Animal and Plant Health Inspection Service
Federal Crop Insurance Corporation
Forest Service
Grain Inspection, Packers and Stockyards Administration
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Centers for Disease Control and Prevention
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Fish and Wildlife Service
Reclamation Bureau
Justice Programs Office
Employment and Training Administration
Mine Safety and Health Administration
Occupational Safety and Health Administration
Agency for Healthcare Research and Quality
Centers for Disease Control and Prevention
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Committee for the Implementation of Textile Agreements
Coast Guard
Federal Aviation Administration
Federal Highway Administration
Maritime Administration
Customs Service
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Federal Crop Insurance Corporation, USDA.
Final rule.
The Federal Crop Insurance Corporation (FCIC) is removing an outdated malting barley provision option that is no longer required in the administration of the Federal crop insurance program.
September 20, 2002.
Louise Narber, Insurance Management Specialist, Product Development Division, Federal Crop Insurance Corporation, 6501 Beacon Drive, Stop 0812, Room 421, Kansas City, MO, 64133-4676, telephone (816) 926-7730.
This rule has been determined to be exempt for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget (OMB).
This rule does not contain information collection requirements that would require approval by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35).
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments or the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.
The rule will not have a substantial direct effect on states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Nor does this rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with the states is not required
This regulation will not have a significant economic impact on a substantial number of small entities. No additional work is required as a result of this action on the part of either the insured or the insurance companies. Additionally, the regulation does not require any greater action on the part of small entities than is required on the part of large entities. Therefore, this action is determined to be exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605), and no Regulatory Flexibility Analysis was prepared.
This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.
This program is not subject to the provisions of Executive Order 12372 which require intergovernmental consultation with State and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115, June 24, 1983.
This rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith. The administrative appeal provisions published at 7 CFR part 11 or 7 CFR § 400.169, as applicable, must be exhausted before any action for judicial review of any determination or action by FCIC may be brought.
This action is not expected to have a significant impact on the quality of the human environment, health, and safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.
FCIC has reviewed its regulations published at 7 CFR part 457 and determined that the provisions for malting barley published at § 457.103 are no longer applicable because the provisions currently in effect for malting barley are published at 7 CFR § 457.118.
Since the purpose of this rule is simply to remove the provisions that are no longer necessary in the administration of the Federal crop insurance program, this rule is considered a rule of agency practice or procedure. Therefore, under section 553(b) of the Administrative Procedures Act, this rule does not need to be published for notice and comment.
Crop Insurance, Malting barley.
Accordingly, under the authority of 7 U.S.C. 1506(l) and 1506(p), the Federal Crop Insurance Corporation hereby amends 7 CFR Chapter IV as follows:
1. The authority citation for part 457 continues to read as follows:
7 U.S.C. 1506(l), 1506(p).
Federal Aviation Administration, DOT.
Direct final rule; confirmation of effective date.
This document confirms the effective date of a direct final rule which establishes Class E airspace at Caruthersville, MO. The initial publication identified the airspace action as a modification of Class E airspace but, in fact, no Class E airspace area extending upward from 700 above the surface of the earth existed at Caruthersville, MO. The description of the established Class E airspace at Caruthersville, MO is unchanged from that of the initial publication.
0901 UTC, October 3, 2002.
Brenda Mumper, Air Traffic Division, Airspace Branch, ACE-520A, DOT Regional Headquarters Building, Federal Aviation Administration, 901 Locust, Kansas City, MO 64106; telephone: (816) 329-2524.
The FAA published this direct final rule with a request for comments in the
Federal Energy Regulatory Commission, DOE.
Final rule; annual update of Commission filing fees.
In accordance with 18 CFR 381.104, the Commission issues this update of its filing fees. This document provides the yearly update using data in the Commission's Management, Administrative, and Payroll System to calculate the new fees. The purpose of updating is to adjust the fees on the basis of the Commission's costs for Fiscal Year 2001.
September 20, 2002.
Troy Cole, Office of the Executive Director, Federal Energy Regulatory Commission, 888 First Street, NE., Room 42-66, Washington, DC 20426, 202-502-6161.
From FERC's Home Page on the Internet, this information is available in both the Commission Issuance Posting System (CIPS) and the Records and Information Management System (RIMS).
—CIPS provides access to the texts of formal documents issued by the Commission since November 14, 1994.
—CIPS can be accessed using the CIPS link or the Energy Information Online icon. The full text of this document is available on CIPS in ASCII and WordPerfect 8.0 format for viewing, printing, and/or downloading.
—RIMS contains images of documents submitted to and issued by the Commission after November 16, 1981. Documents from November 1995 to the present can be viewed and printed from FERC's Home Page using the RIMS link or the Energy Information Online icon. Descriptions of documents back to November 16, 1981, are also available from RIMS-on-the-Web; requests for copies of these and other older documents should be submitted to the Public Reference Room.
User assistance is available for RIMS, CIPS, and the Web site during normal business hours from our Help line at (202) 502-8222 (e-mail to
During normal business hours, documents can also be viewed and/or printed in FERC's Public Reference Room, where RIMS, CIPS, and the FERC Web site are available. User assistance is also available.
The Federal Energy Regulatory Commission (Commission) is issuing this document to update filing fees that the Commission assesses for specific services and benefits provided to identifiable beneficiaries. Pursuant to 18 CFR 381.104, the Commission is establishing updated fees on the basis of the Commission's Fiscal Year 2001 costs. The adjusted fees announced in this document are effective September 20, 2002. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, that this final rule is not a major rule within the meaning of section 251 of Subtitle E of Small Business Regulatory Enforcement Fairness Act, 5 U.S.C. 804(2). The Commission is submitting this final rule to both houses of the United States Congress and to the Comptroller General of the United States.
The new fee schedule is as follows:
Electric power plants, Electric utilities, Natural gas, Reporting and recordkeeping requirements.
15 U.S.C. 717-717w; 16 U.S.C. 791-828c, 2601-2645; 31 U.S.C. 9701; 42 U.S.C. 7101-7352; 49 U.S.C. 60502; 49 App. U.S.C. 1-85.
2. In 381.302, paragraph (a) is amended by removing “$16,530” and adding “$18,260” in its place.
3. In 381.303, paragraph (a) is amended by removing “$24,140” and adding “$26,660” in its place.
4. In 381.304, paragraph (a) is amended by removing “$12,650” and adding “$13,980” in its place.
5. In 381.305, paragraph (a) is amended by removing “$4,740” and adding “$5,240” in its place.
6. Section 381.403 is amended by removing “$8,230” and adding “$9,090” in its place.
7. In 381.505, paragraph (a) is amended by removing “$14,220” and adding “$15,700” in its place and by removing “$16,090” and adding “$17,770” in its place.
8. Section 381.801 is amended by removing “$970” and adding “$990” in its place.
Internal Revenue Service (IRS), Treasury.
Final regulations.
These regulations provide guidance on the treatment of self-charged items of income and expense under section 469. The regulations recharacterize a percentage of certain portfolio income and expense as passive income and expense (self-charged items) when a taxpayer engages in a lending transaction with a partnership or an S corporation (passthrough entity) in which the taxpayer owns a direct or indirect interest and the loan proceeds are used in a passive activity. Similar rules apply to lending transactions between two identically owned passthrough entities. These final regulations affect taxpayers subject to the limitations on passive activity losses and credits.
Danielle M. Grimm at (202) 622-3070 (not a toll-free number).
The collection of information contained in these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act (44 U.S.C. 3507) under control number 1545-1244. Responses to this collection of information are required to obtain the benefit of self-charged treatment of income and expense under section 469.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number assigned by the Office of Management and Budget.
The estimated annual burden per respondent varies from 5 minutes to 15 minutes, depending on individual circumstances, with an estimated average of 6 minutes.
Comments concerning the accuracy of this burden estimate and suggestions for reducing this burden should be sent to the Internal Revenue Service, Attn: IRS Reports Clearance Officer, W:CAR:MP:FP:S Washington, DC 20224, and to the Office of Management and Budget, Attn: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503.
Books or records relating to this collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Section 469(a)(1)(A) of the Internal Revenue Code (Code) provides that if aggregate losses from passive activities exceed aggregate income from passive activities for the taxable year, the excess losses are not allowable for that taxable year. Under section 469(e)(1), passive activity income does not include income from interest, dividends, annuities, and royalties not derived in the ordinary course of a trade or business. However, under the rules of § 1.163-8T, if borrowed funds are used in a passive activity, the interest expense is treated as a passive activity deduction. Consequently, in certain lending transactions, a taxpayer may have interest income that is characterized as portfolio income under section 469(e)(1) and interest expense that is characterized as a passive activity deduction under § 1.163-8T. The legislative history of section 469 indicates that this result is inappropriate because the items of interest income and expense are essentially “self-charged” and thus lack economic significance.
On April 5, 1991, the IRS published in the
A number of public comments were received and a public hearing was held on September 6, 1991. Given the significant period of time that had elapsed since the former comment period, additional comments were solicited in Notice 2001-47 (2001-36 I.R.B. 212). After consideration of all of the comments received, the proposed regulations are adopted, as revised by this Treasury decision.
The proposed regulations provide self-charged treatment for items of interest income and interest expense in lending transactions between a taxpayer and a passthrough entity in which the taxpayer holds a direct or qualifying indirect interest. Several commentators suggested that the regulations should also apply to lending transactions between related passthrough entities such as brother-sister entities in which the taxpayer owns interests because such transactions also may result in mismatched income and expense for purposes of section 469. In response to the suggestions, the self-charged rules are extended to identically owned passthrough entities. This extension is limited to identically owned entities because of concerns regarding the difficulty of identifying self-charged items in transactions between less closely related or unrelated entities.
Certain commentators requested the removal of the qualifying indirect interest rule in the proposed regulations. The qualifying indirect interest rule provides that a taxpayer must have at least a 10-percent indirect interest in a passthrough entity to qualify for self-charged treatment. Commentators noted that a taxpayer that owns less than a 10 percent interest nevertheless may receive large amounts of self-charged income and expense. This suggestion has been adopted. Accordingly, the regulations no longer contain the qualifying indirect interest rule.
Noting that Congress authorized the Secretary to identify other situations in which self-charged treatment is appropriate, several commentators suggested that self-charged treatment be extended to other transactions involving rental real estate activities, such as the payment of management fees and salaries. After publication of the proposed regulations, Congress considered the impact of section 469 on rental real estate transactions and enacted specific relief in section 469(c)(7) for certain real estate professionals for taxable years beginning after 1993. There was no indication in the legislative history of section 469(c)(7) that Congress considered additional relief for real estate transactions necessary or desirable. Moreover, there is less justification for the complexity of a self-charged rule in this area after the enactment of section 469(c)(7) because that change substantially reduced the number of real estate transactions that would benefit from a self-charged rule. Accordingly, the regulations do not extend the self-charged treatment to other transactions involving rental real estate.
A number of comments suggested that the regulations clarify whether the self-charged rules apply to guaranteed payments to a partner for the use of capital. Section 1.469-2(e)(2)(ii) of the regulations treats these payments as interest income. Accordingly, the regulations clarify that lending transactions include guaranteed payments for the use of capital under section 707(c).
Some comments requested clarification on the types of interest eligible for self-charged treatment. The comments noted that the examples in the regulations may be interpreted as precluding certain types of interest because the introductory language states that the lending transactions described in the examples do not result in foregone interest (within the meaning of section 7872(e)(2)), original issue discount (within the meaning of section 1273), or total unstated interest (within the meaning of section 483(b)). Accordingly, the regulations clarify that the examples assume, solely for purposes of simplifying the presentation, that the lending transactions do not involve foregone interest, original issue discount, or total unstated interest.
A few comments responded to the notice of proposed rulemaking's solicitation for suggestions on the proper treatment of items recognized in different taxable years. One comment suggested the use of a suspense account. Under this suggestion, in the year in which the taxpayer identifies the corresponding item of self-charged income or expense, that item would be netted against the self-charged item in the suspense account. Another comment suggested that where the recognition of passive interest expense precedes the recognition of passive income, the taxpayer could elect to treat the income as passive when ultimately recognized. Another suggestion was to allow the taxpayer to recharacterize interest income or expense equal to the amount calculated on a cumulative basis. The commentators recognize that to implement the above methods would require more complex regulations.
After consideration of these comments, the final regulations adopt the rule of the proposed regulations that the self-charged rules apply only to self-charged items recognized in the same taxable year. This rule is consistent with the legislative history and avoids the complexity of the other suggested methods. For similar reasons, comments suggesting special rules for capitalized expenses are not adopted.
Certain commentators requested that the regulations be extended to apply to transactions between taxpayers and their trusts, estates, REMICs and housing cooperatives. The regulations address the transactions identified by Congress involving S corporations and partnerships (including entities classified as partnerships for federal tax purposes). Application of the self-charged rules to other types of entities would require a significant expansion of the scope of these regulations to address broader issues concerning the manner in which section 469 applies to those entities.
The applicability date of the final regulations is consistent with the applicability date as proposed. However, certain clarifications have been made to the transition rule. In the transition period, a taxpayer may use any reasonable method to offset items of interest income and interest expense from lending transactions.
These regulations are applicable for taxable years beginning after December 31, 1986. However, for taxable years beginning before June 4, 1991, a taxpayer that owns an interest in a passthrough entity is not required to apply these provisions and may use any reasonable method to offset items of interest income and interest expense from lending transactions between the passthrough entity and its owners or between certain passthrough entities. Items from nonlending transactions cannot be offset under the self-charged rules.
It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12886. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) and the Regulatory Flexibility Act (5 U.S.C. chapter 6) do not apply to these regulations, and, therefore, a Regulatory Flexibility Analysis is not required.
The principal author of these regulations is Danielle M. Grimm, Office of the Associate Chief Counsel (Passthroughs and Special Industries), Internal Revenue Service. However, personnel from other offices of the Internal Revenue Service and Treasury Department participated in their development.
Income Taxes, Reporting and recordkeeping requirements.
Reporting and recordkeeping requirements.
26 U.S.C. 7805 * * *
Section 1.469-7 also issued under 26 U.S.C. 469(l). * * *
(a)
(i) Treat certain interest income resulting from these lending transactions as passive activity gross income;
(ii) Treat certain deductions for interest expense that is properly allocable to the interest income as passive activity deductions; and
(iii) Allocate the passive activity gross income and passive activity deductions resulting from this treatment among the taxpayer's activities.
(2)
(b)
(1)
(2)
(3)
(4)
(5)
(c)
(i) The borrowing entity has deductions for the entity taxable year for interest charged to the borrowing entity by persons that own direct or indirect interests in the borrowing entity at any time during the entity taxable year (the borrowing entity's self-charged interest deductions);
(ii) The taxpayer owns a direct or an indirect interest in the borrowing entity at any time during the entity taxable year and has gross income for the taxable year from interest charged to the borrowing entity by the taxpayer or a passthrough entity through which the taxpayer holds an interest in the borrowing entity (the taxpayer's income from interest charged to the borrowing entity); and
(iii) The taxpayer's share of the borrowing entity's self-charged interest deductions includes passive activity deductions.
(2)
(i) The applicable percentage of each item of the taxpayer's income for the taxable year from interest charged to the borrowing entity is treated as passive activity gross income from the activity; and
(ii) The applicable percentage of each deduction for the taxable year for interest expense that is properly allocable (within the meaning of paragraph (f) of this section) to the taxpayer's income from the interest charged to the borrowing entity is treated as a passive activity deduction from the activity.
(3)
(i) The taxpayer's share for the taxable year of the borrowing entity's self-charged interest deductions that are treated as passive activity deductions from the activity by
(ii) The greater of—
(A) The taxpayer's share for the taxable year of the borrowing entity's aggregate self-charged interest deductions for all activities (regardless of whether these deductions are treated as passive activity deductions); or
(B) The taxpayer's aggregate income for the taxable year from interest charged to the borrowing entity for all activities of the borrowing entity.
(d)
(i) The lending entity has gross income for the entity taxable year from interest charged by the lending entity to persons that own direct or indirect interests in the lending entity at any time during the entity taxable year (the lending entity's self-charged interest income);
(ii) The taxpayer owns a direct or an indirect interest in the lending entity at any time during the entity taxable year and has deductions for the taxable year for interest charged by the lending entity to the taxpayer or a passthrough entity through which the taxpayer holds an interest in the lending entity (the taxpayer's deductions for interest charged by the lending entity); and
(iii) The taxpayer's deductions for interest charged by the lending entity include passive activity deductions.
(2)
(i) The applicable percentage of the taxpayer's share for the taxable year of each item of the lending entity's self-charged interest income is treated as passive activity gross income from the activity.
(ii) The applicable percentage of the taxpayer's share for the taxable year of each deduction for interest expense that is properly allocable (within the meaning of paragraph (f) of this section) to the lending entity's self-charged interest income is treated as a passive activity deduction from the activity.
(3)
(i) The taxpayer's deductions for the taxable year for interest charged by the lending entity, to the extent treated as passive activity deductions from the activity; by
(ii) The greater of—
(A) The taxpayer's aggregate deductions for all activities for the taxable year for interest charged by the lending entity (regardless of whether these deductions are treated as passive activity deductions); or
(B) The taxpayer's aggregate share for the taxable year of the lending entity's self-charged interest income for all activities of the lending entity.
(e)
(2)
(3)
(i) A and B, both calendar year taxpayers, each own a 50-percent interest in the capital and profits of partnerships RS and XY, both calendar year partnerships. Under the partnership agreements of RS and XY, A and B are each entitled to a 50-percent distributive share of each partnership's income, gain, loss, deduction, or credit. RS makes a $20,000 loan to XY and XY pays RS $2,000 of interest for the taxable year. A's distributive share of interest income attributable to this loan is $1,000 (50 percent × $2,000). XY uses all of the proceeds received from RS is a passive activity. A's distributive share of interest expense attributable to the loan is $1,000 (50 percent × $2,000).
(ii) This paragraph (e) applies in determining A's passive activity gross income because RS and XY are identically-owned passthrough entities as described in paragraph (e)(1) of this section. Under paragraph (e)(2) of this section, the RS-to-XY loan is treated as if A made the loan to XY. Therefore, A must apply paragraph (c) of this section to determine the applicable percentage of portfolio income that is recharacterized as passive income.
(iii) Paragraph (c) of this section applies in determining A's passive activity gross income because: XY has deductions for interest charged to XY by RS for the taxable year (XY's self-charged interest deductions); A owns an interest in XY during XY's taxable year and has gross income for the taxable year from interest charged to XY by RS; and A's share of XY's self-charged interest deductions includes passive activity deductions. See paragraph (c)(1) of this section.
(iv) Under paragraph (c)(2)(i) of this section, the applicable percentage of A's interest income is recharacterized as passive activity gross income from the activity. Paragraph (c)(3) of this section provides that the applicable percentage is obtained by dividing A's share for the taxable year of XY's self-charged interest deductions that are treated as passive activity deductions from the activity ($1,000) by the greater of A's share for the taxable year of XY's self-charged interest deductions ($1,000), or A's income for the year from interest charged to XY ($1,000). Thus, A's applicable percentage is 100 percent ($1,000/$1,000), and $1,000 (100 percent x $1,000) of A's income from interest charged to XY is treated as passive activity gross income from the passive activity.
(f)
(1) Is properly chargeable to capital account with respect to the investment producing the item of interest income; or
(2) May reasonably be taken into account as a cost of producing the item of interest income.
(g)
(2)
(3)
(4)
(h)
(i) A and B, two calendar year individuals, each own 50-percent interests in the capital, profits and losses of AB, a calendar year partnership. AB is engaged in a single rental activity within the meaning of § 1.469-1T(e)(3). AB borrows $50,000 from A and uses the loan proceeds in the rental activity. AB pays $5,000 of interest to A for the taxable year. A and B each incur $2,500 of interest expense as their distributive share of AB's interest expense.
(ii) AB has self-charged interest deductions for the taxable year (
(iii) Under paragraph (c)(2)(i) of this section, the applicable percentage of A's interest income is recharacterized as passive activity gross income from AB's rental activity. Paragraph (c)(3) of this section provides that the applicable percentage is obtained by dividing A's share for the taxable year of AB's self-charged interest deductions that are treated as passive activity deductions from the activity ($2,500) by the greater of A's share for the taxable year of AB's self-charged interest deductions ($2,500), or A's income for the taxable year from interest charged to AB ($5,000). Thus, A's applicable percentage is 50 percent ($2,500/$5,000), and $2,500 (50 percent × $5,000) of A's income from interest charged to AB is treated as passive activity gross income from the passive activity A conducts through AB.
(iv) Because B does not have any gross income for the year from interest charged to AB, this section does not apply to B. See paragraph (c)(1)(ii) of this section.
(i) C and D, two calendar year taxpayers, each own 50-percent interests in the capital and profits of CD, a calendar year partnership. CD is engaged in a single rental activity, within the meaning of § 1.469-1T(e)(3). C obtains a $10,000 loan from a third-party lender, and pays the lender $900 in interest for the taxable year. C lends the $10,000 to CD, and receives $1,000 of interest income from CD for the taxable year. D lends $20,000 to CD and receives $2,000 of interest income from CD for the taxable year. CD uses all of the proceeds in the rental activity. C and D are each allocated $1,500 (50 percent x $3,000) of interest expense as their distributive share of CD's interest expense for the taxable year.
(ii) CD has self-charged interest deductions for the taxable year (i.e., deductions for interest charged to CD by C and D); C and D each own direct interests in CD during CD's taxable year and have gross income for the taxable year from interest charged to CD; and both C's and D's shares of CD's self-charged interest deductions include passive activity deductions. Accordingly, paragraph (c) of this section applies in determining C's and D's passive activity gross income. See paragraph (c)(1) of this section.
(iii) Under paragraph (c)(2)(i) of this section, the applicable percentage of each partner's interest income is recharacterized as passive activity gross income from CD's rental activity. Paragraph (c)(3) of this section provides that C's applicable percentage is obtained by dividing C's share for the taxable year of CD's self-charged interest deductions that are treated as passive activity deductions from the activity ($1,500) by the greater of C's share for the taxable year of CD's self-charged interest deductions ($1,500), or C's income for the taxable year from interest charged to CD ($1,000). Thus, C's applicable percentage is 100 percent ($1,500/$1,500), and all of C's income from interest charged to CD ($1,000) is treated as passive activity gross income from the passive activity C conducts through CD. Similarly, D's applicable percentage is obtained by dividing D's share for the taxable year of CD's self-charged interest deductions that are treated as passive activity deductions from the activity ($1,500) by the greater of D's share for the taxable year of CD's self-charged interest deductions ($1,500), or D's income for the taxable year from interest charged to CD ($2,000). Thus, D's applicable percentage is 75 percent ($1,500/$2,000), and $1,500 (75 percent × $2,000) of D's income from interest charged to CD is treated as passive activity gross income from the rental activity.
(iv) The $900 of interest expense that C pays to the third-party lender is allocated under § 1.163-8T(c)(1) to an expenditure that is properly chargeable to capital account with respect to the loan to CD. Thus, the expense is properly allocable to the interest income C receives from CD (see paragraph (f) of this section). Under paragraph (c)(2)(ii) of this section, the applicable percentage of C's deductions for the taxable year for interest expense that is properly allocable to C's income from interest charged to CD is recharacterized as a passive activity deduction from CD's rental activity. Accordingly, all of C's $900 interest deduction is treated as a passive activity deduction from the rental activity.
(i) E and F, calendar year taxpayers, each own 50 percent of the stock of X, a calendar year S corporation. E borrows $30,000 from X, and pays X $3,000 of interest for the taxable year. E uses $15,000 of the loan proceeds to make a personal expenditure (as defined in § 1.163-8T(b)(5)), and uses $15,000 of loan proceeds to purchase a trade or business activity in which E does not materially participate (within the meaning of § 1.469-5T) for the taxable year. E and F each receive $1,500 as their pro rata share of X's interest income from the loan for the taxable year.
(ii) X has gross income for X's taxable year from interest charged to E (X's self-charged interest income); E owns a direct interest in X during X's taxable year and has deductions for the taxable year for interest charged by X; and E's deductions for interest charged by X include passive activity deductions. Accordingly, paragraph (d) of this section applies in determining E's passive activity gross income. See paragraph (d)(1) of this section.
(iii) Under the rules in paragraph (d)(2)(i) of this section, the applicable percentage of E's share of X's self-charged interest income is recharacterized as passive activity gross income from the activity. Paragraph (d)(3) of this section provides that the applicable percentage is obtained by dividing E's deductions for the taxable year for interest charged by X, to the extent treated as passive activity deductions from the activity ($1,500), by the greater of E's deductions for the taxable year for interest charged by X, regardless of whether those deductions are treated as passive activity deductions ($3,000), or E's share for the taxable year of X's self-charged interest income ($1,500). Thus, E's applicable percentage is 50 percent ($1,500/$3,000), and $750 (50 percent × $1,500) of E's share of X's self-charged interest income is treated as passive activity gross income.
(iv) Because F does not have any deductions for the taxable year for interest charged by X, this section does not apply to F. See paragraph (d)(1)(ii) of this section.
(i) This
(ii) For A's taxable years from 1990 through 1993 and AB's corresponding entity taxable years (as defined in paragraph (b)(4) of this section) A's interest income and AB's interest deductions from the loan are as follows:
(iii) For A's taxable year ending December 31, 1990, the corresponding entity taxable year is AB's taxable year ending June 30, 1990. Because AB does not have any deductions for the entity taxable year for interest charged to AB by A, paragraph (c) of this section does not apply in determining A's passive activity gross income for 1990 (see paragraph (c)(1)(i) of this section). Accordingly, A reports $1,250 of portfolio income on A's 1990 income tax return.
(iv) For A's taxable year ending December 31, 1991, the corresponding entity taxable year ends on June 30, 1991. AB has $3,750 of deductions for the entity taxable year for interest charged to AB by A (AB's self-charged interest deductions); A owns a direct interest in AB during the entity taxable year and has $5,000 of interest income for A's taxable year from interest charged to AB; and A's share of AB's self-charged interest deductions includes passive activity deductions. Accordingly, paragraph (c) of this section applies in determining A's passive activity gross income.
(v) Under paragraph (c)(2)(i) of this section, the applicable percentage of A's 1991 interest income is recharacterized as passive activity gross income from the activity. Paragraph (c)(3) of this section provides that the applicable percentage is obtained by dividing A's share for A's 1991 taxable year of AB's self-charged interest deductions that are treated as passive activity deductions from the activity (50 percent × $3,750 = $1,875) by the greater of A's share for A's taxable year of AB's self-charged interest deductions ($1,875), or A's income for A's taxable year from interest charged to AB ($5,000). Thus, A's applicable percentage is 37.5 percent ($1,875/$5,000), and $1,875 (37.5 percent × $5,000) of A's income from interest charged to AB is treated as passive activity gross income from the passive activity A conducts through AB.
(vi) For A's taxable year ending December 31, 1992, the corresponding entity taxable year ends on June 30, 1992. AB has $5,000 of deductions for the entity taxable year for interest charged to AB by A (AB's self-charged interest deductions); A owns a direct interest in AB during the entity taxable year and has $3,750 of gross income for A's taxable year from interest charged to AB; and A's share of AB's self-charged interest deductions includes passive activity deductions. Accordingly, paragraph (c) of this section applies in determining A's passive activity gross income.
(vii) The applicable percentage for 1992 is obtained by dividing A's share for A's 1992 taxable year of AB's self-charged interest deductions that are treated as passive activity deductions from the activity ($2,500) by the greater of A's share for A's taxable year of AB's self-charged interest deductions ($2,500), or A's income for A's taxable year from interest charged to AB ($3,750). Thus, A's applicable percentage is 66
(viii) Paragraph (c) of this section does not apply in determining A's passive activity gross income for the taxable year ending December 31, 1993, because A has no gross income for the taxable year from interest charged to AB (see paragraph (c)(1)(ii) of this section). A's share of AB's self-charged interest deductions for the entity taxable year ending June 30, 1993 ($625) is taken into account as a passive activity deduction on A's 1993 income tax return.
(ix) Because B does not have any gross income from interest charged to AB for any of the taxable years, this section does not apply to B. See paragraph (c)(1)(ii) of this section.
(i) This
(ii) LTP has deductions for interest charged to LTP by UTP for the taxable year (LTP's self-charged interest deductions); G owns an indirect interest in LTP during LTP's taxable year and has gross income for the taxable year from interest charged to LTP by a passthrough entity (UTP) through which G owns an interest in LTP; and G's share of LTP's self-charged interest deductions includes passive activity deductions. Accordingly, paragraph (c) of this section applies in determining G's passive activity gross income. See paragraph (c)(1) of this section.
(iii) Under paragraph (c)(2)(i) of this section, the applicable percentage of G's interest income is recharacterized as passive activity gross income from the activity. Paragraph (c)(3) of this section provides that the applicable percentage is obtained by dividing G's share for the taxable year of LTP's self-charged interest deductions that are treated as passive activity deductions from the activity ($400) by the greater of G's share for the taxable year of LTP's self-charged interest deductions ($400), or G's income for the year from interest charged to LTP ($1,600). Thus, G's applicable percentage is 25 percent ($400/$1,600), and $400 (25 percent × $1,600) of G's income from interest charged to LTP is treated as passive activity gross income from the passive activity that G conducts through UTP and LTP.
(iv) G's $800 distributive share of the interest expense that UTP pays to the third-party lender is allocated under § 1.163-8T(c)(1) to an expenditure that is properly chargeable to capital account with respect to the loan to LTP. Thus, the expense is a deduction properly allocable to the interest income that G receives as a result of the UTP-to-LTP loan (see paragraph (f) of this section). Under paragraph (c)(2)(ii) of this section, the applicable percentage of G's deductions for the taxable year for interest expense that is properly allocable to G's income from interest charged by UTP to LTP is recharacterized as a passive activity deduction from LTP's passive activity. Accordingly, $200 (25 percent x $800) of G's interest deduction is treated as a passive activity deduction from LTP's activity.
(i) This
(ii) Y has self-charged interest deductions for the taxable year (i.e., the deductions for interest charged to Y by J); J owns a direct interest in Y during Y's taxable year and has gross income for J's taxable year from interest charged to Y; and J's share of Y's self-charged interest deductions includes passive activity deductions. Accordingly, paragraph (c) of this section applies in determining J's passive activity gross income. See paragraph (c)(1) of this section.
(iii) Under paragraph (c)(2)(i) of this section, the applicable percentage of J's interest income is recharacterized as passive activity gross income attributable to the rental activity. Paragraph (c)(3) of this section provides that the applicable percentage is
(iv) Under paragraph (c)(2)(i) of this section, the applicable percentage of J's interest income is recharacterized as passive activity gross income attributable to the passive trade or business activity. Paragraph (c)(3) of this section provides that the applicable percentage is obtained by dividing J's share for the taxable year of Y's self-charged interest deductions that are treated as passive activity deductions from the passive trade or business activity ($2,000) by the greater of J's share for the taxable year of Y's self-charged interest deductions ($8,000), or J's income for the taxable year from interest charged to Y ($8,000). Thus, J's applicable percentage is 25 percent ($2,000/$8,000), and $2,000 of J's income from interest charged to Y is treated as passive activity gross income from the passive trade or business activity J conducts through Y.
(a) * * *
(4) The rules contained in § 1.469-7 apply for taxable years ending after December 31, 1986; and
(c) * * *
(1)
(iii)
(
(
26 U.S.C. 7805.
(b) * * *
Court Services and Offender Supervision Agency for the District of Columbia.
Interim Rule.
The Court Services and Offender Supervision Agency for the District of Columbia (“CSOSA”) is issuing interim regulations that set forth procedures and requirements relating to the registration of sex offenders, verification of the information maintained on sex offenders, and reporting of changes in that information. These regulations carry out responsibilities of CSOSA under federal and District of Columbia law.
Effective August 21, 2002; comments must be submitted by October 21, 2002; incorporation by reference of publications listed in the regulation is approved by the Director of the Federal Register as of August 21, 2002.
Office of the General Counsel, CSOSA, Room 1253, 633 Indiana Avenue, NW., Washington, DC 20004.
Roy Nanovic, Records Manager (telephone (202) 220-5359; e-mail
The Court Services and Offender Supervision Agency for the District Of Columbia (“CSOSA”) is adopting interim regulations on the registration of sex offenders (28 CFR part 811).
Under the Sex Offender Registration Act of 1999 (“SORA” or “Act”, D.C. Law 13-137, D.C. Official Code sections 22-4001
CSOSA is adopting these interim regulations, which exercise and implement powers and authorities of CSOSA under existing Federal and District of Columbia laws and District of Columbia regulations, in order to fully
The implementation of these regulations as interim regulations, with provision for post-promulgation public comments, is based on the “good cause” exceptions found at 5 U.S.C. 553(b)(3)(B) and (d)(3). The regulations implement, in part, section 166(a) of the Consolidated Appropriations Act, 2000 (Pub. L. 106-113 section 166(a), 113 Stat. 1530; D.C. Official Code section 24-133(c)(5)), which directs CSOSA to carry out sex offender registration functions in the District of Columbia, and various provisions of District of Columbia law and regulations, including sections 3, 8, 9 and 10 of the Sex Offender Registration Act of 1999 (D.C. Official Code section 22-4002, 4007, 4008 & 4009) and 6A DCMR sections 405.1, 409.1, 409.2, 410.1, which grant CSOSA the authority to make certain decisions and to adopt procedures and requirements relating to sex offender registration in the District of Columbia.
As stated in the report of the District of Columbia Council's Judiciary Committee for the District's Sex Offender Registration Act, “[a] sex offender registration and notification program, if appropriately designed and effectively implemented, can promote public safety in at least three ways: by facilitating effective law enforcement; by enabling members of the public to take direct measures of a lawful nature for the protection of themselves and their families; and by reducing registered offenders' exposure to temptation to commit more offenses.” Committee on the Judiciary, Report on Bill 13-250, The Sex Offender Registration Act of 1999, at 3 (Nov. 15, 1999). Given the importance of having accurate, complete, and up-to-date information about sex offenders available to both law enforcement officials and to the public, and the fact that the formulation of implementing regulations closely follows the statutory framework and existing District of Columbia regulations, it is impracticable and unnecessary to adopt this rule with the prior notice and comment period normally required under 5 U.S.C. 553(b) or with the delayed effective date normally required under 5 U.S.C. 553(d). Moreover, as noted, the collection of sex offender registration information and its release to law enforcement and other agencies and the public pursuant to the Sex Offender Registration Act of 1999 furthers important public safety interests by facilitating the solution and prevention of crime by law enforcement, enabling lawful community self-protection measures, and reducing the temptation for recidivism. Delay in the full implementation of the law—including the ability to prosecute and take other actions in relation to sex offenders who fail to comply with its requirements—would thwart or delay the realization of these public safety benefits. Therefore, it would be contrary to the public interest to adopt these regulations with the prior notice and comment period normally required under 5 U.S.C. 553(b) or with the delayed effective date normally required under 5 U.S.C. 553(d).
For the foregoing reasons, CSOSA is issuing these regulations without any delay in their effectiveness as an interim rule and without a prior notice of proposed rulemaking. Any interested person, however, who wishes to submit comments on the interim rule may do so by writing or e-mailing the agency at the addresses given above in the
This rule has been determined to be significant under Executive Order 12866 and has been reviewed by the Office of Management and Budget (OMB).
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, in accordance with Executive Order 13132, the Director of CSOSA has determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
The Director of CSOSA, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this rule and by approving it certifies that this rule will not have a significant economic impact upon a substantial number of small entities. This rule pertains to agency management, and its economic impact is limited to the agency's appropriated funds.
This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, the Director of CSOSA has determined that no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment,
If you have suggestions on how to improve the clarity of these regulations, write, e-mail, or call the Records Manager (Roy Nanovic) at the address or telephone number given above in the
Incorporation by Reference; Probation and Parole.
Accordingly, we amend chapter VIII, Title 28 of the Code of Federal Regulations by adding a new Part 811 as set forth below.
5 U.S.C. 301; Pub. L. 105-33, 111 Stat. 251; Pub. L. 106-113, sec. 166(a), 113 Stat. 1530
(a) In accordance with its sex offender registration functions authorized by section 166(a) of the Consolidated Appropriations Act, 2000 (Pub. L. 106-113, sec. 166(a), 113 Stat. 1530; D.C. Official Code secs. 24-133(c)(5)) and as further authorized by the Sex Offender Registration Act of 1999 (“the Act,” D.C. Law 13-137, D.C. Official Code, secs. 22-4001
(b) Chapter 4 of Title 6A, District of Columbia Municipal Regulations (DCMR)(47 D.C. Reg. 10042, December 22, 2000), contains regulations issued by the government of the District of Columbia for the sex offender registration system in the District of Columbia (“District of Columbia regulations”). Chapter 4 of Title 6A, DCMR (47 D.C. Reg. 10042, December 22, 2000) is incorporated by reference in this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Chapter 4 of Title 6A, DCMR, is available for inspection at the Office of the Federal Register, 800 N. Capitol Street, NW., Suite 700, Washington, DC. Copies of Chapter 4 of Title 6A, DCMR, may be obtained from the District of Columbia's Office of Documents and Administrative Issuances, 441 4th Street, NW., Room 520S, Washington, DC 20001. CSOSA hereby adopts all powers and authorities that the District of Columbia regulations authorize CSOSA to exercise, and hereby adopts all procedures and requirements that the District of Columbia regulations state that CSOSA shall adopt or carry out, including but not limited to all such powers, authorities, procedures and requirements relating to registration, verification, and changes in information.
(a) Sex offender registration requirements apply to all persons who live, reside, work, or attend school in the District of Columbia, and who:
(1) committed a registration offense on or after July 11, 2000;
(2) committed a registration offense at any time and were in custody or under supervision on or after July 11, 2000;
(3) were required to register under the law of the District of Columbia as was in effect on July 10, 2000; or
(4) committed a registration offense at any time in another jurisdiction and, within the registration period (see §§ 811.5 and 811.6), entered the District of Columbia to live, reside, work or attend school.
(b) “Committed a registration offense” means that a person was found guilty or found not guilty by reason of insanity of a registration offense or was determined to be a sexual psychopath. Registration offenses are defined in section 2(8) of the Sex Offender Registration Act of 1999 (D.C. Official Code § 22-4001(8)), subject to the exceptions in section 17(b) of that Act (D.C. Official Code section 22-4016), and are listed descriptively in the Appendix to Part 811 (which also provides information on registration and notification classes). Any future revision to the statutory provisions designating registration offenses will be effective notwithstanding the timing of any conforming revision of these regulations, including the Appendix.
(a) Sex offenders may be notified of their obligation to register under various provisions of law. See sections 4, 6 and 8 of the Sex Offender Registration Act of 1999 (D.C. Official Code sections 22-4003, 4005, 4007) (relating to notice by the District of Columbia Superior Court, Department of Corrections, or CSOSA); 18 U.S.C. 4042(c) (relating to notice by Federal Bureau of Prisons and probation offices); 18 U.S.C. 3563(a)(8), 3583(d), 4209(a) (inclusion of registration requirements as conditions of release under federal law); 42 U.S.C. 14071(b)(1) (notice under federal law standards for state sex offender registration programs).
(b) In some cases, sex offenders may not be notified of their obligation to register. Lack of notice does not excuse a failure to register because sex offenders have an independent obligation to register. Persons who have been convicted or found not guilty by reason of insanity of a sex offense or who have been determined to be a sexual psychopath should report to CSOSA in order to ascertain whether they are required to register.
(a) If the Superior Court finds that a person committed a registration offense, the Superior Court enters an order certifying that the person is a sex offender and that the person is subject to registration for a prescribed period of time (see § 811.6).
(b) If a court order has not been entered certifying that a person is a sex offender and that the person is subject to registration for a prescribed period of time, CSOSA makes those determinations. CSOSA also determines the notification classification if the Court has not done so. Facts on which CSOSA's determination may be based include:
(1) The offense or offenses of conviction (or finding of not guilty by reason of insanity) or a determination that the person is a sexual psychopath;
(2) For certain offenses, facts that may not be apparent on the face of the
(i) the age of the victim;
(ii) whether force was involved; or
(iii) whether the offense involved an undercover law enforcement officer who was believed to be an adult;
(3) Prior criminal history;
(4) For an offense committed in or prosecuted under the law of another jurisdiction, whether the offense involved conduct that was the same as or substantially similar to a District of Columbia registration offense; and
(5) The amount of time that has elapsed as computed under § 811.6.
(a) A sex offender's obligation to register starts when the sex offender is found guilty or not guilty by reason of insanity of a registration offense or is determined to be a sexual psychopath. However, CSOSA may suspend registration requirements during any period of time in which a sex offender is detained, incarcerated, confined, civilly committed, or hospitalized in a secure facility.
(b) A sex offender must register if the sex offender is placed on probation, parole, supervised release, or convalescent leave, is conditionally or unconditionally released from a secure facility, is granted unaccompanied grounds privileges or other unaccompanied leave, absconds or escapes, is otherwise not detained, incarcerated, confined, civilly committed, or hospitalized in a secure facility, or enters the District of Columbia from another jurisdiction to live, reside, work, or attend school. Registration shall be effectuated as provided in § 811.7 and may be carried out prior to the occurrence of a circumstance described in this paragraph, including the release of or granting of leave to a sex offender.
(a)
(b)
(2) In computing ten years, CSOSA will not count:
(i) Any time in which the sex offender has failed to register or otherwise failed to comply with requirements of the Act or any procedures, requirements, rules, or regulations promulgated under the Act, including these regulations and the District of Columbia regulations;
(ii) Any time in which a sex offender is detained, incarcerated, confined, civilly committed, or hospitalized in a mental health facility; and
(iii) Any time in which a sex offender was registered prior to a revocation of probation, parole, supervised release, conditional release, or convalescent leave.
(3) In computing ten years, CSOSA will count any time in which a sex offender was registered in another jurisdiction unless that time is not counted because of a circumstance set forth in paragraph (b)(2) of this section.
(c)
(d)
(a)
(2) A sex offender must meet with a responsible officer or official, as directed by CSOSA, for the purpose of registration, and must cooperate in such a meeting, including:
(i) Providing any information required for registration and cooperating in photographing and fingerprinting;
(ii) Reviewing information obtained by CSOSA pursuant to paragraph (b) of this section as CSOSA directs and either attesting to its accuracy or setting forth in writing, under penalties of perjury, the exact portion or portions that are not accurate; and
(iii) Acknowledging receipt of information concerning the sex offender's duties under the Act, including reading (or, if the sex offender cannot read, listening to a reading of) and signing a form or forms stating that these duties have been explained to the sex offender.
(3) In case of disagreement with CSOSA's determination that the person must register or with CSOSA's determination of the person's classification for purposes of registration or notification, the person must follow the review procedures set forth in § 811.8.
(b)
(i) Name(s) and alias(es);
(ii) Date of birth;
(iii) Physical description such as sex, race, height, weight, eye color, hair color, tattoos, scars, or other marks or characteristics;
(iv) Social security, PDID, DCDC and FBI numbers;
(v) Driver's license number and make, model, color, and license plate number of any motor vehicle(s) the sex offender owns;
(vi) A photograph and set of fingerprints;
(vii) Current and/or anticipated home, school, work address(es) and telephone number(s); and
(viii) Other information that may assist CSOSA or the Metropolitan Police Department in locating the sex offender.
(2) CSOSA shall also obtain a detailed description of the offense(s) on the basis of which a sex offender is required to register, the presentence report(s), the victim impact statement(s), the date(s) of conviction and any sentence(s) imposed, the sex offender's criminal record and a detailed description of any relevant offense or offenses, pertinent statutes and case law in other jurisdictions, and any other information it deems useful in order to determine a sex offender's obligation to register, term of registration, and notification classification, to verify the accuracy of the information provided, to assist other jurisdictions' sex offender registration agencies and authorities, or to assist the Metropolitan Police Department in its law enforcement functions.
(3) CSOSA shall inform a sex offender of the sex offender's duty to:
(i) Comply with the requirements set forth in paragraph (a) of this section for initial registration;
(ii) Periodically verify the address(es) at which the sex offender lives, resides, works, and/or attends school, and other information, as provided in § 811.9;
(iii) Report any change of address and any other changes in registration information (including changes in appearance), as provided in § 811.10;
(iv) Notify CSOSA if the sex offender is moving to another jurisdiction or works or attends school in another jurisdiction and to register in any such jurisdiction; and
(v) Comply with the requirements of the Act and any procedures, requirements, rules, or regulations promulgated under the Act, including these regulations and the District of Columbia regulations.
(4) CSOSA shall inform the sex offender of the penalties for failure to comply with the sex offender's duties.
(5) If the Superior Court has not entered an order certifying that a person is a sex offender, CSOSA shall inform the person that, if the person disagrees with CSOSA's determination that the person must register or CSOSA's determination of the person's classification for purposes of registration or notification, then the person must follow the review procedures set forth in § 811.8. CSOSA shall provide the person with a form to notify CSOSA of an intent to seek such review.
(a) If a person, other than a person who has been certified as a sex offender by the Court, disagrees with CSOSA's determination that the person is subject to registration or with CSOSA's determination of the person's classification for purposes of registration or notification, the person may seek judicial review of the determination, subject to the limitations of section 5(a)(1) of the Act (D.C. Official Code § 22-4004(a)(1)), by:
(1) Immediately providing CSOSA with a notice of intent to seek review upon being informed of the determination; and
(2) Within 30 calendar days of the date on which the person is informed of CSOSA's determination, filing a motion in the Superior Court setting forth the disputed facts and attaching any documents or affidavits upon which the person intends to rely.
(b) A person who fails to comply with paragraph (a) of this section may seek review of CSOSA's determination only in conformity with the limitations of section 5(a)(1) of the Act (D.C. Official Code Section 4004(a)(1)) and for good cause shown and to prevent manifest injustice by filing a motion in the Court within three years of the date on which the person is informed of CSOSA's determination.
(a) Sex offenders who are required to register for life must verify registration information quarterly pursuant to the procedures set forth in paragraph (d) of this section.
(b) All other sex offenders must verify registration information annually pursuant to the procedures set forth in paragraph (d) of this section.
(c) Quarterly or annually, as appropriate, CSOSA will mail a verification form to the home address of the sex offender.
(d) The sex offender must correct any information on the form which is inaccurate or out of date and must sign, thumb-print, and return the form to CSOSA no later than 14 calendar days after the date on which CSOSA placed it in the mail. The sex offender has the option of returning the form by mail or in person unless:
(1) The sex offender is also on probation, parole, or supervised release or otherwise must report to CSOSA, and CSOSA directs the sex offender to verify the registration information in person;
(2) CSOSA directs the sex offender to appear in person because the sex offender has previously failed to submit a timely verification or submitted an incomplete or inaccurate verification; or
(3) CSOSA directs the sex offender to appear in person for the purpose of taking a new photograph documenting a significant change in physical appearance or updating a photograph that is five or more years old.
(a)(1) A sex offender must notify CSOSA if the sex offender:
(i) Ceases to live or reside at the registered address or moves to a different address;
(ii) leaves a job or obtains a new job, or leaves a school or enrolls in a new school; or
(iii) ceases to own or becomes an owner of any motor vehicle.
(2) A sex offender must notify CSOSA if there is a significant change in the sex offender's appearance and report as directed for the purpose of having a new photograph taken. Any question regarding whether a change in physical appearance is significant is to be referred to CSOSA.
(3) A sex offender must notify CSOSA if the sex offender is moving to another jurisdiction or if the sex offender works or attends school in another jurisdiction and must register in any such jurisdiction.
(b) Notice of the changes described in paragraph (a) of this section must be in writing and must be provided prior to the change if feasible and in any event within three days of the change. Notices of change in address or place of work or school attendance must include new address, location, and phone number information. Notice relating to ownership of a motor vehicle must include the make, model, color, and license plate number of the vehicle.
(a) A sex offender may be excused from strict compliance with the time limits set forth in these regulations if the sex offender notifies CSOSA in advance of circumstances that will interfere with compliance and makes alternative arrangements to satisfy the requirements or, in the case of an emergency, notifies CSOSA as soon as the sex offender is able to do so.
(b) CSOSA may direct that a sex offender meet with a responsible officer or official for the purpose of securing compliance or discussing non-compliance with any requirements of the Act or any procedures, requirements, rules, or regulations promulgated under the Act, including these regulations and the District of Columbia regulations.
A violation of the requirements of the Act or any procedures, requirements, rules, or regulations promulgated under the Act, including these regulations and the District of Columbia regulations, may result in criminal prosecution under section 16 of the Act (D.C. Official Code Section 22-4015), revocation of probation, parole, supervised release, or conditional release, and extension of the registration period under § 811.6(b)(2).
Unless otherwise directed by the Court or CSOSA,
(a) Notices or reports that are required to be submitted in writing should be sent to: Sex Offender Registration Unit, Court Services and Offender Supervision Agency, Room 2002, 300 Indiana Avenue, NW., Washington, DC 20001.
(b) A person who is required to report in person should go to: Sex Offender Supervision Office, Court Services and Offender Supervision Agency, Room
(a) The terms “attends school,” “Court,” “in custody or under supervision,” “sex offender,” and “works” shall have the same meaning as set forth in Section 2 of the Sex Offender Registration Act of 1999 (D.C. Official Code Section 22-4001).
(b) The term “the Act” means the Sex Offender Registration Act of 1999 (D.C. Official Code Section 22-4001
(c) The term “days” means business days unless otherwise specified.
(d) In relation to a motor vehicle, the term “owns” includes both exclusive ownership and co-ownership, and the term “owner” includes both exclusive owners and co-owners.
1. Class A includes offenders who have been convicted or found not guilty by reason of insanity of:
(a) First degree sexual abuse;
(b) Second degree sexual abuse;
(c) Rape;
(d) Forcible sodomy;
(e) First degree child sexual abuse committed against a child under 12;
(f) Carnal knowledge (statutory rape) committed against a child under 12;
(g) Sodomy committed against a child under 12;
(h) Murder committed before, during, or after engaging in or attempting to engage in a sexual act or contact or rape;
(i) Manslaughter committed before, during, or after engaging in or attempting to engage in a sexual act or contact or rape;
(j) Attempting to commit any of the foregoing offenses;
(k) Conspiring to commit any of the foregoing offenses; or
(l) Assault with intent to commit any of the foregoing offenses.
2. Class A also includes offenders who:
(a) In two or more trials or plea proceedings, have been convicted or found not guilty by reason of insanity of a felony registration offense or any registration offense against a minor. (Recidivism).
(b) In a single trial or plea proceeding, have been convicted or found not guilty by reason of insanity of registration offenses against two or more victims where each offense is a felony or committed against a minor (Multiple victims).
(c) Have been determined to be sexual psychopaths.
3. Class A also includes offenders who have been convicted or found not guilty by reason of insanity under the law of another jurisdiction of offenses that involved conduct that is the same as or substantially similar to that above.
1. Class B includes offenders who are not included in Class A and have been convicted or found not guilty by reason of insanity of any of the following crimes against a minor (that is, a person under the age of 18):
(a) Third degree sexual abuse;
(b) Fourth degree sexual abuse;
(c) Misdemeanor sexual abuse;
(d) First degree child sexual abuse;
(e) Second degree child sexual abuse;
(f) Carnal knowledge (statutory rape);
(g) Sodomy committed against a minor;
(h) Indecent acts on a child;
(i) Enticing a child;
(j) Lewd, indecent or obscene acts;
(k) Sexual performance using a minor;
(l) Incest;
(m) Obscenity;
(n) Prostitution/Pandering;
(o) Assault (unwanted sexual touching);
(p) Threatening to commit a sexual offense;
(q) First or second degree burglary with intent to commit sex offense;
(r) Kidnapping (does not require a sexual purpose);
(s) Assault with intent to commit any of the foregoing offenses;
(t) Attempting to commit any of the foregoing offenses;
(u) Conspiring to commit any of the foregoing offenses; or
(v) Any offense against a minor for which the offender agreed in a plea agreement to be subject to sex offender registration requirements.
2. Class B also includes offenders who are not included in Class A and have been convicted or found not guilty by reason of insanity of any of the following crimes regardless of the age of the victim:
(a) First degree sexual abuse of a ward or resident of a hospital, treatment facility or other institution.
(b) Second degree sexual abuse of a ward or resident of a hospital, treatment facility or other institution.
(c) First degree sexual abuse of a patient or client.
(d) Second degree sexual abuse of a patient or client.
3. Class B also includes offenders who are not included in Class A and have been convicted or found not guilty by reason of insanity under the law of another jurisdiction of offenses that involved conduct that is the same as or substantially similar to that above.
1. Class C includes offenders who are not included in Class A or Class B and have committed any of the following crimes against an adult (that is, a person 18 years of age or older):
(a) Third degree sexual abuse;
(b) Fourth degree sexual abuse;
(c) First or second degree burglary with intent to commit sex offense;
(d) Kidnapping with intent to commit sex offense;
(e) Threatening to commit a sexual offense (felony);
(f) Assault with intent to commit any of the foregoing offenses;
(g) Attempting to commit any of the foregoing offenses;
(h) Conspiring to commit any of the foregoing offenses, or;
(i) Any offense for which the offender agreed in a plea agreement to be subject to sex offender registration requirements.
2. Class C also includes offenders who are not included in Class A or Class B and have been convicted or found not guilty by reason of insanity under the law of another jurisdiction of offenses that involved conduct that is the same as or substantially similar to that above.
The following do not constitute registration offenses:
1. Any sexual offense between consenting adults or an attempt, conspiracy or solicitation to commit such an offense, except for offenses to which consent is not a defense as provided in Section 218 of the Anti-Sexual Abuse Act of 1994 (D.C. Official Code § 22-3017).
2. Any misdemeanor offense that involved a person's sexual touching or attempted or solicited sexual touching of an undercover law enforcement officer where the person believed that the officer was an adult.
3. Any misdemeanor offense committed against an adult, except where the offender agrees in a plea agreement to be subject to sex offender registration requirements.
Court Services and Offender Supervision Agency for the District of Columbia.
Interim Rule.
The Court Services and Offender Supervision Agency for the District of Columbia (“CSOSA”) is adopting interim regulations to implement section 4 of the DNA Analysis Backlog Elimination Act of 2000, in conjunction with District of Columbia laws enacted pursuant to that Act which specify qualifying District of Columbia offenses for purposes of DNA
Effective August 21, 2002; comments must be submitted by October 21, 2002.
Office of the General Counsel, CSOSA, Room 1253, 633 Indiana Avenue, NW., Washington, DC 20004.
Roy Nanovic, Records Manager (telephone: (202) 220-5359; e-mail:
The Court Services and Offender Supervision Agency for the District of Columbia (“CSOSA”) is adopting interim regulations on the collection and use of DNA information (28 CFR part 812).
The DNA Analysis Backlog Elimination Act of 2000 (Pub. L. 106-546, 114 Stat. 2726) authorizes the collection of DNA samples from persons convicted of “qualifying District of Columbia offenses” who are in the custody of the Federal Bureau of Prisons (“BOP”) or who are on supervised release, parole, or probation and under CSOSA's supervision. Qualifying District of Columbia offenses were identified by the Council of the District of Columbia in the DNA Sample Collection Act of 2001, District of Columbia Act 14-076, the DNA Sample Collection Emergency Act of 2001, District of Columbia Act 14-077, and the DNA Sample Collection Congressional Review Emergency Act of 2001, District of Columbia Act 14-130.
The DNA information becomes part of the Combined DNA Index System (“CODIS”), a national database of DNA profiles from convicted offenders, unsolved crime scenes, and missing persons. CODIS allows State and local forensic laboratories to exchange and compare DNA profiles electronically, thereby linking serial violent crimes, especially sexual assaults, to each other, and to identify suspects by matching DNA from crime scenes to convicted offenders.
CSOSA is responsible for the supervision of adults on probation, parole, or supervised release for District of Columbia Code offenses in the District of Columbia. Under the provisions of the DNA Analysis Backlog Elimination Act of 2000, CSOSA must collect a DNA sample from each individual under its supervision who is, or has been, convicted of a qualifying District of Columbia offense. CSOSA has the discretion not to collect a sample from the individual if CODIS already has a DNA analysis for the individual. CSOSA also has the authority to use such means as are reasonably necessary to collect a sample from an individual who refuses to cooperate in the collection of the sample.
CSOSA's regulations list the qualifying District of Columbia offenses in an appendix to the part. The offenses are listed in three tables. Table 1 presents the offenses as they were identified in the “DNA Sample Collection Act of 2001”. Table 2 presents the offenses in numerical order under the D.C. Code, (1981 Edition). Table 3 presents the offenses in numerical order under the D.C. Official Code (2001 Edition). These tables are presented for informational purposes only. Any future revision to the District of Columbia Code sections designating the qualifying offenses will be effective notwithstanding the timing of a conforming revision of the appendix by CSOSA.
Section 812.2 of CSOSA's interim regulations establishes procedures for coordinating the collection of samples with BOP. BOP has the authority to collect DNA samples from District of Columbia Code offenders in its custody. CSOSA will exchange information concerning the collection of the DNA sample from District of Columbia Code offenders in their custody or under their supervision in order to ensure that DNA samples will not be taken from District of Columbia Code offenders unnecessarily.
Section 812.4 pertains to collection procedures. Paragraph (a) specifies that the DNA sample (currently in the form of a blood sample) will be collected in accordance with FBI guidelines. Paragraph (b) establishes what CSOSA deems to be a refusal to cooperate by an individual who is subject to collection. Paragraph (c) describes what reasonably necessary measures CSOSA will take in response to such refusal, including administrative sanctions, referral for criminal prosecution, and a request for revocation of probation, parole, or supervised release which could result in commitment to the custody of the Federal Bureau of Prisons, thereby facilitating collection procedures authorized by Department of Justice regulations (28 CFR part 28).
The implementation of these regulations as interim regulations, with provision for post-promulgation public comments, is based on the “good cause” exceptions found at 5 U.S.C. 553(b)(3)(B) and (d)(3). The rule implements section 4 of Pub. L. 106-546 (42 U.S.C. 14135b), which requires the Director of CSOSA to “collect a DNA sample from each individual under the supervision of the Agency who is on supervised release, parole, or probation who is, or has been, convicted of a qualifying District of Columbia offense” and requires collection of DNA samples to commence not later than 180 days after the effective date of the Act. Given that section 4(d) authorizes the government of the District of Columbia to “determine those offenses under the District of Columbia Code that shall be treated * * * as qualifying District of Columbia offenses,” Congress must have been aware that it would not be feasible within a 180-day time period to enact the required District of Columbia legislation, publish a proposed regulation for notice and comment, as well as a subsequent final rule, and for the period of the final rule's delayed effective date to have run. Public Law 106-546, in conjunction with the District of Columbia legislation, is explicit and comprehensive concerning the types of offenses that will be treated as qualifying District of Columbia offenses and concerning the responsibilities of CSOSA in collecting DNA samples. In light of the short statutory time frame for the implementation of this law and the fact that the formulation of implementing regulations involves the exercise of relatively little discretion, it is impracticable and unnecessary to adopt this rule with the prior notice and comment period normally required
Moreover, the collection, analysis, and indexing of DNA samples as required by Public Law 106-546 furthers important public safety interests by facilitating the solution and prevention of crime,
Any interested person who wishes to submit comments on the interim rule, however, may do so by writing or e-mailing the agency at the addresses given above in the
This interim rule has been determined to be significant under Executive Order 12866 and has been reviewed by the Office of Management and Budget (OMB).
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, in accordance with Executive Order 13132, the Director of CSOSA has determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
The Director of CSOSA, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this rule and by approving it certifies that this rule will not have a significant economic impact upon a substantial number of small entities. This rule pertains to agency management, and its economic impact is limited to the agency's appropriated funds.
This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, the Director of CSOSA has determined that no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
We want to make CSOSA's documents easy to read and understand. If you have suggestions on how to improve the clarity of these regulations, write, e-mail, or call the Records Manager (Roy Nanovic) at the address or telephone number given above in the
Probation and Parole.
5 U.S.C. 301; Pub. L. 106-546 (114 Stat. 2726).
The Court Services and Offender Supervision Agency for the District of Columbia (“CSOSA”) cooperates with other federal agencies to ensure that DNA samples from offenders are appropriately furnished to the Federal Bureau of Investigation (“FBI”) for DNA analysis. The results of the DNA analyses are to be included in the Combined DNA Index System (“CODIS”).
CSOSA is responsible for collecting a DNA sample from each individual under its supervision who is, or has been, convicted of a qualifying District of Columbia Code offense. Qualifying District of Columbia Code offenses were designated by the Council of the District of Columbia in the “DNA Sample Collection Act of 2001.” CSOSA provides a listing of these offenses in the Appendix to this part. The list is presented for informational purposes only. Any future revision to the District of Columbia Code sections designating the qualifying offenses will be effective notwithstanding the timing of a conforming revision of the Appendix by CSOSA. CSOSA may choose not to collect a sample from an individual if it determines that CODIS already contains a DNA analysis for the individual.
(a) CSOSA will coordinate with the Federal Bureau of Prisons in order to obtain documentation regarding the collection of a DNA sample when the Federal Bureau of Prisons releases an inmate to CSOSA's supervision or as requested by CSOSA.
(b) CSOSA shall provide the Federal Bureau of Prisons with documentation regarding the collection of a DNA sample from a District of Columbia Code offender when CSOSA returns the District of Columbia Code offender to the custody of the Federal Bureau of Prisons or as requested by the Federal Bureau of Prisons.
(a) DNA samples will be collected, handled, preserved, and submitted to
(b) CSOSA has the authority to use such means as are reasonably necessary to collect a sample from an individual who refuses to cooperate in the collection of the sample. Unless CSOSA determines that there are mitigating circumstances, CSOSA will consider that an individual is refusing to cooperate if:
(1) The individual is being ordered or transferred to CSOSA's supervision, but fails to report to CSOSA for collection of the sample within 15 business days of being sentenced to probation or being discharged from a correctional institution; or
(2) The individual is already under CSOSA supervision and has been notified by his or her Community Supervision Officer of the time to report for collection of the sample, but fails to report for collection of the sample; or
(3) The individual has reported to CSOSA for collection of the sample, but fails to provided the sample after being given a minimum of one hour to do so; or
(4) The individual specifically states that he or she will not cooperate.
(c) When an individual has refused to cooperate in the collection of the sample, CSOSA deems the following to be reasonably necessary means for obtaining the sample:
(1) Impose administrative sanctions;
(2) Request a revocation hearing by the releasing authority; and/or
(3) Refer the individual who refuses to cooperate for criminal prosecution for a class A misdemeanor pursuant to section 4(a)(5) of the DNA Analysis Backlog Elimination Act of 2000 (42 U.S.C. 14135b(a)(5)).
As enacted by the Council of the District of Columbia, the DNA Sample Collection Act of 2001 identifies the criminal offenses listed in Table 1 of this appendix as “qualifying District of Columbia offenses” for the purposes of the DNA Analysis Backlog Elimination Act of 2000 (Pub. L. 106-546, 114 Stat. 2726). Table 2 of this Appendix lists these same offenses in numerical order under the D.C. Code, 1981 Edition. Table 3 of this Appendix lists these same offenses in numerical order under the D.C. Official Code, 2001 Edition. The tables follow:
(1) Section 820 of An Act To establish a code of law for the District of Columbia (arson);
(2) Section 821 of An Act To establish a code of law for the District of Columbia (burning of one's own property with intent to defraud or injure another);
(3) Section 848 of An Act To establish a code of law for the District of Columbia (malicious burning, destruction, or injury of another's property);
(4) Section 803 of An Act To establish a code of law for the District of Columbia (assault with intent to kill, rob, or poison, or to commit first degree sexual abuse, second degree sexual abuse or child sexual abuse);
(5) Section 804 of An Act To establish a code of law for the District of Columbia, (assault with intent to commit mayhem or with dangerous weapon);
(6) Section 806a of An Act To establish a code of law for the District of Columbia (aggravated assault);
(7) Section 432(b) of the Revised Statutes, relating to the District of Columbia (assault on member of police force, campus or university special police, or fire department using a deadly or dangerous weapon);
(8) Section 807 of An Act To establish a code of law for the District of Columbia (mayhem or maliciously disfiguring);
(9) Section 3 of An act for the protection of children in the District of Columbia and for other purposes (cruelty to children);
(10) Section 9 of An Act for the preservation of the public peace and the protection of property within the District of Columbia (lewd, indecent, or obscene acts (knowingly in the presence of a child under the age of 16 years));
(11) Section 823 of An Act To establish a code of law for the District of Columbia (burglary);
(12) Section 875 of An Act To establish a code of law for the District of Columbia (incest);
(13) Section 872 of An Act To establish a code of law for the District of Columbia (certain obscene activities involving minors);
(14) Section 3 of the District of Columbia Protection of Minors Act of 1982 (sexual performances using minors);
(15) Section 812 of An Act To establish a code of law for the District of Columbia (kidnapping);
(16) Section 798 of An Act To establish a code of law for the District of Columbia (murder in the first degree);
(17) Section 799 of An Act To establish a code of law for the District of Columbia (murder in the first degree—obstructing railroad);
(18) Section 800 of An Act To establish a code of law for the District of Columbia (murder in the second degree);
(19) Section 802 of An Act To establish a code of law for the District of Columbia (voluntary manslaughter only);
(20) Section 802a of An Act To establish a code of law for the District of Columbia (murder of a law enforcement officer);
(21) Section 813 of An Act To establish a code of law for the District of Columbia (abducting, enticing, or harboring a child for prostitution);
(22) Section 1 of An Act In relation to pandering, to define and prohibit the same and to provide for the punishment thereof (pandering; inducing or compelling an individual to engage in prostitution);
(23) Section 2 of An Act In relation to pandering, to define and prohibit the same and to provide for the punishment thereof (compelling an individual to live life of prostitution against his or her will);
(24) Section 4 of An Act In relation to pandering, to define and prohibit the same and to provide for the punishment thereof (causing spouse to live in prostitution);
(25) Section 5 of An Act In relation to pandering, to define and prohibit the same and to provide for the punishment thereof (detaining an individual in disorderly house for debt there contracted);
(26) Forcible rape, carnal knowledge or statutory rape as these offenses were proscribed until May 23, 1995 by section 808 of An Act To establish a code of law for the District of Columbia;
(27) Section 810 of An Act To establish a code of law for the District of Columbia (robbery);
(28) Section 811 of An Act To establish a code of law for the District of Columbia (attempted robbery);
(29) Section 811a of An Act To establish a code of law for the District of Columbia (carjacking);
(30) lndecent acts with children as this offense was proscribed until May 23, 1995 by section 103(a) of An Act To provide for the treatment of sexual psychopaths in the District of Columbia, and for other purposes;
(31) Enticing a child as this offense was proscribed until May 23, 1995 by section 103(b) of An Act To provide for the treatment of sexual psychopaths in the District of Columbia, and for other purposes;
(32) Sodomy as this offense was proscribed until May 23, 1995 by section 104(a) of An Act To provide for the treatment of sexual psychopaths in the District of Columbia, and for other purposes where the offense was forcible or committed against a minor;
(33) Section 201 of the Anti-Sexual Abuse Act of 1994 (first degree sexual abuse);
(34) Section 202 of the Anti-Sexual Abuse Act of 1994 (second degree sexual abuse);
(35) Section 203 of the Anti-Sexual Abuse Act of 1994 (third degree sexual abuse);
(36) Section 204 of the Anti-Sexual Abuse Act of 1994 (fourth degree sexual abuse);
(37) Section 205 of the Anti-Sexual Abuse Act of 1994 (misdemeanor sexual abuse);
(38) Section 207 of the Anti-Sexual Abuse Act of 1994 (first degree child sexual abuse);
(39) Section 208 of the Anti-Sexual Abuse Act of 1994 (second degree child sexual abuse);
(40) Section 209 of the Anti-Sexual Abuse Act of 1994 (enticing a child);
(41) Section 212 of the Anti-Sexual Abuse Act of 1994 (first degree sexual abuse of a ward);
(42) Section 213 of the Anti-Sexual Abuse Act of 1994 (second degree sexual abuse of a ward);
(43) Section 214 of the Anti-Sexual Abuse Act of 1994 (first degree sexual abuse of a patient or client);
(44) Section 215 of the Anti-Sexual Abuse Act of 1994 (second degree sexual abuse of a patient or client);
(45) Section 217 of the Anti-Sexual Abuse Act of 1994 (attempts to commit sexual offenses); and
(46) Attempt or conspiracy to commit any of the offenses listed in items (1) through (45) of this table.
(1) D.C. Code section 22-401—arson;
(2) D.C. Code section 22-402—burning of one's own property with intent to defraud or injure another;
(3) D.C. Code section 22-403—malicious burning, destruction or injury of another's property;
(4) D.C. Code section 22-501—assault with intent to kill, rob, or poison, or to commit first degree sexual abuse, second degree sexual abuse or child sexual abuse;
(5) D.C. Code section 22-502—assault with intent to commit mayhem or with dangerous weapon;
(6) D.C. Code section 22-504.1—aggravated assault;
(7) D.C. Code section 22-505(b)—assault on member of police force, campus or university special police, or fire department using a deadly or dangerous weapon;
(8) D.C. Code section 22-506—mayhem or maliciously disfiguring;
(9) D.C. Code section 22-901—cruelty to children;
(10) D.C. Code section 22-1112(b)—lewd, indecent or obscene acts (knowingly in the presence of a child under the age of 16 years);
(11) D.C. Code section 22-1801—burglary;
(12) D.C. Code section 22-1901—incest;
(13) D.C. Code section 22-2001—certain obscene activities involving a minor;
(14) D.C. Code section 22-2012—sexual performances using minors;
(15) D.C. Code section 22-2101—kidnapping;
(16) D.C. Code section 22-2401—murder in the first degree;
(17) D.C. Code section 22-2402—murder in the first degree (obstructing railroad);
(18) D.C. Code section 22-2403—murder in the second degree;
(19) D.C. Code section 22-2405—voluntary manslaughter only;
(20) D.C. Code section 22-2406—murder of a law enforcement officer;
(21) D.C. Code section 22-2704—abducting, enticing, or harboring a child for prostitution;
(22) D.C. Code section 22-2705—pandering; inducing or compelling an individual to engage in prostitution;
(23) D.C. Code section 22-2706—compelling an individual to live life of prostitution against his or her will;
(24) D.C. Code section 22-2708—causing spouse to live in prostitution;
(25) D.C. Code section 22-2709—detaining an individual in disorderly house for debt there contracted;
(26) D.C. Code section 22-2801 [repealed May 23, 1995]—forcible rape, carnal knowledge or statutory rape;
(27) D.C. Code section 22-2901—robbery;
(28) D.C. Code section 22-2902—attempted robbery;
(29) D.C. Code section 22-2903—carjacking;
(30) D.C. Code section 22-3501(a) [repealed May 23, 1995]—indecent acts with children;
(31) D.C. Code section 22-3501(b) [repealed May 23, 1995]—enticing a child;
(32) D.C. Code section 22-3502(a) [repealed May 23, 1995]—sodomy where the offense was forcible or committed against a minor;
(33) D.C. Code section 22-4102—first degree sexual abuse;
(34) D.C. Code section 22-4103—second degree sexual abuse;
(35) D.C. Code section 22-4104—third degree sexual abuse;
(36) D.C. Code section 22-4105—fourth degree sexual abuse;
(37) D.C. Code section 22-4106—misdemeanor sexual abuse;
(38) D.C. Code section 22-4108—first degree child sexual abuse;
(39) D.C. Code section 22-4109—second degree child sexual abuse;
(40) D.C. Code section 22-4110—enticing a child;
(41) D.C. Code section 22-4113—first degree sexual abuse of a ward;
(42) D.C. Code section 22-4114—second degree sexual abuse of a ward;
(43) D.C. Code section 22-4115—first degree sexual abuse of a patient or client;
(44) D.C. Code section 22-4116—second degree sexual abuse of a patient or client;
(45) D.C. Code section 22-4118—attempts to commit sexual offenses;
(46) Attempt or conspiracy to commit any of the offenses listed in items (1) through (45) of this table.
