Transaction Credit”). The Exchange believes the credit is a logical next step in its efforts to provide competitive exchange services to CSE members trading Nasdaq/NM Securities. Under the Nasdaq program,
The proposed rule change is generally consistent with section 6(b) of the Act.
The CSE does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended.
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Persons making written submissions should file six copies thereof with the Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room. Copies of such filing will also be available for inspection and copying at the principal office of the CSE. All submissions should refer to File No. SR-CSE-2001-05 and should be submitted by January 9, 2002.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Phlx proposed to allow Inactive Nominees,
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change. The text of these statements may be examined at
The purpose of the proposed rule change is to allow Inactive Nominees, upon request, to act as effective members of the Phlx on Wednesday, December 5, 2001 on the Phlx Equity Trading Floor. Wednesday, December 5, 2001 is the 6th Annual McNamara Trading Day benefiting St. Jude Children's Research Hospital. McNamara Trading Company, the largest floor brokerage member organization on the Equity Floor, donates all commissions from the day's trading to the St. Jude Children's Research Hospital. The Equity Floor typically experiences a very large increase in volume that day. The Exchange believes that making Inactive Nominees effective members upon their request on that day should better enable the Exchange and its members to maintain fair and orderly markets in securities due to the expected increased volume.
The Phlx has authority to make Inactive Nominees effective members. Phlx By-law Article XII, Sections 12-10(a) and (b) state that an Inactive Nominee is “an individual * * * approved for membership” in the Exchange, but “shall have no rights or privileges of membership unless and until said Inactive Nominee becomes an effective member.” One way that an Inactive Nominee becomes an effective member is by assuming, pursuant to Phlx Rule 21, legal title to a membership through an intra-firm transfer. This allows an Inactive Nominee to become an effective member of the Exchange through the transfer of a membership from another member, associated with the Inactive Nominee's firm, to the Inactive Nominee. Consequently, the member leaving the membership goes on Inactive Nominee status.
The Exchange now proposes to permit an Inactive Nominee to become an effective member on December 5, 2001 without receiving transfer of membership from the Inactive Nominee's associated member.
The Exchange believes that the current proposal should allow the Exchange to continue to maintain fair and orderly markets on the Phlx Equity Floor on Wednesday, December 5, 2001 in light of the expected increase in trading activity that day. As such, the Exchange believes the proposed rule change is consistent with Section 6(b) of the Act,
The Phlx does not believe that the proposed rule change will impose any inappropriate burden on competition.
No written comments were received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(i) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing including whether the proposed rule change is consistent with the Act. Persons making written submissions should file six copies thereof with the Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room. Copies of such filing will also be available for inspection and copying at the principal office of the Phlx. All submissions should refer to File No. SR-Phlx-2001-110 and should be submitted by January 9, 2002.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Small Business Administration.
Notice of reporting requirements submitted for OMB review.
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before January 18, 2002. If you intend to comment but cannot prepare comments promptly, please advise the OMB Reviewer and the Agency Clearance Officer before the deadline.
Address all comments concerning this notice to: Agency Clearance Officer, Jacqueline White, Small Business Administration, 409 3rd Street, SW., 5th Floor, Washington, DC 20416; and OMB Reviewer, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Jacqueline White, Agency Clearance Officer, (202) 205-7044.
Notice.
The Department of State has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the emergency review procedures of the Paperwork Reduction Act of 1995.
The proposed information collection is published to obtain comments from the public and affected agencies. Emergency review and approval of this collection has been requested from OMB by December 20, 2001. If granted, the emergency approval is valid only for 180 days. Comments should be directed to the State Department Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20530, who may be reached on 202-395-3897.
During the first 60 days of this same period a regular review of this information collection is also being undertaken. Comments are encouraged and will be accepted until 60 days from the date that this notice is published in the
• Evaluate whether the proposed information collection is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including through the use of automated collection techniques or other forms of technology.
Public comments, or requests for additional information, regarding the collection listed in this notice should be directed to Eric Cohan of the Office of Visa Services, U.S. Department of State, 2401 E St. NW., Rm L-703, Washington, DC 20520, who may be reached on 202-663-1164.
The Overseas Schools Advisory Council, Department of State, will hold its Executive Committee Meeting on Thursday, January 31, 2002, at 9:30 a.m. in Conference Room 1105, Department of State Building, 2201 C Street, NW, Washington, DC. The meeting is open to the public.
The Overseas Schools Advisory Council works closely with the U.S. business community in improving those American-sponsored schools overseas, which are assisted by the Department of State and which are attended by dependents of U.S. Government families and children of employees of U.S. corporations and foundations abroad.
This meeting will deal with issues related to the work and the support provided by the Overseas Schools Advisory Council to the American-sponsored overseas schools. The agenda includes a review of the recent activities of American-sponsored overseas schools and the overseas schools regional associations, a presentation on the status of education in the United States and its impact on American-sponsored overseas schools, and selection of projects for the 2002 program.
Members of the general public may attend the meeting and join in the discussion, subject to the instructions of the Chair. Admittance of public members will be limited to the seating available. Access to the State Department is controlled, and individual building passes are required for all attendees. Persons who plan to attend should so advise the office of Dr. Keith D. Miller, Department of State, Office of Overseas Schools, Room H328, SA-1, Washington, DC 20522-0132, telephone 202-261-8200, prior to January 21, 2002. Each visitor will be asked to provide a date of birth and Social Security number at the time of registration and attendance and must carry a valid photo ID to the meeting. All attendees must use the C Street entrance to the building.
Federal Highway Administration (FHWA), DOT.
Amended Notice of Intent.
The FHWA is issuing this notice to advise the public that an additional component, a recreational trail, will be added and the termini changed for the supplement to a final environmental impact statement being prepared for a proposed highway project in Utah and Wasatch Counties, Utah.
William R. Gedris, Environmental Coordinator, Federal Highway Administration, 2520 West 4700 South, Suite 9A, Salt Lake City, Utah 84118, Telephone: (801) 963-0078 ext, 243; or Brent Schvaneveldt; Utah Department of Transportation, Region 3, 658 North 1500 West, Orem, Utah 84057, Telephone: (801) 222-3406.
The FHWA, in cooperation with the Utah Department of Transportation (UDOT), previously issued a Notice of Intent in the
The trail will extend from its present termini at Vivian Park through the U.S. Highway 189 /Provo River corridor to the vicinity of the Deer Creek Dam utilizing appropriate combinations of abandoned highway, Heber Creeper Railroad right of way, existing local roads and bridges, water aqueduct right of way, and new alignment. Future extension of the trail is planned for the west side of Deer Creek Reservoir to the Soldier Hollow Olympic Venue in Wasatch Mountain State Park and will be addressed in a new environmental document at a later date.
Comments are being solicited from appropriate Federal, State, and local agencies and from private organizations and citizens who have previously expressed or are known to have interest in this proposal. A public scoping and information meeting and a public hearing will be held during the course of the analysis. Public notice will be given of the time and place of the meetings and hearing. The draft SEIS will be available for public and agency review prior to the public hearing.
To ensure that the full range of issues related to this proposed action are addressed and all significant issues identified, comments and suggestions are invited from all interested parties. Comments and/or questions concerning this proposed action and the EIS should be directed to the FHWA or UDOT at the addresses provided above.
Norfolk Southern Railway Company (NSR) has filed a notice of exemption under 49 CFR 1152 Subpart F—
NSR has certified that: (1) No local traffic has moved over the line for at least 2 years; (2) any overhead traffic, if there is any, can be rerouted over other lines; (3) no formal complaint filed by a user of rail service on the line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the line either is pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of complainant within the 2-year period; and (4) the requirements at 49 CFR 1105.7 (environmental reports), 49 CFR 1105.8 (historic reports), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
A copy of any petition filed with the Board should be sent to applicant's representative: James R. Paschall, General Attorney, Norfolk Southern Corporation, Three Commercial Place, Norfolk, VA 23510.
If the verified notice contains false or misleading information, the exemption is void
NSR has filed an environmental report which addresses the abandonment's effects, if any, on the environment and historic resources. SEA will issue an environmental assessment (EA) by December 21, 2001. Interested persons may obtain a copy of the EA by writing to SEA (Room 500, Surface Transportation Board, Washington, DC 20423) or by calling SEA, at (202) 565-1552. Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), NSR shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the line. If consummation has not been effected by NSR's filing of a notice of consummation by December 19, 2002, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
Norfolk Southern Railway Company (NSR) has filed a notice of exemption under 49 CFR 1152 Subpart F—
NSR has certified that: (1) No local traffic has moved over the line for at least 2 years; (2) any overhead traffic, if there is any, can be rerouted over other lines; (3) no formal complaint filed by a user of rail service on the line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the line either is pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of complainant within the 2-year period; and (4) the requirements at 49 CFR 1105.7 (environmental reports), 49 CFR 1105.8 (historic reports), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
A copy of any petition filed with the Board should be sent to NSR's representative: James R. Paschall, General Attorney, Norfolk Southern Corporation, Three Commercial Place, Norfolk, VA 23510.
If the verified notice contains false or misleading information, the exemption is void
NSR has filed an environmental report which addresses the abandonment's effects, if any, on the environment and historic resources. SEA will issue an environmental assessment (EA) by December 21, 2001. Interested persons may obtain a copy of the EA by writing to SEA (Room 500, Surface Transportation Board, Washington, DC 20423) or by calling SEA, at (202) 565-1552. Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), NSR shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned its line. If consummation has not been effected by NSR's filing of a notice of consummation by December 19, 2002, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our website at
Decided: December 11, 2001.
By the Board, David M. Konschnik, Director, Office of Proceedings.
Norfolk Southern Railway Company (NSR) has filed a verified notice of exemption under 49 CFR 1152 subpart F—
Applicant has certified that: (1) No local or overhead traffic has moved over the line for at least 2 years; (2) any overhead traffic, if there is any, can be rerouted over other lines; (3) no formal complaint filed by a user of rail service on the line (or by a state or local government agency acting on behalf of such user) regarding cessation of service over the line either is pending with the Surface Transportation Board (Board) or any U.S. District Court or has been decided in favor of complainant within the 2-year period; and (4) the requirements at 49 CFR 1105.7 (environmental reports), 49 CFR 1105.8 (historic reports), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
A copy of any petition filed with the Board should be sent to applicant's representative: James R. Paschall, Esq., Norfolk Southern Corporation, Three Commercial Place, Norfolk, VA 23510. If the verified notice contains false or misleading information, the exemption is void
Applicant has filed a separate environmental report which addresses the abandonment's effects, if any, on the environment and historic resources. SEA will issue an environmental assessment (EA) by December 21, 2001. Interested persons may obtain a copy of the EA by writing to SEA (Room 500, Surface Transportation Board, Washington, DC 20423-0001) or by calling SEA, at (202) 565-1552. Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), NSR shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the line. If consummation has not been effected by NSR's filing of a notice of consummation by December 19, 2002, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our web site at
Decided: December 11, 2001.
By the Board, David M. Konschnik, Director, Office of Proceedings.
The Department of Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 2110, 1425 New York Avenue, NW., Washington, DC 20220.
Written comments should be received on or before January 18, 2002 to be assured of consideration.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before February 19, 2002.
Submit written comments on the collection of information to Nancy J. Kessinger, Veterans Benefits Administration (20S52), Department of Veterans Affairs, 810 Vermont Avenue, NW, Washington, DC 20420 or e-mail:
Nancy J. Kessinger at (202) 273-7079 or FAX (202) 275-5947.
Under the PRA of 1995 (Public Law 104-13; 44 U.S.C., 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C., 3501
Comments must be submitted on or before January 18, 2002.
Denise McLamb, Information Management Service (045A4), Department of Veterans Affairs, 810 Vermont Avenue, NW, Washington, DC 20420, (202) 273-8030, FAX (202) 273-5981 or e-mail:
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
Send comments and recommendations concerning any aspect of the information collection to VA's Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 (202) 395-7316. Please refer to “OMB Control No. 2900-0394” in any correspondence.
By direction of the Secretary.
In notice document 01-30650 beginning on page 64327 in the issue of Wednesday, December 12, 2001, make the following correction:
On page 64327, in the first column, the Release No. should be as set forth above.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Notice of proposed rulemaking (NPRM).
In response to the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act of 2000, this document proposes to establish a new Federal Motor Vehicle Safety Standard that contains provisions to improve the labeling of tires to assist consumers in identifying tires that may be the subject of a safety recall. It also contains proposals for providing other consumer information to increase public awareness of the importance and methods of observing motor vehicle tire load limits and maintaining proper tire inflation levels for the safe operation of a motor vehicle. The proposals would apply to all new and retreaded tires for use on vehicles with a gross vehicle weight rating of 10,000 pounds or less and to all vehicles with a gross vehicle weight rating of 10,000 pounds or less, except for motorcycles and low speed vehicles. NHTSA will also be proposing upgraded safety performance requirements for tires in a forthcoming proposal, which would also be included in this new standard.
Written comments may be submitted to this agency and must be received by February 19, 2002.
You may submit your comments in writing to: Docket Management, Room PL-401, 400 Seventh Street, SW., Washington, DC, 20590. Alternatively, you may submit your comments electronically by logging onto the Docket Management System website at http://dms.dot.gov. Click on “Help & Information” or “Help/Info” to view instructions for filing your comments electronically. Regardless of how you submit your comments, you should mention the docket number of this document.
For technical and policy issues: Mr. Roger Kurrus, Office of Planning and Consumer Programs. Telephone: (202) 366-2750. Fax: (202) 493-2290. Mr. Joseph Scott, Office of Crash Avoidance Standards, Telephone: (202) 366-2720. Fax: (202) 366-4329.
For legal issues: Nancy Bell, Attorney Advisor, Office of the Chief Counsel, NCC-20. Telephone: (202) 366-2992. Fax: (202) 366-3820.
All of these persons may be reached at the following address: National Highway Traffic Safety Administration, 400 Seventh Street, SW., Washington DC 20590.
The agency is proposing to establish a new standard that would contain revisions to the agency's existing tire labeling requirements, as well as contain revisions to its current regulations to improve tire information for light vehicles and light vehicle tires and its availability and understandability to consumers. As used in this document, “light vehicles” are vehicles (except motorcycles and low speed vehicles (LSVs)) with a gross vehicle weight rating (GVWR) of 10,000 pounds or less. The new standard will also contain requirements and test procedures addressing various aspects of tire performance. The agency will be issuing a separate NPRM that proposes these performance requirements and procedures. Today's NPRM concerns the labeling and other informational requirements.
Today's proposed amendments address the following aspects of tire and vehicle labeling: Tire markings, the Tire Identification Number (TIN), vehicle placard content and format, placard location, and owner's manual information. The proposal would extend all passenger car labeling requirements, including those requiring the labeling of combined occupant and cargo weight capacity and designated seating positions, to light trucks and multipurpose passenger vehicles (MPVs) with a GVWR or 10,000 pounds or less. The proposal is substantially based on NHTSA's activities undertaken in response to the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act of 2000, including publication of an ANPRM, consideration of comments in response to the ANPRM, data gathering and analysis, and NHTSA sponsored focus groups.
