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Presidential Documents
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Animal and Plant Health Inspection Service, USDA.
Affirmation of interim rule as final rule.
We are adopting as a final rule, without change, an interim rule that amended the gypsy moth regulations by adding one county in Ohio and seven counties in Wisconsin to the list of generally infested areas based on the detection of infestations of gypsy moth in those counties. As a result of the interim rule, the movement of regulated articles from those areas is restricted. The interim rule was necessary to prevent the artificial spread of gypsy moth to noninfested areas of the United States.
Dr. Weyman Fussell, Program Manager, Pest Detection and Management Programs, PPQ, APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-1231; (301) 734-5705.
The gypsy moth,
In an interim rule effective and published in the
Comments on the interim rule were required to be received on or before August 6, 2004. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.
This action also affirms the information contained in the interim rule concerning Executive Orders 12866, 12372, and 12988 and the Paperwork Reduction Act.
Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.
This rule affirms an interim rule that amended the regulations by adding one county in Ohio and seven counties in Wisconsin to the list of generally infested areas. As a result of the interim rule, the interstate movement of certain articles from those areas is restricted. The interim rule was necessary to prevent the artificial spread of the gypsy moth to noninfested areas of the United States.
The following analysis addresses the economic effects of the interim rule on small entities, as required by the Regulatory Flexibility Act.
The interim rule placed restrictions on the movement of regulated articles and outdoor household articles (OHAs) from and through the one county in Ohio and the seven counties in Wisconsin that were designated as generally infested areas. These restrictions will have their primary effect on persons moving OHAs, nursery stock, Christmas trees, logs and wood chips, and mobile homes from a generally infested area into or through any area that is not generally infested.
Under the regulations, OHAs may not be moved from a generally infested area into or through a noninfested area unless they are accompanied by either a certificate issued by an inspector or an OHA document issued by the owner of the articles, attesting to the absence of all life stages of gypsy moth. Most individual homeowners moving their own articles who comply with the regulations choose to self-inspect and issue an OHA document. This takes a few minutes and involves no monetary cost unless treatment is necessary. Individuals may also have State-certified pesticide applicators, trained by the State or the U.S. Department of Agriculture (USDA), inspect and issue certificates.
Generally, regulated articles (such as logs, pulpwood, wood chips, mobile homes, nursery stock, OHAs, and Christmas trees) may only be moved from a generally infested area if they are accompanied by a certificate or limited permit issued by an inspector. However, logs, wood chips, and pulpwood may be moved without a certificate or limited permit if the person moving the articles attaches a signed accurate statement to the waybill as specified in the Gypsy Moth Program Manual, stating that he or she has inspected the articles and has found them free of all life stages of the gypsy moth. This exception minimizes the costs of moving logs, pulpwood, and wood chips. Regulated articles may also be moved from a generally infested area without a certificate if they are moved by the USDA for experimental or scientific purposes and they are accompanied by a permit issued by the Administrator of the Animal and Plant Health Inspection Service (APHIS).
Persons moving regulated articles from a generally infested area may obtain a certificate or limited permit from an inspector or a qualified certified applicator. Inspectors will issue these documents at no charge, but costs may result from delaying the movement of commercial articles while waiting for the inspection. Certificates for the movement of mobile homes from a generally infested area may also be obtained from qualified certified applicators.
When inspection of regulated articles or OHAs reveals the presence of gypsy moths, treatment is often necessary in order for the articles to be eligible for movement into or through noninfested areas. The preferred treatment, scraping egg masses and spraying caterpillars, costs an average of $10 to $30 per shipment. Fumigation is another alternative, but it is more expensive, at $100 to $150 per shipment, and may damage the shipment. Treatment is done by qualified certified applicators, most of which are small businesses. These businesses might experience a
Nurseries and Christmas tree growers that move a substantial number of shipments from the generally infested areas would be able to minimize treatment costs by treating their premises for gypsy moths under a compliance agreement with APHIS. These treatments cost businesses between $10 and $20 per acre. This alternative allows nurseries and Christmas tree growers to issue their own certificates provided they are under a compliance agreement and is less costly than treating individual shipments. The entities most likely to choose this option are nurseries that move a substantial number of shipments from generally infested areas and that treat their premises for other pests in addition to the gypsy moth. Producers that do not operate under a compliance agreement with APHIS, but treat their premises under this option, would receive certification for each shipment from an inspector.
The economic impact of the interim rule will vary depending on the size of the entities affected, the levels of infestation, and the size and number of shipments to noninfested areas. Within the one Ohio county and seven Wisconsin counties added to the list of generally infested areas, there are approximately 450 Christmas tree growers, nurseries, loggers, sawmills, and individuals involved in the movement of regulated articles that may incur costs from the interim rule. According to the size standards established by the Small Business Administration, all of these businesses are considered small entities.
In Hocking County, the newly regulated county in Ohio, there are 25 potentially affected establishments. The value of Christmas tree and greenhouse/nursery products sold by these establishments in 2002 was $541,000, which represents 0.12 percent of the total value of sales of these products in Ohio. These businesses annually ship about 400 shipments, of which approximately half, or 200 shipments, leave the regulated area. Approximately 58 percent of the shipments leaving the regulated area would require treatment, creating an approximate cost range of $11,600 to $17,400 annually. Given these estimates, the cost of additional treatments would be small relative to the total value of sales in Hocking County.
There are 425 potentially affected establishments in the seven Wisconsin counties. The value of Christmas tree and greenhouse/nursery products sold by these establishments in 2002 was $25.546 million, which represents approximately 11.57 percent of the total value of sales of these products in Wisconsin. These businesses annually ship about 2,150 shipments, of which approximately 34 percent, or 723 shipments, leave the regulated area. Only about 16 percent of the shipments from these areas would require treatment, with costs of approximately $11,568 to $17,352 annually. With these estimates, the cost of additional treatments would be very small relative to the total value of sales in the newly affected Wisconsin counties.
The regulatory requirements imposed by the interim rule are expected to cause a slight increase in costs for the affected entities. The relative negative impact that may result from the interim rule is very small when compared with the potential for harm to related industry and the U.S. economy as a whole resulting from the further spread of the pest. Since the total value of the regulated articles moved from infested to noninfested areas is a small fraction of the national total, the effect on national prices is expected to be slight. Additionally, since the rule is not prohibitive, articles that meet the requirements of the regulations would continue to enter the market. Therefore, the overall impact upon price and competitiveness is expected to be relatively insignificant.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Services has determined that this action will not have a significant impact on a substantial number of small entities.
Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation.
7 U.S.C. 7701-7772; 7 CFR 2.22, 2.80, and 371.3.
Section 301.75-15 also issued under Sec. 204, Title II, Pub. L. 106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 also issued under Sec. 203, Title II, Pub. L. 106-224, 114 Stat. 400 (7 U.S.C. 1421 note).
Agricultural Marketing Service, USDA.
Final rule.
This rule establishes the Mango Promotion, Research, and Information Order (Order) under the Commodity Promotion, Research, and Information Act of 1996. Under the Order, first handlers and importers of 500,000 or more pounds of mangos will pay an initial assessment of
Effective November 3, 2004. Collection and remittance of assessments and applicable reporting will begin January 3, 2005.
Jeanette A. Palmer, Research and Promotion Branch, FV, AMS, USDA, Stop 0244, 1400 Independence Avenue, SW., Room 2535-S, Washington, DC 20250-0244, telephone (202) 720-9915, fax (202) 205-2800, e-mail
This Order is issued under the Commodity Promotion, Research, and Information Act of 1996 (Act) (7 U.S.C. 7411-7425; Public Law 104-127; 110 Stat. 1029), or any amendments thereto.
In a recent referendum, eligible first handlers and importers of fresh mangos voted in favor of implementing the Order. This final rule, which will become effective in 30 days, completes the rulemaking process.
The purpose of the program is to maintain, expand, and develop domestic markets for fresh mangos.
Domestic first handlers and importers of 500,000 or more pounds of mangos per calendar year will pay assessments under the program. Domestic mangos that are exported will not be assessed under the Order.
The assessment rate is
Collection and remittance of assessments and applicable reporting will begin 90 days after publication in the
Assessments will be due as long as the Order is in effect. However, every five years, USDA will conduct a referendum to determine whether first handlers and importers of fresh mangos want the program to continue. The program will continue if a majority of the voters in the referendum vote for approval.
The National Mango Board will administer this Order under the supervision of USDA. The Board members will be appointed by the Secretary from nominations received from the mango industry.
The Order provides that there will be a 20-member Board consisting of eight U.S. importers, one U.S. first handler, two U.S. producers, seven foreign producers, and two non-voting U.S. wholesalers and/or retailers of mangos. The chairperson shall reside in the United States.
USDA will handle the nomination process for the initial Board. The U.S. importers, first handlers, and producers will be nominated by U.S. importers, first handlers, and producers, respectively. Foreign producers will be nominated by foreign producer associations. After the initial Board is seated, the U.S. wholesalers and/or retailers will be nominated by the Board. Two names must be submitted for each position. From the names submitted, the Secretary will appoint the members.
This final rule has been determined to be not significant for purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget (OMB).
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have a retroactive effect. Section 524 of the Act provides that the Act shall not preempt any other Federal or state law authorizing promotion or research relating to an agricultural commodity. Under section 519 of the Act, a person subject to the Order may file a petition with USDA stating that an order, any provision of an order, or any obligation imposed in connection with an order, is not established in accordance with the law, and requesting a modification of an order or an exemption from an order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of an order, provision or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, USDA will issue a ruling on the petition. The Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of entry of USDA's final ruling.
In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
The Order provisions were carefully reviewed, and every effort was made to minimize any unnecessary information collection and recordkeeping costs or requirements. In accordance with OMB regulations [5 CFR part 1320], which implement the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements that are imposed by this Order were submitted to OMB for review and approved under OMB control numbers 0581-0209 and 0505-0001. Upon reevaluation of the response time for the ballot and nomination forms, it was determined that the response time could be reduced from 30 minutes to 15 minutes. Also, the burden for the form AD-755 was inadvertently calculated as a part of this collection. Its burden is covered under 0505-0001. These two adjustments resulted in an overall decrease of 15 burden hours between the proposed rule and the final rule.
Copies of the final regulatory flexibility analysis and the discussion of the information collection and recordkeeping requirements contained in this rulemaking can be obtained from Jeanette Palmer at the address listed above or by e-mail at
On June 29, 2001, the Fresh Produce Association of the Americas (Association) submitted a proposal for a national promotion, research, and information order for fresh mangos to the Department, pursuant to the Act to: (1) develop and finance an effective and coordinated program of research, promotion, industry information, and consumer information regarding mangos; (2) strengthen the position of the mango industry in U.S. markets; and (3) maintain, develop, and expand domestic markets for mangos. The Association submitted changes to their proposal on November 1, 2001 and the Department published the modified proposed rules on both the Order [67 FR 54908] and the referendum procedures [67 FR 54920] in the
First handlers and importers of mangos voted to implement the program in a referendum held November 10 through November 28, 2003. Under the Order, first handlers and importers of 500,000 or more pounds of mangos per calendar year will pay an initial assessment of
The program will be administered by the Board under USDA supervision. The Board will be composed of 20-members; eight U.S. importers, one U.S. first handler, two U.S. producers, seven foreign producers, and two non-voting wholesalers and/or retailers. If domestic production increases, additional U.S. first handlers will be added to the Board.
The Order is summarized as follows:
Sections 1206.1 through 1206.24 of the Order define certain terms, such as mango, first handler and importer, which are used in the Order.
Sections 1206.30 through 1206.37 include provisions relating to the establishment, adjustment, and membership; nominations; appointments; term of office; vacancies; procedures; compensation; reimbursement; and powers, duties, and prohibited activities of the Board. The Board is the governing body authorized to administer the Order through the implementation of programs, plans, projects, budgets, and contracts to promote and disseminate information about mangos, subject to oversight of the Department.
Sections 1206.40 through 1206.43 cover budget review and approval; financial statements; authorize the collection of assessments; specify how assessments are used; specify who pays the assessment and how; exemptions; and authorize the imposition of a late-payment charge on past-due assessments.
The initial assessment rate shall be
Sections 1206.50 through 1206.52 address programs, plans, and projects; require the Board to periodically conduct an independent review of its overall program; and address patents, copyrights, trademarks, information, publications, and product formulations developed through the use of assessment funds.
Sections 1206.60 through 1206.62 concern reporting and recordkeeping requirements for persons subject to the Order and protect the confidentiality of information from such books, records, or reports.
Sections 1206.70 through 1206.78 describe the rights of the Secretary; address referenda; authorize the Secretary to suspend or terminate the Order when deemed appropriate; prescribe proceedings after suspension or termination; and address personal liability, separability, amendments, and the OMB control numbers.
Finally, §§ 1206.14 and 1206.42(b) have been slightly modified for clarity.
The Department conducted a referendum among eligible first handlers and importers of mangos from November 10, 2003 through November 28, 2003, to determine whether the Order would become effective. First handlers and importers who handled or imported 500,000 pounds or more of fresh mangos, respectively, from January 1 through December 31, 2002, were eligible to vote. It is determined that a majority of the eligible first handlers and importers voting in the referendum favored implementation of the Order. After consideration of all relevant materials presented, including the proposal, comments received, and the referendum results, it is found that the Order is consistent with and effectuates the policy and purpose of the Act.
The effective date of this action will be 30 days after publication in the
Administrative practice and procedure, Advertising, Consumer information, Mangos, Marketing agreements, Promotion, Reporting and recordkeeping requirements.
7 U.S.C. 7411-7425.
(1) Who is engaged in the production and sale of mangos outside of the United States and who owns, or shares the ownership and risk of loss of the crop for sale in the U.S. market or
(2) Who is engaged, outside of the United States, in the business of producing, or causing to be produced, mangos beyond the person's own family use and having value at first point of sale.
(a) Consumer information, which means any action taken to provide information to, and broaden the understanding of, the general public regarding the consumption, use, nutritional attributes, and care of mangos; and
(b) Industry information, which means information and programs that will lead to the development of new markets, new marketing strategies, or increased efficiency for the mango industry, and activities to enhance the image of the mango industry.
(a)
(b)
(1)
(2)
(3)
(4)
(c)
(a) Voting for first handler, importer, and domestic producer members will be made by mail ballot.
(b) There shall be two nominees for each position on the Board.
(c) Nominations for the initial Board will be handled by the Department. Subsequent nominations will be handled by the Board's staff.
(d) Nominees to fill the first handler member position on the Board shall be solicited from all known first handlers. The nominees shall be placed on a ballot which will be sent to all first handlers for a vote. The nominee receiving the highest number of votes and the nominee receiving the second highest number of votes shall be submitted to the Department as the first handlers' first and second choice nominees.
(e) Nominees to fill the importer positions on the Board shall be solicited from all known importers of mangos. The members from each district shall select the nominees for two positions on the Board. Two nominees shall be submitted for each position. The nominees shall be placed on a ballot which will be sent to importers in the districts for a vote. For each position, the nominee receiving the highest number of votes and the nominee receiving the second highest number of votes shall be submitted to the Department as the importers' first and second choice nominees.
(f) Nominees to fill the domestic producer member positions on the Board shall be solicited from all known domestic producers. The nominees shall be placed on a ballot which will be sent to all domestic producers for a vote. The nominee receiving the highest number of votes and the nominee receiving the second highest number of votes shall be submitted to the Department as the producers' first and second choice nominees.
(g) Nominees to fill the foreign producer member positions on the Board shall be solicited from organizations of foreign mango producers. Each organization shall submit two nominees for each position, and the nominees shall be representative of the major countries exporting mangos to the United States.
(h) The Board will nominate the wholesaler and/or retailer members.
(i) From the nominations, the Secretary shall select the members of the Board.
The term of office for first handler, importer, domestic producer, and foreign producer members of the Board will be three years, and these members may serve a maximum of two consecutive three-year terms. The term of office for wholesaler/retailer members shall be one year, and these members may serve a maximum of three consecutive one-year terms. When the Board is first established, the first handler, two importers, one domestic producer, and two foreign producers will be assigned initial terms of four years; three importers, one domestic producer, and two foreign producers will be assigned initial terms of three years; and three importers and three foreign producers will be assigned initial terms of two years. Thereafter, each of these positions will carry a full three-year term. Members serving initial terms of two or four years will be eligible to serve a second term of three years. Each term of office will end on December 31, with new terms of office beginning on January 1.
(a) In the event that any member of the Board ceases to be a member of the category of members from which the member was appointed to the Board, such position shall automatically become vacant.
(b) If a member of the Board consistently refuses to perform the duties of a Board member, or if a member of the Board engages in acts of
(c) Should any member position become vacant, successors for the unexpired term of the member shall be appointed in the manner specified in § 1206.31, except that nomination and replacement shall not be required if the unexpired term is less than six months.
(a) At a Board meeting, it will be considered a quorum when at least ten voting members are present.
(b) At the start of each fiscal period, the Board will select a chairperson and vice chairperson who will conduct meetings throughout that period.
(c) All Board members will be notified at least 30 days in advance of all Board and committee meetings unless an emergency meeting is declared.
(d) Each voting member of the Board will be entitled to one vote on any matter put to the Board, and the motion will carry if supported by one vote more than 50 percent of the total votes represented by the Board members present.
(e) It will be considered a quorum at a committee meeting when at least one more than half of those assigned to the committee are present. Committees may consist of individuals other than Board members, and such individuals may vote in committee meetings. Committee members shall serve without compensation but shall be reimbursed for reasonable travel expenses, as approved by the Board.
(f) In lieu of voting at a properly convened meeting and, when in the opinion of the chairperson of the Board such action is considered necessary, the Board may take action if supported by one vote more than 50 percent of the members by mail, telephone, electronic mail, facsimile, or any other means of communication. In that event, all members must be notified and provided the opportunity to vote. Any action so taken shall have the same force and effect as though such action had been taken at a properly convened meeting of the Board. All telephone votes shall be confirmed promptly in writing. All votes shall be recorded in Board minutes.
(g) There shall be no voting by proxy.
(h) The chairperson shall be a voting member and shall reside in the U.S.
(i) The organization of the Board and the procedures for conducting meetings of the Board shall be in accordance with its bylaws, which shall be established by the Board and approved by the Department.
The members of the Board shall serve without compensation but shall be reimbursed for reasonable travel expenses, as approved by the Board, incurred by them in the performance of their duties as Board members.