(1) D.C. Code section 22-301—arson;
(2) D.C. Code section 22-302—burning of one's own property with intent to defraud or injure another;
(3) D.C. Code section 22-303—malicious burning, destruction, or injury of another's property;
(4) D.C. Code section 22-401—assault with intent to kill, rob, or poison, or to commit first degree sexual abuse, second degree sexual abuse or child sexual abuse;
(5) D.C. Code section 22-402—assault with intent to commit mayhem or with dangerous weapon;
(6) D.C. Code section 22-404.01—aggravated assault;
(7) D.C. Code section 22-405(b)—assault on member of police force, campus or university special police, or fire department using a deadly or dangerous weapon;
(8) D.C. Code section 22-406—mayhem or maliciously disfiguring;
(9) D.C. Code section 22-801—burglary;
(10) D.C. Code section 22-1101—cruelty to children;
(11) D.C. Code section 22-1312(b)—lewd, indecent, or obscene acts (knowingly in the presence of a child under the age of 16 years);
(12) D.C. Code section 22-1901—incest;
(13) D.C. Code section 22-2001—kidnapping;
(14) D.C. Code section 22-2101—murder in the first degree;
(15) D.C. Code section 22-2102—murder in the first degree—obstructing railroad;
(16) D.C. Code section 22-2103—murder in the second degree;
(17) D.C. Code section 22-2105—voluntary manslaughter only;
(18) D.C. Code section 22-2106—murder of a law enforcement officer;
(19) D.C. Code section 22-2201—certain obscene activities involving minors;
(20) D.C. Code section 22-2704—abducting, enticing, or harboring a child for prostitution;
(21) D.C. Code section 22-2705—pandering; inducing or compelling an individual to engage in prostitution;
(22) D.C. Code section 22-2706—compelling an individual to live life of prostitution against his or her will;
(23) D.C. Code section 22-2708—causing spouse to live in prostitution;
(24) D.C. Code section 22-2709—detaining an individual in disorderly house for debt there contracted;
(25) D.C. Code section 22-2801—robbery;
(26) D.C. Code section 22-2802—attempted robbery;
(27) D.C. Code section 22-2803—carjacking;
(28) D.C. Code section 22-3002—first degree sexual abuse;
(29) D.C. Code section 22-3003—second degree sexual abuse;
(30) D.C. Code section 22-3004—third degree sexual abuse;
(31) D.C. Code section 22-3005—fourth degree sexual abuse;
(32) D.C. Code section 22-3006—misdemeanor sexual abuse;
(33) D.C. Code section 22-3008—first degree child sexual abuse;
(34) D.C. Code section 22-3009—second degree child sexual abuse;
(35) D.C. Code section 22-3010—enticing a child;
(36) D.C. Code section 22-3013—first degree sexual abuse of a ward;
(37) D.C. Code section 22-3014—second degree sexual abuse of a ward;
(38) D.C. Code section 22-3015—first degree sexual abuse of a patient or client;
(39) D.C. Code section 22-3016—second degree sexual abuse of a patient or client;
(40) D.C. Code section 22-3018—attempts to commit sexual offenses;
(41) D.C. Code section 22-3102—sexual performances using minors;
(42) D.C. Code section 22-3801(a) [repealed May 23, 1995]—indecent acts with children;
(43) D.C. Code section 22-3801(b) [repealed May 23, 1995]—enticing a child;
(44) D.C. Code section 22-3802(a) [repealed May 23, 1995]—sodomy where the offense was forcible or committed against a minor;
(45) D.C. Code section 22-4801 [repealed May 23, 1995]—forcible rape, carnal knowledge or statutory rape;
(46) D.C. Code section 22-1803 or section 22-1805a—attempt or conspiracy to commit any of the offenses listed in items (1) through (45) of this table.
Occupational Safety and Health Administration, U.S. Department of Labor.
Regulatory Flexibility Act review; request for comments.
The Occupational Safety and Health Administration (OSHA) is conducting a review of the Excavations Standard pursuant to Section 610 of the Regulatory Flexibility Act and Section 5 of Executive Order 12866 on Regulatory Planning and Review. The purpose of this review is to determine, while protecting worker safety, whether this standard should be maintained without change, rescinded, or modified in order to minimize any significant impact of the rule on a substantial number of small entities and whether the rule should be changed to reduce regulatory burden or improve its effectiveness. Written public comments on these and other relevant issues are welcomed.
Written comments to OSHA must be sent or postmarked by November 19, 2002.
You may submit three copies of your written comments to the OSHA Docket Office, Docket No. S204A, Technical Data Center, Room N-2625, U.S. Department of Labor, 200 Constitution Ave., NW., Washington, DC 20210; telephone (202) 693-2350. If your written comments are 10 pages or fewer, you may fax them to the OSHA Docket Office at (202) 693-1648. You do not have to send OSHA a hard copy of your faxed comments.
You may submit comments electronically through OSHA's Homepage at
Joanna Dizikes Friedrich, Directorate of Policy, Occupational Safety and Health Administration, Room N3641, 200 Constitution Avenue, NW., Washington, DC 20210, Telephone (202) 693-2400, Fax (202) 693-1641.
In 1971, the Secretary of Labor promulgated a safety standard for excavations (36 FR 7340, April 17, 1971) pursuant to section 107 of the Contract Work Hours and Safety Standards Act. Later in 1971, OSHA designated this Standard as an established occupational safety and health standard (36 FR 10466, May 29, 1971) in accordance with section 6(a) of the Occupational Safety and Health Act.
In 1989, OSHA revised this Standard (54 FR 45894, October 31, 1989) to use performance criteria where possible, rather than specification requirements; to consolidate and simplify existing provisions; to add and clarify definitions; to eliminate duplicate provisions and ambiguous language; to provide a consistent method of soil classification; and to give employers added flexibility in providing protection for employees. The Standard was amended August 9, 1994 (59 FR 40730) to protect workers using walkways over excavations.
The Excavations Standard is currently found in 29 CFR, subpart P, 1926.650-1926.652 and Appendices A-F, and covers the construction industry. The purpose of the Standard is to protect employees from deaths and injuries resulting from excavation work, including deaths and injuries resulting from cave-ins. The Standard regulates the use of support systems, sloping and benching systems, and other systems of protection as means of protection against excavation cave-ins. In addition, the Standard regulates the means of access to and egress from excavations, along with employee exposure to vehicular traffic, falling loads, hazardous atmospheres, water accumulation, and unstable structures in and adjacent to excavations. The Standard applies to all types of excavations, including trenches, made in the earth's surface.
OSHA has selected the Excavation Standard for review in accordance with the regulatory review provisions of Section 610 of the Regulatory Flexibility Act (5 U.S.C. 601
(S)hall be to determine whether such rule should be continued without change, or should be rescinded, or amended consistent with the stated objectives of applicable statutes to minimize any significant impact of the rules on a substantial number of small entities.
The Agency shall consider the following factors:
(1) The continued need for the rule;
(2) The nature of complaints or comments received concerning the rule from the public;
(3) The complexity of the rule;
(4) The extent to which the rule overlaps, duplicates or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and
(5) The length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule.
To reduce the regulatory burden on the American people, their families, their communities, their State, local, and tribal governments, and their industries; to determine whether regulations promulgated by the [Agency] have become unjustified or unnecessary as a result of changed circumstances; to confirm that regulations are both compatible with each other and not duplicative or inappropriately burdensome in the aggregate; to ensure that all regulations are consistent with the President's priorities and the principles set forth in this Executive Order, within applicable law; and to otherwise improve the effectiveness of existing regulations.
An important step in the review process involves the gathering and analysis of information from affected persons about their experience with the rule and any material changes in circumstances since issuance of the rule. This document requests written comments on the continuing need for the rule, its adequacy or inadequacy, its small business impacts, and other relevant issues. Comments concerning the following subjects would assist the Agency in its review. (The purpose of these questions is to assist commenters in their responses and not to limit the format or substance of their comments. Of course, comments are requested on all issues raised by Section 610 of the Regulatory Flexibility Act and Section 5 of Executive Order 12866.)
1. Do any aspects of Subpart P need to be updated as a result of technological developments over the past decade?
2. Does compliance with the Excavations Standard at 29 CFR subpart P (i.e., §§ 1926.650-1926.652 and Appendices A-E) provide safety from cave-ins and other trenching and excavation accidents? Are there additional protections which could improve safety?
3. If firms fail to comply with the Excavations Standard, is non-compliance more commonly the result of: (1) A lack of information (e.g., about the dangers, or the safety requirements); (2) inadequate supervision; (3) cost pressures; or (4) other factors? How could OSHA encourage improved compliance?
4. Are OSHA's requirements in the Excavations Standard known to firms that do trenching and excavation jobs, including small firms and firms that dig trenches only occasionally? How could awareness be increased for such firms?
5. Does OSHA's Excavations Standard impose an unnecessary burden to small businesses, or to industry in general? If so, which requirements, and how could this burden be reduced without decreasing safety?
6. Do any of the requirements in the Excavations Standard lead to a disproportionate burden on small entities? If so, which requirements lead to a disproportionate burden, and how?
7. What percent of the time and cost of an excavation job do safety measures represent? Do these percentages vary significantly depending on the type of job, soil, firm, or other factors? Provide data, if possible.
8. Which types of safety measures have the greatest impact on productivity? The lowest impact on productivity?
9. Do bidding practices (or requirements) for construction jobs encourage or discourage uniform compliance with the Excavations Standard (e.g., by explicitly identifying planned subpart P safety measures in bids delivered to customers, or by certifying compliance with subpart P as part of the bid)?
10. How have changes in technology, the economy, or other factors affected the compliance costs associated with the rule over the past decade or so?
11. How might OSHA modify the requirements to reduce costs without jeopardizing safety?
12. Are any aspects of the Excavations Standard unclear, needlessly complex, or duplicative? Do any portions of the Excavations Standard overlap, duplicate, or conflict with other Federal, State or local government rules?
13. Do other government entities, including other countries, have alternative trenching and excavation approaches? If so, how do they differ from OSHA's approach? Are these alternative approaches more effective?
Excavation work is performed during the construction of buildings, bridges, towers, and other construction projects. There is a greater economic incentive to shore excavations, as opposed to trenches, due to the greater risks of incurring re-excavation expenses due to collapsed walls, and due to the possibility that damage suits would result from the collapse of buildings located adjacent to an excavation. In comparison, trenching is primarily performed by utility contractors who construct gas, sewer, water, and utility lines. Much of this work is performed as a result of competitive bids from state and local governments or local utilities. Trenches are less likely to be in close proximity to other structures; structures adjacent to trenches are less likely to collapse; and the cost of redigging a collapsed trench is far less than of re-excavating the foundation of a building.
OSHA statistics show that during the period 1990-2000, an average of approximately 70 fatalities per year occurred as a result of excavation and trenching accidents. These fatalities fall across numerous Standard Industrial Classifications (SICs),
While the annual number of fatalities has remained fairly constant over this 1990-2000 period, the fatality rate as a percentage of the real value of construction activity has declined. One factor contributing to this decline has been an increased use of new “trenchless” technologies, such as directional drilling, pipejacking, microtunnelling, auger boring, impact ramming, pipe bursting, folded pipes, and spray on linings. These technologies can result in fewer accidents by eliminating or reducing the amount of time that workers are physically exposed to the hazards of trenching. For example, some of these technologies use remote-controlled equipment to dig and lay cables, to install pipe, or to replace existing pipes.
The construction industry has grown by approximately 20 percent (constant dollars) since the Excavations Standard was last modified in 1989. The Small Business Administration (SBA) generally classifies the entities affected by this standard as small if their annual revenues are less than $12 million (for affected entities falling within NAIC 235) or $28.5 million (for affected entities falling within NAICs 233 and 234). Under these guidelines, the vast majority of entities affected by the Standard are small entities.
This document was prepared under the direction of John L. Henshaw, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue, NW., Washington, DC 20210.
Coast Guard, DOT.
Temporary final rule.
The Coast Guard is establishing temporary special local regulations during the “Harford County Power Boat Regatta”, a marine event to be held on the waters of Bush River near Abingdon, Maryland. These special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic in portions of the Bush River during the event.
This rule is effective from 11:30 a.m. on August 31, 2002 to 6:30 p.m. on September 1, 2002.
Documents indicated in this preamble as being available in the docket are part of docket CGD05-02-057 and are available for inspection or copying at Commander (Aoax), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004, between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays.
Ronald Houck, Marine Information Specialist, Commander, Coast Guard Activities Baltimore, at (410) 576-2674.
We did not publish a notice of proposed rulemaking (NPRM) for this regulation. In keeping with 5 U.S.C. 553(b)(B) and 553(d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this rule effective less than 30 days after publication in the
On August 31 and September 1, 2002, the Harford County Power Boat Association will sponsor the “Harford County Power Boat Regatta”, on the waters of the Bush River, near Abingdon, Maryland. The event will consist of approximately 75 inboard hydroplanes and runabouts racing in heats counter-clockwise around a 1.25-mile oval racecourse. A fleet of spectator vessels is anticipated. Due to the need for vessel control during the races, vessel traffic will be temporarily restricted to provide for the safety of spectators, participants and transiting vessels.
The Coast Guard is establishing temporary special local regulations on specified waters of the Bush River. The temporary special local regulations will be enforced from 11:30 a.m. to 6:30 p.m. on both August 31 and September 1, 2002. The effect will be to restrict general navigation in the regulated area during the event. Except for participants in the “Harford County Power Boat Regatta” and vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area. The Patrol Commander will allow non-participating vessels to transit the event area between races at slow speed. These regulations are needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.
This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979).
Although this rule prevents traffic from transiting a portion of the Bush River during the event, the effect of this rule will not be significant due to the limited duration of the regulation, the fact that the Patrol Commander will allow non-participating vessels to transit the event area between races, and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in the effected portions of the Bush River during the event.
Although this rule prevents traffic from transiting or anchoring in a portion of the Bush River during the event, the effect of this rule will not be significant because of its limited duration, the fact that the Patrol Commander will allow non-participating vessels to transit the event area between races, and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this temporary rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial and direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
We prepared an “Environmental Assessment” in accordance with Commandant Instruction M16475.1C, and determined that this rule will not significantly affect the quality of the human environment. The “Environmental Assessment” and “Finding of No Significant Impact” is available in the docket where indicated under
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
33 U.S.C. 1233; 49 CFR 1.46.
(a)
(1)
(2)
(3)
(b)
(c)
(1) Except for event participants and persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area.
(2) The operator of any vessel in the regulated area shall:
(i) Stop the vessel immediately when directed to do so by any official patrol.
(ii) Proceed as directed by any official patrol.
(iii) Unless otherwise directed by the official patrol, operate at a minimum wake speed not to exceed six (6) knots.
(d)
Coast Guard, DOT.
Temporary final rule.
The Coast Guard is establishing moving safety zones extending one-hundred (100) yards around each vessel participating in the Parade of Ships-Festival of Sail as each vessel transits through San Francisco Bay to its respective mooring site on August 28, 2002. These temporary safety zones are necessary to provide for the safety of the crews, spectators, participants of the event, participating vessels and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within these safety zones unless authorized by the Captain of the Port, or his designated representative.
This rule is effective from 12 [PDT] to 4:30 [PDT] on August 28, 2002.
Documents indicated in this preamble as being available in the docket are part of docket [COTP San Francisco 02-017] and are available for inspection or copying at U.S. Coast Guard Marine Safety Office San Francisco Bay, Coast Guard Island, Building 14, Alameda, CA 94501-5100, between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays.
Lieutenant Diana Cranston, Chief, Waterways Management Branch, U.S. Coast Guard Marine Safety Office San Francisco Bay, at (510) 437-3073.
We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Final approval and permitting of this event were not issued in time to engage in notice and comment rulemaking. Moreover, through various meetings and correspondence, the Coast Guard has attempted to involve other agencies in the planning process of the Parade of Ships-Festival of Sail. The public will also be reminded about this event through Broadcast Notice to Mariners (BNM) announcements and Local Notice to Mariner (LNM) publications. Moreover, the event will have minimal impact on the public since it is of a short duration, four and one-half (4.5) hours, and will take place during non-commute hours from 12 p.m. until 4:30 p.m.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The American Sail Training Association, in coordination with local sponsors like “Sail San Francisco”, is sponsoring the 2002 Tall Ships Challenge race series transiting the Pacific Ocean along the west coast of North America. Between the races, the participating vessels will visit several ports including San Francisco Bay. These temporary safety zones are established in support of the Parade of Ships-Festival of Sail, a marine event that includes participating vessels transiting through San Francisco Bay and, upon completion of the parade, mooring in San Francisco Bay, giving spectators an opportunity to tour the participating vessels. These temporary safety zones are necessary to provide for the safety of the crews, spectators, and participants of the Parade of Ships-Festival of Sail and are also necessary to protect other vessels and users of waterway.
The Coast Guard establishes moving safety zones extending one-hundred (100) yards around each vessel participating in the Parade of Ships-Festival of Sail as each vessel transits through San Francisco Bay to its respective mooring site. Vessels participating in the event will fly a black-and-yellow pennant indicating their official association with the Parade of Ships-Festival of Sail. The safety zones surrounding the participant vessels will be enforced from 12 p.m. to 4:30 p.m. on August 28, 2002. The safety zones are necessary to provide for the safety of the crews, spectators, and participants of the Parade of Ships-Festival of Sail and to protect other vessels and users of the waterways. Persons and vessels would be prohibited from entering into, transiting through, or anchoring within these safety zones unless authorized by the Captain of the Port, or his designated representative.
This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979).
We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary because of its limited duration of four and one-half (4.5) hours and the limited geographic scope of the safety zones.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.
These safety zones would not have a significant economic impact on a substantial number of small entities because these zones are limited in scope and duration (in effect for only four and one-half (4.5) hours on August 28, 2002). In addition, the Coast Guard will issue broadcast notice to mariners alerts via VHF-FM marine channel 16 before the safety zone is enforced.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
We have considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation because we are proposing to establish a safety zone. A “Categorical Exclusion Determination” is available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
33 U.S.C. 1231; 50 U.S.C. 191, 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; 49 CFR 1.46.
(a)
(b)
(c)
Environmental Protection Agency (EPA).
Final rule.
This regulation re-establishes time-limited tolerances for combined residues of the insecticide imidacloprid (1-[6-chloro-3-pyridinyl) methyl]-
This regulation is effective August 21, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0150, must be received on or before October 21, 2002.
Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit III. of the
By mail: Andrew Ertman, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9367; e-mail address: ertman.andrew@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.
EPA issued a final rule, published in the
These tolerances were subsequently extended on in
Recently, EPA has received an objection to a tolerance it established for imidacloprid on a different food commodity. The objection was filed by the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. Although this objection concerns separate rulemaking proceedings under the FFDCA, EPA has considered whether it is appropriate to re-establish the emergency exemption tolerances for imidacloprid while the objection is still pending.
Factors taken into account by EPA included how close the Agency is to concluding the proceedings on the objection, the nature of the current action, whether NRDC's objection raised frivolous issues, and the extent to which the issues raised by NRDC had already been considered by EPA. Although NRDC's objection is not frivolous, the other factors all support extending these tolerances at this time. First, the objections proceeding is not near to conclusion. NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA has just initiated a 60 day public comment period on them. (See 67 FR 41628, June 19, 2002, FRL-7167-7) Second, the nature of the current actions are extremely time-sensitive as they address emergency situations. Third, the issues raised by NRDC are not new matters but questions that have been the subject of considerable study by EPA and comment by stakeholders. Accordingly, EPA is proceeding with re-establishing the tolerances for imidacloprid.
EPA established the tolerances because section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment.
EPA received a request to extend the use of imidacloprid on turnips and garden beets for this year's growing season due to a continuation of the emergencies in California and Arizona. After having reviewed the submission, EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of imidacloprid on turnips and garden beets for control of aphids in Arizona and California, respectively.
EPA assessed the potential risks presented by residues of imidacloprid in or on turnip roots, turnip tops, garden beet roots, and garden beet tops. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerances under FFDCA section
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0150 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 21, 2002.
1.
Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2.
EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
3.
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
This final rule re-establishes time-limited tolerances under FFDCA section 408. 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), 346(a) and 371.
(b) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes time-limited tolerances for combined residues of sulfentrazone, N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl] methanesulfonamide, and its metabolites 3-hydroxymethyl sulfentrazone (HMS) and 3-desmethyl sulfentrazone (DMS) in or on flax, seed; potato; potato, wet peel; and potato, granules/flakes. This action is in response to EPA's granting of an emergency exemption under section 18
This regulation is effective August 21, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0176, must be received on or before October 21, 2002.
Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VII. of the
By mail: Andrew Ertman, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9367; e-mail address: Ertman.Andrew@epamail.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.
EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for combined residues of the herbicide sulfentrazone, N-[2,4-dichloro-5-[4-(difluoromethyl)- 4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl] methanesulfonamide, and its metabolites 3-hydroxymethyl sulfentrazone (HMS) and 3-desmethyl sulfentrazone (DMS), in or on flax, seed at 0.20 part per million (ppm); potato at 0.10 ppm; potato, wet peel at 0.15 ppm; and potato, granules/flakes at 0.20 ppm. These tolerances will expire and are revoked on December 31, 2004. EPA will publish a document in the
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.
North Dakota submitted a section 18 request for the emergency use of sulfentrazone on flax to control kochia. EPA reviewed this request and concluded that the situation was urgent and non-routine.
Colorado and Nebraska submitted section 18 requests for the emergency use of sulfentrazone on potatoes to control ALS-inhibitor and triazine-resistant Palmer amaranth, redroot pigweed, common waterhemp. EPA reviewed these requests and concluded that the situations were urgent and non-routine. EPA has authorized under FIFRA section 18 the use of sulfentrazone on flax to control kochia in North Dakota, and on potatoes for control of ALS-inhibitor and triazine-resistant Palmer amaranth, redroot pigweed, common waterhemp in Colorado and Nebraska. After having reviewed these submissions, EPA concurs that emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of sulfentrazone in or on flax and potatoes. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6). Although these tolerances will expire and are revoked on December 31, 2004, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on flax, seed; potato; potato, wet peel; potato, granules/flakes after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether sulfentrazone meets EPA's registration requirements for use on flax and/or potatoes or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of sulfentrzone by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than North Dakota, Colorado and Nebraska to use this pesticide on these crops under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for sulfentrazone, contact the Agency's Registration Division at the address provided under
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of sulfentrazone and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for combined residues of sulfentrazone in or on flax, seed at 0.20 ppm; potato at 0.10 ppm; potato, wet peel at 0.15 ppm; and potato, granules/flakes at 0.20 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.
The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10
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The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide
None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to sulfentrazone they are further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the EECs of sulfentrazone for acute exposures are estimated to be 16 parts per billion (ppb) for surface water and 16 ppb for ground water. The EECs for chronic exposures are estimated to be 4 ppb for surface water and 16 ppb for ground water.
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Sulfentrazone is not registered for use on any sites that would result in residential exposure.
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EPA does not have, at this time, available data to determine whether sulfentrazone has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, sulfentrazone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that sulfentrazone has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
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In the dermal developmental study in rats, the maternal (systemic) NOAEL was 250 mg/kg/day and a LOAEL was not determined. The developmental (fetal) NOAEL was 100 mg/kg/day, based on decreased fetal weight and increased fetal variations (hypoplastic or wavy ribs, incompletely ossified lumbar vertebral arches, incompletely ossified ischia or pubes, and reduced numbers of thoracic vertebral and rib ossification sites) at the LOAEL of 250 mg/kg/day.
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To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water [e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + chronic non-dietary, non-occupational exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to sulfentrazone in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of sulfentrazone on drinking water as a part of the aggregate risk assessment process.
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An analytical methodology for the determination of sulfentrazone, 3-desmethyl sulfentrazone, and 3-hydroxymethyl sulfentrazone residues in/on various matrices was submitted with a petition for a sulfentrazone tolerance on soybeans. A petition method validation (PMV) was successfully completed by the Agency's Analytical Chemistry Laboratory. The Limit of Quantitation (LOQ) and Minimum Detection Limit (MDL) were determined to be 0.05 ppm and 0.005-0.025 ppm, respectively. EPA concluded that the method is suitable for enforcement purposes.
Adequate enforcement methodology (example—gas chromotography) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
There are no Codex maximum residue limits (MRLs) established for sulfentrazone on either flax or potatoes.
Therefore, the tolerances are established for combined residues of sulfentrazone, N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide, and its metabolites 3-hydroxymethyl sulfentrazone (HMS) and 3-desmethyl sulfentrazone (DMS), in or on flax, seed at 0.20 ppm; potato at 0.10 ppm; potato, wet peel at 0.15 ppm; and potato, granules/flakes at 0.20 ppm
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0176 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 21, 2002.
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Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.
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EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
This final rule establishes time limited tolerances under FFDCA section 408. 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), 346(a) and 371.
(b) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes for tolerances for residues of clomazone in or on peppermint tops and spearmint tops. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
This regulation is effective August 21, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0178, must be received on or before October 21, 2002.
Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the
By mail: Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: (703) 308-3194; e-mail address: brothers.shaja@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
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The petition requested that 40 CFR 180.425 be amended by establishing tolerances for residues of the herbicide clomazone, 2-(2-chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinone, in or on peppermint tops and spearmint tops at 0.05 part per million (ppm).
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for residues of clomazone on peppermint tops and spearmint tops at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follow.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by clomazone is discussed in Unit III.A. of the Final Rule on Clomazone Pesticide Tolerance published in the
The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10
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The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and Screening Concentration in Ground Water (SCI-GROW), which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to clomazone, they are further discussed in Unit II.E.
The EECs were based on the proposed uses of clomazone as specified on the CommandR 3 ME label (maximum application rate = 1.25 pound active ingredient per acre (lb ai/A)).
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Clomazone is not registered for use on any sites that would result in residential exposure.
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EPA does not have, at this time, available data to determine whether clomazone has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, clomazone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that clomazone has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
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To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water (e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)). This allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be
When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.
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Adequate enforcement methods are available for the determination of the residues of clomazone in plants. Briefly, samples are acid hydrolyzed, hexane extracted, Na
Adequate enforcement methodology (example—gas chromotography) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.
There is neither a Codex proposal, nor Canadian or Mexican maximum residue limits (MRLs) for residues of clomazone in/on mint.
Therefore, tolerances are established for residues of clomazone, 2-(2-chlorophenyl)methyl- 4,4-dimethyl-3-isoxazolidinone, in or on peppermint tops and spearmint tops at 0.05 ppm.
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0178 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 21, 2002.
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Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.
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EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled
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), 346(a) and 371.
(a) * * *
Environmental Protection Agency.
Final rule.
The Environmental Protection Agency (EPA or Agency) today is granting a petition submitted by the United States Department of Energy Savannah River Operations Office (DOE-SR) to exclude (or “delist”) certain hazardous wastes from the lists of hazardous wastes under the Resource Conservation and Recovery Act (RCRA). DOE-SR generated the petitioned waste by treating wastes from various activities at the Savannah River Site (SRS). The petitioned waste meets the definitions of listed RCRA hazardous wastes F006 and F028. DOE-SR petitioned EPA to grant a one-time, generator-specific delisting for its F006 and F028 waste, because DOE-SR believes that its waste does not meet the criteria for which theses types of wastes were listed. The waste is a radioactive mixed waste (RMW) because it is both a RCRA hazardous waste and a radioactive waste. EPA reviewed all of the waste-specific information provided by DOE-SR, performed calculations, and determined that the waste, which has a low level of radioactivity, could be disposed in a landfill for low-level radioactive waste without harming human health and the environment. The petition is for a one-time delisting, because the petitioned waste has been generated, will be completely disposed of at one time, and will not be generated again. Today's final rule grants DOE-SR's petition to delist its F006 and F028 waste. No public comments on the proposed rule were received. Today's final action means that DOE-SR's petitioned waste will no longer be classified as F006 and F028, and will not be subject to regulation as a hazardous waste under Subtitle C of RCRA, provided that it is disposed in a low-level radioactive waste landfill, in accordance with the Atomic Energy Act. The waste will still be subject to the Atomic Energy Act and local, State, and Federal regulations for low-level radioactive solid wastes that are not RCRA hazardous wastes.
This rule is effective on August 21, 2002.
The RCRA regulatory docket for this final rule is located at the EPA Library, U.S. Environmental Protection Agency, Region 4, Sam Nunn Atlanta Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303, and is available for viewing from 9 a.m. to 4 p.m., Monday through Friday, excluding Federal holidays.
The reference number for this docket is R4-01-02-DOESRSF. The public may copy material from any regulatory docket at no cost for the first 100 pages, and at a cost of $0.15 per page for additional copies. For copying at the South Carolina Department of Health and Environmental Control (SCDHEC), please see below.
For general and technical information concerning this final rule, please contact Judy Sophianopoulos, RCRA Enforcement and Compliance Branch (Mail Code 4WD-RCRA), U.S. Environmental Protection Agency, Region 4, Sam Nunn Atlanta Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303, (404) 562-8604, or call, toll free (800) 241-1754, and leave a message, with your name and phone number, for Ms. Sophianopoulos to return your call. Questions may also be e-mailed to Ms. Sophianopoulos at
The contents of today's preamble are listed in the following outline:
Rule?
A delisting petition is a request made by a hazardous waste generator to exclude one or more of his/her wastes from the lists of RCRA-regulated hazardous wastes in §§ 261.31, 261.32, and 261.33 of Title 40 of the Code of Federal Regulations (40 CFR 261.31, 261.32, and 261.33). The regulatory requirements for a delisting petition are in 40 CFR 260.20 and 260.22. EPA, Region 6 has prepared a guidance manual,
On January 16, 1981, as part of its final and interim final regulations implementing section 3001 of RCRA, EPA published an amended list of hazardous wastes from non-specific and specific sources. This list has been amended several times, and is published in 40 CFR 261.31 and 261.32. These wastes are listed as hazardous because they exhibit one or more of the characteristics of hazardous wastes identified in subpart C of part 261 (
Individual waste streams may vary, however, depending on raw materials, industrial processes, and other factors. Thus, while a waste that is described in these regulations generally is hazardous, a specific waste from an individual facility meeting the listing description may not be. For this reason, §§ 260.20 and 260.22 provide an exclusion procedure, allowing persons to demonstrate that a specific waste from a particular generating facility should not be regulated as a hazardous waste.
To have their wastes excluded, petitioners must show, first, that wastes generated at their facilities do not meet any of the criteria for which the wastes were listed.
In addition, residues from the treatment, storage, or disposal of listed hazardous wastes and mixtures containing listed hazardous wastes are also considered hazardous wastes. See 40 CFR 261.3 (a)(2)(iv) and (c)(2)(i), referred to as the “mixture” and “derived-from” rules, respectively. Such wastes are also eligible for exclusion and remain hazardous wastes until excluded. On December 6, 1991, the U.S. Court of Appeals for the District of Columbia vacated the “mixture/derived-from” rules and remanded them to the EPA on procedural grounds.
On October 10, 1995, the Administrator delegated to the Regional Administrators the authority to evaluate and approve or deny petitions submitted in accordance with §§ 260.20 and 260.22 by generators within their Regions (National Delegation of Authority 8-19) in States not yet authorized to administer a delisting program in lieu of the Federal program. On March 11, 1996, the Regional Administrator of EPA, Region 4, redelegated delisting authority to the Director of the Waste Management Division (Regional Delegation of Authority 8-19).
The United States Department of Energy Savannah River Operations Office (DOE-SR), Aiken, South Carolina (DOE-SR), is seeking a delisting for vitrified radioactive mixed waste (RMW) generated at the Savannah River Site (SRS) in Aiken, South Carolina. The petitioned waste meets the listing definitions of F006 and F028 in § 261.31
F028: “Residues resulting from the incineration or thermal treatment of soil contaminated with EPA Hazardous Waste Nos. F020, F021, F023, F026, and F027.”
The hazardous constituents of concern
DOE-SR petitioned EPA, Region 4, in September 1996 and submitted revised petitions in September 1998 and September 2000, to exclude this F006 and F028 waste, on a one-time, generator-specific basis, from the lists of hazardous wastes in 40 CFR part 261, subpart D.
As a result of the EPA's evaluation of DOE-SR's petition, the Agency proposed to grant a delisting to DOE-SR on March 15, 2002.
DOE-SR petitioned EPA, Region 4, in September 1996 and submitted revised petitions in September 1998 and September 2000, to exclude 538 cubic yards of vitrified F006 and F028 waste and 0.12 cubic yards of cementitious treatability sample F006 waste, on a one-time, generator-specific basis, from the lists of hazardous wastes in 40 CFR part 261, subpart D. DOE-SR treated ten waste streams generated in the Savannah River Site M-Area from 1983 through 1999, by vitrification. The treatment residue of all these streams is the 538 cubic yards of petitioned waste. The 0.12 cubic yards of petitioned waste comes from treatability studies of cementing F006 waste, and is referred to as cementitious treatability samples.
In support of its petition, DOE-SR submitted: (1) Descriptions
Please see the proposed rule, 67 FR 11639-11651, March 15, 2002 for details on DOE-SR's analytical data, vitrification process, and generation process for the petitioned waste. A summary of analytical data was presented in Preamble Section II, Table 1B of the proposed rule (67 FR 11639-11651, March 15, 2002). EPA does not generally verify submitted test data before proposing delisting decisions. The sworn affidavit submitted with this petition binds the petitioner to present truthful and accurate results. The Agency, however, has maintained a spot-check sampling and analysis program to verify the representative nature of data for some percentage of the submitted petitions. A spot-check visit to a selected facility may be initiated before or after granting a delisting. Section 3007 of RCRA gives EPA the authority to conduct inspections to determine if a delisted waste is meeting the delisting conditions.
In today's final rule, EPA is finalizing the delisting exactly as proposed in 67 FR 11639-11651, March 15, 2002. Appendix IX, Table 1 of 40 CFR part 261 is amended as proposed (67 FR 11650-11651). Table 1 below, which is a reproduction of Table 2 of the proposed rule (67 FR 11645-11646), summarizes delisting and risk levels calculated by DRAS for DOE-SR's petitioned waste.
After reviewing the analytical data and information on processes and vitrification feed materials that DOE-SR submitted in the delisting petition, EPA developed a list of constituents of concern and calculated delisting levels and risks using Region 6 Delisting Risk Assessment Software (DRAS) and Dilution Attenuation Factors (DAFs) from the EPA Composite Model for Landfills with Transformation Products (EPACMTP) (67 FR 11639-11651, March 15, 2002). EPA requested public comment on this proposed method of calculating delisting levels and risks for DOE-SR's petitioned waste. No public comments were received.
EPA also requested comment on three additional methods of evaluating DOE-SR's delisting petition and determining delisting levels: (1) Use of the Multiple Extraction Procedure (MEP), SW-846 Method 1320, to evaluate the long-term resistance of the waste to leaching in a landfill; (2) comparing total concentrations of constituents in the waste to the results obtained by DRAS for total concentrations; and (3) comparing concentrations of constituents in the waste and waste leachate to the Land Disposal Restrictions (LDR) Universal Treatment Standards. (1) The MEP results for DOE-SR's petitioned waste indicated long-term resistance to leaching in a landfill. For example, less than 1% of
In today's final rule, EPA is excluding DOE-SR's petitioned waste from being listed as F006 and F028, based on descriptions of waste management and waste history, evaluation of the results of waste sample analysis, and on the requirement that DOE-SR's petitioned waste must be disposed in accordance with the Atomic Energy Act. This exclusion is valid only if the petitioner disposes of the waste in a low-level radioactive waste landfill in accordance with the Atomic Energy Act, as required by the amended Table 1 of appendix IX of 40 CFR part 261. Under these conditions, the petitioned waste is not subject to regulation under 40 CFR parts 262 through 268 and the permitting standards of 40 CFR part 270. Although management of the waste covered by this petition is relieved from Subtitle C jurisdiction, the waste remains a solid waste under RCRA and a low-level radioactive waste under the Atomic Energy Act. As such, the waste must be handled in accordance with all applicable Federal, State, and local solid waste management and low-level radioactive waste regulations. Pursuant to RCRA section 3007, EPA may also sample and analyze the waste to verify reported analytical data.
This final rule is effective on August 21, 2002. The Hazardous and Solid Waste Amendments of 1984 amended section 3010 of RCRA to allow rules to become effective in less than six months when the regulated community does not need the six-month period to come into compliance. That is the case here, because this final rule reduces the existing requirements for the petitioner. In light of the unnecessary hardship and expense that would be imposed on this petitioner by an effective date six months after publication and the fact that a six-month deadline is not necessary to achieve the purpose of section 3010, EPA believes that this exclusion should be effective immediately upon final publication. These reasons also provide a basis for making this rule effective immediately, upon final publication, under the Administrative Procedure Act, pursuant to 5 U.S.C. 553(d).
This final rule is issued under the Federal (RCRA) delisting program. States, however, are allowed to impose their own, non-RCRA regulatory requirements that are more stringent than EPA's, pursuant to section 3009 of RCRA. These more stringent requirements may include a provision which prohibits a Federally issued exclusion from taking effect in the States. Because a petitioner's waste may be regulated under a dual system (
Under section 3006 of RCRA, EPA may authorize qualified States to administer the RCRA hazardous waste program within the State.
After a State receives initial authorization, new Federal requirements promulgated under RCRA authority existing prior to the 1984 Hazardous and Solid Waste Amendments (HSWA) do not apply in that State until the State adopts and receives authorization for equivalent State requirements. The State must adopt such requirements to maintain authorization.
In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), new Federal requirements and prohibitions imposed pursuant to HSWA provisions take effect in authorized States at the same time that they take effect in unauthorized States. Although authorized States are still required to update their hazardous waste programs to remain equivalent to the Federal program, EPA carries out HSWA requirements and prohibitions in authorized States, including the issuance of new permits implementing those requirements, until EPA authorizes the State to do so. Authorized States are required to modify their programs only when EPA promulgates Federal requirements that are more stringent or broader in scope than existing Federal requirements. RCRA section 3009 allows the States to impose standards more stringent than those in the Federal program.
Today's final rule is promulgated pursuant to HSWA authority, and contains provisions that are less stringent than the current Federal program. The final exclusion for DOE-SR's petitioned waste would be less stringent. Consequently, States would not be required to adopt this final exclusion as a condition of authorization of their hazardous waste programs.
No one submitted comments on the proposed rule to EPA.
EPA did not receive any comments.
Under Executive Order 12866, EPA must determine whether a regulatory action is significant and, therefore, subject to comprehensive review by the Office of Management and Budget (OMB), and the other provisions of the Executive Order. A significant regulatory action is defined by the Order as one that may:
EPA has determined that today's final rule is not a significant regulatory action as defined by Executive Order 12866 and is, therefore, not subject to OMB comprehensive review and the other provisions of the Executive Order.
No economic and equity analyses were required in support of the March 15, 2002 proposed rule. The proposed rule applies only to a one-time generated waste at a single facility. Therefore the proposal would have had no generalized effect on industrial compliance costs and would have reduced compliance costs for the single facility, DOE-SR Savannah River Site.
EPA received no public comments on the proposed rule to delist DO-ESR's petitioned waste.
The value of any regulatory action is traditionally measured by the net change in social welfare that it generates. All other factors being equal, a rule that generates positive net welfare would be advantageous to society, while a rule that results in negative net welfare to society should be avoided.
Today's final rule applies to a one-time generated waste at a single facility. Therefore, EPA has determined that the rule is not expected to have any generalized economic, health, or environmental effects on society.
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedures Act or any other statute, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's final rule on small entities, a small entity is defined either by the number of employees or by the annual dollar amount of sales/revenues. The level at which an entity is considered small is determined for each North American Industrial Classification System (NAICS) code by the Small Business Administration (SBA).
EPA has examined the potential effects today's final rule may have on small entities, as required by the RFA/Small Business Regulatory Enforcement Fairness Act (SBREFA). Today's final rule affects a one-time generated waste at a single facility, DOE-SR Savannah River Site. Therefore, EPA has determined and certifies that this rule will not have a significant economic impact on a substantial number of small entities.
Executive Order 12875, “Enhancing the Intergovernmental Partnership” (October 26, 1993), called on federal agencies to provide a statement supporting the need to issue any regulation containing an unfunded federal mandate and describing prior consultation with representatives of affected state, local, and tribal governments.
Signed into law on March 22, 1995, the Unfunded Mandates Reform Act (UMRA) supersedes Executive Order 12875, reiterating the previously established directives while also imposing additional requirements for federal agencies issuing any regulation containing an unfunded mandate.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any single year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted.
Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, the Agency must develop a small government agency plan, as required under section 203 of UMRA. This plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.
Today's final rule is not subject to the requirements of sections 202 and 205 of UMRA. Today's final rule will not result in $100 million or more in incremental expenditures. The aggregate annualized incremental social costs for today's final rule are projected to be near zero. Furthermore, today's final rule is not subject to the requirements of section 203 of UMRA. Section 203 requires agencies to develop a small government Agency plan before establishing any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments. EPA has determined that this final rule will not significantly or uniquely affect small governments.
By applicable executive order, we are required to consider the impacts of today's rule with regard to environmental justice and children's health.
Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Population” (February 11, 1994), is designed to address the environmental and human health conditions of minority and low-income populations. EPA is committed to addressing environmental justice concerns and has assumed a leadership role in environmental justice initiatives to enhance environmental quality for all citizens of the United States. The Agency's goals are to ensure that no segment of the population, regardless of race, color, national origin, income, or net worth bears disproportionately high and adverse human health and environmental impacts as a result of EPA's policies, programs, and activities. In response to Executive Order 12898, and to concerns voiced by many groups outside the Agency, EPA's Office of Solid Waste and Emergency Response (OSWER) formed an Environmental Justice Task Force to analyze the array of environmental justice issues specific to waste programs and to develop an overall strategy to identify and address these issues (OSWER Directive No. 9200.3-17). Today's final rule applies to a one-time generated waste at a single facility. We have no data indicating that today's final rule would result in disproportionately negative impacts on minority or low income communities.
“Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. Today's final rule is not subject to the Executive Order because it is not economically significant, as defined in Executive Order 12866.”
Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”
Today's final rule does not have tribal implications. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in the Order. Today's final rule will not significantly or uniquely affect the communities of Indian tribal governments, nor impose substantial direct compliance costs on them.
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”
Today's final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in the Order. Thus, Executive Order 13132 does not apply to this final rule.
Executive Order 13211, “Actions Concerning Regulations That Affect Energy Supply, Distribution, or Use” (May 18, 2001), addresses the need for regulatory actions to more fully consider the potential energy impacts of the proposed rule and resulting actions. Under the Order, agencies are required to prepare a Statement of Energy Effects when a regulatory action may have significant adverse effects on energy supply, distribution, or use, including impacts on price and foreign supplies. Additionally, the requirements obligate agencies to consider reasonable alternatives to regulatory actions with adverse effects and the impacts the alternatives might have upon energy supply, distribution, or use.
Today's final rule applies to a one-time generated waste at a single facility and is not likely to have any significant adverse impact on factors affecting energy supply. EPA believes that Executive Order 13211 is not relevant to this action.
This final determination does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
This final rule involves evaluation of environmental monitoring or measurement. Consistent with the Agency's Performance Based Measurement System (“PBMS”), EPA proposed not to require the use of specific, prescribed analytical methods, except when required by regulation in 40 CFR parts 260 through 270. Therefore, today's final rule allows the use of any method that meets the prescribed performance criteria. The
The Congressional Review Act, 5 U.S.C. 801
The EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability. Section 804 exempts from section 801 the following types of rules: rules of particular applicability; rules relating to agency management or personnel; and rules of agency organization, procedures, or practice that do not substantially affect the rights or obligations of non-agency parties.
Environmental protection, Hazardous waste, Recycling, Reporting and recordkeeping requirements.
Sec. 3001(f) RCRA, 42 U.S.C. 6921(f).
42 U.S.C. 6905, 6912(a), 6921, 6922, and 6938.
Office of Governmentwide Policy, GSA.
Correction and technical amendment to final rule.
This document makes amendments to the Federal Management Regulation (FMR) in order to correct references and make a technical amendment to the mail management regulations of the FMR.
Effective Date: August 21, 2002.
Laurie Duarte, Regulatory Secretariat, Acquisition Policy Division (MVP), General Services Administration, 1800 F Street, NW., Washington, DC 20405, (202) 208-7312.
Government contracts, Intergovernmental relations, Reporting and recordkeeping requirements, Security measurements.
Sec. 2, Pub. L. 94-575, as amended, 44 U.S.C. 2904; 40 U.S.C. 486(c); Sec. 205(c), 63 Stat. 390.
Grain Inspection, Packers and Stockyards Administration, USDA
Proposed rule.
The Grain Inspection, Packers and Stockyards Administration (GIPSA) is proposing to revise the regulations under the United States Grain Standards Act (Act), as amended, to allow interested persons to specify the quality factor(s) that would be redetermined during a reinspection or appeal inspection for grade. Currently, reinspections and appeal inspections for grade must include a redetermination (i.e., a complete review or examination) of all official factors that may determine the grade, are reported on the original certificate, or are required to be shown. Requiring that all quality factors be completely reexamined during a reinspection or appeal inspection is not efficient, is time consuming, and can be costly. Further, a detailed review of the preceding inspection service is not always needed to confirm the quality of the grain. This proposed action would allow interested parties to specify which official factor(s) should be redetermined during the reinspection or appeal inspection service.
Comments must be received on or before October 21, 2002.
Written comments must be submitted to Tess Butler, GIPSA, USDA, Room 1647-S, Stop 3604, Washington, DC 20250; FAX (202) 690-2755; e-mail,
All comments received will be made available for public inspection in Room 1647-South Building, 1400 Independence Avenue, SW., Washington, DC, during regular business hours (7 CFR 1.27(b)).
John Giler, at (202) 720-1748.
Pursuant to the United States Grain Standards Act (Act) (7 U.S.C. 71
1. Condition factors include heating, odor (musty, sour, and commercially objectionable), infestation, special grade factors (
2. Grade determining factors include, but are not limited to, test weight per bushel, foreign material, damaged kernels, and other classes. These factors are common to most grain. As the percentage of such factors increase (or decreases, as in the case of test weight per bushel), the numerical grade decreases. For example: U.S. No. 2 Hard Red Winter wheat may contain not more than 4.0% total damaged kernels, U.S. No. 3 may contain not more than 7.0%, and U.S. No. 4 may contain not more than 10.0%.
3. Non-grade determining factors include moisture in all grains, dockage in certain small grains, protein in wheat and soybeans, oil in soybeans and sunflower seed, and aflatoxin in corn. The value of each of these factors varies with crop year and end-use. Therefore, except for dockage and moisture, which must always be determined, these factors are only determined upon request.
After the sample has been analyzed for all factors, a grade is assigned to the sample equal to the lowest grade determined for any one of the factors. For example, if all of the factors were determined to be at the U.S. No. 1 level, except for one factor that was at the U.S. No. 3 level, then the lot would be graded U.S. No. 3. Therefore, the final grade assigned to a sample or lot is directly dependent on achieving accuracy (closeness to the true value) and precision (repeatability) in the values obtained for the various grading factors. Accuracy and precision are affected mainly by the type of sampling device, the sampling procedure, and the grading factors; i.e., machine-determined values (objective), human judgement values (subjective), and sample homogeneity (inherent). The sources of variation are highly interrelated; each is involved, to some extent, in the final value ascribed to each grading factor of a lot and to the grade designation of that lot.
Due to inherent sampling and inspection variability, users of the official inspection system have an opportunity to obtain another inspection service when certificated results are questionable. That is, if an interested party disagrees with the grade or factor results assigned to a lot of grain, they may request that the official agency (or in some cases, GIPSA) reinspect the grain or ask GIPSA to perform an appeal inspection. There is a limit, however, on the number of times this can be done. From the original inspection service an interested person may obtain a reinspection service, an appeal inspection service, and a Board Appeal inspection service. The same inspection office that provided the original inspection service provides the reinspection service. The appeal inspection service is handled at one of the GIPSA field offices. The Board of Appeals and Review provides the Board Appeal inspection service, the highest level of inspection service available, in Kansas City, Missouri. The scope of the reinspection or appeal inspection is limited to the scope of the original inspection. Official criteria are considered separately from official grade and official factors when determining kind and scope. If the request specifies a different kind and scope, the request must be dismissed.
Finally, a reinspection certificate supersedes the original inspection certificate and an appeal inspection certificate supersedes the original and reinspection certificate, if a reinspection was performed. The superseded certificate(s) are considered null and void as of the date of the reinspection or appeal inspection certificate, and must be promptly surrendered. If the
For export vessels, a reinspection or appeal inspection may be requested on either the entire lot or on a material portion (
In addition to these restrictions, §§ 800.125 and .135 of the regulations currently require that reinspections and appeal inspections for grade must include a complete review of all official factors that: (1) May determine the grade; or (2) are reported on the original certificate; and (3) are required to be shown. Consequently, even if the official inspector who is performing the reinspection or appeal inspection finds there is only one grade-determining factor, all of the factors that were reported on the original certificate must be redetermined.
In most instances, the applicant for service does not need a complete review. Usually, applicants for a reinspection or an appeal inspection service only question the result of a specific quality factor. This is evidenced by the many applications for reinspections and appeal inspections that request a review inspection of a specific factor. In addition to being unwanted, redetermining all official factors requires significant time to complete. This increases inspection costs and may cause delays in elevator operations.
Various industry groups have indicated that requiring all factors to be completely reviewed on reinspections and appeal inspections is usually unnecessary and always costly. But, others have indicated that the regulations must not allow official personnel to overlook questionable factor results just because the applicant for the inspection does not request that certain factors be redetermined during the course of a review inspection. Both of these views have merit. All official inspections (original, reinspection, or appeal inspection) must be accurate.
To provide effective and efficient official inspection services that better meet industry needs, GIPSA proposes that applicants for service would be allowed to specify the factor(s) that are to be redetermined as part of a reinspection or an appeal inspection service. However, reinspections for grade, appeal and Board appeal inspections for grade may include a review of any pertinent factor(s), as deemed necessary by official personnel. If there is an indication that a factor (or factors) may have been misgraded or overlooked on the previous inspection, then the factor(s) in question will be redetermined.
Under the current regulations, when official grade or official factor and official criteria are reported on the same certificate, a reinspection or appeal inspection certificate is required to show a special statement. The special statement indicates that the reinspection results or appeal or Board appeal inspection results represent the official grade, official factors or official criteria and that all other results are those of the original, reinspection, or, in the case of a Board appeal, the appeal inspection service. In formulating this proposal, GIPSA considered requiring reinspection and appeal inspection certificates to show a statement that would identify which factors were determined during the review inspection(s) and which were determined on a preceding inspection. GIPSA has not included such additional certification requirements in this proposal. However, GIPSA is seeking comments specifically about this issue, particularly from those who are currently using official inspection services.
GIPSA proposes to revise § 800.125 to allow requests for reinspection to be limited to one or more grade or condition factors, and to revise § 800.135 to allow requests for appeal inspections to be limited to one or more grade or condition factors. In addition, GIPSA is proposing to revise §§ 800.125 and 800.135 to simplify the wording of both regulations.
This proposed rule has been determined to be significant for purpose of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget (OMB). In addition, pursuant to requirements set forth in the Regulatory Flexibility Act (RFA)(5 U.S.C. 601
The proposed rule will affect entities engaged in shipping grain to and from points within the United States and exporting grain from the United States. GIPSA estimates there are approximately 9,500 off-farm storage facilities and 57 export elevators in the United States that could receive official inspection services by GIPSA, delegated States, or designated agencies. Official inspection services are provided by 12 GIPSA field offices, 2 Federal/State offices, 7 GIPSA suboffices, 8 delegated States, and 59 designated agencies. Under provisions of the Act, it is not mandatory for non-export grain to be officially inspected. Further, most users of the official inspection services and those entities that perform these services do not meet the requirements for small entities. Even though some users could be considered small entities, this proposed rule relieves regulatory requirements and improves the efficiency of official inspection services. No additional cost is expected to result from this action.
Requiring all reinspections and appeal inspections for grade to include a complete review of all official factors is not needed by applicants or other parties to transactions, or by official inspection personnel. Furthermore, this requirement often reduces the efficiency of providing official inspection services and may cause unnecessary delays in elevator operations. Allowing applicants to specify which official factor(s) are to be redetermined during the reinspection or appeal inspection service will improve the efficiency of the inspection service due to the time required to analyze all official quality factors.
Prior to developing this proposed rule change, GIPSA considered restricting the proposed action to either appeal
GIPSA inspectors, who are assigned to specific GIPSA field offices, are the only ones who can perform appeal inspections. Currently, GIPSA has only fourteen field offices and less than 200 full-time GIPSA inspectors nationwide. Most domestic inspection services are provided by official agencies and not by GIPSA field offices. Therefore, applicants for service usually opt for a reinspection, rather than requesting an appeal inspection. (
Licensed inspectors employed by state or private official agencies perform most reinspections. GIPSA only performs reinspections at certain export port locations. GIPSA believes that if the proposed action were limited to reinspections, more applicants for service could potentially benefit than limiting the proposed action to appeal inspections. Some applicants, however, might be placed at a competitive disadvantage because their sales contracts require them to request appeal inspections on some or all original inspection services. Additionally, about ten percent of all reinspections are appealed. If the grading procedures for appeals are different from the preceding reinspection, the review inspection process is not similar for all levels of the review inspection process.
The review inspection process should provide all applicants the same opportunity for inspection services. Reinspection services and appeal inspection services should be similar in scope and effect. For this reason, GIPSA decided to propose the regulatory change that would favorably affect both the reinspection process and the appeal inspection process.
The cost savings of the proposed action on the grain industry could be very positive. Although it is impossible to estimate an exact dollar savings, the time spent waiting for inspection results could be reduced by at least 50 percent and could, in certain circumstances, exceed 90 percent. Since grain elevators often “idle” their load-out operations until the results of a reinspection or appeal are known, domestic shippers could save several hundred dollars in operation and demurrage costs on an average 100-car unit train. The savings for exporters could reach $10,000 for some vessels. For example: If elevator X has a fixed operating cost of $500 an hour and it takes an average of 30 minutes to perform a reinspection or appeal inspection, then each reinspection or appeal will cost the elevator an additional $250 in down time. If the time required to perform the reinspection or appeal is reduced to 15 minutes, the elevator saves $125 per inspection due to the more efficient inspection service. These savings could be multiplied if the time saved on performing the reinspections or appeals allows the elevator to avoid or limit demurrage (
The potential revenue impact of the proposed action on GIPSA and official agencies should not be significant. In the long run, this proposed rule may encourage slightly more reinspection and appeal inspection services because of the increased efficiencies associated with the proposal. However, GIPSA does not believe that its net revenue will significantly change. GIPSA routinely reviews the agency's revenue and cost of service as part of its ongoing fee review process. If inspection services and revenue from those services change significantly, GIPSA may determine a change in fees is needed and would do so as part of a fee proposal.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have a retroactive effect. This rule will not preempt any state or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. There are no administration procedures that must be exhausted prior to any judicial challenge to the provision of this rule.
Pursuant to Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations,” GIPSA has considered potential civil rights implications of this proposed rule on minorities, women, or persons with disabilities to ensure that no person or group will be discriminated against on the basis of race, color, sex, national origin, religion, age, disability, or marital or familial status. The proposed rule will apply in the same manner to all persons and groups whose activities are regulated, regardless of race, gender, national origin, or disability. Preliminary information indicates that the proposal will have no effect on protected populations. GIPSA will make wide distribution of this proposal and will address all comments in the final rulemaking.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Administrative practice and procedure, Grains.
For reason set out in the preamble, GIPSA proposes to amend 7 CFR part 800 as follows:
1. The authority citation for part 800 continues to read as follows:
Pub. L. 94-582, 90 Stat. 2867, as amended (7 U.S.C. 71
2. Section 800.125 (b) is revised to read as follows:
(b)
3. Section 800.135(b) is revised to read as follows:
(b)
Bureau of Industry and Security, Commerce.
Request for comments.
The Bureau of Industry and Security (BIS) is requesting public comments on the effectiveness of its licensing procedures as defined in the Export Administration Regulations for the export of agricultural commodities to Cuba. BIS is required to submit a biennial report to the Congress on the operation of the licensing system for such exports, which was created to implement the Trade Sanctions Reform and Export Enhancement Act of 2000. To help make this assessment, BIS is seeking public comments on the effectiveness of these measures.
Comments must be received by September 20, 2002.
Written comments (three copies) should be sent to Sheila Quarterman, Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, P.O. Box 273, Washington, DC 20044. Comments may also be e-mailed to Brian Nilsson, Office of Strategic Trade and Foreign Policy Controls, at
Joan Roberts, Director, Foreign Policy Controls Division, Bureau of Industry and Security, Telephone: (202) 482-5400. Additional information on BIS procedures is available under the heading “Trade Sanctions Reform and Export Enhancement Act” at
The current procedures of the Bureau of Industry and Security (BIS) for authorizing the export of agricultural commodities to Cuba are set forth in § 740.18 of the Export Administration Regulations (EAR). Under the provisions of section 906(c) of the Trade Sanctions Reform and Export Enhancement Act of 2000 (TSRA) (Pub. L. 106-387), as amended, BIS must submit a report to the Congress on the operation of the licensing system under Section 906 of TSRA for the preceding two-year period. This report is to include the number and types of licenses applied for, the number and types of licenses approved, the average amount of time elapsed from the date of filing of a license application until the date of its approval, the extent to which the licensing procedures were effectively implemented, and a description of comments received from interested parties about the extent to which the licensing procedures were effective, after holding a public 30-day comment period. This notice serves as public notice to solicit such comments.
Parties submitting comments are asked to be as specific as possible. All comments received by the close of the comment period will be considered by BIS in developing the report to Congress. All information relating to the notice will be a matter of public record and will be available for public inspection and copying. In the interest of accuracy and completeness, BIS requires written comments. Oral comments must be followed by written memoranda, which will also be a matter of public record and will be available for public review and copying.
Copies of the public record concerning these regulations may be requested from: Bureau of Industry and Security, Office of Administration, U.S. Department of Commerce, Room 6883, 1401 Constitution Avenue, NW., Washington, DC 20230; (202) 482-0637. This component does not maintain a separate public inspection facility. Requesters should first view BIS's website (which can be reached through
Customs Service, Department of the Treasury.
Notice of proposed rulemaking.
This document proposes to amend the Customs Regulations to reflect a planned closure of the Customs Drawback Centers located at the ports of Boston, Massachusetts; Miami, Florida; and New Orleans, Louisiana. Because of a sustained decrease in the number of drawback claims and the amount of drawback payments, Customs is proposing a consolidation of the Drawback Program. The closing of the three Drawback Centers is part of the planned consolidation and is intended to promote operational efficiency in the processing of drawback claims.
Comments must be received on or before September 20, 2002.
Written comments (preferably in triplicate) may be submitted to the U.S. Customs Service, Office of Regulations & Rulings, Attention: Regulations Branch, 1300 Pennsylvania Avenue NW., Washington, DC 20229. Submitted comments may be inspected at the U.S. Customs Service, 799 9th Street, NW., Washington, DC, during regular business hours. Arrangements to inspect submitted comments should be made in advance by calling Mr. Joseph Clark at (202) 572-8768.
Sherri Hoffman, U.S. Customs Service, Entry and Drawback Management, (202) 927-0300.
Since 1996, Customs has recognized a decrease in both the number of drawback claims and the amount of drawback payments. To verify these trends, and to determine how to most efficiently operate the Drawback Program, Customs conducted an internal evaluation of the program. Customs also retained the services of an independent contractor to review the Drawback Program to ensure that the agency's findings were valid.
The findings of both the agency-led review and the independent contractor's assessment indicated the benefits of consolidating the processing of drawback claims by reducing the number of Drawback Centers.
In a Notice to Congress on March 12, 2001, filed in accordance with 19 U.S.C. 2075, Customs proposed the closure of four Drawback Centers. The Senate Finance and House Ways and Means Committees concurred with the proposal for consolidation, but with the recommendation that only three Drawback Centers be eliminated and the San Francisco Drawback Center remain operational. The Commissioner of Customs concurred with this recommendation and it was proposed to phase-in the closure of the Drawback Centers located at the ports of Boston, MA; Miami, FL; and New Orleans, LA. The remaining five Drawback Centers, located at the ports of New York, NY/Newark, NJ; Houston, TX; Chicago, IL; Los Angeles, CA; and San Francisco, CA would remain operational.
To assist the remaining five Drawback Centers in accommodating an increased number of drawback claims, it is proposed to phase-in the closing of the three Drawback Centers. If, after further consideration and review of any comments submitted in response to the solicitation of comments set forth in this document, Customs decides to adopt as a final rule these proposed changes, it is proposed to phase-in the closing of the Drawback Centers as follows:
(1) The first Drawback Centers to close would be the centers at the ports of Boston, Massachusetts and New Orleans, Louisiana. These two centers would close 30 days from the date a final rule adopting these proposed changes is published in the
(2) The third Drawback Center to close would be the one located at the port of Miami, Florida. This center would close 180 days from the date a final rule adopting these proposed changes is published in the
In order to file a drawback claim at one of the five remaining Drawback Centers, a claimant would be required to possess either a district permit for the location at which the claim will be filed or a national permit. Claimants are reminded that a national permit requires use of the Automated Broker Interface of Customs Automated Commercial System when filing drawback claims. Claimants must ensure that all permit, license and bond requirements are met in accordance with the regulations.
Throughout the staged consolidation period, claimants would be required to provide Customs with advance notification of any changes in the information provided regarding a drawback claim. This notification must be provided in accordance with part 191 of the Customs Regulations (19 CFR part 191).
Section 101.3(b)(1) of the Customs Regulations lists the Customs ports of entry. Eight ports are denoted with an asterisk that designates their status as a “Drawback unit/office.” This document proposes to amend § 101.3(b)(1) to delete the asterisks in § 101.3(b)(1) next to the port listings for Boston, Miami and New Orleans.
Before adopting this proposal as a final rule, consideration will be given to any written comments timely submitted to Customs, including comments on the clarity of this proposed rule and how it may be made easier to understand. Comments submitted will be available for public inspection in accordance with the Freedom of Information Act (5 U.S.C. 552), § 1.4 of the Treasury Department Regulations (31 CFR 1.4), and § 103.11(b) of the Customs Regulations (19 CFR 103.11(b)), on regular business days between the hours of 9 a.m. and 4:30 p.m. at the Regulations Branch, Office of Regulations and Rulings, U.S. Customs Service, 799 9th Street, NW., Washington, DC.
Although this document is being issued with notice for public comment, because it relates to agency management and organization, it is not subject to the notice and public procedure requirements of 5 U.S.C. 553. Accordingly, this document is not subject to the Regulatory Flexibility Act (5 U.S.C. 601
Agency organization matters, such as this proposed closing of three Customs Drawback Centers, are not subject to Executive Order 12866.
The principal author of this document was Ms. Suzanne Kingsbury, Office of Regulations and Rulings, U.S. Customs Service. However, personnel from other offices participated in its development.
Customs duties and inspection, Customs ports of entry.
For the reasons stated above, it is proposed to amend part 101 of the Customs Regulations (19 CFR part 101) as follows:
1. The general authority citation for part 101 continues to read as follows:
5 U.S.C. 301; 19 U.S.C. 2, 66, 1202 (General Note 23, Harmonized Tariff Schedule of the United States), 1623, 1624, 1646a.
Section 101.3 and 101.4 also issued under 19 U.S.C. 1 and 58b;
2. In § 101.3, the table in paragraph (b)(1) is amended by removing the plus sign in the “Ports of entry” column before the column listings for “Miami” under the state of Florida, “New Orleans” under the state of Louisiana, and “Boston” under the state of Massachusetts.
Food and Drug Administration, HHS.
Proposed rules; withdrawal.
The Food and Drug Administration (FDA) is announcing the withdrawal of two proposed rules. One proposed rule, which appeared in the
The proposed rules are withdrawn August 21, 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.
On November 24, 1998, FDA published a proposed rule in the
On January 22, 2001, FDA and the Department of the Treasury jointly prescribed a proposed rule in the
We received comments on both rules and also held public meetings to discuss the proposed rule on the marking of refused food imports. After reviewing the comments, we wrote and intended to issue final rules in 2002.
On June 12, 2002, the President signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188). The new law contains provisions that change the legal context of the two proposed FDA regulations
The new law also significantly revises section 801(d)(3) of the act; it prescribes new reporting requirements that differ from those in the FDA proposed rule.
Because of the changes brought about by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, FDA is withdrawing both proposed rules. FDA will consider whether new rulemakings or other actions are necessary to implement the new statutory requirements.
Food and Drug Administration, HHS.
Proposed rule; correction.
The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the
Submit written or electronic comments by October 28, 2002.
Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments at http://www.fda.gov/dockets/ecomments. All comments should be identified with the docket number found in brackets in the heading of this document.
Doris B. Tucker, Office of Policy, Planning, and Legislation (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.
In FR Doc. 02-20300, appearing on page 52429 in the
1. On page 52429, in the third column, in the seventh line “§ 201.323©” is corrected to read “§ 201.3239(c)”.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective analgesic/antipyretic active ingredient for OTC use. FDA is also proposing to amend its regulations to include consistent allergy warnings for OTC IAAA drug products containing nonsteroidal anti-inflammatory active ingredients. These proposals are in response to a citizen petition (Ref. 1) and to a comment submitted in response to that petition (Ref. 2) and are part of the ongoing review of OTC drug products conducted by FDA.
Submit written or electronic comments by November 19, 2002. Submit written or electronic comments on the agency's economic impact determination by November 19, 2002. Please see section XII of this document for the effective date of any final rule that may publish based on this proposal.
Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
Ida I. Yoder, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.
A. Use for a Material Time and to a Material Extent
B. Safety
C. Effectiveness
D. Labeling
Ibuprofen is benzeneacetic acid, α-methyl-4-(2-methylpropyl), (±)-, a member of the propionic acid class of nonsteroidal anti-inflammatory drugs (NSAIDs). The commercially available drug is a racemic mixture of two optical isomers (S-[+] and R-[-] ibuprofen). The racemic mixture is recognized in the U.S. Pharmacopeia (U.S.P.) (Ref. 3). Ibuprofen has been available as a prescription drug for the treatment of osteoarthritis and rheumatoid arthritis at a dose of 1,200 to 3,200 milligrams (mg) per (/) day since 1974 in the United States and since 1969 in the United Kingdom. Ibuprofen has also been marketed by prescription and OTC in numerous countries throughout the world (Ref. 4).
Safety and effectiveness data submitted to the agency to support the approval of the OTC marketing of a 200-mg ibuprofen tablet were considered by the Arthritis Advisory Committee (AAC)
The AAC suggested warnings and precautions that it believed should appear in labeling to alert individuals to certain risks, especially those individuals who should not use ibuprofen without the supervision of a physician. The AAC was concerned that the promotion of OTC ibuprofen not counteract a warning regarding ibuprofen's cross-reactivity with aspirin (Ref. 5). The agency's approved labeling for ibuprofen includes warnings for aspirin sensitive individuals and people taking other OTC pain reliever/fever reducer products (Ref. 6).
On October 17, 1983, a citizen petition (Ref. 7) was submitted that requested the agency to reopen the administrative record for OTC IAAA drug products to amend the proposed monograph to include ibuprofen as an internal analgesic ingredient in a 200-mg tablet with a maximum 1,200-mg total daily dose. The agency denied the petition on May 18, 1984 (Ref. 8) for several reasons, one of which (use for a material time and to a material extent) is discussed in section III.A of this document.
In the
Subsequent to the TFM, the agency received a citizen petition (Ref. 1) requesting that the TFM be amended to include racemic ibuprofen in an oral dosage form, as a single active ingredient. The petition recommended a minimum effective dose of 200 mg ibuprofen for use by adults and children 12 years and older. The petition requested the same indications as proposed for other monograph IAAA active ingredients in § 343.50(b)(1) (21 CFR 343.50(b)(1)): “For the temporary relief of minor aches and pains associated with a cold, sore throat, headache, toothache, muscular aches, backache, premenstrual and menstrual cramps (dysmenorrhea), and for the minor pain from arthritis, and to reduce fever.”
The petition requested warnings specific for the OTC use of ibuprofen, including the following warning, in this form, or in a different format conveying the same information:
ASPIRIN SENSITIVE PATIENTS: Although this product does not contain aspirin, it may cause a severe reaction in people allergic to aspirin. Do not take ibuprofen if you have had any of the following reactions to any pain reliever/fever reducer:
• allergic reaction
• shock
• hives
• difficulty breathing
• asthma
• swelling
If you are under a doctor's care for any serious condition, consult a doctor before taking this product. As with aspirin and acetaminophen, if you have any condition which requires you to take prescription drugs or if you have had any problems or serious side effects from taking any nonprescription pain reliever, do not take this product without first discussing it with your doctor. IF YOU EXPERIENCE ANY SYMPTOMS WHICH ARE UNUSUAL OR SEEM UNRELATED TO THE CONDITION FOR WHICH YOU TOOK IBUPROFEN, CONSULT A DOCTOR BEFORE TAKING ANY MORE OF IT. Although ibuprofen is indicated for the same conditions as aspirin and acetaminophen, it should not be taken with them except under a doctor's direction. Do not combine this product with any other ibuprofen-containing product.
The petition also suggested the following directions for use:
Adults: Take 200 mg every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 200 mg, 400 mg may be used but do not exceed 1,200 mg in 24 hours, unless directed by a doctor. The smallest effective dose should be used. Take with food or milk if occasional and mild heartburn, upset stomach, or stomach pain occurs with use. Consult a doctor if these symptoms are more than mild or if they persist. Children: Do not give this product to children under 12 years of age except under the advice and supervision of a doctor.
The petition asserted that ibuprofen has been marketed for a material time and to a material extent. To support this statement, the petition presented information indicating that from May 1984 (when ibuprofen first became available OTC in the United States) through 1996 over 90 billion 200-mg tablet doses were sold (Ref. 1). The petition noted that more than 20 companies now market OTC ibuprofen drug products and provided information to show that the sale of OTC ibuprofen in the United States is comparable to that of aspirin and acetaminophen. Thus, the petitioner said, given the enormous volume of sales and more than 13 years of marketing, ibuprofen has been available as an OTC drug product for a material time and to a material extent, is now generally recognized as safe and effective, and is no longer a new drug. The petition did not request monograph status for ibuprofen for children under 12 years of age.