NHTSA proposes that the TIN, size designation, maximum permissible inflation pressure, and maximum load rating be placed on both sides of light vehicle tires. The Firestone tire recalls last year highlighted the difficulty that
NHTSA is proposing two changes to the TIN. First, the agency proposes to require a re-ordering of information in the TIN so that the first six characters would contain the information required for determining whether a particular tire is subject to a recall. The first two characters would reflect the plant code, and the next four characters would reflect the date code. Second, the agency proposes to require that each character be 6 mm (
The agency proposes four sets of revisions for the presentation of tire inflation pressure and load limit information on the vehicle placard currently required for passenger cars by S4.3 of § 571.110 and to be required for all light vehicles with a GVWR of 10,000 pounds or less under this proposal.
First, the agency proposes that tire inflation pressure information would be visually separated by a red colored border on the vehicle placard or, alternatively, be placed on a separate tire inflation pressure label. The vehicle placard would contain only the information required by the proposed information specified in the proposed version of S4.3 (paragraphs (a)-(e)).
(b) Designated seating capacity (expressed in terms of total number of occupants and in terms of occupant for each seat location);
(c) Vehicle manufacturer's recommended cold tire inflation pressure;
(d) Tire size designation for the tire installed as original equipment on the vehicle by the vehicle manufacturer; and
(e) “SEE OWNER'S MANUAL FOR ADDITIONAL INFORMATION'.
Second, the agency also proposes that the tire inflation pressure label and vehicle placard meet the following three requirements: (1) The tire inflation pressure information on the placards would be in color—red, yellow, and black on a white background, (2) contain a black and white tire symbol icon in the upper left corner of the placards, 13 millimeters (.51 inches) wide and 14 millimeters (.55 inches), and (3) the placard and label would both include the phrases “Tire Information” and “See Owner's Manual For Additional Information” in yellow text on a black background.
Third, the agency proposes to replace the vehicle capacity weight statement on the vehicle placard with the following sentence: “[t]he combined weight of occupants and cargo should never exceed XXX pounds.” The “XXX” amount would equal the “vehicle capacity weight” of the vehicle as defined in FMVSS No. 110. The information is the same as that currently required to be placed on the vehicle placard by manufacturers. However, the agency believes that the statement “the combined weight of occupants and cargo should never exceed * * *” is easier for consumers to comprehend than a technical phrase such as “vehicle capacity weight.” “Vehicle capacity weight” is not intuitive to consumers and it requires a vehicle operator to look to the owner's manual or standard to understand which factors are included in the calculation of the sum/amount on the placard.
Fourth, the agency proposes to replace the vehicle's recommended tire size designation with the tire size designation for the tire installed as original equipment on the vehicle by the vehicle manufacturer. While in most instances these two numbers would be identical, this minor revision insures that the consumer is provided with the correct tire inflation pressure information for the tire size actually installed on his vehicle as original equipment by the manufacturer.
We are proposing these placard changes in response to survey data which indicate that consumers need assistance in locating recommended tire pressures for their vehicle's tires and understanding load limits. The use of colors and a visual cue, such as a tire symbol icon, would aid drivers in noticing and locating this imperative information. By expressing the vehicle's load limit in easily recognizable terms such as “passenger and cargo weight”, as opposed to “vehicle capacity weight” the proposed placard revisions would also aid consumers in understanding and adhering to load limit guidelines.
The agency proposes that the placard and/or label containing tire inflation pressure by tire size and other required information specified in S4.3 of FMVSS No. 110 be located on the driver's side B-pillar. If a vehicle does not have a B-pillar, then the placard and/or label would be placed on the edge of the driver's door. Currently, S4.3 of 571.110 specifies that the vehicle placard be affixed to the glove compartment door or an equally accessible location. A standardized location for tire information placards and labels would contribute to consumer awareness of recommended tire inflation pressures and load limits.
The agency proposes that owner's manuals for light vehicles contain discussion of the following five subject areas: (1) Tire labeling, (2) recommended tire inflation pressure, (3) glossary of tire terminology, (4) tire care, and (5) vehicle load limits. A single, reliable source containing the proposed required information for the tires and tire safety information listed above would aid consumers by providing to them, in one centralized location, the information that they need to properly maintain their tires and adhere to recommended load limits.
Finally, the agency proposes revising FMVSS Nos. 110, Tire selection and rims, for passenger cars, 49 CFR 571.110, and 120 Tire selection and rims for motor vehicles other than passenger cars, 49 CFR 571.120, to reflect the applicability of the proposed light vehicle tire standard to vehicles with a GVWR of 10,000 pounds or less, and revising FMVSS Nos. 117, Retreaded pneumatic tires, 49 CFR 571.117, and 129, New non-pneumatic tires for passenger cars, 49 CFR 571.129, to replace the labeling requirements contained therein with those specified in the proposed new light vehicle tire standard.
NHTSA believes that this proposal would result in minimal costs for tire and manufacturers. NHTSA estimates that the added cost for labeling tires under this proposal would equal $0.01 per tire or less. Vehicle labeling, including vehicle placards for passenger cars and owner's manual information for light vehicles, is already required. Therefore the cost of labeling the tire, printing new or revised placards and/or tire inflation labels, the owner's manual pages and installation of the placard and/or tire inflation pressure label should be minimal. The only costs would be one-time costs to change production for the new vehicle placard and/or tire inflation pressure label, the application of the vehicle placard and/or tire inflation pressure label to all light vehicles, not only passenger cars, and the new owner's manual pages. NHTSA estimates that, adding the total tire and vehicle manufacturing costs together, the total annual costs equal approximately $5.5 million.
NHTSA believes that this proposal would be effective in increasing public awareness of tire safety, particularly the understanding and maintenance of proper tire inflation and load limits. This proposal will also enable consumers to more easily identify the TIN and other tire information for recalls and other notifications. The proposal will standardize the location and content of important information relating to proper inflation and load limits and other tire safety concerns. These measures, by increasing consumer knowledge and awareness, should result in reduced tire failures and tire related crashes, and therefore fewer deaths and injuries.
The Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act of 2000, Pub. L. 106-414, requires the agency to address numerous matters through rulemaking. One of these matters, set forth in section 11 of the Act, is the improvement of the labeling of tires required by section 30123 of title 49, United States Code, to assist consumers in identifying tires that may be the subject of a recall. Section 11 provides that the agency must initiate a rulemaking proceeding for that purpose within 30 days after the enactment of the Act and must complete it not later than June 1, 2002.
Additionally, that section provides that the agency may take whatever additional action it deems appropriate to ensure that the public is aware of the importance of observing motor vehicle tire load limits and maintaining proper tire inflation levels for the safe operation of a motor vehicle. Section 11 states that such additional action may, for example, include a requirement that the manufacturer of motor vehicles provide the purchasers of the motor vehicles information on appropriate tire inflation levels and load limits if the agency determines that requiring such manufacturers to provide that information is the most appropriate way that information can be provided.
On December 1, 2000, this agency published an Advance Notice of Proposed Rulemaking (ANPRM) (65 FR 75222), as required by the TREAD Act, announcing our plans to (1) improve the labeling of tires, (2) assist consumers in identifying tires that may be the subject of a recall, and (3) ensure that the public is aware of the importance of observing motor vehicle tire load limits and maintaining proper tire inflation levels for the safe operation of a motor vehicle. Specifically, we discussed tire label requirements and prior rulemakings, as well as presented a number of questions for public comment on issues such as general consumer knowledge and behavior, availability of information to consumers, and Tire Identification Number (TIN) information and location.
NHTSA's existing labeling requirements for new passenger car tires are set forth in Federal Motor Vehicle Safety Standard (FMVSS) No. 109, New Pneumatic Tires—Passenger Cars (49 CFR 571.109). Specifically, section S4.3 of FMVSS No. 109 sets forth information labeling requirements for tires, including requirements regarding the positioning of the information on the sidewall to ensure that it is readily visible and to minimize the possibility that it will be scuffed off if the sidewall hits a curb or similar object. It provides that the information listed in paragraphs S4.3 (a) through (e) (e.g., number of plies and maximum permissible inflation pressure) must appear, on at least one sidewall, in an area between the maximum section width and the bead of the tire, unless the maximum section width of the tire falls between the bead and one-fourth of the distance from the bead to the shoulder of the tire. For tires for which the maximum section width falls in that area, all required labeling must be located between the bead and a point one-half the distance from the bead to the shoulder of the tire.
NHTSA's labeling requirement for retreaded passenger car tires is set forth in FMVSS No. 117, Pneumatic Retreaded Tires (49 CFR 571.117). FMVSS No. 117 requires that each newly retreaded passenger car tire have molded into its sidewalls information similar to that required in FMVSS No.109, plus the words bias, or bias belted, or radial, as applicable. FMVSS No. 117 does not, though, require that the name of the manufacturer or brand name and number assigned to the manufacturer be placed on retreaded tires as is required on new passenger vehicle tires by FMVSS No. 109.
NHTSA's labeling requirements for new tires for vehicles other than passenger cars are set forth in FMVSS No. 119, New Pneumatic Tires for Vehicles other than Passenger Cars (49 CFR § 571.119). Paragraph S6.5 of FMVSS No. 119 specifies that all tires for vehicles other than passenger cars must have certain markings on the sidewalls. Among other things, these tires must show the actual number of plies in the tire, the composition of the ply cord material (S6.5(f)), and a letter designating the load range (S6.5(j)). S6.5 also provides that the designated information must appear, on at least one sidewall, in an area between the maximum section width and bead of the tire, unless the maximum section width of the tire falls between the bead and one-fourth of the distance from the bead
NHTSA's labeling requirements for new temporary spare non-pneumatic tires for passenger cars are set forth in FMVSS No. 129, New non-pneumatic tires for passenger cars (49 CFR 571.129). The FMVSS No. 129 labeling requirements are similar to those set forth in section S4.3 in FMVSS No. 109 for size designation, load, rating, rim size and type designation, manufacturer or brand name, certification, and tire identification number. The standard also includes temporary use and maximum speed labeling requirements (which provide an extra margin of safety relating to the handling and braking of these tires) and allows methods of permanent marking other than “molding” in anticipation of the difficulty of molding required information on non-pneumatic tire designs. Paragraph S.4 of FMVSS No. 129 specifies that each non-pneumatic tire must have certain markings on the sidewalls including the non-pneumatic tire identification code (NPTIC), the load rating, and the tire identification number required in Part 574. These labeling requirements also specify that the labeling information must appear on both sides of the tire, except, in the case of a tire that has a particular side that must always face outward where the information must appear on the outward facing side.
Section 574.5 of Title 49, CFR, Tire Identification Requirements, sets forth the methods by which new tire manufacturers and new tire brand name owners must identify tires for use on motor vehicles.
In a final rule published on November 10, 1970 (35 FR 17257), the agency revised the requirements proposed in the NPRM in response to the suggestions of various commenters. Specifically, NHTSA reversed the order of the manufacturer's optional information and the date of manufacture, so that the latter would appear in the fourth grouping and the manufacturer's optional information would appear in the third grouping. NHTSA also stated that the tire identification number need only appear on one sidewall in response to concerns relating to worker safety, and that the figures need only be
Specifically, 574.5 requires each new tire manufacturer and each tire retreader to mold a TIN into or onto the sidewall of each tire produced, in the manner and location specified in the section and as depicted in Figures 1 and 2 of that section. The TIN is composed of four groups:
1. The first group represents the manufacturer's identification mark assigned to such manufacturer by this agency in accordance with § 574.6;
2. The second group represents the tire size for new tires; for retreaded tires, the second group represents the retread matrix in which the tire was processed or, if no matrix was used, a tire size code;
3. The third group may, at the option of the manufacturer, be used as a descriptive code for identifying significant characteristics of the tire. If the tire is produced for a brand name owner, the third grouping must identify such brand name owner; and
4. The fourth group identifies the week and year of manufacture. The first two figures identify the week, starting with “01” to represent the first full week of the calendar year; the second two figures represent the year. For example, “2198” represents the 21st week of 1998.
In that rulemaking, all commenters supported adding a fourth digit to the date code. Two of the commenters, though, opposed reducing the size of the numbers in the TIN on the basis that such reduction would make it more difficult for consumers to see, especially those with visual pathologies. These commenters did not, however, provide any data showing that drivers cannot read 4 mm figures. NHTSA said that its experience to date with 4 mm figures on tires suggest that figures of that size do not present a problem. (It should be noted that many tire manufacturers actually use figures larger than 4 mm for the date code. As discussed in the final rule, 4 mm is approximately the equivalent of font size 16 in Windows 95, which is approximately double the font size used in the
Labeling requirements are also contained in 49 CFR part 567, Certification, 49 CFR part 575, Consumer Information Regulations, FMVSS No. 110, Tire Selection and Rims, applicable to passenger cars and to non-pneumatic spare tire assemblies for use on passenger cars, and FMVSS No. 120, Tire Selection and Rims for Motor Vehicles Other Than Passenger Cars.
Section 567.4 requires vehicle manufacturers to affix to each vehicle a label bearing, among other things, the Gross Vehicle Weight Rating (GVWR), which must not be less than the sum of the unloaded vehicle weight, rated cargo load, and 150 pounds times the vehicles
Section 30123(e) of Title 49, U.S. Code, requires the Secretary of Transportation to prescribe a uniform quality grading system for motor vehicle tires to help consumers make an informed choice when purchasing tires. NHTSA implemented this statutory mandate by issuing the Uniform Tire Quality Grading System (UTQGS) at 49 CFR 575.104, applicable to new passenger car tires. The UTQGS require passenger car and tire manufacturers and tire brand name owners to provide consumers with information with respect to the treadwear,
Section 575.6(a) of Title 49, CFR, requires that when a motor vehicle is delivered to the first purchaser for purposes other than resale, the vehicle manufacturer must provide, in writing and in the English language, the information specified in Section 575.103 applicable to that vehicle, and in the owner's manual, the information specified in Section 575.104.
Paragraph S4.3 of FMVSS No. 110 requires manufacturers to affix a placard to each passenger car's glove compartment door or an equally accessible location showing the vehicle's capacity weight, designated seating capacity, the manufacturer's recommended cold tire inflation pressure for maximum loaded vehicle weight, the manufacturer's recommended tire size designation, and, for a vehicle equipped with a non-pneumatic spare tire assembly, the non-pneumatic identification code required by FMVSS No. 129, New Non-Pneumatic Tires for Passenger Cars. The required information is intended to promote the vehicle's safe performance by preventing overloading of the tires or the vehicle itself.
After a full and careful review of the petition, NHTSA decided to deny it based on several factors (57 FR 45759; October 5, 1992). First, there already existed a vast amount of information on proper tire maintenance. Additionally, the agency stated that there was no reason to believe that requiring the same information be made available in another place would increase consumer's responsiveness to such information. Finally, the petitioner presented no data, and this agency was aware of none, that would support petitioner's assertion that improper maintenance causes the vast majority of tire failures or that a significant number of vehicles are running on underinflated, overloaded, worn out or damaged tires.