The Board shall have the following powers and duties:
(a) To administer the Order in accordance with its terms and conditions and to collect assessments;
(b) To develop and recommend to the Department for approval such bylaws as may be necessary for the functioning of the Board, and such rules as may be necessary to administer the Order, including activities authorized to be carried out under the Order;
(c) To meet, organize, and select from among the members of the Board a chairperson, other officers, committees, and subcommittees, as the Board determines appropriate;
(d) To employ persons, other than the members, as the Board considers necessary to assist the Board in carrying out its duties and to determine the compensation and specify the duties of such persons;
(e) To develop programs, plans, and projects, and enter into contracts or agreements, which must be approved by the Department before becoming effective, for the development and carrying out of programs or projects of research, information, or promotion, and the payment of costs thereof with funds collected pursuant to this subpart. Each contract or agreement shall provide that: any person who enters into a contract or agreement with the Board shall develop and submit to the Board a proposed activity; keep accurate records of all of its transactions relating to the contract or agreement; account for funds received and expended in connection with the contract or agreement; make periodic reports to the Board of activities conducted under the contract or agreement; and, make such other reports available as the Board or the Department considers relevant. Furthermore, any contract or agreement shall provide that:
(1) The contractor or agreeing party shall develop and submit to the Board a program, plan, or project together with a budget or budgets that shall show the estimated cost to be incurred for such program, plan, or project;
(2) The contractor or agreeing party shall keep accurate records of all its transactions and make periodic reports to the Board of activities conducted, submit accounting for funds received and expended, and make such other reports as the Department or the Board may require;
(3) The Department may audit the records of the contracting or agreeing party periodically; and
(4) Any subcontractor who enters into a contract with a Board contractor and who receives or otherwise uses funds allocated by the Board shall be subject to the same provisions as the contractor.
(f) To prepare and submit for approval of the Department calendar year budgets in accordance with § 1206.40;
(g) To maintain such records and books and prepare and submit such reports and records from time to time to the Department as the Department may prescribe; to make appropriate accounting with respect to the receipt and disbursement of all funds entrusted to it; and to keep records that accurately reflect the actions and transactions of the Board;
(h) To cause its books to be audited by a competent auditor at the end of each calendar year and at such other times as the Department may request, and to submit a report of the audit directly to the Department;
(i) To give the Department the same notice of Board and committee meetings as is given to members in order that the Department's representative(s) may attend such meetings.
(j) To act as intermediary between the Department and any first handler or importer;
(k) To furnish to the Department any information or records that the Department may request;
(l) To receive, investigate, and report to the Department complaints of violations of the Order;
(m) To recommend to the Department such amendments to the Order as the Board considers appropriate; and
(n) To work to achieve an effective, continuous, and coordinated program of promotion, research, consumer information, evaluation, and industry information designed to strengthen the mango industry's position in the U.S. domestic market; maintain and expand existing markets and uses for mangos; and to carry out programs, plans, and projects designed to provide maximum benefits to the mango industry.
The Board may not engage in, and shall prohibit the employees and agents of the Board from engaging in:
(a) Any action that is a conflict of interest; and
(b) Using funds collected by the Board under the Order to undertake any action
(a) At least 60 days prior to the beginning of each calendar year, and as may be necessary thereafter, the Board shall prepare and submit to the Department a budget for the calendar year covering its anticipated expenses and disbursements in administering this subpart. Each such budget shall include:
(1) A statement of objectives and strategy for each program, plan, or project;
(2) A summary of anticipated revenue, with comparative data or at least one preceding year (except for the initial budget);
(3) A summary of proposed expenditures for each program, plan, or project; and
(4) Staff and administrative expense breakdowns, with comparative data for at least one preceding year (except for the initial budget).
(b) Each budget shall provide adequate funds to defray its proposed expenditures and to provide for a reserve as set forth in this subpart.
(c) Subject to this section, any amendment or addition to an approved budget must be approved by the Department, including shifting funds from one program, plan, or project to another. Shifts of funds which do not cause an increase in the Board's approved budget and which are consistent with governing bylaws need not have prior approval by the Department.
(d) The Board is authorized to incur such expenses, including provision for a reserve, as the Department finds reasonable and likely to be incurred by the Board for its maintenance and functioning, and to enable it to exercise its powers and perform its duties in accordance with the provisions of this subpart. Such expenses shall be paid from funds received by the Board.
(e) With approval of the Department, the Board may borrow money for the payment of administrative expenses, subject to the same fiscal, budget, and audit controls as other funds of the Board. Any funds borrowed by the Board shall be expended only for startup costs and capital outlays and are limited to the first year of operation of the Board.
(f) The Board may accept voluntary contributions, but these shall only be used to pay expenses incurred in the conduct of programs, plans, and projects. Voluntary contributions shall be free from any encumbrance by the donor, and the Board shall retain complete control of their use.
(g) The Board shall reimburse the Department for all expenses incurred by the Department in the implementation, administration, and supervision of the Order, including all referendum costs in connection with the Order.
(h) The Board may not expend for administration, maintenance, and functioning of the Board in any calendar year an amount that exceeds 15 percent of the assessments and other income received by the Board for that calendar year. Reimbursements to the Department required under paragraph (g) of this section, are excluded from this limitation on spending.
(i) The Board may establish an operating monetary reserve and may carry over to subsequent fiscal periods excess funds in any reserve so established: Provided that the funds in the reserve do not exceed one fiscal period's budget. Subject to approval by the Department, such reserve funds may be used to defray any expenses authorized under this part.
(a) As requested by the Department, the Board shall prepare and submit financial statements to the Department on a periodic basis. Each such financial statement shall include, but not be limited to, a balance sheet, income statement, and expense budget. The expense budget shall show expenditures during the time period covered by the report, year-to-date expenditures, and the unexpended budget.
(b) Each financial statement shall be submitted to the Department within 30 days after the end of the time period to which it applies.
(c) The Board shall submit annually to the Department an annual financial statement within 90 days after the end of the calendar year to which it applies.
(a) The funds to cover the Board's expenses shall be paid from assessments on first handlers and importers, donations from any person not subject to assessments under this Order, and other funds available to the Board and subject to the limitations contained therein.
(b) The assessment rate shall be
(c)
(d)
(1) The assessment rate for imported mangos shall be the same or equivalent to the rate for mangos produced in the United States.
(2) The import assessment shall be uniformly applied to imported mangos that are identified by the numbers 0804.50.4040 and 0804.50.6040 in the Harmonized Tariff Schedule of the United States.
(3) The assessments due on imported mangos shall be paid when they enter or are withdrawn for consumption in the United States.
(e) Each person responsible for remitting assessments under paragraph (c) of this section shall remit the amounts due to the Board's office on a monthly basis no later than the fifteenth day of the month following the month in which the mangos were marketed, in such manner as prescribed by the Board.
(f) A late payment charge shall be imposed on any person failing to remit to the Board the total amount for which the person is liable by the payment due date established under this section. The amount of the late payment charge shall be prescribed by the Department.
(g) An additional charge shall be imposed on any person subject to a late payment charge in the form of interest on the outstanding portion of any amount for which the person is liable. The rate of interest shall be prescribed by the Department.
(h) Persons failing to remit total assessments due in a timely manner may also be subject to actions under federal debt collection procedures.
(i) The Board may authorize other organizations to collect assessments on its behalf with the approval of the Department.
(a) Any first handler or importer of less than 500,000 pounds of mangos per calendar year may claim an exemption from the assessments required under § 1206.42. Mangos produced domestically and exported from the United States may annually claim an exemption from the assessments required under § 1206.42.
(b) A first handler or importer desiring an exemption shall apply to the Board, on a form provided by the Board, for a certificate of exemption. A first handler shall certify that the first handler will handle less than 500,000 pounds of domestic mangos for the fiscal period for which the exemption is claimed. An importer shall certify that the importer will import less than 500,000 pounds of mangos during the fiscal period for which the exemption is claimed.
(c) Upon receipt of an application, the Board shall determine whether an exemption may be granted. The Board then will issue, if deemed appropriate, a certificate of exemption to each person who is eligible to receive one. It is the responsibility of these persons to retain a copy of the certificate of exemption.
(d) Importers who receive a certificate of exemption shall be eligible for reimbursement of assessments collected by Customs. These importers shall apply to the Board for reimbursement of any assessments paid. No interest will be paid on the assessments collected by Customs. Requests for reimbursement shall be submitted to the Board within 90 days of the last day of the calendar year the mangos were actually imported.
(e) Any person who desires an exemption from assessments for a subsequent calendar year shall reapply to the Board, on a form provided by the Board, for a certificate of exemption.
(f) The Board may require persons receiving an exemption from assessments to provide to the Board reports on the disposition of exempt mangos and, in the case of importers, proof of payment of assessments.
(a) The Board shall receive and evaluate, or on its own initiative develop, and submit to the Department for approval any program, plan, or project authorized under this subpart. Such programs, plans, or projects shall provide for:
(1) The establishment, issuance, effectuation, and administration of appropriate programs for promotion, research, and information, including producer and consumer information, with respect to mangos; and
(2) The establishment and conduct of research with respect to: the use, nutritional value and benefits, sale, distribution, and marketing of mangos in the United States; the creation of new products thereof, to the end that the marketing and use of mangos in the United States may be encouraged, expanded, improved, or made more acceptable; and to advance the image, desirability, or quality of mangos in the United States.
(b) No program, plan, or project shall be implemented prior to its approval by the Department. Once a program, plan, or project is so approved, the Board shall take appropriate steps to implement it.
(c) Each program, plan, or project implemented under this subpart shall be reviewed or evaluated periodically by the Board to ensure that it contributes to an effective program of promotion, research, or information. If it is found by the Board that any such program, plan, or project does not contribute to an effective program of promotion, research, or information, then the Board shall terminate such program, plan, or project.
(d) No program, plan, or project including advertising shall be false or misleading or disparaging to another agricultural commodity. Mangos of all origins shall be treated equally.
The Board shall, not less often than every five years, authorize and fund, from funds otherwise available to the Board, an independent evaluation of the effectiveness of the Order and other programs conducted by the Board pursuant to the Act. The Board shall submit to the Department, and make available to the public, the results of each periodic independent evaluation conducted under this paragraph.
Patents, copyrights, trademarks, information, publications, and product formulations developed through the use of funds received by the Board under this subpart shall be the property of the U.S. Government, as represented by the Board, and shall, along with any rents, royalties, residual payments, or other income from the rental, sales, leasing, franchising, or other uses of such patents, copyrights, trademarks, information, publications, or product formulations, inure to the benefit of the Board; shall be considered income subject to the same fiscal, budget, and audit controls as other funds of the Board; and may be licensed subject to approval by the Department Upon termination of this subpart, § 1206.73 shall apply to determine disposition of all such property.
(a) Each first handler will be required to provide to the Board periodically such information as may be required by the Board, with the approval of the Department, which may include but not be limited to the following:
(1) Number of pounds of domestic mangos handled;
(2) Number of pounds of domestic mangos on which an assessment was paid;
(3) Name and address of the producers from whom the first handler has received mangos;
(4) Date that assessment payments were made on each pound of domestic mangos handled;
(5) Number of pounds of domestic mangos exported;
(6) The first handler's tax identification number;
(b) Each importer may be required to provide to the Board periodically such information as may be required by the Board, with the approval of the Department, which may include but not be limited to the following:
(1) Number of pounds of mangos imported;
(2) Number of pounds of mangos on which an assessment was paid;
(3) Name, address, and tax identification number of the importer; and
(4) Date that assessment payments were made on each pound imported.
Each first handler and importer shall maintain and make available for inspection by the Department such books and records as are necessary to carry out the provisions of this part, any regulations issued under this part, including such records as are necessary to verify any reports required. Such records shall be retained for at least two years beyond the fiscal period of their applicability.
All information obtained from books, records, or reports under the Act and this part shall be kept confidential by all persons, including all employees and former employees of the Board, all officers and employees and former officers and employees of contracting and subcontracting agencies or agreeing parties having access to such information. Such information shall not be available to Board members, first handlers, or importers. Only those persons having a specific need for such information to effectively administer the provisions of this subpart shall have access to such information. Only such information so obtained as the Secretary deems relevant shall be disclosed by them, and then only in a judicial proceeding or administrative hearing
(a) The issuance of general statements based upon the reports of the number of persons subject to this subpart or statistical data collected therefrom, which statements do not identify the information furnished by any person; and
(b) The publication, by direction of the Secretary, of the name of any person who has been adjudged to have violated this part, together with a statement of the particular provisions of this part violated by such person.
All fiscal matters, programs, plans, or projects, rules or regulations, reports, or other substantive actions proposed and prepared by the Board shall be submitted to the Secretary for approval.
(a)
(1) The Department determines that the Order is consistent with and will effectuate the purposes of the Act; and
(2) The Order is approved by a majority of the first handlers and importers voting, who, during a representative period determined by the Department, have been engaged in the handling or importation of mangos.
(b)
(a) The Department shall suspend or terminate this part or subpart or a provision thereof if the Department finds that the subpart or a provision thereof obstructs or does not tend to effectuate the purposes of the Act, or if the Department determines that this subpart or a provision thereof is not favored by persons voting in a referendum conducted pursuant to the Act.
(b) The Department shall suspend or terminate this subpart at the end of the marketing year whenever the Department determines that its suspension or termination is approved or favored by a majority of the first handlers and importers voting who, during a representative period determined by the Department, have been engaged in the handling or importation of mangos.
(c) If, as a result of a referendum the Department determines that this subpart is not approved, the Department shall:
(1) Not later than 180 days after making the determination, suspend or terminate, as the case may be, collection of assessments under this subpart; and
(2) As soon as practical, suspend or terminate, as the case may be, activities under this subpart in an orderly manner.
(a) Upon the termination of this subpart, the Board shall recommend not more than five of its members to the Department to serve as trustees for the purpose of liquidating the affairs of the Board. Such persons, upon designation by the Department, shall become trustees of all of the funds and property then in the possession or under control of the Board, including claims for any funds unpaid or property not delivered, or any other claim existing at the time of such termination.
(b) The said trustees shall:
(1) Continue in such capacity until discharged by the Department;
(2) Carry out the obligations of the Board under any contracts or agreements entered into pursuant to the Order;
(3) From time to time, account for all receipts and disbursements and deliver all property on hand, together with all books and records of the Board and the trustees, to such person or persons as the Department may direct; and
(4) Upon request of the Department, execute such assignments or other instruments necessary and appropriate to vest in such persons title and right to all funds, property and claims vested in the Board or the trustees pursuant to the Order.
(c) Any person to whom funds, property or claims have been transferred or delivered pursuant to the Order shall be subject to the same obligations imposed upon the Board and upon the trustees.
(d) Any residual funds not required to defray the necessary expenses of liquidation shall be turned over to the Department to be disposed of, to the extent practical, to one or more mango industry organizations in the interest of continuing mango promotion, research, and information programs.
Unless otherwise expressly provided by the Department, the termination or amendment of this part or any subpart thereof, shall not:
(a) Affect or waive any right, duty, obligation or liability which shall have arisen or which may thereafter arise in connection with any provision of this part; or
(b) Release or extinguish any violation of this part; or
(c) Affect or impair any rights or remedies of the United States, or of the Department, or of any other persons with respect to any such violation.
No member or employee of the Board shall be held personally responsible, either individually or jointly with others, in any way whatsoever, to any person for errors in judgment, mistakes, or other acts, either of commission or omission, as such member or employee, except for acts of dishonesty or willful misconduct.
If any provision of this subpart is declared invalid or the applicability thereof to any person or circumstances is held invalid, the validity of the remainder of this subpart or the applicability thereof to other persons or circumstances shall not be affected thereby.
Amendments to this subpart may be proposed from time to time by the Board or by any interested person affected by the provisions of the Act, including the Department.
The control numbers assigned to the information collection requirements of this part by the Office of Management and Budget pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35, are OMB control number 0505-0001 and OMB control number 0581-0209.
Federal Aviation Administration (FAA), DOT.
Direct final rule; request for comments.
This action amends title 14 Code of Federal Regulations, part 71 (14 CFR 71) by revising Class E airspace at Lamar, MO. A review of the Class E airspace area extending upward from 700 feet above the surface at Lamar, MO revealed it does not reflect the current Lamar Municipal Airport airport reference point (ARP) and is not in compliance with established airspace criteria. This airspace area is enlarged and modified to conform to FAA Orders.
This direct final rule is effective on 0901 UTC, January 20, 2005. Comments for inclusion in the Rules Docket must be received on or before November 9, 2004.
Send comments on this proposal to the Docket Management System, U.S. Department of Transportation, Room Plaza 401, 400 Seventh Street, SW., Washington, DC 20590-0001. You must identify the docket number FAA-2004-18826/Airspace Docket No. 04-ACE-52, at the beginning of your comments. You may also submit comments on the Internet at
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.
This amendment to 14 CFR part 71 modifies the Class E airspace area extending upward from 700 feet above the surface at Lamar, MO. An examination of controlled airspace for Lamar, MO revealed that the Lamar Municipal Airport ARP used in the legal description for this Class E airspace area is incorrect and that the airspace area does not comply with airspace requirements for diverse departures as set forth in FAA Order 7400.2E, Procedures for Handling Airspace Matters. The examination also identified that the dimensions of the extension to the Class E airspace area are not in compliance with FAA Order 8260.19C, Flight Procedures and Airspace. This action expands the Lamar, MO Class E airspace area extending upward from 700 feet above the surface from a 6-mile radius to a 6.3-mile radius of Lamar Municipal Airport, corrects the ARP in the legal description, decreases the length and width of the extension from 7.4 to 7 miles and from 2.6 to 2.5 miles respectively and brings the legal description of the airspace area into compliance with FAA Orders 7400.2E and 8260.19C. This area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9M, Airspace Designations and Reporting Points, dated August 30, 2004, and effective September 16, 2004, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative, comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the
Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2004-18826/Airspace Docket No. 04-ACE-52.” The postcard will be date/time stamped and returned to the commenter.
The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.
The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Airspace, Incorporated by reference, Navigation (air)
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.3-mile radius of Lamar Municipal Airport and within 2.5 miles each side of the 221° bearing from the Spring River NDB extending from the 6.3-mile radius of the airport to 7 miles southwest of the NDB.
Securities and Exchange Commission.
Publication of staff accounting bulletin.
The interpretations in this staff accounting bulletin express the staff's views regarding the application of FASB Statement No. 143,
Effective September 28, 2004.
Cathy J. Cole or John W. Albert, Office of the Chief Accountant (202) 942-4400 or Leslie A. Overton, Division of Corporation Finance (202) 942-2960, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-1103.
The statements in staff accounting bulletins are not rules or interpretations of the Commission, nor are they published as bearing the Commission's official approval. They represent interpretations and practices followed by the Division of Corporation Finance and the Office of the Chief Accountant in administering the disclosure requirements of the Federal securities laws.
The text of SAB 106 will not appear in the Code of Federal Regulations.
The staff hereby adds Section 4 to Topic 12-D of the staff accounting bulletin series. Topic 12-D.4 provides guidance regarding the interaction of Statement of Financial Accounting Standards No. 143,
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides revised labeling for ivermectin oral paste used in horses.
This rule is effective October 4, 2004.
Martine Hartogensis, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-7815, e-mail:
Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, filed a supplement to NADA 134-314 for EQVALAN (ivermectin 1.87 percent) Paste for Horses. The supplemental application provides for revisions to the labeled indications. Specifically, under the sub-heading “Small Strongyles,” the labeling has been revised to separate the listing of adult species from the fourth-stage larvae. The supplemental NADA is approved as of August 9, 2004, and 21 CFR 520.1192 is amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Animal drugs.