The petition (Ref. 1) included a summary of safety and effectiveness data (through 1982) previously submitted to FDA to support the prescription-to-OTC switch of ibuprofen. That summary included effectiveness data for ibuprofen for analgesic (dysmenorrhea, dental, musculoskeletal, postpartum and postsurgical pain, and headache), antipyretic, and anti-inflammatory use and a safety overview of specific organ systems, special populations, and postmarketing data. The petition (Ref. 1) also included the results from a search of the worldwide medical literature from 1983 through August 1996 of adverse events associated with ibuprofen, mostly in the OTC dosage range.
The published studies and case reports included in the petition involved mainly OTC doses of ibuprofen (less than or equal to 1,200 mg/day) for an OTC-indicated duration (less than 10 days use for pain, or 3 days for fever) that occurred in generally healthy individuals, 12 years of age or older. The agency's comments on the citizen petition are on file in the Dockets Management Branch (Ref. 9). The petitioner subsequently submitted additional information in support of ibuprofen's safety profile (Ref. 10), which included publications from 1990 through 1998, generated from a number of databases.
The agency also received a comment opposing the petition's request to include ibuprofen in the TFM (Ref. 2). The petition, related correspondence, additional information, and the opposing comment are on public
One comment (Ref. 2), opposing the petition's request, stated there is: (1) A lack of a general recognition of safety and effectiveness of all oral ibuprofen dosage forms, (2) a significant potential for use of OTC ibuprofen products at prescription dosage levels, and (3) a continued need for adverse event reporting and other marketing controls. Therefore, the comment contended, ibuprofen (200 mg) should remain subject to the NDA process.
The comment suggested that allowing marketing of ibuprofen (200 mg) in any “suitable” oral dosage form (as provided for in the TFM) creates a potential for consumer harm. As examples, the comment mentioned several risks if ibuprofen would be included in the monograph: (1) Changes in product composition and manufacturing methods that would not be subject to prior FDA review, and (2) possible misuse of ibuprofen products due to the concurrent marketing of ibuprofen suspensions (one marketed under a monograph for adults and the other marketed under the new drug approval process and labeled for children).
The comment also criticized the data included in the petition. The comment observed that although data on adverse events in prescription dosages is relevant to the consideration of whether an ingredient is appropriate for inclusion in the monograph, the petition submitted only information on adverse effects at OTC doses. The comment asserted that ingestion of larger doses (2,400 to 3,600 mg) has not been seen due to the relative expense of the OTC tablets. The comment contended that the lowered prices that would result from monograph status of ibuprofen (200 mg) could increase the potential for harm because prescription ibuprofen users may be enticed to switch to OTC drug products and self-medicate at prescription dose levels without a doctor's supervision. The comment did not provide any data to support its assertions.
The agency agrees with the opposing comment (Ref. 2) that ibuprofen is not generally recognized as safe and effective in all dosage forms. For instance, ibuprofen in suspension formulation for adult use has not been marketed OTC, and children's formulations have been marketed OTC less than 5 years. Thus, these formulations are not generally recognized as safe and effective for OTC use. In some studies evaluating the effectiveness of ibuprofen, capsule formulations were used as a means of blinding the studies. However, ibuprofen has been marketed OTC for adult use almost entirely in tablet formulations (i.e., tablets, caplets, and gelcaps (a tablet dosage form)) throughout its marketing history. Thus, current evidence for ibuprofen to be generally recognized as safe and effective for OTC use is only sufficient for tablet formulations. This proposal does not include liqui-gel formulations (ibuprofen solubilized in a gel matrix).
The comment raised a concern about the potential for OTC ibuprofen to be used at prescription-dose levels. Currently approved NDA and abbreviated new drug application (ANDA) labeling for OTC ibuprofen drug products contains directions for appropriate OTC dosing. Products marketed under an OTC drug monograph will contain the same directions. Further, both the NDA/ANDA and the proposed monograph labeling alert consumers of the hazards associated with improper use and when to seek the advice of a physician. Given that the comment did not include any data to support its concern, the agency finds no basis to believe that the potential for misuse of these OTC ibuprofen drug products will be greater if their marketing status is changed from an NDA/ANDA to OTC drug monograph.
The agency appreciates the comment's concern for the need for continued adverse event reporting and other marketing controls. The safety of ibuprofen has been monitored since it was first marketed in the United States under the new drug approval process (as a prescription drug in 1974 and as an OTC drug in 1984) and as a generic drug (for prescription use in 1985 and for OTC use in 1986). The agency monitors the quality of products marketed under OTC drug monographs through its current good manufacturing practice regulations in part 211 (21 CFR part 211) and its inspection authority. Based on the available data, the agency finds the safety profile of ibuprofen to be comparable to that of other OTC internal analgesics (e.g., aspirin and acetaminophen) that have been proposed as generally recognized to be safe for OTC use.
During ibuprofen's extensive OTC marketing history significant formulation and manufacturing issues have not arisen. The agency does not anticipate any potential problems if ibuprofen, in specific tablet formulations, is included in the monograph for adult use. Specifications for ibuprofen tablets are recognized in the U.S.P. (Ref. 3). Although there is some degree of risk associated with the use of any OTC drug, whether marketed through the NDA/ANDA process, as a generic drug, or under an OTC drug monograph, the agency believes ibuprofen 200 mg in a tablet dosage form for adult use has been marketed safely OTC for a sufficient time and extent that it can be generally recognized as safe and effective for OTC use.
In 1984, the agency denied a petition (Ref. 7) to include ibuprofen in the OTC IAAA monograph because the request was for a new dosage strength (200 mg) which the agency determined had not been used to a material extent and for a material time in the United States and, thus, was considered a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)). The petitioner had contended that ibuprofen had been available in the United States since 1974 as a prescription drug with more than 18.8 billion cumulative 400-mg doses of the drug distributed worldwide through August 1982, and that the drug is currently the fourth largest prescription drug by volume in the United States. In its denial letter (Ref. 8), the agency pointed out that experience with ibuprofen at prescription strength is pertinent to the drug's safety, but such experience cannot support general recognition that the product, at a different strength and daily dose, can be used safely and effectively by the patient alone. The agency concluded that the petition ignored the lack of experience with the proposed single 200-mg tablet dose as an OTC drug product.
Since that time, the current petition (Ref. 1) points out that from May 1984 (when ibuprofen 200-mg first became available OTC in the United States) through 1996 over 90 billion 200-mg tablet doses were sold. That number has substantially increased since 1996. The agency has determined that ibuprofen's 17 years of OTC marketing with over 100 billion doses of 200-mg tablets sold shows that the drug at this dosage and in this dosage form as an internal analgesic and antipyretic has been used for a material time and to a material extent to qualify it for inclusion in an OTC drug monograph.
a.
Newly weaned male and female rats were given 180, 60, 20, and 7.5 mg/kg/day ibuprofen by oral gavage for 26 weeks (Ref. 12) . Rats receiving ibuprofen grew normally except for male rats receiving the 180-mg/kg/day dose which gained significantly less weight than controls. When examined hematologically in the final week of dosing, both males and females on the 180 mg/kg/day dose were anemic as evidenced by low erythrocyte counts, hemoglobin concentrations, and hematocrits. Significant increases in the weights of the kidney, liver, and spleen occurred in both sexes. Histologic examination of the tissues revealed no significant changes except for one male and three female rats in the 180-mg dose group (10 animals/sex/group) that had intestinal ulcers.
In a followup experiment (Ref. 12) to determine if the changes observed in the 26-week study were reversible, male and female rats were given 180, 60, and 20 mg/kg/day for 13 weeks. The day after dosing ended, half the animals in each group were sacrificed and the rest were kept undosed for 3 weeks. Generally, the results from this experiment were supportive of the 26-week study. Males given 180 mg/kg/day had enlarged kidneys, spleen, and testes. A dose-dependant enlargement of the kidney occurred in females. An enlargement of the liver and ovaries occurred in females on 180 mg/kg/day, and of the spleen and ovaries in females on 60 mg/kg/day. None of the enlarged organs were histologically abnormal. These changes were found to be reversible 3 weeks after the end of dosing.
No significant hematological or biochemical alterations were observed in dogs (two dogs/sex/group) given 16, 4, or 2 mg/kg/day ibuprofen (administered as two doses 6 hours apart) for 26 weeks (Ref. 12). In the eighth week of dosing, female dogs in the high-dose group showed gross signs of gastrointestinal (GI) disturbance characterized by frequent vomiting, diarrhea (with occasional passage of fresh blood), and loss of blood. Occult blood was irregularly detected in fecal samples obtained from all dogs in the high-dose group from day 8 on. At autopsy, organ weights were normal and pathologic changes were limited to ulcerative lesions of the GI tract.
The effects of ibuprofen on reproduction have been studied in rats and rabbits (Ref. 12). Rats were administered 180, 60, 20, or 7.5 mg/kg/day ibuprofen on days 1 through 20 of pregnancy. All litters were of normal size and weight. No difference in the incidence of fetal malformations was found between the treated and control groups.
A reproduction study in rabbits (Ref. 12) at doses of 60, 20, or 7.5 mg/kg/day was conducted on days 1 through 29 of pregnancy. Female rabbits given 60 mg/kg/day had fewer live fetuses per litter than did controls, but there was no significant difference in the number of dead and resorbed rabbits per litter. However, there was a reduction in the ratio of implants to corpora lutea, which suggested that the decrease in live litter size was due to interruption of early pregnancy. The average fetal weight was normal. At the lower doses, the litter size was unaffected. Apart from four young in one litter (60 mg/kg/day) with multiple malformations characteristic of cyclopia, there was no consistent pattern of dose-related malformations. The authors concluded that ibuprofen is not teratogenic but may reduce fertility by affecting early pregnancy at the high dose.
The labeling of ibuprofen drug products currently marketed under an NDA/ANDA includes the general pregnancy/breast-feeding warning in § 201.63(a) (21 CFR 201.63(a)) advising that a health professional should be consulted before use. It also includes a statement like that required for aspirin drug products in § 201.63(e), which warns that it is especially important not to use the product during the third trimester of pregnancy because it could cause problems in the unborn child and complications during delivery. The agency is proposing to expand the warning in § 201.63(e) to include ibuprofen. (See section V, number 1 of this document.)
b.
The pharmacokinetics of ibuprofen have been well documented (Ref. 20). The absorption of orally administered ibuprofen is rapid and approximately 80 percent of the dose is absorbed from the GI tract. Peak plasma levels in humans are reached between 45 and 90 minutes after administration of a single oral dose on an empty stomach, depending upon the formulation (Ref. 21). The extent of absorption is unchanged when ibuprofen is taken with meals (Ref. 22).
Following oral administration, the apparent plasma volume of distribution has been reported to be between 0.1 to 0.2 liter (L)/kg, which approximates plasma volume and suggests minimal tissue binding is present (Refs. 23 and 24). Ibuprofen is extensively bound (more than 98 percent) to whole human plasma and purified serum albumin at therapeutic concentrations, and may participate in plasma protein binding displacement reactions (Refs. 25 and 26). The apparent volume of distribution, based on total concentration, increases significantly with dose, but there is no attendant change in free drug volume of distribution (Ref. 27). The protein binding of ibuprofen is similar between normal individuals and people with osteoarthritis and rheumatoid arthritis and is not influenced by age or gender (Refs. 28 and 29).
Plasma concentrations of ibuprofen appear to decline in a biphasic manner with a plasma half-life of 2 to 4 hours for the racemate (Ref. 20). Ibuprofen is metabolized via oxidation by the cytochrome P-450 enzyme CYP 2C9 to form two inactive metabolites, hydroxy- and carboxypropyl-phenylpropionic acid (Refs. 30 and 31). These metabolites (or their glucuronide conjugates) are excreted in the urine and account for about 50 to 60 percent of the oral dose administered (Refs. 32 and 33). Less than 10 percent of the drug is excreted in urine unchanged (Ref. 32). The remainder is eliminated in the feces, as metabolites and unabsorbed drug. Excretion of ibuprofen is essentially complete within 24 hours following oral administration of a single dose (Ref. 33). While total clearance may be affected by age, no dosage adjustment is needed in the elderly (Ref.
Ibuprofen is neither an inducer or an inhibitor of cytochrome P-450 mediated metabolism. At doses above those recommended for OTC use (1,200 mg daily, in divided doses), ibuprofen may decrease the renal excretion of some drugs due to ibuprofen's ability to interfere with renal prostaglandin synthesis necessary for normal renal function. This interference in the renal elimination of other drugs can be estimated by following the net reduction in creatinine clearance. Ibuprofen can cause an increase in blood pressure in hypertensive patients being treated with diuretics alone or diuretics combined with other agents (Ref. 36).
The petition (Ref. 1) and a subsequent submission (Ref. 10) provided extensive published clinical data on the safety of OTC use of ibuprofen. The data provide a safety profile typical of other OTC drugs in the NSAID class.
a.
Additional support in favor of ibuprofen's overall gastric tolerability was generated in a recent study by Moore et al. (Ref. 40), which evaluated the tolerability of ibuprofen (1,200 mg/day) and acetaminophen (up to 3 grams (g)/day) to that of aspirin (up to 3 g/day). This study was a large, blinded, randomized, multicenter, 7-day analgesic study conducted in France in 8,677 adults with mild to moderate pain due to a variety of conditions. Although the incidence for significant (serious, severe, or moderate) adverse events (including all body systems) for the ibuprofen treated group (13.7 percent) was comparable to that of the acetaminophen treated group (14.5 percent), both drugs were shown to be significantly better tolerated than aspirin (18.7 percent; p < 0.001 via a one-sided 96.5 percent confidence interval (CI)). A total of six subjects reported having GI bleeds during this study, four from the acetaminophen group and two from the aspirin group, one of whom developed peptic ulcer. Overall, treatment with ibuprofen was associated with fewer significant adverse GI events than aspirin (p < 0.001) or acetaminophen (p < 0.02). The incidences of abdominal pain and dyspepsia were both significantly lower in the ibuprofen group as compared with the aspirin (p < 0.001) or acetaminophen (p < 0.02) groups. Although this study was designed to approximate the general population who would use OTC doses and durations of these three analgesics, its selection criteria prohibited any individual with known risk factors for GI bleeding from participating. Thus, selection bias may have been introduced and resulted in a lower incidence of GI adverse events than what may be seen in the general population at risk.
In a retrospective, nested, case-controlled study of Medicaid enrollees, Griffin et al. (Ref. 41) compared the relative risk (RR) for the development of peptic ulcer disease (PUD) in 1,415 subjects 65 years and older who were current nonaspirin NSAID users to nonusers. Eighty-three of the 1,415 subjects who were hospitalized due to PUD during the period studied were identified as having been exposed to OTC doses (1,200 mg) of ibuprofen. The overall RR for the development of PUD in this group was found to be 2.3 (95 percent CI: 1.8 to 3.0). Further examination by dose revealed that in 70 subjects exposed to doses less than 2,400 mg ibuprofen the RR for the development of PUD was 2.2 (95 percent CI: 1.7 to 2.9), and in 13 subjects exposed to 2,400 mg or greater the RR increased to 3.3 (95 percent CI: 1.7 to 6.5).
Bradley et al. (Ref. 42) conducted a 4-week, double-blind, randomized trial in 184 subjects comparing the effectiveness and safety of the maximum approved OTC daily dose of 1,200 mg of ibuprofen (number of subjects (n) = 62) to that of a prescription dose of 2,400 mg/day (n = 61), and to 4,000 mg/day of acetaminophen (n = 59) for the treatment of osteoarthritis. While there were no significant differences in the number of side effects reported during this study, the study demonstrated a trend towards a dose-dependent increase in minor GI adverse events (nausea and dyspepsia) associated with higher doses of ibuprofen (1,200 mg/day: 7/62 or 11.3 percent; versus 2,400 mg/day: 14/61 or 23 percent). In addition, two subjects treated with 2,400 mg/day of ibuprofen became positive for occult blood while participating in the study.
Although these studies (Refs. 41 and 42) demonstrate that a dose-dependent relationship exists for ibuprofen-induced gastrotoxicity, the number of subjects exposed to OTC doses of ibuprofen (1,200 mg or less a day) is too small to draw valid conclusions. Further, the study results may also be confounded since the studies did not control for other risk factors (i.e., smoking, alcoholism, concomitant use of corticosteroids and anticoagulants, advanced age, prior history of PUD, or deteriorated general health status) which are known to increase the risk of developing GI bleeding while using NSAIDs. In addition, the results of the retrospective study (Ref. 41) may be biased because the exposure data from that study were generated from records of prescriptions written for both the study and control populations rather than what was actually used by the subjects.
In a matched, case-controlled, international study of upper gastrointestinal bleeding (UGIB), Kaufman et al. (Ref. 43) evaluated the association between regular and occasional NSAID use and the risk of major UGIB in subjects hospitalized with their first major UGIB. Subjects were asked about their history of NSAID use, and details of timing, duration, frequency, and the daily dose of each episode of use. The focus of the data analysis was on NSAID use in the week immediately before the day of onset of bleeding. Exposure was defined as any use in the week before the index day. No evidence of an association of gastric bleeding with either regular use (n = 9; RR: 1.0 [95 percent, 0.4 to 2.6]) or occasional use (n = 14; RR 1.1 [95 percent, 0.5 to 2.4]) of ibuprofen was identified in this study. Among the cases of gastric bleeding, the median ibuprofen dose was 2,332 mg. The RR for developing a duodenal bleed with regular use (n = 7) of ibuprofen was 2.4 (95 percent, 0.5 to 11), the median daily ibuprofen dose ingested was 1,074 mg.
Strom et al. (Ref. 44) did a retrospective, case-controlled study in a Medicaid population generated database and evaluated the risk of developing GI bleeding associated with the use of OTC-simulated doses of naproxen sodium (600 mg/day or less) versus ibuprofen (1,200 mg/day or less). (At the time of the study, naproxen sodium was not yet approved for OTC use.) Although this study demonstrated that the overall incidence of UGIB associated with either the use of naproxen sodium [0.026 percent (95 percent CI, 0.017 percent to 0.038 percent)] or ibuprofen [0.012 percent (95 percent CI, 0.008 percent to 0.017 percent)] at simulated OTC doses was relatively low, the RR for developing an UGIB was approximately twofold higher for the
Endoscopic data (Refs. 45 and 46) demonstrated that while ibuprofen produced less GI mucosal toxicity or gastric injury than other NSAIDs, low doses of ibuprofen produced lesions in some subjects. In a study by Bergmann et al. (Ref. 45), endoscopic lesions of 12 healthy volunteers were evaluated after the administration of single doses of ketoprofen (25 mg), ibuprofen (200 mg), and aspirin (500 mg), and rated on a scale of 0 to 4. Endoscopic scores for ketoprofen were comparable to those for ibuprofen. After a single dose of ibuprofen 200 mg, eight subjects had endoscopic scores of 0, one had a score of 1, and three had scores of 2. For ketoprofen, nine subjects had a score of 0, two had a score of 2, and one had a score of 3.
Lanza (Ref. 46) conducted an endoscopic study of normal volunteers without histories of PUD. Subjects were prohibited from using alcohol and other NSAIDs for the week before and during the study. Ingestion of 1,200 mg/day of ibuprofen for 7 days produced a gastric injury score of 0.46 (on a scale of 0 to 4) and a 0 ulcer incidence rate in the 13 subjects studied. However, an increase in the ibuprofen dose to 1,600 mg/day for 7 days under the same conditions produced ulcers in 5 out of the 55 (9.1 percent) subjects studied, and an injury score of 1.24.
A chromium 51-labeled fecal blood loss study (Ref. 47) indicated that after 5 days of treatment with either ibuprofen 1,500 mg/day, aspirin 1,500 mg/day, lysine clonixinate 375 mg/day, or placebo, the fecal blood loss in subjects treated with ibuprofen was significantly less than the aspirin treated group. Nevertheless, treatment with ibuprofen lead to a small increase in mean daily blood loss of +0.52 milliliter (mL)/day.
These studies indicate that ibuprofen, at OTC doses, has a low level of GI toxicity but is not entirely devoid of such toxicity. The agency believes that even this low level of toxicity could increase the risk of GI bleeding in people who have other risk factors for developing GI bleeding. Therefore, the agency is proposing including a warning in the labeling of OTC ibuprofen to alert individuals at risk for GI problems associated with the use of the product. The warning would include: “Ask a doctor before use if you have: • stomach problems that last or come back, such as heartburn, upset stomach, or pain • ulcers • bleeding problems”.
b.
The petition (Ref. 1) included a summary package that was prepared for the August 18, 1983, AAC meeting in which ibuprofen 200 mg was considered for OTC marketing. The summary included safety data generated from clinical trials and supportive evidence from a review of then-published case reports of ibuprofen-associated nephrotoxicity. The summary concluded that although ibuprofen does cause cyclo-oxygenase mediated renal toxicity like other members of the NSAID class, the reversibility of this condition is dependent upon its recognition and the discontinuation of the drug, particularly when it occurs in those at risk, such as the chronically ill or the elderly (Ref. 39).
In support of ibuprofen’s renal safety profile, four studies (Refs. 50 through 53) that evaluated the prostaglandin-mediated effects of OTC doses of ibuprofen (≤ 1,200 mg a day) on renal function were reviewed. In a crossover study, Farquhar (Ref. 50) evaluated the renal effects of ibuprofen (1,200 mg daily) and acetaminophen (4 g daily) versus a placebo in 12 healthy men (n = 6) and women (n = 6) who were subjected to progressive renal stress. Subjects were on a low-sodium diet, on limited exercise, and given a drug or placebo for 3 days and the morning of day four. On day four, the participants were subjected to treadmill exercise, in the heat, to cause dehydration. The combined stressors caused decreases in effective renal plasma flow, glomerular filtration rate (GFR), and sodium excretion. Baseline GFR (range 118 to 123 mL/minute (min) decreased to 73 ± 5, 78 ± 4, and 82 ± 5 mL/min, post-exercise, in the ibuprofen, acetaminophen, and placebo groups, respectively, with a significantly greater decrease in GFR for ibuprofen than placebo (p < 0.05). The decrease in GFR for the acetaminophen group was not significantly different from placebo. The authors attributed the lower GFR that occurred in the ibuprofen arm of the study to renal prostaglandin inhibition by the drug.
In a randomized, disease-controlled study, Ciabattoni et al. (Ref. 51) evaluated the prostacyclin-mediated effects on GFR and renal blood flow of 20 women with chronic glomerular disease versus 19 normal healthy control subjects following 7 days of treatment with ibuprofen (1,200 mg daily) versus sulindac (400 mg daily). In the 10 subjects with renal insufficiency who were given ibuprofen, the serum creatinine level was increased by about 40 percent and the creatinine and para-aminohippurate clearances were decreased by 28 ± 7 and 35 ± 8 percent, respectively, during treatment (p < 0.01). Renal function returned to baseline values after ibuprofen was discontinued, although the serum creatinine and creatinine clearance were still significantly altered up to 5 days after ibuprofen was stopped.
Welton et al. (Ref. 52) evaluated the renal effects of ibuprofen (800 mg three times daily), piroxicam (20 mg daily), and sulindac (200 mg twice daily) in an 11-day, randomized, triple crossover study of 12 women with asymptomatic, mild, stable, chronic renal failure with serum creatinine ranging from 130 to 270 micromoles (μmol)/L. Although all the subjects were able to complete courses of treatment with piroxicam and sulindac, three subjects developed acute decreases in renal function with an elevation in their renal parameters that met the study criteria for stopping (defined as an increase in serum creatinine of 130 μmol/L or more, or a serum potassium value of more than 6 millimole/L (mmol/L)) by the eighth day of treatment with ibuprofen. When these three subjects were rechallenged with ibuprofen, 400 mg three times a day, two again developed acute deterioration of renal function. The authors
In contrast, Furey et al. (Ref. 53) did a 7-day, double-blind, randomized study comparing the renovascular effects of ibuprofen (400 mg three times daily) versus that of aspirin (650 mg three times daily) and acetaminophen (650 mg three times daily) in 25 elderly subjects with mild renal insufficiency, and hypertension controlled with thiazide diuretics. Although the mean baseline serum creatinine levels for all three treatment groups were comparable, the mean baseline serum creatinine clearances were higher in both the acetaminophen (78.9 ± 8.3 mL/min) and aspirin (67.1 ± 6.4 mL/min) treatment groups as compared to the ibuprofen group (56.3 ± 5.3 mL/min). On analysis, this was not found to be statistically different. This study failed to demonstrate any statistically significant changes in the five renal parameters (serum creatinine, creatinine clearance, blood urea nitrogen (BUN), serum potassium and sodium) evaluated in any of the three treatment groups.
The three studies by Farquhar (Ref. 50), Ciabattoni et al. (Ref. 51), and Welton et al. (Ref. 52) demonstrated that, at an OTC dose of ibuprofen (1,200 mg daily), hemodynamic changes in the kidney do occur in subjects with prostaglandin-dependent states, which can lead to diminished renal function. The inability of the study by Furey et al. (Ref. 53) to demonstrate any significant deterioration in any of the renal parameters studied may be due to the fact that the subjects who participated in this study may not have had severe enough renal disease as manifested by the mildly elevated range of their baseline mean serum creatinine from 1.4 ± 0.08 mg/deciliter (dL) to 1.5 ± 0.07 mg/dL to demonstrate ibuprofen’s prostaglandin-dependent renal effects. Thus, despite their histories of hypertension and the concomitant use of diuretics, these subjects may also have had adequate renal reserves to compensate for any ibuprofen-mediated decreases in their renal function.
The largest study involving an OTC dose of ibuprofen that included monitoring of renal function was the 4-week study by Bradley et al. (Ref. 42). This study compared the effectiveness of low-dose (1,200 mg daily) and high-dose (2,400 mg daily) ibuprofen and acetaminophen (4,000 mg daily) in the treatment of osteoarthritis in 184 subjects. Side effects were similar in all three groups. The serum creatinine level increased by more than 17 μmol/L (0.2 mg/dL) in four of the subjects receiving low-dose ibuprofen, six receiving high-dose ibuprofen, and one receiving acetaminophen. As a group, the serum creatinine concentration increased only slightly (2.7 μmol/L) in the high-dose ibuprofen group (p = 0.04), but there was no increase in the low-dose group. Although this trial is the only study which compared a low-dose (i.e., OTC dose) to a high-dose (i.e., prescription-strength dose) ibuprofen and could possibly be interpreted as a dose-ranging study for the renal effects of ibuprofen-mediated prostaglandin inhibition, the subjects who were entered into this trial were healthy with a mean age of 55.7 ± 13.7 to 57.2 ± 11.7 years. Exclusion criteria prohibited participation by subjects with medical conditions that contraindicated the use of the study medications. Thus, the study subjects were not reflective of the population identified at risk for developing this type of nephrotoxicity.
The petition included numerous case reports (Refs. 54 through 61) of renal failure associated with the use of OTC doses of ibuprofen in people with normal renal function. Four cases (Refs. 54 through 57) described the syndrome of acute flank pain with reversible renal failure following short-term doses of 1,200 mg, or less, of ibuprofen. One (Ref. 54) of these four cases was confounded by the concomitant use of alcohol, and one (Ref. 55) used alcohol and acetaminophen, both of which can cause nephrotoxicity. Four reports (Ref. 58 through 61) described cases of idiosyncratic drug-induced types of renal failure. One of the cases (Ref. 61) discussed a case of idiosyncratic hypersensitivity reaction in an elderly man who experienced acute renal failure twice; once after taking ibuprofen orally and, again, a few years later, after using a topical formulation of ibuprofen. Renal function returned to normal in all eight people after medical therapy. The agency is aware of additional case reports of patients who developed renal toxicity after taking ibuprofen (Refs. 62 through 66).
In 1996, the National Kidney Foundation published a position paper in which it recommended that consumer labeling of OTC analgesic drug products contain warnings directed to the population at risk for the development of nephrotoxicity associated with the use of these products (Ref. 67). These recommendations were based on the review of a database that contained 556 articles on aspirin, acetaminophen, aspirin/acetaminophen combinations, and NSAID-related renal disease by an ad hoc group of expert investigators and clinicians. This committee suggested the following consumer warning for OTC NSAID-containing products:
DO NOT TAKE THIS PRODUCT WITHOUT PHYSICIAN SUPERVISION IF: (1) You are allergic to aspirin; (2) you are under a physician’s care for asthma or stomach problems (such as heartburn); (3) you take diuretic medicine; (4) you have heart disease, high blood pressure, kidney disease, or liver disease; (5) you are over 65 years of age.
The information contained in the literature review and case reports submitted in support of this petition confirms that OTC doses of ibuprofen can exert a variety of renal adverse effects, particularly in those who are predisposed by prostaglandin-dependent states. Although the sporadic nature of the idiosyncratic drug-induced type of ibuprofen nephrotoxicity makes it impossible to predict which group of individuals is at risk for developing this type of adverse event, this is not the case with individuals who experience prostaglandin-driven hemodynamic changes in renal function. The latter, if recognized, is reversible following discontinuation of the drug. Thus, based on the information reviewed, the agency concurs with the recommendations made by the National Kidney Foundation that the consumer labeling for OTC ibuprofen should have a warning directed at those at risk for the development of acute renal failure associated with the use of the product. The agency is proposing a warning that includes: “Ask a doctor before use if you have: • high blood pressure, heart or kidney disease, are taking a diuretic, or are over 65 years of age”.
c.
In a retrospective, crossover cohort study, Garcia-Rodriguez et al. (Ref. 70) evaluated the risk of developing serious, acute, noninfectious liver injury associated with the use of NSAIDs. One of the 16 subjects was identified as having NSAID-induced hepatitis: A 93-year-old male who developed cholestatic jaundice after taking 1,200
In a review of FDA postmarketing data of NSAID-induced hepatotoxicity, Katz et al. (Ref. 71) noted that while ibuprofen is known to cause idiosyncratic metabolic toxicity of the liver, ibuprofen and ketoprofen were found to have the lowest reported calculated incidences of hepatotoxicity (0.55 percent and 0.56 percent respectively) of all NSAIDs evaluated at that time. Due to the limitations of FDA’s reporting requirements, the authors were unable to estimate separately the incidence of this phenomena associated with OTC doses of ibuprofen. Given the available information, the agency sees no need to propose a hepatitis warning at this time.
d.
e.
Hypersensitivity reactions were also reported in one individual (Ref. 80) with general allergies (including a known aspirin sensitivity), in one individual (Ref. 82) with systemic lupus erythematosus, and in three individuals (Refs. 83, 84, and 85) with no apparent underlying illnesses (one (Ref. 84) had taken aspirin just prior to the reaction). The petition also included an abstract of a report of challenge testing with ibuprofen (Ref. 87) in 42 people with histories of allergies to various analgesic agents. Five people experienced anaphylactic reactions to incremental doses of up to 500 mg of ibuprofen. Eleven of 33 subjects had similar reactions to aspirin. The agency is proposing an “Allergy alert” warning and additional allergy warning statements for all OTC drug products containing NSAID IAAA active ingredients. (See section IV of this document.)
f.
g.
h.
The petition analyzed adverse event data from the FDA SRS for all single-ingredient OTC ibuprofen drug products marketed in the United States for the time period from May 1984 through July 1996. Adverse reaction reports associated with a generic OTC ibuprofen drug product marketed under an ANDA or prescription ibuprofen drug products used at OTC doses were excluded from this analysis. A total of 8,168 case reports associated with 16,627 adverse events in the SRS database attributed to the use of single-ingredient, nongeneric OTC ibuprofen were thus identified. The total number of adverse events was greater than the total number of case reports because some case reports included more than one adverse reaction associated with the use of the drug.
The petitioner screened the electronic records of all case reports for confounding factors. Reports were
The 592 serious nonconfounded case reports included 7 deaths associated with the use of OTC ibuprofen (2 GI, 1 hematological effects, 2 anaphylaxis, 1 miscarriage, and 1 in utero exposure resulting in the postpartum death of an encephalic infant). As shown above in table 1 of this document, the largest number of adverse events involved the GI system. Of the 236 nonconfounded serious case reports related to the GI system, 94 were GI hemorrhage, 52 were various ulcerations, 32 were melena, 25 were abdominal pain, and 20 were hematemesis. This additional evidence supports the need for a GI tract warning in the consumer labeling of OTC ibuprofen drug products.
FDA queried its AERS database for reports of renal failure in adults, over 16 years of age, associated with the use of OTC doses of ibuprofen for the period extending from the time of initial approval for OTC marketing (May 18, 1984) through August 10, 1999 (Ref. 129). For completeness, a search of the AERS database was also done for reports of renal failure in people 16 years of age and under. Fourteen cases of renal failure were identified in this population. In 8 of the 14 cases, a children's suspension formulation was used while, in the remaining 6 cases, 200-mg tablets were reportedly ingested. After excluding cases involving prescription dosages, overdoses, or duplication, there were a total of 80 cases of renal failure in adults over 16 years of age associated with the use of 1,200 mg, or less, of ibuprofen a day. Although 37 of these 80 cases had positive dechallenges with the discontinuation of ibuprofen (which is supportive of the reversibility of this drug-induced adverse event), 9 cases required dialysis treatment. Of these 80 cases, 56 were severe enough to require hospitalization, with 9 reported deaths, out of which 5 listed ibuprofen-induced renal failure as a contributing cause of death. Hypertension (16), pre-existing renal insufficiency (8), diabetes (7), other cardiac problems (8), alcoholism (3), and hepatic disease (2) were some of the most commonly concurrent medical disorders reported. In addition, 15 people were reported to have been taking diuretics prior to developing renal failure. These cases further support the need for consumer labeling directed at those individuals with predisposing medical conditions for the development of ibuprofen-induced prostaglandin-dependent renal toxicity. (See section III.B.2.b of this document.)
The petition (Ref. 1) also included data on ibuprofen from the Toxic Exposure Surveillance System (TESS) collected by the AAPCC from 1987 to 1996. During that time, TESS reported only 9 fatalities from 163,948 OTC ibuprofen exposures compared to 450 fatalities from 312,618 acetaminophen exposures, and 401 fatalities from 153,495 aspirin exposures. The supplemental submission (Ref. 10) included additional information on the nine deaths, reports of seven additional deaths related to OTC ibuprofen in 1997, and three other deaths related to OTC or prescription-strength ibuprofen that occurred in 1996.
Of these 19 deaths, 14 were classified as intentional suicides. One person ingested 165 tablets of 200-mg strength ibuprofen and the other 13 ingested other drugs in combination with OTC ibuprofen. Of the remaining five cases, one was classified as a therapeutic error in a person with a history of alcoholism and hepatic disease waiting for a liver transplant, who reportedly took “excessive” amounts of acetaminophen and ibuprofen for pain. This person's death was attributed to chronic hepatic failure associated with ethanol and
Another case was reported as intentional misuse in a patient with a history of chronic alcoholism, cirrhosis, and portal hypertension who developed acute liver failure following the chronic use of ibuprofen and acetaminophen. Another case of reported intentional misuse involved a patient with a history of drug abuse who reportedly ingested 27 tablets containing 100 mg propoxyphene napsylate and 650 mg acetaminophen and 50 tablets of ibuprofen (strength not specified) over a 16- to 48-hour period. The remaining two cases were listed as adverse drug reactions in young children. Thus, a large majority of the deaths were suicidal overdoses or intentional abuse associated with the concomitant use of other drugs, and should not be directly attributed to ibuprofen. A few of the cases could have been due to allergic reactions related to ibuprofen use. An allergy warning is required to appear in the labeling of OTC ibuprofen drug products marketed under an NDA/ANDA to alert consumers of that risk.
The petition (Ref. 1) included eight journal articles (Refs. 53 and 130 through 135) that described clinical trials involving a variety of antihypertensive agents (i.e., calcium channel blockers, angiotensin converting enzyme inhibitors, and triamterene-hydrochlorothiazide) in chronically treated and elderly hypertensive patients with renal insufficiency who took OTC doses of ibuprofen. The studies did not demonstrate any diminished antihypertensive effectiveness when these drugs were coadministered with ibuprofen. This is in contrast to the diminution in the effectiveness of a variety of antihypertensive medications such as beta-blockers, ACE inhibitors, hydralazine, and diuretic agents in patients who use prescription doses of NSAIDs (Ref. 136).
Based on the evaluation of available information, the agency concludes ibuprofen is generally recognized as safe for OTC use by adults and children 12 years of age and older, if the labeling includes appropriate warnings and directions for use. The agency is proposing to include warnings to alert individuals of the potential for renal and GI problems associated with the use of ibuprofen. For consistency in labeling, the agency is also proposing to include the same allergy alert warning statements in the labeling of all OTC NSAID products.
The reports of clinical effectiveness trials submitted in the petition (Ref. 1) compared OTC doses of ibuprofen to aspirin, acetaminophen, and/or codeine-containing analgesic compounds. The petition identified a number of double-blind, randomized clinical trials, either placebo or active controlled. Most of the studies are generally applicable to the indications proposed in § 343.50 of the TFM for other OTC internal analgesic/antipyretic drug products (e.g., dental pain, pain of arthritis, dysmenorrhea, headache, and sore throat). Nineteen studies (Refs. 137 through 155) were placebo-controlled, and the reports concluded that ibuprofen, at the OTC doses studied, was a more effective analgesic agent than placebo. The authors of these studies (Refs. 137 through 155) and three active-controlled trials (Refs. 156, 157, and 158) also reported that, at the OTC doses studied, ibuprofen was either comparable to or more effective than aspirin, acetaminophen, and various strengths of codeine-containing analgesics or other NSAIDs tested. The pain models included in the studies were dental, headache, episiotomy, sore throat, and dysmenorrhea. One report (Ref. 159) described the results of two randomized, double-blind, parallel studies that compared the antipyretic effectiveness of ibuprofen to aspirin in adults, which showed effectiveness of both the 200- and 400-mg doses of ibuprofen.
The only dosage forms used in the trials and identified in the reports were tablets, caplets, and capsules. Some of the reports did not identify the dosage form. Table 2 of this document summarizes the placebo-controlled and active-controlled trials the agency reviewed to demonstrate the effectiveness of OTC doses of ibuprofen for various pain and fever models.
The agency has evaluated the reports and agrees that the studies support the effectiveness of ibuprofen as an OTC drug product for a variety of pain and fever models. These studies support the general recognition of racemic ibuprofen as an effective internal analgesic/antipyretic drug at a minimum dose of 200 mg every 4 to 6 hours.
Internal analgesic/antipyretic drug products containing ibuprofen have been marketed for OTC use under the NDA/ANDA process for many years with indications for use and warnings similar to those proposed in § 343.50(b) and (c) of the TFM for other OTC internal analgesic/antipyretic drug products. In the
In addition to the indications approved for currently marketed OTC ibuprofen 200-mg products, the proposed labeling in the TFM for other internal analgesic/antipyretic drug products includes an indication for sore throat in § 343.50(b)(1). The agency will discuss the proposed sore throat indication for all of these drug products in a future issue of the
The approved labeling of OTC drug products containing aspirin, ibuprofen, ketoprofen, and naproxen sodium as active ingredients, marketed under the NDA/ANDA process, includes an “Allergy alert” warning and additional allergy warning statements under the headings “Do not use” and “Stop use and ask a doctor if” (see table 3 of this document). These allergy warning statements are similar to the allergy warnings requested in the petition. Proposed labeling for OTC drug products containing aspirin ingredients in § 343.10(b) and (c) (21 CFR 343.10(b) and (c)) of the TFM also includes an allergy warning in § 343.50(c)(1)(iv), which states: “Do not take this product if you are allergic to aspirin or if you have asthma unless directed by a doctor.” For those products containing salicylate active ingredients in § 343.10(d) through (f) the proposed warning in § 343.50(c)(1)(vi) of the TFM states: “Do not take this product if you are allergic to salicylates (including aspirin) unless directed by a doctor.”
The Advisory Review Panel on OTC Internal Analgesic and Antirheumatic Drug Products (the Panel) proposed allergy warnings for aspirin. In discussing the safety of OTC aspirin use (42 FR 35346 at 35397 through 35399, July 8, 1977), the Panel concluded that in sensitive individuals aspirin produces allergic type reactions, that include: (1) Rash, (2) swelling, (3) hives and giant hives, (4) shortness of breath to severe asthma attacks, and (5) anaphylactic shock involving laryngeal swelling and a precipitous drop in blood pressure. The Panel provided a detailed discussion of the importance of an aspirin hypersensitivity warning (42 FR 35346 at 35397). The Panel noted that the incidence of hypersensitivity reactions (dermal and pulmonary) has been estimated to be about 0.2 percent of the general population, but that as much as 20 percent is found in some subgroups (asthmatics and people with chronic urticaria). Thus, the Panel concluded that these adverse effects occur in a significant proportion of the population and they can be serious and even life-threatening in some instances.
The Panel suggested an asthmatic response to aspirin is nonimmunologic and related to the inhibition of prostaglandin synthesis, and noted that cross-sensitivity is commonly seen with other prostaglandin synthesis inhibitors including indomethacin, flufenamic acid, mefenamic acid, ibruprofen, and phenylbutazone. The Panel suggested dermal hypersensitivity is an immunologic response, and that these individuals also appear to be susceptible to anaphylaxis and more susceptible to cross-sensitivity to salicylic acid and acetaminophen (42 FR 35346 at 35398). The Panel concluded, based on the known risk of aspirin and salicylate hypersensitivity in a significant portion of the general population, that these products should bear warnings alerting consumers who are allergic to these products to consult a doctor before using the products (42 FR 35346 at 35499). The agency has determined that a consistent approach is needed for all OTC NSAID drug products. As discussed in section IV of this document, the agency is proposing standardized allergy alert and warning statements for all OTC NSAID IAAA drug products.
In the safety discussion above (sections III.B.2.a, III.B.2.b, III.B.2.d, and III.B.3), the agency noted that the use of ibuprofen has some risk for certain individuals. GI bleeding may be increased for certain at-risk individuals (i.e., people with ulcers). For people taking anticoagulants, the risk for GI bleeding is already increased, and the use of ibuprofen by those individuals is likely to further increase that risk. Individuals with certain medical conditions are at increased risk for developing renal failure. The agency believes individuals need to be alerted to these risks. The agency is proposing that the labeling of ibuprofen include warnings related to GI bleeding, use of anticoagulant drugs, and medical conditions that predispose individuals to renal failure, using the standardized labeling format for OTC drug products.
After reviewing the information submitted and other relevant information, FDA has determined that ibuprofen 200-mg tablets have been used for a material time and to a material extent to qualify for inclusion in an OTC drug monograph. Therefore, FDA is proposing that ibuprofen, in 200-mg tablet formulation, be generally recognized as safe and effective as an OTC IAAA drug for adults and children 12 years of age and older. The safety and effectiveness of ibuprofen are further supported by the data the agency evaluated in two NDAs in 1983, the findings of the AAC in 1983, and the subsequent marketing history of ibuprofen for OTC use. The agency believes ibuprofen can be marketed OTC under the monograph system for the indications previously approved under the NDA/ANDA process for adult formulations if labeled with the appropriate warnings and directions for use. The agency agrees with the petition that the proposed labeling should only include adults and children 12 years of age and older. The agency is proposing to amend the TFM for OTC IAAA drug products to include ibuprofen 200 mg, in tablet formulation, in § 343.10(g) as a safe and effective ingredient for the relief of pain and fever in adults and children 12 years of age and older, and to include specific warnings and directions for use in § 343.50(c) and (d), similar to those suggested by the petition and those approved by FDA for currently marketed OTC ibuprofen drug products under the new drug review process. The proposed labeling is in a different format than that requested by the petition. However, the format is consistent with the new OTC labeling format in § 201.66, which was issued after the petition was submitted. In addition to the warnings already included in the labeling for OTC ibuprofen drug products under the NDA/ANDA process, the agency is proposing warning statements related to GI and renal problems and use of anticoagulant drugs.
The agency also tentatively concludes that, for consistency, the “Allergy alert” and additional allergy warning statements required for ibuprofen, ketoprofen, and naproxen sodium should be extended to all OTC NSAID IAAA drug products, whether marketed under an OTC drug monograph or an NDA/ANDA. These standardized allergy alert and warning statements (in proposed § 201.324) would provide the following information:
(a) Allergy alert: [insert name of active ingredient (first letter of first word for ingredient in uppercase)] may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock
(b) Do not use: • if you have ever had an allergic reaction to any other pain reliever/fever reducer [This statement appears as the first warning under the subheading “Do not use.”]
(c) Stop use and ask a doctor if: • an allergic reaction occurs. Seek medical help right away. [These statements appear as the first warning under the subheading “Stop use and ask a doctor if.”]
Should this proposed amendment to part 201 relating to allergy warning statements for OTC IAAA drug products be published as a final rule, then the proposed allergy warnings in §§ 343.50(c)(1)(iv)(A), (c)(1)(vi), (c)(2)(iv)(A), and (c)(2)(vi) will be replaced with a reference to the allergy warning requirements in proposed § 201.324. Final agency action on this proposal will occur in a future issue of the
1. The agency is proposing to amend the third-trimester pregnancy warning to include OTC drug products containing ibuprofen.
2. The agency is proposing to require an “Allergy alert” and additional allergy warning statements for all OTC drug products containing NSAID IAAA active ingredients—including, but not limited to, aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, and sodium salicylate. (See section III of this document.)
3. The agency is proposing to add a definition for ibuprofen in § 343.3.
4. The agency is proposing to add § 343.10(g) to include ibuprofen as an active ingredient.
5. The agency is proposing to reword the statements in § 343.20(b)(2) providing for the combination of any analgesic/antipyretic in § 343.10 and cough-cold products and in § 343.20(b)(4) providing for the combination of any analgesic in § 343.10 and diuretic drug products to provide for combinations with specific IAAA active ingredients (but not including ibuprofen). The petition did not include data for the safety and effectiveness of ibuprofen in combination with these ingredients, nor did it request ibuprofen, as a combination drug product, to be included in the TFM.
6. The agency is proposing to revise the headings in proposed § 343.50(b)(1), (c)(1)(i), and (c)(2)(i) from “For products containing any ingredient in § 343.10.” to “For products containing any ingredient in § 343.10(a) through (f)” to limit those paragraphs to specific active ingredients (not including ibuprofen).
7. The agency is proposing to add § 343.50(b)(5) to include indications for ibuprofen.
8. The agency is proposing to revise the phrase related to allergy in the allergy/asthma warning for adults in proposed § 343.50(c)(1)(iv)(A) to read as follows: “Do not use this product if you have asthma unless directed by a doctor”. Similarly, for products labeled for children in § 343.50(c)(2)(iv)(A) the agency is proposing to revise the warning to read as follows: “Do not give this product to children who have asthma unless directed by a doctor”.
9. The agency is proposing to revise the warning in proposed § 343.50(c)(1)(iv)(B) to reference the pregnancy/breast-feeding warnings in § 201.63(a) and (e).
10. The agency is proposing to revise the warnings in § 343.50(c)(1)(iv)(A), (c)(1)(vi), (c)(2)(iv)(A), and (c)(2)(vi) for adults and children, respectively, to require the allergy warning statements in proposed § 201.324 for products containing any ingredient in § 343.10(b) through (g). (The allergy part of the previously proposed allergy/asthma warning in § 343.50(c)(1)(iv)(A) is now covered by proposed § 201.324.)
11. The agency is proposing the following warnings for drug products containing ibuprofen in § 343.10(g) labeled for use by adults:
(a) The “Allergy alert” warnings in proposed § 201.324(a), (b), and (c).
(b) The alcohol warning in § 201.322(a)(2).
(c) The following statements after the subheading “Ask a doctor before use if you have:
• problems or serious side effects from taking pain relievers or fever reducers
• stomach problems that last or come back, such as heartburn, upset stomach, or pain
• ulcers
• bleeding problems
• high blood pressure, heart or kidney disease, are taking a diuretic, or are over 65 years of age”.
(d) The following statements after the subheading “Ask a doctor or pharmacist before use if you are:
• under a doctor's care for a serious condition
• taking any other product that contains ibuprofen, or any other pain reliever/fever reducer
• taking a prescription drug for anticoagulation (blood thinning)
• taking any other drug”.
(e) The following statement after the subheading “When using this product take with food or milk if stomach upset occurs”.
(f) The following statements after the subheading “Stop use and ask a doctor if:
• an allergic reaction occurs. Seek medical help right away.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• stomach pain or upset gets worse or lasts
• redness or swelling is present in the painful area
• any new symptoms appear”.
(g) The pregnancy/breast-feeding warning in § 201.63 of this chapter.
(h) The “Keep out of reach of children” warning in § 330.1(g).
12. The agency is proposing the following directions for ibuprofen in § 343.10(g):
“• do not take more than directed [in bold type]
• adults and children 12 years and over:
• 200 milligrams
• if pain or fever does not respond to 200 milligrams
• do not exceed 1,200 milligrams
• the smallest effective dose should be used
• children under 12 years: ask a doctor”.
In the
Ibuprofen may be marketed only under an approved drug application prior to completion of a final rule for OTC IAAA drug products.
The agency encourages manufacturers to comply voluntarily with the provisions of this proposed rule for the labeling of OTC NSAID IAAA drug products that do not contain ibuprofen and that are marketed under an OTC drug TFM prior to the completion of a final rule, despite the fact that revisions in the requirements may occur in the final rule in response to submitted comments. Such labeling may be disseminated pending issuance of a final rule, subject to the risk that the agency may, in the final rule, adopt a different position that could require relabeling, recall, or other regulatory action. Should any manufacturer choose to adopt the labeling described in this proposed rule, and should any revisions occur in the final rule, the agency will permit the use of existing stocks of
FDA has examined the impacts of this proposed rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501
The agency believes that this proposed rule is consistent with the principles set out in the Executive order and in these two statutes. OMB has determined that the proposed rule is a significant regulatory action as defined by the Executive order. This economic analysis, together with other relevant sections of this document, serves as the agency's initial regulatory flexibility analysis, as required under the Regulatory Flexibility Act.
The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for this proposed rule, because the proposed rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation adjusted statutory threshold is about $110 million.
The purpose of this proposed rule is to include ibuprofen in the monograph for OTC IAAA drug products and to require consistent “Allergy alert” and additional allergy warning statements in the labeling of all OTC NSAID IAAA products. As most OTC NSAID IAAA products will be marketed under the final OTC IAAA monograph, these products will not have to include the allergy warnings in this proposal in product labeling until the final monograph is issued and becomes effective.
Current manufacturers of OTC 200-mg ibuprofen drug products should incur only minor one-time costs to relabel their products to meet the monograph. These costs may be offset by the elimination of the cost to maintain a market application, such as filing annual reports and submitting manufacturing supplements. Other manufacturers who may wish to market OTC 200-mg ibuprofen drug products would be able to enter the marketplace without the costs associated with obtaining an approved NDA/ANDA. Their costs would be those associated with the standard startup of any OTC drug marketed under the monograph system.
This proposed rule amends part 201 (21 CFR part 201) and will require relabeling for many OTC drug products containing NSAID IAAA ingredients. Most manufacturers that market such products under an approved NDA/ANDA already include the proposed “Allergy alert” and allergy warning statements in the product's labeling. Some manufacturers of these products, however, would have to revise the “Allergy alert” and allergy warning statements to conform to the proposed labeling. In addition, manufacturers of monograph products containing NSAID IAAA ingredients will have to relabel and include the revised allergy warnings in accord with the compliance dates specified in the IAAA products final rule. However, these allergy warnings are only one part of the overall labeling changes that will occur at that time when IAAA products are required to implement the standardized format and content requirements in § 201.66. The agency does not believe the proposed revised warnings will have a measurable impact on product usage.
The agency's analysis of impacts in the final rule that established the labeling requirements in § 201.66 applied only to products covered by the final OTC drug monographs or approved product applications (64 FR 13254 at 13283). Because these relabeling costs for OTC IAAA products have not been accounted for in earlier rules, the agency is presenting them here. The following discussion addresses the cost of product relabeling under § 201.66 that will result from the IAAA final monograph, which includes, in part, the labeling in this proposal.
Based on information in the agency's Drug Listing System, there are approximately 102 manufacturers and 322 distributors that together account for 2,000 to 2,400 OTC NSAID IAAA products. Assuming an average of 3 individual stockkeeping units (SKUs) (individual products, packages, and sizes) per product, up to 7,200 SKUs would require the allergy warnings. Estimates of relabeling costs for the type of changes required by the IAAA final monograph vary greatly and range from $500 to $15,000 per SKU depending on whether the products are nationally branded or private label. Because of the large number of products affected, the agency used the same weighted average cost to relabel (i.e., $3,600 per SKU)
In addition to the above costs, some manufacturers may incur one-time and annually recurring costs if they need to increase the size of the label and/or package size of some SKUs because of the additional information required by this proposed rule. The agency had estimated that about 6,400 of the almost 100,000 marketed OTC drug SKUs may require increased label and/or package sizes to comply with the final labeling rule (64 FR 13254). As many of these 6,400 SKUs were for products subject to this final rule, much of the costs for increasing label and/or package sizes may have already been accounted for in the agency's impact analysis of that broader rule. The agency estimates that the additional lines of labeling required by this proposed rule could compel an additional 5 percent of the approximately 7,200 affected SKUs to increase their label size and/or package size.
Because of the large number of products affected by this rule, the agency assumes that the average cost per SKU to increase label and/or package sizes would be similar to that previously estimated by FDA for its analysis of the standardized format and content requirements for OTC drug products in § 201.66 (64 FR 13254). The model used to estimate the cost to change label/package sizes for that rule was developed by Eastern Research Group, Inc. (ERG), a private economics consulting firm under contract to FDA (Ref. 160). ERG assigned probabilities to several options for package changes, including adding a carton (if not already present), adding a fifth panel, increasing the size of the packaging or switching to a nonstandard form of labeling such as peel-back or accordion labels. Where applicable, the cost for changing a container size included container inventory loss, adjustment of the packaging line, and stability testing. Based on this model, FDA had estimated that the cost to increase label/package sizes to comply with the standardized format and content requirements for OTC drug products in § 201.66 was $38.1 million for 6,313 SKUs, with an annual recurring cost of $11.5 million. Consequently the average per SKU one-time cost was $6,038, and the average per SKU recurring cost was $1,820. Under the same assumptions, this proposed rule would impose additional one-time costs for increasing label/package sizes of $2.2 million (0.05 x 7,200 SKUs x $6,038), with annual recurring costs of $0.7 million (0.05 x 7,200 SKUs x $1,820). Thus, FDA estimates the overall costs of the OTC IAAA final monograph, which would include the labeling in this proposed rule, and the labeling required under § 201.66 to be $28.1 million in one-time costs and $0.7 million in annual recurring costs.
The proposed rule would not require any new reporting and recordkeeping activities, and no additional professional skills are needed. The March 17, 1999, standardized format and content requirements final rule for OTC drug product labeling in § 201.66 (64 FR 13254) will have an effect on the labeling of most of these products. There are no Federal rules that duplicate, overlap, or conflict with the proposed rule.
This proposed rule should not have a significant economic impact on a substantial number of small entities. However, the agency lacks sales information for the affected companies to quantify the impact. The Small Business Administration has determined that a small firm in this industry employs fewer than 750 employees. Approximately 70 percent of the 102 manufacturers affected by this proposed rule are estimated to be small. (Note: The cost to relabel private label goods are usually bourne by the manufacturer rather than the distributor.) The economic impact on any particular small firm is difficult to measure, because it will vary with the number of products affected, the number of SKUs per product, and the number of label and/or package sizes that require changing. For example, if a small manufacturer must relabel three products, or nine SKUs, the total one-time cost would be $32,400 assuming $3,600 as the average cost to relabel. Another small manufacturer of private label products may also need to relabel 3 products, with 3 SKUs per product, but for 20 customers. Its cost would be $648,000. If either of these manufacturers had to increase the label and/or package sizes of their SKUs, the costs would be even higher. However, the total cost will primarily result from relabeling OTC IAAA drug products in accord with the future final monograph for those products and the standardized format and content requirements for labeling OTC drug products in § 201.66 (64 FR 13254) at the same time. The agency invites small firms to address this economic impact. (See section XI of this document—request for comments.)
Concerning the allergy alert warning, the agency considered but rejected the following alternatives: (1) Voluntary relabeling, and (2) longer implementation period. The agency does not consider either of these approaches acceptable because they do not ensure that consumers will have the most updated information needed for the safe and effective use of OTC drug products containing NSAID IAAA active ingredients. Concerning ibuprofen, the agency considered: (1) Not including ibuprofen in the monograph, and (2) marketing before a final rule is issued. The option to not include ibuprofen in the monograph was rejected because the agency considers the data presented supportive of monograph status. The agency is not allowing marketing under the monograph to occur prior to a final rule because of a number of new labeling statements being proposed. Not allowing marketing under this proposed rule does not interrupt current OTC marketing of products containing ibuprofen and will allow the agency to consider comments on the additional labeling for OTC ibuprofen drug products before finalizing the monograph labeling. The agency does not consider an exemption for small entities who wish to market ibuprofen to be necessary because those manufacturers or distributors can enter the marketplace under the monograph at any time after a final rule issues.
The agency invites public comment regarding any substantial or significant economic impact that this rulemaking would have on OTC drug products that contain ibuprofen or other NSAID IAAA active ingredients. Comments regarding the impact of this rulemaking on these OTC drug products should be accompanied by appropriate documentation. The agency will evaluate any comments and supporting data that are received and will reassess the economic impact of this rulemaking in the preamble to the final rule.
FDA tentatively concludes that the labeling requirements in this proposal are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The agency has determined under 21 CFR 25.31(a) 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.
Interested persons may submit to the Dockets Management Branch (address above) written or electronic comments regarding this proposal by November 19, 2002. Submit written comments on the agency's economic impact determination by November 19, 2002. Three copies of all written comments are to be submitted. Individuals submitting written comments or anyone submitting electronic comments may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this
FDA is proposing that any final rule based on this proposal become effective 12 months after the date of its publication in the
The following references are on display in the Dockets Management Branch (address above), under Docket No. 77N-094I (or 77N-0094, where indicated), and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Comment No. CP13, Docket No. 77N-0094, Dockets Management Branch.
2. Comment No. C233, Docket No. 77N-0094, Dockets Management Branch.
3.
4.
5. Minutes of the Seventeenth Meeting of the Arthritis Advisory Committee, OTC Vol. 03BTFM(I), Docket No. 77N-094I, Dockets Management Branch.
6. Summary Basis of Approval for New Drug Application for Ibuprofen (200 mg), OTC Vol. 03BTFM(I), Docket No. 77N-094I, Dockets Management Branch.
7. Comment No. CP3, Docket No. 77N-0094, Dockets Management Branch.
8. Comment No. PDN002, Docket No. 77N-0094, Dockets Management Branch.
9. Memoranda of Telecon Between Representatives of Whitehall Robins Health Care and FDA on August 6, 1998, and August 26, 1998, coded MT12 and MT13, respectively, Docket No. 77N-0094, Dockets Management Branch.
10. Comment No. SUP44, Docket No. 77N-0094, Dockets Management Branch.
11. Davies, E. F. and G. S. Avery, “Ibuprofen: A Review of Its Pharmacological Properties and Therapeutic Efficacy in Rheumatic Disorders,”
12. Adams, S. S. et al., “Absorption, Distribution, and Toxicity of Ibuprofen,”
13. Neupert, W. et al., “Effects of Ibuprofen Enantiomers and Its Coenzyme a Thioester on Human Prostaglandin Endoperoxide Synthases,”
14. Abernathy, D. R. and D. J. Greenblatt, “Ibuprofen Disposition in Obese Individuals,”
15. Adams, S. S., P. Bresloff, and C. G. Mason, “Pharmacological Differences Between the Optical Isomers of Ibuprofen, Evidence for Metabolic Inversion of the (-)-Isomer,”
16. Geisslinger, G. et al., “Pharmacological Differences Between the R(-)- and S(+)-Ibuprofen,”
17. Cheng, H. et al., “Pharmacokinetics and Bioinversion of Ibuprofen Enantiomers in Humans,”
18. Cox, S. R., “Effect of Route of Administration on the Chiral Inversion of R(-)-Ibuprofen” (abstract),
19. Jamali, F. et al., “Human Pharmacokinetics of Ibuprofen Enantiomers Following Different Doses and Formulations: Intestinal Chiral Inversion,”
20. Davies, N. M., “Clinical Pharmacokinetics of Ibuprofen,”
21. Gillespie, W. R. et al., “Relative Bioavailability of Commercially Available Ibuprofen Oral Dosage Forms in Humans,”
22. Adams, S. S. and J. Warwick-Buckler, “Ibuprofen and Flurbiprofen,”
23. Verbeeck, R. K., “Pathophysiologic Factors Affecting the Pharmacokinetics of Nonsteroidal Anti-Inflammatory Drugs,”
24. Jamali, F. and D. R. Brocks, “Clinical Pharmacokinetics of Ketoprofen and Its Enantiomers,”
25. Whitlam, J. B. and K. F. Brown, “Ultrafiltration in Serum Protein Binding Determinations,”
26. Vowles, D. T. and B. Marchant, “Protein Binding of Ibuprofen and Its Relationship to Drug Interactions,”
27. Albert, K. S. and C. M. Gernaat, “Pharmacokinetics of Ibuprofen,”
28. Wanwimolruk, S., D. J. Birkett, and P. M. Brooks, “Protein Binding of Some Nonsteroidal Anti-Inflammatory Drugs in Rheumatoid Arthritis,”
29. Greenblatt, D. J. et al., “Absorption and Disposition of Ibuprofen in the Elderly,”
30. Leeman, T. D. et al., “A Major Role for Cytochrome P450TB (CYP23) Subfamily in the Actions of Non-Steroidal Anti-Inflammatory Drugs,”
31. Hamman, M. A., G. A. Thompson, and S. D. Hall, “Regioselective and Stereoselective Metabolism of Ibuprofen by Human Cytochrome P450 2C,”
32. Evans, A. M. et al., “The Relationship Between the Pharmacokinetics of Ibuprofen Enantiomers and the Dose of Racemic Ibuprofen in Humans,”
33. Rudy, A. C. et al., “Stereoselective Metabolism of Ibuprofen in Humans: Administration of R-, S- and Racemic Ibuprofen,”
34. Albert, K. S. et al., “Effects of Age on the Clinical Pharmacokinetics of Ibuprofen,”
35. Walter, K. and C. Dilger, “Ibuprofen in Human Milk,”
36. Gurwitz, J. H. et al., “The Impact of Ibuprofen on the Efficacy of Antihypertensive Treatment With Hydrochlorthiazide in Elderly Patients,”
37. Agency Letter to Prescription NSAID Manufacturers/Sponsors, OTC Vol. 03BTFM(I), Docket No. 77N-094I, Dockets Management Branch.
38. Motrin (prescription) Label,
39. “Summary of Safety and Efficacy Data From the Advil New Drug Application (1983),” Appendix C, Comment No. CP13, Docket No. 77N-0094, Dockets Management Branch.
40. Moore, N. et al., “The PAIN Study: Paracetamol, Aspirin, and Ibuprofen, New Tolerability Study. A Large-Scale, Randomized Clinical Trial Comparing the Tolerability of Aspirin, Ibuprofen, and Paracetamol for Short-Term Analgesia,”
41. Griffin, M. R. et al., “Nonsteroidal Anti-Inflammatory Drug Use and Increased Risk for Peptic Ulcer Disease in Elderly Persons,”
42. Bradley, J. D. et al., “Comparison of an Anti-Inflammatory Dose of Ibuprofen, An Analgesic Dose of Ibuprofen, and Acetaminophen in the Treatment of Osteoarthritis of the Knee,”
43. Kaufman, D. W. et al., “Nonsteroidal Anti-Inflammatory Drug Use in Relation to Major Upper Gastrointestinal Bleeding,”
44. Strom, B. L. et al., “Gastrointestinal Tract Bleeding Associated With Naproxen Sodium Versus Ibuprofen,”
45. Bergmann, J. F. et al., “Endoscopic Evaluation of the Effect of Ketoprofen, Ibuprofen, and Aspirin on the Gastroduodenal Mucosa,”
46. Lanza, F. L., “A Review of Gastric Ulcer and Gastrointestinal Injury in Normal Volunteers Receiving Aspirin and Other Nonsteroidal Anti-Inflammatory Drugs,”
47. Bidlingmaier, A. et al. “Gastrointestinal Blood Loss Induced by Three Different Nonsteroidal Anti-Inflammatory Drugs,”
48. Insel, P. A., “Analgesic-Antipyretic and Anti-Inflammatory Agents and Drugs Employed in the Treatment of Gout” (Chapter 27),
49. Kirschenbaum, M. A. and G. A. Shah, “Nephropathy of Nonsteroidal Anti-Inflammatory Agents,”
50. Farquhar, W. B. et al., “Effects of Acetaminophen and Ibuprofen on Renal Function in the Stressed Kidney,”
51. Ciabottoni, G. et al., “Effects of Sulindac and Ibuprofen in Patients With Chronic Glomerular Disease: Evidence for the Dependence of Renal Function on Prostacyclin,”
52. Whelton, A. et al., “Renal Effects of Ibuprofen, Piroxicam, and Sulindac in Patients With Asymptomatic Renal Failure: Prospective, Randomized, Crossover Comparison,”
53. Furey, S. A., R. Vargas, and F. G. McMahan, “Renovascular Effects of Nonprescription Ibuprofen in Elderly Hypertensive Patients With Mild Renal Impairment,”
54. Elsasser, G. N., L. Lopez, and E. Evans, “Reversible Acute Renal Failure Associated With Ibuprofen Ingestion and Binge Drinking,”
55. Johnson, G. and S. F. Wen, “Syndrome of Flank Pain and Acute Renal Failure After Binge Drinking and Nonsteroidal Anti-Inflammatory Drug Ingestion,”
56. McIntire, S. C. et al., “Acute Flank Pain and Reversible Renal Dysfunction Associated With Nonsteroidal Anti-Inflammatory Drug Use,”
57. Wattad, A., T. Feehan, and F. M. Shepard, “A Unique Complication of Nonsteroidal Anti-Inflammatory Drug Use,”
58. Moss, A. H. et al., “Over-the-Counter Ibuprofen and Renal Failure,”
59. Corwin, H. L. and J. V. Bonventure, “Renal Insufficiency Associated With Nonsteroidal Anti-Inflammatory Drugs,”
60. Marasco, W. A., P. W. Gikas, and R. Azziz-Baumgartener, “Ibuprofen-Associated Renal Dysfunction, Pathophysiologic Mechanisms of Acute Renal Failure Hyperkalemia, Tubular Necrosis, and Proteinuria,”
61. Fernando, A. H. N. et al., “Renal Failure After Topical Use of NSAID's,”
62. Spierto, T. J., M. B. Kaufman, and C. A. Stoukedes, “Acute Renal Failure Associated With the Use of Over-the-Counter Ibuprofen,”
63. Atkinson, L. K., G. H. Goodship, and M. K. Ward, “Acute Renal Failure Associated With Acute Pyelonephritis and Consumption of Non-Steroidal Anti-Inflammatory Drugs,”
64. Sheiner, P. A. et al., “Acute Renal Failure Associated With the Use of Ibuprofen in Two Liver Transplant Recipients on FK506,”
65. Rault, R. M., “Case Report: Hyponatremia Associated With Non-Steroidal Anti-Inflammatory Drugs,”
66. Wachtel, A. et al., “Non-Steroidal Anti-Inflammatory Agents and Acute Renal Failure,”
67. Henrich, W. L. et al., “Analgesic and the Kidney: Summary and Recommendations to the Scientific Advisory Board of the National Kidney Foundation From an Ad Hoc Committee of the National Kidney Foundation,”
68. Fukui, M. et al., “A Case of Drug-Induced Hepatitis With Multinuclear Giant Hepatic Cells in Adult,”
69. Alam, I., L. D. Ferrell, and M. Bass, “Vanishing Bile Duct Syndrome Temporarily Associated With Ibuprofen Use,”
70. Garcia-Rodriguez, L.A. et al., “The Role of Non-Steroidal Anti-Inflammatory Drugs in Acute Liver Injury,”
71. Katz, L. M., and P. Y. Love, “NSAIDs and the Liver,”
72. Jain, S., “Ibuprofen-Induced Thrombocytopenia,”
73. Manus, S. W. et al., “Ibuprofen Associated Pure White-Cell Aplasia,”
74. Deutsch P. H. and G. L. Mandell, “Reversible Pelger-Huet Anomaly Associated With Ibuprofen Therapy,”
75. Wittkowsky, A. K., “Thrombosis,”
76. Mathur, S. L., “Ibuprofen in Bronchial Asthma,”
77. Ayers, J. G., D. M. Flemming, and R. M. Whittington, “Asthma Death Due to Ibuprofen,”
78. Anderson, J. S. and H. Guldager, “Ibuprofen-Triggered Asthma Attack in a Patient With Known Aspirin Hypersensitivity,”
79. Antonicelli, L. and A. Tagliabracci, “Asthma Death Induced by Ibuprofen,”
80. Jamil, A. S. and F. S. Majd, “Life-Threatening Asthma and Anti-Inflammatory Drugs,”
81. Sharma, S. K., “Ibuprofen (Brufen) Induced Bronchial Asthma,”
82. Mandell, B. F. and Raps, E. C., “Severe Systemic Hypersensitivity Reaction to Ibuprofen Occurring After Prolonged Therapy,”
83. Lee, R. P., E. G. King, and A. S. Russell, “Ibuprofen: A Severe Reaction,”
84. Harman Fridrich, H., G. A. Zach, and K. L. Fridrich, “Aspirin-Intolerance Syndrome: Report of a Case,”
85. Butterfield H. et al., “Severe Generalized Reaction to Ibuprofen: Report of a Case,”
86. Katz, J. et al., “Drug Allergy in Sjögren's Syndrome,”
87. Ekert, F. et al, “Anaphylactoid Reactions Due to Ibuprofen” (abstract),
88. Grimm, A. M. and J. E. Wolf, “Aseptic Meningitis Associated With Nonprescription Ibuprofen Use” (letter to the editor),
89. Katona, B. G. et al., “Aseptic Meningitis From Over-the-Counter Ibuprofen,”
90. Durback, M. A., J. Freeman, and V. R. Schumacher, “Recurrent Ibuprofen-Induced Aseptic Meningitis: Third Episode After Only 200 mg of Generic Ibuprofen,”
91. Agus, B. et al., “Acute Central Nervous System Symptoms Caused by Ibuprofen in Connective Tissue Disease,”
92. Ewert, B. H., “Ibuprofen-Associated Meningitis in a Woman With Only Serologic Evidence of a Rheumatologic Disorder,”
93. Lortholary, A. et al., “Generalized Status Epilepticus After Ingestion of Ibuprofen (Brufen) Disclosing Lupus Erythematosus,”
94. Treves, R. et al., “Aseptic Meningitis and Acute Renal Failure Induced by Ibuprofen During the Treatment of Systemic Lupus Erythematosus,”
95. Colamarino, R., M. Soubrier, and M. Zenut-Leaud, “Aseptic Meningitis Due to Ibuprofen (Nuprofen) in Cases of Connective-Tissue Disease,”
96. Perera, D. R., A. K. Seiffert, and H. M. Greeley, “Ibuprofen and Meningoencephalitis,”
97. Thilman, A. F. et al., “Recurrent Aseptic Meningitis (Mollaret Meningitis)—Spontaneous and Drug-Induced Appearance,”
98. Gilbert, G. J. and H. W. Eichenbaum, “Ibuprofen-Induced Meningitis in an Elderly Patient With Systemic Lupus Erythematosus,”
99. Hanson, L. and H. J. Morgan, “Ibuprofen-Induced Aseptic Meningitis,”
100. Lawson, J. M. and M. J. Grady, “Ibuprofen-Induced Aseptic Meningitis in a Previously Healthy Patient,”
101. Quinn, J. P., R. A. Weinstein, and L. R. Caplan, “Eosinophilic Meningitis and Ibuprofen Therapy,”
102. Mifsud, A. J., “Drug-Related Recurrent Meningitis,”
103. Van der Zwan, A. and J. G. Van Dam, “Side Effects of Medicinal Agents—Ibuprofen Meningitis,”
104. Chez, M. et al., “Ibuprofen-Induced Meningitis: Detection of Intrathecal IgG Synthesis and Immune Complexes,”
105. Bouland, D. L., N. L. Specht, and D. R. Hegstad, “Ibuprofen and Aseptic Meningitis,”
106. Davis, B. J. et al., “Drug-Induced Aseptic Meningitis Caused by Two Medications,”
107. Chaudhry, H. J. and B. A. Cunha, “Drug-Induced Aseptic Meningitis,”
108. Morgan, A. and D. Clark, “CNS Adverse Effects of Nonsteroidal Anti-Inflammatory Drugs,”
109. Hoppmann, R. A., J. G. Peden, and S. K. Ober, “Central Nervous System Side Effects of Nonsteroidal Anti-Inflammatory Drugs,”
110. Perlman, D. M., “Ibuprofen-Induced Aseptic Meningitis in Individuals With HIV,”
111. Horn, A. C. and S. W. Jarrett, “Ibuprofen-Induced Aseptic Meningitis in Rheumatoid Arthritis,”
112. Eustace, S. and B. Buff, “Magnetic Resonance Imaging in Drug-Induced Meningitis,”
113. Greenberg, G. N., “Recurrent Sulindac-Induced Aseptic Meningitis in a Patient Tolerant to Other Nonsteroidal Anti-Inflammatory Drugs,”
114. Jensen, S. et al., “Ibuprofen-Induced Meningitis in a Male With Systemic Lupus Erythematosus,”
115. Rottach, K. et al., “Mollaret's Meningitis: A New Aetiologic Feature,”
116. Bharija, S. C. and M. S. Belhaj, “Fixed Drug Eruption on Three Independent Sites Induced by Chemically Unrelated Drugs,”
117. Khan, A. R., “Erythema Nodosum After Ibuprofen,”
118. Laing, V. B. et al., “Pemphigold-Like Bullous Eruption Related to Ibuprofen,”
119. Shelly, E. D. and W. B. Shelley, “Ibuprofen Urticaria,”
120. Ben-Chetrit, E. and A. Rubinow, “Exacerbation of Psoriasis by Ibuprofen,”
121. Pavithran, K., “Exacerbation of Psoriasis by Ibuprofen,” Indian Journal of Dermatology,
122. Tousignant, J. et al., “Dermatitis Herpetiformis Induced by Nonsteroidal Anti-Inflammatory Drugs,”
123. Kanwar, A. J. et al., “Drugs Causing Fixed Eruptions,”
124. Kanwar, A. J. et al., “Ninety-eight Fixed Drug Eruptions With Provocation Tests,”
125. Kaplan, B. H. et al., “Aseptic Meningitis and Iridocyclitis Related to Ibuprofen,”
126. Kinshuck, D. and L. Stevenson, “Complications of NSAID Therapy in Patients With Macular Disease,”
127. Fitt, A. et al., “Vortex Keratopathy Associated With Ibuprofen Therapy,”
128. Ridder III, W. H. and A. Tomlinson, “Effect of Ibuprofen on Contrast Sensitivity,”
129. FDA's evaluation of data in its Adverse Event Reporting System, OTC Vol. 03BTFM(I), Docket No. 77N-094I, Dockets Management Branch.