In summary, NHTSA believed at that time that the wealth of safety materials already available to the public through industry, government, and consumer sources adequately addressed the issue of proper tire inflation and maintenance; that existing labeling requirements provided sufficient information to enable consumers to maintain tires properly and safely; and that the petitioner had not shown that the amendments he proposed would significantly change the behavior of the public in that respect.
FMVSS No. 120 requires that each vehicle show, on the label required by 567.4, or on a tire information label (S5.3.2(b)), the recommended tire size designation appropriate for the GAWR, the size and type designation of rims appropriate for those tires, and the recommended cold inflation pressure for those tires such that the sum of the load ratings of the tires on each axle (when the tires load carrying capacity at the specified pressure is reduced by dividing 1.10, in the case of a tire subject to FMVSS No. 109, i.e., a passenger car tire) is appropriate for the GAWR.
The continued use of tires determined to be unsafe poses a safety risk not only for the occupants of the vehicles equipped with those tires, but also for other highway users near those vehicles.
One effect of the combination of the prevalence of long-life radial tires is that tires have significantly longer service life now than 20 years ago. Another effect of radials is that there are large numbers of persons who purchase a used car with used radial tires. Unlike the case of first purchasers, there is no procedure for providing tire manufacturers with the names and addresses of subsequent purchasers. Thus there is no way for the tire manufacturers to directly contact subsequent purchasers in the event of a recall. The only way that either of these groups could determine that their tires
As a result of the difficulty and inconvenience of checking the TINs, the percentage of people who respond to a tire recall campaign is reduced and motorists unknowingly continue to drive their vehicles with potentially unsafe tires.
The side of a tire bearing the TIN is often mounted so that it faces inward. In the case of whitewall tires, this occurs because the TIN is almost always molded on the blackwall (i.e., inside sidewall) of the tire. Whitewall tires account for a small and declining percentage (currently about 5 percent or less) of original equipment tire sales in this country, but about 40 percent of replacement tires. There are about three times as many replacement tires as original equipment tires sold each year. Blackwall tires, which have the TIN on one sidewall, are as likely to be mounted with the number side facing in as out. Based on this information, we estimate that approximately 65 percent of all tires are mounted with their TINs not readily visible.
When the TINs appear on the inside sidewalls of the tires mounted on vehicles, motorists have three inconvenient ways of finding and recording the TINs. They must either: (1) Slide under the vehicle with a flashlight, pencil and paper and search the inside sidewalls for the TINs; (2) remove each tire, find and record the TIN, and then replace the tire; or (3) enlist the aid of a garage or service station which can perform option 1 or place the vehicle on a vehicle lift so that the TINs can be found and recorded.
Maintaining proper inflation pressure in motor vehicle tires is important to the safe and efficient use of motor vehicles.
The recommended inflation pressure is labeled on the vehicle on a placard or the vehicle certification label by the vehicle manufacturer to provide the cold tire inflation pressure for the maximum loaded vehicle weight based upon vehicle specification and operation as determined by the vehicle manufacturer. The recommended inflation pressure is often confused with the maximum inflation pressure which is labeled on the tire by the tire manufacturer to provide the maximum cold inflation pressure to which a tire may be inflated based upon the maximum load rating for that tire.
Maintaining tires at their proper inflation pressure, instead of allowing them to become underinflated, reduces heat build up, minimizes tire wear, contributes to good vehicle handling and improves fuel economy through decreasing the rolling resistance of the tires. In light of the trend toward self-service gas stations, the motorist's responsibility for maintaining proper inflation pressure is more significant. Unfortunately, surveys indicate that a significant number of vehicles are being operated with underinflated, overloaded and/or damaged tires and that the public needs to be reminded to inspect and properly maintain their tires.
The 2000 Bureau of Transportation Statistics (BTS) Omnibus Survey, conducted in September 2000, contained four questions on the public's knowledge of tire pressure issues. This survey, which contained 1,017 household interviews, indicated that, among other things, at least 54.7 percent of the respondents do not know how to determine the proper pressure for their tires.
The AAA Tire Safety Survey, based on an omnibus nationwide telephone survey of 1070 adult Americans (539 males and 531 females) who drive a car, motorcycle, or other motor vehicle at least once a week, queried participants on how to identify the correct tire pressure.
The Rubber Manufacturers Association (RMA) survey, based on four hundred 11-minute telephone interviews conducted between October 12 and 19, 2000, with consumers who own or lease a vehicle they drive at least once a week and are responsible for making decisions about the routine maintenance of their vehicle, explored the extent to which consumers are aware of and knowledgeable about tire safety.
In Spring 2001, the National Center for Statistics and Analysis (NCSA) conducted the 2001 National Automotive Sampling System (NASS) Tire Pressure Special Study (NASS Study) in response to the TREAD Act.
During a total of 336 visits to gas stations, a NASS team collected survey data from drivers from each of the following vehicle categories: passenger cars; sport utility vehicles; vans; and pickup trucks. A total of 11,350 vehicle drivers were surveyed about their knowledge of the vehicle manufacturers recommended tire pressure.
This data indicates that only about 26 (17.84 + 8.39) percent of drivers of passenger cars, 22 (14.8 + 7.06) percent of drivers of pick-up trucks, SUVS, and vans with P-metric tires, and 32 (21.9 + 10.84) percent of drivers of pick-up trucks, SUVs, and vans with either LT or flotation tires know how to consult either the vehicle placard or the owner's manual to determine the correct inflation pressure for their vehicles' tires.
Tire under-inflation, high ambient temperatures, and vehicle overloading are among the factors being considered in the ongoing evaluation of the radial tire failures that have occurred in recent years which have been associated with rollover and other crashes. For example, when a tire is used while significantly under-inflated, its sidewalls flex more and the air temperature inside it increases, making the tire more prone to failure. In addition, a significantly under-inflated tire loses lateral traction, making handling more difficult. The agency also has received data from Goodyear indicating that significantly under-inflated tires increase a vehicle's stopping distance on wet surfaces.
NHTSA's crash files do not contain any direct evidence that points to low tire pressure as the cause of any particular crash. However, this lack of data does not imply that low tire pressure does not cause or contribute to any crashes. It simply reflects the fact that measurements of tire pressure are not among the vehicle information included in the crash reports received by the agency and placed in its crash data bases.
The only tire-related data element in the agency's data bases is “flat tire or blowout.” Even in crashes for which a flat tire or blowout is reported, crash investigators cannot tell whether low tire pressure contributed to the tire failure.
Under-inflated tires can contribute to other types of crashes than those resulting from blow outs or tire failure, including crashes which result from: an increase in stopping distance; skidding and/or a loss of control of the vehicle in a curve or in a lane change maneuver; or hydroplaning on a wet surface. However, the agency does not have any data on how often under-inflated tires cause crashes or contribute to their occurrence.
Additionally, under-inflation contributes to tire overload. Tire overload describes a condition in which the vehicle is carrying more weight than the tire is rated to carry at a specified inflation pressure. For instance, for every 1-psi reduction in inflation pressure, a vehicle's tires suffer a 1.6% reduction in vehicle capacity weight (passenger plus cargo capacity). Overloading can result in handling or steering problems, brake failure, and tire failure.
Several crash files contain information on “general” tire related problems that precipitate crashes. The more recent of these files are The National Automotive Sampling System—Crashworthiness Data System (NASS-CDS)
NASS-CDS data for 1995 through 1998 indicate that there are an estimated 23,464 tow-away crashes caused per year by blowouts or flat tires.
Therefore, about one half of one percent of all crashes are caused by these tire problems. The rate of blowout-caused crashes for light trucks (0.99 percent) is more than three times the rate of those crashes for passenger cars (0.31 percent). Blowouts cause a much higher proportion of rollover crashes (4.81) than non-rollover crashes (0.28); and again more than three times the rate in light trucks (6.88 percent) than in passenger cars (1.87 percent).
FARS data for 1995 through 1998 show that 1.10 percent of all light vehicles in fatal crashes were coded with tire problems. Light trucks had slightly higher rates of tire problems (1.20 percent) than passenger cars (1.04 percent). The annual average number of vehicles with tire problems in FARS was 535 (313 passenger cars and 222 light trucks).
As stated above, the TIN originated with the May 22, 1970 amendments to the National Traffic and Motor Vehicle Safety Act of 1966. Prior to that time, there were no tire labeling requirements in effect. Tire manufacturers simply followed standard industry practices.
In the early 1980's, NHTSA granted a petition for rulemaking filed by the Center for Auto Safety (the Center) requesting that 49 CFR part 574, Tire Identification and Recordkeeping, be amended to require that the TIN be placed on the outside sidewall (i.e., the sidewall visible when a tire is mounted on a vehicle) of whitewall tires and on both sides of blackwall tires. The Center stated that the current tire industry practice of placing the TIN on the inside sidewall of whitewall tires and on only one side of blackwall tires made it very difficult for most motorists to find and read the TINs on their tires once they are mounted on vehicles.
Prior to publishing an NPRM (45 FR 82293; December 15, 1980), the agency sent special orders to nine tire manufacturers who together represented 84 percent of world tire production and 90 percent of domestic production of tires for use in this country to gather information on the feasibility and costs of implementing the proposed requirements. Among the questions in the special orders were ones asking whether the tire presses were operated 24 hours a day seven days a week and, if so, what measures could be taken to ensure that workers could safely change the identification number plates in the presses. (A tire press generally works like a clam shell. The lower half of the press remains in a fixed horizontal position, while the upper half is movable. The tire mold, which also has upper and lower halves, fits inside the press.) None of the respondents suggested that changing the number plates would present insurmountable safety problems.
On April 9, 1981, the agency published a notice of intent listing 17 actions that the agency said it intended to take to reduce unnecessary regulatory burdens upon the motor vehicle and related manufacturing industries (46 FR 21203). Among them was terminating rulemaking on the location of the TIN.
Subsequently, the agency terminated the rulemaking (48 FR 19761; May 2, 1983). The agency stated that it was taking that action because it was unable to determine that the adoption of the proposal would significantly contribute to motor vehicle safety and because the compliance costs would be $4.25 to $5.9 million. Although the agency anticipated that the adoption of the amendment would increase the response to tire recall campaigns and that ultimately the action would reduce the chance of potentially unsafe tires being used on public roads, it was not able to provide a quantified estimate of the benefits to be gained from the proposed amendment. The data relied upon by the agency in issuing the proposal consisted solely of anecdotal comments by 13 consumers on difficulties they experienced in locating tire identification numbers. These 13 comments were among about 9,500 responses received by the agency in response to a survey in which it sent questionnaires to approximately 100,000 consumers. Thus, only 0.013 percent of the questionnaire recipients and 0.14 percent of the respondents reported this type of difficulty. Prior to issuing the proposal, the agency did not have any data or perform any analysis regarding the extent to which the proposed requirement would increase the number of people who find the identification number on their tires, the number of those people who respond to a recall, or the number of potentially defective or noncomplying tires that would be removed from service. No additional data regarding benefits were obtained by the agency as a result of the comment process.
On December 1, 2000, NHTSA published an advanced notice of proposed rulemaking pursuant to the TREAD Act and in recognition of the importance of obtaining public input before making decision regarding activities under the provisions arising under the TREAD Act. (65 FR 75222, December 1, 2000).
The ANPRM discussed NHTSA's existing tire information labeling and marking requirements, tire identification number requirements, and other labeling requirements such as those contained within its Consumer
In addition, NHTSA solicited comments in areas such as general consumer knowledge and behavior, availability of information to consumers, TIN information, and other tire labeling information. The agency asked an extensive number of specific questions related to such matters such as tire identification number content, readability and location, loading, plies and cord material, tread wear indicators, UTQGS, speed rating, run-flat and extended mobility tires, tire inflation pressure, and the dissemination of tire safety information.
NHTSA received 21 comments on the December 1, 2000 ANPRM. The 21 comments were submitted by: 4 manufacturers (1 tire manufacturer and 3 vehicle manufacturers), 9 associations, and 6 other entities (2 consumer advocacy organizations and 4 individuals). The comments are summarized below.
• Commenters, as a group, stated that consumers are generally provided with the information that they need to properly maintain their tires, determine safe loads, and identify recalled tires. However, they also stated that this information must be presented in a simple, accurate, and comprehensive manner that would be understood by the average consumer who is not well educated about tires and tire maintenance.
• Commenters, as a group, also said that drivers are often unaware of tire safety and maintenance information or are confused by the information and need to be educated about the interaction between the information provided. While a small percentage of motorists understand and respond to load and speed rating, tread indicators, ply and cord materials, the vast majority remains unaware of this information. RMA reports that only 45% of drivers in its survey responded correctly to the question as to the source of information for recommended tire pressure and survey generally revealed that consumers do not know how to use tire information currently available. Consumers Union (CU) recommended that additional wording of uniform size and standard location appear on both sidewalls stating “cold operating pressure: consult vehicle information.”
• According to a tire safety survey prepared for the American Automobile Association (AAA) Foundation for Traffic Safety, 50% of American drivers who check their own tire pressure incorrectly consulted the sidewall, 27% consulted the owners manual and only 18% correctly consulted the vehicle (placard) to determine the correct tire pressure. Ford reported that the owner's guide was most popular source for obtaining tire pressure information, followed by the tire pressure information on the tire itself and the certification label on the vehicle.
• Ford suggested that NHTSA conduct a focus group to better understand consumer behavior. Prior to tire recalls, consumers simply wanted clear tire pressure information, but Ford's recent experience indicated that they also want to be able to easily read their TIN numbers and to identify recalled tires and suggested ways to improve tire safety.
• Commenters, as a group, generally believed that the TIN would be easier to find for consumers if it were located on the outward facing sidewall of tires or on both sidewalls and was of sufficient size as to be easily found and read.
• Several tire manufacturer association commenters objected to requiring a tire manufacturer to mark the TIN on both tire sidewalls because they believe that this continues to present tire manufacturing workers with a serious potential safety hazard. One of these commenters stated that, when marking a TIN on both sidewalls, an operator is exposed to danger such as a fatal accident due to mis-operation of curing machine, or burns, bone fracture or blow on head, arm, leg, the back and so on because the operator is forced to work looking up inside of a curing machine to put a stencil plate of the TIN on the upper mold. RMA suggested that the agency should require that the TIN be placed on the intended outward facing sidewall of the tire to minimize risks to workers.
• Tire manufacturing association commenters stated that, besides adverse safety consequences, cost and time due to changes in the manufacturing process are issues of concern and they recommend a suitable phase-in period. RMA, for example, states that manufacturers would face substantial costs if they must change existing molds and that total costs to the economy (costs for changing existing molds, including cost of lost production during the initial change over plus the additional ongoing weekly manufacturing costs to make the additional changes) could exceed $100 million annually. RMA states that, based on the number of recalls made over the past 30 years, the requirement to place the TIN on both sides of the sidewall is unnecessary given the cost of implementation and lack of added benefit and proposes placement of the TIN on the intended outboard side of the tire as a reasonable alternative solution.