21 U.S.C. 360b.
(e)
(ii)
(A) Large Strongyles (adults):
(B) Large Strongyles (adult) (
(iii)
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
This rule is effective October 4, 2004. Under this final rule, a PMA or a notice of completion of a PDP is required to be filed on or before January 3, 2005, for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
Pei Sung, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2036.
The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295) and the Safe Medical Devices Act of 1990 (Public Law 101-629), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) established the requirement that a preamendments device that FDA has classified into class III is subject to premarket approval. A preamendments class III device may be commercially distributed without an approved PMA or a notice of completion of a PDP until 90 days after FDA issues a final rule requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the act, whichever is later. Also, a preamendments device subject to the rulemaking procedure under section 515(b) of the act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final rule requiring the submission of a PMA for the device. At that time, an IDE is required only if a PMA has not been submitted or a PDP completed.
When a rule to require premarket approval for a preamendments device is finalized, section 501(f)(2)(B) of the act (21 U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of a PDP for any such device be filed within 90 days of the date of issuance of the final rule or 30 months after the final classification of the device under section 513 of the act, whichever is later. If a PMA or notice of completion of a PDP is not filed by the latter of the two dates, commercial distribution of the device must cease.
The device may, however, be distributed for investigational use if the manufacturer, importer, or other sponsor of the device complies with the IDE regulations. If a PMA or notice of completion of a PDP is not filed by the latter of the two dates, and no IDE is in effect, the device is deemed to be adulterated within the meaning of
The act does not permit an extension of the 90-day period after issuance of a final rule within which an application or notice is required to be filed. The House Report on the 1976 amendments states that “* * * the thirty month ‘grace period’ afforded after classification of a device into class III * * * is sufficient time for manufacturers and importers to develop the data and conduct the investigations necessary to support an application of premarket approval” (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).
In the
In the
The March 5, 2004, proposed rule also provided an opportunity for interested persons to submit comments on the proposed rule and the agency's proposed findings. In accordance with section 515(b)(2)(A) of the act, FDA also provided an opportunity for interested persons to request a change in the classification of the device based on new information relevant to its classification. Interested persons requesting a change in the classification of the devices were to submit a petition by March 22, 2004. The comment period closed June 3, 2004.
FDA received no petitions requesting a change in the classification of the hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. FDA received no comments on the proposed rule.
A hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis is a two-part device intended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device includes prostheses that consist of a femoral cap component made of a metal alloy, such as cobalt-chromium-molybdenum, or a ceramic material, that is placed over a surgically prepared femoral head, and an acetabular resurfacing polymer component. Both components are intended for use with bone cement.
Under section 515(b)(3) of the act, FDA is adopting the findings as published in the proposed rule of March 5, 2004. As required by section 515(b) of the act, FDA published its findings regarding the following topics: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring that these devices have an approved PMA or a declared completed PDP and (2) the benefits to the public from the use of the device.
These findings are based on the reports and recommendations of the Orthopaedic Device Classification Panel, an FDA advisory committee, for the classification of the device, along with FDA's comprehensive review of the literature.
Under section 515(b)(3) of the act, FDA adopts the findings as published in the preamble to the proposed rule and issues this final rule to require premarket approval for the hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. This final rule revises part 888 (21 CFR part 888).
Under the final rule, a PMA or a notice of completion of a PDP is required to be filed on or before 90 days after the date of publication of this rule in the
If a PMA or a notice of completion of a PDP for a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis is not filed on or before 90 days after the date of publication of this rule in the
The exemptions in § 812.2(c)(1) and (c)(2) from the requirements of the IDE regulations for preamendments class III devices cease to apply to any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that is either: (1) Not legally on the market on or before 90 days after the date of publication of this rule in the
A PMA for these devices must include the information required by section 515(c)(1) of the act. Such a PMA should also include a detailed discussion of the risks identified previously, as well as a discussion of the effectiveness of the device for which premarket approval is sought. In addition, a PMA must include all data and information on the following topics: (1) Any risks known, or that should be reasonably known, to the applicant that have not been identified in this document; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.
A PDP for any of these devices may be submitted in lieu of a PMA, and must follow the procedures outlined in section 515(f) of the act. A PDP should provide the following information: (1) A description of the device, (2) preclinical trial information (if any), (3) clinical trial information (if any), (4) a description of the manufacturing and processing of the devices, (5) labeling of the device, and (6) all other relevant information about the device. In addition, the PDP must include progress reports and records of the trials conducted under the protocol on the safety and effectiveness of the device for which the completed PDP is sought.
Information about the PDP process is also available from the Center for Devices and Radiological Health on the Internet at
The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the device has fallen out of use and FDA is not aware of any firm marketing the device, the agency has concluded that there is little or no interest in marketing this device in the future. The agency, therefore, certifies that the final rule will not have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $110 million. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.
This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA). The burden hours required for § 888.3410(c), included in the collection entitled “Premarket Approval of Medical Devices—21 CFR Part 814,” are reported and approved under OMB control number 0910-0231. Therefore, clearance by OMB under the PRA is not required.
Medical devices.
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(a)
(b)
(c)
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, First Coast Guard District, has issued a temporary deviation from the drawbridge operation regulations for the SR 127 Bridge, mile 0.0, across the Annisquam River, Blynman Canal, at Gloucester, Massachusetts. This deviation allows the bridge to remain in the closed position from 6 a.m. on November 6, 2004 through 6 p.m. on November 7, 2004. In the event of inclement weather the alternate bridge closure would be from 6 a.m. on November 13, 2004 through 6 p.m. on November 14, 2004. This temporary deviation is necessary to facilitate structural repairs at the bridge.
This deviation is effective from November 6, 2004 through November 14, 2004.
John McDonald, Project Officer, First Coast Guard District, at (617) 223-8364.
The SR 127 Bridge, at mile 0.0, across the Annisquam River, Blynman Canal, has a vertical clearance of 7 feet at mean high water, and 16 feet at mean low water in the closed position. The existing regulations are listed at 33 CFR 117.586.
The bridge owner, Massachusetts Highway Department, requested a temporary deviation from the drawbridge operating regulations to facilitate necessary structural repairs, the replacement of the swing cables, at the bridge.
This deviation to the operating regulations allows the SR 127 Bridge to remain in the closed position from 6 a.m. on November 6, 2004 through 6 p.m. on November 7, 2004. In the event the repair work scheduled above can not be performed due to inclement weather an alternate bridge closure will be implemented from 6 a.m. on November 13, 2004 through 6 p.m. on November 14, 2004.
This deviation from the operating regulations is authorized under 33 CFR 117.35 and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, First Coast Guard District, has issued a temporary deviation from the drawbridge operation regulations for the Newburyport US1 Bridge, mile 3.4, across the Merrimack River, Massachusetts. This deviation allows the bridge to remain in the closed position from 6 a.m. on October 18, 2004 through 6 p.m. on October 22, 2004. This temporary deviation is necessary to facilitate structural repairs at the bridge.
This deviation is effective from October 18, 2004 through October 22, 2004.
John McDonald, Project Officer, First Coast Guard District, at (617) 223-8364.
The Newburyport US1 Bridge, at mile 3.4, across the Merrimack River, has a vertical clearance of 35 feet at mean high water and 44 feet at mean low water in the closed position. The existing regulations are listed at 33 CFR 117.605(a).
The bridge owner, Massachusetts Highway Department, requested a temporary deviation from the drawbridge operating regulations to facilitate necessary structural repairs, the replacement of the locking pin motor and the brake unit, at the bridge.
This deviation to the operating regulations allows the bridge to remain in the closed position from 6 a.m. on October 18, 2004 through 6 p.m. on October 22, 2004.
This deviation from the operating regulations is authorized under 33 CFR 117.35 and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, First Coast Guard District, has issued a temporary deviation from the drawbridge operation regulations for the Amtrak Old Saybrook-Old Lyme Bridge, mile 3.4, across the Connecticut River, Connecticut. This deviation from the regulations allows the bridge to remain closed from 9 p.m. on October 5, 2004 through 9 a.m. on October 6, 2004, and from 9 p.m. on October 6, 2004 through 9 a.m. on October 7, 2004. This deviation is necessary in order to facilitate necessary inspection and repairs at the bridge.
This deviation is effective from October 5, 2004 through October 7, 2004.
Judy Leung-Yee, Project Officer, First Coast Guard District, at (212) 668-7195.
The Old Saybrook-Old Lyme, at mile 3.4, across the Connecticut River has a vertical clearance in the closed position of 19 feet at mean high water and 22 feet at mean low water. The existing drawbridge operating regulations are listed at 33 CFR 117.205(b).
The owner of the bridge, Amtrak, requested a temporary deviation from the drawbridge operating regulations to facilitate inspection and maintenance repairs at the bridge.
This deviation to the operating regulations allows the Old Saybrook-Old Lyme Bridge to remain closed from 9 p.m. on October 5, 2004 through 9 a.m. on October 6, 2004, and from 9 p.m. on October 6, 2004 through 9 a.m. on October 7, 2004.
In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, First Coast Guard District, has issued a temporary deviation from the drawbridge operation regulations for the Route 82 Bridge, mile 16.8, across the Connecticut River at East Haddam, Connecticut. This deviation from the regulations allows the bridge to operate on a fixed opening schedule from October 16, 2004 through November 30, 2004. Under this temporary deviation the bridge must open on signal at 5:30 a.m., 1:30 p.m., and 8 p.m., daily. The bridge must open on signal at all times for commercial vessels after at least a two-hour advance notice is given. This deviation is necessary in order to facilitate necessary repairs at the bridge.
This deviation is effective from October 16, 2004 through November 30, 2004.
Judy Leung-Yee, Project Officer, First Coast Guard District, at (212) 668-7195.
The Route 82 Bridge, at mile 16.8, across the Connecticut River has a vertical clearance in the closed position of 22 feet at mean high water and 25 feet at mean low water. The existing drawbridge operating regulations are listed at 33 CFR 117.205(c).
The owner of the bridge, Connecticut Department of Transportation, requested a temporary deviation from the drawbridge operating regulations to facilitate maintenance repairs at the bridge.
This deviation to the operating regulations allows the Route 82 Bridge to operate on a fixed opening schedule from October 16, 2004 through November 30, 2004. Under this temporary deviation the bridge must open on signal at 5:30 a.m., 1:30 p.m., and 8 p.m., daily. At all other times, the bridge must open on signal for commercial vessels, provided that at least a two hour advance notice is given.
In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary security zone in the navigable waters of the United States adjacent to Pier Three at the Military Ocean Terminal Concord (MOTCO), California (formerly United States Naval Weapons Center Concord, California). In light of recent terrorist actions against the United States, this security zone is necessary to ensure the safe loading of military equipment and to ensure the safety of the public from potential subversive acts. The security zone will prohibit all persons and vessels from entering, transiting through or anchoring within a portion of Suisun Bay within 500 yards of Pier Three at the MOTCO facility unless authorized by the Captain of the Port (COTP) or his designated representative.
This rule is effective from 11:59 p.m. on October 2, 2004, to 11:59 p.m. on October 12, 2004. If the need for this security zone ends before the scheduled termination time, the Captain of the Port will cease enforcement of the security zone and will announce that fact via Broadcast Notice to Mariners.
Documents indicated in this preamble as being available in the docket are part of docket [COTP San Francisco Bay 04-022] and are available for inspection or copying at Coast Guard Marine Safety Office San Francisco Bay, Coast Guard Island, Alameda, California, 94501, between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays.
Lieutenant Doug L. Ebbers, U.S. Coast Guard Marine Safety Office San Francisco Bay, at (510) 437-2770.
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 because the duration of the NPRM rulemaking process would extend beyond the actual period of the scheduled operations and defeat the protections afforded by the temporary rule to the cargo vessels, their crews, the public and national security.
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
Since the September 11, 2001 terrorist attacks on the World Trade Center in New York; the Pentagon in Arlington, Virginia; and Flight 93; the Federal Bureau of Investigation (FBI) has issued several warnings concerning the potential for additional terrorist attacks within the United States. In addition, the ongoing hostilities in Afghanistan and the conflict in Iraq have made it prudent for U.S. ports to be on a higher state of alert because Al-Qaeda and other organizations have declared an ongoing intention to conduct armed attacks on U.S. interests worldwide.
The threat of maritime attacks is real as evidenced by the attack on USS COLE and the subsequent attack in October 2002 against a tank vessel off the coast of Yemen. These threats manifest a continuing threat to U.S. assets as described in the President's finding in Executive Order 13273 of August 21, 2002 (67 FR 56215, September 3, 2002) that the security of
In its effort to thwart terrorist activity, the Coast Guard has increased safety and security measures on U.S. ports and waterways. As part of the Diplomatic Security and Antiterrorism Act of 1986 (Pub. L. 99-399), Congress amended section 7 of the Ports and Waterways Safety Act (PWSA), 33 U.S.C. 1226, to allow the Coast Guard to take actions, including the establishment of security and safety zones, to prevent or respond to acts of terrorism against individuals, vessels, or public or commercial structures. The Coast Guard also has authority to establish security zones pursuant to the Act of June 15, 1917, as amended by the Magnuson Act of August 9, 1950, (50 U.S.C. 191
In this particular rulemaking, to address the aforementioned security concerns, United States Army officials have requested that the Captain of the Port, San Francisco Bay, California, establish a temporary security zone in the navigable waters of the United States within 500 yards of Pier Three at the Military Ocean Terminal Concord (MOTCO), California, to safeguard vessels, cargo and crew engaged in military operations. This temporary security zone is necessary to safeguard the MOTCO terminal and the surrounding property from sabotage or other subversive acts, accidents or criminal acts. This zone is also necessary to protect military operations from compromise and interference and to specifically protect the people, ports, waterways, and properties of the Port Chicago and Suisun Bay areas.
In this temporary rule, the Coast Guard is establishing a fixed security zone encompassing the navigable waters, extending from the surface to the sea floor, within 500 yards of any portion of Pier Three at Military Ocean Terminal Concord (MOTCO), California. There are three existing piers at the MOTCO facility. Originally there were four piers, numbered One through Four from west to east, but Pier One was destroyed in an explosion in 1944. Therefore, Pier Three is the middle of the 3 remaining piers. The area encompassed by this security zone includes a portion of the Port Chicago Reach section of the deepwater channel. Persons and vessels are prohibited from entering, transiting through or anchoring within this security zone unless authorized by the Captain of the Port (COTP) or his designated representative.
The Captain of the Port will enforce this zone and may enlist the aid and cooperation of any Federal, State, county, municipal, and private agency to assist in the enforcement of the regulation. Section 165.33 of Title 33, Code of Federal Regulations, prohibits any unauthorized person or vessel from entering or remaining in a security zone. Vessels or persons violating this section may be subject to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192. Pursuant to 33 U.S.C. 1232, any violation of the security zone described herein, is punishable by civil penalties (not to exceed $32,500 per violation, where each day of a continuing violation is a separate violation), criminal penalties (imprisonment from 5 to 10 years and a maximum fine of $250,000), and in rem liability against the offending vessel. Any person who violates this section using a dangerous weapon, or who engages in conduct that causes bodily injury or fear of imminent bodily injury to any officer authorized to enforce this regulation, will also face imprisonment from 10 to 25 years. Vessels or persons violating this section are also subject to the penalties set forth in 50 U.S.C. 192: Seizure and forfeiture of the vessel to the United States, a maximum criminal fine of $10,000, imprisonment up to 10 years, and a civil penalty of not more than $25,000 for each day of a continuing violation.
This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).
Although this regulation restricts access to a portion of navigable waters, the effect of this regulation will not be significant because mariners will be advised about the security zone via public notice to mariners, and the zone will encompass only a small portion of the waterway for a short duration. In addition, vessels and persons may be allowed to enter this zone on a case-by-case basis with permission of the Captain of the Port or his designated representative.
The size of the zone is the minimum necessary to provide adequate protection for MOTCO, vessels engaged in operations at MOTCO, their crews, other vessels operating in the vicinity, and the public. The entities most likely to be affected are commercial vessels transiting to or from Suisun Bay via the Port Chicago Reach section of the channel.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners and operators of vessels intending to anchor or transit to or from Suisun Bay via the Port Chicago Reach section of the channel. Although the security zone will occupy a section of the navigable channel (Port Chicago Reach) adjacent to the Marine Ocean Terminal Concord (MOTCO), vessels may receive authorization to transit through the zone by the Captain of the Port or his designated representative on a case-by-case basis. Additionally, vessels engaged in recreational activities, sightseeing and commercial fishing will have ample space outside of the security zone to engage in those
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under
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). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation because we are establishing a security zone.
A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where located under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(2) Persons desiring to transit the area of this security zone may contact the Patrol Commander on scene on VHF-FM channel 13 or 16 or the Captain of the Port at telephone number 415-399-3547 to seek permission to transit the area. If permission is granted, all persons and vessels must comply with the instructions of the Captain of the Port or his designated representative.
(c)
Postal Service.
Final Rule.
This rule amends the Postal Service regulations to reflect current information regarding the publication and availability of the Domestic Mail Manual (DMM).
Sherry L. Freda, (202) 268-7259.
This rule amends 39 CFR part 111 to conform to the yearly publication schedule of the Domestic Mail Manual, and to reflect the publication and availability of the DMM to all users on the Internet at
Administrative practice and procedure.
5 U.S.C. 552(a); 39 U.S.C. 101, 401, 403, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3626, 5001.
Environmental Protection Agency (EPA).
Immediate final rule.
Nebraska has applied to the EPA for final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). The EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through this immediate final action. The EPA is publishing this rule to authorize the changes without a prior proposal because we believe this action is not controversial and do not expect comments that oppose it. Unless we receive written comments which oppose this authorization during the comment period, the decision to authorize Nebraska's changes to its hazardous waste program will take effect. If we receive comments that oppose this action, we will publish a document in the
This final authorization will become effective on December 3, 2004 unless the EPA receives adverse written comment by November 3, 2004. If the EPA receives such comment, it will publish a timely withdrawal of this immediate final rule in the
Submit your comments by one of the following methods:
1. Federal eRulemaking Portal:
2. E-mail:
3. Mail: Lisa Haugen, Environmental Protection Agency, ARTD/RESP, 901 North 5th Street, Kansas City, Kansas 66101.
4. Hand Delivery or Courier. Deliver your comments to Lisa Haugen, Environmental Protection Agency, ARTD/RESP, 901 North 5th Street, Kansas City, Kansas 66101.
Publicly available materials are available in hard copy at the Environmental Protection Agency, ARTD/RESP, 901 North 5th Street, Kansas City, Kansas 66101. The Regional Office's official hours of business are Monday through Friday, 8 a.m. to 4:30 p.m., excluding Federal holidays. Interested persons wanting to examine these documents should make an appointment with the office at least 24 hours in advance.