130. Minuz, P. et al., “Antihypertensive Activity of Enalapril. Effect of Ibuprofen and Different Salt Intakes,”
131. Gehr, T. W. B. et al., “Interaction of Triamterene-Hydrochlorothiazide (T-H) and Ibuprofen (I),”
132. Radack, K. L. et. al., “Ibuprofen Interferes With the Efficacy of Antihypertensive Drugs,”
133. Minuz, P. et al., “Amlodipine and Haemodynamic Effects of Cyclo-Oxygenase Inhibition,”
134. Pancera, P. et al., “Changes in Peripheral Hemodynamics and Vasodilating Prostaglandins After High-Dose Short-Term Ibuprofen in Chronically Treated Hypertensive Patients,”
135. Halawa, B., “Effect of Indomethacin and Ibuprofen on the Blood Pressure of Patients Treated With Nifedipine or Captopril,”
136. Brater, D. G., “Drug-Drug and Drug-Disease Interactions With Nonsteroidal Anti-Inflammatory Drugs,”
137. Cooper, S. A., “Five Studies on Ibuprofen for Postsurgical Dental Pain (Study 2),”
138. Cooper, S. A., “Five Studies on Ibuprofen for Postsurgical Dental Pain (Study 5),”
139. Cooper, S. A., “The Relative Effectiveness of Ibuprofen in Dental Pain (Study 3),”
140. Cooper, S. A., “The Relative Effectiveness of Ibuprofen in Dental Pain (Study 4),”
141. Cooper, S. A., “The Relative Effectiveness of Ibuprofen in Dental Pain (Study 5),”
142. Cooper, S. A., “The Relative Effectiveness of Ibuprofen in Dental Pain (Study 2),”
143. Cooper, S. A. et al., “Ibuprofen and Acetaminophen in the Relief of Acute Pain: A Randomized, Double-Blind, Placebo-Controlled Study,”
144. Forbes, J. A. et. al., “Evaluation of Ketorolac, Ibuprofen, Acetaminophen, and an Acetaminophen-Codeine Combination in Post-Operative Oral Surgery Pain,”
145. Forbes, J. A. et al., “Evaluation of Bromfenac, Aspirin, and Ibuprofen in Postoperative Oral Surgery Pain,”
146. Forbes, J. A. et al., “Analgesic Efficacy of Bromfenac, Ibuprofen, and Aspirin in Postoperative Oral Surgery Pain,”
147. Giles, A. D. et al., “A Single-Dose Assessment of an Ibuprofen/Codeine Combination in Post-Operative Dental Pain,”
148. Jain, A. K. et al., “Analgesic Efficacy of Low-Dose Ibuprofen in Dental Extraction Pain,”
149. Mehlisch, D. R. et al., “Multi-Center Clinical Trial of Ibuprofen and Acetaminophen in the Treatment of Postoperative Dental Pain,”
150. Ngan, P. et al., “The Effect of Ibuprofen on the Level of Discomfort in Patients Undergoing Orthodontic Treatment,”
151. Diamond, S., “Ibuprofen Versus Aspirin and Placebo in the Treatment of
152. Schachtel, B. P., S. A. Furey, and W. R. Thoden, “Nonprescription Ibuprofen and Acetaminophen in the Treatment of Tension-Type Headache,”
153. Nebe, J., M. Heier, and H. C. Diener, “Low-Dose Ibuprofen in Self-Medication of Mild to Moderate Headache: A Comparison With Acetylsalicylic Acid and Placebo,”
154. Schachtel, B., W. R. Thoden, and R. I. Baybutt, “Ibuprofen and Acetaminophen in the Relief of Postpartum Episiotomy Pain,”
155. Schachtel, B. P. et al., “Sore Throat Pain in the Evaluation of Mild Analgesics,”
156. Habib, S. et al., “A Study of the Comparative Effectiveness of Four Common Analgesics in the Control of Post-Surgical Dental Pain,”
157. Noyelle, R. M. et al., “Ibuprofen, Aspirin, and Paracetamol Compared in a Community Study,”
158. Milsom, I. and B. Andersch, “Effect of Ibuprofen, Naproxen Sodium, and Paracetamol on Intrauterine Pressure and Menstrual Pain in Dysmenorrhea,”
159. Gaitonde, B. B. et al., “Antipyretic Activity of Ibuprofen (Brufen),”
160. Eastern Research Group, Inc., “Cost Impacts of the Over-the-Counter Pharmaceutical Labeling Rule,” OTC Vol. 28FR, Docket No. 96N-0420, Dockets Management Branch.
Drugs, Labeling, Reporting and recordkeeping requirements.
Labeling, Over-the-counter drugs.
21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
(e) The labeling of orally or rectally administered OTC aspirin- and ibuprofen-containing products must bear a warning that immediately follows the general warning identified in paragraph (a) of this section. The warning shall be as follows:
“It is especially important not to use” [select “aspirin,” “carbaspirin calcium,” or “ibuprofen,” as appropriate] “during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.”
The labeling for all over-the-counter (OTC) drug products containing nonsteroidal anti-inflammatory internal analgesic/antipyretic active ingredients—including but not limited to aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, and sodium salicylate—whether subject to an applicable OTC drug monograph or an approved drug application, contains the following allergy warnings under the heading “Warnings”:
(a) “Allergy alert: [insert name of active ingredient (first letter of first word for ingredient in uppercase)] may cause a severe allergic reaction which may include: [bullet]
(b) “Do not use [insert bullet if more than one warning occurs under this subheading] if you have ever had” or for products labeled only for use in children under 12 years of age, “Do not use [insert bullet if more than one warning occurs under this subheading] if your child has ever had” followed by, “an allergic reaction to any other pain reliever/fever reducer”. [This statement appears as the first warning under the subheading “Do not use.”]
(c) “Stop use and ask a doctor if [insert bullet if more than one warning occurs under this heading] an allergic reaction occurs. Seek medical help right away.” [These statements appear as the first warning under the subheading “Stop use and ask a doctor if.”]
21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
(g) Ibuprofen 200-milligram tablet.
(b) * * *
(2)
(4)
(b) * * *
(1)
(5)
(c) * * *
(1) * * *
(i)
(iv) * * *
(A) “Do not use this product if you have asthma unless directed by a doctor”.
(B) The labeling contains the pregnancy/breast-feeding warnings set forth in § 201.63(a) and (e) of this chapter.
(vi)
(ix)
(B) “Ask a doctor before use if you have: [bullet]
(C) “Ask a doctor or pharmacist before use if you are: [bullet] under a doctor's care for any serious condition [bullet] taking any other product that contains ibuprofen, or any other pain reliever/fever reducer [bullet] taking a prescription drug for anticoagulation (blood thinning) [bullet] taking any other drug”.
(D) “When using this product: [insert bullet if more than one warning occurs under this subheading] take with food or milk if stomach upset occurs”.
(E) In addition to the warning required in § 201.324(c) of this chapter, the following statements appear after the subheading “Stop use and ask a doctor if: [bullet] pain gets worse or lasts more than 10 days [bullet] fever gets worse or lasts more than 3 days [bullet] stomach pain gets worse or lasts [bullet] redness or swelling is present in the painful area [bullet] any new symptoms appear”.
(F) The labeling contains the pregnancy/breast-feeding warnings set forth in § 201.63(a) and (e) of this chapter.
(2) * * *
(i)
(iv) * * *
(A) “Do not give this product to children who have asthma unless directed by a doctor”.
(vi)
(d) * * *
(7)
Environmental Protection Agency (EPA).
Proposed rule.
EPA proposes to determine that the Birmingham marginal ozone nonattainment area (hereinafter referred to as the Birmingham area) attained the 1-hour ozone National Ambient Air Quality Standard (NAAQS) by November 15, 1993, the date required by the Clean Air Act (CAA). The Birmingham area is comprised of Jefferson and Shelby Counties. On July, 10, 2002, the United States District Court for the District of Columbia concluded that EPA failed to exercise its non-discretionary duty to make a final attainment determination for the Birmingham area by May 15, 1994. The Court required that EPA make a formal attainment determination within 120 days from date of opinion.
Written comments must be received on or before September 20, 2002.
All comments should be addressed to: Sean Lakeman; Regulatory Development Section; Air Planning Branch; Air, Pesticides and Toxics Management Division; U.S. Environmental Protection Agency Region 4; 61 Forsyth Street, SW, Atlanta, Georgia 30303-8960.
Copies of documents relative to this action are available at the following address for inspection during normal business hours: Environmental Protection Agency, Region 4, Air Planning Branch, 61 Forsyth Street, SW, Atlanta, Georgia 30303-8960.
The interested persons wanting to examine these documents should make an appointment at least 24 hours before the visiting day and reference file AL-200234.
Sean Lakeman, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street, SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9043. Mr Lakeman can also be reached via electronic mail at
Pursuant to section 181(b)(2)(A) of the CAA, EPA is proposing to determine that the Birmingham area has attained the 1-hour NAAQS for ozone by November 15, 1993, the date required by section 181(a)(1) of the CAA. This determination is based upon three years of complete, quality-assured, ambient air monitoring data for the years 1991-1993 which indicate that Birmingham area attained the 1-hour ozone NAAQS.
The Clean Air Act (CAA) requires EPA to establish NAAQS for certain pollutants that cause or contribute to air pollution that is reasonably anticipated to endanger public health or welfare (CAA sections 108 and 109). In 1979, EPA promulgated the 1-hour 0.12 parts per million (ppm) ground-level ozone NAAQS (44 FR 8202 (February 8, 1979)). Ground-level ozone is not emitted directly by sources. Rather, emissions of nitrogen oxides (NO
An area exceeds the 1-hour ozone NAAQS each time an ambient air quality monitor records a 1-hour average ozone concentration above 0.124 ppm. An area is violating the NAAQS when the average of expected exceedances during a consecutive three-year period is greater than 1 at any one monitor (40 CFR part 50, appendix H). The CAA required EPA to designate as nonattainment any area that was violating the 1-hour ozone NAAQS, generally based on air quality monitoring data from the three-year period from 1987-1989, or any area contributing to a violation (CAA section 107(d)(4); 56 FR 56694 (November 6, 1991)). The CAA further classified these areas, based on the area's design value (
The control requirements and dates by which attainment needs to be achieved vary with the area's classification. Marginal areas were subject to the fewest mandated control requirements and had the earliest attainment date. Marginal areas were required to attain the 1-hour NAAQS by November 15, 1993. Section 181(a) of the CAA.
The Birmingham area was originally designated as a 1-hour ozone nonattainment area by EPA on March 3, 1978 (43 FR 8962). The Birmingham nonattainment area at that time was geographically defined as Jefferson County, Alabama. On November 6, 1991, by operation of law under section 181(a) of the CAA, EPA classified the Birmingham nonattainment area as a marginal nonattainment area for ozone and added Shelby County to the nonattainment area (56 FR 56693). The nonattainment classification for the Birmingham marginal ozone area was based on ambient air sampling measurements for ozone made during 1987-1989. The area was required to attain the 1-hour ozone NAAQS by November 15, 1993, (
For further background, see the Court's opinion in
Section 181(b)(2)(A) of the Clean Air Act states that:
Within 6 months following the applicable attainment date (including any extension thereof) for an ozone nonattainment area, the Administrator shall determine, based on the area's design value (as of the attainment date), whether the area attained the standard by that date. Except for any Severe or Extreme area, any area that the Administrator finds has not attained the standard by that date shall be reclassified by operation of law in accordance with table 1 of subsection (a) to the higher of—
(i) the next higher classification for the area, or
(ii) the classification applicable to the area's design value as determined at the time of the notice required under subparagraph (B).
No area shall be reclassified as extreme under clause (ii).
After the end of the 1993 ozone season, the Birmingham area had three years of quality assured air monitoring data (1991, 1992 and 1993) which demonstrated that the 1-hour ozone NAAQS was attained. Table 1 shows the number of exceedances at each of the monitoring sites in Jefferson and Shelby Counties. No individual monitor recorded more than two exceedances during the three year period. The national 1-hour primary and secondary ambient air quality standard for ozone is attained when the expected number of days per calendar year with maximum hourly average concentrations above 0.12 ppm is equal to or less than 1, averaged over a three year period (40 CFR part 50, appendix H). The design value for the Birmingham area is 0.124 ppm, based on the fourth highest 1-hour value recorded at the Bearden Farm monitor. The recorded values for that monitor were 0.144, 0.125, 0.124, and 0.124 ppm.
Therefore, in accordance with section 181(b)(2) of the CAA, EPA proposes to determine that the Birmingham area attained the standard by the area's November 15, 1993, attainment date.
In 2000, the Sierra Club brought suit in district court, seeking, among other claims, an order requiring EPA to issue a determination pursuant to section 181(b) as to whether the Birmingham area had attained the NAAQS.
On July, 10, 2002, the United States District Court for the District of Columbia concluded that EPA failed to perform its non-discretionary duty to
Pursuant to section 181(b)(2)(A) of the CAA, EPA is proposing to determine that the Birmingham area attained the 1-hour NAAQS for ozone by November 15, 1993. This determination is based upon the area's design value as of its attainment date, and upon three years of complete, quality-assured, ambient air monitoring data for the years 1991-1993 which indicate that Birmingham area attained the 1-hour ozone NAAQS.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed 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 proposed action merely proposes to approve state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this proposed 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
This proposed rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely proposes to approve a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This proposed rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.
In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed determination of attainment does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Environmental protection, Air pollution control, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notification of a proposal for EFPs to conduct experimental fishing; request for comments.
NMFS announces that the Administrator, Northeast Region, NMFS (Regional Administrator), has determined that an application for EFPs contains all of the required information and warrants further consideration. The Regional Administrator is considering the impacts of the activities to be authorized under the EFPs with respect to the Northeast (NE) Multispecies Fishery Management Plan (FMP). However, further review and consultation may be necessary before a final determination is made to issue EFPs. Therefore, NMFS announces that the Regional Administrator proposes to issue EFPs in response to an application submitted by the Groundfish Group Associated Fisheries of Maine (Associated Fisheries of Maine), in collaboration with Manomet Center for Conservation Sciences (Manomet). These EFPs would allow up to 12 vessels to fish for yellowtail flounder in NE multispecies year-round Closed Area II (CA II) during the months of August through December, 2002, and July, 2003, with the potential of the August trips occurring in 2003 depending on when the EFPs are issued.
The purpose of the study is to collect observer-based data to determine whether seasonal access to portions of CA II for the purpose of harvesting Georges Bank (GB) yellowtail flounder is possible without significant bycatch and discard of other regulated NE multispecies, particularly Atlantic cod and haddock. This information could then be used by the New England Fishery Management Council (Council) and NMFS to determine the feasibility of establishing a seasonal access program that would allow the harvest of GB yellowtail flounder in portions of CA II.
Comments on this action must be received at the appropriate address or
Written comments should be sent to Patricia A. Kurkul, Regional Administrator, National Marine Fisheries Service, Northeast Regional Office, 1 Blackburn Drive, Gloucester, MA 01930. Mark the outside of the envelope “Comments on Yellowtail EFP Proposal.” Comments may also be sent via facsimile (fax) to (978) 281-9135. Comments will not be accepted if submitted via e-mail or the Internet.
Copies of the Environmental Assessment (EA) are available from the NE Regional Office at the same address.
Allison Ferreira, Fishery Policy Analyst, (978) 281-9103, email
Three year-round closed areas were established in 1994 under Amendment 5 to the FMP to provide protection to concentrations of regulated NE multispecies, particularly Atlantic cod, haddock, and yellowtail flounder. These closure areas, Closed Area I, Closed Area II and the Nantucket Lightship Closure Area, have proven to be effective in improving the stock status of several species, in particular, the status of GB yellowtail flounder. Spawning stock biomass (SSB) for GB yellowtail flounder increased from 2,600 mt in 1992 to 33,500 mt in 1999. Mean stock biomass also increased from 4,500 mt in 1992 to 49,600 mt in 1999. In 2001, the Transboundary Resources Assessment Committee's (TRAC) Advisory Report on Stock Status estimated GB yellowtail flounder SSB to be between 37,000 and 50,500 mt (80-percent probability) and the mean biomass to be between 48,000 and 66,500 mt (80-percent probability). Furthermore, in 2001, the Multispecies Monitoring Committee (MMC) estimated the mean biomass for GB yellowtail flounder to be 55,437 mt, which is well above the biomass target (B
In their EFP application, Manomet and the Associated Fisheries of Maine state that common knowledge within the fishing and scientific communities suggests that Atlantic cod and haddock are less available in certain portions of CA II during specific seasons. The applicants feel that there is a need to support this knowledge with scientific data, potentially enabling the rebuilt GB yellowtail flounder resource to be utilized without impacting the management programs that currently protect the rebuilding stocks of cod and haddock on Georges Bank.
The Associated Fisheries of Maine, in collaboration with Manomet, have submitted an application for 17 EFPs (12 vessels and 5 alternates) that would exempt these vessels from the days-at-sea (DAS) requirements specified under 50 CFR 648.80 and 648.82, and CA II restrictions specified under § 648.81. The proposed study would occur in the area south of 41°30′ N. lat. within CA II. The experiment would consist of two vessels conducting one concurrent 5-day trip each month for the months of August through December, 2002 and July, 2003, for a total of 6 concurrent trips and 12 total vessel trips for the study. Each trip would consist of 2 transiting days and 3 sampling days, for a total of 24 vessel transiting days and 36 vessel sampling days over the course of the study. Participating vessels would be prohibited from fishing in areas outside of CA II during an experimental fishing trip. In order to offset the cost of the experiment, the applicant has requested that the participating vessels be exempt from DAS requirements while participating in the proposed experimental fishery.
Survey operations would follow a pre-determined sampling design. The sample area would be divided into grids of approximately 6 square miles (15.5 sq. km) During each trip, hauls would be conducted in each grid, with each haul lasting 20 minutes. The sampling design would enable comparison trawls between vessels in order to standardize catch data between vessels. A total of 51 hauls, 26 hauls for vessel 1 and 25 hauls for vessel 2, would be conducted during each trip. Vessels would utilize standard otter trawl gear having a codend mesh size of 6.5-inch (16.5 cm) square mesh, the minimum mesh size for the GB Regulated Mesh Area.
A total allowable catch (TAC) of GB yellowtail flounder of 220 mt would be established for the experimental fishery. This equates to approximately 40,000 lb (18,144 kg) of yellowtail flounder per vessel, per trip. Incidental catch of cod and haddock would be limited to 2,000 lb (907 kg) and 3,000 lb (1,361 kg) per DAS, respectively. In addition, all fish landed would have to meet minimum size requirements.
Several species of skates are found in the southern portion of CA II where the proposed experimental fishery would be conducted. Due to concerns over skate bycatch, particularly the bycatch of thorny and barndoor skate, the applicants have agreed to identify and record all skates caught and return all skates caught to the sea immediately in order to minimize mortality. No skates would be retained for landing or sale. In addition, the applicants have stated that the bycatch of skates would be avoided to the extent practicable.
A minimum of two observers, consisting of Manomet scientific staff, would be present on board each participating vessel, equating to 100-percent observer coverage for this experimental fishery. All catch would be sorted, weighed and recorded by species. In addition, commercially important species, including all skate species, would be individually weighed and measured. Observers would be responsible for collecting all biological and environmental data on NMFS observer forms. Interim reports would be provided to NMFS at the end of each trip outlining total catch, including bycatch and discards. Participating vessels may also be required to report estimates of daily catch to NMFS via a call-in system in order to monitor the GB yellowtail TAC of 220 mt requested for this experimental fishery.
The EFPs would contain a provision that the Regional Administrator has the authority to reconsider the continuation of the proposed experimental fishery on a month-by-month basis. The Regional Administrator would be authorized to terminate the experimental fishery if the yellowtail flounder TAC of 220 mt is exceeded or if excessive bycatch of cod, haddock and other species of concern (including, but not limited to, skate) occurs during any given trip.
A draft EA has been prepared that analyzes the impacts of the proposed experimental fishery on the human environment. This draft EA concludes that the proposed activities to be conducted under the requested EFPs are consistent with the goals and objectives of the FMP, would not be detrimental to the well-being of any stocks of fish harvested, and would have no significant environmental impacts. The draft EA also concludes that the proposed experimental fishery would not be detrimental to Essential Fish Habitat, marine mammals, or protected species.
EFPs would be issued to up to 17 vessels exempting them from the DAS requirements and CA II restrictions of the FMP.
Based on the results of the proposed experimental fishery, this action may lead to future rulemaking.
Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested
16 U.S.C. 1801
Animal and Plant Health Inspection Service, USDA.
Notice of availability and request for comments; correction.
In a notice published in the
We will consider all comments that we receive on Docket No. 01-018-2 on or before September 16, 2002.
You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 01-018-2, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 01-018-2. If you use e-mail, address your comment to
You may read the evaluation and any comments that we receive on the evaluation in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.
APHIS documents published in the
Dr. Anne Goodman, Supervisory Staff Officer, Regionalization Evaluation Services, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
On July 16, 2002, we published in the
In the background portion of the notice, we provided an Internet address where the evaluation could be viewed. This address was incorrect. The Internet address should have read:
In FR Doc. 02-17795, published on July 16, 2002 (67 FR 46628-46629), make the following correction: On page 46629, first column, fourth full paragraph, in the first sentence, correct “http://www.aphis.usda/gov/vs/reg-request.html” to read “http://www.aphis.usda.gov/vs/reg-request.html”.
Forest Service, USDA.
Notice of intent to prepare a Supplemental Environment Impact Statement.
The USDA Forest Service will prepare a Supplemental Environmental Impact Statement (SEIS) to the South Spruce Ecosystem Rehabilitation Project EIS (1999) to implement vegetation management treatments in the spruce/fir forests within the Cedar City Ranger District, Dixie National Forest, Utah. The agency gives notice of the full environmental analysis and decision-making process that will occur on the proposal so that interested and affected people may become aware of how they can participate in the process and contribute to the final decision.
Comments concerning the scope of the analysis must be received by thirty days after publication of this Notice of Intent in the
Send written comments to: Long Deer Interdisciplinary Team Leader, Cedar City Ranger District, Dixie National Forest, 1789 Wedgewood, Cedar City, Utah 84720.
Long Deer Interdisciplinary Team Leader, Cedar City Ranger District, Dixie National Forest, 1789 Wedgewood, Cedar City, Utah 84720.
The proposed project is located in a 10,436 acre analysis area in portions of the Tommy, Duck, and Upper Midway Creek watersheds. Approximately 7,514 acres of the project area are forested and 2,922 acres are non-forested. The proposed commercial conifer treatment areas currently are infested with spruce beetle (
The purpose of the project is to harvest approximately 2,443 acres of dead, dying, and high risk Engelmann spruce trees to recover wood products that would otherwise be lost, while still meeting desired resources objectives for the project area. Minor amounts of subalpine fir trees (less than 15% of the total removed) would also be removed to encourage open growth, spruce or subalpine fir regeneration, improve residual stand vigor, or that will likely be damaged or killed during the removal of the spruce trees.
Rehabilitation of areas heavily impacted by bark beetle mortality through the completion of natural and artificial regeneration activities would occur as needed. An estimated 1,000 acres would be planted with spruce seedlings. Reforestation is essential to providing for the most rapid progression toward the desired future condition for forest cover in the project area.
Aspen regeneration of approximately 470 acres is also included in this proposal. These areas are included with the 2,443 acres of salvage/improvement treatments. Treatments would include tree removal followed by burning or mechanical treatment (commercial harvest) with or without burning.
Within the areas proposed for treatments, approximately 102 acres would be machine piled and burned and 619 acres would be broadcast burned to reduce fuels to the desired levels and to help stimulate the regeneration of aspen.
Travel management is proposed for portions of the project area. The purpose of this activity is to restore and rehabilitate ecological values in areas where excessive numbers of open roads exist; primarily to offset the loss of big game hiding cover from harvest activities. Moving these portions of the project area toward or below the Land Resource Management Plan guideline of two miles of open road per square mile will reduce the adverse environmental impacts associated with excessive numbers of open roads and loss of cover. A reduction in open road density will also reduce long-term maintenance costs while promoting safe, efficient public travel on the open road system. Road closures would be accomplished with earth and rock barriers, fences, or gates. The open road density for the analysis area would be reduced from the current 2.39 miles per square mile to 1.70 miles per square mile.
Vegetation management treatments involving commercial harvest, aspen regeneration, and travel management would occur on National Forest system lands located within portions of section 19, 30-32 of Township (T) 37 South (S), Range (R) 8 West (W); sections 13, 14, 23-26, 35, and 36 of T37S, R8
The transportation system required to access commercial harvest areas is in place. All skid trails would be obliterated and may be seeded upon completion of the project.
The proposed actions would implement management direction, contribute to meeting the goals and objectives identified in the DNF-LRMP, and move the project area toward the desired condition. This project SEIS would be tiered to the Dixie National Forest LRMP EIS (1986), which provides goals, objectives, standards and guidelines for the various activities and land allocations on the Forest.
The Forest Service would analyze and document direct, indirect, and cumulative environmental effects for a range of alternatives. Each alternative would include mitigation measures and monitoring requirements. One alternative to the proposed action has been identified at this time. Alternative A was developed to address an issue identified during scoping. This alternative would close less roads in order to maintain access to dispersed campsites and popular off highway vehicle routes. The open road density would be reduced from the existing 2.39 miles per square mile to 1.80 miles per square mile under this alternative. All other actions would be identical to the Proposed Action. No other issue has been identified beyond those initially identified and analyzed under separate alternatives in the South Spruce Ecosystem Rehabilitation Project EIS.
The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewers' position and contentions.
To assist the Forest Service in identifying and considering issues and concerns about the proposed action, comments on the draft supplemental environmental impact statement should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.
In the final SEIS, the Forest Service is required to respond to substantive comments and responses received during the comment period that pertain to the environmental consequences discussed in the draft SEIS and applicable laws, regulations, and policies considered in making a decision regarding the proposal. The Responsible Official will document the decision and rationale for the decision in a Record of Decision. The final SEIS is scheduled for completion in December, 2002. The decision will be subject to review under Forest Service Appeal Regulations.
Forest Service, USDA.
Revised notice of intent to prepare an environmental impact statement in conjunction with revision of the Land and Resource Management Plan for the Medicine Bow National Forest.
The Forest Service will prepare an environmental impact statement in conjunction with the revision of the Land and Resource Management Plan (hereafter referred to as the Forest Plan or Plan) for the Medicine Bow National Forest.
Comments concerning the issues, concerns and scope of the analysis with regard to the proposed action were requested to be received in writing by November 15, 1999. The Forest Service expects to file a Draft Environmental Impact Statement with the Environmental Protection Agency (EPA) and make it available for public comment in December 2002. The agency expects to file the Final Environmental Impact Statement in December 2003.
Send written comments to: Mary Peterson, Forest Supervisor, Medicine Bow-Routt National Forests, 2468 Jackson Street, Laramie, Wyoming 82070.
Dave Harris, Planning Team Leader, (307) 745-2403.
This is a revised Notice of Intent for the prior notice promulgated in the
(1) The draft EIS has been delayed two years. The original expected release date was October 2000; the new expected date is December 2002. The final EIS is expected to be published December 2003.
(2) Two cooperating agencies have been added. The Bureau of Land Management in Wyoming (USDI-BLM) will cooperate on the preparation of the EIS and decisions regarding mineral leasing. Seven Wyoming Conservation Districts (Little Snake River, Saratoga-Encampment-Rawlins, Medicine Bow, Conserve County, Laramie County, and Laramie Rivers Conservation Districts and the Platte County Resource District, hereinafter referred to as County Conservation Districts) will cooperate in water quality monitoring, planning for impaired watersheds, socio-economic analysis, and public involvement.
(3) The responsible official has changed. Rick D. Cables is the current Regional Forester for the Rocky Mountain Region and responsible official for the Medicine Bow Forest Plan Revision.
Pursuant to part 36 Code of Federal Regulations (CFR) 219.10(g), the Regional Forester for the Rocky Mountain Region gives notice of the agency's intent to prepare an environmental impact statement for the revision effort described above. According to 36 CFR 219.10(g), land and resource management plans are ordinarily revised on a 10- to 15-year cycle. The existing Forest Plan was approved November 20, 1985.
The Forest Service is the lead agency in this revision effort. The State of Wyoming, by and through the Office of Federal Land Policy; USDI-BLM; and County Conservation Districts are cooperating agencies by virtue of special expertise and jurisdiction. The State of Wyoming was listed as a cooperating agency in the 1999 Notice of Intent.
Forest Plans describe the intended management of National Forests. Agency decisions in the Plan will do the following:
* Establish multiple-use goals and objectives (36 CFR 219.11);
* Establish forestwide management requirements (standards and guidelines) to fulfill the requirements of 16 USC 1604 applying to future activities (resource integration requirements, 36 CFR 219.13 to 219.27);
* Establish management areas and management area direction (management area prescriptions) applying to future activities in that management area (resource integration and minimum specific management requirements) 36 CFR 219.11(c);
* Establish monitoring and evaluation requirements (36 CFR 219.11(d));
* Determine suitability and potential capability of lands for producing forage for grazing animals and for providing habitat for management indicator species (36 CFR 219.20), designate lands not suited for timber production, and, where applicable, establish allowable timber sale quantity (36 CFR 219.14, 219.15, and 219.21);
* Where applicable to oil and gas resources, determine the planning area leasing decision (lands administratively available for leasing) and the leasing decision for specific lands [36 CFR 228.102(4)(d) & (e)]. Where applicable, BLM will issue a decision document on leasing for federal minerals, both under
* Where applicable, recommend Wild and Scenic River designations, in cooperation with the National Park Service, in accordance with 16 USC 1274; and
* Where applicable, recommend non-Wilderness allocations or Wilderness recommendations for roadless areas (26 CFR 219.17).
The authorization of project level activities within the planning area occurs through project decison-making, the second stage of forest and grassland planning. Project-level decisions must comply with National Environmental Policy Act (NEPA) procedures and must include a determination that the project is consistent with the Management Plan, or the Plan must be amended according to the National Forest Management Act (NFMA).
Reviewers of the DEIS must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions; Vermont
To assist the Forest Service in identifying and considering issues and concerns on the proposed actions, comments on the DEIS should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the DEIS. Comments may also address the adequacy of the DEIS or the merits of the alternatives formulated and discussed in the statements. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.
After the comment period ends on the DEIS, comments will be analyzed, considered, and responded to by the Forest Service in preparing the Final EIS. The FEIS is scheduled to be completed in December 2003. The responsible officials will consider the comments, responses, environmental consequences discussed in the FEIS, and applicable laws, regulations, and policies in making decisions regarding these revisions. The responsible official will document his decision and reasons for the decision in a Record of Decision for the revised Management Plan. The decision will be subject to appeal in accordance with 36 CFR 217.
Forest Service, USDA.
Notice of meeting.
The Deschutes Provincial Advisory Committee will meet on September 11-12, 2002. The first day is a field trip to the Dilman project on the Deschutes River to view implementation of activities related to forest health and dispersed recreation on the Deschutes National Forest. The second day will be a business meeting beginning 9 a.m. and ending 4 p.m. at the La Pine Library at 16425 1st St. in La Pine, Oregon. Topics include Northwest Forest Plan Monitoring, Deschutes National Forest Recreation Strategy, Upper Deschutes Resource Management Plan, Hosmer, Subcommittee updates/Round Robin, and a Public Forum from 3-3:30 p.m.
Chris Mickle, Province Liaison, USDA, Bend-Ft. Rock Ranger District, 1230 NE. 3rd., Bend, OR, 97701, Phone (541) 383-4769.
Forest Service, USDA.
Notice of meeting.
The Lake County Resource Advisory Committee (RAC) will hold a meeting.
The meeting will be held on September 19, 2002, from 3 p.m. to 6 p.m.
The meeting will be held at the Lake County Board of Supervisor's Chambers at 255 North Forbes Street, Lakeport.
Debbie McIntosh, Committee Coordinator, USDA, Mendocino National Forest, Upper Lake Ranger District, 10025 Elk Mountain Road, Upper Lake, CA 95485. (707) 275-2361; e-mail
Agenda items to be covered include: (1) Roll Call/Establish Quorum; (2) Review and Approval of the Minutes of the August 8, 2002 Meeting; (3) Finalize business for 2002; (4) Discuss/revise evaluation criteria for projects; (5) Evaluate Committee Membership; (6) Discussion on Chair Position for 2003; (7) Discussion on Next Meeting Date; and (8) Discuss Project Cost Accounting USFS/County of Lake; (9) Recommend Projects for 2003; (10) Public Comment period. The meeting is open to the public. Public input opportunity will be provided and individuals will have the opportunity to address the Committee at that time.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Yuma County Airport Authority, Inc., grantee of Foreign-Trade Zone 219, requesting authority to expand FTZ 219, Yuma, Arizona, to include an additional site within the San Luis Customs port of entry. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR Part 400). It was formally filed on August 14, 2002.
FTZ 219 was approved by the Board on April 2, 1997 (Board Order 874, 62 FR 17580, 4/10/97), and expanded on April 5, 2001 (Board Order 1161, 66 FR 19422, 4/16/01). The zone project currently consists of two parcels (125 acres) within the Yuma International Airport complex (Site 1), 2191 East 32nd Street, Yuma.
The applicant is now requesting authority to expand the general-purpose zone to include an additional site (95 acres) in Yuma:
In accordance with the Board's regulations, a member of the FTZ Staff has been designated examiner to investigate the application and report to the Board.
Public comment on the application is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at one of the following addresses:
1. Submission via Express/Package Delivery Services: Foreign-Trade Zones Board U.S. Department of Commerce, Franklin Court Building—Suite 4100W, 1099 14th Street, NW, Washington, DC 20005; or
2. Submissions via the U.S. Postal Service: Foreign-Trade Zones Board, U.S. Department of Commerce, FCB—Suite 4100W, 1401 Constitution Avenue, NW, Washington, DC 20230.
The closing period for their receipt is October 21, 2002. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period (to November 4, 2002).
A copy of the application and accompanying exhibits will be available during this time for public inspection at the Office of the Foreign-Trade Zones Board's Executive Secretary at address Number 1 listed above, and at the Yuma Main Library, 350 South 3rd Avenue, Yuma, Arizona 85364.
An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Port of Tacoma, Washington, grantee of FTZ 86, requesting on behalf of Matsushita Kotobuki Electronics Industries of America, Inc. (MKA), to expand the scope of manufacturing authority under zone procedures within Subzone 86E, at the MKA facilities in Vancouver, Washington. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally filed on August 12, 2002.
Subzone 86E was approved by the Board in 2000 at four sites in Vancouver, Washington (five buildings and two trailers, 427,300 sq. ft. total). Authority was granted for the manufacture of 9- and 13-inch television/video cassette recorder/DVD combination units (Board Order 1176, 66 FR 32933, 6/19/2001).
MKA is now proposing to expand the scope of manufacturing activity conducted under zone procedures at Subzone 86E to include 20-inch flat and round screen television/video cassette recorder/DVD combination units and 27-inch flat screen television/video cassette recorder/DVD combination units. The finished products would have duty rates of 3.9%
Expanded subzone authority would exempt MKA from Customs duty payments on the aforementioned foreign components when used in export production. On its domestic sales, MKA would be able to choose the lower duty rate that applies to the finished products for the foreign components, when applicable.
In accordance with the Board's regulations, a member of the FTZ Staff has been designated examiner to investigate the application and report to the Board.
Public comment is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at one of the following addresses:
1. Submissions via Express/Package Delivery Services: Foreign-Trade-Zones Board, U.S. Department of Commerce, Franklin Court Building—Suite 4100W, 1099 14th St. NW., Washington, DC 20005; or
2. Submissions via the U.S. Postal Service: Foreign-Trade-Zones Board, U.S. Department of Commerce, FCB—Suite 4100W, 1401 Constitution Ave. NW., Washington, DC 20230.
The closing period for their receipt is October 21, 2002. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to November 4, 2002. A copy of the application and accompanying exhibits will be available for public inspection at the Office of the Foreign-Trade Zones Board's Executive Secretary at address Number 1 listed above, and at the U.S. Department of Commerce Export Assistance Center, One World Trade Center, 121 SW Salmon Street, Suite 242, Portland, OR 97204.
International Trade Administration, Commerce.
Announcement of meeting.
The APAC will have a closed meeting on September 9, 2002, at the U.S. Department of Commerce to discuss U.S.-made automotive parts sales in Japanese and other Asian markets.
September 9, 2002.
Dr. Robert Reck, U.S. Department of Commerce, Room 4036, Washington, DC 20230, telephone: 202-482-1418.
The U.S. Automotive Parts Advisory Committee (the “Committee”) advises U.S. Government officials on matters relating to the implementation of the Fair Trade in Automotive Parts Act of 1998 (Public Law 105-261). The Committee: (1) Reports to the Secretary of Commerce on barriers to sales of U.S.-made automotive parts and accessories in Japanese and other Asian markets; (2) reviews and considers data collected on sales of U.S.-made auto parts and accessories in Japanese and other Asian markets; (3) advises the Secretary of Commerce during consultations with other Governments on issues concerning sales of U.S.-made automotive parts in Japanese and other Asian markets; and (4) assists in establishing priorities for the initiative to increase sales of U.S.-made auto parts and accessories to Japanese markets, and otherwise provide assistance and direction to the Secretary of Commerce in carrying out the intent of that section; and (5) assists the Secretary of Commerce in reporting to Congress by submitting an annual written report to the Secretary on the sale of U.S.-made automotive parts in Japanese and other Asian markets, as well as any other issues with respect to which the Committee provides advice pursuant to its authorizing legislation. At the meeting, committee members will discuss specific trade and sales expansion programs related to automotive parts trade policy between the United States and Japan and other Asian markets.
The Acting Assistant Secretary for Administration, with the concurrence of the General Counsel formally determined on August 14, 2002, pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, that the September 9th meeting of the Committee and of any subcommittee thereof, dealing with privileged or confidential commercial information may be exempt from the provisions of the Act relating to open meeting and public participation therein because these items are concerned with matters that are within the purview of 5 U.S.C. 552b (c)(4) and (9)(B). A copy of the Notice of Determination is available for public inspection and copying in the Department of Commerce Records Inspection Facility, Room 6020, Main Commerce.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for nominations.
NMFS solicits nominations for the Highly Migratory Species (HMS) advisory panel (AP) and the Billfish AP, and announces a joint meeting tentatively for November 2002, in Silver Spring, MD. The purpose of the AP’s will be to assist NMFS in the collection and evaluation of information relevant to modification or amendment of the fisheries management plan for Atlantic tunas, swordfish, and sharks (HMS FMP) and to modification of the Billfish FMP Amendment. The AP will include representatives from all interests in HMS fisheries and billfish fisheries, respectively.
Nominations must be submitted on or before October 7, 2002.
Nominations and comments on Statement of Organization, Practices and Procedures revision recommendations should be submitted in writing to Chris Rogers, Chief, Highly Migratory Species Division, NMFS, 1315 East-West Highway, Silver Spring, MD, 20910. Nominations may be submitted by fax; 301-713-1917.
Othel Freeman or Carol Douglas (301) 713-2347.
In accordance with the Magnuson-Stevens Fishery Conservation and Management Act, (Magnuson-Stevens Act), 16 U.S.C. 1801
The purpose of the HMS AP is to advise and assist the Secretary of Commerce (Secretary) in the collection and evaluation of information relevant to any amendment to the HMS FMP (April 1999). The HMS AP evaluates future management options for Atlantic tunas, swordfish and sharks under the requirements of the Magnuson-Stevens Act.
The purpose of the Billfish AP is to advise and assist the Secretary in the collection and evaluation of information relevant to any amendment to the Billfish FMP. The Billfish AP evaluates future management options for Atlantic billfish under the requirements of the Magnuson-Stevens Act.
Individuals with definable interests in the recreational and commercial fishing and related industries, environmental community, academia, governmental entities and non-governmental organizations will be considered for membership in the AP.
Nominations are invited from all individuals and constituent groups. The nomination should include:
1. The name of the applicant or nominee and a description of their interest in highly migratory species (HMS) or one species in particular from among sharks, swordfish, tunas and billfish;
2. A statement of background and/or qualifications;
3. The AP to which the applicant seeks appointment;
4. A written commitment that the applicant or nominee shall actively participate in good faith in the tasks of the AP.
Tenure for the HMS AP:
Member tenure will be for 3 years, with one third of the members’ terms expiring on the last day of each calendar year. All appointments will be for 3 years (36 months).
Tenure for the Billfish AP:
Member tenure will be for 2 years, with one half of the terms expiring on the last day of each calendar year. All appointments will be for 2 years (24 months).
The HMS AP consists of not less than twenty-two (22) members who are knowledgeable about the pelagic fisheries for all Atlantic HMS species. The Billfish AP consists of not less than eight (8) members who are knowledgeable about the pelagic fisheries for all billfish species. Nominations for each AP will be accepted to allow representation from recreational and commercial fishing interests, the conservation community, and the scientific community.
NMFS does not believe that each potentially affected organization or individual must necessarily have its own representative, but each area of interest must be adequately represented. The intent is to have a group that, as a whole, reflects an appropriate and equitable balance and mix of interests given the responsibilities of each AP. Criteria for membership include one or more of the following: (a) Experience in the recreational fishing industry involved in catching swordfish, tunas, billfish, or sharks; (b) experience in the commercial fishing industry for HMS; (c) experience in fishery-related industries (marinas, bait and tackle shops); (d) experience in the scientific community working with HMS; (e) representation of a private, non-governmental, regional, (non-Federal) state, national, or international organization representing marine fisheries, environmental, governmental or academic interests dealing with HMS.
Five (5) additional members of the AP include one voting representative each of the New England Fishery Management Council, the Mid-Atlantic Fishery Management Council, the South Atlantic Fishery Management Council, the Gulf of Mexico Fishery Management Council, and the Caribbean Fishery Management Council. The AP also includes twenty-two (22) ex-officio participants: twenty (20) representatives of the constituent states and two (2) representatives of the constituent interstate commissions; the Atlantic States Marine Fisheries Commission and the Gulf States Marine Fisheries Commission.
NMFS will provide the necessary administrative support, including technical assistance, for the AP. However, NMFS will not compensate participants with monetary support of any kind. Depending on availability of funds members maybe reimbursed for for travel costs related to the AP meetings.
Meetings of each AP will be held as frequently as necessary but are routinely held once each year in the Spring. Often the meetings are held jointly, and may be held in conjunction with other advisory panel meetings or public hearings. The meeting is tentatively scheduled for November 2002, in Silver Spring, MD. This meeting is being held in addition to the routinely held Spring meeting.
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Enforcement Committee and Advisory Panel and its Vessel Monitoring Systems (VMS) Committee in September, 2002 to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from these groups will be brought to the full Council for formal consideration and action, if appropriate.
The meetings will be held on September 4 and 5, 2002. See
The meetings will be held at the New England Fishery Management Council Office, 50 Water Street, Mill #2, Newburyport, MA 01950; telephone: (978) 465-0492.
Paul J. Howard, Executive Director, New England Fishery Management Council; (978) 465-0492.
The committee will review federal vessel permit issues associated with the Atlantic herring fishery and requiring fishermen to have a valid VMS number prior to issuance of the permit. This would be consistent with previous federal fisheries that require VMS. They will also discuss prohibiting fishermen with federal vessel permits from selling fish to unlicensed dealers. Current regulations prohibit dealers without permit from buying fish from federally permitted vessels.
Also included in the agenda will be review of the enforceability of the following: alternatives for Multispecies Amendment 13; draft enforcement analysis for scallops; general category landings restriction, particularly those in the state-waters only exemption for scallops; review of species ID guide for skates and its utility for enforcement as well as proposed prohibitions on possession, landing, sale and recommendations for tolerances on prohibitions and/or possession limits to account for mis-identification of skates. The committee will also discuss whether to increase advisory panel membership.
Location: New England Fishery Management Council Office, 50 Water Street, Mill #2, Newburyport, MA 01950; telephone: (978) 465-0492.
The committee will discuss the concept of using automated vessel monitoring systems in New England fisheries. The agenda will include discussion of current VMS performance, alternative tracking devices now available, future expansion of VMS programs and VMS use for other management measures. The committee also may discuss other business.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scallop Oversight Committee in September, 2002. Recommendations from the committee will be brought to the full Council for formal consideration and action, if appropriate.
The meeting will held on Monday, September 9, 2002, at 1 p.m.
The meeting will be held at Providence Biltmore, 11 Dorrance Street, Kennedy Plaza, Providence, RI 02903; telephone: (401) 421-0700.
Paul J. Howard, Executive Director; telephone: (978) 465-0492.
The committee will meet to develop recommendations for approval of final alternatives in the annual adjustment to the Scallop Fishery Management Plan (FMP) (Framework Adjustment 15 to the FMP); options under consideration for the 2003 fishing year include but are not limited to: an adjustment to the annual day-at-sea allocations for vessels with limited access permits, continuing the controlled access program for one or both of the Hudson Canyon and VA/NC Areas, and a day-at-sea tradeoff exemption procedure. The committee will also review the Habitat Committee’s recommendations for alternatives in Amendment 10 and may develop advice for the September 10-12, 2002 Council meeting. Other business may be taken up as needed.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of Gulf of Alaska (GOA) and Bering Sea/Aleutian Islands (BS/AI) Groundfish Plan Team meetings.
The North Pacific Fishery Management Council’s (Council) GOA and BS/AI Groundfish Plan Team will meet in Alaska.
The meeting will be held on September 9-10, 2002.
The Groundfish Plan Teams will meet at the Alaska Fishery Science Center, 7600 Sand Point Way NE, Bldg. 4, Seattle, WA 98115.
Council Staff: 907-271-2809.
On Monday, the 9th of September at 1 p.m., the Groundfish Plan Teams will meet at the Alaska Fishery Science Center. Items to be discussed include, Status of DPSEIS, SSL Protection Measures, Ecosystem Chapter, Other Species update, ESA listings. BS/AI will review preliminary drafts of Arrowtooth, Eastern Bering Sea Pollock and Atka mackerel. GOA will review a preliminary draft of pollock hydroacoustic survey results, assessment update.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council’s intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Gail Bendixen, 907-271-2809, at least 5 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of committee meeting.
The North Pacific Fishery Management Council’s (Council) Gulf of Alaska Working Group will meet in Kodiak, AK.
The meeting will be held on September 19-21, 2002.
The meeting will be held at the Best Western Kodiak Inn, 236 Rezanof Drive, in the Harbor Room, Kodiak, AK 99615.
Council staff: 907-271-2809.
On Thursday, September 19th, the committee will meet starting at 1 p.m.
Alhough non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council’s intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Gail Bendixen, 907-271-2809, at least 5 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Pacific Fishery Management Council (Council) and its advisory bodies will hold public meetings.
The Council and its advisory bodies will meet September 7-13, 2002. The Council meeting will begin on Tuesday, September 10, at 10 a.m., reconvening each day through Friday. All meetings are open to the public, except a closed session will be held from 8 a.m. until 10 a.m. on Tuesday, September 10 to address litigation and personnel matters. The Council will meet as late as necessary each day to complete its scheduled business.
The meetings will be held at the DoubleTree Hotel Columbia River, 1401 N Hayden Island Drive, Portland, OR 97217; telephone: 503-283-2111.
Dr. Donald O. McIsaac, Executive Director; telephone: 503-820-2280 or 866-806-7204.
The following items are on the Council agenda, but not necessarily in this order. All items listed are subject to potential Council action.
1. Opening Remarks, Introductions
2. Council Member Appointments
3. Roll Call
4. Executive Director's Report
5. Approve Agenda
6. Approve March and April Minutes
Essential Fish Habitat Issues
1. NMFS Report on Groundfish Management
2. Final Harvest Levels and Other Specifications for 2003
3. Adoption of 2003 Groundfish Management Measures
4. Status of Fisheries and Inseason Adjustments
5. Exempted Fishing Permits (EFP): Update and New Proposals
6. Groundfish Programmatic and Essential Fish Habitat FMP Environmental Impact Statements
7. Update on Amendment 16-Rebuilding Plans
8. Groundfish Stock Assessment Priorities for 2003
9. Amendment 17- Multi-Year Management
10. Scoping for Delegation of Nearshore Management Authority
1. NMFS Report
2. Update of Ongoing Fisheries
3. Scientific and Statistical Committee Methodology Review Priorities
1. Marine Reserve Proposals for Channel Island National Marine Sanctuary
2. Update on Marine Reserves Processes
1. Status of 2002 Pacific Halibut Fisheries
2. Proposed Changes to the Catch Sharing Plan and Annual Regulations
1. NMFS Report
2. Pacific Sardine Fishery Update
1. Legislative Matters
2. Financial Matters
3. Appointments to Advisory Bodies, Standing Committees, and Other Forums
4. Council Staff Work Load Priorities
5. November 2002 Council Meeting Draft Agenda
Although non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subject of formal Council action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Ms. Carolyn Porter at (503)820-2280 or (866)806-7204 at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The Pacific Fishery Management Council's (Council) Coastal Pelagic Species Advisory Subpanel (CPSAS) will hold a conference call, which is open to the public.
The CPSAS will convene via conference call Friday, September 6, 2002, from 1 p.m. until business for the day is completed.
See
Mr. Dan Waldeck, Pacific Fishery Management Council; telephone: (503) 820-2280.
Public listening stations will be available at the following locations:
1. National Marine Fisheries Service, 501 W Ocean Blvd., Long Beach, CA 90802, (562) 980-4000, Contact: Jim Morgan;
2. California Department of Fish and Game, 1933 Cliff Drive, Suite 9, Santa Barbara, CA 93109, (805) 568-1231, Contact: Marija Vojkovich;
3. California Department of Fish and Game, 20 Lower Ragsdale Drive, Suite 100, Monterey, CA 93940, (831) 649-2870, Contact: Travis Tanaka; and
4. Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 200, Portland, OR 97220-1384, (503) 820-2280, Contact: Dan Waldeck.
The purpose of the work session is to prepare CPSAS comments to the Council regarding two matters, (1) potential collateral impacts on CPS fisheries from proposed regulations for the 2003 West Coast groundfish fishery, and (2) recommendations from the
Although nonemergency issues not contained in the CPSAS meeting agenda may come before the CPSAS for discussion, those issues may not be the subject of formal CPSAS action during this meeting. CPSAS action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the CPSAS's intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Ms. Carolyn Porter at (503) 820-2280 at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The Pacific Fishery Management Council's (Council) Highly Migratory Species Plan Development Team (HMSPDT) will hold a work session, which is open to the public.
The HMSPDT will meet Wednesday, September 4, 2002 from 8 a.m. until 5 p.m.; and Thursday, September 5, 2002 from 8 a.m. until business for the day is completed.
The work session will be held at the Hubbs-Sea World Research Institute, Auditorium, 2595 Ingraham Street, San Diego, CA 92109; telephone: (619) 226-3870.
Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 200, Portland, OR 97220-1384.
Mr. Dan Waldeck, Pacific Fishery Management Council, telephone: (503) 820-2280.
The primary purpose of the work session is to review comments on the draft fishery management plan (FMP) for West Coast highly migratory species (HMS) and revise the FMP accordingly for presentation to the Council at the November Council meeting. The HMS FMP is scheduled for final Council action in November 2002.
Although nonemergency issues not contained in the HMSPDT meeting agenda may come before the HMSPDT for discussion, those issues may not be the subject of formal HMSPDT action during this meeting. HMSPDT action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the HMSPDT's intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Ms. Carolyn Porter at (503) 820-2280 at least 5 days prior to the meeting date.
Committee for the Implementation of Textile Agreements (CITA).
Issuing a directive to the Commissioner of Customs adjusting limits.
August 21, 2002.
Ross Arnold, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-4212. For information on the quota status of these limits, refer to the Quota Status Reports posted on the bulletin boards of each Customs port, call (202) 927-5850, or refer to the U.S. Customs website at http://www.customs.gov. For information on embargoes and quota re-openings, refer to the Office of Textiles and Apparel website at http://otexa.ita.doc.gov.
Section 204 of the Agricultural Act of 1956, as amended (7 U.S.C. 1854); Executive Order 11651 of March 3, 1972, as amended.
The current limits for certain categories are being adjusted for swing and carryforward.
A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (see
Dear Commissioner: This directive amends, but does not cancel, the directive issued to you on November 27, 2001, by the Chairman, Committee for the Implementation of Textile Agreements. That directive concerns imports of certain cotton, wool, man-made fiber, silk blend and other vegetable fiber textiles and textile products, produced or manufactured in Thailand and exported during the twelve-month period which began on January 1, 2002 and extends through December 31, 2002.
Effective on August 21, 2002, you are directed to adjust the limits for the following categories, as provided for under the Uruguay Round Agreement on Textiles and Clothing:
The Committee for the Implementation of Textile Agreements has determined that these actions fall within the foreign affairs exception to the rulemaking provisions of 5 U.S.C. 553(a)(1).
Committee for the Implementation of Textile Agreements (CITA).
Denial of the request alleging that certain100 percent cotton yarn-dyed flannel fabrics, for use in apparel articles, cannot be supplied by the domestic industry in commercial quantities in a timely manner.
On June 11, 2002, the Chairman of CITA received a request from Intradeco Corporation of Miami, Florida alleging that certain fabrics, classified under subheading 5208.43.00 of the Harmonized Tariff Schedule of the United States (HTSUS), cannot be supplied by the domestic industry in commercial quantities in a timely manner. It requested that apparel of such fabrics be eligible for preferential treatment under the CBTPA. Based on currently available information, CITA has determined that these subject fabrics can be supplied by the domestic industry in commercial quantities in a timely manner and therefore denies the request.
For Further Information Contact: Richard Stetson, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-3400.
Section 213(b)(2)(A)(v)(II) of the Caribbean Basin Economic Recovery Act, as added by Section 211(a) of the CBTPA; Section 6 of Executive Order No. 13191 of January 17, 2001.
The CBTPA provides for quota- and duty-free treatment for qualifying textile and apparel products. Such treatment is generally limited to products manufactured from yarns or fabrics formed in the United States or a beneficiary country. The CBTPA also provides for quota- and duty-free treatment for apparel articles that are both cut (or knit-to-shape) and sewn or otherwise assembled in one or more CBTPA beneficiary countries from fabric or yarn that is not formed in the United States or a CBTPA beneficiary country, if it has been determined that such fabric or yarn cannot be supplied by the domestic industry in commercial quantities in a timely manner. In Executive Order No. 13191, the President delegated to CITA the authority to determine whether yarns or fabrics cannot be supplied by the domestic industry in commercial quantities in a timely manner under the CBTPA. On March 6, 2001, CITA published procedures that it will follow in considering requests. (66 FR 13502).
On June 11, 2002, the Chairman of CITA received a request from Intradeco Corporation of Miami, Florida alleging that certain 100 percent cotton yarn-dyed flannel fabrics, classified under subheading 5208.43.00 of the HTSUS, of construction 2X2 twill weave 64X54, cannot be supplied by the domestic industry in commercial quantities in a timely manner. It requested that apparel of such fabric that are both cut and sewn or otherwise assembled in one or more CBTPA beneficiary countries be eligible for preferential treatment under the CBTPA.
On June 17, 2002, CITA solicited public comments regarding this request, particularly with respect to whether these fabrics can be supplied by the domestic industry in commercial quantities in a timely manner. On July 5, 2002, CITA and the Office of the U.S. Trade Representative offered to hold consultations with the relevant Congressional committees. We also requested the advice of the U.S. International Trade Commission and the relevant Industry Sector Advisory Committees.
CITA has determined that certain 100 percent cotton yarn-dyed flannel fabrics, classified under subheading 5208.43.00 of the HTSUS, of construction 2X2 twill weave 64X54, used in apparel, can be supplied by the domestic industry in commercial quantities in a timely manner. On the basis of currently available information, including review of the request, public comment and advice received, and its understanding of the industry, CITA has determined that there is domestic capacity to supply these fabrics. Intradeco's request is denied.
Committee for the Implementation of Textile Agreements (CITA).
Request for public comments concerning a petition for a modification of the NAFTA rules of origin for certain products made of yarn from combed fine animal hair.
On July 12, 2002, the Chairman of CITA received a petition from Amicale Industries, Inc. (Amicale) alleging that yarn of combed fine animal hair, classified in subheading 5108.20.60 of the Harmonized Tariff Schedule of the United States (HTSUS), cannot be supplied by the NAFTA region in commercial quantities in a timely manner and requesting that the President proclaim a modification of the NAFTA rules of origin. Amicale requests that the NAFTA rules of origin for woven fabrics of subheadings, 5112.11.60, 5112.19.95, and for men's and women's apparel of subheadings 6203.11.30, 6203.11.90, 6203.21.30, 6203.21.90, 6203.31.90, 6203.41.18, 6204.11.00, 6204.21.00, 6204.31.10, 6204.31.20, 6204.51.00, and 6204.61.90,
For Further Information Contact: Richard Stetson, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-3400.
Section 204 of the Agricultural Act of 1956, as amended (7 USC 1854); Section 202(q) of the North American Free Trade Agreement Implementation Act (19 USC 3332(q)); Executive Order 11651 of March 3, 1972, as amended.
Under the North American Free Trade Agreement (NAFTA), NAFTA countries are required to eliminate customs duties on textile and apparel goods that qualify as originating goods under the NAFTA rules of origin, which are set out in Annex 401 to the NAFTA. The NAFTA provides that the rules of origin for textile and apparel products may be amended through a subsequent agreement by the NAFTA countries. In consultations regarding such a change, the NAFTA countries are to consider issues of availability of supply of fibers, yarns, or fabrics in the free trade area and whether domestic producers are capable of supplying commercial quantities of the good in a timely manner. The Statement of Administrative Action (SAA) that accompanied the NAFTA Implementation Act stated that any interested person may submit to CITA a request for a modification to a particular rule of origin based on a change in the availability in North America of a particular fiber, yarn or fabric and that the requesting party would bear the burden of demonstrating that a change is warranted. The SAA provides that CITA may make a recommendation to the President regarding a change to a rule of origin for a textile or apparel good. The NAFTA Implementation Act provides the President with the authority to proclaim modifications to the NAFTA rules of origin as are necessary to implement an agreement with one or more NAFTA country on such a modification.
On July 12, 2002, the Chairman of CITA received a petition from Amicale Industries, Inc. (Amicale) alleging that yarn of combed fine animal hair, classified in subheading 5108.20.60 of the Harmonized Tariff Schedule of the United States (HTSUS), cannot be supplied by the NAFTA region in commercial quantities in a timely manner and requesting that the President proclaim a modification of the NAFTA rules of origin. Amicale requests that the NAFTA rules of origin for woven fabrics of subheadings, 5112.11.60, 5112.19.95, and for men's and women's apparel of subheadings 6203.11.30, 6203.11.90, 6203.21.30, 6203.21.90, 6203.31.90, 6203.41.18, 6204.11.00, 6204.21.00, 6204.31.10, 6204.31.20, 6204.51.00, and 6204.61.90, be modified to allow for the use of non-North American origin yarn of subheading 5108.20.60. Such a proclamation may be made only after reaching agreement with the other NAFTA countries on the modification.
CITA is soliciting public comments regarding this request, particularly with respect to whether yarn of combed fine animal hair, classified in HTSUS subheading 5108.20.60, can be supplied by the domestic industry in commercial quantities in a timely manner. To be ensured full consideration, comments must be received no later than September 20, 2002. Interested persons are invited to submit six copies of such comments or information to the Chairman, Committee for the Implementation of Textile Agreements, Room 3100, U.S. Department of Commerce, 14th and Constitution Avenue, N.W., Washington, DC 20230.
If a comment alleges that yarn of fine animal hair can be supplied by the domestic industry in commercial quantities in a timely manner, CITA will closely review any supporting documentation, such as a signed statement by a manufacturer of the yarn stating that it produces the yarn that is in the subject of the request, including the quantities that can be supplied and the time necessary to fill an order, as well as any relevant information regarding past production.
CITA will protect any business confidential information that is marked business confidential from disclosure to the full extent permitted by law. CITA will make available to the public non-confidential versions of the request and non-confidential versions of any public comments received with respect to a request in room 3100 in the Herbert Hoover Building, 14th and Constitution Avenue, N.W., Washington, DC 20230. Persons submitting comments on a request are encouraged to include a non-confidential version and a non-confidential summary.
Pursuant to section 254(b) of the Balanced Budget and Emergency Deficit Control Act of 1985 (2 U.S.C. 904(b)), the Congressional Budget Office hereby reports that it has submitted its
Department of the Army, DoD.
Notice; date correction.
The open meetings scheduled for June 25, 2002 from 8 a.m. to 5 p.m. and June 27, 2002 from 8 a.m. to 5 p.m. published in the
Commander, HQ U.S. Army Cadet Command, ATTN: ATCC-TT (Mrs. Johnson), Fort Monroe, VA 23651. Telephone number is (757) 788-4586.
This meeting is open to the public. Any interested person may attend, appear
Department of Education.
The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before October 21, 2002.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.
Requests for copies of the proposed information collection request may be accessed from
Comments regarding burden and/or the collection activity requirements should be directed to Joe Schubart at (202) 708-9266. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Take notice that on August 14, 2002, Edison Mission Energy, Inc. filed a complaint against PJM Interconnection L.L.C. and the PJM Market Monitoring Unit objecting to the lack of confidentiality safeguards contained in the PJM Market Mitigation Plan that would protect the disclosure of confidential fuel cost information requested by the PJM Market Monitoring Unit.
Any person desiring to be heard or to protest this filing should file 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). 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. The answer to the complaint and all comments, interventions or protests must be filed on or before September 3, 2002. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
The Federal Energy Regulatory Commission (Commission) is reviewing the application for a new license for the El Dorado Project (FERC No. 184), filed on February 22, 2000. The El Dorado Project, licensed to the El Dorado Irrigation District (EID), is located on the South Fork American River, in El Dorado, Alpine, and Amador Counties, California. The project occupies lands of the Eldorado National Forest.
The EID, several state and federal agencies, and several non-governmental agencies are working collaboratively with a facilitator to resolve certain issues relevant to this proceeding. This meeting is a part of that collaborative process.
On Friday, August 30, 2002, the Aquatics/Hydrology workgroup will meet from 9:00 a.m. until 4:00 p.m. The meeting will focus on hydrologic modeling of different operational alternatives for the project. We invite the participation of all interested governmental agencies, non-governmental organizations, and the general public in this meeting.
The meeting will be held at the Rancho Cordova Holiday Inn, located at 11131 Folsom Blvd.,Rancho Cordova, California.
For further information, please contact Elizabeth Molloy at (202) 502-8771 or John Mudre at (202) 502-8902.
Take notice that on August 14, 2002, The Kroger Co. tendered for filing with the Federal Energy Regulatory Commission (Commission) a complaint against Dynegy Power Marketing, Inc. (Dynegy) seeking Commission action: to declare the prices contained in four wholesale confirmations executed in Spring 2001 as unjust and unreasonable and contrary to the public interest; to set just and reasonable prices based on current market conditions; to establish a refund effective date within 60 days of filing of the complaint; and to initiate hearing procedures.
Any person desiring to be heard or to protest this filing should file 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). 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. The answer to the complaint and all comments, interventions or protests must be filed on or before September 13, 2002. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 18, 2002, Union Light, Heat and Power Company (Union) filed pursuant to section 284.123(b)(2) of the Commission's regulations, a petition for rate approval requesting that the Commission approve the proposed rates as fair and equitable for transportation and storage services performed under section 311 of the Natural Gas Policy Act of 1978 (NGPA).
Union proposes to establish a monthly 100% reservation charge rate of $0.3046 per Dekatherm of demand associated with a no-notice quality service to be rendered pursuant to its Order No. 63 blanket certificate issued on December 1, 1998, in Docket No. CP98-70-000.
Pursuant to section 284.123(b)(2)(ii), if the Commission does not act within 150 days of the date of this filing, the rates will be deemed to be fair and equitable and not in excess of an amount which interstate pipelines would be permitted to charge for similar transportation service. The Commission may, prior to the expiration of the 150 day period, extend the time for action or institute a proceeding to afford parties an opportunity for written comments and for the oral presentation of views, data, and arguments.
Any person desiring to participate in this rate proceeding must file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed with the Secretary of the Commission on or before August 22, 2002. 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 proceedings. Any person wishing to become a party must file a motion to intervene. This petition for rate approval is on file with the Commission are available for public inspection. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
The following filings have been made with the Commission. The filings are listed in ascending order within each docket classification.
Take notice that on August 5, 2002, the Midwest Independent Transmission System Operator, Inc. (the Midwest ISO), submitted certain revisions to the Joint Open Access Transmission Tariff of the Midwest Independent Transmission System Operator, Inc. for the Transmission System (Michigan) in compliance with the Federal Energy Regulatory Commission's (Commission) July 5, 2002 order in these proceedings. The Midwest ISO requests that these changes become effective May 1, 2002.
A copy of the filing was served upon the parties on the official Commission service lists established in these proceeding, on all affected state commissions, and on other affected parties.
Take notice that on July 31, 2002, Conoco Gas & Power Marketing, a Division of Conoco, Inc., tendered for filing a Notice of Withdrawal. This entity is no longer involved in power transactions.
Take notice that on August 5, 2002, the New York Independent System Operator, Inc. (NYISO) filed in this docket a response to the Commission's July 5, 2002 deficiency letter. The NYISO has requested an effective date of June 1, 2002 for the filing.
The NYISO has served a copy of this filing upon all parties that have executed service agreements under the NYISO's OATT and Services Tariff and on the electric utility regulatory agencies of New York, New Jersey and Pennsylvania, including, as directed in the Deficiency Letter, a copy of this filing to all parties who have either requested or been granted intervention in these proceedings.
Take notice that on August 7, 2002, Puget Sound Energy, Inc. (Puget) submitted for filing, a revised Rate Schedule, a First Revised Service Agreement No. 1, which includes the Amendment No. 1 to the Agreement for the Installation of Electrical Facilities—South SeaTac filed on June 4, 2002. This First Revised Service Agreement No. 1 is effective May 17, 2002.
Take notice that on August 6, 2002, Southaven Power, LLC submitted a Notice of Withdrawal of the Request for Authorization to Amend Market-Based Rate Tariff filed June 10, 2002 in the above referenced docket.
Take notice that on August 6, 2002, Green Country Energy, LLC, submitted a Notice of Withdrawal of the Request for Authorization to Amend Market-Based Rate Tariff filed in the above referenced docket on June 10, 2002.
Take notice that on August 6, 2002, Cogentrix Energy Power Marketing, Inc., submitted a Notice of Withdrawal of the Request for Authorization to Amend Market-Based Rate Tariff in the above referenced docket on June 10, 2002.
Take notice that on August 6, 2002, Rathdrum Power, LLC, submitted a Notice of Withdrawal of the Request for Authorization to Amend Market-Based Rate Tariff in the above referenced docket on June 10, 2002.
Take notice that on August 6, 2002, Jackson County Power, LLC, submitted a Notice of Withdrawal of the Requests for Authorization to Amend Market-Based Rate Tariff in the above referenced docket on June 10, 2002.