• According to tire manufacturing association commenters, to place the TIN on both sidewalls, existing tire molds would have to be changed and because tire production occurs 24 hours a day, seven days a week, there would be substantial lost production costs to make the changes, plus on-going costs, to make changes to both sides of molds.
• Commenters generally agreed that the TIN should be placed where there will be a minimum possibility of scuffing. Commenters stated that the TIN should be placed as closely to the wheel's mounting bead or rim flange as possible, as is current practice, to avoid contact with curbs. One of these commenters stated that while it believes that the TIN would be easier for consumers if it were located on the outboard sidewall of the tires, it would be less vulnerable to abrasion as a result of contact with curbs and other hard objects if it were on the inboard sidewall of the tire as compared with the outboard sidewall. Two association commenters stated that the TIN should remain in its current location.
• No commenter suggested that additional information be added to the TIN. Most commenters suggested that no change be made to contents of the TIN. Ford recommended that NHTSA should require a standardized format and font height on the outward facing sidewall of a tire and General Motors recommended that the size code in the TIN is redundant information that can only be understood by reference to Section 574 and could be eliminated from the TIN. Consumer's Union recommended standardizing placement of the TIN and date of production information and including the lettering “Manuf. ID” and “Prod. Date. ww/yy” above these codes.
• Most commenters stated that optional information in the TIN should not be removed because, for example,
• Consumer group commenters stated that the TIN should be standardized by NHTSA in terms of font, font size, space, raised letters, and placement and location on the sidewall.
• Tire manufacturer association commenters stated that the symbol height of the TIN should not be changed because it will complicate the limited sidewall space available and because placing the TIN on the intended outboard sidewall will eliminate any perceived problem. Consumers Union commented that
• Generally, commenters, as a group, asserted that either the maximum load rating or a load index value should continue to be shown on tires. Although the commenters disagree on which form of information makes load information more accessible to the consumer, most acknowledged that it is generally difficult for a consumer to know the actual load on an individual tire. Several commenters suggested improvements in consumer education concerning the importance of load and its relationship to proper tire inflation. RMA suggested that the maximum load rating be removed from the tire so that consumers will seek out the appropriate vehicle loading on the certification label or vehicle tire placard.
• RMA commented that the most effective way to communicate the relationship between a tire's load carrying capacity and vehicle load at a given wheel position and to ensure the purchase of correct replacement tires is through the use of load index values. If a load index value were required on the tire and the vehicle tire placard, the consumer would then simply match a two or three digit number on the tires and vehicle tire placard to assure proper tire load capacity for their vehicle.
• Tire manufacturer and dealer associations commenters stated that most customers rely on dealers for most information on tire safety and maintenance. One tire dealer association commenter said that approximately half of the tire dealers provide information to all customers and approximately half supply information upon request. The same commenter stated that most dealers do not routinely check to see that the tires purchased are correct for the GVWR and GAWR, although most do reference GVWR or GAWR as necessary.
• Commenters, as a group, agreed that few motorists use or understand the load rating information found on sidewall tires. Advocates suggested that the load rating information remain on the tire and that NHTSA needs to provide specific consumer information about the consequences of under- and of overinflation of tires and their interdependent relationship with vehicle loads and potential instability. Tire manufacturer association commenters suggested that the load ratings be removed from the tires so that drivers will have to consult the vehicle placard for load limit information. Vehicle manufacturers generally support leaving load rating information on the tire sidewalls.
• Commenters generally stated that motorists rarely know the weight of their vehicles, empty or loaded, because this would require weighing of the vehicle. A tire manufacturer association stated that some motorists load to the capacity of the dimensions of the vehicle or they conduct an eyeball inspection.
• Commenters indicated that overloading frequently occurs, to varying degrees, on pick-up trucks, particularly full-size pick up-trucks. Data provided by a vehicle manufacturer indicate that almost all respondents surveyed in a study underestimated load, with the average respondent underestimating load for his or her vehicle by 36%. Tire manufacturer association commenters asserted that consumer knowledge, or lack thereof, instead of current allowances in tire load ratings, is to blame for overloading.
• Commenters, as a group, generally agreed that while ply and cord information is generally of no value to consumers except when replacing tires or in the event of a recall, it should remain on the tire for these purposes. Commenters agreed that “mileage warranty” information is of no safety value to consumers and should be communicated at point of sale instead of on tires. One tire retread association commenter noted that ply and cord material is important for tire retread, repair, and recycling.
• Vehicle manufacturer and tire manufacturer association commenters stated the treadwear indicator information should not be required to be labeled on the vehicle or tire because the information is more effectively and comprehensively provided in owner's manuals. RMA recommends that NHTSA regulations for inspection of vehicles in use (49 CFR 570.9 & 570.62) be changed to indicate that the presence of a treadwear indicator in any major groove be used as an indication of wear out rather than the current requirement of the presence of treadwear indicators in two adjacent major grooves (at three locations spaced approximately equally around the tire.) One consumer commenter stated that consumers could benefit from clearer sidewall identification and that consumers would benefit if the following words appeared elsewhere on the sidewall, “replace tire when worn to indicator.”
• One consumer commenter stated that the UTQGS information is possibly the most important item of consumer information regarding tire performance and should be required to be marked on tire sidewalls for all light vehicles weighing 10,000 GVWR or less. A consumer commenter also stated that this information should be provided in large block letters in contrasting colors. Further, consumers should be provided with a plain language explanation of the safety considerations underlying the UTQGS ratings. The commenter also said it is preferable that an explanation of UTQGS be provided at the point of sale. A vehicle manufacturer added that more consumer education concerning the effect of inflation and loading conditions on UTQGS ratings is necessary. One tire manufacturer association commenter argued that UTQGS only serves to confuse consumers, is generally ignored, and should be discontinued. Another commenter asserts that the treadwear rating should be changed to a statement concerning the expected miles of treadwear.
• Tire manufacturer association commenters did not support labeling additional categories of tires with UTQGS information and suggested that UTQGS information either be eliminated or be replaced by a service description (load index and speed rating) and that treadwear and traction should be made available to consumers at point of sale. Consumer commenters, on the other hand, stated that UTQGS
• Generally, commenters, as a group, believed that a tire's speed rating is important, although not necessarily intuitive, to consumers and should be required to be indicated on the tire. Commenters agreed that consumers should be helped to understand, through consumer education, that they should purchase replacement tires of an equal or greater speed rating to those issued as original equipment. One consumer group commenter suggested that maximum speed limitations should be noted on the sidewall as “speed capacity” rather than “maximum speed” and that UTQG temperature grades could be eliminated since they are redundant with the “speed capacity” information.
• Tire association commenters and Harley Davidson stated that run-flat and extended mobility tire capability should be labeled on the tire sidewall as well as on the vehicle placard. General Motors (GM) commented that this labeling would not add any additional value because low inflation pressure warning systems accompany these tires and the capability is noted in the owner's manual.
• A tire retread association commenter stated that the current labeling requirements for retreated tires are sufficient because those tires comprise a very small market share, are used primarily for commercial applications, and are serviced by well-trained service personnel.
• Commenters suggested that the following items be added to the vehicle placard: payload information (including an explanation of payload), tire service description (load index and speed symbol), high speed inflation pressure information, and speed rating. Commenters suggested the following locations for the tire placard: Door edge pillar, fuel door, visor, dashboard, glove box, door jamb. Commenters also suggested that the placard be in a standardized format and location in the vehicle. One vehicle manufacturer stated that the tire size, speed rating, cold inflation pressure and load capacity should be on the certification label.
• While General Motors and the International Tire and Rubber Association (ITRA) supported retaining the maximum inflation pressure label because it provides a “point of reference” inflation pressure, most commenters argued that the maximum inflation pressure should be removed from the sidewall of tires because consumers confuse it with the recommended inflation pressure found on vehicles and because inflating a tire to maximum inflation pressure may cause uneven wear and other failures. Further, one tire manufacturer association commenter suggested that consumers will look at the certification label or vehicle placard for pressure information if pressure information is not contained on the tire. One tire manufacturer association commenter asserted that removing the maximum inflation pressure would improve safety if the correct inflation pressure is clearly and conveniently communicated to consumers and if consumers act on this information. One vehicle manufacturer commenter remarked that there should be a marking requirement for tires that would direct operators to use the information contained on the vehicle tire placard.
• Commenters neither supported nor opposed a tire inflation warning label. Most, however, suggested that consumer awareness of correct tire pressure, size, and the relationship of load and tire pressure is appropriately addressed through consumer education.
• Commenters, as a group, said that messages about tire inflation, vehicle loads and handling, and other safety effects need to be communicated repeatedly and through the use of different media such as agency brochures, manufacturer labels, owner's manual entries, and point-of-sale literature provided by tire manufacturers. Also, a hierarchical system of providing safety information to consumers in varying forms and details based on the essential nature of the performance and safety information should be employed. The placard should be mounted consistently in the same place on all vehicles and be both easily found and readable.
• One vehicle manufacturer opposed including applying amendments to the tire information labeling requirements to motorcycle tires. Two tire manufacturer associations stated that trailer and motorcycle tires should be required to have the same information as other highway tire categories molded into the sidewall.
• Two tire manufacturer association commenters stated that there is no need to change the current font height specified and indicated that this issue needs to be considered as a part of a broader evaluation of tire marking and consumer awareness. Consumer group commenters, however, argued that the current font height is inadequate and needs to be increased and made uniform for the different labeling requirements. Commenters generally expressed the view that using contrasting colors for labeling is not feasible due to manufacturing process concerns and consumer preference.
• RMA suggested that ECE regulations 30 and 54 address issues similar to those raised in the ANPRM. Additionally, RMA called attention to the work being done under WP.29's ongoing process for developing a global technical regulation for tires and the industry's GTS-2000 proposal.
• Manufacturers and association commenters pointed to both the WP.29 process and to the GTS-2000 proposal as means to best accomplish harmonization of this standard with foreign standards and to reduce redundancy in the current situation. These commenters suggested that decreased costs and increased information consistency would be benefits of minimizing regulatory divergence.
• Some comments included suggestions for improving the organization and coherency of the tire information that currently appears in more than six different standards and sections on tire information.
• Commenters also suggested requiring improved availability of safety related service information, including an in-vehicle safety information booklet which, in addition to owner's manual, would provide explanations concerning the operation and use of safety related systems and equipment such as tires.
In March 2001, NHTSA conducted a series of eight focus groups to (1) explore consumer perceptions of motor vehicle tire labeling, (2) identify aspects of motor vehicle tire labels that are potentially confusing, and (3) identify means for optimizing the likelihood that
The moderator for the focus groups conducted three exercises for each group of participants. In the first exercise, the moderator discussed with participants their current use of tire information. In the second exercise, the moderator solicited responses to a tire information presentation using a brand new tire and a diagram provided by NHTSA to demonstrate the variety and nature of NHTSA-mandated information on tires. In the third exercise, the moderator presented four variations on standard tire placards (called Concepts A through D in the Report) and solicited comments from the participants. The four formats included 2 black-and-white and 2 color versions. The color and black-and-white versions each included a small version that focused on air pressure and a longer version that included tire and other vehicle information, e.g., load, seating designation, etc. Conclusions from the first two exercises were:
• Tire information is ignored except when consumers are responding to conspicuously low tire pressure or buying new tires;
• Participants only had knowledge of one or two of the following aspects of tire information: tire size, brand name, price, weight load;
• At point of sale, tire information and documentation other than price receipt and warranty is not provided;
• Retailers should be required to provide tire information, e.g., adhesive tire information labels or brochure, at point of sale;
• Consumers are unaware that there is a tire placard in their personal vehicle;
• Owner's manuals are used on a limited basis for tire information;
• Consumers have little knowledge of the information available on the tire sidewall, besides tire pressure, type and brand name. Most were perplexed by the array of alpha and numeric codes appearing on the demonstration tire;
• Metric numbers are not understood by consumers;
• Too much information on a tire is preferable to too little information;
• Tire information sheets, similar to those provided with prescription drugs, should be readily available to vehicle and tire purchasers;
• Consumers want to learn more about the meaning of the information that appears on tires, e.g., tire codes and ratings;
• The following information should be displayed on the tire: date of manufacture and recommended replacement interval;
• Tire information should be presented in “plain language”;
• Tire information should be presented in a larger typeface;
• Tire information should appear on both sides of the tire;
• Tire safety information is too important and too tire-specific to be relegated to the owner's manual or tire placard—it should be provided at the point of new vehicle or replacement tire purchase in paper form, e.g., brochure;
• Owner's manuals, while a good location for general tire safety and education information, is not an appropriate location for tire-specific information; and
• The term “cold tire pressure” is not readily understood or is often misunderstood as relating to the outside temperature/weather conditions.
With regard to the actual content, placement and design of the Tire Safety Information Placards discussed in the third exercise, the following recommendations were made:
• Add/use color formats for the tire placard instead of only black-and-white;
• Use small placard formats rather than large placard formats;
• Use a tire icon, as a visual cue, on the placard (an icon makes the purpose and subject matter of the placard more easily identifiable and facilitates use of the placard information by drivers with marginal literacy skills); and
• Standardize the placement of tire placards on the B-pillar.
The agency is proposing a single standard for light vehicle tires, FMVSS No. 139,
NHTSA proposes that the TIN, size designation, maximum permissible inflation pressure, and maximum load rating be placed on both sides of light vehicle tires. Requiring the TIN and size designation to be on both sides would ensure that that information would be on the sidewall facing outward, regardless of how the tire is mounted. Requiring that the other items of information be on both sidewalls would aid consumers in properly maintaining their tires and loading their vehicles.
NHTSA is proposing two changes to the TIN. First, the agency proposes to require a reordering of information in the TIN so that the first six characters would contain the information required for determining whether a particular tire is subject to a recall. The first two characters would reflect the plant code, and the next four characters would reflect the date code. Second, the agency proposes to require that each character be 6 mm (
The agency proposes four sets of revisions for the presentation of tire inflation pressure and load limit information on the vehicle placard required for passenger cars by S4.3 of § 571.110 and to be required for all light vehicles with a GVWR of 10,000 pounds or less under this proposal.
First, the agency proposes that tire inflation pressure information would be visually separated by a red colored border on the existing vehicle placard or, alternatively, be placed on a separate tire inflation pressure label. The vehicle placard would contain only the information specified in the proposed version of S4.3 (paragraphs (a)-(e)).
(b) Designated seating capacity (expressed in terms of total number of occupants and in terms of occupant for each seat location);
(c) Vehicle manufacturer's recommended cold tire inflation pressure;
(d) Tire size designation for the tire installed as original equipment on the vehicle by the vehicle manufacturer; and
(e) “SEE OWNER'S MANUAL FOR ADDITIONAL INFORMATION”.
Second, the agency also proposes that the tire inflation pressure label and vehicle placard meet the following three requirements: (1) The tire inflation pressure information would be in color—red, yellow, and black on a white background, (2) contain a black and white tire symbol icon in the upper left corner, 13 millimeters (.51 inches) wide and 14 millimeters (.55 inches) tall/high, and 3) include the phrases “Tire Information” and “See Owner's Manual For Additional Information” in yellow text on a black background.