Lisa V. Haugen, U.S. EPA Region 7, ARTD/RESP, 901 North 5th Street, Kansas City, Kansas 66101, (913) 551-7877, or by e-mail at
States which have received final authorization from the EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask the EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to the EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 266, 268, 270, 273, and 279.
We conclude that Nebraska's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant Nebraska final authorization to operate its hazardous waste program with the changes described in the authorization application. Nebraska has responsibility for permitting treatment, storage, and disposal facilities within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that the EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, the EPA will implement those requirements and prohibitions in Nebraska, including issuing permits, until the State is granted authorization to do so.
The effect of this decision is that a facility in Nebraska subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. Nebraska has enforcement responsibilities under its State hazardous waste program for violations of such program, but the EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:
• Do inspections, and require monitoring, tests, analyses, or reports;
• Enforce RCRA requirements and suspend or revoke permits.
This action does not impose additional requirements on the regulated community because the regulations for which Nebraska is being authorized by today's action are already effective under State law, and are not changed by today's action.
The EPA did not publish a proposal before today's rule because we view this as a routine program change and do not expect comments that oppose this approval. We are providing an opportunity for public comment now. In addition to this rule, in the proposed rules section of today's
If the EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in the
Nebraska initially received final authorization on January 24, 1985, effective February 7, 1985 (50 FR 3345), to implement the RCRA hazardous waste management program. We granted authorization for changes to its program on October 4, 1985, effective December 3, 1988 (53 FR 38950); June 25, 1996, effective August 26, 1996 (61 FR 32699); June 4, 2002, effective April 22, 2002 (67 FR 38418); and April 10, 2003, effective June 9, 2003 (68 FR 17553).
On May 11, 2004, Nebraska submitted a final complete program revision application, seeking authorization of its changes in accordance with 40 CFR 271.21. We now make an immediate final decision, subject to the EPA's receipt of written comments that oppose this action, that Nebraska's hazardous waste program revision satisfies all of the requirements necessary to qualify for final authorization. Therefore, we grant Nebraska final authorization for the following program changes:
In this authorization of the Fourth Program Revision for the State of Nebraska there are no provisions that are more stringent or broader in scope. Broader in scope requirements are not part of the authorized program and the EPA cannot enforce them.
Nebraska will issue permits for all the provisions for which it is authorized and will administer the permits it issues. The EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization. We will not issue any more new permits or new portions of permits for the provisions listed in the Table above after the effective date of this authorization. The EPA will continue to implement and issue permits for HSWA requirements for which Nebraska is not yet authorized.
Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the CFR. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart CC for this authorization of Nebraska's program changes until a later date.
The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
Under RCRA 3006(b), the EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous waste, Hazardous waste transportation, Indian lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements.
This action is issued under the authority of sections 2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as amended 42 U.S.C. 6912(a), 6926, 6974(b).
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Amendment of February 4, 2004, order to embargo bird and bird products imported from Malaysia.
On February 4, 2004, the Centers for Disease Control and Prevention (CDC) issued an order immediately banning the import of all birds (Class:
This action is effective on September 28, 2004 and will remain in effect until further notice.
Paul Arguin, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Mailstop C-14, 1600 Clifton Road, Atlanta, GA 30330, telephone, 404-498-1600.
On August 19, 2004, the Office of International Epizootics (OIE), an international organization that reports the occurrence of animal diseases detected worldwide, listed Malaysia among the countries in which an outbreak of avian influenza was occurring. According to the OIE emergency report, there was a laboratory-confirmed report of H5N1 influenza virus on one farm in Malaysia at Kelantan State, Tumpat district, Pasir Pekan village. The initial flock of village chickens consisted of 60 birds of mixed ages, reared free range. Within a 1-km radius of the affected flock there are another 103 village chickens, 62 birds of mixed species and 8 ducks (173 birds total). On September 9, 2004, OIE reported a second laboratory-confirmed occurrence of H5N1 influenza in a flock of birds located in an area 5 kilometers from the previously infected flock. The susceptible avian population within the village included 1,608 chickens, 68 bantam chickens, 4 turkeys, 93 ducks, 9 geese, 60 quail, and 193 other species (2,035 birds total).
The government of Malaysia has instituted a number of control measures, including depopulation of poultry and birds within a one-kilometer radius of the infective flock; quarantine and clinical surveillance within a 10-kilometer radius of the inflected flock; and restrictions on the movement of birds and their products to other states within Malaysia.
Introduction of influenza A (H5N1)-infected birds into the United States could lead to outbreaks of disease in the human population, a significant public health threat. Banning the importation of all avian species from affected countries, including Malaysia, is an effective means of limiting this threat. CDC is therefore taking this action to reduce the chance of introduction or spread of influenza A (H5N1).
Therefore, pursuant to 42 CFR 71.32(b), the February 4, 2004, order is amended to add Malaysia to the list of countries subject to that order's embargo of birds and products derived from birds (including hatching eggs). All other portions of the February 4, 2004 order (69 FR 7165, Feb. 13, 2004) and the March 10, 2004 amendment (69 FR 12975, Mar. 19, 2004) shall remain in effect until further notice.
Federal Communications Commission.
Final rule, correction.
This document corrects an error in the dates and final rules sections of a
Effective October 4, 2004.
Jennifer Schneider, Attorney, Telecommunications Access Policy Division, Wireline Competition Bureau, (202) 418-7400.
This summary contains a correction to the dates and final rules sections of a
Federal Communications Commission.
Correcting amendment.
On April 11, 2002, the Commission adopted rules to establish technical, service and licensing rules governing Multichannel Video Distribution and Data Service (MVDDS) in the 12 GHz band. Because an error was made in the final rules, this document contains correcting amendments to the final rules that were published in the
Effective on October 4, 2004.
Jennifer Mock, Broadband Division, Wireless Telecommunications Bureau at (202) 418-2487.
The Federal Communications Commission published in the
Any impact as defined by the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, the Congressional Review Act (CRA), and the Regulatory Flexibility Act of 1980, as amended (RFA) was addressed at the time of adoption and release of the
Communications common carriers, Communications equipment, Radio.
47 U.S.C. 154, 303.
(g) * * *
(6) * * *
Waivers of § 101.1412(f) may be granted upon an affirmative showing:
(a) That the interest holder has less than a fifty percent voting interest in the licensee and there is an unaffiliated single holder of a fifty percent or greater voting interest;
(b) That the interest holder is not likely to affect the local market in an anticompetitive manner;
(c) That the interest holder is not involved in the operations of the licensee and does not have the ability to influence the licensee on a regular basis; and
(d) That grant of a waiver is in the public interest because the benefits to the public of common ownership outweigh any potential anticompetitive harm to the market.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Correcting amendments.
This document corrects a final rule (Docket NHTSA-03-15351) that was published Tuesday, June 24, 2003 (68 FR 37620). The rule updated test procedures in Federal Motor Vehicle Safety Standard (FMVSS) No. 213, “Child Restraint Systems,” and expanded the standard to restraints for children weighing up to 65 pounds.
Effective October 4, 2004.
Deirdre Fujita, Office of the Chief Counsel, NHTSA, telephone 202-366-2992; fax 202-366-3820, 400 Seventh St., SW., Washington, DC 20590.
The final rule that is the subject of this correction amended Federal Motor Vehicle Safety Standard No. 213,
As published, the final rule contains two minor errors that the agency wants to correct to ensure the clarity of the standard. First, there are two paragraphs designed (ii) in S6.1.1(a)(1). The first such paragraph should be changed to (i). Second, paragraph (e) of S7.1.1 should be removed. S7.1.1 sets forth requirements that apply to child restraints manufactured before August 1, 2005. Paragraph (e) relates to child restraints manufactured on or after August 1, 2005 and thus does not belong in S7.1.1.
Imports, Incorporation by reference, Motor vehicle safety, Reporting and recordkeeping requirements, Tires.
49 U.S.C. 322, 30111, 30115, 30117 and 30166; delegation of authority at 49 CFR 1.50.
S6.1.1 Test conditions.
(a)
(1) Add-on child restraints.
(i) The test device for add-on restraint systems manufactured before August 1, 2005 is a standard seat assembly consisting of a simulated vehicle bench seat, with three seating positions, which is described in Drawing Package SAS-100-1000 with Addendum A: Seat Base Weldment (consisting of drawings and a bill of materials), dated October 23, 1998 (incorporated by reference in § 571.5). The assembly is mounted on a dynamic test platform so that the center SORL of the seat is parallel to the direction of the test platform travel and so that movement between the base of the assembly and the platform is prevented.
(ii) The test device for add-on restraint systems manufactured on or after August 1, 2005 is a standard seat assembly consisting of a simulated vehicle bench seat, with three seating positions, which is depicted in Drawing Package, “NHTSA Standard Seat Assembly; FMVSS No. 213, No. NHTSA-213-2003,” (consisting of drawings and a bill of materials) dated June 3, 2003 (incorporated by reference; see § 571.5). The assembly is mounted on a dynamic test platform so that the center SORL of the seat is parallel to the direction of the test platform travel and so that movement between the base of the assembly and the platform is prevented.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain Gulfstream Aerospace LP Model Gulfstream 100 airplanes; and Model Astra SPX and 1125 Westwind Astra series airplanes. This proposed AD would require adjusting the ground contact switches of the main landing gear. This proposed AD is prompted by two occurrences of uncommanded deployments of the ground airbrakes during descent. We are proposing this AD to prevent a false “Ground” position signal, which could result in deployment of the ground airbrakes and reduced controllability of the airplane.
We must receive comments on this proposed AD by November 3, 2004.
Use one of the following addresses to submit comments on this proposed AD.
• DOT Docket Web site: Go to
• Government-wide rulemaking Web site: Go to
• Mail: Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, room PL-401, Washington, DC 20590.
• By fax: (202) 493-2251.
• Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For service information identified in this proposed AD, contact Gulfstream Aerospace Corporation, P.O. Box 2206, Mail Station D-25, Savannah, Georgia 31402.
You can examine the contents of this AD docket on the Internet at
The FAA has implemented new procedures for maintaining AD dockets electronically. As of May 17, 2004, new AD actions are posted on DMS and assigned a docket number. We track each action and assign a corresponding directorate identifier. The DMS AD docket number is in the form “Docket No. FAA-2004-99999.” The Transport Airplane Directorate identifier is in the form “Directorate Identifier 2004-NM-999-AD.” Each DMS AD docket also lists the directorate identifier (“Old Docket Number”) as a cross-reference for searching purposes.
We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed under
We will post all comments we receive, without change, to
We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications that affect you. You can get more information about plain language at
You can examine the AD docket on the Internet at
The Civil Aviation Administration of Israel (CAAI), which is the airworthiness authority for Israel, notified us that an unsafe condition may exist on certain Gulfstream Aerospace LP Model Gulfstream 100 airplanes; and Model Astra SPX and 1125 Westwind Astra series airplanes. The CAAI advises that increasing the adjustment margin of the ground contact switches of the main landing gear (MLG) could prevent a false “Ground” position signal. This condition, if not corrected, could result in deployment of the ground airbrakes and reduced controllability of the airplane.
Gulfstream Aerospace LP has issued Alert Service Bulletin 1125-32A-233, Revision 1, dated August 1, 2003. The service bulletin describes procedures for adjusting the ground contact switches of the MLG. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The CAAI mandated the service information and issued Israeli airworthiness directive 32-03-08-05, dated September 4, 2003, to ensure the continued airworthiness of these airplanes in Israel.
These airplane models are manufactured in Israel and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the CAAI has kept the FAA informed of the situation described above. We have examined the CAAI's findings, evaluated all pertinent information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.
Therefore, we are proposing this AD, which would require adjusting the ground contact switches of the MLG. The proposed AD would require you to use the service information described previously to perform these actions, except as discussed under “Difference Between the Proposed AD and Service Bulletin.”
Operators should note that, although the Accomplishment Instructions of the referenced service bulletin describe procedures for submitting a service reply card, this proposed AD would not require that action. We do not need this information from operators.
This proposed AD would affect about 106 airplanes of U.S. registry. The proposed actions would take about 3 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the proposed AD for U.S. operators is $20,670, or $195 per airplane.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD. See the
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):
(a) The Federal Aviation Administration must receive comments on this AD action by November 3, 2004.
(b) None.
(c) This AD applies to Gulfstream Aerospace LP Model Gulfstream 100 airplanes; and Model Astra SPX and 1125 Westwind Astra series airplanes; serial numbers 004 through 127 inclusive; certificated in any category.
(d) This AD was prompted by two occurrences of uncommanded deployments of the ground airbrakes during descent. We are issuing this AD to prevent a false “Ground” position signal, which could result in deployment of the ground airbrakes and reduced controllability of the airplane.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) Within 250 flight hours after the effective date of this AD, adjust the ground contact switches of the left and right main landing gear, in accordance with the Accomplishment Instructions of Gulfstream Alert Service Bulletin 1125-32A-233, Revision 1, dated August 1, 2003. Although the service bulletin referenced in this AD specifies to submit certain information to the manufacturer, this AD does not include that requirement.
(g) The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(h) Israeli airworthiness directive 32-03-08-05, dated September 4, 2003, also addresses the subject of this AD.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain RRD Tay 650-15 series turbofan engines. This proposed AD would require inspection of the high pressure compressor (HPC) shaft and high pressure turbine (HPT) shaft for spline flank wear. This proposed AD results from a number of occurrences of excessive HPC shaft and HPT shaft
We must receive any comments on this proposed AD by December 3, 2004.
Use one of the following addresses to submit comments on this proposed AD.
• DOT Docket Web site: Go to
• Government-wide rulemaking Web site: Go to
• Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590-001.
• Fax: (202) 493-2251.
• Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
You can get the service information identified in this proposed AD from Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, D-15827 Dahlewitz, Germany; telephone 49 (0) 33-7086-1768; fax 49 (0) 33-7086-3356.
You may examine the comments on this proposed AD in the AD docket on the Internet at
Ian Dargin, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803-5299; telephone (781) 238-7178; fax (781) 238-7199.
We have implemented new procedures for maintaining AD dockets electronically. As of May 17, 2004, we post new AD actions on the DMS and assign a DMS docket number. We track each action and assign a corresponding Directorate identifier. The DMS docket No. is in the form “Docket No. FAA-200X-XXXXX.” Each DMS docket also lists the Directorate identifier (“Old Docket Number”) as a cross-reference for searching purposes.
We invite you to submit any written relevant data, views, or arguments regarding this proposal. Send your comments to an address listed under
We will post all comments we receive, without change, to
We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications that affect you. You can get more information about plain language at
You may examine the docket that contains the proposal, any comments received, and any final disposition in person at the DMS Docket Offices between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone (800) 647-5227) is located on the plaza level of the Department of Transportation Nassif Building at the street address stated in
The Civil Aviation Authority (CAA), which is the airworthiness authority for the United Kingdom, recently notified us that an unsafe condition might exist on certain RRD Tay 650-15 series turbofan engines. The CAA advises that the spline flanks on the HPC shaft and HPT shaft may be developing excessive wear. The amount of wear is directly related to the amount of relative movement between the HPC and an immobilized HPT. You can detect wear by inspecting the engine to determine the amount of relative movement between the HPC and an immobilized HPT. On-wing and in-shop inspections found excessive spline flank wear on HPC shafts and HPT shafts that incorporated Service Bulletin (SB) No. TAY-72-1327 (hard coated abutment face) and HPC shafts and HPT shafts that did not incorporate SB No. TAY-72-1327.
We have reviewed and approved the technical contents of RRD SB No. TAY-72-1485, Revision 2, dated March 21, 2003 that describes procedures for inspecting the flanks on the HPC shaft and HPT shaft for wear. The CAA classified the initial Rolls-Royce plc (RR) SB as mandatory and issued airworthiness directive CAA 001-01-2002, dated January 11, 2002 in order to ensure the airworthiness of these RR engines in the United Kingdom. Subsequently, the certification responsibility was transferred to RRD and Revision 1 and Revision 2 were reclassified to “Recommended” by the Luftfahrt-Bundesamt (LBA), which is the aviation authority for Germany.
The RRD SB No. TAY-72-1485, Revision 2, dated March 21, 2003 specifies compliance times based on the date of receipt of the SB. We have mandated compliance times based on the effective date of this proposed AD.
At initial inspection, if the HPC shaft or HPT shaft has accumulated 3,000 flight cycles or more, RRD SB No. TAY-72-1485, dated January 11, 2002, specifies compliance within 12 months. At initial inspection, if the HPC shaft or HPT shaft has accumulated 3,000 flight cycles or more, we specify compliance within six months from the effective date of the final rule.
This engine model, manufactured in Germany, is type-certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. In keeping with this bilateral airworthiness agreement, the CAA and LBA have kept us informed of the situation described above. We have examined the findings of the CAA and LBA, reviewed all available information, and determined that AD action is necessary for products
There are about 390 RRD Tay 650-15 series turbofan engines of the affected design in the worldwide fleet. We estimate that 172 engines installed on airplanes of U.S. registry would be affected by this proposed AD. We also estimate that it would take about 4 work hours per engine to perform the proposed actions, and that the average labor rate is $65 per work hour. Based on these figures, we estimate the total cost of the proposed AD to U.S. operators, per inspection cycle, to be $44,720. We also estimate, for the HPC shaft of 172 engines to be replaced at teardown, with a parts cost of approximately $13,862 per shaft, the total cost of the proposed AD to U.S. operators to be $2,384,264.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a summary of the costs to comply with this proposal and placed it in the AD Docket. You may get a copy of this summary at the address listed under
Air transportation, Aircraft, Aviation safety, Safety.
Under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The Federal Aviation Administration (FAA) amends § 39.13 by adding a new airworthiness directive (AD) to read as follows:
(a) The FAA must receive comments on this AD action by December 3, 2004.
(b) None.
(c) This AD applies to RRD Tay 650-15 series turbofan engines. These engines are installed on, but not limited to, Fokker F100 airplanes.
(d) This AD results from a number of occurrences of excessive high pressure compressor (HPC) and high pressure turbine (HPT) shaft spline wear and spline flank wear discovered during on-wing and in-shop inspections. We are issuing this AD to prevent spline disengagement resulting in an overspeed event, which could lead to an uncontained engine failure and possible damage to the airplane.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified unless the actions have already been done.
(f) Within the compliance times specified in Table 1 of this AD, perform initial inspections of the HPC shaft splines and HPT shaft splines of RRD Tay 650-15 series turbofan engines. Use paragraph 3.A. of Accomplishment Instructions of RRD Service Bulletin (SB) No. TAY-72-1485, Revision 2, dated March 21, 2003, to do the inspections. Calculate spline wear using Appendix 1, paragraph 4.K., of RRD SB No. TAY-72-1485, Revision 2, dated March 21, 2003.
(g) Disposition the HPC shaft, HPT shaft, or engine as specified in Table 2 of this AD.