Take notice that on August 6, 2002, Caledonia Generating, LLC, submitted a Notice of Withdrawal of the Request for Authorization to Amend Market-Based Rate Tariff filed in the above referenced docket on June 10, 2002.
Take notice that on August 6, 2002, Quachita Power, LLC, submitted a Notice of Withdrawal of the Request for Authorization to Amend Market-Based Rate Tariff filed in the above referenced docket on June 10, 2002.
Take notice that on August 6, 2002, Cogentrix Lawrence County, LLC, submitted a Notice of Withdrawal of the Request for Authorization to Amend Market-Based Rate Tariff in the above referenced docket on June 10, 2002.
Take notice that on August 6, 2002, Southwestern Power Marketers, Inc., has formally ceased operations. Please withdraw the market based tariff in Docket No. ER97-2529-000.
Take notice that on August 8, 2002, Enerserve, L.C. was closed. Enerserve, L.C. is requesting termination of the certificate authorizing to engage in wholesale electric power and energy transaction as a marketer.
Take notice that on August 8, 2002, pursuant to Section 205 of the Federal Power Act and Section 35.15(a), 18 CFR 35.15(a) of the Commission's Regulations, Alcoa Power Generating, Inc. (APGI) filed with the Federal Energy Regulatory Commission a Notice of Termination of its Long-Term Agreement by and between APGI and Aquila Merchant Services, Inc., successor to Aquila Energy Marketing Corporation. Pursuant to Section 35.15(a) of the Commission's Regulations, APGI requests an effective date for this termination of August 9, 2002.
Take notice that on August 8, 2002, Tucson Electric Power Company tendered for filing one (1) Umbrella Service Agreement (for short-term firm service) and one (1) Service Agreement (for non-firm service) pursuant to Part II of Tucson's Open Access Transmission Tariff, which was filed in Docket No. ER01-208-000.
The details of the service agreements are Umbrella Agreement for Short-Term Firm Point-to-Point Transmission Service dated as of August 2, 2002 by and between Tucson Electric Power Company and UBS AG, London Branch—FERC Electric Tariff Vol. No. 2, Service Agreement No. 200. No service has commenced at this time.
Form of Service Agreement for Non-Firm Point-to Point Transmission Service dated as of August 2, 2002 by and between Tucson Electric Power Company and UBS AG, London Branch—FERC Electric Tariff Vol. No. 2, Service Agreement No. 201. No service has commenced at this time.
E. Any person desiring to intervene or to protest this filing should file 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). 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. All such motions or protests should be filed on or before the comment date, and, to the extent applicable, must be served on the applicant and on any other person designated on the official service list. This filing is available for review at the Commission or may be viewed on the Commission's web site at
The Federal Energy Regulatory Commission hereby gives notice that on August 22, 2002, members of its staff will attend the MISO-PJM-SPP Single Market Design Forum meeting, concerning the development of a joint and common wholesale energy market for the Midwest Independent Transmission System Operator, Inc. (MISO), PJM Interconnection (PJM) and Southwest Power Pool, Inc. (SPP) regions. The staff's attendance is part of the Commission's ongoing outreach efforts. The meeting is sponsored by MISO, PJM and SPP, and will be held on August 22, 2002, 10:00 a.m. at the Sheraton Suites International, 7032 Elm Road, Baltimore, MD 20240. This meeting is open to the public. The meeting may discuss matters at issue in Docket No. RM01-12-000, Remedying Undue Discrimination Through Open Access Transmission Service and Standard Electricity Market Design, and in Docket No. EL02-65-000,
For more information, contact Mike Gahagan, Vice President, Chief Information Officer & Chief Strategic Officer, Midwest Independent Transmission System Operator, Inc. at (317) 249-5450, or Lawrence R. Greenfield, Senior Counsel, Federal Energy Regulatory Commission at (202) 502-6415 or
Environmental Protection Agency (EPA).
Notice.
EPA today, pursuant to section 209(b) of the Clean Air Act (Act), 42 U.S.C. 7543(b), is granting California its request for a waiver of federal preemption, with the exceptions noted below, for its Onboard Refueling Vapor Recovery (ORVR) regulations. By letter dated July 22, 1997, the California Air Resources Board (CARB) requested that EPA grant California a waiver of federal preemption for its ORVR regulations which primarily incorporate EPA's ORVR regulations and with a phase-in commencing in 1998.
The Agency's Decision Document, containing an explanation of the Assistant Administrator's decision, as well as all documents relied upon in making that decision, including those submitted to EPA by CARB, are available at the EPA's Air and Radiation Docket and Information Center (Air Docket). The Air Docket Office is open from 8 to 4 p.m. Monday through Friday, at EPA, Air Docket (6102), Room M-1500, Waterside Mall, 401 M Street, SW., Washington, DC 20460. The reference number for this docket is A-97-38.
Electronic copies of this Notice and the accompanying Decision Document are available via the Internet on the Office of Transportation and Air Quality (OTAQ) website (
Please note that due to differences between the software used to develop the documents and the software into which the documents may be downloaded, changes in format, page length, etc., may occur.
David J. Dickinson, Certification and Compliance Division, U.S. Environmental Protection Agency, Ariel Rios Building (6405J), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Telephone: (202) 564-9256. Fax: (202) 565-2057. E-Mail address:
I have decided to grant California a waiver of Federal preemption pursuant to section 209(b) of the Act for amendments to its motor vehicle pollution control program for ORVR which incorporates (1) EPA's emission standards (0.20 grams hydrocarbon, Organic Material Hydrocarbon Equivalent, for alcohol
Section 209(b) of the Act provides that, if certain criteria are met, the Administrator shall waive Federal preemption for California to enforce new motor vehicle emission standards and accompanying enforcement procedures. The criteria include consideration of whether California arbitrarily and capriciously determined that its standards are, in the aggregate, at least as protective of public health and welfare as the applicable Federal standards; whether California needs State standards to meet compelling and extraordinary conditions; and whether California's amendments are consistent with section 202(a) of the Act.
CARB determined that its ORVR standards and accompanying enforcement procedures do not cause California's standards, in the aggregate, to be less protective of public health and welfare than the applicable Federal standards. EPA received no comments that questioned CARB's determination. As indicated in footnote one, to the extent that CARB's ORVR regulation does not apply to gaseous fueled vehicles a waiver for such vehicles is not granted, and as further explained in the Decision Document the federal ORVR regulations apply to such vehicles. In all other respects EPA cannot make a finding that CARB's determination, that its ORVR requirements are, in the aggregate, at least as protective of public health and welfare, is arbitrary and capricious.
CARB has continually demonstrated the existence of compelling and extraordinary conditions justifying the need for its own motor vehicle pollution control program, which includes the subject standards and procedures. No information has been submitted to demonstrate that California no longer has a compelling and extraordinary need for its own program. Therefore, I agree that California continues to have compelling and extraordinary conditions which require its own program, and, thus, I cannot deny the waiver on the basis of the lack of compelling and extraordinary conditions.
CARB has submitted information that the requirements of its emission standards and test procedures are technologically feasible and present no inconsistency with federal requirements and are, therefore, consistent with section 202(a) of the Act. No information has been presented to demonstrate that CARB's requirements are inconsistent with section 202(a) of the Act, nor does EPA have any other reason to believe that CARB's requirements are inconsistent with section 202(a). Thus, I cannot find that California's ORVR requirements will be inconsistent with section 202(a) of the Act. Accordingly, I hereby grant the waiver requested by California.
My decision will affect not only persons in California but also the manufacturers outside the State who must comply with California's requirements in order to produce motor vehicles for sale in California. For this reason, I hereby determine and find that this is a final action of national applicability.
Under section 307(b)(1) of the Act, judicial review of this final action may be sought only in the United States Court of Appeal for the District of Columbia Circuit. Petitions for review must be filed by October 21, 2002. Under section 307(b)(2) of the Act, judicial review of this final action may not be obtained in subsequent enforcement proceedings.
As with past waiver decisions, this action is not a rule as defined by Executive Order 12866. Therefore, it is exempt from review by the Office of Management and Budget as required for rules and regulations by Executive Order 12866.
In addition, this action is not a rule as defined in the Regulatory Flexibility Act, 5 U.S.C. 601(2). Therefore, EPA has not prepared a supporting regulatory flexibility analysis addressing the impact of this action on small business entities.
Finally, the Administrator has delegated the authority to make determinations regarding waivers of Federal preemption under section 209(b) of the Act to the Assistant Administrator for Air and Radiation.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency established the Clean Air Excellence Awards Program in February 2000. This is an annual awards program to recognize outstanding and innovative efforts that support progress in achieving clean air. This notice announces the competition for the Year 2002 program.
For further information concerning this new awards program please use the CAAAC Web site cited above or contact Paul Rasmussen at the telephone and address cited above.
Environmental Protection Agency.
Notice; announcement of a program to assist local agencies that wish to voluntarily develop and implement environmental management systems (EMS); request for applications.
The Environmental Protection Agency (EPA) announces its intention to assist up to ten local government organizations that wish to develop and implement environmental management systems (EMS). While no direct financial assistance would be provided to participants. Other assistance, in the form of training workshops, on-site visits, and electronic materials/consultation would be provided. EPA would provide partial funding for this program through a cooperative agreement with the Global Environment and Technology Foundation (GETF), a non-profit organization that specializes in EMS training and implementation, located in Annandale, Virginia, but the majority of the funding would be provided by the participants through individual agreements with GETF. GETF will then work closely with each participant throughout the life of the program and provide training, technical assistance, site visits, and other materials designed to help each participant develop a complete EMS, using the ISO 14001 International EMS Standard as a baseline. Participants would also be asked to communicate and share information with local stakeholders as their EMS is developed. Each participant would also provide data about their EMSs, including a short case study, to a National Clearinghouse of EMS Information that is designed to help a wide range of public agencies develop EMSs for their operations. This clearinghouse is located at
This initiative is similar to and builds on the successes of two previous projects sponsored by EPA. More information on these projects can also be found at
This initiative is being led by EPA's Office of Water and co-sponsored by the Office of Air and Radiation and the Office of Solid Waste.
Letters of Application from interested organizations should be submitted no later than September 30, 2002.
Letters of application should be submitted in writing or faxed to: Craig Ruberti, Global Environment and Technology Foundation (GETF), 7010 Little River Turnpike, Suite 460, Annandale, Virginia, 22003, (703) 750-640, FAX (703) 750-6506.
Jim Horne, U.S. EPA, Office of Wastewater Management, 1200 Pennsylvania Avenue, NW., 20460, (202) 564-0571,
Over the past 8-10 years, there has been increasing evidence that organizations that adopt environmental management systems (EMS) for their operations can realize significant benefits in terms of improved environmental performance, including but not limited to environmental compliance, prevention of pollution, increased operational efficiency, and improved relations with regulatory agencies. Originally adopted in the private sector, EMSs are now proving to be a powerful tool that can also help public agencies, especially local governments. EMSs do not impose new technical requirements, nor do they act as a substitute for existing regulatory requirements. EMSs provide a powerful and replicable method for an organization to more effectively
Since 1997, the U.S. Environmental Protection Agency (EPA) has led a major effort to assist and build partnerships with public agencies, primarily local governments, voluntarily adopt environmental management systems (EMS) for their operations, using the ISO 14001 International EMS Standard as a baseline. These initiatives have documented a series of important benefits for the 23 organizations that have participated including improved environmental performance, cost savings, and better community relations. The experiences of these agencies have also helped to demonstrate the value of EMSs in the public sector, provided much valuable information that can
As a result of the successes of these efforts, EPA has recently launched the Public Entity EMS Resource Center Initiative (PEER). The PEER Initiative consists of two major components—(1) A national clearinghouse of EMS information geared to the particular needs of public agencies, especially local governments, located at
Participants in this program would be required to:
(1) Develop an environmental management system (EMS) for an operation of their choosing, using the ISO 14001 International Standard as a baseline. Participants will be provided with information on the process, costs, and benefits of achieving 3rd party certification for their EMS, but will not be required to achieve certification;
(2) Communicate and share information with local stakeholders as the EMS is developed;
(3) Adopt performance objectives for the EMS that address compliance, environmental performance beyond compliance, and pollution prevention;
(4) Share information about their EMS and other relevant information through the national clearinghouse of EMS information for public entities described above (
The Global Environment and Technology Foundation (GETF) , through a cooperative agreement with U.S. EPA, will work closely with each participant to help them meet these requirements, over a two year period beginning in late 2002. GETF will provide this assistance through regular workshops involving all participants, site assistance visits for each participants, regular conference calls, and other written and electronic materials. In addition, participants will receive informal mentoring, as appropriate, from agencies that have participated in the two previous local government EMS initiatives sponsored by U.S. EPA.
Organizations wishing to apply for this program need to:
1. Submit a letter of application to the person listed above in the summary of this Notice no later than September 30, 2002;
2. This letter should be signed by the head of the organization and contain the following information:
EPA funding will be provided through GETF and used to offset some of the costs of participating in the program, such as travel to workshops. However, participants will be asked to pay the majority of the costs of participation, through an agreement with GETF. This funding can be provided on a yearly basis. EPA believes the costs of participation are competitive with costs incurred by other local governments to develop EMSs and that participation in this national program will provide significant benefits to each participant.
Once all applications are received, follow up interviews will be conducted by GETF with each applicant to discuss the information contained in their letter of application in more detail, along with any other information needed before final decisions on program participation are made. GETF will consult with EPA before final decisions are made. These final decisions are expected no later than November 20, 2002, after which GETF will work with each participant to schedule the first program workshop.
Environmental Protection Agency (EPA),
Notice.
The Environmental Protection Agency established the Clean Air Act Advisory Committee (CAAAC) on November 19, 1990, to provide independent advice and counsel to EPA on policy issues associated with implementation of the Clean Air Act of 1990. The Committee advises on economic, environmental, technical scientific, and enforcement policy issues.
For Further Information concerning this meeting of the full CAAAC, please contact Paul Rasmussen, Office of Air and Radiation, US EPA (202) 564-1306, FAX (202) 564-1352 or by mail at US EPA, Office of Air and Radiation (Mail code 6102 A), 1200 Pennsylvania Avenue, NW., Washington, DC 20004. For information on the subcommittee meetings, please contact the following individuals: (1) Permits/NSR/Toxics Integration—Debbie Stackhouse, 919-541-3554; and (2) Linking Transportation, Land Use and Air Quality Concerns—Robert Larson, 734-214-4277; and (3) Economic Incentives and Regulatory Innovations—Carey Fitzmaurice, 202-564-1667. Additional information on these meetings and for the CAAAC and its Subcommittees can be found on the CAAAC Web Site:
Environmental Protection Agency (EPA).
Notice.
The Tribal Pesticide Program Council (TPPC), will hold a 2-day meeting, beginning on September 25, 2002, and ending on September 26, 2002. This notice announces the location and times for the meeting and sets forth the tentative agenda topics.
The meeting will be held on September 25, 2002, from 9 a.m. to 5 p.m., and September 26, 2002, from 9 a.m. to 5 p. m. On September 25 and 26 at 1:15 to 2:15 p.m., the Tribal caucus is closed to EPA and the general public.
This meeting will be held at the Silver Star Hotel and Casino at Pearl River Resort, Highway 16 West, Choctaw, MS.
Georgia A. McDuffie, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone number: (703) 605-0195; fax number: (703) 308-1850; e-mail address: mcduffie.georgia@epa.gov.
Lillian Wilmore, Tribal Pesticide Program Council Facilitator, P.O. Box 470829; Brookline Village, MA 02447-0829; telephone number (617) 232-5742; fax number: (617) 277-1656; e-mail address: naecology@aol.com.
This action is directed to the public in general. This action may, however, be of interest to Tribes with pesticide programs or pesticide interests. 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 ID number OPP-2002-0207 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 or collection activity.
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 ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
This unit provides tentative agenda topics for the 2-day meeting.
1. TPPC State of the Council Report.
2. Presentation and questions and answers by EPA's Office of Pesticide Programs, Field and External Affairs Division.
3. Reports from Working Groups and TPPC participation in other meetings:
Environmental indicators, Tribal Strategy and FOSTTA, Pesticide Program Dialogue Committee, Report on the Western Regional Pesticide Conference, Certification and Training Advisory Group (CTAG), Water Quality and Pesticides Management, and Worker Protection.
4. Tribal caucus.
5. Reports from other Tribal organizations:
American Indian Environmental Office (AIEO), Tribal Operations Committee (TOC), Regional Tribal Operations Committee (RTOC), Intertribal Agricultural Council (IAC), and National Tribal Environmental Council (NTEC).
6. Homeland security.
7. Environmental Justice: Fish Consumption Report.
8. EPA's Office of Enforcement and Compliance Assurance (OECA) related issues.
i. Continuing issues reference.
ii. Data collections issues - Form 5700-33H.
9. Tribal caucus.
10. Section 18 and other Tribal authority issues.
11. Pesticide priorities for 2004 and 2005.
12. Updates from the Regional Offices.
13. EPA's Office of Prevention, Pesticides, and Toxic Substances (OPPTS) - Overview and subsistence issues focus.
14. Report on funding of special projects and water quality projects to Tribes and report from Blackfeet nation on their special project.
15. NAGPRA Working Group.
16. Federal Inspector credentials criteria.
17. Tribal code development: A panel discussion - with opportunity for questions.
Environmental protection, Pesticide and pests.
Environmental Protection Agency (EPA).
Notice.
This notice of a tolerance reassessment for pronamide starts a 30-day public comment period during which the public is encouraged to submit comments on the Agency's “Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED) for pronamide.” The Agency is providing an opportunity, through this notice, for interested parties to comment in accordance with procedures described in Unit I of this document. All comments will be carefully considered by the Agency. If any comment causes the Agency to revise its decision on reassessment of these tolerances, EPA will publish notice of its amendment in the
Comments, identified by docket control number OPP-2002-0159 must be received on or before September 20, 2002.
Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the
Cecelia Watson, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-4329; e-mail address: watson.cecelia@epa.gov.
This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) or the Federal Food, Drug, and Cosmetic Act (FFDCA); environmental, human health, and agricultural advocates; pesticides users; and members of the public interested in the use of pesticides. 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.
To access TRED documents electronically, go directly to the TREDs table on the EPA Office of Pesticide Programs Home Page, at http://www.epa.gov/pesticides/reregistration/status.htm
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 ID number OPP-2002-0159 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 appropriate 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 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 ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
This notice constitutes and announces the availability of the TRED for pronamide. This decision has been developed as part of the public participation process that EPA and the U.S. Department of Agriculture (USDA) are using to involve the public in the reassessment of pesticide tolerances under FFDCA. EPA must review tolerances and tolerance exemptions that were in effect when FQPA was enacted in August 1996, to ensure that these existing pesticide residue limits for food and feed commodities meet the safety standard of the new law.
FFDCA requires EPA to review all the tolerances for registered chemicals in effect on or before the date of the enactment. In reviewing these tolerances, the Agency must consider, among other things, aggregate risks from non-occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. The tolerances are considered reassessed once the safety finding has been made or a revocation occurs. A reregistration eligibility decision (RED) was completed for pronamide in April 1994, prior to FQPA enactment, and therefore needed an updated assessment to consider the provisions of the Act.
FFDCA requires that the Agency, when considering whether to establish, modify, or revoke a tolerance, consider “available information” concerning the cumulative effects of a particular pesticide's residue and “other substances that have a common mechanism of toxicity.”
As indicated above, the Agency will also evaluate the cumulative risk, if necessary, posed by the entire group of chemicals with which a common mechanism of toxicity is shared, and issue a final tolerance reassessment decision once the cumulative
All registrants of pesticide products containing one or more of the active ingredients listed in this document are being sent the TRED, and must respond to labeling requirements within 8 months of receipt. Furthermore, the Agency requests a response to all generic confirmatory data from technical registrants within 90 days of receipt.
The reregistration program is being conducted under congressionally-mandated time frames, and EPA recognizes both the need to make timely reregistration decisions and to involve the public. Therefore, EPA is issuing this TRED as a final document with a 30-day comment period. All comments will be carefully considered by the Agency. If any comment significantly affects the TRED, EPA will amend the TRED by publishing the amendment in the
The legal authority for these TREDs falls under FIFRA, as amended in 1988 and 1996. Section 4(g)(2)(A) of FIFRA directs that, after submission of all data concerning a pesticide active ingredient, “the Administrator shall determine whether pesticides containing such active ingredients are eligible for reregistration,” and either reregistering products or taking “other appropriate regulatory action.”
Environmental protection, Chemicals, Pesticides and pests, Tolerances.
Environmental Protection Agency (EPA).
Notice.
This notice announces Agency approval of an application to register the pesticide product Bollgard II containing an active ingredient not included in any previously registered product pursuant to the provisions of section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.
Leonard Cole, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5412; e-mail address: cole.leonard@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 also available for public inspection. 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. The request 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.
The Agency approved the application after considering all required data on risks associated with the proposed use of Cry1Ac and Cry2Ab stacked proteins, and information on social, economic, and environmental benefits to be derived from use. Specifically, the
EPA issued a notice, published in the
The application was approved on June 14, 2002, as Bollgard II, Plant-incorporated protectant containing Cry1Ac and Cry2Ab stacked proteins (EPA Registration Number 524-522) for a 20,000 acre seed increase.
Environmental protection, Chemicals, Pesticides and pests.
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 pesticide chemical in or on various food commodities.
Comments, identified by docket ID number OPP-2002-0208, must be received on or before September 20, 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: Joanne Miller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-6224; e-mail address: miller.joanne@epamail.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 ID number OPP-2002-0208 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. 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 ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
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, Feed additives, Food additives, Pesticides and pests.
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. EPA is publishing the petition summary verbatim without editing it in any way. 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 (0F6094) from Bayer Corporation, 8400 Hawthorn Road, Kansas City MO, 64120-0013, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances for residues of propoxycarbazone-sodium, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate, sodium salt and its metabolite, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-(2'-hydroxy-propoxy)-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate in or on the raw agricultural commodities (RACs) wheat forage, wheat hay, wheat straw, wheat grain, meat, and meat byproducts, (cattle, sheep, goats, horses, hogs), and milk at 1.5, 0.15, 0.05, 0.01, 0.05, and 0.002 parts per million (ppm); respectively. EPA has determined that the petition contain data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; 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.
1.
2.
ii.
3.
1.
ii. MKH-6561 is not toxic to rats following a single dermal application. The acute dermal LD
iii. An acute inhalation study with rats showed low toxicity with a 4-hour dust aerosol LC
iv. An eye irritation study in rabbits showed minimal irritation completely reversible within 48 hours.
v. A dermal irritation study in rabbits showed slight irritation completely reversible within 48 hours.
vi. MKH-6561 has no skin sensitizing potential under the conditions of the maximization test in guinea pigs.
2.
3.
ii. A developmental toxicity study was conducted with Wistar rats via oral gavage of MKH-6561 at levels of 0, 100, 300, and 1,000 mg/kg bwt/day on days 6 through 19 of gestation. There were no signs of maternal toxicity, embryotoxicity, fetotoxicity, or teratogenicity at the level of 1,000 mg/kg bwt/day. Therefore, the maternal and developmental NOAELs for rats were established at 1,000 mg/kg bwt/day, the limit dose for this study type. No teratogenic potential of MKH-6561 was evident in rats.
iii. Himalayan rabbits were administered MKH-6561 at levels of 0, 20, 100, 500, or 1,000 mg/kg bwt/day by oral gavage on days 6 through 28 post coitum in a test for developmental toxicity. A maternal NOAEL of 100 mg/kg bwt/day was established based on cold ears, alopecia, swelling of vulva, decreased feed, and water intake, body weight loss, gastrointestinal tract (GI) effects, liver effects, and thyroid hormone level effects. The gestation rate NOAEL of 100 mg/kg bwt/day was based on one abortion (assessed as secondary due to maternal toxicity) at 500 mg/kg bwt/day. The NOAEL for fetal parameters of 500 mg/kg bwt/day was based on placental effects, increased post-implantation loss, decreased number of fetuses, decreased fetal weight, retarded fetal skeletal ossification, and possible increase in lobulation of liver in fetuses at 1,000 mg/kg bwt/day. No teratogenic potential of MKH-6561 was evident in rabbits.
4.
ii. A 14-week feeding study was conducted with Wistar rats at dietary dose levels of 0, 250, 1,000, 4,000, or 20,000 ppm. The NOAEL was determined to be 4,000 ppm (286.4 mg/kg bwt/day in males and 350.6 mg/kg bwt/day in females) based upon increased water consumption (reversible during the 4-week recovery period) and an irritative effect of the forestomach epithelium (reversible during the 4-week recovery period) in males and females dosed at 20,000 ppm as well as reduced glucose and triglyceride levels in females only dosed at 20,000 ppm.
iii. A 91-day feeding study was conducted with B6C3F
iv. A 2-month range-finding feeding study in Beagle dogs, at levels of 0, 1,000, 5,000, 10,000, and 40,000 ppm in the diet established a NOAEL of 10,000 ppm ( 322.2 mg/kg bwt/day in males and 285.6 mg/kg bwt/day in females) based on elevated hepatic biotransformation enzymes at 40,000 ppm.
5.
ii. B6C3F
iii. A 1-year feeding study in Beagle dogs was conducted at 0, 2,000, 10,000, and 25,000 ppm in the diet. The NOAEL in males was determined to be 10,000 ppm (258.0 mg/kg bwt/day) based upon increased absolute adrenal gland weight without an increase in relative adrenal gland weight and slight enlargement of
6.
ii. Single oral doses of 2 mg/kg/bwt and 200 mg/kg/bwt [phenyl-UL-
iii. Laying hens were given a daily dose of protonated MKH-6561 [phenyl-UL-
iv. Laying hens were given a daily dose of protonated MKH-6561 [triazolinone-3-
v. Goats were dosed with 1.0 mg/kg/bwt of MKH-6561 [phenyl-UL-
vi. Goats were dosed with MKH-6561 [triazolinone-3-
7.
ii. MKH-8394 is of very low acute toxicity to fasted rats following a single oral administration. The acute oral LD
iii. KTS-9061 (Pr-2-OH MKH-6561) is not toxic to fasted rats following a single oral administration. The acute oral LD
iv. KTS-9304 has low to moderate acute toxicity to fasted rats following a single oral administration. The acute oral LD
8.
9.
ii. A 13-week neurotoxicity screening study in Wistar rats established a NOAEL of 20,000 ppm (1,321 mg/kg bwt/day in males and 1,651 mg/kg/day in females) (HDT). No neurotoxic potential was observed..
iii. A Plaque-Forming-Cell Assay to investigate immunotoxicological potential was performed on male Wistar rats after an approximate 4-week exposure of 0, 4,000, 10,000, or 20,000 ppm in the diet. The Plaque-Forming-Cell Assay NOAEL was 20,000 ppm (2,144 mg/kg bwt/day; HDT). The
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ii.
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BAY MKH-6561 is a sulfonamide herbicide. There is no information to suggest that any chemical in this class of herbicides has a common mechanism of mammalian toxicity or that chemicals in this class produce similar effects so it is not appropriate to combine exposures of BAY MKH-6561 with other herbicides. Bayer Corporation is considering only the potential risk of BAY MKH-6561.
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2.
There are currently no international Codex tolerances established for BAY MKH-6561. It is not currently registered in any other countries. There are no harmonized maximum residue levels at the European Union level at present.
Environmental Protection Agency (EPA).
Notice.
This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.
Comments, identified by docket ID number OPP-2002,-0172, must be received on or before September 20, 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: Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-3194; e-mail address: brothers.shaja@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 particularly 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 ID number OPP-2002-0172 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 to 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 ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
EPA has received pesticide petitions 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 the petitions 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, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.
The petitioner summary of the pesticide petitions is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petitions were prepared by the Interregional Research Project No. 4 (IR-4) and represents the view the Interregional Research Project No. 4 EPA is publishing the petition summary verbatim without editing it in any way. 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 pesticide petitions (0E6178, 2E6386, 2E6410, and 2E6432) from the Interregional Research Project No. 4 (IR-4), Rutgers, The State University of New Jersey, Highway No. 1 South, North Brunswick, NJ, 08902-3390 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR 180.493 by establishing tolerances for residues of the fungicide dimethomorph [(E,Z)4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]-morpholine] in or on the following raw agricultural commodities: Dried cone hop at 60 parts per million (ppm) (0E6178); leaf lettuce and head lettuce at 10 ppm (2E6386); cucurbit vegetable group at 0.5 ppm (2E6410); and bulb vegetable group at 2 ppm (2E6432). A related petition (PP 8F4946) for the establishment of a tolerance for residues of dimethomorph in or on imported dried hops cones at 45 ppm has previously been filed by American Cyanamid Company. This notice includes summaries of the petitions prepared by BASF Corporation, Research Triangle Park, NC. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of these petitions. Additional data may be needed before EPA rules on these petitions.
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2.
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ii. Oral LD
a. An acute oral toxicity study in the wistar rat for the E-isomer with a LD
b. An acute oral toxicity study in the wistar rat for the Z-isomer with a LD
iii. An acute dermal toxicity study was conducted in the Wistar rat for dimethomorph technical with a dermal LD
iv. A 4-hour inhalation study was conducted in wistar rats for dimethomorph technical with a lethal concentration (LC)
2.
ii. Two chinese hamster lung structural chromosomal studies were reportedly positive for chromosomal aberrations at the highest dose tested (HDT) (160 grams milliliter (g/mL)/-S9; 170 g/mL/+S9). Dimethomorph induced only a weak response in increasing chromosome aberrations in this test system. These results were not confirmed in two micronucleus tests under in vivo conditions.
iii. Structural chromosomal aberration studies were weakly positive in human lymphocytic cultures, but only in S9 activated cultures treated at 422 g/mL, the HDT, were strongly cytotoxic. No increase in chromosomal aberrations was observed in the absence of S9 activation at all doses. Furthermore, the positive clastogenic response observed under the in vitro conditions was not conformed in two in vivo micronucleus assays.
iv. Micronucleus assay (2 studies) indicated that dimethomorph was negative for inducing micronuclei in bone marrow cells of mice following intraperitoneal administration of doses up to 200 mg/kg or oral doses up to the limit dose of 5,000 mg/kg. Thus, dimethomorph was found to be negative in these studies for causing cytogenic damage in vivo.
v. Dimethomorph was negative for inducing unscheduled DNA synthesis, in cultured rat liver cells, at doses up to 250 g/mL, a weakly cytotoxic level.
vi. Dimethomorph was negative for transformation in Syrian hamster embryo cells treated, in the presence and absence of activation, up to cytotoxic concentrations (265 g/mL/+S9; 50 g/mL/-S9).
3.
ii. A rabbit development toxicity study was conducted with a LOAEL for maternal toxicity of 650 mg/kg/day and a NOAEL for maternal toxicity of 300 mg/kg/day. The NOAEL for developmental toxicity is 650 mg/kg/day, the HDT.
iii. A two-generation rat reproduction study was conducted with a LOAEL for parental systemic toxicity of 1,000 ppm, or approximately 80 mg/kg/day, and a NOAEL for parental systemic toxicity of 300 ppm, or approximately 24 mg/kg/day. The NOAEL for fertility and reproductive function was 1,000 ppm, the highest concentration tested (HCT), or approximately 80 mg/kg bwt/day.
4.
ii. A 90-day dog dietary study was conducted with a NOAEL of 450 ppm, or approximately 15 mg/kg/day, and a LOAEL of 1,350 ppm, or approximately 43 mg/kg/day.
5.
ii. A 1-year chronic toxicity study was conducted in dogs with a NOAEL of 450 ppm, or approximately 14.7 mg/kg/day and a LOAEL of 1,350, or approximately 44.6 mg/kg/day.
iii. A 2-year carcinogenicity study was conducted in Sprague-Dawley rats with a NOAEL for systemic toxicity of 200 ppm, or approximately 9 mg/kg/day for males and 11 mg/kg/day for females. The LOAEL for systemic toxicity was 750 ppm, or approximately 34 mg/kg/day for males and 46 mg/kg/day for females. There was no evidence of increased incidence of neoplastic lesions in treated animals. The NOAEL for carcinogenicity is 2,000 ppm, the HCT, or approximately 95 mg/kg/day for males and 132 mg/kg/day for females.
iv. A 2-year carcinogenicity study was conducted in mice with a NOAEL for systemic toxicity of 100 mg/kg/day and a LOAEL of 1,000 mg/kg/day. There was no evidence of increased incidence of neoplastic lesions in treated animals. The NOAEL for carcinogenicity is 1,000 mg/kg/day, the HDT.
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There is no information to indicate that any toxic effects produced by dimethomorph would be cumulative with those of any other chemical. The fungicidal mode of action of dimethomorph is unique; dimethomorph inhibits cell wall formation only in Oomycete fungi. The result is lysis of the cell wall that kills growing cells and inhibits spore formation in mature hyphae. This unique mode of action and limited pest spectrum suggest that there is little or no potential for cumulative toxic effects in mammals. In addition, the toxicity studies submitted to support this petition do not indicate that dimethomorph is a particularly toxic compound. No toxic end-points of potential concern were identified.
1. U.S. population. The cPAD is 0.1 mg/kg bwt/day, based on a NOAEL of approximately 10 mg/kg bwt/day (200 ppm) from a 2-year dietary toxicity study in rats that demonstrated decreased body weight and liver foci in females at 750 ppm. The cPAD is calculated using an uncertainty factor of 100. The theoretical maximum residue contribution (TMRC) for lettuce, cucurbit and bulb vegetable is estimated at 0.003 mg/kg bwt/day for the general population. This represents a dietary exposure to the general population of the United States that is 3.0% of the cPAD. The TMRC for dried hops cones is estimated at 0.0000515 mg/kg bwt/day for the general population. This represents a dietary exposure to the general population of the United States which is 0.05% of the cPAD. The combined TMRC for all current and pending dimethomorph tolerances in potato, tomato, grape, hop, cereal grain commodities, lettuce (head and leaf), endive (escarole), radicchio, cucurbit vegetable (crop group 9), and bulb vegetable (crop group 3) will utilize less than 10% of the cPAD for the general U.S. population. Since EPA generally has no concern for exposures below 100% of the cPAD, there is a reasonable certainty that no harm will result from aggregate exposure to dimethomorph residues in or on commodities of the cited crops.
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ii.
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The results of the studies submitted to support this package provide no evidence that dimethomorph caused reproductive, developmental or reproductive effects. No such effects were noted at dose levels that were not maternally toxic. The NOAELs observed in the developmental and reproductive studies were 6 to 65 times higher than the NOAEL used to establish the cPAD. There is no evidence to indicate that children or infants would be more sensitive than adults to toxic effects caused by exposure to dimethomorph.
Therefore, the registrant believes that the results of the toxicology and metabolism studies support both the safety of dimethomorph to humans based on the intended use as a fungicide on domestically produced hops, lettuce (head and leaf), cucurbit vegetables (crop group 9), and bulb vegetables (crop group 3) and the granting of the requested tolerances.
There are no Canadian, Mexican, or codex MRLs established for dimethomorph for the commodities associated with this request; consequently, a discussion of international harmonization is not relevant.
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 pesticide chemical in or on various food commodities.
Comments, identified by docket ID number OPP-2002-0170, must be received on or before September 20, 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: Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-3194; e-mail address: brothers.shaja@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 ID number OPP-2002-0170 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. 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 ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
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, Feed additives, Food additives, Pesticides and pests, 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 Interregional Research Project Number 4 (IR-4), and represents the view of IR-4. EPA is publishing the petition summary verbatim without editing it in any way. 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 2E6404 from Interregional Research Project Number 4 (IR-4), 681 US Highway #1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR 180.473 by establishing a tolerance for residues of the herbicide glufosinate ammonium (butonoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-methylphosphinico-propionic acid, expressed as 2-amino-4-(hydroxmethylphosphinyl) butanoic acid in or on the raw agricultural commodities blueberry, lingonberry, juneberry, and salal at 0.10 part per million (ppm). This notice includes a summary of the petition prepared by Aventis CropScience U.S.A., P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; 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.
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In a developmental toxicity study, groups of 15 pregnant female Himalayan rabbits were administered glufosinate-ammonium by gavage at doses of 0, 2.0, 6.3, or 20.0 mg/kg/day from days 7 to 19 of pregnancy. In maternal animals, decreases in food consumption and body weight gain were observed at the 20 mg/kg/day dose level. The NOAEL for maternal toxicity was 6.3 mg/kg/day and that for developmental toxicity was 20 mg/kg/day.
In a multi-generation reproduction study, glufosinate-ammonium was administered to groups of 30 male and 30 female Wistar/Han rats in the diet at concentrations of 0, 40, 120, or 360 ppm. The LOAEL for systemic toxicity is 120 ppm based on increased kidney weights in both sexes and generations. The systemic toxicity NOAEL is 40 ppm. The LOAEL for reproductive/developmental toxicity is 360 ppm based on a decreased number of viable pups at this dose. The NOAEL is 120 ppm.
4.
5.
In a carcinogenicity study, glufosinate-ammonium was administered to 50 NMRI mice/sex/dose in the diet at dose levels of 0, 80, 160 (males only), or 320 (females only) ppm for 104 weeks. The NOAEL for systemic toxicity is 80 ppm (10.82/16.19 mg/kg/day in males/females (M/F), and the LOAEL is 160/320 ppm (22.60/ 63.96 mg/kg/day in M/F), based on increased mortality in males, increased glucose levels in males and females, and changes in glutathione levels in males. No increase in tumor incidence was found in any treatment group.
In a chronic feeding study, technical glufosinate-ammonium was fed to male and female beagle dogs for 12 months in the diet at levels of 2.0, 5.0, or 8.5 mg/kg/day. The NOAEL is 5.0 mg/kg/day based on clinical signs of toxicity, reduced weight gain and mortality at the 8.5 mg/kg/day dose level. In a rat carcinogenicity study, glufosinate-ammonium was administered to Wistar rats (60/sex/group) for up to 24 months at 0, 1,000, 5,000, or 10,000 ppm (equivalent to 0, 45.4, 228.9, or 466.3 mg/kg/day in males and 0, 57.1, 281.5, or 579.3 mg/kg/day in females). The LOAEL for chronic toxicity is 5,000 ppm (equivalent to 228.9 mg/kg/day for male rats and 281.5 mg/kg/day for females), based on increased incidences of retinal atrophy. The chronic NOAEL is 1,000 ppm. Under the conditions of this study, there was no evidence of carcinogenic potential. Dosing was considered adequate based on the increased incidence of retinal atrophy.
6.
The metabolic profile and the quantitative distribution of metabolites were very similar in both goat and hen. The vast majority of the dose was excreted, primarily as parent compound. The very limited residues found in edible tissues, milk and eggs were comprised principally of glufosinate and 3-methylphosphinico-propionic acid (Hoe 061517), with lesser amounts of N-acetyl-L-glufosinate (Hoe 099730) and 2-methylphosphinico-acetic acid (Hoe 064619).
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8.
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i.
Chronic dietary analysis was conducted to estimate exposure to potential glufosinate-ammonium residues in or on registered and proposed commodities. The DEEM software and the 1994-1996 USDA food consumption data were used. Tolerance level residues were assumed for all commodities. Percent crop treated values generated by the agency were incorporated as follows: Tree nuts 1%; apples, 1%; field corn, 2.6%; grapes, 1%; and soybeans, 1%. Aventis CropScience estimates that an upper bound value for cotton at market maturity is 20% and that for potato is 10%. All other crops are included at 100% of crop treated. Chronic dietary exposure estimates from residues of glufosinate-ammonium for the U.S. population represented approximately 25% of the chronic RfD; whereas that for children 1-6, the subpopulation with the highest exposure, represented approximately 61% of the chronic RfD. This analysis was based on highly conservative assumptions, yet still indicates that dietary exposures for all segments of the population are well within the chronic RfDs. The Agency has no concerns with RfD utilization up to 100%.
ii.
The chronic DWLOC calculated for adults is 185 ppb and that for children/toddlers is 41 ppb. The chronic DWEC calculated using a worst case scenario is 31 ppb (GENEEC). The DWLOCs are based on highly conservative dietary (food) exposures and are expected to be much higher in real world situations reducing further the percent utilization of the DWLOC.
2.
EPA has determined that there are no acute or chronic non-dietary exposure scenarios. Further, the Agency has determined that it is not appropriate to aggregate short- and intermediate-term non-dietary exposure with dietary exposures in risk assessments because the end-points are different.
Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has indicated that, at this time, the Agency does not have available data to determine whether glufosinate-ammonium has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, glufosinate-ammonium does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance petition, therefore, it has not been assumed that glufosinate-ammonium has a common mechanism of toxicity with other substances.
1.
The acute population of concern, female 13+ utilizes 36% of the acute RfD. This is a tier one highly conservative assessment and actual exposure is likely to be far less. DWLOCs based on dietary exposures are greater than highly conservative estimated levels, and would be expected to be well below the 100% level of the RfD, if they occur at all. Therefore, there is a reasonable certainty that no harm will occur to the U.S. population from aggregate exposure (food, drinking water and nonresidential) to residues of glufosinate-ammonium and metabolites.
2.
The codex maximum residue limit for glufosinate-ammonium and metabolite in or on berries and other small fruits (except for currants) has been
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 pesticide chemical in or on various food commodities.
Comments, identified by docket ID number OPP-2002-0177, must be received on or before September 20, 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: Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-3194; e-mail address: brothers.shaja@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 ID number OPP-2002-0177 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. 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 ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
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, Feed additives, Food additives, Pesticides and pests, 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 petitioners. EPA is publishing the petition summary verbatim without editing it in any way. 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 pesticide petitions (1E6321, 2E6354, 2E6370, 2E6384, 2E6400, and 2E6422) from IR-4 New Jersey Agricultural Experiment Station, P.O. Box 231, Rutgers University, New Brunswick, NJ 08903 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.495 by establishing tolerances for residues of spinosad, Spinosyn A (Factor A; CAS#131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H- as Indaceno [3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS# 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9, 10,11,12,13,14,16a, 16b-tetradecahydro-4,14-methyl-1H- as Indaceno [3,2-d]oxacyclododecin-7,15-dione in or on the following raw agricultural commodities: fig at 0.1 parts per million (ppm) (1E6321), herbs subgroup at 8.0 ppm (2E6354), root vegetable subgroup at 0.1 (2E6384), dry bulb onion at 0.1 ppm (2E6384), caneberry subgroup at 0.7 ppm (2E6400), grape at 0.6 ppm (2E6422), raisin at 0.6 ppm (2E6422), grape juice at 1.2 ppm (2E6422), and peanut at 0.02 ppm (2E6370).
This notice includes a summary of the petitions prepared by Dow Agro Sciences LLC, Indianapolis, IN 46268. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on these petitions.
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Using the Guidelines for Carcinogen Risk Assessment published September 24, 1986 (51 FR 33992), it is proposed that spinosad be classified as Group E for carcinogenicity (no evidence of carcinogenicity) based on the results of carcinogenicity studies in 2 species. There was no evidence of carcinogenicity in an 18-month mouse feeding study and a 24-month rat feeding study at all dosages tested. The NOAEL shown in the mouse carcinogenicity study was 11.4 and 13.8 mg/kg/day, respectively for male and female mice. A maximum tolerated dose was achieved at the top dosage level tested in both of these studies based on excessive mortality. Thus, the doses tested are adequate for identifying a cancer risk. Accordingly, a cancer risk assessment is not needed.
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The potential for cumulative effects of spinosad and other substances that have a common mechanism of toxicity is also considered. In terms of insect control, spinosad causes excitation of the insect nervous system, leading to involuntary muscle contractions, prostration with tremors, and finally paralysis. These effects are consistent with the activation of nicotinic acetylcholine receptors by a mechanism that is clearly novel and unique among known insecticidal compounds. Spinosad also has effects on the GABA receptor function that may contribute further to its insecticidal activity. Based on results found in tests with various mammalian species, spinosad appears to have a mechanism of toxicity like that of many amphiphilic cationic compounds. There is no reliable information to indicate that toxic effects produced by spinosad would be cumulative with those of any other pesticide chemical. Thus it is appropriate to consider only the potential risks of spinosad in an aggregate exposure assessment.
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FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for pre- and post-natal toxicity and the completeness of the database. Based on the current toxicological data requirements, the data base for spinosad relative to pre- and post-natal effects for children is complete. Further, for spinosad, the NOAEL in the dog chronic feeding study which was used to calculate the RfD (0.027 mg/kg/day) is already lower than the NOAEL from the developmental studies in rats and rabbits by a factor of more than 10-fold.
Concerning the reproduction study in rats, the pup effects shown at the HDT were attributed to maternal toxicity. Therefore, it is concluded that an additional uncertainty factor is not needed and that the RfD at 0.027 mg/kg/day is appropriate for assessing risk to infants and children.
In addition, the 10X factor to account for enhanced sensitivity of infants and children is not needed because: (1) The data provided no indication of increased susceptibility of rats or rabbits to
Using the conservative exposure assumptions previously described (tolerance level residues), the percent RfD utilized by the aggregate exposure to residues of spinosad on existing crop uses is 84.4% for children 1 to 6 years old, the most sensitive population subgroup from an EPA assessment based on the chronic population adjusted dose (cPAD). The new crop uses proposed in this notice are minor ones and are expected to contribute only a negligible impact to the RfD. Thus, based on the completeness and reliability of the toxicity data and the conservative exposure assessment, it is concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to spinosad residues on the above proposed uses including existing crop uses.
There are no Codex maximum residue levels (MRLs) established for residues of spinosad on grapes, herbs, caneberries, root vegetables, dry bulb onions, or figs.
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 pesticide chemical in or on various food commodities.
Comments, identified by docket ID number OPP-2002-0184, must be received on or before September 20, 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: Bipin Gandhi, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-8380; e-mail address: gandhi.bipin@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 ID number OPP-2002-0184 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. 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 ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
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, Feed additives, Food additives, Pesticides and pests, 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. EPA is publishing the petition summary verbatim without editing it in any way. 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 (2E6476) from Magna Bon Corporation, 1531 NW 25th Drive, Okeechobee, FL 34972 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by amending an established exemption from the requirement of a tolerance for sulfuric acid in 40 CFR 180.1001(c). Currently this tolerance exemption allows the use of sulfuric acid as an inert ingredient for pre-harvest and post-harvest uses with a limitation of 0.1% in the pesticide formulation when used as a pH control agent. This petition proposes to increase the limitation to 10% and to include a new use as a chelating agent. This petition also requests the establishment of an exemption from the requirement of a tolerance in plants and plants products, meat, milk, poultry, eggs, fish, shellfish, and irrigated crops when it results from the use of sulfuric acid as an inert ingredient in a pesticide product used in irrigation conveyance systems and lakes, ponds, reservoirs, or bodies of water in which fish or shellfish are cultivated.
EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; 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.
1.
The current exemption from the requirement of a tolerance in 40 CFR 180.1001(c) describing the limitation for sulfuric acid as a inert in the “formulated product” should be changed to read 10% rather than the exemption from a tolerance at the level
The product will also be applied post-harvest and the sulfuric acid in a formulation will not affect the metabolism of harvested products. Sulfuric acid is already used to sanitize milk lines and food processing surfaces by wipe-on and CIP treatments. The use as an inert in formulations in the “final use dilution” will not increase risk when used in formulations applied to growing crops or to raw agricultural commodities after harvest, meat, milk, poultry, eggs, fish, shellfish, and irrigated crops. In addition, sulfuric acid can be used in formulations as an algaecide, herbicide, or fungicide in irrigation conveyance systems and lakes, ponds, reservoirs, or bodies of water which fish or shellfish are cultivated or the bodies of water to be used for drinking water.
2.
3.
Sulfuric acid will be applied as an inert ingredient according to labels approved by the EPA at rates reflected in a change in the wording of the tolerance exemption that reads 0.1% to 10.0%. The “final use dilution” will contain considerably less sulfuric acid when applied to growing crops, post-harvest produce, drinking water, meat, milk, poultry, eggs, fish, shellfish, irrigated crops, conveyance systems, lakes, ponds, reservoirs, or bodies of water in which fish or shellfish are cultivated or water that is used for drinking water. Since the product is not systemic the product can be washed from the surface of the plant or animal parts before being consumed as the normal practice.
1.
The literature is full of references on the acute toxic effects of sulfuric acid. The data file for Magna Bon includes a toxicology study performed with sulfuric acid used as an inert at 4%. A material safety data sheet is available upon request.
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8.
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Sulfuric acid being used as a crop protector or in a post-harvest application will add little exposure given the current exposure.
Although there are no guideline studies for this data requirement
In addition, sulfuric acid is Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration.
i.
ii.
2.
There are no cumulative effects. The amount of sulfuric acid used to treat the plants, harvested plant products, fish, shellfish, poultry, and meat would be a way of lowering bacterial, fungi and even-viral organisms from becoming a problem under most circumstances.
1.
2.
The countries of the world have not restricted sulfuric acid for the purposes requested.
Environmental Protection Agency.
Notice of availability; correction.
On August 14, 2002, the U.S. Environmental Protection Agency's (EPA) National Center for Environmental Assessment (NCEA) of the Office of Research and Development (ORD) published a notice in the
For further information contact the Technical Information Staff, National Center for Environmental Assessment/Washington Office (8623D), U.S. Environmental Protection Agency, 1200
In the
The document is available electronically through the NCEA Web site at (
Environmental Protection Agency (EPA).
Notice.
EPA is soliciting comments on two documents, “PRZM Field and Orchard Crop Scenario Metadata” and “Standard Procedures for Conducting Quality Control and Quality Assurance for Pesticide Root Zone Model (PRZM) Field and Orchard Crop Scenarios.” Interested parties may request a copy of the draft proposed procedures and scenario documentation as a set in Unit I.B. of this notice. The PRZM Field and Orchard Crop Scenario Metadata documents the crop-specific parameters (specific value used and its reference) which are key elements of the exposure scenario used to determine surface water concentrations in ecological and drinking water assessments. Standard Procedures for Conducting Quality Control and Quality Assurance for PRZM Field and Orchard Crop Scenarios provides a defined set of steps (methods of selecting or estimating specific scenario values and available references) to develop and/or ensure the quality of a crop scenario. Both documents provide a transparent description of each environmental modeling scenario and the procedures used to create them while providing consistent and reproducible products.
Comments, identified by docket ID number OPP-2002-0182, must be received on or before October 21, 2002.
Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the
Sid Abel, Environmental Fate and Effects Division (7507C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-7346; fax number: (703) 305-6309; e-mail address: abel.sid@epa.gov.
This action is directed to the public in general. This action may, however, be of interest to those who are or may be conducting surface water modeling assessments on behalf of pesticide registration, risk assessments or those who may be involved in developing information directly related to data necessary to develop a modeling scenario. 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 ID number OPP-2002-0182 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 or collection activity.
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 ID 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 Agency is seeking comment on two documents that describe how EPA develops and uses pesticide surface water modeling scenarios in ecological and drinking water exposure and risk assessments. These documents are entitled “Pesticide Root Zone Model (PRZM) Field and Orchard Crop Scenario Metadata” and “Standard Procedures for Conducting Quality Control and Quality Assurance for PRZM Field and Orchard Crop Scenarios” and can be found at the following web addresses: http://www.epa.gov/oppefed1/models/water/op_scenario_metadata_df_061602.htm and http://www.epa.gov/oppefed1/models/water/qa_qc_documentation_ver2 .htm
Modeling scenarios are defined as the set of characteristics of the agricultural crop to which a pesticide may be applied (e.g., cotton) and the field information on which the crop is actually grown (e.g., soils) that are necessary to estimate pesticide transport to surface water. The modeling sites, or scenarios, the OPP uses to estimate environmental concentrations in surface water are documented in and developed through the use of these documents.
These documents were developed to support the following activities: OP Cumulative Risk Assessment, the Agency's Information Quality Guideline, data quality guidelines and to improve environmental assessments.
The first document, “PRZM Field and Orchard Crop Scenario Metadata,” provides a detailed listing of the parameters and associated values specific to a crop and field combination (e.g., a cotton field in Yazoo County, Mississippi). OPP evaluated several approaches to documenting the parameters from a modeling scenario used to estimate environmental exposures. This format is believed to provide the most appropriate means to readily document and recall critical information contained in a given scenario. Users of this format, whether Agency staff or the public, will be able to quickly document a scenario in a consistent manner that meets quality standards implemented by the OPP. In addition, users who retrieve information or wish to understand the content of a crop-field scenario for a pesticide assessment will be assured of a standardized format which simplifies review. Information in this document reflects the results of the second document “Standard Procedures for Conducting Quality Control and Quality Assurance for PRZM Field and Orchard Crop Scenarios.”
Standard Procedures for Conducting Quality Control and Quality Assurance for PRZM Field and Orchard Crop Scenarios describes the set of procedures, methods, and references to “construct” or review for consistency the information contained in a crop-field scenario. The steps and recommendation described in this guidance provide a sound scientific basis for selecting information with relevance to what is observed in an actual agricultural field such as cotton. The methodology is intended to give the regulated community, decision-makers and the public confidence that assessments resulting from the use of scenarios representing an agricultural field reflect conditions that are likely to occur in the “real world.” Numerous methods and sources of credible scientific information are given in this document and are considered readily available to the public through voice contact, public information sources (e.g., public libraries) or the world wide web. The Agency has identified and described as best possible information to support this guidance and seeks comments on what additional information would help improve modeling scenarios.
Environmental protection, Environmental modeling, Pesticide Root Zone Model, PRZM, Surface water exposure, Pesticides, Crops, Modeling Guidance.
Environmental Protection Agency (EPA).
Notice of proposed de minimis settlement.
Under section 122(g)(4) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the Environmental Protection Agency has offered a de minimis settlement at the Peak Oil Superfund Site (Site) under an Administrative Order on Consent (AOC) to settle claims for past and future response costs at the Site. Approximately 263 parties have returned signature pages accepting EPA's settlement offer. For thirty (30) days following the publication of this notice, EPA will receive written comments relating to the settlement. EPA may withdraw from or modify the proposed settlement should such comments disclose facts or considerations which indicate the proposed settlement is inappropriate, improper, or inadequate. Copies of the proposed settlement are available from:
Comments should reference the Peak Oil Superfund Site, Tampa, Florida, and EPA Docket No. CER-04-2002-3753. Written comments may be submitted to Mr. Greg Armstrong at the above address within 30 days of the date of publication.
Federal Communications Commission.
Notice.
In this document, the FCC designates the applications to assign the licenses of radio stations WSKW(AM) and WHQO(FM), Skowhegan, Maine, from Mountain Wireless, Inc. (“Mountain”) to Clear Channel Broadcasting Licenses, Inc. (“Clear Channel”). The Commission cannot find, based on the record, that grant of these applications is consistent with the public interest, convenience, and necessity. Accordingly, pursuant to 47 U.S.C. 309(e), the Commission designates the applications for hearing to determine whether the public interest, convenience, and necessity will be served by grant of the applications.
See
Please file documents with the Investigations and Hearing Division, Enforcement Bureau, Federal Communications Commission, Room 3-B431, 445 12th Street, SW, Washington, DC 20554.
Charles W. Kelley, Chief, Investigations and Hearing Division, Enforcement Bureau, at (202) 418-1420.
This is a summary of the Federal Communications Commission's Hearing Designation Order, MM Docket No. 02-138, adopted on June 5, 2002 and released on July 10, 2002. The full text is available for inspection and copying during normal business hours in the FCC Reference Information Center, Room CY-A257, 445 12th Street, SW, Washington, DC 20554. The full text may also be purchased from the Commission's copy contractor, Qualex International, Room CY-B402, 445 12th Street, SW, Washington, DC 20554, telephone (202) 863-2983, facsimile (202) 863-2898, or via e-mail at
1. In March 1996, the Commission relaxed the numerical station limits in its local radio ownership rule in accordance with Congress's directive in section 202(b) of the Telecommunications Act of 1996. Since then, the Commission has received applications proposing transactions that would comply with the new limits, but that nevertheless could produce concentration levels that raised significant concerns about the potential impact on the public interest. In response to these concerns, the Commission concluded that it has an independent obligation to consider whether a proposed pattern of radio ownership that complies with the local radio ownership limits would otherwise have an adverse competitive effect in a particular local radio market and thus would be inconsistent with the public interest. In August 1998, the Commission also began flagging public notices of radio station transactions that would result in one entity controlling 50 percent or more of the advertising revenues in the relevant Arbitron radio market or two entities controlling 70 percent or more of the advertising revenues in that market. On November 8, 2001, we adopted the Notice of Proposed Rulemaking in MM Docket No. 01-317, 16 FCC Rcd 19861 (2001), 66 FR 63986, December 11, 2001 (“
2. On September 18, 2001, Mountain and Clear Channel filed applications proposing to assign the licenses of WSKW(AM) and WHQO(FM) from Mountain to Clear Channel. The applications were unopposed. Clear Channel currently owns six stations in the Augusta-Waterville, Maine Arbitron metropolitan market (“Augusta-Waterville metro”): (1) WFAU(AM), Gardiner, Maine; (2) WABK-FM, Gardiner, Maine; (3) WCME(FM), Boothbay Harbor, Maine; (4) WIGY(FM), Madison, Maine; (5) WKCG(FM), Augusta, Maine; and (6) WTOS-FM, Skowhegan, Maine.
3. Section 310(d) of the Communications Act of 1934, as amended (the “Communications Act”), 47 U.S.C. 310(d), requires the Commission to find that the public interest, convenience and necessity would be served by the assignment of Mountain's radio broadcast licenses to Clear Channel before the assignment may occur. Under the interim policy set forth in our
4. Having concluded that the proposed transaction is consistent with the numerical limits set forth in our ownership rules, we turn to our competition analysis. Here, we find that the proposed transaction would create a market in which the combined market share of the top two group owners in the market would be 99.5%. We find that Clear Channel has failed to demonstrate particular circumstances in this market sufficient to overcome a concern that this level of economic concentration in this market will harm the public interest. To the extent Clear Channel presents generic arguments challenging the parameters of our current competition analysis, we will address such concerns in the context of the
5. We direct the Administrative Law Judge (“ALJ”) to examine in an evidentiary hearing the particular circumstances of the Augusta-Waterville metro to determine whether the factual assumptions in Section III.C. of the Hearing Designation Order are correct. We further direct the ALJ to determine, in light of his or her conclusions, whether the transaction is likely to cause any anticompetitive harms, and to determine what, if any, public benefits would accrue from this transaction. Finally, we direct the ALJ to apply these findings to determine whether, on balance, grant of the applications would serve the public interest.
6. To defer further consideration of the applications to assign the licenses of Stations WSKW(AM) and WHQO(FM), Skowhegan, Maine, from Mountain to Clear Channel in accordance with the interim policy, Mountain and Clear Channel must file a joint election to defer consideration of the applications. Such election must be filed by September 5, 2002.
7. In the event the parties do not timely file the joint election set forth in the paragraph above, pursuant to 47 U.S.C. 309(e), the applications to assign the licenses of Stations WSKW(AM) and WHQO(FM), Skowhegan, Maine, from Mountain to Clear Channel are designated for hearing at a time and place to be specified in a subsequent Order, to determine, in light of the evidence to be presented in the hearing, whether the public interest, convenience and necessity would be served by the grant of the above-captioned assignment applications (File Nos. BAL-20010918ABB/BALH-20010918ABC).
8. Pursuant to 47 U.S.C. 309(e), the burden of proof with respect to both the introduction of evidence and the issue specified in this Order shall be upon Mountain and Clear Channel, the applicant parties in this proceeding.
9. A copy of each document filed in this proceeding subsequent to the date of adoption of this Order must be served on the counsel of record appearing on behalf of the Chief, Enforcement Bureau. Parties may inquire as to the identity of such counsel by calling the Investigations and Hearings Division of the Enforcement Bureau at (202) 418-1420. Such service must be addressed to the named counsel of record, Investigations and Hearings Division, Enforcement Bureau, Federal Communications Commission, 445 12th Street, SW, Room 3-B431, Washington, DC 20554.
10. The effectiveness of this Order is stayed until September 11, 2002, no less than 10 days prior to which the parties may amend their applications or file such other information with the Media Bureau as they deem relevant to ameliorate the competition concerns identified in this Order.
11. To avail themselves of the opportunity to be heard, Mountain and Clear Channel, pursuant to 47 CFR 1.221(c) and 1.221(e), in person or by their respective attorneys, must file, in triplicate, a written appearance stating an intention to appear on the date fixed for the hearing and present evidence on the issues specified in this Order. Such written appearance shall be filed by September 11, 2002. Pursuant to 47 CFR 1.221(c) of the Commission's rules, if the parties fail to file an appearance within the specified time period, the assignment applications will be dismissed with prejudice for failure to prosecute.
12. The applicants, pursuant to 47 U.S.C. 311(a)(2) and 47 CFR 73.3594, must give notice of the hearing within the time and in the manner prescribed, and must advise the Commission of the publication of such notice as required by 47 CFR 73.3594(g).
13. The applications to assign the licenses of stations WSKW(AM) and WHQO(FM), Skowhegan, Maine, from Mountain to Clear Channel will be held in abeyance pending the outcome of this proceeding.
14. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send copies of this Order to all parties by Certified Mail—Return Receipt Requested.
Federal Communications Commission.
Notice.
In this document, the FCC designates the applications to assign the licenses of radio stations WNIO(AM) and WNCD(FM), Youngstown, Ohio, WICT(FM), Grove City, Pennsylvania and WAKZ(FM), Sharpsville, Pennsylvania, from Youngstown Radio License, L.L.C. (“Youngstown Radio”) to Citicasters Licenses, Inc., a wholly-owned subsidiary of Clear Channel Communications, Inc. (“Clear Channel”). The Commission cannot find, based on the record, that grant of these applications is consistent with the public interest, convenience, and necessity. Accordingly, pursuant to 47 U.S.C. 309(e), the Commission designates the applications for hearing to determine whether the public interest, convenience, and necessity will be served by grant of the applications.
Please file documents with the Investigations and Hearing Division, Enforcement Bureau, Federal Communications Commission, Room 3-B431, 445 12th Street, SW, Washington, DC 20554.
Charles W. Kelley, Chief, Investigations and Hearing Division, Enforcement Bureau, at (202) 418-1420.
This is a summary of the Federal Communications Commission's Hearing Designation Order, MM Docket No. 02-139, adopted on June 5, 2002 and released on July 10, 2002. The full text is available for inspection and copying during normal business hours in the FCC Reference Information Center, Room CY-A257, 445 12th Street, SW., Washington, DC 20554. The full text may also be purchased from the Commission's copy contractor, Qualex International, Room CY-B402, 445 12th Street, SW., Washington, DC 20554, telephone (202) 863-2983, facsimile (202) 863-2898, or via e-mail at
1. In March 1996, the Commission relaxed the numerical station limits in its local radio ownership rule in accordance with Congress's directive in section 202(b) of the Telecommunications Act of 1996. Since then, the Commission has received applications proposing transactions that would comply with the new limits, but that nevertheless could produce concentration levels that raised significant concerns about the potential impact on the public interest. In response to these concerns, the Commission concluded that it has an independent obligation to consider whether a proposed pattern of radio ownership that complies with the local radio ownership limits would otherwise have an adverse competitive effect in a particular local radio market and thus would be inconsistent with the public interest. In August 1998, the Commission also began flagging public notices of radio station transactions that would result in one entity controlling 50 percent or more of the advertising revenues in the relevant Arbitron radio market or two entities controlling 70 percent or more of the advertising revenues in that market. On November 8, 2001, we adopted the Notice of Proposed Rulemaking in MM Docket No. 01-317, 16 FCC Rcd 19861, 66 FR 63986, December 11, 2001 (“
2. On October 1, 1999, Youngstown Radio and Clear Channel filed applications proposing to assign the licenses of WNIO(AM), WNCD(FM), WICT(FM), and WAKZ(FM) from Youngstown Radio to Clear Channel. The applications were unopposed. Clear Channel currently owns three stations in the Youngstown-Warren, Ohio Arbitron metropolitan market (“Youngstown-Warren metro”): (1) WMXY(FM), Youngstown, Ohio; (2) WKBN(AM), Youngstown, Ohio; and (3) WBBG(FM), Niles, Ohio.
3. Section 310(d) of the Communications Act of 1934, as amended (the “Communications Act”), 47 U.S.C. 310(d), requires the Commission to find that the public interest, convenience and necessity would be served by the assignment of Youngstown Radio's radio broadcast licenses to Clear Channel before the assignment may occur. Under the interim policy set forth in our
4. Having concluded that the proposed transaction is consistent with the numerical limits set forth in our ownership rules, we turn to our competition analysis. Here, we find that the proposed transaction would create a market in which the combined market share of the top two group owners in the market would be 95.3%. We find that Clear Channel has failed to demonstrate particular circumstances in this market sufficient to overcome a concern that this level of economic concentration in this market will harm the public interest. To the extent Clear Channel presents generic arguments challenging the parameters of our current competition analysis, we will address such concerns in the context of the
5. We direct the Administrative Law Judge (“ALJ”) to examine in an evidentiary hearing the particular circumstances of the Youngstown-Warren metro to determine whether the factual assumptions in Section III.C. of the Hearing Designation Order are correct. We further direct the ALJ to determine, in light of his or her conclusions, whether the transaction is likely to cause any anticompetitive harms, and to determine what, if any, public benefits would accrue from this transaction. Finally, we direct the ALJ to apply these findings to determine whether, on balance, grant of the applications would serve the public interest.
6. To defer further consideration of the applications to assign the licenses of stations WNIO(AM) and WNCD(FM), Youngstown, Ohio, WICT(FM), Grove City, Pennsylvania, and WAKZ(FM), Sharpsville, Pennsylvania, from Youngstown Radio to Clear Channel in accordance with the interim policy, Youngstown Radio and Clear Channel must file a joint election to defer consideration of the applications. Such election must be filed by September 5, 2002.
7. In the event the parties do not timely file the joint election set forth in the paragraph above, pursuant to 47 U.S.C. 309(e), the applications to assign the licenses of stations WNIO(AM) and WNCD(FM), Youngstown, Ohio, WICT(FM), Grove City, Pennsylvania, and WAKZ(FM), Sharpsville, Pennsylvania, from Youngstown Radio to Clear Channel are designated for hearing at a time and place to be specified in a subsequent Order, to determine, in light of the evidence to be presented in the hearing, whether the public interest, convenience and necessity would be served by the grant of the above-captioned assignment applications (File Nos. BAL/BALH-19991001ABM-ABP).
8. Pursuant to 47 U.S.C. 309(e), the burden of proof with respect to both the introduction of evidence and the issue specified in this Order shall be upon Youngstown Radio and Clear Channel, the applicant parties in this proceeding.
9. A copy of each document filed in this proceeding subsequent to the date of adoption of this Order must be served on the counsel of record appearing on behalf of the Chief, Enforcement Bureau. Parties may inquire as to the identity of such counsel by calling the Investigations and Hearings Division of the Enforcement Bureau at (202) 418-1420. Such service must be addressed to the named counsel of record, Investigations and Hearings Division, Enforcement Bureau, Federal Communications Commission, 445 12th Street, SW, Room 3-B431, Washington, DC 20554.
10. The effectiveness of this Order is stayed until September 11, 2002, no less than 10 days prior to which the parties may amend their applications or file such other information with the Media Bureau as they deem relevant to ameliorate the competition concerns identified in this Order.
11. To avail themselves of the opportunity to be heard, Youngstown Radio and Clear Channel, pursuant to 47 CFR 1.221(c) and 1.221(e), in person or by their respective attorneys, must file, in triplicate, a written appearance stating an intention to appear on the date fixed for the hearing and present evidence on the issues specified in this Order. Such written appearance shall be filed by September 11, 2002. Pursuant to 47 CFR 1.221(c), if the parties fail to file an appearance within the specified time period, the assignment applications will be dismissed with prejudice for failure to prosecute.
12. The applicants, pursuant to 47 U.S.C. 311(a)(2) and 47 CFR 73.3594, must give notice of the hearing within the time and in the manner prescribed, and must advise the Commission of the publication of such notice as required by 47 CFR 73.3594(g).
13. The applications to assign the licenses of stations WNIO(AM) and WNCD(FM), Youngstown, Ohio, WICT(FM), Grove City, Pennsylvania, and WAKZ(FM), Sharpsville, Pennsylvania, from Youngstown Radio to Clear Channel will be held in abeyance pending the outcome of this proceeding.
14. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send copies of this Order to all parties by Certified Mail—Return Receipt Requested.
Federal Communications Commission.
Notice.
In this document, the FCC designates the application to assign the license of radio station KLFX(FM), Nolanville, Texas, from Sheldon Broadcasting, Ltd. (“Sheldon” to Clear Channel Broadcasting Licenses, Inc. (“Clear Channel”). The Commission cannot find, based on the record, that grant of this application is consistent with the public interest, convenience, and necessity. Accordingly, pursuant to 47 U.S.C. 309(e), the Commission designates the application for hearing to determine whether the public interest, convenience, and necessity will be served by grant of the application.
Please file documents with the Investigations and Hearing Division, Enforcement Bureau, Federal Communications Commission, Room 3-B431, 445 12th Street, SW., Washington, DC 20554.
Charles W. Kelley, Chief, Investigations and Hearing Division, Enforcement Bureau, at (202) 418-1420.
This is a summary of the Federal Communications Commission's Hearing Designation Order, MM Docket No. 02-137, adopted on June 5, 2002 and released on July 10, 2002. The full text is available for inspection and copying during normal business hours in the FCC Reference Information Center, Room CY-A257, 445 12th Street, SW., Washington, DC 20554. The full text may also be purchased from the Commission's copy contractor, Qualex International, Room CY-B402, 445 12th Street, SW., Washington, DC 20554, telephone (202) 863-2983, facsimile (202) 863-2898, or via e-mail at
1. In March 1996, the Commission relaxed the numerical station limits in its local radio ownership rule in accordance with Congress's directive in section 202(b) of the Telecommunications Act of 1996. Since then, the Commission has received applications proposing transactions that would comply with the new limits, but that nevertheless could produce concentration levels that raised significant concerns about the potential impact on the public interest. In response to these concerns, the Commission concluded that it has an independent obligation to consider whether a proposed pattern of radio ownership that complies with the local radio ownership limits would otherwise have an adverse competitive effect in a particular local radio market and thus would be inconsistent with the public interest. In August 1998, the Commission also began flagging public notices of radio station transactions that would result in one entity controlling 50 percent or more of the advertising revenues in the relevant Arbitron radio market or two entities controlling 70 percent or more of the advertising revenues in that market. On November 8, 2001, we adopted the Notice of Proposed Rulemaking in MM Docket No. 01-317, 16 FCC Rcd 19861, 66 FR 63986, December 11, 2001 (“
2. On August 13, 2001, Clear Channel and Sheldon filed an application proposing to assign the license of station KLFX(FM) from Sheldon to Clear Channel. The application was unopposed. Clear Channel currently is the licensee of two stations in the Killeen-Temple, Texas Arbitron metro: KASZ(FM), Gatesville, Texas, and KIIZ(FM), Killeen, Texas.