Third, the agency proposes to replace the vehicle capacity weight statement on the vehicle placard with the following sentence: “[t]he combined weight of occupants and cargo should never exceed XXX pounds.” The “XXX” amount would equal the “vehicle capacity weight” of the vehicle as defined in FMVSS No. 110. The information is the same as that currently required to be placed on the vehicle placard by manufacturers. However, the agency believes that the statement “the combined weight of occupants and cargo should never exceed * * *” is easier for consumers to comprehend than a technical phrase such as “vehicle capacity weight.” “Vehicle capacity weight” is not intuitive to consumers and it requires a vehicle operator to look to the owner's manual or standard to understand which factors are included in the calculation of the sum on the placard.
Fourth, the agency proposes to replace the vehicle's recommended tire size designation with the tire size designation for the tire installed as original equipment on the vehicle by the vehicle manufacturer. While in most instances these two numbers would be identical, this minor revision insures that the consumer is provided with the correct tire inflation pressure information for the tire size actually installed on his vehicle as original equipment by the vehicle manufacturer.
We are proposing these placard changes in response to survey data which indicate that consumers need assistance in locating recommended tire pressures for their vehicle's tires and understanding load limits. The use of colors and a visual cue, such as a tire symbol icon, would aid drivers in noticing and locating this imperative information. By expressing the vehicle's load limit in easily recognizable terms such as “passenger and cargo weight”, as opposed to “vehicle capacity weight” the proposed placard revisions would also aid consumers in understanding and adhering to load limit guidelines.
The agency proposes that the placard and/or label containing tire inflation pressure be located on the driver's side B-pillar. If a vehicle does not have a B-pillar, then the placard and/or label would be placed on the edge of the driver's door. Currently, S4.3 of § 571.110 specifies that the vehicle placard be affixed to the glove compartment door or an equally accessible location. A standardized location for tire information placards and labels would contribute to consumer awareness of recommended tire inflation pressures and load limits.
The agency proposes that owner's manuals for light vehicles contain discussion of the following five subject areas: (1) Tire labeling, (2) recommended tire inflation pressure, (3) glossary of tire terminology, (4) tire care, and (5) vehicle load limits. A single, reliable source containing the proposed required information for the tires and tire safety information listed above would aid consumers by providing the information that they need to properly maintain their tires and adhere to recommended load limits.
The proposed FMVSS No. 139 and its labeling revisions would apply, except where noted, to new pneumatic tires for use on motor vehicles with a GVWR of 10,000 pounds or less, manufactured after 1975, except for motorcycles and LSVs, and for new motor vehicles with a GVWR or 10,000 pounds or less manufactured after September 1, 2003.
Given the increasing consumer preference for light truck use for passenger purposes, the agency is proposing that the safety requirements for passenger car tires also be made applicable to LT tires (load C, D, E) used on light trucks. Further, LT tires are increasingly used in the same type of on-road service as P-metric tires on light vehicles. Recent sales data for heavier trucks indicate that the use of these tires on passenger vehicles will continue to increase in the near future.
NHTSA is not proposing to require that FMVSS No. 139 apply to motorcycle tires because motorcycle tires are of a design and construction unlike the types of vehicle tires that would be subject to the proposed standard. Further, the agency is currently not aware of any consumer information concerns or problems associated with motorcycle tires. For similar reasons, NHTSA is also not proposing to require that the new standard be applicable to tires beyond load range E, which are typically used on medium (10,000-26,000 lbs. GVWR) and heavy vehicles (greater than 26,001 lbs. GVWR), and temporary spare tires.
To maintain consistent labeling requirements for all tires for use on light vehicles, the proposed labeling requirements would also be applicable to retreaded pneumatic passenger car tires and new non-pneumatic tires for passenger cars. More specifically, FMVSS No. 117, which specifies requirements for retreaded pneumatic passenger tires and FMVSS No. 129, which specifies performance requirements for new non-pneumatic tires for passenger cars would be revised to include the proposed labeling requirements.
NHTSA proposes that all labeling information specified under S4.3 of FMVSS No. 109, including the TIN, be placed on both sides of light vehicle tires except for that information cited in paragraphs (d), (e), (f) and (g) of S4.3. The required information in these paragraphs (generic name of cord
Comments to the docket in response to the ANPRM questions concerning placement of the TIN expressed a range of different viewpoints. Most commenters stated that placing the TIN on the outside wall of the tire was a desirable requirement. Further, many respondents also supported putting the TIN on both sides of the tire to ensure that it would be visible on the outboard tire wall, as well as the inside tire wall where there is a lesser chance of it being scuffed off of the tire. However, several tire industry respondents did not support putting the TIN on both sides of the tire because of manufacturing costs and safety issues.
The recent Firestone recall highlighted the difficulty that consumers have in identifying recalled tires when tires are mounted so that the TIN is located on the sidewall facing inwards. Improved access to the TIN would greatly enhance the consumers' ability to determine if their tires have been recalled.
Consumer commenters and focus group participants also said that other tire labeling information, such as size, speed rating, load rating and maximum pressure, should also be required on both sides of the tire to ensure that it is readily visible to consumers.
With regard to the number of plies and generic name of cord material used in the plies, most respondents believed that information to be of limited safety value to consumers and suggested its removal from the sidewall. The ITRA expressed the view that the cord and ply material is very important to the tire retread, repair and recycling industries because this information enables consumers and industry professionals to determine the level of risk when inflating, repairing, retreading or servicing a specific tire. NHTSA believes that it is sufficient to require that this information appear on one sidewall. There is no known advantage that would arise from requiring this information on both sides of the tire.
Several tire manufacturer association commenters objected to requiring a tire manufacturer to mark the TIN on both tire sidewalls because they believe that this continues to present workers with a serious potential safety hazard. As discussed above, the agency learned during prior rulemaking efforts (45 FR 82293, December 15, 1980) that changing the TIN number plates in the tire molds would not present insurmountable safety problems. NHTSA believes that advances in tire manufacturing technology, such as removable stencil plates, have allowed for a significant reduction in the safety hazards associated with the manufacturing process by enabling workers to change labeling information on the molds outside of the tire press (A tire press generally works like a clam shell). Further, the costs associated with changing molds to implement this requirement are not considered to be onerous as discussed in the Costs section of this document. Additionally, the tire manufacturers' suggestion that the TIN be placed on the intended facing sidewall of the tire is not practicable because the vast majority of tires produced are reversible, not asymmetrical.
Requiring that the tire information specified above be placed on both sides of light vehicle tires would provide consumers with readily accessible recall information, without creating significant additional costs to tire manufacturers, and would ensure that the retread, repair and service industries continue to be provided with necessary recall information. Reducing the amount of information required to be placed on both sides of light truck tires would also result in cost savings to manufacturers that would offset some of the increased costs resulting to changes to the TIN and the labeling of passenger car tires.
Several commenters suggested adding additional information to the tire sidewall, e.g., load index values, specifying what the digits of the TIN represent, a marking requirement directing the vehicle operator to use the information contained on the vehicle placard, a marking requirement for run-flat and extended mobility tire capability, and a warning stating: “replace tire when worn to indicator.” NHTSA believes that these suggestions are not feasible. As run-flat tires and high performance low-profile tires are developed and become more common, tire diameters will increase with consequent decrease in sidewall heights. That means that reserving the ever-decreasing space on tire sidewalls for displaying necessary and required information will become even more important in the future. Other suggested tire labeling, such as load index values, are not intuitive to consumers and would require the vehicle operator to seek out reference materials and/or would require the agency to require more information to be added to the already crowded vehicle placard. NHTSA believes the items, explanations, and warnings suggested by the commenters would be better and more effectively addressed through consumer information campaigns rather than through requirements for additional in-vehicle and on-vehicle information.
The agency proposes two revisions to the TIN: (1) Require that the first six characters of the TIN to contain the following information: The first two characters would reflect the plant code, and the next four characters would reflect the date code, and (2) require 6 mm (
The commenters on the ANPRM and the focus groups expressed consistent support for making the TIN more user-friendly and readable. To that end, the first proposed revision to the TIN reorders the sequence of the TIN characters to require that the first six numbers be those that are necessary for identifying recalled tires (i.e., the plant code and the date code). Since the tire size is required to be labeled elsewhere on the tire under another provision, the requirement for including the tire size code in TIN would be deleted. The proposed revisions to the sequence of information in the TIN would make the TIN easier for consumers to read and understand for recall and other purposes.
The second proposal, which would require a 6 mm (
In previous rulemakings and comments to the ANPRM, consumer group commenters have suggested that 4 mm was not a sufficient font size for the TIN, particularly for individuals with visual impairment. Comments on the ANPRM and from the focus groups concerning the readability of the TIN did not specify a particular font size.
The agency believes that a uniform 6 mm TIN font height is a more appropriate size for information that is critical in the event of a recall. The larger size will make the TIN easier to read, without imposing a significant burden on tire manufacturers. 6 mm is approximately the equivalent of Times New Roman font size 20 in Windows 2000. While 6 mm would be the minimum required font size, there is no restriction that would prevent tire manufacturers from using a larger font size for the TIN characters. The agency requests comments on the readability of a 6 mm font size for the TIN characters. Please be specific in your response and provide a basis for your answer.
The agency proposes four sets of revisions for the presentation of tire inflation pressure and vehicle placard information. This placard, permanently affixed to the glove compartment door or an equally accessible location on passenger cars and to be required for all light vehicles with a GVWR of 10,000 pounds or less under this proposal,
First, the agency proposes that tire inflation pressure information would be visually separated from the other information by a red colored border on the existing vehicle placard 13 required by S4.3 of § 571.110 or, alternatively, be placed on a separate tire inflation pressure label. The vehicle placard would contain only the information required by S4.3 of 571.110, could not be combined with information or statements required by other labeling or certification requirements, and would meet the proposed color and content requirements as described below.
Second, the agency also proposes that if a vehicle manufacturer uses the separate tire inflation pressure label, that label must meet the following three requirements: (1) the tire inflation pressure information on the placard would be in color—red, yellow, and black on a white background—as illustrated in Figures 3 & 4 below, (2) contain a black and white tire symbol icon that is in the upper left corner of the placard, and is 13 millimeters (.51 inches) wide and 14 millimeters (.55 inches) (see Figures 3 & 4 below), and (3) the label and placard would both include the phrases “Tire Information” and “See Owner's Manual For Additional Information,” in yellow text on a black background as illustrated in Figures 3 and 4 below. If, alternatively, the manufacturer uses the separate tire inflation pressure label, that label must meet those three requirements.
Third, the “vehicle capacity weight” statement on the vehicle placard would be replaced by the following statement: “[t]he combined weight of occupants and cargo should never exceed XXX pounds.” The “XXX” amount would equal the vehicle capacity weight of the vehicle as defined in FMVSS No. 110. The information is the same as that currently required to be placed on the vehicle placard by manufacturers. However, the agency believes that the statement “the combined weight of occupants and cargo should never exceed * * *” is easier for consumers to comprehend than a technical phrase such as “vehicle capacity weight,” which is not intuitive to consumers. To understand the term “vehicle capacity weight”, a driver must look through the owner's manual for an explanation of how that weight is calculated and what significance that weight has for the safe operation of his or her vehicle.
Fourth, the agency proposes to replace the vehicle's recommended tire size designation with the tire size designation for the tire installed as original equipment on the vehicle by the vehicle manufacturer. While in most instances these two numbers would be identical, this minor revision insures that the consumer is provided with the correct tire inflation pressure information for the tire size actually installed on his vehicle as original equipment by the vehicle manufacturer. The agency considered adding a requirement for the vehicle manufacturer to label all recommended optional tire size designations on the vehicle placard and/or tire inflation pressure label. While this consideration would provide recommended tire inflation pressure information for consumers who opt to replace factory installed tire sizes with optional tire sizes, we have tentatively concluded that this is not a feasible requirement for three reasons. First, most light vehicles are equipped with original equipment and replacement tires having the same tire size designation as those tires installed by the vehicle manufacturer. Second, consumers are typically not familiar with or cognizant of the size of the tires on their vehicles. A listing of more than one tire size designation and recommended tire inflation pressure would require the vehicle operator to seek out the tire size designation on the vehicle's tires. Third, listing more than one tire size designation and recommended inflation pressure would require more information to be added to the already crowded vehicle placard. The agency believes that requiring a vehicle operator to take an extra step to
The following are samples of the proposed vehicle placard and tire inflation pressure label:
As discussed above, survey data indicate that most individuals are unaware of the existence and/or location of the tire inflation pressure and load limit information placards. Surveys also confirm that maximum tire pressure is often confused with recommended inflation pressure. Surveys have not addressed load limit issues, but the results from NHTSA's focus groups and comments received in response to the ANPRM indicate that consumers are unaware of that these limits exist, where they are located, and how to use them.
NHTSA's focus groups tested different versions of existing and proposed tire placards to help determine the most effective way of attracting the attention of consumers to this information and making it more understandable to them. In response to the testing, focus group participants overwhelmingly preferred color formats with contrasting colors, e.g., yellow on black, instead of black and white formats because the color attracted their attention and aided in their comprehension of the material. Participants also strongly believed that a visual cue, such as a tire symbol icon, would aid drivers in identifying and locating this imperative information.
Based on the comments to the ANPRM and the focus group results, NHTSA also recognizes that consumers need assistance in understanding load limits and how inflation pressure affects the load carrying capacity for their vehicle and in determining the total load limit in pounds for their vehicle. For instance, by replacing the technical term “vehicle capacity weight” on the placard with a sentence containing easily understandable terms such as “passenger weight” and “cargo weight”, the proposed placard revisions should also aid consumers in locating and adhering to recommended load limit guidelines as well as recommended inflation pressures.
The agency proposes that the vehicle placard and tire inflation pressure label be located on the driver's side B-pillar. If a vehicle does not have a B-pillar, then the placard and label would be placed on the edge of the driver's door. The tire inflation pressure label would be placed proximate to the vehicle placard. There would be no prohibition on placing additional tire inflation pressure labels on the vehicle in locations other than the B-pillar, except as precluded by other safety standards.
Currently, S4.3 of 571.110 specifies that the vehicle placard be affixed to the glove compartment door or an equally accessible location. NHTSA's focus group results indicate that many consumers are unaware of the existence of and or location of tire inflation pressure and load limit information. Participants in the focus groups noted a strong preference for one standardized location for the placard. Both the focus group participants and commenters on the ANPRM cited the B-pillar, followed by the driver's door edge, as the most preferable locations for the placard. A standardized location for tire information placards would contribute to consumer awareness of recommended tire inflation pressure and load limits by providing a consistent and predictable place for this information.