(h) Perform repetitive inspections of the HPC shaft splines and HPT shaft splines of RRD Tay 650-15 series turbofan engines. Use paragraph 3.A. of Accomplishment Instructions with Appendix 1 of RRD SB No. TAY-72-1485, Revision 2, dated March 21, 2003, to do the inspections. Calculate spline wear using Appendix 1, paragraph 4.K., of RRD SB No. TAY-72-1485, Revision 2, dated March 21, 2003.
(1) If wear measured in paragraph (f) of this AD was greater than or equal to 0.03 inch but less than 0.06 inch, repetitively inspect HPC shaft and HPT shaft within 1,000 cycles-since-last visual inspection (CSLI).
(2) If wear measured in paragraph (f) of this AD was less than 0.03 inch, repetitively inspect HPC shaft and HPT shaft within 5,500 CSLI.
(i) Disposition the HPC shaft, HPT shaft, or engine as specified in Table 2 of this AD.
(j) Previous credit is allowed for performing the initial inspections in paragraph (f) of this AD, that were done using the Accomplishment Instructions of one of the following, before the effective date of this AD:
(1) SB No. TAY-72-1485, dated January 11, 2002;
(2) SB No. TAY-72-1485, Revision 1, dated January 29, 2003; and
(3) SB No. TAY-72-1485, Revision 2, dated March 21, 2003.
(k) None.
(l) Civil Aviation Authority (CAA) airworthiness directive 001-01-2002, dated January 11, 2002, also addresses the subject of this AD.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all Boeing Model 707 airplanes and Model 720 and 720B series airplanes. This proposed AD would require repetitive inspections of the left and right support ribs for the main landing gear (MLG) trunnion, related investigative/corrective actions if necessary, and other specified actions. This proposed AD is prompted by reports of in-service cracking of the support ribs for the MLG trunnion. We are proposing this AD to detect and correct corrosion and cracking of the support ribs for the MLG trunnion, which could result in collapse of the MLG.
We must receive comments on this proposed AD by November 18, 2004.
Use one of the following addresses to submit comments on this proposed AD.
• DOT Docket Web site: Go to
• Government-wide rulemaking Web site: Go to
• Mail: Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, Room PL-401, Washington, DC 20590.
• By fax: (202) 493-2251.
• Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For service information identified in this proposed AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.
You can examine the contents of this AD docket on the Internet at
The FAA has implemented new procedures for maintaining AD dockets electronically. As of May 17, 2004, new AD actions are posted on DMS and assigned a docket number. We track each action and assign a corresponding directorate identifier. The DMS AD docket number is in the form “Docket No. FAA-2004-99999.” The Transport Airplane Directorate identifier is in the form “Directorate Identifier 2004-NM-999-AD.” Each DMS AD docket also lists the directorate identifier (“Old Docket Number”) as a cross-reference for searching purposes.
We invite you to submit any written relevant data, views, or arguments regarding this proposed AD. Send your comments to an address listed under
We will post all comments we receive, without change, to
We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications that affect you. You can get more information about plain language at
You can examine the AD docket on the Internet at
We have received reports of in-service cracking of the support ribs for the main landing gear (MLG) trunnion on Boeing Model 707 airplanes and Model 720 and 720B series airplanes. Investigation revealed that the cracking was caused by stress corrosion. This condition, if not corrected, could result in collapse of the MLG.
We have reviewed Boeing 707 Alert Service Bulletin A3510, dated January 15, 2004. Part I of the Accomplishment Instructions of the alert service bulletin describes procedures for doing a repetitive detailed inspection of the left and right support ribs for the MLG trunnion and related investigative/corrective and other specified actions. The inspection areas include both sides of the rib flanges, the web, the flange radius, and the support rib. The procedures include:
• Removing all corrosion inhibiting compound and sealant from the inspection areas.
• Removing the finish and blending the area smooth if deterioration, discoloration, blistering, wear, scratches, or raised rough/cracked areas in the surface finish are found.
• Contacting Boeing if blending into the base metal is necessary.
• Mechanically removing any corrosion.
• Contacting Boeing for repair information if any cracking is found.
• Applying cadmium plating to all areas where the surface finish was removed.
• Applying corrosion inhibitor to all exposed surfaces of the support fitting for the MLG trunnion.
Part II of the Accomplishment Instructions of the alert service bulletin includes procedures for doing a repetitive HFEC inspection of the left and right support ribs for the MLG trunnion, and corrective and other specified actions. The inspection areas include both sides of the web flange, the flange radius, the area around all bolt heads/nuts and fastener heads/collars for the upper and lower chords, and the rib around the edge of the support fitting for the MLG trunnion. The corrective and other specified actions include:
• Removing all corrosion inhibiting compound and sealant from the inspection areas.
• Contacting Boeing for repair information if any cracking is found.
• Applying cadmium plate to all areas where the surface finish was removed.
• Applying corrosion inhibitor to all exposed surfaces of the support fitting for the MLG trunnion, both sides of the flange radius of the upper and lower chords, and the rib supports.
Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition.
We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other airplanes of this same type design. Therefore, we are proposing this AD, which would require repetitive inspections for corrosion and cracking of the left and right support ribs for the main landing gear (MLG) trunnion, related investigative/corrective actions if necessary, and other specified actions. The proposed AD would require you to use the service information described previously to perform these actions, except as discussed under “Differences Between the Proposed AD and Service Information.”
The alert service bulletin specifies that the manufacturer may be contacted for disposition of certain repair conditions. This proposed AD would require the repair of those conditions in accordance with a method that we have approved or in accordance with data meeting the type certification basis of the airplane approved by a Boeing Company Designated Engineering Representative whom we have authorized to make such findings.
This proposed AD would affect about 227 airplanes worldwide. The following table provides the estimated costs for U.S. operators to comply with this proposed AD.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866;
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD. See the
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):
(a) The Federal Aviation Administration (FAA) must receive comments on this AD action by November 18, 2004.
(b) None.
(c) This AD applies to all Boeing Model 707-100 long body, -200, -100B long body, and -100B short body series airplanes; and Model 707-300, -300B, -300C, and -400 airplanes; and Model 720 and 720B series airplanes; certificated in any category.
(d) This AD was prompted by reports of in-service cracking of the support ribs for the main landing gear (MLG) trunnion. We are proposing this AD to detect and correct corrosion and cracking of the support ribs for the MLG trunnion, which could result in collapse of the MLG.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) The term “alert service bulletin,” as used in this AD, means the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3510, dated January 15, 2004.
(g) Within 6 months after the effective date of this AD: Do a detailed inspection for corrosion and cracking of the left and right support ribs of the MLG trunnion. Do the inspection in accordance with all of the actions in Part I of the alert service bulletin. Repeat the inspection thereafter at intervals not to exceed 6 months.
(h) If any corrosion or cracking is found during any inspection required by paragraph (g) of this AD: Before further flight, do all applicable related investigative and corrective actions, and the other specified actions, in accordance with the alert service bulletin; except, where the alert service bulletin specifies to contact Boeing, before further flight, repair in accordance with a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA; or in accordance with data meeting the type certification basis of the airplane approved by a Boeing Designated Engineering Representative (DER) who has been authorized by the Manager, Seattle ACO, to make such findings. For a repair method to be approved by the Manager, Seattle ACO, as required by this paragraph, the approval letter must specifically reference this AD.
(i) Within 12 months after the effective date of this AD: Do a HFEC inspection for cracking of the left and right support ribs of the MLG trunnion. Do the inspection in accordance with all of the actions in Part II of the alert service bulletin. Repeat the inspection thereafter at intervals not to exceed 12 months.
(j) If cracking is found during any inspection required by paragraph (i) of this AD: Before further flight, repair the cracked area in accordance with a method approved by the Manager, Seattle ACO; or in accordance with data meeting the type certification basis of the airplane approved by a Boeing DER who has been authorized by the Manager, Seattle ACO, to make such findings. For a repair method to be approved, the approval must specifically refer to this AD.
(k)(1) The Manager, Seattle ACO, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by a Boeing Company DER who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the approval must specifically refer to this AD.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede an existing airworthiness directive (AD) that applies to certain Airbus Model A300 B2 and B4 series airplanes; Model A300 B4-600, A300 B4-600R, C4-605R Variant F, and A300 F4-600R (collectively called A300-600) series airplanes; and Model A310 series airplanes. The existing AD currently requires replacement of the transformer rectifier units (TRUs) in the avionics compartment with new, improved TRUs. This proposed AD would require replacement of the TRUs installed according to the existing AD with different TRUs that are improved. This proposed AD is prompted by analysis that has revealed that certain diodes installed in the TRUs are the main factor contributing to the continuing TRU failures. We are proposing this AD to prevent failure of the TRUs. Failure of multiple TRUs could result in loss of the thrust reversers, autothrottle, flaps, and various systems (wing/cockpit window anti-ice, trim tank pumps, and windshield wipers) on the airplane; or display of incorrect information to the flightcrew.
We must receive comments on this proposed AD by November 3, 2004.
Use one of the following addresses to submit comments on this proposed AD.
• DOT Docket Web site: Go to
• Government-wide rulemaking Web site: Go to
• Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, room PL-401, Washington, DC 20590.
• Fax: (202) 493-2251.
• Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For service information identified in this proposed AD, contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.
You can examine the contents of this AD docket on the Internet at
Tim Backman, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 227-2797; fax (425) 227-1149.
The FAA has implemented new procedures for maintaining AD dockets electronically. As of May 17, 2004, new AD actions are posted on DMS and assigned a docket number. We track each action and assign a corresponding directorate identifier. The DMS AD docket number is in the form “Docket No. FAA-2004-99999.” The Transport Airplane Directorate identifier is in the form “Directorate Identifier 2004-NM-999-AD.” Each DMS AD docket also lists the directorate identifier (“Old Docket Number”) as a cross-reference for searching purposes.
We invite you to submit any written relevant data, views, or arguments regarding this proposed AD. Send your comments to an address listed under
We will post all comments we receive, without change, to
We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications that affect you. You can get more information about plain language at
You can examine the AD docket on the Internet at
On August 31, 2000, we issued AD 2000-18-07, amendment 39-11892 (65 FR 54407, September 8, 2000), for certain Airbus Model A300, A300-600, and A310 series airplanes. That AD requires replacement of the transformer rectifier units (TRUs) in the avionics compartment with new, improved TRUs (having part number (P/N) F11QY3121). That AD was prompted by issuance of mandatory continuing airworthiness information by a foreign civil airworthiness authority. We issued that AD to prevent failure of the TRUs. Failure of multiple TRUs could result in loss of the thrust reversers, autothrottle, flaps, and various systems (wing/cockpit window anti-ice, trim tank pumps, and windshield wipers) on the airplane; or incorrect information being displayed to the flightcrew.
Since we issued AD 2000-18-07, the Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, has informed the FAA that failures have continued to occur on the TRUs having P/N F11QY3121, which were installed according to French airworthiness directive 1999-435-296(B), dated November 3, 1999. (French airworthiness directive 1999-435-296(B) is the parallel French airworthiness directive to AD 2000-18-07.) Analysis of these failures by the airplane manufacturer has revealed that certain diodes installed in the TRUs having P/N F11QY3121 are the main factor contributing to the continuing TRU failures.
Airbus has issued Service Bulletins A300-24-0099, A300-24-6082, and A310-24-2088, all Revision 01, all dated December 18, 2003. These service bulletins describe procedures for replacing existing TRUs, having P/N F11QY3121, with new, improved TRUs, having P/N F11QY3714. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The DGAC mandated the service information and issued French airworthiness directive 2003-082R1, dated March 31, 2004, to ensure the continued airworthiness of these airplanes in France.
The Airbus service bulletins refer to Thales Service Bulletin F11QY3121-24-003, dated October 15, 2002, as an additional source of service information for modifying the existing TRUs to the improved configuration. Thales Service Bulletin F11QY3121-24-003 specifies that Thales Service Bulletins F11QY3121-24-001, dated February 2, 1998; and F11QY3121-24-002, dated October 5, 2000; must be done prior to or concurrent with Thales Service Bulletin F11QY3121-24-003. Those service bulletins modify TRUs having P/N F11QY3121 to include Amendments A and B, respectively. Thales Service Bulletin F11QY3121-24-003 modifies TRU P/Ns F11QY3121 with Amendments A and B, to P/N F11QY3714 (which is the P/N for the improved parts that the Airbus service bulletins recommend installing).
These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section
Therefore, we are proposing this AD, which would supersede AD 2000-18-07 to require replacing existing TRUs with new, improved TRUs. The proposed AD would require you to use the Airbus service information described previously to perform these actions.
The applicability of French airworthiness directive 2003-082R1 excludes airplanes on which Airbus Service Bulletin A300-24-0099 (for Model A300 B2 and B4 series airplanes), A300-24-6082 (for Model A300-600 series airplanes), or A310-24-2088 (for Model A310 series airplanes), has been accomplished in service. However, we have not excluded those airplanes from the applicability of this proposed AD. Rather, this proposed AD would include a requirement to accomplish the actions specified in those service bulletins. Such a requirement ensures that the actions specified in the service bulletins and that would be required by this proposed AD are accomplished on all affected airplanes. Operators must continue to operate the airplane in the configuration that would be required by this proposed AD unless an alternative method of compliance is approved.
The Accomplishment Instructions of Thales Service Bulletin F11QY3121-24-003 specify to “complete implementation of the [Service Information Letter] SIL F11QY3121-24-004.” We reviewed that Thales Service Information Letter (SIL), which contains recommendations about TRU overhaul. We have coordinated this issue with Airbus, and they have clarified that it was not their intent to require the recommendations in the SIL. Therefore, this proposed AD does not require doing the SIL.
We have revised the applicability of the existing AD to identify model designations as published in the most recent type certificate data sheet for the affected models.
This proposed AD would affect about 165 airplanes of U.S. registry.
The new proposed actions would take about 2 work hours per airplane, at an average labor rate of $65 per work hour. The parts manufacturer would provide required parts free of charge. Based on these figures, the estimated cost of the new actions specified in this proposed AD for U.S. operators is $21,450, or $130 per airplane.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD. See the
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing 39-11892 (65 FR 54407, September 8, 2000) and adding the following new airworthiness directive (AD):
(a) The Federal Aviation Administration must receive comments on this AD action by November 3, 2004.
(b) This AD supersedes AD 2000-18-07, amendment 39-11892.
(c) This AD applies to Model A300 B2 and B4 series airplanes; Model A300 B4-600, A300 B4-600R, C4-605R Variant F, and A300 F4-600R (collectively called A300-600) series airplanes; and Model A310 series airplanes; certificated in any category; except those on which Airbus Modification 12540 has been accomplished.
(d) This AD was prompted by analysis that has revealed that certain diodes installed in the transformer rectifier units (TRUs) are the main factor contributing to the continuing TRU failures. We are issuing this AD to prevent failure of multiple TRUs, which could result in loss of the thrust reversers, autothrottle, flaps, and various systems (wing/cockpit window anti-ice, trim tank pumps, and windshield wipers) on the airplane; or display of incorrect information to the flightcrew.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) Within 36 months after the effective date of this AD, replace the existing TRUs, having P/N F11QY3121, in the avionics compartment with new, improved TRUs having P/N F11QY3714, according to the Accomplishment Instructions of Airbus Service Bulletin A300-27-0099 (for Model A300 B2 and B4 series airplanes), A300-24-6082 (for Model A300-600 series airplanes), or A310-24-2088 (for Model A310 series airplanes); all Revision 01; all dated December 18, 2003; as applicable.
Airbus Service Bulletin A300-27-0099, A300-24-6082, or A310-24-2088; all Revision 01; refer to Thales Service Bulletin F11QY3121-24-003, dated October 15, 2002, as an additional source of service information for modifying the existing TRUs to the improved configuration. Thales Service Bulletin F11QY3121-24-003 specifies that Thales Service Bulletins F11QY3121-24-001, dated February 2, 1998; and F11QY3121-24-002, dated October 5, 2000; must be done to add Amendments A and B, respectively, to P/N F11QY3121 before the TRU can be modified to P/N F11QY3714 according to Thales Service Bulletin F11QY3121-24-003.
The Accomplishment Instructions of Thales Service Bulletin F11QY3121-24-003 specify to “complete implementation of the [Service Information Letter] SIL F11QY3121-24-004.” This AD does not require doing the Service Information Letter.
(g) Replacements done before the effective date of this AD according to Airbus Service Bulletin A300-27-0099 (for Model A300 B2 and B4 series airplanes), A300-24-6082 (for Model A300-600 series airplanes), or A310-24-2088 (for Model A310 series airplanes); dated October 11, 2002; as applicable; are acceptable for compliance with the corresponding action required by paragraph (a) of this AD.
(h) The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(i) French airworthiness directive 2003-082R1, dated March 31, 2004, also addresses the subject of this AD.
Environmental Protection Agency (EPA).
Proposed rule and request for comment.
EPA is proposing to grant a petition submitted by Bayer Polymers (Bayer) to exclude (or delist) a certain solid waste generated by its Baytown, Texas, facility from the lists of hazardous wastes.
EPA used the Delisting Risk Assessment Software (DRAS) in the evaluation of the impact of the petitioned waste on human health and the environment.
EPA bases its proposed decision to grant the petition on an evaluation of waste-specific information provided by the petitioner. This proposed decision, if finalized, would exclude the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act (RCRA).
If finalized, EPA would conclude that Bayer's petitioned waste is nonhazardous with respect to the original listing criteria and that the generation of K027, K104, K111, and K112 treated effluent from the facility's waste water treatment plant will not be hazardous at the point of generation because of the adequately reduces the likelihood of migration of constituents from this waste. EPA would also conclude that Bayer's process minimizes short-term and long-term threats from the petitioned waste to human health and the environment.
EPA will accept comments until November 3, 2004. EPA will stamp comments received after the close of the comment period as late. These late comments may not be considered in formulating a final decision. Your requests for a hearing must reach EPA by October 19, 2004. The request must contain the information prescribed in 40 CFR 260.20(d).
Please send three copies of your comments. You should send two copies to the Chief, Corrective Action and Waste Minimization Section (6PD-C), Multimedia Planning and Permitting Division, U. S. Environmental Protection Agency Region 6, 1445 Ross Avenue, Dallas, Texas 75202. You should send a third copy to the Texas Commission on Environmental Quality, P.O. Box 13087, Austin, TX 78712. Identify your comments at the top with this regulatory docket number: [R6-TXDEL-FY04-Bayer]. You may submit your comments electronically to Michelle Peace at
You should address requests for a hearing to Ben Banipal, Chief, Corrective Action and Waste Minimization Section (6PD-C), Multimedia Planning and Permitting Division, U.S. Environmental Protection Agency Region 6, 1445 Ross Avenue, Dallas, Texas 75202.
Michelle Peace (214) 665-7430.
The information in this section is organized as follows:
EPA is proposing to grant the delisting petition submitted by Bayer to have its Outfall 007 Treated Effluent (K027, K104, K111, and K112 listed hazardous waste) excluded, or delisted, from the definition of a hazardous waste.