3. Section 310(d) of the Communications Act of 1934, as amended (the “Communications Act”), 47 U.S.C. 310(d), requires the Commission to find that the public interest, convenience and necessity would be served by the assignment of Sheldon's radio broadcast license to Clear Channel before the assignment may occur. Under the interim policy set forth in our
4. Having concluded that the proposed transaction is consistent with the numerical limits set forth in our ownership rules, we turn to our competition analysis. Here, we find that the proposed transaction would create a market in which the combined market share of the top two group owners in the market would be 98.2%. We find that Clear Channel has failed to demonstrate particular circumstances in this market sufficient to overcome a concern that this level of economic concentration in this market will harm the public interest. To the extent Clear Channel presents generic arguments challenging the parameters of our current competition analysis, we will address
5. We direct the Administrative Law Judge (“ALJ”) to examine in an evidentiary hearing the particular circumstances of the Killeen-Temple, Texas metro to determine whether the factual assumptions in Section III.C. of the Hearing Designation Order are correct. We further direct the ALJ to determine, in light of his or her conclusions, whether the transaction is likely to cause any anticompetitive harms, and to determine what, if any, public benefits would accrue from this transaction. Finally, we direct the ALJ to apply these findings to determine whether, on balance, grant of the application would serve the public interest.
6. To defer further consideration of the application to assign the license of station KLFX(FM), Nolanville, Texas, from Sheldon to Clear Channel in accordance with the interim policy, Sheldon and Clear Channel must file a joint election to defer consideration of the application. Such election must be filed by September 5, 2002.
7. In the event the parties do not timely file the joint election set forth in the paragraph above, pursuant to 47 U.S.C. 309(e), the application to assign the license of station KLFX(FM), Nolanville, Texas, from Sheldon to Clear Channel is designated for hearing at a time and place to be specified in a subsequent Order, to determine, in light of the evidence to be presented in the hearing, whether the public interest, convenience and necessity would be served by the grant of the above-captioned assignment application (File No. BALH-20010813AAM).
8. Pursuant to 47 U.S.C. 309(e), the burden of proof with respect to both the introduction of evidence and the issue specified in this Order shall be upon Sheldon and Clear Channel, the applicant parties in this proceeding.
9. A copy of each document filed in this proceeding subsequent to the date of adoption of this Order must be served on the counsel of record appearing on behalf of the Chief, Enforcement Bureau. Parties may inquire as to the identity of such counsel by calling the Investigations and Hearings Division of the Enforcement Bureau at (202) 418-1420. Such service must be addressed to the named counsel of record, Investigations and Hearings Division, Enforcement Bureau, Federal Communications Commission, 445 12th Street, SW, Room 3-B431, Washington, DC 20554.
10. The effectiveness of this Order is stayed until September 10, 2002, no less than 10 days prior to which the parties may amend their application or file such other information with the Media Bureau as they deem relevant to ameliorate the competition concerns identified in this Order.
11. To avail themselves of the opportunity to be heard, Sheldon and Clear Channel, pursuant to 47 CFR 1.221(c) and 1.221(e), in person or by their respective attorneys, must file, in triplicate, a written appearance stating an intention to appear on the date fixed for the hearing and present evidence on the issues specified in this Order. Such written appearance shall be filed by September 10, 2002. Pursuant to 47 CFR 1.221(c) of the Commission's rules, if the parties fail to file an appearance within the specified time period, the assignment application will be dismissed with prejudice for failure to prosecute.
12. The applicants, pursuant to 47 U.S.C. 311(a)(2), and 47 CFR 73.3594 must give notice of the hearing within the time and in the manner prescribed, and must advise the Commission of the publication of such notice as required by 47 CFR 73.3594(g).
13. The application to assign the licenses of station KLFX(FM), Nolanville, Texas, from Sheldon to Clear Channel will be held in abeyance pending the outcome of this proceeding.
14. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send copies of this Order to all parties by Certified Mail—Return Receipt Requested.
Petitions for Reconsideration have been filed in the Commission's rulemaking proceedings listed in this Public Notice and published pursuant to 47 CFR 1.429(e). The full text of this document is available for viewing and copying in Room CY-A257, 445 12th Street, SW., Washington, DC or may be purchased from the Commission's copy contractor, Qualex International (202) 863-2893. Oppositions to these petitions must be filed by September 5, 2002.
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.
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:
Notice is hereby given that the following Ocean Transportation Intermediary licenses have been reissued by the Federal Maritime Commission pursuant to section 19 of the Shipping Act of 1984, as amended by the Ocean Shipping Reform Act of 1998 (46 U.S.C. app. 1718) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR 515.
Notice is hereby given that the following applicants have filed with the Federal Maritime Commission an application for license as a Non-Vessel Operating Common Carrier and Ocean Freight Forwarder—Ocean Transportation Intermediary pursuant to section 19 of the Shipping Act of 1984 as amended (46 U.S.C. app. 1718 and 46 CFR 515).
Persons knowing of any reason why the following applicants should not receive a license are requested to contact the Office of Transportation Intermediaries, Federal Maritime Commission, Washington, DC 20573.
Agency for Healthcare Research and Quality, HHS.
Notice.
In response to its legislative mandate to compile health care quality measures (see Background section below), the Agency for Healthcare Research and Quality (AHRQ) invites
AHRQ is sponsoring the development of NQMC to promote widespread access to quality measures by the health care community and other interested individuals. NQMC is designed to be a database for information on specific health care quality measures and measure sets. The scheduled availability date for the NQMC Web site is December/Winter 2002.
Measure developers are asked to submit measures and measure updates that meet the NQMC inclusion criteria, along with supporting documentation, on an ongoing basis. NQMC will contain descriptive summaries of each measure catalogued in the NQMC database. Developers have the option of making their entire measure available through NQMC or may opt to provide ordering information that NQMC will include in the measure summary. NQMC users will be directed to contact the measure developer to obtain or purchase the entire measure if it is not available via the NQMC Web site. Quality measure summaries will be retrievable by many parameters including topic, target population, and setting of care. Users of NQMC will be able to search NQMC and the National Guideline Clearinghouse
Quality measures and measure sets will be received on an ongoing basis by ECRI at the address below. ECRI, a nonprofit health services research organization, will perform the technical work of the NQMC, under contract with AHRQ.
Organizations interested in contributing to the NQMC should submit two hard copies of each measure and documentation that the measure meets the NQMC Inclusion Criteria in typed format and electronic (if available), including name, address, phone, and e-mail address of a contact person to: Vivian H. Coates, NQMC Project Director, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298.
Forward questions to
AHRQ is the lead Federal agency for enhancing the quality, appropriateness, and effectiveness of healthcare services and access to such services. In carrying out its mission, AHRQ conducts and supports research that develops and presents scientific evidence on methods for measuring quality and strategies for improving quality. Under section 912(a)(2)(C) Title IX, of the Agency for Healthcare Research and Quality Act of 1999, AHRQ is charged with compiling health care quality measures that have been developed in the public and private sector. To this end AHRQ will compile and present measures in the NQMC that have been submitted by the public and private sector, and that meet the following definitions and inclusion criteria.
As part of its mandate to use existing technologies to promote health care quality improvement, NQMC will use the World Wide Web to effectively and efficiently reach a broad audience within the health care community. This Web-based repository of quality measures is intended to facilitate quick identification and access to quality measures by practitioners and health related organizations [
The NQMC defines a quality measure as a mechanism to assign a quantifier to quality of care by comparison to a criterion.
A measure must meet all of the following criteria to be included in the NQMC. If the measures do not meet one or more of these inclusion criteria, the submission forms will be returned to the submitter with a request for further documentation or development in the identified area. The submitter may revise and resubmit measures.
1. The quality measure must address some aspect(s) of quality of care delivered to defined patients by a defined individual, group of individuals or organizations and must relate to at least one of the following domains: (a) Process of care (a health care service provided to or on behalf of a patient); (b) Outcome of care (a health state of a patient resulting from health care); (c) Access to care (the patient's attainment of timely and appropriate health care); and, (d) Patient experience of care (a report by a patient concerning observations of and participation in health care).
2. The submitter must provide English-language documentation that includes at least each of the three following items: (i) The rationale for the measure (The rationale is a brief statement describing the patients and the specific aspect of health care to which the measure applies. The rationale may also include the evidence basis for the measure, and an explanation of how to interpret results, if that information is provided.); (ii) A description of the denominator and numerator of the measure (including specific variables for inclusion or exclusion of cases from either the denominator or numerator). Note—a continuous variable statement (
3. The submitter should provide documentation of supporting evidence appropriate for the measure domain: (1) For process measures, evidence that the measured clinical process has led to improved health outcomes; (2) For outcome measures, evidence that the outcome measure has been used to detect the impact of one or more clinical interventions; (3) For access measures, evidence that an assoication exists between the result of the access measure and the outcomes of or satisfaction with care; and (4) For patient experience measures, evidence that an association exists between the measure of patient experience of health care and the values and preferences of patients/consumers.
The documentation must consist of at least one of the following types of evidence: (1) One or more research studies published in a National Library of Medicine (NLM) indexed, peer-reviewed journal; (2) A systematic review of the clinical literature; (3) A clinical practice guideline or other peer-reviewed synthesis of the clinical evidence; (4) A formal consensus procedure involving expert clinicians and clinical researchers.
Additionally, for patient experience measures, evidence should include focus groups involving patients and/or cognitive testing of the measures by patients. For access measures, the consensus panel should also include other relevant stakeholders.
4. At least one of the following criteria must be satisfied with specific information attached in each case: (1) The measure has been cited in one or more reports in a National Library of Medicine (NLM) indexed, peer-reviewed journal, applying or evaluating the measure's properties; (2) The submitter provides documented peer-reviewed evidence evaluating the reliability (the degree to which the measure is free from random error) and validity (the degree to which the measure is associated with what it
5. The measure must be in current use or currently in pilot testing and must be the most recent version if the measure has been revised. A measure is in current use if at least one health care organization has used the measure to evaluate or report on quality of care within the previous three years.
The Centers for Disease Control and Prevention (CDC) announces the award of fiscal year (FY) 2002 funds for a Cooperative Agreement with the Ministry of Health (MOH), Royal Government of Cambodia (Cambodia), for the improvement and expansion of HIV/AIDS/STD prevention and support activities in Cambodia.
The purpose of this cooperative agreement is to improve and expand laboratory capacity and coordination of HIV prevention activities with the MOH and among non-governmental organizations (NGOs) in Cambodia. This will be accomplished through cooperation between CDC Cambodia, the MOH, National Center for HIV/AIDS Dermatology and STDs (NCHADS), National Clinic for Dermatology and STIs, as well as the MOH National Institute of Public Health (NIPH) to:
(1) Expand the national reference laboratory capacity for HIV and STD at the National Institute of Public Health.
(2) Develop national referral laboratory capacity at NCHADS.
(3) Pilot a program to integrate the various technical strategies of the Global AIDS Program at either the operational health district or the provincial health district level.
These collaborative activities could profoundly impact the scope and intensity of the implementation of the National AIDS Policy, which calls for multi-sectoral action on many fronts. Successful implementation and expansion of laboratory capacity building could substantially increase the MOH's ability to provide high quality reference and referral laboratory service and strengthen ties between NGOs and government HIV/AIDS-related programs. Successful implementation of a pilot integration project through cooperative efforts of MOH, NGOs, and CDC could eventually lead to significant improvements in coordination of HIV/AIDS prevention and care activities country-wide.
The MOH is the only appropriate and qualified organization to fulfill the requirements set forth for Cambodia in this announcement because:
1. The MOH is uniquely positioned, in terms of legal authority, experience and credibility among Cambodian citizens to provide health sector HIV/AIDS/STD Prevention Activities.
2. The purpose of the announcement is to build upon an existing framework of health information and activities for which the MOH has the responsibility for implementing.
3. The MOH has been mandated by the National AIDS Authority(NAA) to coordinate and implement health sector activities necessary for the control of the HIV/AIDS epidemic in Cambodia.
4. The MOH already has established mechanisms to access health information enabling it to immediately become engaged in the activities listed in this announcement.
Approximately $810,000 is being awarded in FY2002. The award will begin on or about August 1, 2002 and will be made for a 12-month budget period within a five-year project period.
To obtain business management technical assistance, contact: Angelia D. Hill, Lead Grants Management Specialist, International & Territories Acquisition & Assistance Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, MS E-09, Atlanta, GA 30341-4146. Telephone number: (770) 488-2785. FAX: (770) 488-2866. E-mail address:
For program technical assistance, contact: Jack N. Spencer, Global AIDS Program (GAP), Cambodia Country Team, National Center for HIV/STD/and TB Prevention, Centers for Disease Control & Prevention, Cambodia-CDC AIDS Project Team, AmEmbassy Phnom Penh, Phnom Penh, Cambodia. Telephone: 011-855 23 217640. E-mail:
National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting:
Written research, data, or supporting materials to be considered in support of the information gathering effort should be submitted to the NIOSH Docket Office, ATTN: Diane Miller, Robert A. Taft Laboratories, M/S C-34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513/533-8450, fax 513/533-8285. Comments may also be submitted by e-mail to:
The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following committee meeting.
In December 2000, the President delegated responsibility for funding, staffing, and operating the Board to HHS, which subsequently delegated this authority to the Centers for Disease Control and Prevention (CDC). NIOSH implements this responsibility for CDC. The charter was signed on August 3, 2001 and in November 2001, the President completed the appointment of an initial roster of 10 Board members. The initial tasks of the Board have been to review and provide advice on the proposed and interim rules of HHS.
Agenda items are subject to change as priorities dictate.
This request has been submitted late as this conference call was scheduled on August 15, 2002. This conference call cannot be delayed as the open comment period closes on August 26, 2002; two business days after this conference call takes place.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
This notice announces fees for vessel sanitation inspections for fiscal year 2003 (October 1, 2002, through September 30, 2003).
October 1, 2002.
David L. Forney, Chief, Vessel Sanitation Program, National Center for Environmental Health, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, NE, Mailstop F-16, Atlanta, Georgia 30341-3724, telephone (770) 488-7333, e-mail:
The fee schedule for sanitation inspections of passenger cruise ships currently inspected under the Vessel Sanitation Program (VSP) was first published in the
The formula used to determine the fees is as follows:
The average cost per inspection is multiplied by a size/cost factor to determine the fee for vessels in each size category. The size/cost factor was established in the proposed fee schedule published in the
The fee schedule is presented in Appendix A and will be effective October 1, 2002, through September 30, 2003. This fee schedule represents a 4.2 percent decrease over the current fee schedule, which became effective October 1, 2001. If travel expenses continue to increase, it may be necessary to readjust the fees before September 30, 2003, because travel comprises a sizable portion of the program's costs. If such a readjustment in the fee schedule is necessary, a notice will be published in the
The fees will be applicable to all passenger cruise vessels for which inspections are conducted as part of CDC's VSP.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Handling and Retention of Bioavailability and Bioequivalence Testing Samples.” Inspection of clinical and analytical sites that perform bioavailability (BA) and bioequivalence (BE) studies frequently reveals the absence of reserve samples at the testing facilities where the studies are conducted. The draft guidance is intended to clarify how to distribute test articles and reference standards to testing facilities, how to randomly select reserve samples, and how to retain reserve samples.
Submit written or electronic comments on the draft guidance by September 20, 2002. General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the
Martin Yau, Center for Drug Evaluation and Research (HFD-45), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5458.
FDA is announcing the availability of a draft guidance for industry entitled “Handling and Retention of Bioavailability and Bioequivalence Testing Samples.” Following the generic drug crisis in the 1980s, FDA issued regulations to deter possible bias and fraud in BA and BE testing by study sponsors and/or drug manufacturers (58 FR 25918, April 28, 1993). In the preamble of the final rule, the agency stated that the study sponsor should not separate out the reserve samples of the test article and reference standard prior to sending the drug product to the testing facility. This is to ensure that the reserve samples are in fact representative of the same batches provided by the study sponsor for the testing. FDA's Division of Scientific Investigations and field investigators from the Office of Regulatory Affairs conduct inspections of clinical and analytical sites that perform BA and BE studies for sponsors and/or drug manufacturers seeking approval of generic and new drug products. A frequent finding from these inspections is the absence of reserve samples at the testing facility. This draft guidance clarifies the responsibilities of the involved parties for retention of samples used in BA and BE studies. It includes recommendations for sampling techniques and responsibilities in various study settings.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on retention of BA and BE testing samples. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An
Interested persons may submit to the Dockets Management Branch (see
Persons with access to the Internet may obtain the document at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.” This guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); human pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs).
Submit written or electronic comments on the draft guidance by November 19, 2002. General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the
Liang Zhou, Center for Drug Evaluation and Research (HFD-180), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7471.
FDA is announcing the availability of a draft guidance for industry entitled “Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.”
Liposome drug products are defined as drug products containing drug substances (active pharmaceutical ingredients) encapsulated in liposomes. A liposome is a microvesicle composed of a bilayer of lipid amphipathic molecules enclosing an aqueous compartment. Liposome drug products are formed when a liposome is used to encapsulate a drug substance within the lipid bilayer or in the interior aqueous space of the liposome. A drug substance in a liposome formulation is intended to exhibit a different pharmacokinetic and/or tissue distribution (PK/TD) profile from the same drug substance (or active moiety) in a nonliposomal formulation given by the same route of administration. The complete characterization of the PK/TD profile of a new liposome drug product is essential to establish the safe and effective dosing regimen of the product.
The guidance provides recommendations to applicants on the CMC, human pharmacokinetics and bioavailability, and labeling documentation for liposome drug products submitted in NDAs. The guidance does not provide recommendations on: (1) Clinical efficacy and safety studies, (2) nonclinical pharmacology and/or toxicology studies, (3) bioequivalence studies or those to document sameness, (4) liposomal formulations of vaccine adjuvants or biologics, or (5) drug-lipid complexes.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on liposome drug products: CMC, human pharmacokinetics and bioavailability, and labeling documentation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit to the Dockets Management Branch (see
Persons with access to the Internet may obtain the document at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.
Health Resources and Services Administration (HRSA), HHS.
Notice of availability of funds.
The Health Resources and Services Administration announces up to $600,000 in FY 2002 funds is available to fund a single competitive
Eligibility is open to any public or private entity. Faith-based organizations are eligible to apply for these funds. Awards will be made under the program authority of Section 301 of the Public Health Service Act. Funds for this award were appropriated under Public Law 107-116. The award will be for a period of three years. Additional funding of up to $600,000 annually in the second or third years is contingent on the availability of funds and grantee performance.
Applicants for this program are requested to notify the Office of Rural Health Policy by September 1, 2002. Notification of intent to apply can be made in one of three ways: telephone: 301-443-0835; e-mail
To receive a complete application kit, applicants may telephone the HRSA Grants Application Center at 1-877-477-2123 (1-877-HRSA-123) beginning August 16, 2002, or register on-line at:
This application guidance and the required form for the Rural Assistance Center Program may also be downloaded in either Microsoft Word or Adobe Acrobat format (.pdf) from the ORHP Homepage at
For the 65 million people living in rural America, the U.S. Department of Health and Human Services' mission to protect health and to provide assistance for those in need is especially relevant. Health care and social service programs in rural communities provide needed support of communities' well-being and represent a significant segment of the local economies. These programs, however, frequently lack adequate funds, personnel and support network.
For more than a decade, the Office of Rural Health Policy has supported activities that assist states, localities and rural citizens as they work to build and sustain high-quality rural health care delivery systems. One component of that support has been the Rural Information Center Health Service (RICHS). The intent of the RAC is to demonstrate that this activity can be expanded and enhanced to better serve rural communities by identifying private and public resources, collecting and sharing information about models that work, and serving as a technical resource for a wide range of health and social service issues.
In July of 2001, Secretary of Health and Human Services Tommy G. Thompson created a rural task force to assess how the Department serves rural communities. Among the key findings of this year-long initiative is that DHHS operates more than 220 discrete programs that affect rural communities. As part of the rural initiative, the Department's Rural Task Force also collected more than 450 public comments on a variety of issues affecting rural communities. One of the key themes that emerged from these public comments is the need to reach out to rural communities and help them identify how best to access the broad range of health and social services programs that are available to rural communities.
The Rural Assistance Center will serve as a focal point of information about the broad range of public and private opportunities that are available to support rural communities. The RAC will help rural communities navigate these opportunities, identify successful state and community models and provide links to existing private and public resources that support rural health care and social service delivery. This will, in turn, help rural communities build and enhance their rural services and strengthen their communities.
The purpose of this cooperative agreement is to assist rural communities in developing and sustaining high-quality rural health care and social service delivery systems through an integrated assistance center. Specifically, through this cooperative agreement the RAC will:
(1) Serve as a support to rural communities and rural citizens to identify available programs for improving the ability of rural communities to provide high-quality health care and social services.
(2) Identify and synthesize information about the availability of existing private and public resources for enhancing rural health care and social service delivery.
(3) Identify and disseminate information about models that work in rural communities that have been able to sustain, enhance and improve their local health care and social service delivery systems.
(4) Promote collaboration among DHHS programs that serve rural communities to increase effectiveness and reduce duplication of effort.
Under section 301 of the Public Health Service Act, any public or private entity is eligible to apply. Under the President's initiative, community-based and faith-based organizations that are otherwise eligible and believe they can contribute to HRSA's program objectives are encouraged to consider this initiative.
The administrative and funding instrument to be used for the RAC will be a cooperative agreement, in which substantial ORHP policy expertise and/or programmatic involvement with the awardee is anticipated during the performance of the project. There is no requirement for matching funds with this program. Under the terms of this cooperative agreement, in addition to the required monitoring and technical assistance, Federal responsibilities will include:
(1) Participation in meetings conducted during the period of the cooperative agreement.
(2) Ongoing review of activities and procedures to be established and implemented.
(3) Review of project information prior to dissemination.
(4) Review of information on project activities.
(5) Assistance with the establishment of contacts with Federal and State agencies, grant projects and other contacts that may be relevant to the project's mission and referrals to these agencies.
One project will be approved for three years. Up to $600,000 in fiscal year 2002 funds will be used to fund the first year. Additional funding of up to $600,000 annually in years two and three will be contingent on the availability of funds and grantee performance.
Applications that are complete and responsive to the guidance will be evaluated by an objective review panel specifically convened for this solicitation and in accordance with HRSA grants management policies and procedures.
Applications will be reviewed using the following criteria:
1. Knowledge and Understanding of the Issues relating to Rural Health and Rural Social Services (Weight: 20%) and the Challenges Facing Providers and Beneficiaries in Rural Areas
• The degree of understanding of the evolution of rural health and social services and the historical challenges facing rural communities in terms of resources and demographics (including populations experiencing cultural and linguistic barriers to care).
• The degree of thoroughness in describing how the RAC will address information gaps for rural communities.
• The extent of applicant knowledge of rural health and social service issues.
• The extent of applicant knowledge of the individuals and organizations involved in the rural health and social services.
2. Soundness and Adequacy of Project Plan (Weight: 30%)
• The extent to which the project objectives address the program purpose and are measurable, time-framed, and appropriate in relation to both the program requirements and identified needs.
• The degree to which the program areas outlined in the grant guidance have been addressed, prioritized and justified.
• The quality and feasibility of the project plan or methodology and its relation to the project's goals and objectives.
• The extent to which the proposed approach identifies the resources that will be used to implement the strategies.
• The degree to which the approaches are technically sound and appropriate to the project goals and objectives.
3. Soundness of Implementation Plan (Weight: 10%)
• The soundness of the plan for creating and implementing the RAC.
• The extent to which the applicant describes how the project staff will determine the degree to which proposed activities are being successfully conducted and completed, based on the objectives outlined.
4. Applicant's Capability and Capacity (Weight: 30%)
• The extent to which the applicant has demonstrated expertise and its capability to oversee and successfully carry out the project.
• Evidence that a sufficient number of project personnel and resources are proposed. Biographical sketches/curricula vitae document education, skills and experience that are relevant and necessary for the proposed project.
5. Appropriateness of Budget (Weight: 10%)
• The extent to which the proposed budget is realistic, adequately justified, and consistent with the proposed project plan.
• The extent to which the costs of administration and monitoring/evaluation are reasonable and proportionate to the costs of service provision.
• The degree to which the costs of the proposed project are economical in relation to the proposed service utilization.
Additional criteria may be used in the review of applications for this competition. Any such criteria will be identified in the program guidance included in the application kit. Applicants should pay strict attention to addressing these criteria, in addition to those referenced above.
This program is not subject to the provision of Executive Order 12372, Intergovernmental Review of Federal Programs (as implemented through 45 CFR part 100). This program is also not subject to the Public Health Systems Reporting Requirements.
OMB approval for any data collection in connection with this cooperative agreement will be sought, as required under the Paperwork Reduction Act of 1995.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Neurological Disorders and Stroke, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussion could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due in the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, National Library of Medicine.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL LIBRARY OF MEDICINE, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the PubMed Central National Advisory Committee.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance into the building by non-government employees. Persons without a government I.D. will need to show a photo I.D. and sign-in at the security desk upon entering the building.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussion could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which could constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Office of the Chief Information Officer, HUD.
Notice.
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval number (2502-0536) and should be sent to: Lauren Wittenberg, OMB Desk Officer, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503; Fax number (202) 395-6974; e-mail
Wayne Eddins, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, Southwest, Washington, DC 20410; e-mail
The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) the office of the agency to collect the information; (3) the OMB approval number, if applicable; (4) the description of the need for the information and its proposed use; (5) the agency form number, if applicable; (6) what members of the public will be affected by the proposal; (7) how frequently information submissions will be required; (8) an estimate of the total number of hours needed to prepare the information submission including number of respondents, frequency of response, and hours of response; (9) whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) the name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department. This Notice also lists the following information:
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended.
Office of the Chief Information Officer, HUD.
Notice.
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval number (2502-0141) and should be sent to: Lauren Wittenberg, OMB Desk Officer, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503; Fax number (202) 395-6974; e-mail
Wayne Eddins, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, Southwest, Washington, DC 20410; e-mail
The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) the office of the agency to collect the information; (3) the OMB approval number, if applicable; (4) the description of the need for the information and its proposed use; (5) the agency form number, if applicable; (6) what members of the public will be affected by the proposal; (7) how frequently information submissions will be required; (8) an estimate of the total number of hours needed to prepare the information submission including the number of respondents, frequency of response, and hours of response; (9) whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) the name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department.
This Notice also lists the following information:
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended.
Fish and Wildlife Service, Interior.
Notice of intent to prepare a Comprehensive Conservation Plan and Associated Environmental Impact Statement for the Desert National Wildlife Refuge Complex.
This notice advises the public that the U.S. Fish and Wildlife Service (Service) intends to gather information necessary to prepare a Comprehensive Conservation Plan (CCP) and an associated Environmental Impact Statement (EIS) for the Desert National Wildlife Refuge Complex. The Desert National Wildlife Refuge Complex is composed of Ash Meadows National Wildlife Refuge, Desert National Wildlife Range, Moapa Valley National Wildlife Refuge and Pahranagat National Wildlife Refuge located in Clark, Lincoln and Nye Counties, Nevada. A Wilderness Review of Desert National Wildlife Range will also be completed concurrently in accordance with the Wilderness Act of 1964, as amended, and Refuge Planning Policy 602 FW Chapters 1, 2, and 3. The Service is furnishing this notice in compliance with our National Wildlife Refuge Planning Policy and the National Environmental Policy Act of 1969, as amended (NEPA), and implementing regulations, to advise other agencies, Tribal Governments, and the public of our intentions, and to obtain suggestions and information on the scope of issues and alternatives to include in the CCP and the environmental document.
A series of public scoping meetings will be held on September 16 through September 19 at the following locations:
Interested persons are encouraged to attend these meetings to identify issues, concerns, and opportunities to be addressed in the CCP. For directions to the meetings, please contact us at the phone number listed below. To ensure that the Service has adequate time to evaluate and incorporate suggestions and other input into the planning process, comments should be received within 60 days from the date of this notice.
Address comments and requests to be put on the mailing list, receive more information, or receive a copy of the most recent planning update to: Project Leader, U.S. Fish and Wildlife Service, 4701 North Torrey Pines, Las Vegas, NV 89130 or call the Complex at (702) 515-5450. Submit faxes to (702) 515-5460. If you choose to submit comments via electronic mail, visit
Richard Birger, Project Leader, at the address and phone number above.
Established in 1984 under the authority of the Endangered Species Act of 1973, as amended, the Refuge comprises 23,000 acres of spring fed wetlands, mesquite bosques, and desert uplands that provide habitat for at least 24 plants and animal species found nowhere else in the world. The primary purpose of the Refuge is to provide for the protection and recovery of endangered fish and plants, such as Devil's Hole, Ash Meadows Amargosa, and Warm Springs pupfish, Ash Meadows speckled dace, Ash Meadows milk-vetch, spring-loving centaury plant, Ash Meadows sunray, Ash Meadows ivesia, Ash Meadows gumplant, and Ash Meadows blazing star. The Amargosa Pupfish Station, located within the Refuge, is home to a vertebrate species that may have one of the most restricted habitats on the planet. The most striking feature of the
The Refuge, established in 1936 by Executive Order No. 7373 for the protection, preservation and management of desert bighorn sheep, as well as other forms of native flora and fauna occurring on the Refuge, encompasses 1.5 million acres of the diverse Mojave Desert in southern Nevada. It is the largest National Wildlife Refuge in the lower 48 states.
The Military Lands Withdrawal Act of 1999, Pub. L. No. 106-65, authorized the withdrawal of 2,919,890 acres of public lands in Clark, Nye, and Lincoln Counties, Nevada from all forms of appropriation under the public lands laws (including the mining laws and the mineral leasing and the geothermal leasing laws). These withdrawn lands were reserved for use by the Secretary of the Air Force for military testing, training and other defense-related purposes. During the period of withdrawal, the Act provides that the lands within the Desert National Wildlife Range will be managed by the Secretary of the Interior pursuant to the National Wildlife Refuge System Administration Act of 1966 (16 U.S.C. 668dd,
The Refuge was established September 10, 1979, under the authority of the Endangered Species Act of 1969, as amended, to secure habitat for the endangered Moapa dace. The Refuge is located on 106 acres in northeastern Clark County. Due to its small size, fragile habitats, on-going habitat restoration work, and unsafe structures, the Refuge is currently closed to the general public.
The Refuge was established in 1963, under the authority of the Migratory Bird Conservation Act, as amended, to provide protection and habitat for migrating birds in the Pahranagat Valley. The 5,382 acre refuge consists of marshes, meadows, lakes, and upland desert habitat. It provides nesting, resting, and feeding areas for ducks, geese, swans, and other birds.
The National Wildlife Refuge System Administration Act of 1966, as amended, requires the Service to manage all lands within the National Wildlife Refuge System in accordance with an approved CCP (16 U.S.C. 668dd(e)). The CCP will guide wildlife, habitat, and public use management decisions and identify refuge goals, long-range objectives, and strategies for achieving Refuge purposes. Public input into this planning process is encouraged. The CCP will provide other agencies and the public with a clear understanding of the desired conditions for the Refuges and how the Service will implement management strategies over the next 15 years. Until the CCP is completed, Refuge management will continue to be guided by refuge purposes, federal legislation regarding management of national wildlife refuges, and other legal, regulatory and policy guidance.
Comments and concerns received will be used to develop goals, key issues and management strategies, and draft alternatives. Additional opportunities for public participation will occur throughout the CCP process, which is expected to be completed by 2005. Input from interested federal, state, and local agencies, Native American tribes, organizations and individuals is encouraged.
During development of the CCP, we will comply with the provisions of NEPA through concurrent preparation of an EIS that will accompany the CCP. The draft EIS will contain a No Action Alternative, a proposed action alternative, and potentially other alternatives. The alternatives will be used to define management options and compare their effects. The potential environmental impacts of each alternative will be analyzed in the draft EIS. A range of alternatives (and their effects on the biological resources and on the local communities) that address the issues and the management strategies associated with the issues will be evaluated in the EIS.
We are required by Service policy to complete a wilderness review of Service managed lands to determine if any lands are suitable for inclusion in the National Wilderness Preservation System. The wilderness review will be integrated into the CCP/EIS process including identification of areas that meet the minimum wilderness criteria; evaluation of the wilderness suitability of alternatives; and documentation of recommendations. Wilderness designation requires Congressional legislation. The last step, if appropriate, would consist of forwarding any suitable recommendations from the Director of the Service, through the Secretary of the Interior and the President, to Congress in a Wilderness Study Report.
With the publication of this notice, the public is encouraged to help identify potential issues, management actions and concerns; significant problems or impacts; and opportunities to resolve them. The public scoping period will continue for 60 days from the date of this notice. However, the Service will accept comments throughout the planning process.
All comments received from individuals on environmental impact statements become part of the official public record. Requests for such comments will be handled in accordance with the Freedom of Information Act, the Council on Environmental Quality's NEPA regulations [40CFR1506.6(f)] and other Service and Departmental policy and procedures.
The environmental review of this project will be conducted in accordance with the requirements of the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
Fish and Wildlife Service, Interior.
Notice of meeting.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. I), this notice announces a meeting of the Klamath Fishery Management Council, established under the authority of the Klamath River Basin Fishery Resources Restoration Act (16 U.S.C. 460ss
The Klamath Fishery Management Council will meet from 10 a.m. to 5 p.m. on Wednesday, October 9, 2002, from 8 a.m. to 5 p.m. on Thursday, October 10, 2002, and from 8 a.m to 1 p.m. on Friday, October 11, 2002.
The meeting will be held at the U.S. Fish and Wildlife Service, Yreka Fish and Wildlife Office, 1829 South Oregon Street, Yreka, California.
Phil Detrich, Project Leader, U.S. Fish and Wildlife Service; 1829 South Oregon Street; Yreka, California 96097; telephone (530) 842-5763.
For background information on the Klamath Fishery Management Council, please refer to the notice of their initial meeting that appeared in the
Bureau of Reclamation, Interior.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the California Bay-Delta Public Advisory Committee will meet on September 19, 2002. The agenda for the Committee meeting will include reports from subcommittees, discussions on future governance, workplans and budgets, and water operations, regional reports, and implementation of the CALFED Bay-Delta Program with State and Federal officials.
The meeting will be held Thursday, September 19, 2002 from 9 a.m. to 4 p.m. If reasonable accommodation is needed due to a disability, please contact Pauline Nevins at (916) 657-2666 or TDD (800) 735-2929 at least 1 week prior to the meeting.
The meeting will be held at the Metropolitan Water District of Southern California located at 700 North Alameda Street, Room 2-456, Los Angeles, California.
Eugenia Laychak, CALFED Bay Delta Program, at (916) 654-4214, or Diane Buzzard, U.S. Bureau of Reclamation, at (916) 978-5022.
The Committee was established to provide assistance and recommendations to Secretary of the Interior Gale Norton and California Governor Gray Davis on implementation of the CALFED Bay-Delta Program. The Committee will advise on annual priorities, integration of the eleven Program elements, and overall balancing of the four Program objectives of ecosystem restoration, water quality, levee system integrity, and water supply reliability. The Program is a consortium of 23 State and Federal agencies with the mission to develop and implement a long-term comprehensive plan that will restore ecological health and improve water management for beneficial uses of the San Francisco/Sacramento and San Joaquin Bay Delta.
Committee and meeting materials will be available on the CALFED Bay-Delta Web site:
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30-Day notice of information collection under review: reinstatement, with change, of a previously approved collection for which approval has expired; Budget Detail Worksheet.
The Department of Justice (DOJ), Office of Justice Programs has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to The Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. Additionally, comments may be submitted to OMB via facsimile to (202) 395-7285.
Request written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1) 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;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who
Overview of This Information Collection:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Mrs. Brenda E. Dyer, Deputy Clearance Officer, United States Department of Justice, Information Management and Security Staff, Justice Management Division, Suite 1600, Patrick Henry Building, 601 D Street, NW., Washington, DC 20530.
Bureau of International Labor Affairs, Labor.
Request for information.
This notice is a request for information to assist the Department of Labor in the examination of whether forced child labor exists in the firecracker industry in China. This review is being conducted pursuant to Executive Order 13126 (“Prohibition of Acquisition of Produced by Forced or Indentured Child Labor”) and the “Procedural Guidelines for Maintenance of the List of Products Requiring Federal Contractor Certification as to Forced or Indentured Child Labor” in the Federal Acquisition Regulation.
The Department anticipates that written information regarding forced child labor in the firecracker industry in China will aid it in determining, in consultation with the Departments of State and Treasury, whether this product, and its originating country, should be added to the Executive Order list.
Submitters of information are requested to provide two (2) copies of their written submission to the International Child Labor Program at the address below by September 20, 2002.
Written submissions should be addressed to Christine Camillo at the International Child Labor Program, Bureau of International Labor Affairs, U.S. Department of Labor, 200 Constitution Avenue, NW., Room S-5307, Washington, DC 20210.
Christine Camillo, International Child Labor Program, Bureau of International Labor Affairs, at (693-4839; fax (202) 693-4830.
Executive Order No. 13126, which was published in the
Pursuant to Section 3 of the Executive Order, the Federal Acquisition Regulatory Councils published a final rule in the
On June 29, 2001, the Department of Labor accepted for review a submission under Executive Order 13126 regarding the use of forced child labor in the firecracker industry in China. The submission, which was provided by State Department Watch, included information describing a March 2001 incident in which children in Jiangxi Province, China were allegedly killed while being forced to manufacture firecrackers at their school.
Under Section 6c of Executive Order 13126—
Forced or indentured child labor means all work or service—
(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or
(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.
The Department is requesting information about the specific child labor incident described above or any other similar incidents where children have been forced to manufacture fireworks in China as well as efforts made by the Government of China to address this problem.
This notice is a general solicitation of comments from the public. All submitted comments will be made a part of the record of the review referred to above and will be available for public inspection.
In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273) the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on June 12, 2002, applicable to workers of Leybold Vacuum USA, Inc., Export, Pennsylvania. The notice was published in the
At the request of the petitioners, the Department reviewed the certification for workers of the subject firm. New information shows that worker separations occurred at the Tempe, Arizona, Milwaukee, Oregon, Austin, Texas and San Jose, California locations of Leybold Vacuum USA, Inc. These employees provided sales and direct field support services supporting the production of dry vacuum pumps and other pumps at the Export, Pennsylvania location of the subject firm.
Based on these findings, the Department is amending this certification to include employees of the Tempe, Arizona, Milwaukee, Oregon, Austin, Texas and San Jose, California facilities of Leybold Vacuum USA, Inc.
The intent of the Department's certification is to include all workers of Leybold Vacuum USA, Inc. who were adversely affected by increased imports.
The amended notice applicable to TA-W-40,609 is hereby issued as follows:
All workers of Leybold Vacuum USA, Inc., Export, Pennsylvania (TA-W-40,609), Tempe, Arizona, (TA-W-40,609A), Milwaukee, Oregon (TA-W-40,609B), Austin, Texas (TA-W-40,609C) and San Jose, California (TA-W-40,609D) who became totally or partially separated from employment on or after December 7, 2000, through June 12, 2004, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (P.L. 103-182) concerning transitional adjustment assistance, hereinafter called (NAFTA-TAA), and in accordance with Section 250(a), Subchapter D, Chapter 2, Title II, of the Trade Act of 1974, as amended (19 USC 2273), an investigation was initiated on March 25, 2002, in response to a petition filed on behalf of workers at Motorola, SDS, BMC, Mesa, Arizona.
The petition has been deemed invalid. The three petitioners were separated from the subject firm more than one year prior to the date of the petition. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
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 Mine Safety and Health Administration (MSHA) is soliciting comments concerning the proposed extension of the information collection related to the Record of Mine Closure addressed in 30 CFR 75.1204 and 75.1204-1; the inclusion of standards requiring MSHA notification and inspection prior to mining when opening a new mine or reopening an inactive or abandoned mine addressed in 30 CFR.75.373 and 75.1721; and, the inclusion of standards requiring underground and surface mine operators to prepare and maintain accurate and up-to-date mine maps addressed in 30 CFR 75.1200, 75.1200-1, 75.1201, 75.1202, 75.1202-1, 75.1203, 75,372, 77.1200, 77.1201 and 77.1202.
• 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, e.g., permitting electronic submissions of responses.
A copy of the proposed information collection request can be obtained by contacting the employee listed below in the For Further Information Contact section of this notice, or viewed on the Internet by accessing the MSHA home page (
Submit comments on or before October 21, 2002.
Send comments to David . Meyer, Director, Administration and Management, 1100 Wilson Boulevard, Room 2125, Arlington, VA 22209-3939. Commenters are encouraged to send their comments on a computer disk, or via Internet E-mail to
Jane E. Tarr, Management Analyst, Records Management Group, U.S. Department of Labor, Mine Safety and Health Administration, Room 2171, 1100 Wilson Boulevard, Arlington, VA 22209-3939. Ms. Tarr can be reached at
Title 30 CFR 75.1200, 75.1200-1, 75.1201, 75.1202, 75.1202-1, and 75.1203 require underground coal mine operators to have in a fireproof repository in an area on the surface of the mine chosen by the mine operator to minimize the danger of destruction by fire or other hazards, an accurate and up-to-date map of such mine drawn on scale. These standards specify the information which must be shown, the range of acceptable scale, the surveying technique or equivalent accuracy required of the surveying which must be used to prepare the map, that the maps must be certified as accurate by a registered engineer or surveyor, that the maps must be kept continuously up-to-date by temporary notations and must be revised and supplemented to include the temporary notations at intervals not more than 6 months. In addition, the mine operator must provide the MSHA District Manager a copy of the certified mine map annually during the operating life of the mine. These maps are essential to the planning and safe operation of the mine. In addition, these maps provide a graphic presentation of the locations of working sections and the locations of fixed surface and underground mine facilities and equipment, escapeway routes, coal haulage and man and materials haulage entries and other information essential to mine rescue or mine fire fighting activities in the event of mine fire, explosion or inundations of gas or water. The information is essential to the safe operation of adjacent mines and mines approaching the worked out areas of active or abandoned mines. Section 75.372 requires underground mine operators to submit three copies of an up-to-date mine map to the District Manager at intervals not exceeding 12 months.
Title 30 CFR 75.1204 and 75.1204-1 require that whenever an underground coal mine operator permanently closes or abandons a coal mine, or temporarily closes a coal mine for a period of 90 days, the operator shall file with MSHA a copy of the mine map revised and supplemented to the date of closure. Maps are retained in a repository and are made available to mine operators of adjacent properties. The maps are necessary to provide an accurate record of underground areas that have been mined to help prevent active mine operators from mining into abandoned areas that may contain water or harmful gases.
Title 30 CFR 77.1200, 77.1201 and 77.1202 require surface coal mine operators to maintain an accurate and up-to-date map of the mine and specified the information to be shown on the map, the acceptable range of map scales, that the map be certified a registered engineer or surveyor, that the be available for inspection by the Secretary or his authorized representative. These maps are essential for the safe operation of the mine and provide essential information to operators of adjacent surface and underground mine operators. Properly prepared effectively utilized surface mine maps can prevent outbursts of water impounded in underground mine workings and/or inundations of underground mines by surface impounded water or water and or gases impounded in surface auger mining worked out areas.
Title 30 75.373 and 75.1721 require that after a mine is abandoned or declared inactive and before it is reopened, mine operations shall not begin until MSHA has been notified and has completed an inspection. Standard 75.1721 specifies that the notification be in writing and lists specific information, preliminary arrangements and mine plans which must be submitted to the MSHA District Manager.
Mine operators are required to conduct surveying such that mine maps are maintained accurate and up-to-date, the maps must be revised every 6 months and certified accurate by a registered engineer or surveyor and to submit copies of the certified underground maps to MSHA annually and an up-to-date and revised mine closure map whenever an operator permanently closes or abandons a coal mine, or temporarily closes a coal mine for a period of more than 90 days, he or she shall promptly notify the Secretary of such closure.
In addition, mine operators must notify MSHA so that an inspection can be conducted when ever a new mine is opened or a previously abandoned or inactive mine is reopened. The information required to be gathered and recorded on mine maps is essential to the safe operation of the mine and essential to the effectiveness of mandatory inspections and mandated mine plan approval by MSHA. Such information cannot be replaced by any other source and anything less than continuously updated and accurate information would place miner's safety at risk.
The information collected through the submittal of mine closure maps is used by operators of adjacent coal mines when approaching abandoned underground mines. The abandoned mine could be flooded with water or contain explosive amounts of methane or harmful gases. If the operator were to mine into such an area, unaware of the hazards, miners could be killed or seriously injured. In addition, it is in the public interest to maintain permanent records of the locations, extent of workings and potential hazards
Agency: Mine Safety and Health Administration.
In addition, mine operators must notify MSHA so that an inspection can be conducted when ever a new mine is opened or a previously abandoned or inactive mine is reopened. The information required to be gathered and recorded on mine maps is essential to the safe operation of the mine and essential to the effectiveness of mandatory inspections and mandated mine plan approval by MSHA. Such information cannot be replaced by any other source and anything less than continuously updated and accurate information would place miner's safety at risk.
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.
The Board of Directors of the Legal Services Corporation will meet on August 24, 2002. The meeting will begin at 9 a.m. and continue until conclusion of the Board's agenda.
The Marriott at Metro Center, 775 12th Street, NW., Washington, DC.
Open, except that a portion of the meeting may be closed pursuant to a vote of the Board of Directors to hold an executive session. At the closed session, the Corporation's General Counsel will report to the Board on litigation to which the Corporation is or may become a party, and the Board may act on the matters reported. The closing is authorized by the relevant provisions of the Government in the Sunshine Act [5 U.S.C. 552b(c)(10)] and the corresponding provisions of the Legal Services Corporation's implementing regulation [45 CFR 1622.5(h)]. A copy of the General Counsel's Certification that the closing is authorized by law will be available upon request.
1. Approval of agenda.
2. Approval of the minutes of the Board's meeting of June 1, 2002.
3. Approval of the minutes of the Executive Session of the Board's meeting of June 1, 2002.
4. Approval of the minutes of the Board's telephonic meeting of May 23, 2002.
5. Chairman's Report.
6. Members' Report.
7. Acting Inspector General's Report.
8. President's Report.
9. Consider and act on the report of the Board's Committee on Provision for the Delivery of Legal Services.
10. Consider and act on the report of the Board's Operations and Regulations Committee.
11. Consider and act on the report of the Board's Finance Committee.
12. Consider and act on changes to the Board's 2002 meeting schedule.
13. Briefing
14. Consider and act on the Office of Legal Affairs' report on potential and pending litigation involving LSC.
15. Consider and act on other business.
16. Public Comment.
Victor M. Fortuno, Vice President for Legal Affairs, General Counsel & Corporate Secretary, at (202) 336-8800.
Upon request, meeting notices will be made available in alternate formats to accommodate visual and hearing impairments. Individuals who have a disability and need an accommodation to attend the meeting may notify Elizabeth S. Cushing, at (202) 336-8800.
The Finance Committee of the Legal Services Corporation Board of Directors will meet on August 23, 2002. The meeting will begin at 3:30 p.m. and continue until the Committee concludes its agenda.
The Marriott at Metro Center, 775 12th Street, NW, Washington, DC.
Open.
1. Approval of agenda.
2. Approval of the minutes of the Committee's meeting of May 31, 2002.
3. Report on the projected operating expenses for Fiscal Year 2002 based on operating experiences through June 30, 2002.
4. Report on the internal budgetary adjustments.
5. Consider and act on the President's recommendations for Consolidated Operating Budget reallocations.
6. Consider and act on proposed Temporary Operating Budget for Fiscal Year 2003.
7. Consider and act on budget mark for Fiscal Year 2004, including receipt of public comment.
8. Consider and act on other business.
9. Public comment.
Victor M. Fortuno, Vice President for Legal Affairs, General Counsel & Corporate Secretary, at (202) 336-8800.
Upon request, meeting notices will be made available in alternate formats to accommodate visual and hearing impairments. Individuals who have a disability and need an accommodation to attend the meeting may notify Elizabeth S. Cushing, at (202) 336-8800.
The Operations and Regulations Committee of the Legal Services Corporation Board of Directors will meet on August 23, 2002. The meeting will begin at 1 p.m. and continue until the Committee concludes its agenda.
The Marriott at Metro Center, 775 12th Street, NW, Washington, DC.
Open.
1. Approval of agenda.
2. Approval of the minutes of the Committee's meeting of May 31, 2002.
3. A panel of three Executive Directors (Michelle DeBord, MidPenn Legal Services, Inc., Harrisburg, PA; Harold E. Creacy, Ocean-Monmouth Legal Services, Inc., Toms River, NJ; and Paul C. Julien, Southern Arizona Legal Aid, Inc., Tucson, AZ) will discuss their experiences undergoing on-site visits from the Office of Compliance & Enforcement conducting a CSM/CMS review, a technical review, and accountability training.
4. Status report on current open rulemakings and Rulemaking Protocol.
5. Consider and act on Rulemaking Protocol.
6. Consider and act on Limited English Proficiency Guidance.
7. Consider and act on potential identification of new appropriate subject(s) for rulemaking.
8. Consider and act on contract renewals for LSC Vice Presidents Randi Youells, Mauricio Vivero, and Victor Fortuno.
9. Consider and act on other business.
10. Public comment.
Victor M. Fortuno, Vice President for Legal Affairs, General Counsel & Corporate Secretary, at (202) 336-8800.
Upon request, meeting notices will be made available in alternate formats to accommodate visual and hearing impairments. Individuals who have a disability and need an accommodation to attend the meeting may notify Elizabeth S. Cushing, at (202) 336-8800.
The Committee on Provision for the Delivery of Legal Services of the Legal Services Corporation Board of Directors will meet on August 23, 2002. The meeting will begin at 9 a.m. and continue until the Committee concludes its agenda.
The Marriott at Metro Center, 775 12th Street, NW., Washington, DC.
Open.
1. Approval of agenda.
2. Approval of the minutes of the Committee's meeting of May 31, 2002.
3. Office of Program Performance (OPP) and Office of Information Management (OIM) “Matters” Project Update by Chris Sundseth and Glenn Rawdon.
4. Update by Randi Youells and John Meyer on 2003 Census Adjustments.
5. Focus on the Field—Presentation by Cynthia Schneider on the Challenges of Delivering Legal Services in Alaska.
6. Update by Althea Hayward on LSC's Diversity Initiatives/Creation of a Grantee Board Training Module on Diversity.
7. Update by Joyce Raby on the 2003 Technology Initiative Grants.
8. State Planning Update by Robert Gross.
9. Update by Reginald Haley on the 2003 Competition.
10. Consider and act on proposed 2003 Grant Assurances.
11. Consider and act on other business.
12. Public comment.
Victor M. Fortuno, Vice President for Legal Affairs, General Counsel & Corporate Secretary of the Corporation, at (202) 336-8800.
Upon request, meeting notices will be made available in alternate formats to accommodate visual and hearing impairments. Individuals who have a disability and need an accommodation to attend the meeting may notify Elizabeth S. Cushing, at (202) 336-8800.
Nuclear Regulatory Commission.
Request for comments and announcement of public meetings.
On December 14, 2001 (66 FR 64890), the Nuclear Regulatory Commission (NRC) announced its intent to evaluate the use of Alternative Dispute Resolution (ADR) in the NRC's enforcement program, which is defined in the NUREG-1600, “General Statement of Policy and Procedure for NRC Enforcement Actions (Enforcement Policy). The NRC is undergoing this evaluation because government-wide, ADR techniques have proven to be efficient and effective in resolving a wide range of disputes. On March 12, 2002, the staff conducted an ADR workshop to evaluate the strengths and weaknesses associated with its use in the enforcement area. The staff has evaluated the outcome of this workshop and concluded that: (1) There may be a role for ADR in the enforcement program; however, further review is needed, (2) if ADR has a role, the NRC should focus on areas resulting in the largest benefits, (3) a pilot program should be the first step to implementation, and (4) additional stakeholder input is needed.
The staff concluded that in order to make any final recommendations for incorporation into the enforcement program or the development of a pilot program, additional stakeholder input is necessary. As a result, additional comment is being sought and a number of public meetings and workshops are being scheduled at various locations throughout the country. Various options associated with the development of a pilot program for the use of ADR in the enforcement process will be discussed. Information on ADR is available on the NRC's Web site at
The comment period expires October 21, 2002.
Submit written responses to the questions contained in the Discussion section of this Notice to Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, Mail Stop T-6D59, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 a.m. and 4:15 p.m., Federal workdays. Comments may be submitted by e-mail to
Barry Westreich, Senior Enforcement Specialist, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 (301) 415-3456, e-mail
“ADR” is a term that refers to a number of voluntary processes, such as mediation and facilitated dialogues, that can be used to assist parties in resolving disputes and potential conflicts. The Administrative Dispute Resolution Act of 1996 (ADRA) encourages the use of ADR by Federal agencies, and defines ADR as “any procedure that is used to resolve issues in controversy, including but not limited to, conciliation, facilitation, mediation, fact finding, mini trials, arbitration, and use of Omsbuds, or any combination thereof.” 5 U.S.C. 571(3). These techniques involve the use of a neutral third party (“neutral”), either from within the agency or from outside the agency, and are typically voluntary processes in terms of the decision to participate, the type of process used, and the content of the final agreement. Federal agency experience with ADR has demonstrated that the use of these techniques can result in the quicker and more economical resolution of issues, more effective outcomes, and improved relationships. The NRC has a general ADR Policy, 57 FR 36678; August 14, 1992, that supports and encourages the use of ADR in NRC activities. In addition, the NRC has used ADR effectively in a variety of circumstances, including rulemaking and policy development, and Equal Employment Opportunity (EEO) disputes.
Although a few enforcement cases have been resolved through the use of “settlement judges” from the Atomic Safety and Licensing Board Panel, pursuant to 10 CFR 2.203 there has been no systematic evaluation of the need for ADR in the enforcement process. As a result of previous stakeholder input, the staff is considering the development of a pilot program for the use of ADR in the enforcement process.
On December 14, 2001, a
The workshop consisted of an overview of the agency's enforcement program to a panel consisting of: one independent ADR specialist; four ADR specialists from various Federal agencies; representatives from the Nuclear Energy Institute (NEI); representatives from the Union of Concerned Scientists; representatives from two law firms representing nuclear utilities; and, representatives from two law firms representing environmental whistle blowers. The panelists discussed the merits and debated the usefulness of ADR techniques in the context of the enforcement process.
Overall, many of the participants (
The citizen group representative was opposed to ADR on the grounds that ADR would only provide an opportunity for the enforcement process to be weakened. In written comments, it was noted that if ADR was to have a role, it should only be considered for establishing the fact set that is then used by the NRC staff to determine sanctions, for example, as to when a non-conforming condition was identified or whether the cause of the violation was wilful. However, its use would be “distasteful” when ADR is used in a case that involved a challenge to a proposed sanction. In respect to the potential need for confidentiality in ADR, this commentor noted that more deals brokered behind closed doors can only expand the widely perceived impression that NRC has an inappropriate close relationship with the industry it regulates.
Based on review of the comments received and provided during the March 12, 2002, workshop, the staff has reached several conclusions and plans to proceed as follows:
• There
Based on the many pros and cons regarding the use of ADR in the NRC enforcement program and that many of the comments received were opposed on the same issues, the staff cannot draw any final conclusions regarding whether ADR should ultimately have a role in the enforcement program and, if it does have a role, how it should be incorporated. However, based on review of stakeholder input, the staff believes that there are areas in the enforcement program which may benefit from the incorporation of ADR and that these areas should be reviewed further.
The staff needs to specifically evaluate whether the use of ADR will not detract from the overall objective of the NRC enforcement program—deterrence and achieving lasting corrective actions, maintaining safety, increasing (or at least maintaining) public confidence, and increasing (or at least maintaining) effectiveness.
• If ADR has a role, NRC should initially focus efforts on areas resulting in the largest benefits.
Commentors provided a wide range of potential benefits and drawbacks to using ADR. While the staff recognizes that it needs to evaluate all benefits and drawbacks, the staff believes that the largest benefits of implementation of ADR in the enforcement program are greater efficiency, lower costs, and better timeliness. Therefore, the staff plans to narrow the initial focus and scope of its review and evaluation of the use of ADR to areas that would realize these benefits. The staff plans to review whether ADR should be incorporated into one of the following areas of the enforcement program for reactor and materials cases: cases involving potential discrimination and cases involving potential wrongdoing. Historically, these types of cases have taken the most time and resources for all parties involved. However, while the staff plans to limit the scope of its review at this time, the staff is not precluding expanded use of ADR in the future. Specifically, if incorporation of ADR is appropriate and demonstrates a benefit, the staff will review further use of ADR in other areas.
• If ADR has a role, it should initially be implemented as a pilot program.
Based on review of the stakeholder's comments, it is clear that some stakeholders, both internal and external, do not see the benefits of incorporating ADR into the enforcement program. In fact, some believe it will have a negative impact on the enforcement process. Therefore, if the staff recommends incorporation of ADR into the enforcement program, it will recommend initial implementation as a pilot program. The staff believes that implementation of a pilot will better demonstrate whether the benefits can be realized, provide confidence that there will be no, or minimal, negative impacts, and will provide additional information for how ADR can be further incorporated into the enforcement program. For a pilot to be successful in demonstrating the use of ADR, the staff believes that the pilot program should include a representative sample of cases. There should be a sufficient number of cases included in the pilot to adequately exercise the enforcement process but not too many that will overwhelm the staff and process. The pilot should specifically address at which points in the enforcement process ADR should be used.
The staff notes that use of an ADR pilot program would be voluntary for all parties, including the NRC. Therefore, if implementation of the pilot for a specific case would compromise the enforcement process, NRC could withdraw from ADR for the case. Other parties would have the same option. In such cases, the NRC would follow the current enforcement process.
• Additional stakeholder input is warranted.
As stated, stakeholder input is very mixed on a number of issues important to the use of ADR. In order to make any final recommendations for incorporation of ADR into the enforcement program, or even the development of a pilot program, additional stakeholder interactions are necessary.
In view of the above, the staff seeks additional input from the public and other stakeholders in written form or at workshops to be scheduled throughout the country over the next few months. The staff proposes to evaluate the use of ADR in a pilot program, initially for some percentage of wrongdoing and discrimination cases in both the materials and reactor areas. The staff is currently evaluating whether to use ADR in a number of points in the process. Specifically, (1) following identification of wrongdoing or an allegation of discrimination but prior to a full investigation into the matter, (2) following an investigation that substantiates the matter but prior to an enforcement conference, (3) following the issuance of a Notice of Violation and Proposed Imposition of Civil Penalty but prior to any Imposition of Civil Penalty, and (4) following an Imposition of Civil Penalty but prior to a Hearing on the matter. The staff requests that comments be focused on issues related to the implementation of a pilot program at the above steps in the NRC process, and include factors such as what ADR techniques would be useful at certain points, what pool of neutrals should be used, who should attend the ADR sessions, and what ground rules should be implemented. Also, the staff requests that comments be focused on the pros and cons of ADR as they relate to these points in the process and in maintaining safety, increasing public confidence, and maintaining the effectiveness of the enforcement program for the above noted areas.
The staff also plans to hold several public meetings and workshops at
The staff will provide specific information regarding the meeting dates times and locations on the NRC's Web site at
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on Thermal-Hydraulic Phenomena will hold a meeting on September 9, 2002, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The entire meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows: Monday, September 9, 2002—1 p.m. until the conclusion of business.
The Subcommittee will continue its review of the proposed resolution of Generic Safety Issue (GSI)-185, “Control of Recriticality Following Small-Break LOCAs in PWRs.” 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 Designated Federal Official 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 Designated Federal Official, Mr. Paul A. Boehnert (telephone 301-415-8065) between 7:30 a.m. and 5 p.m. (EDT). Persons planning to attend this meeting are urged to contact the above named individual at least two working days prior to the meeting to be advised of any potential changes to the agenda that may have occurred.
The ACRS Subcommittee on Fire Protection will hold a meeting on September 11, 2002, Room T-2B3, 11545 Rockville Pike, Rockville, Maryland.
The agenda for the subject meeting shall be as follows: Wednesday, September 11, 2002—8:30 a.m. until the conclusion of business.
The Subcommittee will review the staff's Fire Protection Research Plan, status of fire protection research activities, fire protection inspection process and findings, and other related matters, including industry activities. The purpose of this meeting is to gather information, analyze relevant issues and facts, and to 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 one of the ACRS staff engineers 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 allotted therefor can be obtained by contacting either Mr. Sam Duraiswamy (telephone 301/415-7364) or Mr. Timothy J. Kobetz (Telephone 301-415-8716) between 7:30 a.m. and 4:15 p.m. (EDT). Persons planning to attend this meeting are urged to contact one of the above named individuals at least two working days prior to the meeting to be advised of any potential changes to the agenda that may have occurred.
Peace Corps.
Proposed guidelines.
These proposed information quality guidelines are required by law and are intended to ensure and maximize the quality of information disseminated to the public by the Peace Corps. The guidelines are based on those issued by the Office of Management and Budget (OMB) on January 3, 2002 (67 FR 369-378), as corrected and reprinted on February 22, 2002 (67 FR 8451-8460). The guidelines set out the Agency's policies and procedures for ensuring the quality (objectivity, utility, and integrity) of information provided to the public. The guidelines also establish administrative mechanisms permitting affected persons to seek and obtain, where appropriate, timely correction of information maintained and disseminated by the Agency that does not comply with the OMB or its own guidelines. These guidelines represent Agency policy and procedures and have no legal effect and do not create any legal rights or obligations.
Public comment is requested on the guidelines. Comments must be received September 20, 2002.
Comments should be submitted to Suzanne B. Glasow, Associate General Counsel, Office of the General Counsel, 1111 20th Street NW., Washington, DC 20526.
Suzanne B. Glasow, Associate General Counsel, 202-692-2150.
OMB issued guidelines on January 3, 2002 (67 FR 369-378), as corrected and reprinted on February 22, 2002 (67 FR 8451-8460), to implement Section 515 of the Treasury and General Government Appropriations Act for FY 2001) Public Law 106-554, HR 5658). Section 515 and the OMB Guidelines require each federal agency subject to the Paperwork Reduction Act to issue its own guidelines that provide policies and procedures used by the Agency to ensure the objectivity, utility, and integrity of information disseminated by the Agency. The guidelines must also establish administrative mechanisms allowing affected persons to obtain correction of information disseminated to the public that does not comply with the OMB and Agency guidelines. The Peace Corps requests public comment on these proposed guidelines.
These guidelines are intended to set out the Agency's procedures for ensuring the quality of information it disseminates to the public.
1. “Affected persons” are those who may directly benefit or be harmed by the disseminated information, including: (a) Persons seeking to address information about themselves or about the persons to whom they are directly related or publicly associated; and (b) persons that may reasonably be expected to experience significant adverse impact to their financial interests as a result of the information deficiency.
2. “Dissemination” means the distribution of information initiated or sponsored by the Peace Corps to the general public within the United States. Dissemination does not include distribution of information or other materials that are:
(a) Intended for government employees, including Peace Corps employees and Volunteers, or government contractors or grantees (for example: directories, staffing information, internal manuals; cables);
(b) Intended for U.S. Government agencies;
(c) Produced in response to requests for agency records under the Freedom of Information Act, the Privacy Act, the Federal Advisory Committee Act or similar laws;
(d) Correspondence or other communications limited to individuals (examples include questions or concerns about individual passports, visas, adoptions, missing persons, applications for employment, or federal benefits) or to other persons, as defined in this section;
(e) Distributed to the pass as a summary of a recent event or Peace Corps action;
(f) Archival records; public filings; responses to subpoenas or compulsory document productions; or
(g) Documents prepared and released in the context of adjudicative processes. (These guidelines do not impose any additional requirements on agencies during adjudicative proceedings and do not provide parties to such adjudicative proceedings any additional rights of challenge or appeal.)
3. “Influential,” when used in the phrase “influential scientific, financial, or statistical information,” refers to a narrow category of information with respect to which an agency can reasonably determine that dissemination will have a clear and substantial impact on important public policies or important private sector decisions. To be considered influential, information must be based on objective and quantifiable data that constitute a principal basis for substantive policy positions adopted by the Peace Corps. Any influential information to be disseminated by the Peace Corps is reviewed for quality by the Agency, or another agency within the federal government, depending on who is primarily responsible for developing such information. Where circumstances deem it appropriate, the Agency may include the identity of the federal government agency or international organization originating any cited influential information in information disseminated by the Peace Corps.
4. “Information,” for purposes of these guidelines, means any communication or representation of knowledge, such as facts or data, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual forms. This definition includes information that Peace Corps disseminates on the Agency's external web page, but does not include the provision of hyperlinks to information that others disseminate. “Information” does not include:
(a) Statements on foreign policy or that might cause harm to the national security;
(b) Information originated by, and attributed to, non-Peace Corps sources, provided the Peace Corps does not expressly rely on it;
(c) Opinions, where the Agency's presentation makes it clear that what is being offered is someone's opinion rather than fact or the Agency's views;
(d) Statements related solely to the internal personnel rules and practices of the Peace Corps or materials produced for Peace Corps employees, contractors, Volunteers, agents or alumni;
(e) Descriptions of the Peace Corps, its responsibilities and its organizational components;
(f) Testimony of Peace Corps officials before courts, administrative bodies, or Congress;
(g) Investigatory material complied pursuant to U.S. law or for law enforcement purposes in the United States or abroad; or
(h) Statements which are, or which reasonably may be expected to become, the subject of litigation, whether before a U.S. or foreign court or in an international arbitral or other dispute resolution proceeding.
5. “Integrity” refers to the security of information, that is, the protection of the information from unauthorized access, revision, corruption, or falsification.
6. “Objectivity” addresses whether disseminated information is being presented in an accurate, clear, complete, and unbiased manner,
7. “Person” means an individual, an organization, or a State or local government or division thereof.
8. “Quality” is an umbrella term comprising the terms “utility,” “objectivity,” and “integrity.”
9. “Utility” refers to the usefulness of the information to its intended users.
The Peace Corps is committed to providing the public with reliable and useful information. To meet this goal, the Agency collects information from as many reasonably available and reliable sources as appropriate and subjects draft information intended for public dissemination to a thorough review process. Quality control procedures apply at all stages of the information lifecycle, including the times of creation, collection, maintenance, and dissemination.
1. The office collecting and drafting information intended for public dissemination has the primary responsibility to follow quality control procedures, pursuing the most knowledgeable and reliable sources reasonably available through the Agency's resources and by confirming the objectivity and utility of information internally within the office, with all interested Agency offices, and with other government agencies, when appropriate.
2. The Agency's quality control system for information dissemination is based generally on the “action” and “clearance” processes. The action process constitutes the work done by the office responsible for the product. The “clearance” process involves the review of the product by offices who are authorized to provide clearance and approval of the product. This dual process places responsibility for action upon a particular office while ensuring that the information and opinions of other offices are brought to bear on the proposed action.
3. The action office should assign an action to an “action officer,” typically the principal drafter. The action officer will follow any office specific quality review procedures and consult informally with officers in other interested offices before preparing the information. The action officer's role includes:
(a) Preparing an action document after consulting the necessary materials and people, including government and non-government sources, as appropriate;
(b) Determining clearance points;
(c) Making the initial determination as to where the final decision shall be made;
(d) Obtaining clearances and approvals; and
(e) Overcoming delays and, if necessary, presenting the matter to higher authority.
4. Clearances or approvals of information for dissemination are generally obtained from any office within the Peace Corps or any other agency within the federal government that has a substantive interest in the information. If an office designated for clearance disagrees with the information and differences cannot be resolved at that level, the matter is raised to an Agency official at a higher level.
5. Action officers may also seek advice from other offices having a collateral interest in the subject matter of the information. Offices with collateral interests are offices whose field of responsibility is not vitally affected by the proposed action, but they may have useful information or views to contribute. Clearances from such offices are not required.
6. Where there are differences in views within the Agency concerning proposed information, the differences are generally documented and explained to offices asked to clear or approve the document. After reasonable efforts have been made to resolve any substantive differences, superior officers are informed of the dissenting views and made the necessary decisions. Final clearance of all publications developed for public dissemination must be cleared by the Senior Publications Manager.
7. While the “action” and “clearance” processes are general requirements for a range of information dissemination actions, there are specific requirements for certain categories of information dissemination. For example, information disseminated on the Agency's external web site must be cleared by the Agency's Internet Communications Director. Information disseminated on the Agency's internal web site must be cleared by the Agency's Intranet Manager.
8. The quality of the Agency's disseminated information is also controlled by limits on who may speak on behalf of the Agency. The Agency's Director of Communications has been delegated authority to speak on behalf of the Peace Corps.
9. When the Agency disseminates reports or other statements, it seeks input from multiple qualified and expert sources The Agency also attempts to corroborate all information received. In instances where statements cannot be corroborated adequately, those statements are accompanied by attribution to the source, wherever practicable, to assist the reader in assessing their credibility. Where the Agency disseminates conclusions on an issue, effort is made to identify the facts or events upon which the conclusions are based, to the extent appropriate.
1. “Integrity” refers to the security of information (paper, electronic and other forms), including the protection of the information from unauthorized access, revision, or from being compromised through corruption or falsification.
2. The security of electronic information is the responsibility of the Chief Information Officer (CIO) who approves new policies, oversees security operations related to Agency-wide information resources, management, and systems, and engages in policy development and planning.
3. Within the Agency, the Information Technology (IT) security program gives every Agency staff member general responsibility for the security of the IT systems they use. Technology implementers and the Agency's senior staff are assigned more explicit responsibilities. The IT Security Program Manager's role includes developing and maintaining an information security program, promoting effective implementation and maintenance of information security policies and procedures, controlling techniques throughout the Agency, and training, overseeing and assisting Agency personnel with significant information security related responsibilities. Under the CIO, the Agency develops, implements, and maintains new computer software and hardware systems and provides operational support for systems and system users.
4. Assisted by the IT Security Program Manager, office directors and program managers are primarily responsible and accountable for the integrity of information within their offices. On a day-to-day basis, the responsibilities are carried out by the managers of networks, systems and applications. These technical personnel assess and manage the information security risks associated with the operations and assets for programs and systems within their control. In that capacity, the technical personnel determine the levels of information security appropriate to protect such operations and assets and periodically test and evaluate information security controls and techniques.
5. The security of paper and other forms of information, other than electronic information, is the responsibility of the Director of Security.
The Peace Corps works to be responsive to users of its information and to improve its information products. The procedures set out in this section are available to “affected” persons who seek to correct information publicly disseminated by the Peace Corps and apply to information disseminated by the Peace Corps on or after October 1, 2002.
1. Persons seeking to correct information publicly disseminated by the Peace Corps must send a written request to the Senior Publications Manager, Office of the Director, 1111 20th Street, NW., Washington, DC 20526.
2. Requests for correction are presumed timely if submitted within sixty (60) days of the dissemination date of the information being challenged.
3. Requests will be assigned a reference number and a notice of receipt of the request will be sent to the requester.
4 The reviewing office will give the request due consideration, including a review of the disseminated information at issue and other materials, as appropriate.
5. In determining whether a response to the request for correction is appropriate, the reviewing office shall consider the following factors:
(a) Whether the statements challenged by the requester fall within the scope of “information” that has been disseminated by the Agency, as those terms are defined in these guidelines;
(b) Whether the requester is “affected” by the information at issue, as that term is defined in these guidelines;
(c) The importance of the formations involved; and
(d) The nature and extent of the request and the public benefit of making the requested correction.