The agency proposes that owner's manuals for light vehicles contain discussion of the following five subject areas:
1. Tire labeling, including a description and explanation of
(a) each marking on the tire,
(b) locating information that will aid consumers in identifying tires subject to a recall campaign, and
(c) the TIN;
2. Recommended tire inflation pressure, including a description and explanation of
(a) recommended cold tire inflation pressure,
(b) the vehicle placard and tire inflation pressure label required in Federal Motor Vehicle Safety Standard No. 110 and their location in the vehicle,
(c) the adverse safety consequences of underinflation (including tire failure), and
(d) measuring and adjusting air pressure to achieve proper inflation;
3. Glossary of tire terminology, including “cold tire pressure,” “maximum inflation pressure,” and “recommended inflation pressure,” and all non-technical terms defined in S3 of FMVSS Nos. 110 & 139;
4. Tire care, including maintenance and safety practices; and
5. Vehicle load limits, including a description and explanation of
(a) locating and understanding load limit information, total load capacity, seating capacity, towing capacity, and cargo capacity,
(b) calculating total and cargo load capacities with varying seating configurations including quantitative examples showing/illustrating how the vehicle's cargo and luggage capacity decreases as the combined number and/or size of occupants increases,
(c) determining compatibility of tire and load capabilities,
(d) the adverse safety consequences of overloading on handling and stopping and on tires, and
(e) when to use either the recommended inflation pressure or a higher pressure (up to the maximum inflation pressure) based on the amount of load being carried by the tires. This inflation pressure and load limit information could, for example, be provided on an insert in the following format:
Some commenters on the ANPRM indicated that a majority of consumers rarely consult the owner's manual or have knowledge of the information that it contains. Commenters and focus group participants, however, agreed that the owner's manual should be a primary source of information for vehicle owners and, in particular, is a good location for general tire safety information. As discussed earlier in this document, survey research indicates that a significant minority of participants, up
The agency's review of a limited number of owner's manuals revealed that the amount and type of information provided in these documents varies widely. Based on this observation, as well as the ANPRM comments and focus group results, the agency believes that a single, reliable source containing the proposed required information for the tires and tire safety information listed above would aid consumers in properly maintaining their tires and adhering to load limits.
The purpose of FMVSS Nos. 110 and 120 is to provide safe operational performance by ensuring that vehicles to which they apply are equipped with tires of adequate load rating and rims of appropriate size and type designation. FMVSS No. 110 currently applies to passenger cars and FMVSS No. 120 currently applies to vehicles other than passenger cars including motorcycles and trailers.
The agency proposes that FMVSS Nos. 110 and 120 be revised to correspond with the applicability of the new light vehicle tire standard. FMVSS No. 110 would include passenger cars and other light vehicles with a GVWR of 10,000 pounds or less. Therefore, most SUVs, vans, trailers, and pickup trucks would be required to comply with the same tire selection and rim requirements as passenger cars. FMVSS No. 120 will continue to apply to vehicles over 10,000 pounds GVWR and motorcycles.
Most current requirements of FMVSS No. 110 would be retained, including S4.2.2, which establishes a linkage between the vehicle normal load
The proposal also would extend S4.4.1(b) of FMVSS No. 110, which requires that each rim shall retain a deflated tire in the event of a rapid loss of inflation pressure from a vehicle speed of 97 km/h until the vehicle is stopped with a controlled braking operation, to light trucks and vans for the first time.
Currently, the rim size and type designation label information requirements for light trucks and multipurpose passenger vehicles (MPVs) (which include SUVs) are specified in S5.3.2 of FMVSS No. 120. Light trucks and MPVs, unlike passenger cars, may be outfitted with different sized rims which would require different size tires and recommended inflation pressures for those tires. Under this proposal, the rim size and designation label requirement on the certification label would be added to FMVSS No. 110 for all light vehicles to which FMVSS No. 120 is presently applicable. Rim information would not, however, appear on the proposed vehicle placard or tire inflation pressure label.
The agency is not proposing to remove or to revise the requirement for the maximum permissible inflation pressure marking on the tire, except to extend this requirement to tires for use on all light vehicles with a GVWR of 10,000 pounds or less, except LSVs and motorcycles.
Commenters on the ANPRM and survey data noted that misunderstanding as to the meaning of maximum permissible inflation pressure does exist among consumers. Consumers often confuse the maximum permissible inflation pressure labeled on the tire for the recommended inflation pressure labeled on the vehicle placard. Nevertheless, most commenters did not recommend deleting this labeling requirement. Several commenters to the docket suggested adding information to the tire to distinguish the maximum permissible inflation pressure from the recommended inflation pressure. However, most expressed the view that improved consumer information would be the most effective means to correct the misunderstanding. The agency believes that it would be less effective to require tire manufacturers to add additional language to the sidewall to clarify the distinction between maximum inflation pressure and recommended inflation pressure. Sidewalls are becoming progressively smaller with the advent of low profile tires and requiring additional information in this already crowded space could cause greater consumer confusion.
Several commenters and focus group participants also noted that the maximum inflation pressure provides a failsafe guideline for tire inflation. The agency concurs that the greatest likelihood of tire failure results from underinflation. Additionally, the inflating of tires to the maximum inflation pressure while “warm” (i.e., after being driven for any amount of time) will most likely result in the tires being inflated to an amount below the maximum inflation pressure because the warm tire will register a higher inflation pressure than when the tire is measured when “cold” (not driven for at least three hours).
The agency also anticipates that improvements in the tire placard, standardizing the placard location, and an expanded consumer information program would reduce the number of consumers who mistake the maximum inflation pressure for the recommended inflation pressure.
Several commenters on the ANPRM questioned the utility of the UTQGS ratings to consumers and suggested that they be repealed. Other commenters recommended extending the applicability of UTQGS to additional categories of tires, e.g., mud and snow. One commenter suggested that temperature grades could be eliminated since they are redundant with speed rating information.
In conjunction with the proposals discussed above and in response to the TREAD Act, the agency is also launching a consumer information
The agency, as part of this rulemaking, does not propose to require dealers to provide point-of-sale tire information. The agency does not possess evidence that point-of-sale information would prove more successful than consumer information campaigns at educating the consumer concerning tire safety. Therefore, it cannot presently justify the additional costs to manufacturers and dealers of such a requirement. If the agency's consumer information campaign proves unsuccessful at increasing the public awareness of tire safety, the agency could reexamine this issue in a future rulemaking.
Vehicle certification label requirements, contained in part 567, would not be revised by this proposal except to reference the proposed FMVSS No. 110, as well as FMVSS No. 120, in § 567.4 concerning tire-rim combinations for light trucks and MPVs, and to require that the label contain the tire-rim combination installed as original equipment on the vehicle by the vehicle manufacturer.
NHTSA generally supports international harmonization in cases where such harmonization is consistent with its statutory mandate to ensure motor vehicle safety. The tire industry has become global in manufacturing, marketing, and sales. In 1999, domestic tire manufacturers exported 22.3 million passenger car tires and 3.8 million light truck tires to foreign markets. In the same year, the U.S. imported 45 million passenger car tires and 5.4 million light truck tires from foreign sources. It is apparent, therefore, that maximum harmonization of tire requirements would benefit both U.S. and foreign vehicle and tire manufacturers.
At this time, however, the overall need for safety precludes, in NHTSA's view, the adoption of foreign or international labeling provisions. The labeling requirements contained in GTS-2000 and ECE 30 and 54 do not contain counterparts for some of the provisions in our current requirements, e.g., labeling of maximum permissible inflation pressure on the tire, and in our proposed requirements, e.g., labeling of passenger and cargo weight on the vehicle. Additionally, Canada's tire labeling provisions mirror our current requirements but do not contain the novel labeling requirements proposed in this document.
Furthermore, we believe the two labeling requirements contained in GTS-2000 and ECE 30 and 54, speed-category symbol and load index
The following chart illustrates the rated speed in km/h for each speed symbol. “ZR” is an open-ended speed category for tires with a maximum speed capability above 240 km/h, but is also used specifically for tires having a maximum speed capability above 300 km/h.
The load index requirement in GTS-2000 and ECE Regulation Nos. 30 and 54, in contrast to our current requirement to provide the maximum load rating on the sidewall of the tire, provides a value which is not intuitive to consumers and would require a vehicle operator to look to the owner's manual or standard to determine the actual tire maximum load.
Some comments on the ANPRM suggested improving the organization and coherency of the tire information that currently appears in more than six different standards and sections on tire information. The agency will try to develop a simple brochure that explains to the public what the tire information requirements are and what they mean.
(1) 49 U.S.C. 30123 states: “(c) Maximum load standards. The Secretary shall require a motor vehicle to be equipped with tires that meet maximum load standards when the vehicle is loaded with a reasonable amount of luggage and the total number of passengers the vehicle is designed to carry.” Should NHTSA define or specify what a “reasonable amount of luggage” is for a vehicle with an occupant in every designated seating position? The agency requests comments on this question. Please be specific in your response and provide a basis for your answer.
(2) Tire manufacturer commenters pointed to GTS-2000 and ECE Regulations 30 and 54 to address issues raised in the ANPRM. These commenters generally cited decreased costs and increased information consistency as a benefit of minimized regulatory divergence. These commenters, however, did not cite specific labeling requirements in these international and foreign standards and did not discuss the safety impacts from the adoption of these standards. NHTSA requests comments on which, if any, labeling requirements in any foreign or international standard should be considered by NHTSA and why. Please be specific in your response and provide a basis for your answer.
(3) Most commenters agree that adding additional required information to the tire sidewall is unwarranted or challenging due to space and readability concerns. Additionally, some commenters have indicated that certain information added at the option of the manufacturer, e.g., warranty information, is not useful to consumers. Based on these sentiments, should the agency consider prohibiting some or all non-required information from being labeled on the tire sidewalls? Please be specific in your response and provide a basis for your answer.
NHTSA believes that this proposal would be effective in increasing public
NHTSA believes that this proposal would result in minimal costs for tire manufacturers. Tire labeling information is already required for tires for light vehicles. Therefore, the cost of molding this information should be the same, even if the information is changed. NHTSA estimates that the added cost for labeling tires under this proposal would equal $0.01 per tire or less. Since 300 million tires are produced per year the total annual cost for the proposed tire labeling requirements would equal $3 million ($0.01 × 300 million).
NHTSA also believes that this proposal would result in minimal costs for vehicle manufacturers and consumers. Vehicle placard information is already required for passenger cars and owner's manual information is already required for light vehicles. Therefore, the costs of printing a new or revised vehicle placard and/or tire inflation pressure label, the owner's manual pages, and installation of the placard and/or label should be minimal. The only cost would be a one time cost to change production for the new vehicle placard and/or tire inflation pressure label, the application of the vehicle placard and/or tire inflation pressure label to all light vehicles, not only passenger cars, and the new owner's manual pages.
NHTSA estimates that the cost of a new vehicle placard or tire inflation pressure label would be $0.01 or less per vehicle for producing the new placard or label and $0.04 for the application of the new placard or label. NHTSA estimates that with approximately 100% of light trucks, MPVs, and trailers (9 million annually) utilizing both the placard and label and 30% of passenger cars (.30 × 8 million = 2.4 million) utilizing both the placard and label, the total costs for the vehicle placard and tire inflation pressure label proposals would equal $626,000.
For the owner's manual information, NHTSA estimates that one time writing and editing costs would equal $12,000 ((8 hours labor × $30.00 per hour) x (50 owner's manuals (25 manufacturers, 2 manuals each (one for passenger cars and one for light trucks, MPVs, or trailers)))). The print and layout costs per manual are estimated at $0.10 per manual. Since 17 million light vehicles are produced annually, the total print and layout costs for the manuals equal $1,870,000 with an overprint margin of 10 percent, and the total owner's manual costs equal $1,882,000.
Adding the total tire and vehicle manufacturing costs together results in approximately $5.5 million in annual costs. The agency requests comment on this estimate. Please be specific in your response and provide a basis for your answer.
Section 11 of the TREAD Act requires the agency to issue a final rule on this tire labeling proposal by June 1, 2002. Congress did not set a date by which all covered tires and vehicles would have to meet the improved tire information requirements. The agency proposes to phase-in compliance for tires according to the following schedule: All P-metric tires manufactured on or after September 1, 2003, and all LT tires manufactured on or after September 1, 2004. Additionally, all light vehicles manufactured on or after September 1, 2003 would have to comply with the final rule. This proposed lead time would be consistent with the lead time proposed for the tire performance upgrade.
NHTSA has considered the impact of this rulemaking action under E.O. 12866 and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed under E.O. 12866, “Regulatory Planning and Review.” This action has been determined to be not “significant” under the Department of Transportation's regulatory policies and procedures. The proposal is likely to result in expenditure by tire and automobile manufacturers of approximately $5.5 million in annual costs. As explained above, NHTSA believes that this proposal would result in minimal cost for manufacturers and consumers. As this is a proposal to change existing requirements, the only cost would be a one-time cost to change production to the new tire, vehicle placard and/or tire inflation pressure label, or vehicle owner's manual pages and a minimal costs for installation of the vehicle placard and/or tire inflation pressure label to all light vehicles.
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601
The proposed rule would affect motor vehicle manufacturers and tire manufacturers. The agency does not believe that any of the tire manufacturers are small businesses. However, there are about 1,000 retread manufacturers in the United States, of which about 750 deal with light vehicle tires that will in some small way be impacted by this rule. Most of these retreaders are small businesses.
NHTSA estimates that there are only about four small passenger car and light truck vehicle manufacturers in the United States. These manufacturers serve a niche market. The agency believes that small manufacturers manufacture less than 0.1 percent of total U.S. passenger car and light truck production per year.
The agency requests comments concerning the economic impact of the proposed rule on retreaders and small vehicle manufacturers.
NHTSA has analyzed this proposal for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this action would not have any significant impact on the quality of the human environment.
The agency has analyzed this rulemaking in accordance with the principles and criteria contained in Executive Order 13132 and has determined that it does not have sufficient federal implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. The proposal would not have any substantial impact on the States, or on the current Federal-State relationship, or on the current distribution of power and responsibilities among the various local officials.
The Unfunded Mandates Reform Act of 1995 requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted annually for inflation with base year of 1995). Adjusting this amount by the implicit gross domestic product price deflator for the year 2000 results in $109 million (106.99/98.11 = 1.09). The assessment may be included in conjunction with other assessments, as it is here.
This proposal is likely to result in expenditure by tire and automobile manufacturers of approximately $5.5 million in annual costs.
This proposal would not have any retroactive effect. Under 49 U.S.C. 21403, whenever a Federal motor vehicle safety standard is in effect, a State may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard, except to the extent that the state requirement imposes a higher level of performance and applies only to vehicles procured for the State's use. 49 U.S.C. 21461 sets forth a procedure for judicial review of final rules establishing, amending or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.
This proposal contains the following “collections of information,” as that term is defined in 5 CFR Part 1320 Controlling Paperwork Burdens on the Public:
Tire and Vehicle Placard Labeling Requirements—The Department of Transportation is submitting the following information collection request to OMB for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35).
Executive Order 12866 and the President's memorandum of June 1, 1998, require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:
• Have we organized the material to suit the public's needs?
• Are the requirements in the rule clearly stated?
• Does the rule contain technical language or jargon that isn't clear?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?