Bayer's petition requests a delisting for the treated effluent derived from the treatment of hazardous waste water listed as K027, K104, K111, and K112 and non-hazardous waste water identified as brine header waste water. Bayer does not believe that the petitioned waste meets the criteria for which EPA listed it. Bayer also believes no additional constituents or factors could cause the waste to be hazardous. EPA's review of this petition included consideration of the original listing criteria, and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA). See Section 3001(f) of RCRA, 42 U.S.C. 6921(f), and 40 CFR 260.22 (d)(1)-(4). In making the initial delisting
Bayer currently discharges the treated effluent as permitted by its Texas Pollutant Discharge Elimination System (TPDES) permit. If the delisting exclusion is finalized, Bayer intends to dispose of the petitioned waste (
RCRA section 3001(f) specifically requires EPA to provide notice and an opportunity for comment before granting or denying a final exclusion. Thus, EPA will not grant the exclusion unless and until it addresses all timely public comments (including those at public hearings, if any) on this proposal.
RCRA section 3010(b)(1) at 42 USCA 6930(b)(1), allows rules to become effective in less than six months after EPA addresses public comments when the regulated facility does not need the six-month period to come into compliance. That is the case here, because this rule, if finalized, would reduce the existing requirements for persons generating hazardous wastes.
EPA believes that this exclusion should be effective immediately upon final publication because a six-month deadline is not necessary to achieve the purpose of section 3010(b), and a later effective date would impose unnecessary hardship and expense on this petitioner. These reasons also provide good cause for making this rule effective immediately, upon final publication, under the Administrative Procedure Act, 5 U.S.C. 553(d).
Because EPA is issuing this exclusion under the Federal RCRA delisting program, only States subject to Federal RCRA delisting provisions would be affected. This would exclude States who have received authorization from EPA to make their own delisting decisions.
EPA allows the States to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under section 3009 of RCRA, 42 U.S.C. 6929. These more stringent requirements may include a provision that prohibits a Federally issued exclusion from taking effect in the State. Because a dual system (that is, both Federal (RCRA) and State (non-RCRA) programs) may regulate a petitioner's waste, EPA urges petitioners to contact the state regulatory authority to establish the status of their wastes under the State law. Delisting petitions approved by EPA Administrator under 40 CFR 260.22 are effective in the State of Texas only after the final rule has been published in the
EPA published an amended list of hazardous wastes from nonspecific and specific sources on January 16, 1981, as part of its final and interim final regulations implementing section 3001 of RCRA. EPA has amended this list several times and published it in §§ 261.31 and 261.32. EPA lists these wastes as hazardous because: (1) They typically and frequently exhibit one or more of the characteristics of hazardous wastes identified in Subpart C of Part 261 (that is, ignitability, corrosivity, reactivity, and toxicity) or (2) they meet the criteria for listing contained in § 261.11(a)(2) or (a)(3).
Individual waste streams may vary, however, depending on raw materials, industrial processes, and other factors. Thus, while a waste described in these regulations generally is hazardous, a specific waste from an individual facility meeting the listing description may not be hazardous.
For this reason, §§ 260.20 and 260.22 provide an exclusion procedure, called delisting, which allows persons to prove that EPA should not regulate a specific waste from a particular generating facility as a hazardous waste.
A delisting petition is a request from a facility to EPA or an authorized State to exclude wastes from the list of hazardous wastes. The facility petitions EPA because it does not believe the wastes should be hazardous under RCRA regulations.
In a delisting petition, the petitioner must show that wastes generated at a particular facility do not meet any of the criteria for which the waste was listed. The criteria for which EPA lists a waste are in Part 261 and further explained in the background documents for the listed waste.
In addition, under § 260.22, a petitioner must prove that the waste does not exhibit any of the hazardous waste characteristics (that is, ignitability, reactivity, corrosivity, and toxicity) and present sufficient information for EPA to decide whether factors other than those for which the waste was listed warrant retaining it as a hazardous waste. See Part 261 and the background documents for the listed waste.
Generators remain obligated under RCRA to confirm whether their waste remains nonhazardous based on the hazardous waste characteristics even if EPA has “delisted” the waste.
Besides considering the criteria in § 260.22(a) and section 3001(f) of RCRA, 42 U.S.C. 6921(f), and in the background documents for the listed wastes, EPA must consider any factors (including additional constituents) other than those for which EPA listed the waste, if a reasonable basis exists that these additional factors could cause the waste to be hazardous.
EPA must also consider as hazardous waste mixtures containing listed hazardous wastes and wastes derived from treating, storing, or disposing of listed hazardous waste. See § 261.3(a)(2)(iii) and (iv) and (c)(2)(i), called the “mixture” and “derived-from” rules, respectively. These wastes are also eligible for exclusion and remain hazardous wastes until
On June 25, 2003, Bayer petitioned EPA to exclude from the lists of hazardous waste contained in §§ 261.31 and 261.32, the treated effluent that is discharged pursuant to Bayer's TPDES permit. The discharge originates at Outfall 007 and is piped to the discharge location described as the “diffuser near Hog Island into the Houston Ship Channel.” The waste stream is generated from the Bayer facility located in Baytown, Texas. The waste (EPA Hazardous Waste Nos. K027, K104, K111, and K112) is effluent, which has been treated at the facility's waste water treatment plant and is ultimately discharged to Outfall 007 in accordance with the facility's TPDES permit. Specifically, in its petition, Bayer requested that EPA grant an exclusion for 18,071,150 cubic yards (5.745 billion gallons) per calendar year of treated effluent resulting from the treatment of waste waters from the manufacturing processes at its facility.
Bayer produces plastics, coatings, polyurethanes, and industrial chemicals. Bayer is the first facility in the United States to employ Tower Biology, an onsite waste water treatment plant (the plant) process that uses bacteria to treat waste above ground to protect ground water resources. The waste waters treated at the plant are generated by the various manufacturing operations at the Baytown facility. Influent waste waters enter the plant via the “normal waste water header” or the “brine waste water header.” The waste water entering the plant via the normal waste water header is placed in the primary clarifier. From the primary clarifier, the waste water is placed in a tank that feeds the waste water to a denitrification reactor prior to treatment in the biological oxidation towers. Following biological treatment, the waste water is run through a secondary clarifier. Waste water from the clarifier is sent to an activated carbon absorption system. Upon exiting the carbon absorption system, the waste water is fed to a series of filters. After filtration, the treated waste water is placed in an outfall tank for subsequent discharge under Bayer's TPDES discharge permit.
Influent waste waters that enter the plant via the “brine waste water header” are placed in dedicated brine tanks and a brine carbon absorption system. After filtration, the brine waste water is commingled in the outfall tank with the treated normal waste water prior to being discharged in accordance with the Bayer TPDES discharge permit.
Treatment of the waste waters, which result from the manufacturing process generates the effluent that is classified as K027, K104, K111, and K112 listed hazardous wastes pursuant to 40 CFR § 261.31. The 40 CFR Part 261 Appendix VII hazardous constituents which are the basis for listing K027, K104, K111, and K112 hazardous wastes are: toluene diisocyanate, aniline, benzene, diphenylamine, nitrobenzene, phenylenediamine, 2,4-dinitrotoluene, 2,4-toluenediamine, o-toluidine, and p-toluidine.
To support its petition, Bayer submitted:
(1) Results of the total constituent analysis for volatile and semivolatile organics, pesticides, herbicides, dioxins/furans, PCBs and metals for six samples.
(2) Descriptions of the waste water treatment process and effluent.
EPA believes that the descriptions of Bayer's waste water treatment process, in addition to the analytical data submitted in support of the petition show that the treated effluent is nonhazardous. Analytical data from Bayer's treated effluent samples were used in the Delisting Risk Assessment Software. The data summaries for detected constituents are presented in Table 1. EPA has reviewed the sampling procedures used by Bayer and has determined they satisfy EPA's criteria for collecting representative samples of the variations in constituent concentrations in the treated effluent. The data submitted in support of the petition show that constituents in Bayer's waste is presently below health-based risk levels used in the delisting decision-making. EPA believes that Bayer has successfully demonstrated that the treated effluent is nonhazardous.
For this delisting determination, we assumed that the most reasonable, worst case scenario would be if the effluent were disposed in a surface impoundment and we considered transport of waste constituents through ground water, surface water and air.
We evaluated Bayer's petitioned waste using the Agency's Delisting Risk Assessment Software (DRAS) to predict the concentration of hazardous constituents that might be released from the petitioned waste and to determine if the waste would pose a threat. The DRAS uses EPA's Composite Model for leachate migration with Transformation Products (EPACMTP) to predict the potential for release to groundwater from the wastes and subsequent routes of exposure to a receptor. From a release to ground water, we considered routes of exposure to a human receptor via ingestion of contaminated ground water, inhalation from ground water via showering and dermal contact while bathing. The DRAS program evaluates the subsequent routes of exposure to a human receptor from such releases through exposure pathways of fish ingestion and ingestion of drinking water. The DRAS also considers releases of waste particles and volatile emissions to air from the surface of an open impoundment. From a release to air, we considered as routes of exposure of inhalation of particulates and absorption into the lungs; ingestion of particulates eliminated from respiratory passages and subsequently swallowed, air deposition of particulates and subsequent ingestion of the soil/waste mixture; and inhalation of volatile constituents.
We used the maximum estimated waste volume and the maximum reported total concentration to estimate the constituent concentrations in the ground water, soil, surface water and/or air.
Assuming a cancer risk of 1 × 10 − 5 and a hazard quotient of one, the DRAS program back calculated a maximum allowable concentration level which did not exceed protective levels in the waste for each constituent at the given annual waste volume of 18,071,150 cubic yards (5.475 billion gallons).
EPA concluded, after reviewing Bayer's waste water treatment process that no other hazardous constituents of concern, other than those for which tested, are likely to be present or formed as reaction products or by-products in Bayer's wastes. In addition, on the basis of explanations and analytical data provided by Bayer, pursuant to § 260.22, EPA concludes that the effluent does not exhibit any of the characteristics of ignitability, corrosivity, reactivity, or toxicity. See §§ 261.21, 261.22 ,261.23, and 261.24 respectively.
During the evaluation of this petition, EPA also considered the potential impact of the petitioned waste via non-ground water routes (
The descriptions by Bayer of the hazardous waste process and analytical characterization, with the proposed verification testing requirements (as discussed later in this notice), provide a reasonable basis for EPA to grant the exclusion. The data submitted in support of the petition show that constituents in the waste are below the maximum allowable concentrations (See Table 1). EPA believes that the treated effluent generated by Bayer contains hazardous constituents at levels, which will present minimal short-term and long-term threats to human health and the environment.
Thus, EPA believes that it should grant to Bayer an exclusion for the treated effluent. EPA believes that the
EPA has reviewed the sampling procedures used by Bayer and has determined they satisfy EPA's criteria for collecting representative samples of variable constituent concentrations in the treated effluent. The data submitted in support of the petition show that constituents in Bayer's wastes are presently below the compliance-point concentrations used in the delisting decision-making process and would not pose a substantial hazard to the environment and the public. EPA believes that Bayer has successfully demonstrated that the treated effluent is nonhazardous.
EPA, therefore, proposes to grant an exclusion to Bayer, in Baytown, Texas, for the treated effluent described in its June 2003 petition. EPA's decision to exclude this waste is based on analysis performed on samples taken of the treated effluent.
If EPA finalizes the proposed rule, EPA will no longer regulate the treated effluent under Parts 262 through 268 and the permitting standards of Part 270.
The petitioner, Bayer, must comply with the requirements in 40 CFR Part 261, Appendix IX, Table 2 as amended by this notice. The text below gives the rationale and details of those requirements.
This paragraph provides the levels of constituent concentrations that Bayer must test for in the treated effluent, below which these wastes would be considered nonhazardous.
EPA selected the set of inorganic and organic constituents specified in paragraph (1) and listed in 40 CFR Part 261, Appendix IX, Table 2, based on information in the petition. EPA compiled the inorganic and organic constituents list from descriptions of the manufacturing process used by Bayer, previous test data provided for the waste, and the respective health-based levels used in delisting decision-making. These delisting levels correspond to the allowable levels measured in the total concentrations of the treated effluent. The limits described here do not relieve Bayer of its duty to comply with discharge limits described in its TPDES permit for the effluent.
Waste classification as non-hazardous cannot begin until compliance with the limits set in paragraph (1) has occurred for two consecutive quarterly sampling events. For example, if Bayer is issued a final exclusion in August, the first quarter samples are due in November and the second quarter samples are due in February. If EPA deems that both the first and second quarter samples (a total of four) meet all the delisting limits, classification of the waste as non-hazardous cannot begin until March. If constituent levels in any sample taken by Bayer exceed any of the delisting levels set in paragraph (1), Bayer must do the following: (i) notify EPA in accordance with paragraph (6), and; (ii) manage and dispose the treated effluent per its TPDES discharge permit as hazardous waste generated under Subtitle C of RCRA. The delisting for the treated effluent applies only during periods of TPDES compliance.
Bayer must complete a verification testing program on the treated effluent to assure that the waste does not exceed the maximum levels specified in paragraph (1). If EPA determines that the data collected under this paragraph does not support the data provided for in the petition, the exclusion will not cover the tested waste. This verification program operates on two levels.
The first part of the quarterly verification testing program consists of testing a batch of treated effluent for specified indicator parameters as per paragraph (1). Each quarterly sampling event will consist of at least two samples of the treated effluent. Levels of constituents measured in the samples of the treated effluent that do not exceed the levels set forth in paragraph (1) can be considered nonhazardous after two consecutive quarters of sampling data meet the levels listed in paragraph (1).
The second part of the verification testing program is the annual testing of two representative composite samples of treated effluent for all constituents specified in paragraph (1).
If Bayer demonstrates for two consecutive quarters complete attainment of all specified limits, then Bayer may request approval of EPA to reduce the frequency of testing to annually. If, after review of performance of the treatment system, EPA finds that annual testing is adequately protective of human health and the environment, then EPA may authorize Bayer to reduce the quarterly comprehensive sampling frequency to an annual basis. If the annual testing of the waste does not meet the delisting levels in paragraph 1, Bayer must notify EPA according to the requirements in paragraph 6. EPA will then take the appropriate actions necessary to protect human health and the environment per paragraph 6. Bayer must provide sampling results that support the rationale that the delisting exclusion should not be withdrawn.
The exclusion is effective upon publication in the
Paragraph (4) would allow Bayer the flexibility of modifying its processes (for example, changes in equipment or change in operating conditions) to improve its treatment processes. However, Bayer must prove the effectiveness of the modified process and request approval from EPA. Bayer must manage wastes generated during the new process demonstration as hazardous waste through verification sampling within 30 days of start-up.
To provide appropriate documentation that the Bayer facility is managing the treated effluent, Bayer must compile, summarize, and keep delisting records on-site for a minimum of five years. It should keep all analytical data obtained through paragraph (3), including quality control information, for five years. Paragraph (5) requires that Bayer furnish these data upon request for inspection by any employee or representative of EPA or the State of Texas.
If the proposed exclusion is made final, then it will apply only to 18,071,150 cubic yards (5.475 billion gallons) per calendar year of treated effluent generated at the Bayer facility after successful verification testing.
EPA would require Bayer to submit additional verification data under any of the following circumstances:
(a) If Bayer significantly alters the manufacturing process treatment system except as described in paragraph (4).
(b) If Bayer uses any new manufacturing or production
(c) If Bayer makes any changes that could affect the composition or type of waste generated.
Bayer must submit a modification to the petition complete with full sampling and analysis for circumstances where the waste volume changes and/or additional waste codes are added to the waste stream.
Bayer must manage waste volumes greater than 18,071,150 cubic yards (5.475 billion gallons) per calendar year of treated effluent as hazardous waste until EPA grants a revised exclusion. When this exclusion becomes final, the management of the treated effluent by Bayer covered in this petition would be relieved from Subtitle C jurisdiction. Bayer may not classify the waste as non-hazardous until the revised exclusion is finalized.
The purpose of paragraph (6) is to require Bayer to disclose new or different information related to a condition at the facility or disposal of the waste, if it is pertinent to the delisting. Bayer must also use this procedure, if the waste sample in the annual testing fails to meet the levels found in paragraph (1). This provision will allow EPA to reevaluate the exclusion, if a source provides new or additional information to EPA. EPA will evaluate the information on which it based the decision to see, if it is still correct, or if circumstances have changed so that the information is no longer correct or would cause EPA to deny the petition, if presented.
This provision expressly requires Bayer to report differing site conditions or assumptions used in the petition in addition to failure to meet the annual testing conditions within 10 days of discovery. If EPA discovers such information itself or from a third party, it can act on it as appropriate. The language being proposed is similar to those provisions found in RCRA regulations governing no-migration petitions at § 268.6.
It is EPA's position that it has the authority under RCRA and the Administrative Procedures Act (APA), 5 U.S.C. § 551 (1978)
EPA believes a clear statement of its authority in delistings is merited in light of EPA's experience.
If Bayer violates the terms and conditions established in the exclusion, EPA will start procedures to withdraw the exclusion. Where there is an immediate threat to human health and the environment, EPA will evaluate the need for enforcement activities on a case-by-case basis. EPA expects Bayer to conduct the appropriate waste analysis and comply with the criteria explained above in paragraph (1) of the exclusion.
EPA is requesting public comments on this proposed decision. Please send three copies of your comments. Send two copies to the Chief, Corrective Action and Waste Minimization Section, Multimedia Permitting and Planning Division, U.S. Environmental Protection Agency Region 6, 1445 Ross Avenue, Dallas, Texas 75202. Send a third copy to the Industrial Hazardous Waste Permits Division, Technical Evaluation Team, Texas Commission on Environmental Quality, P.O. Box 13087, Austin, TX 78711-3087. Identify your comments at the top with this regulatory docket number: R6-FY04-Bayer. You may submit your comments electronically to Michelle Peace at
You may review the RCRA regulatory docket for this proposed rule at the U.S. Environmental Protection Agency Region 6, 1445 Ross Avenue, Dallas, TX 75202. It is available for viewing in EPA Freedom of Information Act Review Room from 9 a.m. to 4 p.m., Monday through Friday, excluding Federal holidays. Call (214) 665-6444 for appointments. The public may copy material from any regulatory docket at no cost for the first 100 pages and at fifteen cents per page for additional copies.
Under Executive Order 12866, EPA must conduct an “assessment of the potential costs and benefits” for all “significant” regulatory actions.
The proposal to grant an exclusion is not significant, since its effect, if promulgated, would be to reduce the overall costs and economic impact of EPA's hazardous waste management regulations. This reduction would be achieved by excluding waste generated at a specific facility from EPA's lists of hazardous wastes, thus enabling a facility to manage its waste as nonhazardous.
Because there is no additional impact from this proposed rule, this proposal would not be a significant regulation, and no cost/benefit assessment is required. The Office of Management and Budget (OMB) has also exempted this rule from the requirement for OMB review under Section (6) of Executive Order 12866.
Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, whenever an agency is required to publish a general notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis which describes the impact of the rule on small entities (that is, small businesses, small organizations, and small governmental jurisdictions). No regulatory flexibility analysis is required, however, if the Administrator or delegated representative certifies that the rule will not have any impact on small entities.
This rule, if promulgated, will not have an adverse economic impact on small entities since its effect would be to reduce the overall costs of EPA's hazardous waste regulations and would be limited to one facility. Accordingly, EPA hereby certifies that this proposed regulation, if promulgated, will not have a significant economic impact on a substantial number of small entities. This regulation, therefore, does not require a regulatory flexibility analysis.
Information collection and recordkeeping requirements associated with this proposed rule have been approved by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act of 1980 (Public Law 96 511, 44 U.S.C. 3501
Under section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA),
When such a statement is required for EPA rules, under section 205 of the UMRA EPA must identify and consider alternatives, including the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. EPA must select that alternative, unless the Administrator explains in the final rule why it was not selected or it is inconsistent with law.
Before EPA establishes regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must develop under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, giving them meaningful and timely input in the development of EPA's regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising them on compliance with the regulatory requirements.
The UMRA generally defines a Federal mandate for regulatory purposes as one that imposes an enforceable duty upon state, local, or tribal governments or the private sector.
EPA finds that this delisting decision is deregulatory in nature and does not impose any enforceable duty on any State, local, or tribal governments or the private sector. In addition, the proposed delisting decision does not establish any regulatory requirements for small governments and so does not require a small government agency plan under UMRA section 203.
The Executive Order 13045 is entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This order applies to any rule that EPA determines (1) is economically significant as defined under Executive Order 12866, and (2) the environmental health or safety risk addressed by the rule has a disproportionate effect on children. If the regulatory action meets both criteria, EPA 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 EPA. This proposed rule is not subject to E.O. 13045 because this is not an economically significant regulatory action as defined by Executive Order 12866.
Because this action does not involve any requirements that affect Indian tribes, the requirements of section 3(b) of Executive Order 13084 do not apply.
Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments.
If the mandate is unfunded, EPA must provide to the Office Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation.
In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments to have “meaningful and timely input” in the development of regulatory policies on matters that significantly or uniquely affect their communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.
Under Section 12(d) of the National Technology Transfer and Advancement Act, EPA is directed 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 (
This rule does not establish any new technical standards and thus, EPA has no need to consider the use of voluntary consensus standards in developing this final rule.
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.”
Under section 6 of Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless EPA consults with State and local officials early in the process of developing the proposed regulation.
This action does not have federalism implication. It will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it affects only one facility.
Environmental protection, Hazardous waste, Recycling, Reporting and recordkeeping requirements.
Sec. 3001(f) RCRA, 42 U.S.C. 6921(f).
For the reasons set out in the preamble, 40 CFR part 261 is proposed to be amended as follows:
1. The authority citation for part 261 continues to read as follows:
42 U.S.C. 6905, 6912(a), 6921, 6922, and 6938.
2. In Table 2 of Appendix IX of part 261 add the following waste stream in alphabetical order by facility to read as follows:
Environmental Protection Agency (EPA).
Proposed rule.
Nebraska has applied to the EPA for final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act. The EPA proposes to grant final authorization to Nebraska. In the “Rules and Regulations” section of this
Send your written comments by November 3, 2004.
Comments may be mailed to Lisa Haugen, Environmental Protection Agency, ARTD/RESP, 901 North 5th Street, Kansas City, Kansas 66101. Comments may also be submitted electronically or through hand delivery/courier; please follow the detailed instructions in the
Lisa V. Haugen at the above address, by phone at (913) 551-7877, or by e-mail at
For additional information, please see the immediate final rule published in the “Rules and Regulations” section of this
Federal Communications Commission.
Proposed rule; extension of comment period.
In this document, the Federal Communications Commission is extending the comment and reply comment period for the Third Notice of Proposed Rulemaking (NPRM). The Commission finds that it is in the public interest to extend the time for the filing of comments and reply comments on the NPRM.
The time for filing comments on all issues raised in the NPRM, including Paperwork Reduction Act is extended to December 3, 2004, and the time for filing reply comments is extended January 3, 2005.
Charlie Oliver, 202-418-2487.
This is a summary of an Order released by the Commission, extending the time for filing comments and reply comments on the Third Notice of Proposed Rulemaking (NPRM), FCC 04-78, released on May 5, 2004. Comment due dates contained in the summary of the NPRM published in the
Office of Personnel Management.
Proposed regulations.
The Office of Personnel Management (OPM) is issuing proposed regulations to amend the Federal Employees' Group Life Insurance (FEGLI) Acquisition Regulation. The proposed regulations incorporate changes in administrative policy and practices and make clarifying language changes.
OPM must receive comments on or before December 3, 2004.
Send written comments to Abby L. Block, Deputy Associate Director for Employee and Family Support Policy, Strategic Human Resources Policy Division, Office of Personnel Management, 1900 E Street NW., Washington, DC 20415; or deliver to OPM, Room 3425, 1900 E Street NW.; or FAX to (202) 606-0633.
Karen Leibach, (202) 606-0004.
On August 27, 1993, OPM issued the Life Insurance Federal Acquisition Regulation (LIFAR), 48 CFR chapter 21, which identifies basic and significant acquisition policies that are unique to the FEGLI Program. The proposed regulations explain changes in the FEGLI Program's policies, update Federal Acquisition Regulation (FAR) changes, and make clarifying changes to the language.
Some of the more significant changes in the regulations are:
LIFAR 2101.102(b), Authority, is modified to reflect the prior consolidation of 5 CFR parts 870 through 874 into one part, part 870. An identical change is also made in 2109.7001(a).
The revised regulation provides that both OPM and the Contractor, with the approval of OPM, may issue FEGLI literature to employees (2103.570(a)). The language clarifies that the FEGLI Program Booklet, along with valid election documents, serves as certification of coverage under the FEGLI Program. The Booklet alone does not suffice as certification of coverage.
Under revised 2110.7002, Contractor investment of FEGLI Program funds, the Contractor is not responsible for any actions regarding investment strategy to maximize investment income when and if such actions were directed by OPM. This modification protects the Contractor in the event it is requested to take an action that could have an adverse impact on its responsibility to manage and invest Program funds in a prudent manner. The same modification occurs in 2152.210-70(a).
Section 2131.109, Advance agreements, increases the threshold from $25,000 to $100,000 for precontract and nonrecurring costs of the Contractor. We consider this change reasonable in relation to the total cost of the FEGLI contract. We are making a similar change at 2131.205-32.
A new subparagraph, Administrative Expense Ceiling, is added to 2152.231-70 (Accounting and allowable cost). Calculated annually, the administrative expense ceiling is based on the Contractor's prior year's administrative expense ceiling and adjusted by the percent change in the Consumer Price Index for All Urban Consumers for the preceding 12 months. Both OPM and the Contractor will reexamine the base, including the prior year's actual expenses, if either party so requests.
During a continuation of services period, revised policy allows for a one-time negotiated increase in the administrative expense ceiling to handle phase-in/phase-out costs. All costs, including costs that exceed the revised ceiling, must be actual, allowable, allocable, and reasonable under FAR cost principles. Since indirect costs are charged against an annual administrative expense ceiling, the policy on indirect costs is modified (2131.203) to delete reference to a “dividend or retention formula.” Under the ceiling, a separate annual limit for indirect costs is negotiated between OPM and the Contractor.
An OPM policy change adds an incentive fee the Contractor can earn for exceptional performance during a continuity of services period (2137.102 and 2152.237-70). The incentive fee cannot exceed the pro rata risk or service charge for the same period. A new factor, Transitional services, is added to the weighted guidelines at 2115.404-71 (Profit analysis factors) to reflect this change and is only applicable during a continuity of services period.
Also, during a continuity of services period, OPM will not initiate any changes to the LIFAR (2101.370). This does not, however, exempt the Contractor from complying with statutory changes that may take effect during such a period.
The proposed regulation establishes a letter of credit (LOC) account for the Contractor (2132.170), which will be credited on the first business day of each month with one-twelfth of the estimated annual premium payment. The December payment will be credited to the LOC account no later than the last business day of each calendar year. Interest earnings on the LOC account will be made available for drawdown by the Contractor. Withdrawals from the LOC account for benefit costs of $5,000 or more will be made on a claims-paid basis. Withdrawals from the LOC
The proposed regulation clarifies the start date of the 31-day grace period that follows the date premiums are due. Since OPM cannot credit the LOC account if the first of the month falls on a non-business day, the revised regulations: (1) Define “grace period” at 2102.101 as 31 days from and including the payment due date of the first business day of the month; and (2) provide that the annual estimated premium, which will be credited to the Contractor's LOC account in 12 equal monthly installments, is due and available for drawdown on the first business day of the month. The grace period is also referenced in 2149.002, Applicability, and 2152.249-70, Renewal and termination.
Also under 2152.249-70, Renewal and termination, the Contractor agrees to reinstate the contract if termination occurs as the result of the Government's failure to make premium payments before the grace period ends due to circumstances beyond the Government's control. In such situations, the Contractor will allow an additional 5 days after the expiration of the grace period for OPM to make payment to the Contractor. Notwithstanding the above, the Contractor and OPM can agree to continue the contract.
The proposed regulation states that the Contractor is not responsible for continued performance as a result of OPM's failure to make timely premium payments. Were such a circumstance to occur, it would be unfair to expect the Contractor to continue to make benefits payments on a regular basis and subsequently seek recovery from OPM (2137.102 and 2152.237-70). This Contractor protection is included in revised policy and contract clause provisions on Termination (2149.002(b)) and Renewal and termination (2152.249-70(b)).
We believe it is unnecessary to evaluate annually a Contractor's system of internal controls under a quality assurance program. Accordingly, the language at 2146.201 provides for periodic reviews. While subsequent reviews may be limited to changes in the Contractor's internal control system, the Contractor has an ongoing obligation to fully implement its internal control system at all times.
Our current policy on subcontracting requires advance approval of subcontracts or modifications that exceed $100,000. The proposed regulation increases the threshold to $550,000 (2144.102 and 2152.244-70(a)). We are also making this change in the Notice of significant events clause (2152.210-71(d)).
We are making a number of important additions and clarifying language changes to 2152.231-70, Accounting and allowable costs. We are defining cost as a chargeable cost against the contract which must meet separate cost principle tests for being actual, allowable, allocable, and reasonable. Conforming changes are being made to the definitions of “Administrative expenses” and “Investment income” so that they reference the definition of cost. We are changing the definition of “Benefits” under this section to include excess mortality charges, post-mortem conversion charges, conversion policies, and delayed settlement interest as part of payments made and costs incurred. The term “Overpayments” is being modified to “Overpayments recovered,” since overpayment monies are an offset against benefits paid or incurred.
An expanded Definitions section at subpart 2102.1 includes terms used throughout the LIFAR. Editorial changes to the LIFAR correct typographical errors in the Code of Federal Regulations, provide for consistency throughout, and make the text more readable. Reference changes and updates are made to the FEGLI Clause Matrix at 2152.3 and other sections of the LIFAR, where applicable, to conform to changes in the FAR (chapter 1 of title 48, Code of Federal Regulations) since the original issuance of the LIFAR.
This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.
I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they affect only the Federal life insurance Contractor.
Advertising, Government employees, Government procurement, Life insurance.
Accordingly, OPM proposes to amend 48 CFR chapter 21, as follows:
1. The authority citation for 48 CFR parts 2101, 2102, 2103, 2104, 2105, 2109, 2110, 2115, 2116, 2131, 2132, 2137, 2144, 2146, 2149, and 2152 continues to read as follows:
5 U.S.C. 8716; 40 U.S.C. 486(c); 48 CFR 1.301.
2. In section 2101.102 revise paragraph (b) to read as follows:
(b) The LIFAR does not replace or incorporate regulations found at 5 CFR part 870, which provide the substantive policy guidance for administration of the FEGLI Program under 5 U.S.C. chapter 87. The following is the order of precedence in interpreting a contract provision under the FEGLI Program:
(1) 5 U.S.C. chapter 87.
(2) 5 CFR part 870.
(3) 48 CFR chapters 1 and 21.
(4) The FEGLI Program contract.
3. In section 2101.301 revise paragraph (b) to read as follows:
(b) OPM may issue internal procedures, instructions, directives, and guides to clarify or implement the LIFAR within OPM. Clarifying or implementing procedures, instructions, directives, and guides issued pursuant to this section of the LIFAR must:
(1) Be consistent with the policies and procedures contained in this chapter as implemented and supplemented from time to time; and
(2) Follow the format, arrangement, and numbering system of this chapter to the extent practicable.
4. In section 2101.370 add paragraph (e) to read as follows:
(e) OPM will not initiate any changes to the LIFAR during a continuity of services period, as discussed in 2152.237-70 of this chapter.
5. Revise section 2102.101 to read as follows:
In this chapter, unless otherwise indicated, the following terms have the meaning set forth in this subpart.
(1) A fixed price during the contract year with a cost element that is adjusted at the end of the contract term based on costs incurred under the contract; and
(2) A profit or fee that is fixed at the beginning of the contract term. The amount of adjustment for costs is limited to the amount in the Employees' Life Insurance Fund. The fee will be in the form of either a risk charge or a service charge.
6. In section 2103.570 revise paragraphs (a) and (b) to read as follows:
(a) OPM, or the Contractor with the approval of OPM, makes available to Federal employees a booklet describing the provisions of the FEGLI Program, which includes information about eligibility, enrollment, and general procedures. The booklet, along with valid election documents, serves as certification of the employee's coverage under the FEGLI Program. Any marketing/advertising directed specifically at Federal employees and life insurance contacts with Federal employees for the purpose of selling FEGLI Program coverage must be approved by OPM in advance.
(b) The Contractor is prohibited from making incomplete and/or incorrect comparisons or using disparaging or minimizing techniques to compare its other products or services to those of the FEGLI Program. The Contractor agrees that any advertising material authorized and released by the Contractor which mentions the FEGLI Program will be truthful and not misleading and will present an accurate statement of FEGLI Program benefits. The Contractor will use reasonable efforts to assure that agents selling its other products are aware of and abide by this prohibition.
7. Add subpart 2104.9 consisting of section 2104.9001 to read as follows:
The clause at 2152.204-70 must be inserted in all FEGLI Program contracts.
8. Revise section 2105.7001 to read as follows:
FAR part 5 has no practical application to the FEGLI Program because the requirements for eligible contractors (
9. Revise section 2106.7001 to read as follows:
FAR part 6 has no practical application to the FEGLI Program because 5 U.S.C. chapter 87 exempts the FEGLI Program from competitive bidding.
10. In section 2109.7001 revise paragraphs (a), (f), and (g) to read as follows:
(a) The Contractor must meet the requirements of chapter 87 of title 5, United States Code; part 870 of title 5, Code of Federal Regulations; chapter 1 of title 48, Code of Federal Regulations; and the standards in this subpart. The Contractor must continue to meet these and the following statutory and
(f) The Contractor agrees to enter into annual premium rate redeterminations with OPM.
(g) The Contractor must furnish such reasonable reports as OPM determines are necessary to administer the FEGLI Program. The cost of preparation of such reports will be considered an allowable expense within the administrative expense ceiling defined in 2152.231-70 of this chapter.
11. Revise section 2110.7002 to read as follows:
(a) The Contractor is required to invest and reinvest all FEGLI Program funds on hand, including any attributable to the special contingency reserve (as used in 5 U.S.C. 8712), until needed to discharge promptly the obligations incurred under the contract. Within the constraints of safety and liquidity of investments, the Contractor must seek to maximize investment income. However, the Contractor will not be responsible for any actions taken at the direction of OPM.
(b) The Contractor is required to credit income earned from its investment of FEGLI Program funds to the FEGLI Program. Thus, the Contractor must be able to allocate investment income to the FEGLI Program in an appropriate manner. If the Contractor fails to invest funds on hand, properly allocate investment income, or credit any income due to the contract, for whatever reason, it must return or credit any investment income lost to OPM or the FEGLI Program, retroactive to the date that such funds should have been originally invested, allocated, or credited in accordance with the clause at 2152.210-70.
12. Revise section 2114.7001 to read as follows:
FAR part 14 has no practical application to the FEGLI Program because 5 U.S.C. chapter 87 exempts the FEGLI Program from competitive bidding.
13. Redesignate section 2115.106-270 as section 2115.071 and revise the title to read as “Specific retention periods: Contract clause.”
14. Redesignate section 2115.170 as section 2115.070.
15. Revise the title of subpart 2115.1, remove section 2115.106, and add a new section 2115.170 to read as follows:
FAR subpart 15.1 has no practical application to the FEGLI Program because prospective contractors (insurance companies) are considered for inclusion in the FEGLI Program in accordance with criteria provided in 5 U.S.C. chapter 87, LIFAR 2109.7001, and LIFAR 2115.370.
16. Redesignate subpart 2115.4 as subpart 2115.2 and revise the title, redesignate section 2115.401 as section 2115.270, and revise paragraphs (a) and (c) to read as follows:
(a) FAR subpart 15.2 has no practical application to the FEGLI Program because 5 U.S.C. chapter 87 exempts the FEGLI Program from competitive bidding.
(c) Eligible contractors (
17. Redesignate subpart 2115.6 as subpart 2115.3, and redesignate section 2115.602 as section 2115.370, and revise the introductory paragraph to read as follows:
FAR subpart 15.3 has no practical application to the FEGLI Program because prospective contractors (insurance companies) are considered for inclusion in the FEGLI Program in accordance with criteria provided in 5 U.S.C. chapter 87, LIFAR 2109.7001, and the following:
18. Redesignate subpart 2115.8 as subpart 2115.4 and revise the title, and redesignate section 2115.802 as section 2115.402 and revise it to read as follows:
Pricing of FEGLI Program premium rates is governed by 5 U.S.C. 8707, 8708, 8711, 8714a, 8714b, and 8714c. FAR subpart 15.4 will be implemented by applying cost analysis policies and procedures. To the extent that reasonable or good faith actuarial estimates are used for pricing, such estimates will be deemed acceptable and, if inaccurate, will not constitute defective pricing.
19. Redesignate section 2115.902 as section 2115.404-70, revise the title, and revise paragraph (b)(2) to read as follows:
(b) * * *
(2) Once agreement to relinquish the risk charge is made, the agreement may not be cancelled unless OPM and the Contractor mutually agree to reinstitute payment of a risk charge; or unless the Fund balance falls below the level defined in 2115.404-70(a) and 30 days' notice of cancellation is provided; or unless the Contractor or OPM provides notice of cancellation for any reason 1 year prior to the date cancellation is sought.
20. Redesignate section 2115.905 as section 2115.404-71 and revise it to read as follows:
(a) The OPM Contracting Officer will apply a weighted guidelines method when developing the prenegotiation objective (service charge) for the FEGLI Program contract. In accordance with the factors defined in FAR 15.404-4(d), OPM will apply the appropriate weights derived from the ranges specified in paragraph (b) of this section and will determine the prenegotiation objective based on the total dollar amount of the Contractor's Basic and Option C (family optional insurance) claims paid in the previous contract year.