6. A request will not be considered if the Agency determines:
(a) It is not submitted by an “affected” person, as that term is defined in these guidelines;
(b) It does not involve the correction of information publicly disseminated by the Peace Corps;
(c) It is not timely; or
(d) Consideration of the request would not advance material interests of the requester, the general public, or the Peace Corps.
7. Where the reviewing office determines that the information publicly disseminated by the Agency was incorrect, it may take corrective measures, as appropriate, recognizing the potential implications for the requester, the United States, and the Agency, without disrupting Agency process.
8. Where the Agency determines that a response under these guidelines is not appropriate, it will so advise the requester.
9. In most cases, where response under these guidelines is appropriate, the Agency will respond within sixty (60) days of request. The requester will be notified if additional time is required. Agency responses will describe the disposition of the request, the reasons for the disposition, and any corrective action taken or pending.
10. Subject to applicable law, rules or regulations, notice of corrective measures may include, but are not limited to, personal contacts via letter, press releases, or posting on the Agency's website. Notice of corrective measures, where appropriate, should be designed to provide reasonable notice to all affected persons.
1. An affected person who received notice from the Agency of the disposition of his or her request under Section IV of these guidelines, may request consideration of the disposition, unless the disposition was a determination that a response to the request was not appropriate.
2. To request reconsideration, the requester shall make the request in writing to the Director of the Peace Corps, and include a copy of original request for correction previously submitted to the Agency. The request for reconsideration shall be sent to the Office of the Director, 1111 20th Street, NW., Washington, DC 20526. Requests for Reconsideration must be submitted within thirty (30) days of the date of the Agency's disposition notification to the requester.
3. Requests for Reconsideration shall be reviewed by the Director or designee. The Director or designee shall apply the same standards and procedures applicable to the original request for correction.
4. The Agency will generally respond within sixty (60) days of receipt of the request. The requester will be informed of the disposition of the request and reasonable notice shall be given affected persons of any corrective actions taken. The decision shall constitute a final action by the Agency.
Carolina Power & Light Company, a North Carolina corporation (“Issuer”), has filed an application with the Securities and Exchange Commission (“Commission”), pursuant to section 12(d) of the Securities Exchange Act of 1934 (“Act”)
The Issuer stated in its application that it has met the requirements of Amex Rule 18 by complying with all applicable laws in effect in the state of North Carolina, in which it is incorporated, and with the Amex's rules governing an issuer's voluntary withdrawal of a security from listing and registration. The Issuer's application relates solely to the Security's withdrawal from listing on the Amex and from registration under section 12(b) of the Act,
Any interested person may, on or before September 9, 2002, submit by letter to the Secretary of the Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609, facts bearing upon whether the application has been made in accordance with the rules of the Amex and what terms, if any, should be imposed by the Commission for the protection of investors. The Commission, based on the information submitted to it, will issue an order granting the application after the date mentioned above, unless the Commission determines to order a hearing on the matter.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
On April 23, 2002, the American Stock Exchange LLC (“Amex” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On June 6, 2002, the Amex submitted Amendment No. 1 to the proposed rule change.
The Commission finds that the proposed rule change, as amended, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange
The Commission previously approved similar proposals by the Amex to designate the sections of its trading floor as separate trading areas for the purposes of stock and options trading.
The Commission is satisfied that these conditions are met here. Options on both listed and non-Amex-listed equities are traded on Harry's while Amex-listed equities are traded on the Main Trading Floor. Harry's is located in a separate area on the ground floor of the Exchange and is only accessible from the Exchange's other trading locations by escalator. Accordingly, the trading posts located on Harry's are not visible from the Main Trading Floor. Furthermore, the Exchange represents that it maintains adequate surveillance systems designed to prevent trading abuses and manipulation as well as to ensure compliance with the relevant Exchange rules consistent with the 1988, 1998 and Index Orders.
Therefore, the Commission finds that Harry's is a separate trading area for purposes of trading options on Amex-listed and non-listed stocks. The Commission's approval is premised on the belief that the Amex's proposed trading locations for equities and options are sufficiently separated such that there is no time and place advantage derived from the physical proximity of Harry's to locations where the underlying equities trade. Accordingly, any decision by the Amex to change the location of the designated options relative area to the designated stock area or to modify the means of access between them, would require the submission of a proposed rule change under section 19(b) of the Act.
It is therefore ordered, pursuant to section 19(b)(2) of the Act,
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
The CBOE proposes to amend CBOE Rule 24.4A, “Terms of FLEX Options,” to provide a maximum term of ten years for Flexible Exchange (“FLEX”) index options under certain circumstances.
The text of the proposed rule change is available at the CBOE and at the Commission.
In its filing with the Commission, the CBOE included statements concerning the purpose of, and 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 in Item IV below. The CBOE has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Currently, under CBOE Rule 24A.4(a)(4)(i), FLEX index options are limited to a maturity of five years. The purpose of the proposal is to allow FLEX index options traded on the CBOE to have a maturity beyond five years and up to ten years in certain circumstances.
FLEX index option have traded on the CBOE since February 1993.
The proposed amendment to CBOE Rule 24A.4(a)(4)(i) would permit FLEX index options with terms up to a maximum of ten years when requested by a Submitting Member if the FLEX Post Official determines that sufficient liquidity exists among FLEX index participating members. According to the CBOE, the liquidity requirement will help to ensure that there is not a proliferation of longer-term FLEX index options series where no interest in trading such options exists.
The CBOE states that the proposal will allow institutions to use longer-term FLEX index options to protect portfolios from long-term market moves with a known and limited cost. The CBOE believes that the proposal will better serve the long-term hedging needs of institutional investors and provide those investors with an alternative to hedging their portfolios with off-exchange customized options and warrants.
The CBOE states that by allowing for the extension of the maturity of FLEX index options to ten years in situations where there is demand for a longer-term expiration and where there is sufficient liquidity among FLEX index participating members to support the request, the proposal will better serve the needs of the CBOE's customers and the CBOE members who make a market for such customers. The CBOE believes that the proposal is consistent with and furthers the objectives of section 6(b)(5) of the Act in that it is designed to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and to protect investors and the public interest.
The CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
Within 35 days of the date of publication of this notice in the
(A) By order approve such proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
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 CBOE. All submissions should refer to file number SR-CBOE-2002-23 and should be submitted by September 11, 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”),
Nasdaq proposes to amend NASD Rule 7010(c)(2) to modify Nasdaq's transaction credit pilot program for exchange-listed securities. Nasdaq will implement the proposed rule change on a retroactive basis, as of July 1, 2002. The text of the proposed rule change is below. Proposed new language is in italics; proposed deletions are in brackets.
(a)-(b) No change.
(c)(1) No change.
(2) Exchange-Listed Securities Transaction Credit[.]
For a pilot period, [qualified] NASD members that trade securities listed on the NYSE and Amex in over-the-counter transactions reported by the NASD to the Consolidated Tape Association may receive from the NASD transaction credits based on the number of trades so reported. [To qualify for the credit with respect to Tape A reports, an NASD member must account for 500 or more average daily Tape A reports of over-the-counter transactions as reported to the Consolidated Tape during the concurrent calendar quarter. To qualify for the credit with respect to Tape B reports, an NASD member must account for 500 or more average daily Tape B reports of over-the-counter transactions as reported to the Consolidated Tape during the concurrent calendar quarter. If an NASD member is so qualified to earn credits based either on its Tape A activity, or its Tape B activity, or both, that]
(d)-(r) No change.
In its filing with the Commission, Nasdaq included statements concerning the purpose of and 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 in Item IV below. Nasdaq has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Nasdaq's InterMarket is a quotation, communication, and execution system that allows NASD members to trade stocks listed on the New York Stock Exchange (“NYSE”) and the American Stock Exchange (“Amex”).
Nasdaq is proposing to modify the InterMarket Transaction Credit Pilot Program (the “Program”) that it began in 1999.
Under the Program, Nasdaq calculates two separate pools of revenue from which credits can be earned: one representing 40% of the gross revenues received from the CTA for providing trade reports in NYSE-listed securities executed in the InterMarket for dissemination by the CTA (“Tape A”), the other representing 40% of the gross revenue received from the CTA for reporting Amex trades (“Tape B”). Eligibility for transaction credits is based on concurrent quarterly trading activity.
Nasdaq is proposing to eliminate the requirement that a member print an average of 500 daily trades of Tape A securities during a quarter to qualify for Tape A sharing, as well as the comparable volume threshold for Tape B securities. Nasdaq originally included these thresholds in the Program because it believed that a member should
Nasdaq believes that the proposed rule change is consistent with the Act, including section 15A(b)(5) of the Act,
Nasdaq 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.
Within 35 days of the date of publication of this notice in the
A. by order approve such proposed rule change, or
B. institute proceedings to determine whether the proposed rule change should be disapproved.
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 NASD. All submissions should refer to file number SR-NASD-2002-111 and should be submitted by September 11, 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”),
Nasdaq proposes to amend NASD Rule 7010(r) to modify the fee schedule for the Nasdaq Application of the Primex Auction System (“Primex”). Nasdaq will implement the proposed rule change on August 1, 2002. The text of the proposed rule change is below. Proposed new language is in italics; proposed deletions are in brackets.
The following charges shall apply to the use of the Nasdaq Application of the Primex Auction System:
In its filing with the Commission, Nasdaq included statements concerning the purpose of, and 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 in Item IV below. Nasdaq has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The amendments modify NASD Rule 7010(r), which establishes the fee schedule for Primex. Specifically, the amendments reduce the auction response fee from $.01 to $.005 per execution, per share, and remove the $5.00 maximum fee cap per execution. In addition, the amendments establish the fees for two additional bandwidth options Nasdaq will begin providing to members that access Primex.
While the fee schedule for Primex was filed initially in December 2001, the prices for the fee schedule were established in 2000.
This proposal also establishes the fees for two new bandwidth options for accessing Primex. Nasdaq currently provides a 64 kilobyte per second (“K”) connection that automatically increases to 256K if needed due to increased message traffic (“burst capacity”). The increase to 256K, however, is constrained, and may not be available, if other users are already using the burst capacity. The charge for this bandwidth option will remain unchanged. The two new bandwidth options will accommodate users with high message traffic and those with low message traffic.
To accommodate users with high message traffic, Nasdaq is offering a connection that provides a constant 256K capacity, as opposed to a burst capacity feature. The monthly charge for this option will be $1,781. Members that submit lower amounts of message traffic will have the option to use a 56K constant connection. The monthly charge for this option will be $712.
Nasdaq believes that the proposed rule change is consistent with the provisions of section 15A of the Act,
Nasdaq 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.
Nasdaq has designated the proposed rule change as a fee change pursuant to section 19(b)(3)(A) of the Act and Rule 19b-4(f)(2) thereunder. Accordingly, the proposal will take effect upon filing with the Commission. At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes 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
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 NASD proposes to establish NASD Rule 1043, a new registration category for proctors of in-firm delivery of the Regulatory Element of the NASD's continuing education requirements. The text of the proposed rule change is below. Proposed new language is in italics; proposed deletions are in brackets.
(a) through (c) No change.
(a) through (c) No change.
In its filing with the Commission, the NASD included statements concerning the purpose of and 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 in Item IV below. The NASD has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to establish a new registration category for proctors of in-firm delivery of the Regulatory Element of the NASD's continuing education requirements. The Regulatory Element requires all registered persons to participate in a prescribed computer-based training session within 120 days of their second registration anniversary date and every three years thereafter. The Regulatory Element focuses on compliance, regulatory and ethical standards.
NASD Rule 1120(a)(6) permits each member to administer the continuing education Regulatory Element program to their registered persons through a program delivered on the member's premises, provided that the member adheres to certain technology, administrative and regulatory standards. Among the requirements for in-firm delivery of the Regulatory Element is that the program sessions be proctored by an individual registered with a self-regulatory organization (“SRO”) and supervised by a designated principal.
NASD Rule1120(a)(6) was intended to ease the burden on members to meet their continuing education requirements. However, the NASD has observed that many members have chosen not to avail themselves of the in-firm delivery options. Members have informed the NASD that the registration requirement for proctors is one reason more members have not used in-firm delivery. Members either do not have registered persons available to act as proctors or do not want to commit resources needed to prepare a proctor for an exam-based registration. The Securities Industry/Regulatory Council on Continuing Education recommended that the SROs develop a means to allow proctors to be registered without taking a qualification examination.
Importantly, while the proposed rule change would permit proctors to be registered without an exam, it would still require the proctors to submit an
The NASD believes that the proposed rule change is consistent with the provisions of section 15A(b)(6) of the Act,
The NASD 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.
Within 35 days of the date of publication of this notice in the
A. By order approve such proposed rule change, or
B. institute proceedings to determine whether the proposed rule change should be disapproved.
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 NASD. All submissions should refer to file number SR-NASD-2002-110 and should be submitted by September 11, 2002.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
On June 14, 2002, the National Association of Securities Dealers, Inc. (“NASD”), through its subsidiary, The Nasdaq Stock Market, Inc. (“Nasdaq”), filed with the Securities and Exchange Commission (“Commission”), pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities association
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 Exchange proposes to amend PCX Rule 6.82(d)(2) in order to change the percentage of guaranteed participation afforded to Lead Market Makers (“LMMs”).
The text of the proposed rule change appears below. New text is in italics; deletions are in brackets.
Rule 6.82(a)-(c)-No change.
(d) Rights of Lead Market Makers:
(1)—No change.
(2) Guaranteed Participation. [Except as provided in subsections (A) and (B), below,] LMMs shall be allocated [50%]
[(A) Multiply-traded Issues. If the average daily trading volume in a multiply-traded issue reaches 3,000 contracts at the Exchange during any three-calendar-month period (measured on a “rolling” three-calendar-month basis), and if:]
[(i) in the case of an issue traded by two options exchanges, the Exchange's monthly share of the total multi-exchange customer trading volume in the issue drops from above 70% to below 70%; or]
[(ii) in the case of an issue traded by three or more options exchanges, the Exchange's monthly share of the total multi-exchange customer trading volume in the issue drops from above 45% to below 45%; the Options Allocation Committee will evaluate the LMM's performance in that issue and, based on that evaluation, may reduce the LMM's guaranteed participation in that issue from 50% to 40%.]
[(B) Non multiply-traded Issues. If the average daily trading volume in a non-multiply-traded issue reaches 3,000 contracts at the Exchange during any three-calendar-month period (measured on a “rolling” three-calendar-month basis), the Options Allocation Committee will evaluate the LMM's performance in that issue and, based on that evaluation, may reduce the LMM's guaranteed participation in that issue from 50% to 25%.]
[(C) Return to Previous Levels of Guaranteed Participation. If the Options Allocation Committee has reduced an LMM's guaranteed participation in an issue pursuant to subsections (A) or (B) above, and average daily trading volume in the issue falls below 3,000 contracts at the Exchange during any three-calendar-month period (measured on a “rolling” three-calendar-month basis), the Options Allocation Committee will evaluate the LMM's performance in that issue and, based on that evaluation, may raise the LMM's guaranteed participation in that issue from 40% to 50% (in a multiply-traded issue) or from 25% to 50% (in a non-multiply-traded issue).]
In its filing with the Commission, the Exchange included statements concerning the purpose of and 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 in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Currently, Exchange rules provide that LMMs may be allocated a maximum guaranteed participation of 50% in transactions occurring at their disseminated bid or offer.
The proposed rule also eliminates PCX Rules 6.82(d)(2)(A)-(C), which relate to guaranteed participation for LMMs with respect to multiply-traded and non multiply-traded issues. According to the Exchange, these rules were designed to measure LMM performance and allow the OAC to take
The Exchange believes that the proposed rule change is consistent with section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the Act.
Written comments on the proposed rule change were neither solicited nor received.
The foregoing rule change has become effective pursuant to section 19(b)(3)(A) of the Act
The Exchange has requested that the Commission waive the 30-day operative delay. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Acceleration of the operative date will permit the Exchange to promptly decrease the LMM guaranteed from 50% to 40%, affording Market Makers a greater opportunity to interact with orders and thereby enhancing competition on the Exchange. For these Commission designates the proposal to be become operative immediately.
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 Section. Copies of such filing will also be available for inspection and copying at the principal office of the Exchange. All submissions should refer to File No. SR-PCX-2002-49 and should be submitted by September 11, 2002.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Notice of registration for the Diversity Immigrant Visa Program.
This public notice provides information on how to apply for the DV 2004 Program. This notice is issued pursuant to 22 CFR 42.33(b)(2) which implements sections 201(a)(3), 201(e), 203(c) and 204(a)(1)(I) of the Immigration and Nationality Act, as amended, (8 U.S.C. 1151(a)(3) and (e), 1153(c), and 1154(a)(1)(I)).
Entries for DV-2004 must be received at one of the Kentucky Consular Center Mailing Addresses listed in this Notice between noon on Monday, October 7, 2002 and noon on Wednesday, November 6, 2002. Entries received before or after these dates will be disqualified regardless of when they are postmarked. Entries mailed to any address other than the Kentucky Consular Center addresses listed in this notice will be disqualified.
Visas are apportioned among six geographic regions with a greater number of visas going to regions with lower rates of immigration, and no visas going to countries sending more than 50,000 immigrants to the U.S. in the past five years. Within each of the six regions, no one country may receive more than seven percent of the available Diversity Visas in one year. By law, the U.S. Diversity Visa Program makes available a maximum of 55,000 each year. However, the Nicaraguan and Central American Relief Act (NACARA) stipulates that beginning as early as DV-99 and for as long as necessary, 5,000 of the 55,000 annually-allocated diversity visas will be made available for use under the NACARA Program. This reduction began in DV-1999 and remains in effect for DV-2004.
For DV-2004, natives of the following are not eligible to apply because they sent more than 50,000 immigrants to the United States in the previous five years:
(Persons born in Hong Kong SAR, Macau SAR and Taiwan are eligible.)
To enter, an applicant must be able to claim nativity in an eligible country, and must meet either the education or training requirement of the DV program. Nativity in most cases is determined by the applicant's place of birth. However, if a person was born in an ineligible country but his/her spouse was born in an eligible country, such person can claim the spouse's country of birth rather than his/her own. Also, if a person was born in an ineligible country, but neither of his/her parents was born there or resided there at the time of the birth, such person may be able to claim nativity in one of the parents' country of birth.
To enter, an applicant must have either a high school education or its equivalent, defined in the U.S. as successful completion of a 12-year course of elementary and secondary education; or two years of work experience within the past five years in an occupation requiring at least two years of training or experience to perform. U.S. Department of Labor definitions, as indicated in the O*Net OnLine database, will apply. If a person does not meet these requirements, he/she should not submit an entry to the DV program.
Only one entry may be submitted by or for each applicant during the registration period. Submission of more than one entry will disqualify the person. The applicant must personally sign the entry, in his/her native alphabet. Neither an initialed signature nor block printing of the applicant's name will be accepted and will result in the disqualification of the entry. Failure of the applicant to personally sign his/her own entry will result in disqualification.
There is no specific form for the entry. Failure to provide all of the information listed below will disqualify the applicant. Simply use a plain sheet of paper and type or clearly print in the English (Roman) alphabet (preferably in the order listed below):
1. Full name, with the last (surname/family) name underlined:
Examples: Public, Sara Jane (or) Lopez, Juan Antonio.
2. Date and place of birth:
Date: Day, Month, Year.
Example: 15 November 1961.
Place: City/Town, District/County/Province, Country.
Example: Munich, Bavaria, Germany.
The name of the country should be that which is currently in use for the place where the applicant was born (For example, Slovenia, rather than Yugoslavia; Kazakhstan rather than Soviet Union.)
3. The applicant's native country if different from country of birth:
If the applicant is claiming nativity in a country other than his/her place of birth, this must be clearly indicated on the entry. This information must match with what is put on the upper left corner of the entry envelope. (See “MAILING THE ENTRY” below.) If an applicant is claiming nativity through spouse or parent, please indicate this on the entry. (See “REQUIREMENTS” section for more information on this item.
4. Name, date and place of birth of the applicant's spouse and unmarried children who are under the age of 21 (other than children who are already U.S. citizens or lawful permanent residents). Include natural children, stepchildren, as well as all legally-adopted children. List spouse and children regardless of whether or not they reside with you and whether or not they will immigrate with you. (Failure to provide ALL of this information will disqualify the applicant.) Note: married children and children 21 years or older will not qualify for the DV Program.
5. Full mailing address:
This must be clear and complete, as any communications will be sent there. A telephone number is optional, but useful.
6. Photographs. Attach a recent photograph, either black and white or in color, of the applicant, spouse and each child.
If photos do not conform to the following specifications, the entry will be disqualified:
The photo must between 1
The person photographed must be directly facing the camera. The head should not be tilted up, down or to the side and should cover about 50% of the area of the photo.
The person should be in front of a neutral, light-colored background.
The face must be in focus.
The person photographed may not wear a hat or dark glasses or other paraphernalia which detracts from the face.
Photos with the alien wearing head coverings or hats are only acceptable due to religious beliefs, and even then, may not obscure any portion of the face of the applicant.
Photos of applicants wearing tribal, military, airline or other headware not specifically religious in nature will not be accepted.
The photograph (not a photocopy) should be attached to the entry with clear tape—DO NOT use staples or paperclips, which can jam the mail processing equipment.
7. Signature: The entry will be disqualified if the entry is not personally signed by the applicant with the usual and customary signature in his/her native alphabet. Neither an initialed signature nor block printing of the applicant's name will be accepted.
Submit the entry by regular or airmail to the address matching the region of the applicant's country of nativity. Entries sent by express or priority mail, second day airmail, fax, hand, messenger, or any means requiring receipts or special handling will not be processed.
• The envelope must be between 6 and 10 inches (15 to 25 cm) long and 3
• Postcards are not acceptable.
• Envelopes inside express or oversized mail packets are not acceptable.
• In the upper left-hand corner of the envelope the applicant must write his/her country of nativity, followed by the applicant's name and full return address, even if both are the same.
Failure to provide this information will disqualify the entry.
Every application received during the mail-in period and prepared in accordance with these instructions will have an equal random chance of being selected within its region. No outside service can legitimately improve an applicant's chances of being chosen or guarantee that an entry will win.
Important notice: In order to actually receive a visa, applicants selected in the random drawing must meet all eligibility requirements under U.S. law, including any applicable special processing requirements established in response to the events of September 11, 2001. These requirements may significantly increase the level of scrutiny required and time necessary for processing of applications for natives of some countries listed in this notice; particularly those where a higher level activity related to post-September 11 concerns has been indicated. These include, but are not limited to, countries identified as state sponsors of terrorism. Processing of applications and issuance of diversity visas to successful applicants and their eligible family members MUST occur by September 30, 2004. Family members may not obtain diversity visas to follow to join the applicant in the U.S. after this date. There is NO initial fee, other than postage required to enter the DV-2004 program. The use of an outside intermediary or assistance to prepare a DV-2004 entry is entirely at the applicant's discretion. Qualified entries received directly from applicants or through intermediaries have equal chances of being selected by computer. There is no advantage to mailing early, or mailing from any particular locale. However, more than one application per person will disqualify the person from registration.
The Immigration and Naturalization Service (INS) determines the DV regional limits for each year according to a formula specified in section 203(c) of the Immigration and Nationality Act. Natives of the following countries are eligible for the 2004 DV Program:
Asia countries whose natives do not qualify for this year's diversity program: China (mainland-born), India, Pakistan, South Korea, Philippines, and Vietnam.
European countries whose natives do not qualify for this year's diversity program: Great Britain (including Anguilla, Bermuda, British Virgin Islands, Cayman Islands, Falkland Islands, Gibraltar, Montserrat, Pitcairn, St. Helena, Turks and Caicos Islands.
For the purposes of the diversity program only, Northern Ireland is treated separately and DOES qualify for this year's program.
In North America, natives of CANADA do not qualify for this year's diversity program.
Countries in this region whose natives do not qualify for this year's diversity program: Colombia, Dominican Republic, El Salvador, Haiti, Jamaica and Mexico.
Only successful entrants will be notified. They will be notified by mail
Being selected in the DV Lottery does not automatically guarantee issuance of a visa, even if the applicant is qualified, because the number of entries selected and registered is greater than the number of immigrant visas available. Those selected will, therefore, need to complete and file their immigrant visa applications quickly. Once all the diversity visas have been issued or on September 30, 2004, whichever is sooner, the DV Program for Fiscal Year 2004 will end.
Interested persons may call (202) 331-7199, which describes the various means to obtain further details on entering the DV-2004 program. Applicants overseas may contact the nearest U.S. embassy or consulate for instructions on the DV lottery. DV information is also available in the Visa Bulletin, on the Internet at
Federal Highway Administration (FHWA), DOT.
Notice of intent.
The FHWA is issuing this notice to advise the public that an environmental impact statement will be prepared for improving the freeway system for Interstate-80 (I-80), I-29, and I-480 in the City of Council Bluffs, Pottawattamie County, Iowa, and the City of Omaha, Douglas County, Nebraska.
Rebecca Hiatt, Operations Engineer, FHWA, 105 6th Street, Ames, IA 50010-6337, (515) 233-7321. James P. Rost, Director, Office of Location and Environment, Iowa Department of Transportation, 800 Lincoln Way, Ames, IA 50010, (515) 239-1798.
An electronic copy of this document may be downloaded using a modem and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at (202) 512-1661. Internet users may reach the
The FHWA, in cooperation with the Iowa Department of Transportation, will prepare an environmental impact statement (EIS) for the proposed Council Bluffs Interstate System Improvement Project including improvements to I-80, I-29, and I-480. The system deficiencies noted in an earlier needs study (conducted by the Metropolitan Planning Organization and the City of Council Bluffs in April 1999) included deteriorated roadways and bridges, reduced travel efficiency, substandard roadway geometry, and safety issues. The proposed system improvements include approximately 18 mainline-miles of interstate, and 16 interchanges (3 system, 13 service). The project area includes Interstate 80 from near the 24th Street interchange in the City of Omaha, Nebraska, east to U.S. Hwy 6 (Kanesville Blvd) just northeast of the City of Council Bluffs, Iowa. The project also includes: Interstate 29, from just south of Iowa Hwy 92 and U.S. Hwy 275 south of Council Bluffs, and north to Iowa Hwy 192 (16th Street) just north of Council Bluffs; Interstate 480 from the Missouri River Bridge (on the Nebraska side) to Interstate 29 at the Broadway interchange in Council Bluffs; studies of the Missouri River crossings; and an underpass of the Union Pacific mainline.
Due to the size of the system and the multi-year/multi-project approach, a tiered EIS process will be conducted. A Tier 1 EIS will be prepared to determine the preferred set of long-range improvements for the I-80, I-29, and I-480 freeway system. The EIS will consider a broad range of alternatives including no action, reconstruction of the existing alignment, and improvements to transportation system management, transportation demand management, transit, and cross-town corridors. Following the conclusion of the Tier 1 EIS, preliminary engineering, in-depth environmental studies, and Tier 2 environmental documents (EIS, environmental assessment (EA), or categorical exclusion (CE)) will be completed for individual projects as appropriate.
Letters describing the proposed action and soliciting comments have been sent to appropriate federal, state, and local agencies, and to private organizations and citizens who are known to be interested in this proposed project.
A scoping meeting for identifying significant issues to be addressed in the environmental impact statement will be held on September 12, 2002 from 4 to 7 p.m. at the Best Western Crossroads of the Bluffs at 2216 27th Avenue (I-80 and 24th Street), Council Bluffs, Iowa.
In addition to the scoping meeting, a series of public meetings and a public hearing on the draft EIS will be held in the City of Council Bluffs, Iowa, during 2002, 2003 and 2004. Public notice will be given of the time and place of the public meetings and public hearing. The draft EIS will be available for public and agency review and comment 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 or questions concerning this proposed action and the EIS should be directed to the Iowa Department of Transportation or FHWA at the address provided under the caption
Maritime Administration, Department of Transportation.
Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel DESTINY'S WINDS.
As authorized by Pub. L. 105-383, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a description of the proposed service, is listed below. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines that in accordance with Pub. L. 105-383 and MARAD's regulations at 46 CFR Part 388 (65 FR 6905; February 11, 2000) that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels, a waiver will not be granted.
Submit comments on or before September 20, 2002.
Comments should refer to docket number MARAD-2002-13156. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. DOT Dockets, Room PL-401, Department of Transportation, 400 7th St., SW., Washington, DC 20590-0001. You may also send comments electronically via the Internet at
Kathleen Dunn, U.S. Department of Transportation, Maritime Administration, MAR-832 Room 7201, 400 Seventh Street, SW., Washington, DC 20590. Telephone 202-366-2307.
Title V of Pub. L. 105-383 provides authority to the Secretary of Transportation to administratively waive the U.S.-build requirements of the Jones Act, and other statutes, for small commercial passenger vessels (no more than 12 passengers). This authority has been delegated to the Maritime Administration per 49 CFR § 1.66, Delegations to the Maritime Administrator, as amended. By this notice, MARAD is publishing information on a vessel for which a request for a U.S.-build waiver has been received, and for which MARAD requests comments from interested parties. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in § 388.4 of MARAD's regulations at 46 CFR Part 388.
(1) Name of vessel and owner for which waiver is requested.
(2) Size, capacity and tonnage of vessel.
(3) Intended use for vessel, including geographic region of intended operation and trade. According to the applicant: “I intend to use the vessel for charter work throughout the coastline of Florida. If possible, I would extend the area to include New Orleans to Savannah, GA.”
(4) Date and Place of construction and (if applicable) rebuilding.
(5) A statement on the impact this waiver will have on other commercial passenger vessel operators. According to the applicant: “To my knowledge, there are no long range charter sail operators in the area of Destin, Florida. In researching the feasibility of such an operation, I could only find five advertised charter operators within the geographic area I have requested.”
(6) A statement on the impact this waiver will have on U.S. shipyards. According to the applicant: “Throughout the coastline, there are many facilities that one can get immediate towing and repair service. They could help me if necessary and any work would be of benefit to them should I need their services.”
By order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel WILD FLOWER.
As authorized by Pub. L. 105-383, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a description of the proposed service, is listed below. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines that in accordance with Pub. L. 105-383 and MARAD's regulations at 46 CFR part 388 (65 FR 6905; February 11, 2000) that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels, a waiver will not be granted.
Submit comments on or before September 20, 2002.
Comments should refer to docket number MARAD-2002-13155. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. DOT Dockets, Room PL-401, Department of Transportation, 400 7th St., SW., Washington, DC 20590-0001. You may also send comments electronically via the Internet at
Kathleen Dunn, U.S. Department of Transportation, Maritime Administration, MAR-832 Room 7201, 400 Seventh Street, SW., Washington, DC 20590. Telephone 202-366-2307.
Title V of Pub. L. 105-383 provides authority to the Secretary of Transportation to administratively waive the U.S.-build requirements of the Jones Act, and other statutes, for small commercial passenger vessels (no more than 12 passengers). This authority has been delegated to the Maritime Administration per 49 CFR § 1.66, Delegations to the Maritime Administrator, as amended. By this notice, MARAD is publishing information on a vessel for which a request for a U.S.-build waiver has been
(1) Name of vessel and owner for which waiver is requested.
(2) Size, capacity and tonnage of vessel. According to the applicant: “The vessel is 64′8″ long, her breadth is 17′5″ and her depth is 7′. Her gross tonnage is 29 GRT and her net tonnage is 26 NRT.”
(3) Intended use for vessel, including geographic region of intended operation and trade. According to the applicant: “The vessel is unique in the crewed chartering industry in that . . . she charters only for two passengers . . . The average charter lasts for one week (food and wine included in the price) with the boat on anchor or on a mooring overnight . . . The geographic region of intended operation is in the waters from New York City through the waters of Maine.”
(4) Date and Place of construction and (if applicable) rebuilding.
(5) A statement on the impact this waiver will have on other commercial passenger vessel operators. According to the applicant: “Since there are currently no vessels in the intended area of operation over 55′ that charter exclusively for two passengers, there can be no impact, if the waiver is granted on other commercial vessel operators.”
(6) A statement on the impact this waiver will have on U.S. shipyards. According to the applicant: “If the application is granted, the vessel will be in the United States in the appropriate season and can have her yearly hauling and bottom painting done at U.S. shipyards. This can only have a positive impact on these shipyards.”
1.
2.
3.
4.
a. IRC § 7803(a)(2).
b. Subtitle G of Title XII of the Tax Reform Act of 1986, sections 1271 to 1277 of Pub. Law 99-514, 100 Stat. 2085, 2591-2602.
6.
In rule document 02-19486 beginning on page 50793 in the issue of Tuesday, August 6, 2002 make the following correction:
On page 50794, in §39.13, in the table, under the “ Model” heading, in the third entry “(3)” should read “(3) 230 ”.
Fish and Wildlife Service, Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service (Service), propose designation of critical habitat pursuant to the Endangered Species Act of 1973, as amended (Act), for the Topeka shiner (
We will consider all comments on the proposed rule received from interested parties by October 21, 2002. We will hold public meetings in—Manhattan, KS, on September 4, 2002; Bethany, MO, on September 5, 2002; Fort Dodge, IA, on September 9, 2002; Pipestone, MN, on September 10, 2002; Sioux Falls, SD on September 11, 2002; and, Madison, NE, on September 12, 2002. We will start all meetings promptly at 6 p.m. and end them no later than 9 p.m. (
Send your comments on the proposed rule to the Kansas Ecological Services Field Office, U.S. Fish and Wildlife Service, 315 Houston Street, Suite E, Manhattan, KS 66502. The complete file for the proposed rule will be available for public inspection, by appointment, during normal business hours at the above address. Copies of the proposed rule are available by writing to the above address or by connecting to the Service internet web site at “
Vernon Tabor, Kansas Ecological Services Field Office, at the above address; telephone (785) 539-3474, facsimile (785) 539-8567.
The Topeka shiner is a small, stout minnow, not exceeding 75 millimeters (3 inches) in total length. The head is short with a small, moderately oblique mouth. The eye diameter is equal to or slightly longer than the snout. The dorsal fin is large, with the height more than one half the predorsal length of the fish, originating over the leading edge of the pectoral fins. Dorsal and pelvic fins each contain eight rays. The anal and pectoral fins contain 7 and 13 rays respectively, and there are 32 to 37 lateral line scales. Dorsally the body is olivaceous (olive-green), with a distinct dark stripe preceding the dorsal fin. A dusky stripe is exhibited along the entire longitudinal length of the lateral line. The scales above this line are darkly outlined with pigment, appearing cross-hatched. Below the lateral line the body lacks pigment, appearing silvery-white. A distinct chevron-like spot exists at the base of the caudal fin (Cross 1967; Pflieger 1975; U.S. Fish and Wildlife Service 1993).
The Topeka shiner was first described by C.H. Gilbert in 1884, using specimens captured from Shunganunga Creek, Shawnee County, Kansas (Gilbert 1884), a tributary to the Kansas River. The Topeka shiner is 1 of 83 species within the genus
The Topeka shiner is characteristic of small to mid-size prairie streams with relatively high water quality and cool to moderate temperatures. Many of these streams exhibit perennial flow; however, some become intermittent during summer or periods of prolonged drought. At times when surface flows cease, pool levels and moderate water temperatures are maintained by percolation through the streambed or groundwater seepage. The predominant substrate types within these streams are gravel, cobble, and sand; however, bedrock and clay hardpan overlain by a layer of silt are not uncommon (Minckley and Cross 1959). Recently in northern portions of the species' range, the Topeka shiner has been found to exist at some stream sites with degraded water quality and habitat quality, characterized by moderately high turbidity and thick deposits of fine sediments, respectively (Hatch, University of Minnesota, pers. comm. 2000; Berry, South Dakota State University, pers. comm. 2000). At present, it is unknown whether the species utilizes these sites year-round or seasonally, or moves through these areas in an attempt to disperse from core habitat areas.
In the late 1990s, the Topeka shiner was discovered to inhabit a number of off-channel sites in Minnesota and Iowa, primarily cut-off channels and oxbows that are seasonally flooded (Hatch, pers. comm. 1999; Menzel, Iowa State University, pers. comm. 1999). It is speculated that a common factor of these off-channel sites is a connection with the water table, enabling water quality, particularly temperature and dissolved oxygen concentrations, to stay within the tolerance levels of the species during hot, dry periods. It also is suggested that the ground water contact prevents total freeze-out of these pools during winter.
Topeka shiners most often occur in pool and run areas of streams, seldom being found in riffles. They are most often pelagic (living in open water) in nature, occurring in mid-water and surface areas, and are primarily considered a schooling fish. Occasionally individuals of this species have been found in larger streams, downstream of known populations (Cross 1967; Pflieger 1975; Tabor, U.S. Fish and Wildlife Service 1998).
Historically, the Topeka shiner was widespread and abundant throughout small to mid-size streams of the central prairie regions of the United States. The Topeka shiner's historic range includes portions of Iowa, Kansas, Minnesota, Missouri, Nebraska, and South Dakota. Stream basins within the range historically occupied by the Topeka shiner include the Des Moines, Raccoon, Boone, Missouri, Big Sioux, Cedar, Shell Rock, Rock, and Iowa
The Topeka shiner is impacted by habitat destruction, degradation, modification, and fragmentation resulting from siltation, reduced water quality, tributary impoundment, stream channelization, in-stream gravel mining, and changes in stream hydrology. The species also can be impacted by introduced predaceous fishes. Additional information on the biology and status of the Topeka shiner can be found in the December 15, 1998, final listing determination (63 FR 69008). Biological factors relevant to the species' habitat needs are discussed in the Primary Constituent Elements portion of this proposed rule.
In 1990 the Service's Kansas Field Office began a status review of the Topeka shiner using data collected from stream sampling activities and information requested from knowledgeable individuals and agencies, including State fish and wildlife conservation agencies, State health and pollution control agencies, colleges and universities, and other Service offices. The Topeka shiner first received listing consideration when the species was included in the Animal Candidate Review for Listing as Endangered or Threatened Species, as a category 2 candidate species, published in the
We published a proposed rule to list the Topeka shiner as endangered in the
In early 1999, we assembled the Topeka Shiner Recovery Team. The team is composed of species experts from academia and industry, State natural resource agency personnel with knowledge of the species, and Fish and Wildlife Service staff. Seven team meetings were held between 1999 to 2001, with the task of developing a draft recovery plan for the species. The Service is reviewing this draft and hopes its findings can be used as a basis for its proposed recovery plan.
In an April 4, 2001, court settlement of the case,
Critical habitat is defined in section 3(5)(A) of the Act as—(I) the specific areas within the geographic area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features (I) essential to the conservation of the species and (II) that may require special management considerations or protection; and (ii) specific areas outside the geographic area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. The term “conservation,” as defined in section 3(3) of the Act, means “to use and the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to this Act are no longer necessary.”
Critical habitat receives protection under section 7 of the Act through the prohibition against destruction or adverse modification of critical habitat with regard to actions carried out, funded, or authorized by a Federal agency. Section 7 also requires conferences with the Service on Federal actions that are likely to result in the destruction or adverse modification of proposed critical habitat. In our regulations at 50 CFR 402.02, we define destruction or adverse modification as “a direct or indirect alteration that appreciably diminishes the value of critical habitat for both the survival and recovery of a listed species. Such alterations include, but are not limited to, alterations adversely modifying any of those physical or biological features that were the basis for determining the habitat to be critical.” Aside from the added protection that may be provided under section 7, the Act does not provide other forms of protection to lands designated as critical habitat. Because consultation under section 7 of the Act does not apply to activities on private or other non-Federal lands that
To be included in a critical habitat designation, the habitat must first be “essential to the conservation of the species.” Critical habitat designations identify, to the extent known using the best scientific and commercial data available, habitat areas that provide essential life cycle needs of the species (
Section 4 requires that we designate critical habitat at the time of listing and based on what we know at the time of designation. When we designate critical habitat at the time of listing or under short court-ordered deadlines, we will often not have sufficient information to identify all areas of critical habitat. We are required, nevertheless, to make a decision and thus must base our designations on what, at the time of designation, we know to be critical habitat.
In accordance with sections 3(5)(C) of the Act, not all areas that can be occupied by a species will be designated critical habitat. Within the geographic area occupied by the species we designate only areas currently known to be essential. Essential areas should already have the features and habitat characteristics that are necessary to conserve the species. We will not speculate about what areas might be found to be essential if better information becomes available, or what areas may become essential over time. If the information available at the time of designation does not show that an area provides essential life cycle needs of the species, then the area should not be included in the critical habitat designation. We will not designate areas within the geographic area occupied by the species unless at least one of the primary constituent elements, as defined at 50 CFR 424.12(b), is present. Moreover, areas occupied by certain known populations of the Topeka shiner have not been proposed as critical habitat. For example, we did not propose critical habitat for some small scattered populations or habitats in areas highly impacted by human development.
Our regulations state, “The Secretary shall designate as critical habitat areas outside the geographical area presently occupied by a species only when a designation limited to its present range would be inadequate to ensure the conservation of the species” (50 CFR 424.12(e)). Based on the best available science and commercial data, there appears to be no foundation upon which to make a determination that the conservation needs of the Topeka shiner require designation of critical habitat outside of the geographic area occupied by the species, so we have not proposed to designate critical habitat outside of the geographic area believed to be occupied.
Our Policy on Information Standards Under the Endangered Species Act, published in the
Habitat is often dynamic, and species may move from one area to another over time. Furthermore, we recognize designation of critical habitat may not include all habitat eventually determined as necessary to recover the species. For these reasons, all should understand that critical habitat designations do not signal that habitat outside the designation is unimportant or may not be required for recovery. Areas outside the critical habitat designation will continue to be subject to conservation actions that may be implemented under section 7(a)(1) of the Act, and the regulatory protections afforded by the section 7(a)(2) jeopardy standard and the section 9 take prohibition, as determined on the basis of the best available information at the time of the action. Federally funded or assisted projects affecting listed species outside their designated critical habitat areas may still result in likely-to-jeopardize findings in some cases. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans, or other species conservation planning efforts, if new information available to these planning efforts calls for a different outcome.
In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12, in determining which areas to propose as critical habitat we are required to base critical habitat determinations on the best scientific and commercial data available and to consider physical and biological features (primary constituent elements) that are essential to conservation of the species, and that may require special management considerations and protection. These physical and biological features include, but are not limited to—(1) Space for individual and population growth, and for normal behavior; (2) food, water, air, light, minerals, or other nutritional or physiological requirements; (3) cover or shelter; (4) sites for breeding, reproduction, rearing (or development) of offspring; and (5) habitats protected from disturbance or that are representative of the historic geographical and ecological distributions of a species.
The following studies involving the habitat requirements, life history, and population biology of Topeka shiner serve as the best science available in establishing the primary constituent elements listed below—Barber 1986; Blausey 2001; Cross 1967; Cross 1970; Cross and Collins 1975; Cross and Collins 1995; Deacon and Metcalf 1961; Gelwicks and Bruenderman 1996; Hatch 2001; Hatch and Besaw 2001; Katula 1998; Kerns 1983; Leopold et al. 1992; Michels 2000; Michl and Peters 1993; Minckley and Cross 1959; Pflieger 1975; Pflieger 1997; Rosgen 1996; Shranke
Given the large geographic range the species historically occupied, and the varying habitats used by the different life-history stages, describing specific values or conditions for each of these habitat features is not always possible. However, the following discussion summarizes the biological and habitat requirements of the Topeka shiner relevant to identifying the primary constituent elements of its critical habitat.
Topeka shiners are typically found in small, low order, prairie streams with good water quality, relatively cool temperatures, and low fish diversity (Minckley and Cross 1959; Cross 1967; Barber 1986; Cross and Collins 1995; Pflieger 1997; Blausey 2001). Although Topeka shiners can tolerate a range of water temperatures, cooler, spring-maintained systems are considered
In Kansas, Missouri, and South Dakota, Topeka shiners typically occur in streams with clean gravel, cobble, or sand bottoms (Pflieger 1975; Kerns 1983; Barber 1986; Cross and Collins 1995; Pflieger 1997; Blausey 2001). However, bedrock and clay hardpan covered by a thin layer of silt are not uncommon (Minckley and Cross 1959). In western Kansas pools containing Topeka shiners, Stark
Topeka shiners are short-lived species, rarely surviving to their third summer (Minckley and Cross 1959; Cross 1967; Kerns 1983; Cross and Collins 1995; Pflieger 1997; Hatch 2001). The species typically matures at 12-14 months of age (Kerns 1983; Cross and Collins 1995; Pflieger 1997). Based on ovarian development, Hatch (2001) suggested that Topeka shiners are multiple-clutch spawners. Topeka shiners spawn in pool habitats, over green sunfish (
The Topeka shiner is primarily a schooling fish and found throughout the water column. Pflieger (1997) noted that the species schooled with other cyprinids in mid-water or near the surface. Other studies have reported Topeka shiners schooling in the lower portion of the water column with central stonerollers (
Earlier researchers (Kerns 1983, Cross and Collins 1995) reported that Topeka shiners are benthic insectivores that feed primarily on midges (chironomids), true flies (dipterans), and mayflies (ephemeropterans), with zooplankton (cladocerans and copepods) also contributing to their diet. More recent studies have found Topeka shiner feeding at a variety of trophic levels and on diverse foods. Stark
We determine the primary constituent elements associated with critical habitat for Topeka shiner to be:
1. Streams most often with permanent flow, but that can become intermittent during dry periods;
2. Side channel pools and oxbows either seasonally connected to a stream or maintained by groundwater inputs, at a surface elevation equal to or lower than the bank-full discharge stream elevation. The bankfull discharge is the flow at which water begins leaving the channel and flowing into the floodplain; this level is generally attained every 1 to 2 years. Bankfull discharge, while a function of the size of the stream, is a fairly constant feature related to the formation, maintenance, and dimensions of the stream channel;
3. Streams and side channel pools with water quality necessary for unimpaired behavior, growth, and viability of all life stages. The water quality components can vary seasonally and include—temperature (1 to 30°Centigrade), total suspended solids (0 to 2000 ppm), conductivity (100 to 800 mhos), dissolved oxygen (4 ppm or greater), pH (7.0 to 9.0), and other chemical characteristics;
4. Living and spawning areas for adult Topeka shiner with pools or runs with water velocities less than 0.5 meters/second (approx. 20 inches/second) and depths ranging from 0.1 to 2.0 meters (approximately 4 to 80 inches);
5. Living areas for juvenile Topeka shiner with water velocities less than 0.5 meters/second (approx. 20 inches/second) with depths less than 0.25 meters (approx. 10 inches) and moderate amounts of instream aquatic cover, such as woody debris, overhanging terrestrial vegetation, and aquatic plants;
6. Sand, gravel, cobble, and silt substrates with amounts of fine sediment and substrate embeddedness that allows for nest building and maintenance of nests and eggs by native Lepomis sunfishes (green sunfish, orangespotted sunfish, longear sunfish) and Topeka shiner as necessary for reproduction, unimpaired behavior, growth, and viability of all life stages;
7. An adequate terrestrial, semiaquatic, and aquatic invertebrate food base that allows for unimpaired growth, reproduction, and survival of all life stages;
8. A hydrologic regime capable of forming, maintaining, or restoring the flow periodicity, channel morphology, fish community composition, off-channel habitats, and habitat components described in the other primary constituent elements; and
9. Few or no nonnative predatory or competitive nonnative species present.
The areas we are proposing for designation as critical habitat for Topeka shiner provide the above primary constituent elements essential for the conservation of the species. The proposed areas require special management considerations or protection to ensure their contribution to the conservation of the species.
In proposing critical habitat for Topeka shiner, we reviewed the overall approach to the conservation of the species undertaken by local, State, Tribal, and Federal agencies and private individuals and organizations since the species' listing in 1998. We also considered the measures identified as necessary for recovery, as outlined in the species' preliminary draft recovery plan. Additionally, we solicited information and recommendations from knowledgeable biologists and members of the Topeka Shiner Recovery Team. We also reviewed the available information pertaining to habitat requirements of the species received during the listing process.
Due to the need for additional information on the species, its habitats, restoration potential, possible unknown isolated occurrences, and other factors, interim criteria for downlisting and delisting were set forth in a preliminary draft recovery plan now under review by the Service. The recovery team agreed that even though much
Within the geographic area occupied by the species, we are designating only areas currently known to be “essential to the conservation of the species.” Critical habitat should already have, or have the potential for developing in the near future, many or all of the features and habitat characteristics that are necessary to sustain the species. We do not speculate about what areas might be found to be essential if better information were available, or what areas may become essential over time. If information available at the time of designation does not show an area provides essential support for a species at any phase of its life cycle, then the area should not be included in the critical habitat designation. Within the geographic area occupied by the species, we will not designate areas that do not now have the primary constituent elements that provide essential life cycle needs of the species, as defined at 50 CFR 424.12(b). Furthermore, we recognize designation of critical habitat may not include all habitat eventually determined as necessary to recover the species. For these reasons, areas outside the critical habitat designation will continue to be subject to conservation actions that may be implemented under section 7(a)(1) and the regulatory protections afforded by the section 7(a)(2) jeopardy standard and the section 9 take prohibition, as determined on the basis of the best available information at the time of the action. We specifically anticipate that federally funded or assisted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans, or other species conservation planning efforts if new information available to those planning efforts calls for a different outcome.
The proposed critical habitat described below constitutes our best assessment of areas needed for the conservation of Topeka shiner and is based on the best scientific and commercial information available. The proposed areas are essential to the conservation of the species because they currently support populations of Topeka shiner or provide critical links or corridors to other habitat for the species. The stream segments proposed for designation as critical habitat in this proposed rule are consistent with the preliminary draft recovery plan's first recovery criterion, which states that recovery of the species will be recognized as achieved when all naturally occurring populations within primary and secondary recovery units are determined to be stable or increasing over a period of 10 years.
Important considerations in selection of areas proposed in this rule include factors specific to each geographic area, watershed and stream segment, such as stream size and length, connectivity, and habitat diversity, as well as range-wide recovery considerations, such as genetic diversity and representation of major portions of the species' historical range. The proposed critical habitat reflects the need for habitat complexes and individual stream reaches of sufficient size to provide habitat for Topeka shiner populations large enough to be self-sustaining over time, despite fluctuations in local conditions.
Habitat complexes contain interconnected waters so that Topeka shiners can move between areas, at least during certain flows or seasons. The ability of the fish to repopulate areas where they are now depleted or extirpated is vital to the species' conservation. Some complexes may include stream reaches with minimal instream habitat, but which provide migration corridors for Topeka shiners. These corridors play a vital role in the dispersal of the species and the overall functioning of the aquatic ecosystem and, therefore, the integrity of upstream and downstream habitats.
The proposed designation includes representatives of all known populations of the species so as to conserve and protect genetic diversity within the species. Information on the Topeka shiner indicates a high degree of genetic differentiation among many of the remnant populations (Michels 2000), making conservation of as many of these populations as possible important to efforts to preserve genetic diversity.
Uncertainty on upstream and downstream distributional limits of some populations may result in areas of occupied habitat being excluded from the designation. Additionally, there are streams with some recent association with Topeka shiners that may not be proposed for designation. These could include streams with records of one-time captures of Topeka shiner; streams for which habitat conditions are unknown; streams with unprecise, generalized, or questionable capture locations; and streams with severely altered habitat, lacking the primary constituent elements (
Our determination of which stream segments to propose for designation used the best scientific information and data available. We began the process by
Factors considered in determining specific stream segments included—streams with occupancy and habitat information for the species; stream reaches with all or some of the primary constituent elements for Topeka shiners, including those able to attain them in the foreseeable future; habitat models; information on the species' ecology and biology; stream morphology and hydrology information; regional habitat use by the species, such as use of side-channel pools in Iowa, Minnesota, and the Big Sioux drainage in South Dakota; major habitat alterations, such as channelization and dams; and information on the mobility of Topeka shiner in reference to connectivity of adjacent stream reaches, and to home range and dispersal characteristics. Information and suggested changes provided by the individuals and agencies who reviewed the draft maps were carefully considered and implemented where they were consistent with the Service's criteria for designating critical habitat.
The proposed designation includes 186 stream segments, encompassing 3,765.9 kilometers (2,340 miles) of streams, including adjacent off-channel pool habitats in Iowa, Minnesota, and the Big Sioux River watershed of South Dakota. The stream segments are within 11 major watersheds in the States of Iowa, Kansas, Minnesota, Nebraska, and South Dakota. These 186 proposed stream segments encompass 23 stream complexes (2 or more connecting stream segments) and 18 individual, isolated streams. No habitat is proposed for Missouri (see Exclusions from Critical Habitat section below).
Proposed critical habitat includes the stream channels within the identified stream reaches and off-channel pools and oxbows in the Minnesota, Iowa, and the Big Sioux River portion of the South Dakota range. Side channel pools and oxbows that are proposed for designation are typically either seasonally connected to a stream or have waters maintained by groundwater inputs. The defining stream elevation for determining the lateral extent of proposed critical habitat in stream channels and off-channel or oxbow pools is the elevation equal to the bankfull discharge stream elevation. The bankfull discharge is the flow at which water begins leaving the channel and flowing into the floodplain (Rosgen 1996). This level is generally attained every 1 to 2 years (Leopold
We propose the following areas for designation as critical habitat. These areas—(1) Are currently considered occupied or provide critical links or corridors between occupied habitats and/or potentially occupied habitat; (2) provide all or some of the primary constituent elements essential to the conservation of the species; and (3) may require special management considerations or protection. (See the Regulation Promulgation section of this rule for legal descriptions and maps of the boundaries.)
1.
Section 3(5) of the Act defines critical habitat, in part, as areas within the geographical area occupied by the species “on which are found those physical and biological features (I) essential to the conservation of the species and (II) which may require special management considerations and protection.” Special management consideration is not required if adequate management or protection is already in place. Adequate special management consideration or protection is provided by a legally operative plan or agreement that addresses the maintenance and improvement of the primary constituent elements important to the species and manages for the long-term conservation of the species. We use the following three criteria to determine if a plan provides adequate special management or protection—(1) A current plan or agreement must be complete and provide sufficient conservation benefit to the species; (2) the plan must provide assurances that the conservation management strategies will be implemented; and (3) the plan must provide assurances that the conservation management strategies will be effective, (
In Missouri, the Topeka shiner historically occurred in small, headwater streams in northern portions of the State, within the Missouri/Grand River Watershed. This area has been designated as Primary Recovery Unit 5 by the Topeka Shiner Recovery Team in the preliminary Draft Topeka Shiner Recovery Plan. The Topeka shiner has been a focal species for planning and conservation efforts on various levels in the State since the mid-1990s. In 1995, the Missouri Department of Conservation (MDC) established a 5-member Topeka shiner Working Group and a 16-member Advisory Group to direct, implement, and facilitate Topeka shiner recovery actions in Missouri. In 1996, MDC, with approval of the Conservation Commission of Missouri (Conservation Commission), listed the Topeka shiner as an endangered species under the State's Wildlife Code (Conservation Commission of Missouri 2001). In January 1999, MDC adopted and approved an Action Plan for the Topeka shiner (
Within the Missouri/Grand Watershed in Missouri, the following Topeka shiner conservation actions have been completed or are ongoing—(1) Establishment of the Missouri Topeka Shiner Working Group to direct the recovery of the species throughout the State; (2) the development and ongoing implementation of the Action Plan; (3) establishment of permanent sampling sites and standardized monitoring of Missouri's Topeka shiner populations and completion of a recent state-wide survey for the species (Gelwicks and Bruenderman 1996); (4) initiation of artificial propagation of Topeka shiners including the development and refinement of captive rearing techniques that will be applicable across the range of the species; (5) completion of genetic analyses of different populations of Topeka shiners in Missouri; (6) incorporation of Topeka shiner recovery and conservation efforts in State strategic planning documents on several different levels (
Other specific Topeka shiner conservation efforts being undertaken within the Missouri/Grand Watershed in Missouri in accordance with the Action Plan are—(1) Implementation of a landowner incentive program and completion of a study on the potential impacts of Confined Animal Feeding Operations within the Moniteau Creek Watershed; (2) development of 10-year fish monitoring plans for the Moniteau, Bon Femme, and Sugar Creek watersheds; (3) development and implementation of a Sugar Creek sub-basin management plan; (4) development and implementation of a Three Creeks Conservation Area Management Plan within the Bon Femme Creek Watershed; (5) protection and management of Bon Femme Creek by establishing these watersheds as Missouri Department of Natural Resources' Agricultural Non-point Source Pollution Special Area Land Treatment watersheds; and (6) reestablishment or restoration of riparian corridors through tree plantings, natural regeneration, fencing to restrict livestock use of stream banks, creation of alternative livestock watering sources, establishment of warm season grass buffer strips, streambank stabilization activities, and actions outlined in a grazing plan developed for private landowners within the Bon Femme, Moniteau, and Sugar Creek watersheds. Additionally, 10 Missouri Stream Teams formally “adopted” various stretches of occupied Topeka shiner habitat within the Bon Femme, Moniteau, and Sugar Creek watersheds. Stream teams assist in the conservation of the Topeka shiner in these watersheds by promoting local citizen awareness of Topeka shiners and stream health, and by direct involvement with stream cleaning and water quality monitoring activities.
Additional assurances that the Action Plan will be implemented and conservation of the Topeka shiner will be achieved in Missouri is demonstrated by the following actions—(1) To date, at least $105,000 has been expended on recovery actions for the Topeka shiner in Missouri, and is likely to increase to at least $600,000 within the next 10 years; (2) 80 percent (
We evaluated the Action Plan and associated Topeka shiner conservation actions that have been completed, ongoing, or planned in Missouri against our three criteria used to determine whether lands require “special management considerations or protections,” under the definition of critical habitat in section 3 of the Act. The Action Plan clearly provides conservation benefits to the species; the Action Plan provides assurances that conservation efforts will be implemented since MDC has authority to implement the plan, has put in place the funding and staffing necessary to implement the Plan, and has completed or begun work on many significant elements of the Plan; and the Action Plan and efforts of MDC will be effective since they include biological goals, restoration objectives, and monitoring consistent with the preliminary draft
The Fort Riley Military Installation, located in Riley and Geary Counties, Kansas, is primarily an infantry and tank training facility. Fort Riley lies within the Flint Hills Region of Kansas and has several low order streams that drain to the Kansas River. Presently, the Topeka shiner occurs in four streams on Fort Riley—Wildcat Creek and its tributaries, Wind Creek, Little Arkansas Creek, and Sevenmile Creek. These streams are within Primary Recovery Unit 1, as designated by the preliminary draft Topeka Shiner Recovery Plan.
The Topeka shiner has been a focal species for planning and conservation efforts on Fort Riley since the early 1990s, with numerous stream surveys occurring from this time to the present. Development of management guidelines for the species was initialized in 1994. The first Endangered Species Management Plan for Topeka Shiner on Fort Riley was formalized in 1997. This management plan was revised and incorporated into Fort Riley's Integrated Natural Resource Management Plan 2001-2005, which was formalized July 30, 2001 (Keating, Ft. Riley Natural Resources Division, pers. comm. 2002). This management plan outlines and describes—conservation goals; management prescriptions and actions; a monitoring plan; estimates of time, cost, and personnel needed; a checklist of tasks; and an annual report (Department of the Army 2001).
We evaluated the Fort Riley Endangered Species Management Plan for Topeka Shiner and the Fort's associated Topeka shiner conservation actions that have been completed, ongoing, or planned, against our three criteria used to determine whether lands require “special management considerations or protections,” under the definition of critical habitat in section 3 of the Act. This management plan provides conservation benefits to the species; the plan provides assurances that conservation efforts will be implemented; and the plan and efforts of the Army will be effective since they include biological goals, restoration objectives, and monitoring consistent with the draft Recovery Plan. Therefore, we determine that all Topeka shiner areas on Fort Riley do not meet the definition of critical habitat because there is adequate special management or protection, and we did not include them in this proposal.
The vast majority (approximately 98 percent) of proposed critical habitat is in private ownership. Private lands are primarily used for grazing and agriculture, but also include some urban, suburban, and industrial areas. Additionally, there are small, scattered tracts of State and Federal lands.
Designating critical habitat does not, in itself, lead to the recovery of a listed species. The designation does not establish a reserve, create a management plan, establish numerical population goals, prescribe specific management practices (inside or outside of critical habitat), or directly affect areas not designated as critical habitat. Specific management recommendations for areas designated as critical habitat are most appropriately addressed in recovery and conservation plans, and through section 7 consultation and section 10 permits.
However, designation of critical habitat can help focus conservation activities for listed species by identifying areas essential to conserve the species. Designation of critical habitat also alerts the public, as well as land-managing agencies, to the importance of these areas. As a result of critical habitat designation, Federal agencies may be able to prioritize landowner incentive programs such as Conservation Reserve Program enrollment and other private landowner agreements that benefit the Topeka shiner. Critical habitat designation also may assist States and local governments in prioritizing their conservation and land management programs.
The regulatory effects of a critical habitat designation under the Act are triggered through the provisions of section 7, which apply only to activities conducted, authorized, or funded by a Federal agency (Federal actions). Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR 402. Individuals, organizations, States, local governments, and other non-Federal entities are not affected by the designation of critical habitat unless their actions occur on Federal lands, require Federal authorization, or involve Federal funding.
Section 7(a)(2) of the Act requires Federal agencies, including us, to insure that their actions are not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. This requirement is met through section 7 consultation under the Act. Adverse modification might result from alterations that include, but are not limited to, adverse changes to the physical or biological features,
Section 7(a)(4) of the Act requires Federal agencies to confer with us on any action that is likely to result in the destruction or adverse modification of proposed critical habitat. The regulations for interagency cooperation regarding proposed critical habitat are codified at 50 CFR 402.10. During a conference on the effects of a Federal action on proposed critical habitat, we make nonbinding recommendations on ways to minimize or avoid adverse effects of the action. We document these recommendations and any conclusions reached in a conference report provided to the Federal agency and to any applicant involved.
If requested by the Federal agency and deemed appropriate by us, the conference may be conducted in accordance with the procedures for formal consultation under 50 CFR 402.14. We may adopt an opinion issued at the conclusion of the conference as our biological opinion when the critical habitat is designated by final rule, but only if new information or changes to the proposed Federal action would not significantly alter the content of the opinion.
If a Federal action may affect a listed species or its designated critical habitat, the action agency must initiate consultation with us (50 CFR 402.14). Through this consultation, we would advise the agency whether the action would likely jeopardize the continued existence of the species or adversely modify its critical habitat.
When we issue a biological opinion that concludes that an action is likely to result in the destruction or adverse modification of critical habitat, we must provide reasonable and prudent alternatives to the action, if any are identifiable. Reasonable and prudent alternatives are actions identified during consultation that can be implemented in a manner consistent with the intended purpose of the proposed action, are
A Federal agency may request a conference with us for any previously reviewed action that is likely to destroy or adversely modify proposed critical habitat and over which the agency retains discretionary involvement or control, as described above under “Conference for Proposed Critical Habitat.” Following designation of critical habitat, regulations at 50 CFR 402.16 require a Federal agency to reinitiate consultation for previously reviewed actions that may affect critical habitat and over which the agency has retained discretionary involvement or control.
Section 4(b)(8) of the Act requires us to include in any proposed or final regulation that designates critical habitat a description and evaluation of those activities involving a Federal action that may adversely modify such habitat or that may be affected by such designation. A wide range of Federal activities have the potential to destroy or adversely modify critical habitat for the Topeka shiner. These activities may include land and water management actions of Federal agencies (
(1) Significantly and detrimentally altering the minimum flow or the natural flow regime of any of the designated stream segments. Possible actions include groundwater pumping, impoundment, and water diversion. We note that flow reductions that result from actions affecting tributaries of the proposed stream reaches also may destroy or adversely modify critical habitat;
(2) Significantly and detrimentally altering the characteristics of the riparian zone in any of the designated stream segments. Possible actions would include vegetation manipulation, timber harvest, road construction and maintenance, livestock grazing, off-road vehicle use, powerline or pipeline construction and repair, mining, and urban and suburban development;
(3) Significantly and detrimentally altering the channel morphology of any of the stream segments listed above. Possible actions include channelization, impoundment, road and bridge construction, deprivation of substrate source, destruction and alteration of riparian vegetation, reduction of available floodplain, removal of gravel or floodplain terrace materials, reduction in stream flow, and excessive sedimentation from mining, livestock grazing, road construction, timber harvest, off-road vehicle use, and other watershed and floodplain disturbances;
(4) Significantly and detrimentally altering the water chemistry in any of the designated stream segments. Possible actions include release of chemical or biological pollutants into the surface water or connected groundwater at a point source or by dispersed release (non-point); and
(5) Introducing, spreading, or augmenting nonnative aquatic species in any of the designated stream segments. Possible actions include fish stocking for sport, aesthetics, biological control, or other purposes; use of live bait fish; aquaculture; construction and operation of canals; and interbasin water transfers.
Not all of the identified activities are necessarily of current concern within the range of the Topeka shiner; however, they do indicate the potential types of activities that will require consultation in the future and, therefore, may be affected by critical habitat designation. We note that the areas we propose for designation as critical habitat for the Topeka shiner are occupied by the species, and actions that adversely modify critical habitat may also jeopardize the continued existence of the species.
As discussed previously, Federal actions that are found likely to destroy or adversely modify critical habitat may often be modified, through development of reasonable and prudent alternatives, in ways that will remove the likelihood of destruction or adverse modification of critical habitat. Such project modifications may include such things as adjusting the timing of projects to avoid sensitive periods for the species and its habitat; replanting riparian vegetation; minimizing work and vehicle use in the wetted channel; restricting riparian and upland vegetation clearing; fencing to exclude livestock and limit recreational use; use of alternative livestock management techniques; avoidance of pollution; minimizing ground disturbance in the floodplain; use of alternative material sources; storage of equipment and staging of operations outside the floodplain; use of sediment barriers; access restrictions; and use of best management practices to minimize erosion.
If you have questions regarding whether specific activities will likely constitute destruction or adverse modification of critical habitat, contact the Field Supervisor, Kansas Ecological Services Field Office (
A preliminary draft recovery plan for the Topeka shiner has been developed and is undergoing internal review prior to being formally proposed, peer-reviewed by scientists, and published to solicit public comments. The recovery plan, when finalized, will provide recommendations on recovering this species, including recommendations on management of critical habitat. Should the recovery plan recommend adding or deleting areas as critical habitat, we will consider whether a future revision of critical habitat is appropriate.
Section 4(b)(2) of the Act requires us to designate critical habitat on the basis of the best scientific and commercial information available, and to consider the economic and other relevant impacts of designating these areas as critical habitat. We may exclude areas from critical habitat upon a determination that the benefits of such exclusions outweigh the benefits of designating these areas as critical habitat. We cannot exclude areas from critical habitat when the exclusion will result in the extinction of the species. We will conduct an analysis of the economic impacts of designating these areas as critical habitat prior to a final determination. When completed, we will announce the availability of the
In accordance with the Presidential Memorandum of April 29, 1994, we believe that, to the maximum extent possible, tribes should be the governmental entities to manage their lands and tribal trust resources. To this end, we support tribal measures that preclude the need for conservation regulations, and we provide technical assistance to Indian tribes who wish assistance in developing and expanding tribal programs for the management of healthy ecosystems so that Federal conservation regulations, such as designation of critical habitat, on tribal lands are unnecessary. The Presidential Memorandum of April 29, 1994, also requires us to consult with the tribes on matters that affect them, and section 4(b)(2) of the Act requires us to gather information regarding the designation of critical habitat and the effects thereof from all relevant sources, including the tribes.
In examining the geographic extent of areas proposed for designation as critical habitat, we did not identify any tribal trust resources, tribally owned fee lands, or tribal rights that might be affected by the designation. Our South Dakota Field Office corresponded with the Bureau of Indian Affairs (BIA), Great Plains Regional Office, which identified two potentially affected tribes, the Sisseton—Wahpeton Sioux Tribe and the Flandreau Santee Sioux Tribe. The BIA communicated that these tribes do have land held in trust, either by the tribe or individuals, within the general range of the Topeka shiner, but did not provide locality information. We further contacted the tribes. The Sisseton—Wahpeton Sioux Tribe responded with general information on potential Topeka shiner habitat on their tribal lands and requested funding from the Service and the BIA for surveys for the Topeka shiner. However, up to the time of this publication, no maps identifying the location of these trust lands have been provided. Therefore, we are unable to identify any tribal trust lands potentially proposed for designation as critical habitat. We do not anticipate that proposal of critical habitat on non-tribal lands will result in any impact on tribal trust resources or the exercise of tribal rights. In complying with our tribal trust responsibilities, we must communicate with all tribes potentially affected by the designation. Therefore, we are soliciting additional information during the comment period on potential effects to the tribes or tribal resources that may result from critical habitat designation.
We intend for any final action resulting from this proposal to be as accurate and effective as possible. Therefore, we are soliciting comments or suggestions from the public, other concerned governmental agencies, the scientific community, industry, or any other interested party regarding this proposed rule. We particularly seek comments concerning:
(1) The reasons why any habitat should or should not be determined to be critical habitat as provided by section 4 of the Act, including whether the benefits of excluding areas will outweigh the benefits of including areas as critical habitat;
(2) Specific information on the abundance of the Topeka shiner and the amount and distribution of its habitat;
(3) Areas that are essential to the conservation of the species and that may require special management considerations or protection and why;
(4) Land use practices and current or planned activities in the subject areas and their possible impacts on proposed critical habitat;
(5) Any foreseeable economic or other impacts resulting from the proposed designation of critical habitat, in particular, any impacts on small entities or families; and
(6) Economic and other values associated with designating critical habitat for the Topeka shiner, such as those derived from nonconsumptive uses (
Our practice is to make comments that we receive on this rulemaking, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home address from the rulemaking record, which we will honor to the extent allowable by law. In some circumstances, we would withhold from the rulemaking record a respondent's identity, as allowable by law. If you wish for us to withhold your name and/or address, you must state this request prominently at the beginning of your comment. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, including the individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety.
Executive Order 12866 requires each agency to write regulations and notices that are easy to understand. We invite your comments on how to make this proposed rule easier to understand including answers to questions such as the following:
(1) Are the requirements in the document clearly stated?
(2) Does the proposed rule contain technical language or jargon that interferes with the clarity?
(3) Does the format of the proposed rule (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce its clarity?
(4) Is the description of the proposed rule in the
(5) What else could we do to make the proposed rule easier to understand?
Send a copy of any comments that concern how we could make this proposed rule easier to understand to—Office of Regulatory Affairs, Department of the Interior, Room 7229, 1849 C Street, NW., Washington, DC 20240. You also may e-mail comments to
In accordance with our policy published on July 1, 1994 (59 FR 34270), we will seek the expert opinions of at least three appropriate and independent specialists regarding this proposed rule. The purpose of such review is to ensure listing decisions are based on scientifically sound data, assumptions, and analyses. We will
The Act provides for one or more public hearings or meetings on this proposal, if requested. Given the large geographic extent covered by this proposal, we have scheduled six public meetings.
Public meetings will be held at:
1. Manhattan, KS, on September 4, 2002, at the Ramada Inn, Landon Room, 17th and Anderson Avenue;
2. Bethany, MO, on September 5, 2002, at the Bethany Community Center, 105 North 25th Street;
3. Fort Dodge, IA, on September 9, 2002, at the Best Western Starlite Village, 1518 3rd Avenue NW.;
4. Pipestone, MN, on September 10, 2002, at the Pipestone National Monument;
5. Sioux Falls, SD, on September 11, 2002, at the Country Inn and Suites, Riverfront Room, 200 East 8th Street;
6. Madison, NE., on September 12, 2002, at the Shelter House, 300 West 10th Street.
All public meetings will run from 6 p.m. to 9 p.m.