• Would more (but shorter) sections be better?
• Could we improve clarity by adding tables, lists, or diagrams?
• What else could we do to make the rule easier to understand?
If you have any responses to these questions, please include them in your comments on this proposal.
In developing this proposal, we tried to address the concerns of all our stakeholders. Your comments will help us improve this rule. We invite you to provide views on options we propose, to suggest new approaches we have not considered, provide new data, indicate how this proposed rule may affect you, or provide other relevant information. We welcome your views on all aspects of this proposed rule, but request comments on specific issues throughout this document. We grouped these specific requests near the end of the sections in which we discuss the relevant issues. Your comments will be most effective if you follow the suggestions below:
• Explain your views and reasoning as clearly as possible.
• Provide solid technical and cost data to support your views.
• If you estimate potential costs, explain how you arrived at the estimate.
• Tell us which parts of the proposal you support, as well as those with which you disagree.
• Provide specific examples to illustrate your concerns.
• Offer specific alternatives.
• Refer your comments to specific sections of the proposal, such as the units or page numbers of the preamble, or the regulatory sections.
• Be sure to include the name, date, and docket number with your comments.
Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments.
Your comments must not be more than 15 pages long. (49 CFR 553.21). We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.
Please submit two copies of your comments, including the attachments, to Docket Management at the address given above under
Comments may also be submitted to the docket electronically by logging onto the Dockets Management System Web site at
If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, at the address given above under
We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
You may read the comments received by Docket Management at the address given above under
You may also see the comments on the Internet. To read the comments on the Internet, take the following steps:
(1) Go to the Docket Management System (DMS) Web page of the Department of Transportation (
(2) On that page, click on “search.”
(3) On the next page (
(4) On the next page, which contains docket summary information for the docket you selected, click on the desired comments. You may download the comments. However, since the comments are imaged documents, instead of word processing documents, the downloaded comments are not word searchable.
Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.
Certification, Consumer information, Imports, Motor vehicle safety, Motor vehicles, Rubber and rubber products, Tires.
In consideration of the foregoing, we propose to amend 49 CFR parts 567, 571, 574 and 575 as follows:
1. The authority citation for part 567 would continue to read as follows:
49 U.S.C. 322, 30111, 30115, 30117, 30166, 32502, 32504, 33101-33104, 33108, and 33109; delegation of authority at 49 CFR 1.50.
2. Part 567 would be amended by revising § 567.4(h)(2) as follows:
(h) * * *
(2) (For multipurpose passenger vehicles, trucks, buses, trailers, and motorcycles.) The manufacturer may, at its option, list more than one GVWR-GAWR-tire-rim combination on the label as long as the listing contains the tire-rim combination installed as original equipment on the vehicle by the vehicle manufacturer and conforms in content and format to the requirements for the Tire-rim-inflation information set
3. The authority citation for part 571 would continue to read as follows:
49 U.S.C. 322, 2011, 30115, 30166 and 30177; delegation of authority at 49 CFR 1.50.
4. Section 571.110 would be amended by revising its heading and S2, S4.3 and S4.3.1, by adding S4.3.2, and by adding Figure 1 and Figure 2 at the end of Section 571.110, to read as follows:
S4. * * *
(a) Vehicle capacity weight expressed as “THE COMBINED WEIGHT OF OCCUPANTS AND CARGO SHOULD NEVER EXCEED XXX POUNDS”;
(b) Designated seated capacity (expressed in terms of total number of occupants and number of occupants for each seat location);
(c) Vehicle manufacturer's recommended cold tire inflation pressure, subject to the limitations of 4.3.2;
(d) Tire size designation for the tire installed as original equipment on the vehicle by the vehicle manufacturer;
(e) “TIRE INFORMATION”;
(f) “SEE OWNER'S MANUAL FOR ADDITIONAL INFORMATION”; and
(g) For a vehicle equipped with a non-pneumatic assembly, the tire identification code with which that assembly is labeled pursuant to the requirements of S4.3(a) of § 571.129, New Non-Pneumatic Tires for Passenger Cars.
S4.3.2 No inflation pressure other than the maximum permissible inflation pressure may be shown unless—
(a) It is less than the maximum permissible inflation pressure;
(b) It is appropriate for the load limits as calculated in accordance with S4.2; and
(c) The tire load rating specified in a submission by an individual manufacturer, pursuant to S4.1.1(a) of § 571.139 or contained in one of the publications described in S4.1.1.(b) of § 571.139, for the tire size at that inflation pressure is not less than the vehicle maximum load and the vehicle normal load.
5. Section 571.117 would be amended by revising S6.3 (including removing Table 1 and the undesignated paragraph following S6.3(h)), to read as follows:
S6. * * *
6. Section 571.120 would be amended by revising its heading, and S3 to read as follows:
7. Section 571.129 would be amended by revising S4.3 to read as follows:
S4. * * *
8. Section 571.139 would be added to read as follows:
S4.1. Each manufacturer of tires shall ensure that a listing of the rims that may be used with each tire that it produces is provided to the public in accordance with S4.1.1 and S4.1.2.
S4.1.1 Each rim listing for a tire shall include dimensional specifications and a diagram of the rim and shall be in one of the following forms:
(a) Listed by manufacturer name or brand name in a document furnished to dealers of the manufacturer's tires, to any person upon request, and in duplicate to: Docket Section, National Highway Traffic Safety Administration, 400 Seventh Street, SW, Washington, DC 20590; or
(b) Contained in publications, current at the date of manufacture of the tire or any later date, of at least one of the following organizations:
(1) The Tire and Rim Association.
(2) The European Tyre and Rim Technical Organization.
(3) Japan Automobile Tire Manufacturers' Association, Inc.
(4) Tyre & Rim Association of Australia.
(5) Associacao Latino Americana de Pneus e Aros (Brazil).
(6) South African Bureau of Standards.
S4.1.2 A listing compiled in accordance with paragraph (a) of S4.1.1 need not include dimensional specifications or a diagram of a rim whose dimensional specifications and diagram are contained in a listing published in accordance with paragraph (b) of S4.1.1.
S4.2. Information contained in a publication specified in S4.1(b) that lists general categories of tires and rims by size designation, type of construction, and/or intended use, shall be considered to be manufacturer's information pursuant to S4.1 for the listed tires, unless the publication itself or specific information provided according to S4.1(a) indicates otherwise.
(a) The symbol DOT, which shall constitute a certification that the tire conforms to applicable Federal motor vehicle safety standards;
(b) The tire identification number required by part 574 of this chapter;
(c) The tire size designation as listed in the documents and publications specified in S4.1.1;
(d) The maximum permissible inflation pressure;
(e) The maximum load rating;
(f) The generic name of each cord material used in the plies (both sidewall and tread area) of the tire;
(g) The actual number of plies in the sidewall, and the actual number of plies in the tread area if different;
(h) The words “tubeless” or “tube type” as applicable; and
(i) The word “radial” if the tire is a radial ply tire.
S5.5.1 Each tire shall be labeled with the name of the manufacturer, or brand name and number assigned to the manufacturer in the manner specified in part 574.
S5.5.2 [Reserved]
S5.5.3 If the maximum inflation pressure of a tire is 240, 280, 290, 300, 330, 340, 350 or 390 kPa, then:
(a) Each marking of that inflation pressure pursuant to S5.5(d) shall be followed in parenthesis by the equivalent psi, rounded to the next higher whole number; and
(b) Each marking of the tire's maximum load rating pursuant to S5.5(e) in kilograms shall be followed in parenthesis by the equivalent load rating in pounds, rounded to the nearest whole number.
S5.5.4 If the maximum inflation pressure of a tire is 420 kPa (60 psi), the tire shall have permanently molded into or onto both sidewalls, in letters and numerals not less than
S7. [Reserved]
9. The authority citation for part 574 would continue to read as follows:
15 U.S.C. 1392, 1401, 1403, 1407, 1411-1420, 1421; delegation of authority at CFR 1.50.
10. Section 574.5 would be amended by revising paragraphs (b) and (d), and Figures 1 and 2 to read as follows:
(b)
(d)
11. The authority citation for part 575 would continue to read as follows:
15 U.S.C. 322, 30111, 30115, 30117, and 30166; delegation of authority at CFR 1.50.
12. Section 575.6 would be amended by adding paragraph (a)(4) to read as follows:
(a)(4) At the time that a motor vehicle with a GVWR of 10,000 pounds or less, except a motorcycle or low speed vehicle, manufactured on or after September 1, 2003 is delivered to the first purchaser for purposes other than resale, the manufacturer shall provide to the purchaser, in writing in the English language and not less than 10 point type, a discussion of the items specified in paragraphs (a)(4) (i) through (v) of this section in the owner's manual, or, if there is no owner's manual, in a document.
(i) Tire labeling, including a description and explanation of each marking on the tires provided with the vehicle, including locating the Tire Identification Number (TIN);
(ii) Recommended tire inflation pressure, including a description and explanation of
(A) Recommended cold tire inflation pressure,
(B) The vehicle placard and tire inflation pressure label specified in Federal Motor Vehicle Safety Standard No. 110 and their location in the vehicle,
(C) Adverse safety consequences of underinflation (including tire failure), and
(D) Measuring and adjusting air pressure to achieve proper inflation;
(iii) Glossary of tire terminology, including “cold tire pressure,” “maximum inflation pressure,” and “recommended inflation pressure,” and all non-technical terms defined in S3 of FMVSS Nos. 110 & 139;
(iv) Tire care, including maintenance and safety practices;
(v) Vehicle load limits, including a description and explanation of
(A) Locating and understanding load limit information, total load capacity, seating capacity, towing capacity, and cargo capacity,
(B) Calculating total and cargo load capacities with varying seating configurations including quantitative examples showing/illustrating how the vehicle's cargo and luggage capacity decreases as the combined number and size of occupants increases,
(C) Determining compatibility of tire and load capabilities,
(D) Adverse safety consequences of overloading on handling and stopping and on tires, and
(E) When to use either the recommended inflation pressure or a higher inflation pressure (up to the maximum inflation pressure) based on the amount of load being carried by the tires. This information, for example, could be provided on an insert in the following format:
Department of Education.
Notice of final priorities, application requirements, and selection criteria for Fiscal Year (FY) 2001.
The Assistant Secretary for Elementary and Secondary Education and the Assistant Secretary for Vocational and Adult Education announce final priorities, application requirements, and selection criteria for the Smaller Learning Communities (SLC) program for fiscal year (FY) 2001.
These priorities, application requirements and selection criteria are effective January 18, 2002.
For information on the program and to download an application, you may access the SLC program web site at
Individuals who use the telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to the contact persons listed above.
This notice of final priorities, application requirements, and selection criteria does not solicit applications. A notice inviting applications under this competition is published elsewhere in this issue of the
Research suggests that the positive outcomes associated with smaller schools stem from the schools' ability to create close, personal environments in which teachers can work collaboratively, with each other and with a small set of students, to challenge students and support learning. A variety of structures and complementary strategies are thought to provide important supports for smaller learning environments; some data suggest these approaches offer substantial advantages to both teachers and students (Ziegler 1993; Caroll 1994).
The Smaller Learning Communities program is authorized under section 10105 of part A of title X of the Elementary and Secondary Education Act of 1965 (ESEA) (20 U.S.C. 8005). Title X, Part A authorizes the Secretary to support nationally significant programs and projects to: (1) Improve the quality of education; (2) assist all students in meeting challenging State content standards; and (3) contribute to achieving National Education Goals.
The purpose of the Smaller Learning Communities program is to support the planning, implementation, or expansion of small, safe, and successful learning environments in large public high schools through competitive grants to local educational agencies (LEAs). LEAs may apply on behalf of large high schools including large high schools funded by the Bureau of Indian Affairs (BIA schools). For the purposes of this program, a large high school is defined as a school that includes grades 11 and 12 and enrolls at least 1,000 students in grades 9 and above.
Methods for recasting large schools as a set of smaller learning communities are included in the Conference Report for the Consolidated Appropriations Act, 2000 [Pub. L. 106-113, H.R. Conference Report No. 106-479, at 1240 (1999)]. Such restructuring methods include establishing small learning clusters, “houses,” career academies, magnet programs, or schools-within-a-school. Strategies that complement a restructured large high school include block scheduling, freshman transition activities, advisory or adult advocate systems, academic teaming, multi-year groupings, and other innovations designed to create a more personalized high school experience for students and thus, improve student achievement.
In FY 2000, Congress appropriated $45 million, of which the Department awarded $42.3 million in support of 149 grants to local educational agencies. The Secretary awarded 84 one-year planning grants and 65 three-year implementation grants. A total of 349 schools, serving over 450,000 students, benefited during the first year of the program. The Secretary reserved the remaining $2,250,000 to fund national leadership activities.
Congress appropriated $125 million for this program in FY 2001. The Administration is not requesting funds for the Smaller Learning Communities program in FY 2002. Rather, the Administration is proposing a new Choice and Innovation State Grants program under which States and LEAs would have greater flexibility in using funds for activities, such as the creation of smaller learning communities, that will support educational reform and improvement.
Prospective applicants are encouraged to review the Program Web site for non-regulatory guidance, information about current grantees, and to review successful applications at:
In response to the Assistant Secretaries' invitation to comment, five parties submitted comments on the proposed priorities, application requirements, and selection criteria. An analysis of the comments and of the changes in the priorities, application requirements, and selection criteria since publication of the July 19, 2001, notice follows.
We discuss substantive issues under the priority, requirement, or criterion to which they pertain. Generally, we do not address technical changes, minor changes, and suggested changes the law does not authorize the Assistant Secretaries to make under the applicable statutory authority.
Under 34 CFR 75.105(c)(2), the Secretary gives a competitive priority to applications that request funding to support smaller learning communities in low-performing high schools that meet all other eligibility requirements for the competition. Applicants will receive up to five additional points based on the proportion of participating schools included in the application that are identified as low-performing. These points are in addition to any points the applicant earns under the selection criteria of the program. Low-performing schools can be identified by local and State educational agencies using the criteria in Title I, Part A, section 1116(c) of the Elementary and Secondary Education Act, which identifies for improvement any Title I school that has not made continuous and sustained progress over two years. In addition, for the purposes of this program, States and LEAs that have their own established criteria for identifying low-performing schools may use those criteria to provide evidence for the competitive priority. Applicants must specify the method used to identify schools as low-performing.
The Secretary announces the following application requirements for the Smaller Learning Communities program. These are in addition to the
To be considered for funding, LEAs must include the name(s) of the eligible school(s) and the number of students enrolled in each school. Enrollment must be based upon data from the current school year or data from the most recently completed school year. LEAs applying on behalf of schools that are being constructed and do not have an active student enrollment at the time of application are not eligible under this program.
The Secretary will award both planning and implementation grants under this year's competition. Applicants pursuing planning grants must not yet have developed a viable plan for creating smaller learning communities. To apply for implementation funds, applicants must be prepared either to implement a new smaller learning community program within each targeted high school, or to expand an existing smaller learning community program.
For a one-year planning grant, LEAs may receive, on behalf of a single school, $25,000 to $50,000 per project. LEAs applying on behalf of a group of eligible schools may receive up to $250,000 per planning grant. As this program is designed to finance direct student services and local redesign and improvement efforts, districts should stay within the minimum and maximum school allocations when determining their group award request. Therefore, in order to ensure sufficient planning funds at the local level, LEAs may not request funds for more than 10 schools under a single application.
The chart below provides eligible ranges for awards under the planning grant:
To ensure maximum flexibility and competitiveness, LEAs may submit multiple applications targeting distinct schools within each funding category. However, LEAs may not apply on behalf of a single high school in more than one application. Schools that received support through planning grants in the 2000 competition are not eligible to receive additional planning grants under the 2001 competition.
For a three-year implementation grant, LEAs may receive, on behalf of a single school, $250,000 to $500,000 per project. LEAs applying on behalf of a group of eligible schools may request up to $2,500,000 per implementation grant. As this program is designed to finance direct student services and local redesign and improvement efforts, districts should stay within the minimum and maximum school allocations when determining their group award request. Therefore, in order to ensure sufficient implementation funds at the local level, LEAs may not request funds for more than 10 schools under a single application.
The chart below provides eligible ranges for awards under the implementation grant:
To ensure maximum flexibility and competitiveness, LEAs may submit multiple applications targeting distinct schools within each application. However, LEAs may not apply on behalf of a single high school in more than one application. Schools that benefited from FY 2000 implementation awards are not eligible to receive additional support under this competition. The total amount an LEA may receive, in any fiscal year under this program, may not exceed $5 million.
Planning grants will fund activities up to 12 months. Implementation grants will fund activities up to 36 months.
Applicants for multi-year awards must provide detailed, yearly budget information for the total grant period requested. Understanding the unique complexities of implementing a program that affects a school's organization, physical design, curriculum, instruction, and preparation of teachers, the Secretary anticipates awarding the entire grant amount for implementation projects at the time of the initial award. This will provide the applicant with the capacity to effectively carry out the comprehensive long-term activities involved in model development, documentation, evaluation, and dissemination of products and practices developed through the federal grant. Uninterrupted access to funds will depend upon a grantee's close adherence to its yearly budget projections as well as submission of an annual performance report, showing adequate progress, during the three-year period of the grant.
Applicants should limit the application narrative to no more than 25 double-spaced pages using the following standards:
(1) A page is 8.5″ x 11″, on one side only;
(2) The page limit includes all narrative, titles, headings, footnotes, quotations, references, and captions, as well as charts, tables, figures, and graphs. Charts, tables, figures, and graphs may be single-spaced;
(3) The font should be 11-point or larger;
(4) The page limit does not apply to the Application for Federal Education Assistance Form (424); the SLC cover page; the Budget Information Form (ED 524) and attached itemization of costs; any other required or supplementary application forms and attachments to those forms; the assurances and certifications; the table of contents; the one-page abstract (which should precede the narrative section and provide enrollment data for each eligible high school and a short description of the project); documentation of the extent to which the applicant meets the competitive priority for the competition; or appendices. Appendices used should relate directly to the selection criteria and project activities. Pages should be numbered.
For both planning and implementation grants, applicants must describe their:
(a) Project objectives;
(b) Measures of student outcomes and performance; and
(c) Indicators to gauge progress toward meeting project objectives.
In addition, the Secretary requires implementation grantees to collect data that address the performance indicators for this program in order to produce annual performance reports. These reports will document the grantees' yearly progress toward expected project
Applicants must submit initial baseline data for each student outcome measure described below. Baseline data should come from either the current or previous school year. Applicants
Required student outcome measures include:
(a) The number of students scoring at each proficiency level for each subject measured by a State assessment (district assessments may substitute where State assessments do not yet exist) in grades 9-12;
(b) The number of students taking the SAT and ACT, and their average scores;
(a) The number of students who take courses for which they receive both high school and college credit;
(b) The number of students completing high school;
(c) The overall reported average daily attendance for October.
(a) The number of incidents of student violence, alcohol and drug use;
(b) The number of expulsions, suspensions, or other serious disciplinary actions; and
(c) The number of students involved in extracurricular activities.
Percentages may be used in place of number of students where appropriate.
(a) Definitions in EDGAR—Definitions defined in 34 CFR 77.1 are applicable to this program.
(b) Other definitions—The following definitions also apply to this program:
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Under the Smaller Learning Communities program competition, a peer review panel will make a careful evaluation of applications. Each panelist will evaluate the applications against the criteria listed below. The panel results are advisory in nature and not binding on the Secretary. The Secretary will use the following selection criteria and associated point values in evaluating applications for planning and implementation grants:
(a) The maximum score for all of these criteria is 100 points. Applicants that meet the competitive priority eligibility requirements may receive up to 105 points.
(b) The maximum score for each criterion is indicated in parentheses. Within each criterion, the Secretary evaluates each factor equally.
The Secretary will base final funding decisions on the panel review ranking of applications. Geographic balance is no longer a consideration in funding decisions.
(a)
(1) The description and documentation of the targeted schools' need for the services provided and the need for the activities carried out by the proposed project consistent with the educational problems generally associated with the impersonal nature of large high schools. Need may consider factors such as: enrollment; attendance and drop-out rates; incidents of violence, drug and alcohol use, and disciplinary actions; percentage of students who pass graduation exams or State assessments (local assessments may be substituted in states that do not yet administer State assessments), enroll in advanced level courses, register for college entrance exams, and matriculate into postsecondary institutions or training; percentage of students who have limited English proficiency, who are migrant youth, who come from low-income families, or are otherwise disadvantaged; the applicant's fiscal capacity to fund programs described here without Federal assistance; or other local need factors as described by the applicant.
(2) The extent to which specific gaps or weaknesses [including the nature and magnitude of those gaps and weaknesses] in services, infrastructure, or opportunities have been identified by the applicant and will be addressed by the proposed project.
(b)
(1) Involves and documents the support of stakeholders both within the school community (e.g. administrators, staff, students, and parents) and within the greater community (e.g. representatives of institutions of higher education, employers, workforce investment boards, youth councils, and community-based organizations).
(2) Provides clear evidence of teacher involvement and support, particularly of those teachers who will be directly affected by the implementation plan.
(3) Indicates the collection and use of data that describe school needs.
(4) Documents the use of research-based findings in the proposed restructuring of the learning environment.
(c)
(1) Are based on a commitment to meeting the needs of all students and ensuring the successful completion of their education or career goals.
(2) Will lead to the establishment of smaller learning communities having clear goals and objectives connected to a mission statement and to student needs.
(3) Follow a timeline appropriate to the goals and objectives to be achieved.
(4) Involve key personnel who are qualified to undertake project activities.
(d)
(1) The requested budget adequately supports the proposed activities.
(2) State, local, and other Federal funds will be used to support the development of the plan.
(3) The administrative and managerial relationship between the LEA, the school(s), and the smaller learning community(ies) demonstrates a commitment to the concept of a smaller learning community and the planning process.
(a)
(1) The description and documentation of the targeted schools' need for the services provided and the need for the activities carried out by the proposed project consistent with the educational problems generally associated with the impersonal nature of large high schools. Need may consider factors such as: enrollment; attendance and drop-out rates; incidents of violence, drug and alcohol use, and disciplinary actions; percentage of students who pass graduation exams or State assessments (local assessments may be substituted in states that do not yet administer State assessments), enroll in advanced level courses, register for college entrance exams, and matriculate into postsecondary institutions or training; percentage of students who have limited English proficiency, who are migrant youth, who come from low-income families, or are otherwise disadvantaged; the applicant's fiscal capacity to fund programs described here without Federal assistance; or other local need factors as described by the applicant.
(2) The extent to which specific gaps or weaknesses (including the nature and magnitude of those gaps and weaknesses) in services, infrastructure, or opportunities have been identified by the applicant and will be addressed by the proposed project.
(b)
(1) Documents the involvement and support of stakeholders both within the school community (e.g., administrators, staff, students, and parents) and within the greater community (e.g. representatives of institutions of higher education, employers, workforce investment boards, youth councils, and community-based organizations).
(2) Provides clear evidence of teacher involvement and support, particularly of those teachers who will be directly affected by the implementation plan.
(3) Uses research-based findings and outside technical assistance in the proposed restructuring and in determining appropriate strategy(ies) to be implemented.
(c)
(1) The goals and objectives of the smaller learning communities correspond to identified needs and are written in terms of student outcomes, including academic achievement.
(2) The curriculum and instructional practices within each smaller learning community are aligned with its goals, theme, and emphases, where they exist.
(3) The proposed smaller learning communities intervention(s) will benefit all students in the school and enable them to reach challenging State content standards and performance standards, ensuring their successful completion of high school and preparation for postsecondary education or a career.
(4) Professional development activities offered to teachers, non-instructional school staff, and others are aligned with smaller learning community goals.
(5) The applicant provides a rationale for—
• Identifying grade levels and ages of students to be served by the smaller learning community(ies); and
• The methods and timetable for placing students in the smaller learning community(ies). Note: Students are not to be placed according to ability, performance, or any other measure of merit. The Department expects that all students will benefit from the SLC intervention.
(6) The management plan appears capable of achieving the objectives of the proposed project on time and within budget, including:
• The past experience, training, and clearly defined responsibilities of personnel who have key roles in carrying out the project; and
• The timelines and milestones for accomplishing project tasks.
(d)
(1) Collecting student performance data, including:
• Required data for annual performance reports,
• Baseline data (to be included as an Appendix; refer to “Reporting Requirements and Expected Outcomes”), and data for three years preceding the baseline (the latter due upon award); and
• A process for monitoring and understanding changes in student outcomes for continuous improvement.
(2) Describing, on an annual basis, the progress towards implementing smaller learning communities and implementing related program changes undertaken to make the smaller learning communities safe and successful. This information will be reported in the Annual Performance Report.
(3) Disseminating best practices and products designed under this grant.
(e)
(1) State, local, foundation, and other Federal funds will be used to support the implementation of the plan.
(2) The applicant will limit equipment, administrative costs, and other purchases in order to maximize the amount spent on delivery of services to students.
(3) The applicant demonstrates a commitment to sustain the project beyond the period covered by the Federal grant.
This program is subject to the requirements of Executive Order 12372 (Intergovernmental Review of Federal Programs) and the regulations in 34 CFR part 79.
The objective of the Executive order is to foster an intergovernmental partnership and to strengthen federalism by relying on State and local processes for State and local government coordination and review of proposed Federal financial assistance.
Applicants must contact the appropriate State Single Point of Contact to find out about, and to comply with, the State's process under Executive Order 12372. Applicants proposing to perform activities in more than one State should immediately contact the Single Point of Contact for each of those States and follow the procedures established in each State under the Executive Order.
If you want to know the name and address of any State Single Point of Contact (SPOC), see the latest list official SPOC list on the OMB Web site of the Office of Management and Budget at the following address:
In States that have not established a process or chosen a program for review, State, area-wide, regional, and local entities may submit comments directly to the Department.
Any State Process Recommendation and other comments submitted by a State Single Point of Contact and any comments from State, area-wide, regional, and local entities must be mailed or hand-delivered by the date indicated in this notice to the following address: The Secretary, E.O. 12372-CFDA #84.215L, U.S. Department of Education, Room 7E200, 400 Maryland Avenue, SW., Washington, DC 20202-0125.
We will determine proof of mailing on the same basis as we determine proof of mailing for applications (see 34 CFR 75.102). Recommendations or comments may be hand-delivered until 4:30 p.m. (Washington, DC time) on the date indicated in this notice. Please Note That the Above Address Is Not the Same Address as the One to Which the Applicant Submits Its Completed Application. Do not Send Applications to the Above Address.
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The official version of this document is the document published in the
Notice inviting applications for new awards for fiscal year (FY) 2001.
Schools that benefited from FY 2000 implementation awards are not eligible to receive additional implementation support under this competition. Schools that benefited from FY 2000 planning awards are not eligible to receive additional planning support under this competition, but may apply for an implementation grant. The total amount an LEA may receive through any combination of awards, in any fiscal year of this program, may not exceed $5 million.
The size of awards will be based on a number of factors. These factors include the scope, quality, and comprehensiveness of the proposed program; the size of the population to be served; and the recommended range of awards indicated in the application.
The Department of Education is not bound by any estimates in this notice.
Applicants for multi-year awards must provide detailed, yearly budget information for the total grant period requested. Understanding the unique complexities of implementing a program that affects a school's organization, physical design, curriculum, instruction, and preparation of teachers, the Secretary anticipates awarding the entire grant amount for implementation projects at the time of the initial award. This will provide the applicant with the capacity to effectively carry out the comprehensive long-term activities involved in model development, documentation, evaluation, and dissemination of products and practices developed through the federal grant. Uninterrupted access to funds will depend upon a grantee's close adherence to its yearly budget projections as well as submission of an annual performance report, showing adequate progress, during the three-year period of the grant.
This competition gives a competitive priority to projects that meet the priority in the Notice of the Final Priorities for this program, which is published elsewhere in this issue of the
For information on the program and to download an application, you may access the SLC program web site at
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339. Individuals with disabilities may obtain this notice in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to one of the contact persons listed in the preceding paragraph.
You may view this document, as well as all other Department of Education documents published in the
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have any questions about using PDF, call the U.S. Government Printing Office (GPO); toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
20 U.S.C. 8005.
Pension and Welfare Benefits Administration, Department of Labor.
Notice on the availability of the Year 2001 Form M-1.
This document announces the availability of the Year 2001 Form M-1, Annual Report for Multiple Employer Welfare Arrangements and Certain Entities Claiming Exception. A copy of this new form is attached.
Amy J. Turner, Pension and Welfare Benefits Administration, Department of Labor, at (202) 693-8335.
The Form M-1 is required to be filed under section 101(g) and section 734 of the Employee Retirement Income Security Act of 1974, as amended (ERISA), and 29 CFR 2520.101-2.
This document announces the availability of the Year 2001 Form M-1, Annual Report for Multiple Employer Welfare Arrangements (MEWAs) and Certain Entities Claiming Exception (ECEs). A copy of the new form is attached.
This year's Form M-1 is substantively identical to the Year 2000 Form M-1. In addition, the filing deadlines for the Year 2001 Form M-1 parallel those for last year's form. Specifically, the Year 2001 Form M-1 is generally due March 1, 2002, with an extension until May 1, 2002 available. These Year 2001 deadlines were also previously published; they are included in the Department of Labor's regulations implementing the Form M-1 filing requirement and they were set forth in last year's Form M-1.
PWBA is committed to working together with administrators to help them comply with this filing requirement. Additional copies of the Form M-1 are available on the Internet at:
Sec. 29 U.S.C. 1024, 1027, 1059, 1132(c)(5), 1135, 1181-1183, 1185, 1185a, 1185b, 1191, 1191a, 1191b, 1191c; Sec. 101, Pub. L. 104-191, 101 Stat. 1936 (29 U.S.C. 1181); Secretary of Labor's Order No. 1-87, 52 FR 13139, April 21, 1987.