In accordance with Executive Order 12866, this document is a significant rule and was reviewed by the Office of Management and Budget (OMB). The Service is preparing a draft economic analysis of this proposed rule, and will use this analysis to meet the requirement of section 4(b)(2) of the ESA to determine the economic consequences of designating the specific areas as critical habitat and excluding any area from critical habitat if it is determined that the benefits of exclusion outweigh the benefits of specifying such areas as part of the critical habitat, unless failure to designate such areas as critical habitat will lead to the extinction of the Topeka shiner. This analysis will be available for public comment before finalizing this designation. The availability of the draft economic analysis will be announced in the
In the economic analysis, we will determine whether designation of critical habitat will have a significant effect on a substantial number of small entities. As discussed under Regulatory Planning and Review above, this rule is expected to result in few, if any, restrictions in addition to those currently in existence. As indicated on Table 1 (
Within these areas, the types of Federal actions or authorized activities that we have identified as potential concerns are:
(1) Regulation of activities affecting waters of the United States by the Corps under section 404 of the Clean Water Act, and section 10 of the Rivers and Harbors Act;
(2) Regulation of water flows, water delivery, and diversion by Federal agencies;
(3) Sale, exchange, or lease of lands owned by a Federal agency;
(4) Road construction and maintenance and right-of-way designation;
(5) Funding of low-interest loans to facilitate the construction of low-income housing by the Department of Housing and Urban Development;
(6) Hazard mitigation and post-disaster repairs funded by the Federal Emergency Management Agency;
(7) Promulgation of air and water quality standards under the Clean Air Act and the Clean Water Act and the cleanup of toxic waste and superfund sites under the Resource Conservation and Recovery Act and the Comprehensive Environmental Response, Compensation, and Liability Act by the U.S. Environmental Protection Agency;
(8) Issuance of Endangered Species Act section 10(a)(1)(B) permits by the Fish and Wildlife Service; and
(9) Activities funded, carried out, or authorized by any Federal agency.
Many of these activities sponsored by Federal agencies within the proposed critical habitat areas are carried out by small entities (as defined by the Regulatory Flexibility Act) through contract, grant, permit, or other Federal authorization. As discussed above, these actions are currently required to comply with the listing protections of the Act, and the designation of critical habitat is not anticipated to have any additional effects on these activities in areas of critical habitat occupied by the species. In the economic analysis, we will evaluate whether designation of critical habitat will have an effect on activities carried out by small entities.
For actions on non-Federal property that do not have a Federal connection (such as funding or authorization), the current restrictions concerning take of the species remain in effect, and this rule will have no additional restrictions.
In the economic analysis, we will determine whether designation of critical habitat will cause—(a) Any effect on the economy of $100 million or more, (b) any increases in costs or prices for consumers, individual industries, Federal, State, Tribal, or local government agencies, or geographic regions, or (c) any significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.
On May 18, 2001, the President issued an Executive Order (Executive Order 13211) on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. As this proposed rule is not expected to significantly affect energy supplies, distribution, or use, this action is not a significant energy action and no Statement of Energy Effects is required.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
In accordance with Executive Order 12630, this rule does not have significant takings implications, and a takings implication assessment is not required. This determination will not “take” private property and will not alter the long-term value of private property. As discussed above, the designation of critical habitat affects only Federal agency actions. The rule will not increase or decrease the current restrictions on private property concerning take of Topeka shiner as defined in section 9 of the Act and its implementing regulations (50 FR 17.31). Due to current public knowledge of the species' protection, the prohibition against take of Topeka shiner both within and outside of the proposed areas, and the fact that critical habitat
In accordance with Executive Order 13132, the rule does not have significant Federalism effects. A Federalism assessment is not required. In keeping with Department of the Interior policy, the Service requested information from and coordinated development of this critical habitat proposal with appropriate State resource agencies in Iowa, Kansas, Minnesota, Missouri, Nebraska, and South Dakota, as well as during the listing process. We will continue to coordinate any future designation of critical habitat for Topeka shiner with the appropriate State agencies. The designation of critical habitat for the Topeka shiner imposes few additional restrictions to those currently in place and, therefore, has little incremental impact on State and local governments and their activities. The designation may have some benefit to these governments in that the areas essential to the conservation of the species are more clearly defined and the primary constituent elements of the habitat necessary to the conservation of the species are specifically identified. While making this definition and identification does not alter where and what federally sponsored activities may occur, doing so may assist these local governments in long-range planning (rather than waiting for case-by-case section 7 consultations to occur).
In accordance with Executive Order 12988, the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. We are proposing to designate critical habitat in accordance with the provisions of the Act and plan public meetings on the proposed designation during the comment period. The rule uses standard property descriptions and identifies the primary constituent elements within the designated areas to assist the public in understanding the habitat needs of the Topeka shiner.
This rule does not contain any information collection requirements for which OMB approval under the Paperwork Reduction Act is required. Information collections associated with Endangered Species permits are covered by an existing OMB approval and are assigned control number 1018-0094, which expires on July 31, 2004. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number.
Our position is that, outside the Tenth Circuit, we do not need to prepare environmental analyses as defined by the National Environmental Policy Act (NEPA) in connection with designating critical habitat under the Endangered Species Act of 1973, as amended. We published a notice outlining our reasons for this determination in the
In accordance with the President's memorandum of April 29, 1994,
A complete list of all references cited in this proposed rule is available upon request from the Kansas Ecological Services Field Office (
The primary author of this proposed rule is Vernon Tabor, Kansas Ecological Services Field Office (
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations as set forth below:
1. The authority citation for part 17 continues to read as follows:
16 U.S.C. 1361-1407; 16 U.S.C. 1531-1544; 16 U.S.C. 4201-4245; Pub. L. 99-625, 100 Stat. 3500; unless otherwise noted.
2. Amend § 17.11(h), by revising the entry for “Shiner, Topeka” under “FISHES” to read as follows:
(h) * * *
3. Amend § 17.95(e) by adding critical habitat for the Topeka shiner (
(e)
(1) Critical habitat is depicted for Calhoun, Carroll, Dallas, Greene, Hamilton, Lyon, Osceola, Sac, Webster, and Wright Counties, Iowa; Butler, Chase, Dickinson, Geary, Greenwood, Marion, Marshall, Morris, Pottawatomie, Riley, Shawnee, Wabaunsee, and Wallace Counties, Kansas; Lincoln, Murray, Nobles, Pipestone, and Rock Counties, Minnesota; Madison County, Nebraska; Aurora, Beadle, Brookings, Clay, Davison, Deuel, Hamlin, Hanson, Hutchinson, Lincoln, McCook, Miner, Minnehaha, Moody, and Turner Counties, South Dakota, on the maps and as described below.
(2) Critical habitat includes all proposed stream channels up to the bankfull discharge elevation. Additionally, in Iowa, Minnesota, and the Big Sioux River drainage of South Dakota, the off-channel, side-channel, and oxbow pools at elevations at or below the bankfull discharge elevation. Bankfull discharge is the flow at which water begins to leave the channel and move into the floodplain and generally occurs with a frequency of every 1 to 2 years.
(3) Within these areas, the primary constituent elements include, but are not limited to, those habitat components that are essential for the primary biological needs of foraging, sheltering, and reproduction. These elements include the following for Topeka shiner—(1) Streams most often with permanent flow, but that can become intermittent during dry periods; (2) Side channel pools and oxbows either seasonally connected to a stream or maintained by groundwater inputs, at a surface elevation equal to or lower than the bankfull discharge stream elevation. The bankfull discharge is the flow at which water begins leaving the channel and flowing into the floodplain; this level is generally attained every 1 to 2 years. Bankfull discharge, while a function of the size of the stream, is a fairly constant feature related to the formation, maintenance, and dimensions of the stream channel; (3) Streams and side channel pools with water quality necessary for unimpaired behavior, growth, and viability of all life stages. (The water quality components include—temperature, turbidity, conductivity, salinity, dissolved oxygen, pH, chemical contaminants, and other chemical characteristics); (4) Living and spawning areas for adult Topeka shiner with pools or runs with water velocities less than 0.5 meters/second (approx. 20 inches/second) and depths ranging from 0.1-2.0 meters (approx. 4-80 inches); (5) Living areas for juvenile Topeka shiner with water velocities less than 0.5 meters/second (approx. 20 inches/second) with depths less than 0.25 meters (approx. 10 inches) and moderate amounts of instream aquatic cover, such as woody debris, overhanging terrestrial vegetation, and aquatic plants; (6) Sand, gravel, cobble, and silt substrates with amounts of fine sediment and substrate embeddedness that allows for nest building and maintenance of nests and eggs by native
(4) Critical habitat was identified using—the Fifth Principal Meridian in Iowa, Missouri, and Minnesota; the Sixth Principal Meridian in Kansas and Nebraska; U.S. Geological Survey 30*60 minute (1:100,000) quadrangle maps; the National Hydrography Dataset (1:100,000) for hydrology; and Digital Line Graph (1:2,000,000) for county and State boundaries.
(5) Map 1 follows:
1a. Indian Creek from its confluence with the North Raccoon River (T87N, R35W, Sec. 24), upstream through T87N, R35W, Sec. 29.
1b. Tributary to Indian Creek (Ditch 57), from their confluence (T87N, R35W, Sec. 23), upstream to the confluence with the outlet creek from Black Hawk Lake (T86N, R36W, Sec. 1).
1c. Outlet Creek from Black Hawk Lake from its confluence with Ditch 57 (T86N, R36W, Sec. 1), upstream to lake outlet (T87N, R35W, Sec. 35).
2a. Camp Creek from its confluence with the North Raccoon River (T86N, R34W, Sec. 7), upstream through T87N, R34W, Sec. 8.
2b. West Fork Camp Creek from its confluence with Camp Creek (T87N, R34W, Sec. 8), upstream through T88N, R34W, Sec. 32.
3. Prairie Creek from its confluence with the North Raccoon River (T86N, R34W, Sec. 16), upstream through T87N, R34W, Sec. 35.
4. Lake Creek from its confluence with the North Raccoon River (T86N, R34W, Sec. 23), upstream through T87N, R33W, Sec. 25.
5. Purgatory Creek from its confluence with the North Raccoon River (T84N, R33W, Sec. 11), upstream through T86N, R32W, Sec. 17.
6a. Cedar Creek from its confluence with the North Raccoon River (T85N, R32W, Sec. 33), upstream to the confluence of West Cedar Creek and East Cedar Creek (T87N, R31W, Sec. 31).
6b. West Cedar Creek from its confluence with East Cedar Creek (T87N, R31W, Sec. 31), upstream through T87N, R31W, Sec. 18.
6c. East Cedar Creek from its confluence with West Cedar Creek (T87N, R31W, Sec. 31), upstream through T87N, R31W, Sec. 9.
7. Short Creek from its confluence with the North Raccoon River (T84N, R31W, Sec. 33), upstream through T84N, R31W, Sec. 28.
8. Hardin Creek from its confluence with the North Raccoon River (T83N, R30W, Sec. 23), upstream through T85N, R31W, Sec. 27.
9a. Buttrick Creek from its confluence with the North Raccoon River (T83N, R30W, Sec. 26), upstream to the confluence of West Buttrick Creek and East Buttrick Creek (T84N, R30W, Sec. 25).
9b. West Buttrick Creek, from its confluence with East Buttrick Creek (T84N, R30W, Sec. 25), upstream through T86N, R30W, Sec. 3.
9c. East Buttrick Creek, from its confluence with West Buttrick Creek (T84N, R30W, Sec. 25), upstream through T85N, R29W, Sec. 20.
10a. Elm Branch from its confluence with the North Raccoon River (T81N, R28W, Sec. 28), upstream to its confluence with Swan Lake Branch T81N, R28W, Sec. 28.
10b. Swan Lake Branch from its confluence with Elm Branch (T81N, R28W, Sec. 28), upstream through T80N, R28W, Sec. 4.
11. Off-channel and side-channel pools (that meet the previously described criteria) adjacent to the North Raccoon River from U.S. Highway 6 (T79N, R27W, Sec. 32), upstream to U.S. Highway 20 (T88N, R36W, Sec. 24).
(6) Map 2 follows:
12. Eagle Creek from its confluence with the Boone River (T89N, R25W, Sec. 6), upstream through T91N, R25W, Sec. 30.
13a. Ditch 3 from its confluence with the Boone River (T91N, R26W, Sec. 32), upstream through T91N, R26W, Sec. 30.
13b. Ditch 19 from its confluence with Ditch 3 (T91N, R26W, Sec. 31), upstream through T91N, R26W, Sec. 31.
(7) Map 3 follows:
14. Rock River from its confluence with Kanaranzi Creek (T100N, R45W, Sec. 28), upstream to the Iowa/Minnesota State border (T100N, R45W, Sec. 8).
15. Kanaranzi Creek from its confluence with the Rock River (T100N, R45W, Sec. 28), upstream to the Iowa/Minnesota State border (T100N, R45W, Sec. 11).
16. Little Rock River from State Highway 9 (T100N, R43W, Sec. 34), upstream to the Iowa/Minnesota State border (T100N, R42W, Sec. 7).
(8) Map 4 follows:
1a. Fox Creek from U.S. Highway 50 (T19S, R8E, Sec. 17), upstream through T18S, R8E, Sec. 29.
1b. Unnamed tributary to Fox Creek, from their confluence (T18S, R8E, Sec. 32), upstream through T18S, R8E, Sec. 31.
1c. Unnamed tributary to Fox Creek, from their confluence (T18S, R8E, Sec. 29), upstream through T18S, R8E, Sec. 19.
2a. Diamond Creek from U.S. Highway 50 (T19S, R7E, Sec. 14), upstream to its confluence with Sixmile Creek (T17S, R6E, Sec. 21).
2b. Gannon Creek from its confluence with Diamond Creek (T19S, R7E, Sec. 10), upstream through T18S, R7E, Sec. 24; and an unnamed tributary to Gannon Creek, from their confluence (T18S, R7E, Sec. 34), upstream through T18S, R7E, Sec. 14.
2c. Mulvane Creek from its confluence with Diamond Creek (T18S, R7E, Sec. 33), upstream through T18S, R7E, Sec. 16.
2d. Schaffer Creek from its confluence with Diamond Creek (T18S, R7E, Sec. 17), upstream through T17S, R7E, Sec. 33; an unnamed tributary stream from its confluence with Schaffer Creek (T18S, R7E, Sec. 5), upstream through T17S, R7E, Sec. 32; an unnamed tributary stream from its confluence with Schaffer Creek (T18S, R7E, Sec. 5), upstream through T18S, R7E, Sec. 3; an unnamed tributary stream from its confluence with Schaffer Creek (T18S, R7E, Sec. 8), upstream through T18S, R7E, Sec. 4; and an unnamed tributary stream from its confluence with Schaffer Creek (T18S, R7E, Sec. 8), upstream through T18S, R7E, Sec. 8.
2e. Dodds Creek from its confluence with Diamond Creek (T17S, R6E, Sec. 26), upstream through T17S, R6E, Sec. 1.
2f. Sixmile Creek from its confluence with Diamond Creek (T17S, R6E, Sec. 22), upstream to its confluence with Mulberry Creek (T17S, R6E, Sec. 21).
2g. Mulberry Creek from its confluence with Sixmile Creek (T17S, R6E, Sec. 21), upstream through T17S, R6E, Sec. 30; and an unnamed tributary to Mulberry Creek from their confluence (T17S, R6E, Sec. 30), upstream through T17S, R6E, Sec. 30.
2h. Unnamed tributary to the Cottonwood River from their confluence (T19S, R7E, Sec. 12), upstream through T18S, R8E, Sec. 30.
3a. Middle Creek from U.S. Highway 50 (T19S, R7E, Sec. 22), upstream to its confluence with Stribby Creek (T19S, R6E, Sec. 8).
3b. Collett Creek from its confluence with Middle Creek (T19S, R7E, Sec. 18), upstream through T18S, R6E, Sec. 26).
3c. Unnamed tributary to Middle Creek, from their confluence (T19S, R6E, Sec. 10), upstream through T18S, R6E, Sec. 33); and an unnamed tributary to the first tributary, from their confluence, upstream through T18S, R6E, Sec. 34.
4a. South Fork from its confluence with the Cottonwood River (T19S, R8E, Sec. 25), upstream through T23S, R8E, Sec. 21.
4b. Sharpes Creek from its confluence with the South Fork (T20S, R8E, Sec. 34), upstream through T21S, R8E, Sec. 36.
4c. Rock Creek from its confluence with the South Fork (T20S, R8E, Sec. 33), upstream through T21S, R7E, Sec. 14.
4d. Den Creek from its confluence with Rock Creek (T20S, R8E, Sec. 31), upstream through T20S, R8E, Sec. 30.
4e. Crocker Creek from its confluence with the South Fork (T21S, R8E, Sec. 31), upstream through T22S, R7E, Sec. 1.
4f. Unnamed tributary to Crocker Creek from their confluence (T21S, R8E, Sec. 31), upstream through T21S, R8E, Sec. 31.
4g. Mercer Creek from its confluence with the South Fork (T22S, R8E, Sec. 8), upstream through T22S, R8E, Sec. 31.
4h. Jack Creek from its confluence with Mercer Creek (T22S, R8E, Sec. 18), upstream through T22S, R7E, Sec. 14.
4i. Unnamed tributary to Mercer Creek, from their confluence (T22S, R8E, Sec. 19), upstream through T22S, R7E, Sec. 26.
4j. Unnamed tributary to Mercer Creek, from their confluence (T22S, R8E, Sec. 19), upstream through T22S, R8E, Sec. 31.
4k. Thurman Creek from its confluence with the South Fork (T22S, R8E, Sec. 29), upstream through T23S, R9E, Sec. 17.
4l. Unnamed tributary to Thurman Creek, from their confluence (T23S, R8E, Sec. 1), upstream through T22S, R9E, Sec. 31.
4m. Little Cedar Creek from its confluence with the South Fork (T22S, R8E, Sec. 8), upstream through T22S, R8E, Sec. 25.
4n. Shaw Creek from its confluence with Little Cedar Creek (T22S, R8E, Sec. 16), upstream through T22S, R8E, Sec. 14.
4o. Bloody Creek from its confluence with the Cottonwood River (T19S, R9E, Sec. 29), upstream through T20S, R9E, Sec. 34.
5. Mud Creek from the south section line of T19S, R3E, Sec. 13, upstream through T18S, R3E, Sec. 28.
(9) Map 5 follows:
6a. Mill Creek from Kansas Highway 30 (T11S, R12E, Sec. 26), upstream to the confluence of West Branch Mill Creek and South Branch Mill Creek (T12S, R10E, Sec. 15).
6b. Mulberry Creek from its confluence with Mill Creek (T11S, R11E, Sec. 25), upstream through T11S, R11E, Sec. 10.
6c. Spring Creek from its confluence with Mill Creek (T11S, R11E, Sec. 28), upstream through T11S, R11E, Sec. 21.
6d. Kuenzli Creek from its confluence with Mill Creek (T11S, R11E, Sec. 33), upstream through T12S, R11E, Sec. 21.
6e. Paw Paw Creek from its confluence with Mill Creek (T11S, R11E, Sec. 31), upstream through T11S, R10E, Sec. 13.
6f. Pretty Creek from its confluence with Mill Creek (T11S, R10E, Sec. 36), upstream to Kansas Highway 99 (T11S, R10E, Sec. 22).
6g. Hendricks Creek from its confluence with Mill Creek (T12S, R10E, Sec. 2), upstream through T11S, R10E, Sec. 31.
6h. West Branch Mill Creek from its confluence with South Branch Mill Creek (T12S, R10E, Sec. 15), upstream through T13S, R9E, Sec. 20.
6i. Loire Creek from its confluence with West Branch Mill Creek (T12S, R10E, Sec. 29), upstream through T12S, R9E, Sec. 11.
6j. Illinois Creek from its confluence with West Branch Mill Creek (T12S, R10E, Sec. 30), upstream through T13S, R9E, Sec. 11.
6k. Spring Creek from its confluence with West Branch Mill Creek (T12S, R10E, Sec. 30), upstream through T12S, R9E, Sec. 21.
6l. South Branch Mill Creek from its confluence with West Branch Mill Creek (T12S, R10E, Sec. 15), upstream to Kansas Highway 4/99 (T13S, R10E, Sec. 26).
6m. East Branch Mill Creek from its confluence with South Branch Mill Creek (T12S, R10E, Sec. 35), upstream through T13S, R11E, Sec. 22.
6n. Nehring Creek from its confluence with East Branch Mill Creek (T13S, R10E, Sec. 1), upstream through T13S, R11E, Sec. 15.
7. Mission Creek from Interstate Highway 70 (T11S, R14E, Sec. 33), upstream to the confluence of North Branch Mission Creek and South Branch Mission Creek (T13S, R12E, Sec. 1).
8a. Deep Creek from Kansas Highway 18 (T10S, R9E, Sec. 26), upstream to Interstate Highway 70 (T11S, R8E, Sec. 26).
8b. School Creek from its confluence with Deep Creek (T11S, R9E, Sec. 6), upstream through T11S, R8E, Sec. 2.
9a. Wildcat Creek from Kansas Highway 18/Ft. Riley Boulevard (T10S, R7E, Sec. 24), upstream to the Ft. Riley boundary near Keats, Kansas (T10S, R6E, Sec. 1).
9b. Wildcat Creek from the Ft. Riley boundary near Riley, Kansas (T9S, R5E, Sec. 12), upstream to U.S. Highway 77 (T9S, R5E, Sec. 3).
10a. Clarks Creek from its confluence with Humboldt Creek (T11S, R6E, Sec. 35), upstream to its confluence with Thomas Creek (T12S, R6E, Sec. 34).
10b. Thomas Creek from its confluence with Clarks Creek (T12S, R6E, Sec. 34), upstream through T13S, R6E, Sec. 34.
10c. Davis Creek from its confluence with Thomas Creek (T13S, R6E, Sec. 2), upstream through T13S, R7E, Sec. 31.
10d. Dry Creek from its confluence with Clarks Creek (T12S, R6E, Sec. 23), upstream through T13S, R7E, Sec. 22.
10e. West Branch Dry Creek from its confluence with Dry Creek (T13S, R7E, Sec. 16), upstream through T13S, R7E, Sec. 21.
11a. Lyon Creek from U.S. Highway 77 (T13S, R5E, Sec. 3), upstream to the confluence with West Branch Lyon Creek (T15S, R4E, Sec. 2).
11b. Rock Springs Creek from its confluence with Lyon Creek (T13S, R5E, Sec. 3), upstream through T14S, R5E, Sec. 5.
11c. Carry Creek from its confluence with Lyon Creek (T13S, R5E, Sec. 31), upstream through T15S, R3E, Sec. 10.
11d. Unnamed tributary to Carry Creek from their confluence (T14S, R4E, Sec. 19), upstream through T14S, R3E, Sec. 24.
11e. West Branch Lyon Creek from its confluence with Lyon Creek (T15S, R4E, Sec. 2), upstream through T15S, R3E, Sec. 25.
(10) Map 6 follows:
12. Walnut Creek from the east section line of T7S, R6E, Sec. 19, upstream through T8S, R5E, Sec. 1.
13. Clear Fork Creek from its confluence with Jim Creek (T5S, R9E, Sec. 17), upstream through T6S, R10E, Sec. 18.
14. North Elm Creek from its confluence with the Big Blue River (T1S, R7E, Sec. 11), upstream through T1S, R8E, Sec. 21.
(11) Map 7 follows:
15. Willow Creek from its confluence with the Smoky Hill River (T13S, R41W, Sec. 17), upstream through T13S, R42W, Sec. 3.
(12) Map 8 follows:
1a. Medary Creek from the MN/SD state border (T109N, R47W, Sec. 13), upstream through T110N, R46W, Sec. 21.
1b. Unnamed tributary to Medary Creek, from their confluence (T109N, R46W, Sec. 18), upstream through T110N, R46W, Sec. 30.
2a. Flandreau Creek from the Minnesota/South Dakota State border (T107N, R47W, Sec. 13), upstream through (T109N, R45W, Sec. 31).
2b. Unnamed tributary to Flandreau Creek, from their confluence (T108N, R46W, Sec. 11), upstream through T108N, R45W, Sec. 6.
2c. East Branch Flandreau Creek from its confluence with Flandreau Creek (T108N, R46W, Sec. 14), upstream through T108N, R45W, Sec. 4.
2d. Willow Creek from its confluence with Flandreau Creek (T107N, R46W, Sec. 6), upstream through T109N, R46W, Sec. 3.
3a. Pipestone Creek from the Minnesota/South Dakota State border (T106N, R47W, Sec. 23), upstream through T106N, R46W, Sec. 1.
3b. Unnamed tributary to Pipestone Creek, from their confluence (T106N, R47W, Sec. 24), upstream through T106N, R46W, Sec. 19.
3c. Unnamed tributary to Pipestone Creek, from the Minnesota/South Dakota State border (T105N, R47W, Sec. 2), upstream through T105N, R46W, Sec. 1.
3d. North Branch Pipestone Creek from its confluence with Pipestone Creek (T107N, R46W, Sec. 5), upstream through T108N, R45W, Sec. 23.
3e. Unnamed tributary to North Branch Pipestone Creek, from their confluence (T108N, R45W, Sec. 22), upstream through T108N, R45W, Sec. 15.
3f. Split Rock Creek from the Minnesota/South Dakota State border (T103N, R47W, Sec. 2), upstream to Split Rock Lake Outlet (T105N, R46W, Sec. 20).
3g. Unnamed tributary to Split Rock Creek from the Minnesota/South Dakota State border (T103N, R47W, Sec. 23), upstream through T103N, R46W, Sec. 29.
3h. Unnamed tributary to Split Rock Creek, from their confluence (T103N, R47W, Sec. 2), upstream through T103N, R46W, Sec. 8.
3i. Unnamed tributary to Split Rock Creek, from their confluence (T104N, R47W, Sec. 25), upstream through T104N, R46W, Sec. 19.
3j. Pipestone Creek from its confluence with Split Rock Creek (T104N, R47W, Sec. 23), upstream to the Minnesota/South Dakota State border (T104N, R47W, Sec. 23).
3k. Unnamed tributary to Split Rock Creek, from their confluence (T104N, R46W, Sec. 6), upstream through T105N, R46W, Sec. 36.
3l. Split Rock Creek from the headwater of Split Rock Lake (T105N, R46W, Sec. 15), upstream through T106N, R46W, Sec. 35.
3m. Unnamed tributary to Split Rock Creek, from their confluence (T105N, R46W, Sec. 3), upstream through T105N, R46W, Sec. 2.
3n. Beaver Creek from the Minnesota/South Dakota State border (T102N, R47W, Sec. 35), upstream through T104N, R45W, Sec. 20.
3o. Springwater Creek from its confluence with Beaver Creek (T102N, R47W, Sec. 35), upstream through T102N, R46W, Sec. 6.
3p. Little Beaver Creek from its confluence with Beaver Creek (T102N, R46W, Sec. 12), upstream through T103N, R45W, Sec. 9.
3q. Unnamed tributary to Beaver Creek, from their confluence (T102N, R46W, Sec. 1), upstream through T103N, R46W, Sec. 35.
3r. Unnamed tributary to Beaver Creek, from their confluence (T103N, R45W, Sec. 18), upstream through T104N, R46W, Sec. 36.
4a. Rock River from the Minnesota/Iowa State border (T101N, R45W, Sec. 36), upstream through T107N, R44W, Sec. 7.
4b. Kanaranzi Creek from the Minnesota/Iowa State border (T101N, R44W, Sec. 33), upstream through T103N, R42W, Sec. 7).
4c. Norwegian Creek from its confluence with Kanaranzi Creek (T101N, R44W, Sec. 25), upstream through T101N, R43W, Sec. 21.
4d. Unnamed tributary to Norwegian Creek, from their confluence (T101N, R44W, Sec. 20), upstream through T101N, R44W, Sec. 16.
4e. East Branch Kanaranzi Creek from its confluence with Kanaranzi Creek (T102N, R42W, Sec. 5), upstream through T102N, R41W, Sec. 5.
4f. Unnamed tributary to East Branch Kanaranzi Creek, from their confluence (T102N, R42W, Sec. 9), upstream through T102N, R42W, Sec. 22.
4g. Unnamed tributary to East Branch Kanaranzi Creek, from their confluence (T102N, R42W, Sec. 5), upstream through T102N, R42W, Sec. 5.
4h. Unnamed tributary to Kanaranzi Creek, from their confluence (T102N, R43W, Sec. 31), upstream through T102N, R43W, Sec. 27.
4i. Ash Creek from its confluence with the Rock River (T101N, R45W, Sec. 24), upstream through T101N, R45W, Sec. 14.
4j. Elk Creek from its confluence with the Rock River (T102N, R45W, Sec. 36), upstream through T103N, R43W, Sec. 22.
4k. Unnamed tributary to Elk Creek, from their confluence (T102N, R44W, Sec. 1), upstream through T102N, R43W, Sec. 6.
4l. Champepadan Creek from its confluence with the Rock River (T103N, R44W, Sec. 29), upstream through T104N, R43W, Sec. 14.
4m. Unnamed tributary to Champepadan Creek, from their confluence (T104N, R43W, Sec. 14), upstream through T104N, R43W, Sec. 13.
4n. Unnamed tributary to Champepadan Creek, from their confluence (T103N, R44W, Sec. 23), upstream through T103N, R44W, Sec. 24.
4o. Unnamed tributary to Champepadan Creek, from their confluence (T103N, R44W, Sec. 23), upstream through T103N, R44W, Sec. 12.
4p. Unnamed tributary to the Rock River, from their confluence (T103N, R44W, Sec. 8), upstream through T104N, R44W, Sec. 26.
4q. Mound Creek from its confluence with the Rock River (T103N, R44W, Sec. 30), upstream through T104N, R45W, Sec. 35).
4r. Unnamed tributary to the Rock River, from their confluence (T103N, R44W, Sec. 7), upstream through T104N, R45W, Sec. 23.
4s. Unnamed tributary to the Rock River, from their confluence (T104N, R44W, Sec. 28), upstream through T104N, R44W, Sec. 11.
4t. Unnamed tributary to the Rock River, from their confluence (T104N, R44W, Sec. 16), upstream through T104N, R44W, Sec. 10.
4u. Poplar Creek from its confluence with the Rock River (T104N, R44W, Sec. 5), upstream through T105N, R45W, Sec. 32.
4v. Unnamed tributary to Poplar Creek, from their confluence (T105N, R45W, Sec. 27, upstream through T105N, R45W, Sec. 9.
4w. Chanarambie Creek from its confluence with the Rock River (T105N, R44W, Sec. 33), upstream through (T105N, R42W, Sec. 8).
4x. North Branch Chanarambie Creek from its confluence with Chanarambie
4y. Unnamed tributary to the Rock River, from their confluence (T105N, R44W, Sec. 8), upstream through T106N, R45W, Sec. 36.
4z. Unnamed tributary to the Rock River, from their confluence (T106N, R44W, Sec. 33), upstream through T106N, R44W, Sec. 23.
4aa. East Branch Rock River from its confluence with the Rock River (T106N, R44W, Sec. 18), upstream through T107N, R44W, Sec. 27.
4bb. Unnamed tributary to East Branch Rock River, from their confluence (T107N, R44W, Sec. 34), upstream through T107N, R44W, Sec. 35.
5a. Little Rock River from the Minnesota/Iowa State border (T101N, R42W, Sec. 35), upstream through T102N, R41W, Sec. 27.
5b. Little Rock Creek from its confluence with the Little Rock River (T101N, R42W, Sec. 26), upstream through T102N, R42W, Sec. 34.
6a. Mud Creek from the Minnesota/Iowa State border (T102N, R46W, Sec. 34), upstream thru T101N, R46W, Sec. 11.
6b. Unnamed tributary to Mud Creek, from their confluence (T101N, R46W, Sec. 22), upstream through T101N, R46W, Sec. 24.
6c. Unnamed tributary to Mud Creek, from their confluence (T101N, R46W, Sec. 10), upstream through T101N, R46W, Sec. 1.
(13) Map 9 follows:
1. Taylor Creek from its confluence with Union Creek (T22N, R1W, Sec. 32), upstream through T22N, R2W, Sec. 22.
(14) Map 10 follows:
1. Hidewood Creek from its confluence with the Big Sioux River (T113N, R51W, Sec. 15), upstream to State Highway 15 (T115N, R49W, Sec. 35).
2. Peg Munky Run from State Highway 28 (T113N, R50W, Sec. 20), upstream through T113N, R50W, Sec. 24 (near Interstate Highway 29).
3a. Sixmile Creek from T110N, R50W, Sec. 33, upstream through T112N, R48W, Sec. 19.
3b. Unnamed tributary to Sixmile Creek, from their confluence (T112N, R48W, Sec. 31), upstream through T112N, R48W, Sec. 33.
4a. Medary Creek from its confluence with the Big Sioux River (T108N, R49W, Sec. 6), upstream to the SD/MN state border (T109N, R47W, Sec. 15).
4b. Deer Creek from its confluence with Medary Creek (T109N, R49W, Sec. 16), upstream through T111N, R47W, Sec. 30.
4c. Unnamed tributary to Deer Creek, from their confluence (T111N, R48W, Sec. 35), upstream through T111N, R48W, Sec. 11.
(15) Map 11 follows:
5. Spring Creek from its confluence with the Big Sioux River (T107N, R48W, Sec. 5), upstream to the South Dakota/Minnesota State border (T109N, R47W, Sec. 34).
6. Flandreau Creek from its confluence with the Big Sioux River (T107N, R48W, Sec. 23), upstream to the South Dakota/Minnesota State border (T107N, R47W, Sec. 15).
7. Brookfield Creek from its confluence with the Big Sioux River (T105N, R49W, Sec. 24), upstream through T106N, R48W, Sec. 28.
8. Slip-Up Creek from it confluence with the Big Sioux River (T102N, R49W, Sec. 36), upstream through T103N, R48W, Sec. 6.
9a. Split Rock Creek from its confluence with the Big Sioux River (T101N, R48W, Sec. 16), upstream to the South Dakota/Minnesota State border (T103N, R47W, Sec. 3).
9b. Pipestone Creek from the South Dakota/Minnesota State border (T104N, R47W, Sec. 22), upstream to the SD/MN state border (T106N, R47W, Sec. 22).
9c. Unnamed tributary to Pipestone Creek, from their confluence (T105N, R47W, Sec. 9), upstream to the South Dakota/Minnesota State border (T105N, R47W, Sec. 3).
9d. Unnamed tributary to Split Rock Creek, from their confluence (T103N, R47W, Sec. 17), upstream to the South Dakota/Minnesota State border (T103N, R47W, Sec. 22).
9e. West Pipestone Creek from its confluence with Split Rock Creek (T102N, R48W, Sec. 11), upstream through T104N, R48W, Sec. 3.
9f. Beaver Creek from its confluence with Split Rock Creek (T101N, R48W, Sec. 10), upstream to the South Dakota/Minnesota State border (T102N, R47W, Sec. 34).
9g. Fourmile Creek from its confluence with Beaver Creek (T101N, R48W, Sec. 13), upstream to the South Dakota/Minnesota State border (T101N, R47W, Sec. 15).
(16) Map 12 follows:
10a. Vermillion River from the southeast corner of T94N, R52W, Sec. 14, upstream to the confluence of West Fork Vermillion River and East Fork Vermillion River (T99N, R53W, Sec. 14).
10b. East Fork Vermillion River, from its confluence with the West Fork Vermillion River (T99N, R53W, Sec. 14), upstream to East Vermillion Lake Dam (T102N, R53W, Sec. 34).
10c. West Fork Vermillion River, from its confluence with the East Fork Vermillion River (T99N, R53W, Sec. 14), upstream through T105N, R56W, Sec. 1.
10d. Silver Lake Creek from its confluence with the West Fork Vermillion River (T100N, R55W, Sec. 10), upstream to the Silver Lake outlet (T100N, R55W, Sec. 30).
10e. Camp Creek from its confluence with the Vermillion River (T99N, R52W, Sec. 32), upstream through T99N, R52W, Sec. 7.
10f. Turkey Ridge Creek from its confluence with the Vermillion River (T96N, R52W, Sec. 28), upstream through T98N, R54W, Sec. 31.
10g. Long Creek from its confluence with the Vermillion River (T97N, R51W, Sec. 31), upstream through T99N, R52W, Sec. 3.
10h. Saddle Creek from its confluence with Long Creek (T97N, R51W, Sec. 20), upstream through T97N, R50W, Sec. 18.
10i. Blind Creek from its confluence with the Vermillion River (T95N, R52W, Sec. 11), upstream through T96N, R51W, Sec. 26.
(17) Map 13 follows:
11a. Lonetree Creek from its confluence with the James River (T97N, R58W, Sec. 14), upstream to its confluence with South Branch Lonetree Creek (T97N, R58W, Sec. 10).
11b. South Branch Lonetree Creek from its confluence with Lonetree Creek (T97N, R58W, Sec. 10), upstream through T97N, R59W, Sec. 23.
12a. Dry Creek from its confluence with the James River (T99N, R59W, Sec. 11), upstream through T98N, R59W, Sec. 9.
12b. North Branch Dry Creek from its confluence with Dry Creek (T99N, R59W, Sec. 28), upstream through T99N, R61W, Sec. 27.
13. Wolf Creek from its confluence with the James River (T99N, R57W, Sec. 31), upstream through T99N, R57W, Sec. 4.
14. Twelvemile Creek from its confluence with the James River (T99N, R59W, Sec. 3), upstream through T101N, R61W, Sec. 23.
15. Enemy Creek from its confluence with the James River (T102N, R59W, Sec. 15), upstream through T102N, R61W, Sec.19.
16. Rock Creek from its confluence with the James River (T103N, R60W, Sec. 13), upstream through T106N, R57W, Sec. 34.
17a. Firesteel Creek from the east section line of T104N, R61W, Sec. 36, upstream to the confluence with West Branch Firesteel Creek (T104N, R62W, Sec. 30).
17b. West Branch Firesteel Creek from its confluence with Firesteel Creek (T104N, R62W, Sec. 30), upstream to Wilmarth Lake outlet (T105N, R64W, Sec. 31).
(18) Map 14 follows:
18a. Pearl Creek from its confluence with the James River (T109N, R61W, Sec. 15), upstream through T112N, R59W, Sec. 16.
18b. Middle Pearl Creek from its confluence with Pearl Creek (T109N, R60W, Sec. 4), upstream through T110N, R59W, Sec. 14.
19. Shue Creek from its confluence with the James River (T111N, R61W, Sec. 11), upstream to Staum Dam (T113N, R59W, Sec. 14).
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Proposed rule.
This proposed rule would amend HUD's regulations for the Section 203(k) Rehabilitation Loan Insurance Program (203(k) Program). The 203(k) Program is the Federal Housing Administration's (FHA's) primary program for the rehabilitation and repair of single family properties. First, the proposed rule would limit 203(k) rehabilitation loan insurance to one-unit structures. The proposed rule would also establish a cap on the total cost of rehabilitation. The dollar amount of the rehabilitation could not exceed 20 percent of the FHA statutory single family mortgage limit for a one-unit structure in a “high cost area.” These changes would simplify the 203(k) Program for both lenders and homebuyers, and strengthen HUD's capacity to safeguard the FHA Insurance Fund.
Interested persons are invited to submit comments regarding this proposed rule to the Regulations Division, Office of General Counsel, Room 10276, Department of Housing and Urban Development, 451 Seventh Street, SW, Washington, DC 20410-0500. Communications should refer to the above docket number and title. Facsimile (FAX) comments are not acceptable. A copy of each communication submitted will be available for public inspection and copying between 7:30 a.m. and 5:30 p.m. weekdays at the above address.
Vance T. Morris, Director, Office of Single Family Program Development, Room 9266, U.S. Department of Housing and Urban Development, 451 Seventh Street, SW, Washington, DC 20410-8000; telephone (202) 708-2121 (this is not a toll-free number). Hearing- or speech-impaired individuals may access this number via TTY by calling the toll-free Federal Information Relay Service at (800) 877-8339.
Section 203(k) of the National Housing Act (12 U.S.C. 1709(k)) authorizes HUD to insure loans for the purchase and/or rehabilitation and repair of residential properties. The 203(k) Program is HUD's primary program for the rehabilitation and repair of single family properties. Section 203(k) loan insurance enables homebuyers and homeowners to finance both the purchase (or refinance) of a house and the cost of its rehabilitation through a single mortgage. The regulations implementing the 203(k) Program are located in 24 CFR 203.50 and 24 CFR 203.440 through 203.495. HUD's Office of Housing—Federal Housing Administration (FHA) administers the Program.
The 203(k) Program fills a unique and important role for homebuyers. In the conventional loan market, a homebuyer who purchases a home that is in need of repair or modernization usually has to follow a time-consuming and costly process. The homebuyer must obtain financing to purchase the dwelling, additional financing for the rehabilitation work, and a permanent mortgage after rehabilitation is completed to pay off the interim loans. The interim acquisition and improvement loans often have relatively high interest rates and short repayment terms. The 203(k) Program was designed to address this situation. Under this program, a homebuyer may obtain a single loan, at a long-term fixed (or variable) rate, to finance both the acquisition and rehabilitation of the property.
The extent of the rehabilitation covered by 203(k) loan insurance may range from relatively minor (though a minimum of $5,000 in cost is required) to virtual reconstruction. For example, a home that has been demolished, or will be razed as part of rehabilitation, is eligible provided that some of the existing foundation system remains in place. Section 203(k) loan insurance can also finance the rehabilitation of the residential portion of a property that has non-residential uses.
This proposed rule would make two amendments to HUD's regulations for the 203(k) Program. Specifically, the proposed rule would: (1) Limit 203(k) rehabilitation loan insurance to one-unit structures; and (2) establish a cap on the total cost of the rehabilitation. These changes would simplify the program for both lenders and homebuyers, and strengthen HUD's capacity to safeguard the FHA Insurance Fund. This section of the preamble describes the proposed changes to the 203(k) Program.
Under HUD's regulations at § 203.50(a), the 203(k) Program may be used for the rehabilitation of a one- to four-unit structure that will be used primarily for residential purposes. In addition to typical home rehabilitation projects, this program can be used to convert a one-unit structure to a two-, three-, or four-unit structure. An existing multi-unit structure can be decreased to a one- to four-unit structure. However, the regulations also require that rehabilitation loan transactions must constitute an acceptable risk, as determined by the Secretary of HUD (see § 203.50(e)).
FHA statistics show that over the past eleven years, the 203(k) Program has experienced unacceptably high default rates for multi-unit (
Another possible reason for the excessive claim and default rates is that the program is complex for both lenders and homebuyers, especially first time homebuyers. Since the 203(k) Program is used for rehabilitation of a property, financing under the program involves the use of contractors, consultants, engineers, and paperwork not required under other FHA insurance programs.
One method for reducing the complexity of the 203(k) Program is to limit the dollar amount of the rehabilitation. Currently, there is no such restriction, although the cost of the rehabilitation must be $5,000 or greater and the overall loan amount may not exceed the limits prescribed in § 203.50(f). This proposed rule would provide that the total cost of the rehabilitation may not exceed 20 percent of the FHA statutory single family mortgage limit for a one-unit structure in a “high cost area,” irrespective of location. The FHA mortgage limits are established by HUD pursuant to section 203(b)(2)(A) of the National Housing Act (12 U.S.C. 1709(b)(2)(A)). HUD announces these mortgage limits annually through a Mortgagee Letter, typically in late December for effect on January 1st of the following year. The most recent single family mortgage limits are set forth in Mortgagee Letter 01-31, issued on December 28, 2001. A copy of the Mortgagee Letter may be obtained through the HUD Web site at
The proposed cap would only include costs related to the actual rehabilitation of the property and would not include costs such as consultant fees, supplemental origination fees, the costs of preparing architectural exhibits, and contingency fees. Additionally, the cap would also exclude: (1) Rehabilitation costs incurred to improve the energy efficiency standards of the home; and (2) six months of mortgage payments.
The Office of Management and Budget (OMB) reviewed this rule under Executive Order 12866,
A Finding of No Significant Impact with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4223). The Finding of No Significant Impact is available for public inspection between the hours of 7:30 a.m. and 5:30 p.m. weekdays in the office of the Department's Rules Docket Clerk, Office of General Counsel, Room 10276, Department of Housing and Urban Development, 451 Seventh Street, SW, Washington, DC 20410-0500.
The Secretary has reviewed this proposed rule before publication and by approving it certifies, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), that this proposed rule would not have a significant economic impact on a substantial number of small entities. The reasons for HUD's determination are as follows.
First, the proposed rule would limit 203(k) rehabilitation loan insurance to one-unit structures. Over the last eleven years, approximately 80 percent of all 203(k) loans have been made for single unit structures. Accordingly, the economic impact on small lenders of limiting the program to one-unit structures would not be significant in comparison to the total number of 203(k) loans made. In addition, although 203(k) loan insurance would no longer be available for the rehabilitation of multi-unit structures, there are other FHA mortgage insurance products that can be used for the rehabilitation of such structures. For example, FHA's Title I program can be used to improve a multi-unit structure after purchase. Nothing in this proposed rule would preclude lenders participating in the FHA programs from offering such alternate mortgage insurance products.
The proposed rule would also cap the total cost of rehabilitation to 20 percent of the HUD single family mortgage limit for a one-unit structure in a “high cost area.” As noted above in this preamble, the average amount of rehabilitation on a 203(k) loan in Fiscal Years 1999 and 2000 was approximately $29,000. Accordingly, HUD believes that the proposed rehabilitation cap of $52,321 is appropriate to prevent the 203(k) Program from being used for overly complicated and expensive work, while continuing to serve the program's primary customer—homebuyers purchasing a one-unit structure in need of moderate rehabilitation.
Finally, as the HUD mortgage limits increase each year, the dollar amount of the proposed cap will also rise. For example, the FHA statutory single family mortgage limit for a one-unit structure in a high-cost area rose over 9 percent from 2001 ($239,250) to 2002 ($261,609).
HUD has taken other steps to help ensure that the proposed cap does not impose a substantial economic burden on either 203(k) lenders or borrowers. For example, the proposed cap would only include costs related to the actual rehabilitation of the property and would not include costs such as consultant fees, supplemental origination fees, the costs of preparing architectural exhibits, and contingency fees. Additionally, the cap would not include rehabilitation costs incurred to improve the energy efficiency standards of the home and six months of mortgage payments.
Notwithstanding HUD's determination that this rule will not have a significant economic effect on a substantial number of small entities, HUD specifically invites comments regarding any less burdensome alternatives to this rule that will meet HUD's objectives as described in this preamble.
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute, or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This proposed rule would not have federalism implications and would not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive Order.
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments, and on the private sector. This proposed rule would not impose any Federal mandates on any State, local, or tribal governments, or on the private sector, within the meaning of the Unfunded Mandates Reform Act of 1995.
The Catalog of Federal Domestic Assistance Number for the Section 203(k) Rehabilitation Loan Insurance program is 14.108.
Hawaiian Natives, Home improvement, Indians—lands, Loan programs—housing and community development, Mortgage insurance, Reporting and recordkeeping requirements, Solar energy.
Accordingly, for the reasons described in the preamble, HUD proposes to amend 24 CFR part 203 as follows:
1. The authority citation for 24 CFR part 203 continues to read as follows:
12 U.S.C. 1709, 1710, 1715b, and 1715u; 42 U.S.C. 3535(d).
2. Amend § 203.50 by revising paragraph (e) and adding paragraph (m) to read as follows:
(e)(1) The loan transaction shall be an acceptable risk as determined by the Secretary.
(2) The Secretary has determined that loan transactions for the rehabilitation of two-, three-, and four-unit structures (other than those involving the conversion of such structures to one-unit structures) constitute an unacceptable risk.
(m)
(1) Costs incurred to improve the energy efficiency standards of the property;
(2) Six months of mortgage payments; and
(3) Costs not directly related to the physical rehabilitation of the property, such as (but not limited to):
(i) Consultant fees;
(ii) Supplemental origination fees;
(iii) The costs of preparing architectural exhibits; and
(iv) Contingency fees.
Office of Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Proposed rule.
Mortgage insurance premiums (“MIPs”) in many of HUD's single family mortgage insurance programs are paid at the beginning of the mortgage, as either a “one-time” or “up-front” payment. Since 1993, HUD has required that all up-front MIPs be paid electronically through automated clearinghouses. One-time MIPs are also paid electronically. Given the electronic processing of payments, which requires only a short time period, a 15 calendar day period in which to remit the funds is no longer necessary, and shortening the period would result in increased efficiencies within the mortgage insurance programs. In addition, some lenders have misused MIP funds during the 15-day period. Therefore, this rule proposes to shorten the remittance period from 15 calendar days to three business days (Monday through Friday, exclusive of Federal holidays) for both one-time and up-front MIPs.
In addition, there is some confusion about when the remittance time period begins. Therefore, this rule proposes a more precise definition of when the remittance period begins.
Interested persons are invited to submit comments regarding this rule to the Rules Docket Clerk, Office of General Counsel, Room 10276, Department of Housing and Urban Development, 451 Seventh Street, SW, Washington, DC 20410-0500. Communications should refer to the above docket number and title. Facsimile (FAX) comments are not acceptable. A copy of each communication submitted will be available for public inspection and copying between 7:30 a.m. and 5:30 p.m. weekdays at the above address.
Vance T. Morris, Director, Office of Single Family Program Development, U.S. Department of Housing and Urban Development, 451 Seventh Street, SW, Washington, DC 20410, at (202) 708-2121. Persons with hearing or speech impairments may access these numbers via TTY by calling the Federal Information Relay Service at (800) 877-8339.
Section 203(c)(1) of the National Housing Act authorizes the Secretary to set the premium charge for insurance of mortgages under Title II of the National Housing Act. In a June 23, 1983, final rule (48 FR 28804) that followed a proposed rule and public comment, HUD established the one-time MIP for single-family programs, citing improved cash management for HUD without increased burdens on borrowers. The specific programs affected by this one-time MIP are listed in 24 CFR 203.259a, and include loans for refinancing loans insured under the National Housing Act (
Under the implementing rule for the one-time MIP, at 24 CFR 203.280—203.283, mortgagees in the affected programs pay the entire premium for the borrower within 15 days of closing. The rule generally contemplates that borrowers would amortize the mortgage insurance premium over the life of the loan, and that the premium amount would be calculated based on actuarial factors including the mortgage term and the costs projected by HUD discounted at a rate based on the expected rate of return of the mortgage insurance fund's investments. (
Section 203(c)(2) of the National Housing Act authorizes the up-front MIP, implemented at 24 CFR 203.284, which applies to all other mortgages executed on or after July 1, 1991 that are obligations of the Mutual Mortgage Insurance Fund. The up-front MIP requires the payment of a single premium of up to 2.25 percent of the original insured principal balance of the mortgage, and annual payments of .50 percent of the remaining insured principal balance for stated periods of time that vary depending on the original principal obligation of the mortgage.
HUD's regulations at 24 CFR 203.280 state that, for mortgages in which a one-time MIP is charged, the payment shall be made within 15 days of closing. In addition, up-front MIPs under 24 CFR 203.284 and 203.285 are subject to the same 15-day requirement. See 24 CFR 203.284(f) and 203.285(c), incorporating 24 CFR 203.280 by cross-reference.
Since April 7, 1993, it has been mandatory for lenders to make up-front MIP payments in the single-family insurance program through an electronic system. (
This proposed rule would amend 24 CFR 203.280 and 203.282 to reduce the remittance period for the up-front and one-time MIP in affected single-family programs from 15 calendar days to 3 business days, and to adjust the late charge provisions accordingly. Business days are Monday through Friday, excluding Federal holidays. In addition, the rule provides that in the case of refinancings, the three-day period will be counted from the date of disbursement of the mortgage proceeds rather than the loan closing.
The Secretary, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed and approved this proposed rule, and in so doing certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule imposes no new obligations of any kind, but only shortens the timing of an existing obligation to remit one-time and up-front mortgage insurance premiums. Because these premiums are remitted electronically, very little remittance time is actually required. This rule should impose no significant burdens on business.
Notwithstanding HUD's determination that this rule does not have a significant economic impact on a substantial number of small entities, HUD specifically invites comment regarding any less burdensome alternatives to this rule that will meet HUD's objectives as described in the preamble.
This proposed rule does not direct, provide for assistance of loan and
Executive Order 13132 (entitled “Federalism”) prohibits, to the extent practicable and permitted by law, an agency from promulgating a regulation that has federalism implications and either imposes substantial direct compliance costs on State and local governments and is not required by statute, or preempts State law, unless the relevant requirements of section 6 of the Executive Order are met. This rule does not have federalism implications and does not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive Order.
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4; approved March 22, 1995) (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments, and on the private sector. This proposed rule does not impose any Federal mandates on any State, local, or tribal governments, or on the private sector, within the meaning of the UMRA.
The Catalog of Federal Domestic Assistance number applicable to this rule is 14.117.
Hawaiian Natives, Home improvement, Indians—lands, Loan programs—housing and community development, Mortgage insurance, Reporting and recordkeeping requirements, Solar energy.
For the reasons stated in the preamble, HUD amends 24 CFR part 203 as follows:
1. The authority citation for 24 CFR part 203 continues to read as follows:
12 U.S.C. 1709, 1710, 1715b, and 1715u; 42 U.S.C. 3535(d).
2. Revise 24 CFR 203.280 to read as follows:
(a) For mortgages for which a one-time or up-front MIP is to be charged in accordance with §§ 203.259a, 203.284, or § 203.285, the mortgagee shall, as a condition to the endorsement of the mortgage for insurance, pay to the Commissioner for the account of the mortgagor, in a manner prescribed by the Commissioner, a premium representing the total obligation for the insuring of the mortgage by the Commissioner or the up-front portion of the total obligation, as applicable, within three business days of the date of closing, or, in the case of a refinancing transaction, within three business days from the date of disbursement of the mortgage proceeds.
(b) For purposes of this section, “business days” means Monday through Friday, exclusive of Federal holidays.
3. Revise 24 CFR 203.282 to read as follows:
(a) Payment of a one-time or up-front MIP is late if not received by HUD within three business days after the closing, or the disbursement of the loan funds in a refinancing transaction. Late payments shall include a late charge of four percent of the amount of the MIP.
(b) If payment of the MIP is not received by HUD within 30 days after the closing, or the disbursement of the loan funds in a refinancing transaction, the mortgagee will be charged additional late fees until payment is received at an interest rate set in conformity with the Treasury Fiscal Requirements Manual.
Office of the Assistant Secretary for Housing-Federal Housing Commissioner, HUD.
Proposed rule.
This proposed rule would amend the Department's regulations with respect to condominium ownership mortgage insurance to provide that the date of recordation for purposes of obtaining Federal Housing Administration (FHA) approval of a condominium development in the Commonwealth of Puerto Rico for mortgage insurance under the Section 234(c) program is the date the condominium legal documents are presented to the Commonwealth Registry of the Property. The Department believes that the proposed change will improve homeownership opportunities through increased FHA activity under the Section 234(c) program.
Interested persons are invited to submit comments regarding this rule to the Rules Docket Clerk, Office of General Counsel, Room 10276, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410. Communications should refer to the above docket number and title. Facsimile (FAX) comments are not acceptable. A copy of each communication submitted will be available for public inspection and copying between 7:30 a.m. and 5:30 p.m. weekdays at the above address.
Vance Morris, Office of the Deputy Assistant Secretary for Single Family Housing, Room 9278, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410. Telephone (202) 708-2121 ext. 2204 (this is not a toll-free number). Hearing- or speech-impaired persons may access this number by calling the Federal Information Relay Service at 1-800-877-8339 (this is a toll-free number).
Section 234(c) of the National Housing Act (12 U.S.C. 1715y(c)) (Act) authorizes the Secretary to insure an individual mortgage on a one-family unit in a multifamily project and an undivided interest in the common areas and facilities that serve the project, provided certain conditions are met. The regulations at 24 CFR 234.26(b) provide that the project in which a unit is located shall be committed to a plan of condominium ownership by a deed or other recorded instrument that is acceptable to the FHA Commissioner. As it relates to condominiums, recordation especially commits the developer to following through with the establishment of a viable condominium. Recordation marks a specific point in time when various fees must be paid and when rights and obligations vest in a non-profit condominium association that has been created by the articles of condominium association.
Section 234(k) of the Act provides that, before FHA mortgage insurance can be placed on a unit in a condominium project converted from rental property, at least one year must elapse between the date of conversion and the date application for insurance is made. Conversion is not defined in the Act. HUD's regulations at 24 CFR 234.3 define conversion as the date on which all documents necessary to create a condominium under State law (and under local law) have been recorded.
Under the Commonwealth of Puerto Rico's inscription law, the legal documents to create a condominium regime are “presented” to the Commonwealth Office of the Property Registry, which closely reviews the documents for sufficiency and accuracy. If the documents are found to be in compliance, or can be corrected to be brought into compliance, the documents then are inscribed or recorded. (Because of a current backlog, the review process now takes several years.) When the condominium documents are presented, a condominium regime is established. During the review period, the purchaser acquires a fee interest in a unit together with a common, undivided interest in the common areas as do purchasers in those jurisdictions with more standard recordation procedures. Only in extraordinary circumstances would recordation of the condominium documents not ultimately occur once the legal documents are presented to the Commonwealth Office of the Property Registry.
From the time the condominium legal documents are presented for inscription, the developer/proponent is responsible for paying assessments and costs associated with operating and maintaining the project as a condominium. This can result in substantial cost to a developer prior to the project's eligibility for FHA mortgage insurance.
This proposed rule would revise the definition of “conversion” in 24 CFR 234.26(b) to provide that, in the case of Puerto Rico, conversion is defined as the date on which a condominium development's legal documents (which must be in compliance with applicable law) are “presented” for inscription (
A Finding of No Significant Impact with respect to the environment for this rule has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969. The Finding of No Significant Impact is available for public inspection between 7:30 a.m. and 5:30 p.m. weekdays in the office of the Rules Docket Clerk, Office of General Counsel, Department of Housing and Urban Development, Room 10276, 451 Seventh Street, SW., Washington, DC 20410.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This proposed rule does not impose a Federal mandate that will result in expenditure by State, local, or tribal governments, within the meaning of the Unfunded Mandates Reform Act of 1995.
The Secretary, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this rule before publication and by approving it certifies that this rule would not have a significant economic impact on a substantial number of small entities. There are no anti-competitive
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute, or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This proposed rule would not have federalism implications and would not impose substantial direct compliance costs on State and local governments nor preempt State law within the meaning of the Executive Order.
The Catalog of Federal Domestic Assistance Numbers for 24 CFR part 234 are 14.117 and 14.133.
Condominiums, Mortgage insurance, Reporting and recordkeeping requirements.
Accordingly, for the reasons described in the preamble, HUD proposes to amend 24 CFR part 234 to read as follows:
1. The authority citation for 24 CFR part 234 continues to read as follows:
12 U.S.C. 1715b and 1715y; 42 U.S.C. 3535(d).
2. The definition of “conversion” in § 234.3 is revised to read as follows:
Conversion means the date on which all documents necessary to create a condominium under State law (and under local law, where applicable) have been recorded, except that in the case of the Commonwealth of Puerto Rico,
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends the flight data recorder regulations by expanding the recording ranges for certain data parameters for all covered airplanes. This amendment is necessary because certain airplanes are unable to record certain flight parameters under the existing resolution criteria without undergoing unintended and expensive retrofit.
This final rule is effective on August 20, 2002.
Gary Davis, Flight Standards Service, Air Transportation Division, AFS-201A, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-8166; facsimile (202) 267-5229, e-mail
You can get an electronic copy using the Internet by taking the following steps:
(1) Go to the search function of the Department of Transportation's electronic Docket Management System (DMS) web page (
(2) On the search page type in the last five digits of the Docket number shown at the beginning of this notice. Click on “search.”
(3) On the next page, which contains the Docket summary information for the Docket you selected, click on the document number for the item you wish to view.
You can also get an electronic copy using the Internet through the Office of Rulemaking's web page at
You can also get a copy by submitting a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9680. Make sure to identify the amendment number or docket number of this rulemaking.
The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. Therefore, any small entity that has a question regarding this document may contact their local FAA official, or the person listed under
The regulations adopted by the FAA in August of 1997 (62 FR 38362) substantially improved the requirements for flight data recorders and mandated that up to 88 parameters of flight data of recorded for diagnostic use in the event of an accident or serious incident. Most of the improvements in the recording capacity did not directly affect Airbus airplanes, however, because almost all of the additional parameters required by the FAA had been incorporated previously into Airbus product specifications. In the case of a few parameters, however, Airbus airplanes were unable to meet the parameter recording requirements adopted in the rule. In 1997, the FAA stated that it had tailored the rule to avoid major equipment redesign or retrofits. The new requirements were to be met in stages, with the first 34 parameters being required at the next heavy maintenance check after August 18, 1999, but no later than August 20, 2001; followed by parameters 35 through 57 for aircraft manufactured after August 18, 2000, upon delivery; and finally parameters 58 through 88 for aircraft manufactured after August 19, 2002, upon delivery.
On August 24, 1999 (64 FR 46117), the FAA amended the digital flight data recorder (DFDR) resolution and sampling requirements for several parameters for Airbus airplanes. The amendments addressed only the first 34 parameters. Similarly, on August 24, 2000 (64 FR 51741), the FAA revised the DFDR regulations, making technical changes related to parameters 35 through 57 to accommodate Airbus airplanes.
By letter dated February 22, 2002, Airbus petitioned the FAA to further amend Appendix M to part 121 and Appendix E to part 125. The letter states that Airbus had completed its audit of compliance requirements for parameters 58 through 88, and identified three specific technical issues of compliance for which it sought relief. Specifically, Airbus seeks minor technical changes to the recording requirements for parameter 83 (cockpit trim control input position—roll), parameter 84 (cockpit trim control input position—yaw), and parameter 88 (cockpit flight control input force—rudder). However, since its February letter, Airbus has withdrawn its request for changes to the requirements for parameter 88.
Airbus notes that the FAA, in adopting the new DFDR recording resolution requirements, did not intend to require equipment redesign or retrofit, and that the requested specification changes would be consistent with that intent. Airbus airplanes have been recording these parameters for many years, and Airbus claims that there would be no safety or analytic benefit to replace sensors that are virtually compliant with the regulatory specifications. According to Airbus, the deviations to current resolution requirements they are seeking are small, and are consistent with the smallest increment employed in the parameters for actual measurement of the respective flight control surfaces.
Specifically, Airbus seeks changes to the DFDR recording requirements for the following parameters as contained in Appendix M to part 121 and appendix E to part 125 of 14 CFR:
Parameter 83, cockpit trim control input position—roll, is required to be resolved to 0.028 degrees (0.2% of operational range of ±7 degrees). On A310 and A300-600 series aircraft this is implemented with a resolution of 0.096 degrees. Airbus asserts that this resolution is nearly identical to the smallest increment used in deflection of the roll control surfaces for each model, which is 0.092 degrees in the A310 aircraft and 0.091 degrees in the A300-600 aircraft. Airbus states that achieving the additional resolution would provide no substantive benefit. Airbus requests that a footnote be added in Appendix M to part 121 and Appendix E to part 125, to reflect this deviation for the airplane models noted.
Parameter 84, cockpit trim control input position—yaw, is required to be resolved to 0.08 degrees (0.2% of operational range of ±20 degrees). On A318/319/320/321 series aircraft, this is
Airbus states that U.S. operators of the affected airplanes would incur substantial costs associated with being involved in the redesign and installation of new DFDR equipment to achieve precise compliance with the recording resolution requirements of the current regulations. In addition, if new aircraft were delivered with DFDR recording equipment that differs from that installed on existing aircraft, operators would have to maintain the equipment separately, increasing recordkeeping requirements and costs. Airbus states that these added costs would not be balanced by any increase in safety or investigative capability. Accordingly, Airbus concludes that it is in the public interest to make the requested regulatory modifications.
On April 22, 2002, the FAA published a notice of petition for rulemaking, with a request for comments, discussing this Airbus request (67 FR 19534). The comment period for that notice (Notice No. PE-2002-28) closed on May 22, 2002. In response to that notice we received two generally favorable comments, one from the Air Transport Association (ATA) and another from the Boeing Airplane Company (Boeing). The ATA supports the Airbus petition, reaffirming that the 1997 rule was not intended to necessitate retrofit modifications. The ATA agrees with the petitioner's claim that the required changes to the production configurations and the resulting differences with the configurations for airplanes already in service would be neither cost effective nor beneficial in mishap investigations.
Boeing concurs with the requested revisions to the parameter 83 and parameter 84 resolutions, stating that they are minor and would not significantly affect the ability of accident investigators to perform their investigation. However, Boeing questioned the need to revise the accuracy requirement for parameter 88, and is concerned that any changes to the rule might affect the method of compliance for which it had received approval. Since Airbus withdrew its request to amend the recording requirements of parameter 88, no change to that parameter is included in this amendment.
The FAA considered carefully all the comments received. Because no commenter opposed the requested changes to parameters 83 and 84, the FAA has determined that the changes would be in the public interest.
Airbus requested that these amendments be codified as footnotes to the affected appendixes. After considerable discussion with technical representatives and accident investigators, however, the FAA has determined the requested changes can be made to the appendices and made available to all airplanes without compromising resources available to accident investigators. The incremental difference in the measurements obtained are considered insignificant. Further, the FAA notes that the same parameters and resolution requirements appear in Appendix F to part 135. Because the changes requested will apply to all airplanes subject to parts 121 and 125, the FAA finds that the same changes are appropriate for the part 135 requirements. Accordingly, in Part 121 Appendix M, Part 125 Appendix E, and Part 135 Appendix F, resolution recording requirements for parameters 83 and 84 will be amended to read 0.7% and 0.3% of full range, respectively.
Sections 553(b)(3)(B) and 553(d)(3) of the Administrative Procedure Act (APA) (5 U.S.C. Sections 553(b)(3)(B) and 553(d)(3)) authorize agencies to dispense with certain notice procedures for rules when they find “good cause” to do so. Under section 553(b)(3)(B), the requirements of notice and opportunity for comment do not apply when the agency, for good cause, finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Section 553(d)(3) allows an agency, upon finding good cause, to make a rule effective immediately, thereby avoiding the 30-day delayed effective date requirement in section 553.
The FAA finds that the requirements for notice and public comment to this amendment have been met because the FAA published for comment Airbus's original petition for rulemaking. Further, if the changes are delayed awaiting additional public notice and comment, regulated entities would be unable to comply with an August 20, 2002, compliance deadline. Therefore, the FAA finds that further notice and comment are unnecessary and that good cause exists for making these amendment effective on August 20, 2002.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the FAA has determined that there are no new requirements for information collection associated with this rule.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to comply with International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA determined that there are no ICAO Standards and Recommended Practices that correspond to these regulations.
Proposed changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 directs each Federal agency to propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (19 U.S.C. section 2531-2533) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act also requires agencies to consider international standards and, where appropriate, use them as the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation.)
Regulations with an expected minimal impact the above-specified analyses are not required. The Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If it is determined that the expected impact is so minimal that the proposal does not warrant a full Evaluation, a statement to
In conducting these analyses, FAA has determined this rule (1) has benefits which justify its costs; (2) is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866 and is not “significant” as defined in DOT's Regulatory Policies and Procedures; (3) will not have a significant impact on a substantial number of small entities; (4) will have little effect on international trade; and (5) does not impose an unfunded mandate on state, local, or tribal governments, or on the private sector.
The purpose of this rule is to eliminate the necessity to incorporate unnecessary changes into an existing type of airplane that already meets the requirements of the rule except for minor variations in the resolution recording requirement. The FAA has determined that allowing the continued resolution-recording at a slightly different value will not impact safety or the collection of accident investigation data. This rule would result in cost savings because air carriers would not have to make minor, but costly, changes and subsequently pass those costs on to the public in the form of higher ticket prices.
The Regulatory Flexibility Act of 1980 (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation.” To achieve that principle, the Act requires agencies to solicit and consider flexible regulatory proposals and to explain the rationale for their actions. The Act covers a wide range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.
Agencies must perform a review to determine whether a proposed or final rule will have a significant economic impact on a substantial number of small entities. If the determination is that it will, the agency must prepare a regulatory flexibility analysis as described in the Act. However, if an agency determines that a proposed or final rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the 1980 Act provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.
This final rule will relieve unnecessary costs to operators of certain airplanes. Therefore, the FAA expects this rule to impose no cost on small entities. Consequently, the FAA certifies that the rule will not have a significant economic impact on a substantial number of small entities.
The Trade Agreement Act of 1979 prohibits Federal agencies from engaging in any standards or related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this rulemaking and has determined that it will reduce costs to U.S. operators of certain airplanes but will have a minimal effect on international trade.
The Unfunded Mandates Reform Act of 1995 (the Act), enacted as Public Law 104-4 on March 22, 1995, is intended, among other things, to curb the practice of imposing unfunded Federal Mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.”
This final rule does not contain such a mandate. Therefore, the requirements of Title II of the Unfunded Mandates Reform Act of 1995 do no apply.
The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. We determined that this action will not have a substantial direct effect on the States, or the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, we determined that this final rule does not have federalism implications.
FAA Order 1050.1D defines FAA actions that may be categorically excluded from preparation of a National Environmental Policy Act (NEPA) environmental impact statement. In accordance with FAA order 1050.1D, appendix 4, paragraph 4(j), this rulemaking action qualifies for a categorical exclusion.
The energy impact of the notice has been assessed in accordance with the Energy Policy and Conservation Act (EPCA) Public Law 94-163, as amended (42 U.S.C. 6362) and FAA Order 1053.1. It has been determined that the final rule is not a major regulatory action under the provisions of the EPCA.
Air carriers, Aircraft, Aviation safety, Reporting and recordkeeping requirements, Safety, Transportation.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
Air taxis, Aircraft, Airmen, Alcohol abuse, Aviation safety, Drug abuse, Drug testing, Reporting and recordkeeping requirements.
49 U.S.C. 106(g), 40113, 40119, 41706, 44101, 44701-44702, 44705, 44709-44711, 44713, 44716-44717, 44722, 44901, 44903-44904, 44912, 45101-45105, 46105, Pub. L. 107-71, 115 Stat. 597-647.
The recorded values must meet the designated range, resolution, and accuracy requirements during dynamic and static conditions. All data recorded must be correlated in time to within one second.
49 U.S.C. 106(g), 40113, 44701-44702, 44705, 44710-44711, 44713, 44716-44717, 44722.
The recorded values must meet the designated range, resolution, and accuracy requirements during dynamic and static conditions. All data recorded must be correlated in time to within one second.
49 U.S.C. 106(g), 41706, 44113, 44701-44702, 44709, 44705, 44711-44713, 44715-44717, 44722.
The recorded values must meet the designated range, resolution, and accuracy requirements during dynamic and static conditions. All data recorded must be correlated in time to within one second.