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(b) The weight ranges for each factor to be used in the weighted guidelines approach are set forth in the following table:
20a. Remove subpart 2115.9.
21. Revise section 2116.270 to read as follows:
FEGLI Program contracts are fixed price with limited cost redetermination plus fixed fee. The premium paid to the Contractor is mutually agreed upon by OPM and the Contractor and is based on an estimate of benefits and administrative costs, plus the fixed service or risk charge, and is determined annually. Claims costs, including benefits and administrative expenses, in excess of premiums are paid up to the amount in the Employees' Life Insurance Fund. Payment for costs exceeding the amount in the Fund are the responsibility of the Contractor and reinsurers. The fee is fixed at the inception of each contract year. The fee does not vary with the actual costs but may be adjusted as a result of changes in the work to be performed under the contract. The fee is in the form of either a risk charge or a service charge.
(a)
(b)
22. Revise section 2131.109 to read as follows:
FAR 31.109 is applicable to FEGLI Program contracts, except that precontract costs and nonrecurring costs that exceed $100,000 will not be allowed in the absence of an advance agreement between OPM and any potential FEGLI Contractor.
23. Revise section 2131.203 to read as follows:
The provisions of FAR 31.203 apply to the allocation of indirect costs.
24. Revise section 2131.205-32 to read as follows:
Precontract costs will be allowable in accordance with FAR part 31, but precontract costs that exceed $100,000 will not be allowable except to the extent allowable under an advance agreement negotiated in accordance with 2131.109 of this chapter.
25. Revise section 2131.205-38 to read as follows:
Selling costs are not allowable costs to FEGLI contracts except to the extent that they are attributable to conducting contract negotiations with the Government and for liaison activities involving ongoing contract administration, including the conduct of informational and enrollment activities as directed or approved by the Contracting Officer.
26. Revise section 2132.170 to read as follows:
(a) OPM will make payments on a letter of credit (LOC) basis. OPM and the Contractor will concur on an estimate of benefits and administrative costs plus the fixed service or risk charge for the forthcoming contract year, as specified in the contract. The annual premium to the Contractor, based on this estimate, will be credited to the Contractor's LOC account in 12 equal monthly installments due on the first business day of each month and available for drawdown. OPM will credit the Contractor's LOC account for the December payment no later than the last business day of each calendar year. Following the close of the contract year, a reconciliation of premiums, benefits, and other costs will be performed as a limited cost redetermination. In addition, interest distribution payments will be made available for Contractor drawdown from the LOC account. The Contractor will use the LOC account in accordance with guidelines issued by OPM.
(b) Withdrawals from the LOC account for benefit costs of $5,000 or more will be made on a claims-paid basis. Withdrawals from the LOC account for benefit costs of less than $5,000 and other FEGLI Program disbursements will be made on a checks-presented basis. Under a checks-presented basis, drawdown on the LOC is delayed until the checks issued for FEGLI Program disbursements are presented to the Contractor's bank for payment.
(c) Nothing in this section will affect the ability of the Contractor to hold the special contingency reserve established and maintained in accordance with the terms of 5 U.S.C. 8712.
27. Revise section 2132.771 to read as follows:
(a) FEGLI Program funds must be maintained in such a manner as to be separately identifiable from other assets of the Contractor. Cash and investment balances reported on the FEGLI Program Annual Financial Report must be supported by the Contractor's books and records.
(b) This requirement may be modified by the Contracting Officer in accordance with the clause at 2152.232-71 of this chapter when adequate accounting and other controls are in effect. If the requirement is modified, such modification will remain in effect until rescinded by OPM.
28. Revise section 2137.102 to read as follows:
(a) The services under this contract are of vital interest to the Government and must be continued without interruption in the event the contract is terminated, unless the termination occurs as a result of OPM's failure to pay premiums on a timely basis.
(b) The Contractor will be reimbursed for all reasonable phase-in and phase-out costs (
29. Revise section 2144.102 to read as follows:
For all FEGLI Program contracts, the Contracting Officer's advance approval will be required on subcontracts or modifications to subcontracts when the cost of that portion of the subcontract that is charged the FEGLI Program contract exceeds $550,000 and is at least 25 percent of the total cost of the subcontract.
30. In section 2146.201 revise paragraph (b) to read as follows:
(b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance program required by 2146.270 of this chapter and will acknowledge in writing whether or not the system is consistent with the requirements set forth in this subpart. After the initial review, subsequent periodic reviews may be limited to changes in the Contractor's internal control guidelines. However, a limited review does not diminish the Contractor's obligation to apply the full internal control system.
31. In section 2146.270 revise paragraph (b) to read as follows:
(b) The Contractor must prepare overpayment recovery guidelines to include a system of internal controls.
32. Revise section 2149.002 to read as follows:
(a)
(2) A life insurance contract entered into by OPM may be terminated by OPM at any time for default by the Contractor in accordance with the provisions of FAR parts 49 and 52.249-8. A life insurance contract entered into by OPM may be terminated by the Contractor at the end of the grace period, after default for nonpayment by OPM. Notwithstanding the preceding sentence, the Contractor will allow OPM an additional 5 days after the end of the grace period to make payment if the failure to make payment was inadvertent and/or due to circumstances beyond the Government's control.
(3) A life insurance contract entered into by OPM may be terminated for convenience of the Government 60 days after the Contractor's receipt of OPM's written notice to terminate.
(4) The Contractor may terminate its contract with OPM at the end of any contract year when notice of intent to terminate is given to OPM in writing at least 60 days prior to the end of the contract year (
(b)
(c)
33. In section 2152.070 revise the listing under Section and Clause Title to read as follows:
34. Revise section 2152.203-70 to read as follows:
As prescribed in 2103.571, insert the following clause:
The Contractor agrees that any advertising material authorized and released by the Contractor which mentions the FEGLI Program must be truthful and not misleading and must present an accurate statement of FEGLI Program benefits. The Contractor is prohibited from making incomplete and/or incorrect comparisons or using disparaging or minimizing techniques to compare its other products or services to those of the FEGLI Program. The Contractor agrees to use reasonable efforts to assure that agents selling its other products are aware of and abide by this provision. The Contractor agrees to incorporate this clause in all subcontracts as defined at LIFAR 2102.101.
35. Add a new section 2152.204-70 to read as follows:
As prescribed in 2104.9001, insert the following clause:
(a) Definitions.
(b) The Contractor must submit the information required in paragraphs (d) through (f) of this clause to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the IRS. The Contractor is subject to the payment reporting requirements described in FAR 4.904. The Contractor's failure or refusal to furnish the information will result in payment being withheld until the TIN is provided.
(c) The Government may use the TIN to collect and report on any delinquent amounts arising out of the Contractor's relationship
(d) Taxpayer Identification Number (TIN).
(e) Type of organization.
(f) Common parent.
36. In section 2152.210-70 revise the clause title date, and revise paragraphs (a), (c), and (d)(2) to read as follows:
(a) The Contractor must invest and reinvest all FEGLI Program funds on hand until needed to discharge promptly the obligations incurred under the contract. Within the constraints of safety and liquidity of investments, the Contractor must seek to maximize investment income. However, the Contractor will not be responsible for any actions taken at the direction of OPM.
(c) When the Contracting Officer concludes that the Contractor failed to comply with paragraph (a) or (b) of this clause, the Contractor must pay to OPM the investment income that would have been earned, at the rate(s) specified in paragraph (d) of this clause, had it not been for the Contractor's noncompliance.
(1) Making any charges against the contract which are not actual, allowable, allocable, or reasonable; or
(2) Failing to credit any income due the contract and/or failing to place funds on hand, including premium payments and payments from OPM not needed to discharge promptly the obligations incurred under the contract, tax refunds, credits, deposits, investment income earned, uncashed checks, or other amounts owed OPM in income-producing investments and accounts.
(d) * * *
(2) Investment income lost by the Contractor as a result of failure to credit income due under the contract or failure to place funds on hand in income-producing investments and accounts must be paid from the date the funds should have been invested or appropriate income was not credited and will end on the earlier of:
(i) The date the amounts are returned to OPM;
(ii) The date specified by the Contracting Officer; or
(iii) The date of the Contracting Officer's final decision.
37. In section 2152.210-71 revise the clause title date, and revise paragraphs (a)(3), (a)(5), (a)(6), (a)(11), (b), and (d) to read as follows:
As prescribed in 2110.7004(b), insert the following clause:
(a) * * *
(3) Loss of 20 percent or more of FEGLI Program reinsurers in a contract year;
(5) The withdrawal of, or notice of intent to withdraw, by any State or the District of Columbia, its license to do life insurance business or any other change of life insurance status under State law;
(6) The Contractor's material default on a loan or other financial obligation;
(11) Any written exceptions, reservations, or qualifications expressed by the independent accounting firm contracted with by the Contractor to provide an audit opinion on the annual financial report required by OPM for the FEGLI Program. (Accounting firm employees must be members of the American Institute of Certified Public Accountants and must audit the report in accordance with Generally Accepted Government Auditing Standards or other requirements issued by OPM.)
(b) Upon learning of a significant event, OPM may institute action, in proportion to the seriousness of the event, to protect the interest of insureds, including, but not limited to—
(1) Directing the Contractor to take corrective action; or
(2) Making a downward adjustment to the weight in the “Contractor Performance” factor of the service charge.
(d) The Contractor agrees to insert this clause in any subcontract or subcontract modification when the amount of the subcontract or modification that is charged to the FEGLI Program contract exceeds $550,000 and is at least 25 percent of the total cost of the subcontract.
38. Revise section 2152.215-70 to read as follows:
As prescribed in 2115.071, insert the following clause:
Notwithstanding the provisions of FAR 52.215-2(f), “Audit and Records—Negotiation,” the Contractor must retain and make available all records applicable to a contract term that support the annual financial report for a period of 5 years after the end of the contract term to which the records relate. Claim records must be maintained for 10 years after the end of the contract term to which the claim records relate. If the Contractor chooses to maintain paper documents in electronic format, the electronic version must be an exact replica of the paper document.
39. Revise section 2152.216-70 to read as follows:
As prescribed in 2116.270-1(a), insert the following clause when a risk charge is negotiated:
(a) This is a fixed price with limited cost redetermination plus fixed fee contract, with the fixed fee in the form of a risk charge. OPM will pay the Contractor the risk charge as specified in a letter from the Contracting Officer.
(b) At the Contractor's request, OPM will furnish, during the third quarter of the current contract year, an accounting of the funds in the Employees' Life Insurance Fund as of the end of the second quarter of the contract year.
40. Revise section 2152.216-71 to read as follows:
As prescribed in 2116.270-1(b), insert the following clause when a service charge is negotiated:
(a) This is a fixed price with limited cost redetermination plus fixed fee contract, with the fixed fee in the form of a service charge. OPM will pay the Contractor the service charge as specified in a letter from the Contracting Officer.
(b) At the Contractor's request, OPM will furnish, during the third quarter of the current contract year, an accounting of the funds in the Employees' Life Insurance Fund as of the end of the second quarter of the contract year.
41. In section 2152.224-70 revise the clause title date, and revise paragraph (a) to read as follows:
(a) The Contractor will use the personal data on employees and annuitants that is provided by agencies and OPM, including social security numbers, for only those routine uses stipulated for the data and published in the
42. Revise section 2152.231-70 to read as follows:
As prescribed in 2131.270, insert the following clause:
(a)
(2) The Contractor must have the most recent financial report for the FEGLI Program audited by an independent public accounting firm, whose employees are members of the American Institute of Certified Public Accountants. The audit must be performed in accordance with Generally Accepted Government Auditing Standards or other requirements issued by OPM. The report by the independent accounting firm on its audit must be submitted to OPM along with the annual financial report.
(3) Based on the results of either the independent audit or a Government audit, the FEGLI contract may be:
(i) Adjusted by amounts found not to constitute chargeable costs; or
(ii) Adjusted for prior overpayments or underpayments.
(b)
(i) An actual, allowable, allocable, and reasonable cost;
(ii) Incurred with proper justification and accounting support;
(iii) Determined in accordance with subpart 31.2 of the Federal Acquisition Regulation (FAR) and subpart 2131.2 of the Federal Employees' Group Life Insurance Acquisition Regulation (LIFAR) applicable on October 1 of each year; and
(iv) Determined in accordance with the terms of this contract.
(2) In the absence of specific contract terms to the contrary, contract costs will be classified in accordance with the following criteria:
(i)
(ii)(A)
(B)
(iii)
(c)
(2) The certification required must be in the following form:
This is to certify that I have reviewed this financial report and, to the best of my knowledge and belief, attest that:
1. The report was prepared in conformity with the guidelines issued by the Office of Personnel Management and fairly presents the financial results of this contract year in conformity with those guidelines;
2. The costs included in the report are actual, allowable, allocable, and reasonable in accordance with the terms of the contract and with the cost principles of the Federal Employees' Group Life Insurance Program Acquisition Regulation (LIFAR) and the Federal Acquisition Regulation (FAR);
3. Income, overpayments, refunds, and other credits made or owed in accordance with the terms of the contract and applicable cost principles have been included in the report.
43. Revise section 2152.232-70 to read as follows:
As prescribed in 2132.171, insert the following clause:
(a) OPM will make available to the Contractor, in full settlement of its obligations under this contract, subject to adjustment based on actual claims and administrative cost, a fixed premium once per month on the first business day of the month. The premium is determined by an estimate of costs for the contract year as provided in Section ___ and is redetermined annually by mutual agreement of OPM and the Contractor. In addition, an annual reconciliation of premiums, benefits, and other costs is performed, and additional payment by OPM or reimbursement by the Contractor is paid as necessary.
(b) If OPM fails to fund the Letter of Credit (LOC) account for the full amount of premium due by the due date, a grace period of 31 days will be granted to OPM for providing any premium due, unless OPM has previously given written notice to the Contractor that the contract is to be discontinued. The contract will continue in force during the grace period.
(c) If OPM fails to fund the LOC account for any premiums within the grace period, the contract may be terminated at the end of the 31
(d) In accordance with LIFAR 2143.205 and LIFAR 2252.243-70, Changes, if a change is made to the contract that increases or decreases the cost of performance of the work under this contract, the Contracting Officer will make an equitable adjustment to the payments under this contract.
(e) In the event this contract is terminated in accordance with LIFAR part 2149, the special contingency reserve held by the Contractor will be available to pay the necessary and proper charges against this contract after other Program assets held by the Contractor are exhausted.
44. Revise section 2152.232-71 to read as follows:
As prescribed in 2132.772, insert the following clause:
(a) The Contractor must maintain FEGLI Program funds in such a manner as to be separately identifiable from other assets of the Contractor.
(b) The Contractor may request a modification of paragraph (a) of this clause from the Contracting Officer. The modification must be requested, and approved by the Contracting Officer, in advance of any change, and the Contractor must demonstrate that accounting techniques have been established that clearly measure
45. In section 2152.237-70 revise the clause title date, and revise paragraphs (a), (c), and (d) to read as follows:
(a) The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption. The Contractor further recognizes that upon contract expiration or termination, including termination by the Contractor for OPM's failure to make timely premium payments, a successor, either the Government or another Contractor, may continue them. The Contractor agrees to furnish phase-in training and exercise its best efforts and cooperation to effect an orderly and efficient transition to a successor.
(c) The Contractor must allow as many experienced personnel as practicable to remain on the job during the transition period to help the successor maintain the continuity and consistency of the services required by this contract. The Contractor also must, except if prohibited by applicable law, disclose necessary personnel records and allow the successor to conduct onsite interviews with these employees. If selected employees are agreeable to the change, the Contractor must release them at a mutually agreeable date and negotiate transfer of their earned fringe benefits to the successor.
(d) The Contractor will be reimbursed for all reasonable phase-in, phase-out costs (
46. In section 2152.243-70 revise the clause title date, and revise paragraphs (a)(1), (a)(2), and (c) to read as follows:
(a) * * *
(1) Description of services to be performed;
(2) Time of performance (
(c) The Contractor must assert its right to an adjustment under this clause within 30 days from the date of receipt of the written order. However, if the Contracting Officer decides that the facts justify it, the Contracting Officer may receive and act upon a proposal submitted before final payment of the contract.
47. In section 2152.244-70 revise the clause title date, and revise paragraphs (a) and (f) to read as follows:
(a) The Contractor must notify the Contracting Officer reasonably in advance of entering into any subcontract or subcontract modification, or as otherwise specified by this contract, when the cost of that portion of the subcontract that is charged the FEGLI Program contract exceeds $550,000 and is at least 25 percent of the total cost of the subcontract.
(f) No subcontract placed under this contract will provide for payment on a cost-plus-a-percentage-of-cost basis. Any fee payable under cost reimbursement type subcontracts will not exceed the fee limitations in FAR 15.404-4(c)(4)(i). Any profit or fee payable under a subcontract will be in accordance with the provisions of Section ___.
48. In section 2152.246-70 revise the clause title date, and revise paragraph (b) to read as follows:
(b) The Contractor must keep complete records of its quality assurance procedures and the results of their implementation and make them available to an authorized Government entity during contract performance and for 5 years after the end of the contract term to which the records relate.
49. In section 2152.249-70 revise the clause title date, and revise paragraphs (b) and (d) to read as follows:
(b) This contract may be terminated by OPM at any time in accordance with FAR part 49 and FAR 52.249-8 for default by the Contractor. This contract terminates at the end of the grace period if the Government does not fund the LOC account for any of the premium due to the Contractor (see LIFAR 2149.002(a)(2)). However, the Contractor and OPM may agree to continue the contract. In addition, the Contractor agrees to reinstate the contract if termination: (1) Arose out of the Government's inadvertent failure to fund the LOC account for the amount of the premium payment prior to the expiration of the grace period as defined in LIFAR 2102.101, and/or (2) was due to circumstances beyond the Government's control, provided that the LOC account is funded in the amount of the premium payment due to the Contractor within 5 days after the expiration of the grace period. In the event of such reinstatement, OPM will equitably adjust the payments due under the contract to compensate the Contractor for any increased costs of performance that result from the Government's failure to fund the LOC account prior to the expiration of the grace period and/or such reinstatement.
(d) Upon termination of the contract for Contractor's default or OPM's convenience, the Contractor agrees to assist OPM with an orderly and efficient transition to a successor in accordance with LIFAR 2137.102, LIFAR 2137.110, and the provisions of the “Continuity of Services” clause at 2152.237-70. The Contractor is not required to continue performance subsequent to OPM's failure to fund the LOC account for premiums due under paragraph (b) of this clause.
50. In section 2152.370 revise the FEGLI Program Clause Matrix to read as follows:
Animal and Plant Health Inspection Service, USDA.
Extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with environmental monitoring.
We will consider all comments that we receive on or before December 3, 2004.
You may submit comments by any of the following methods:
• EDOCKET: Go to
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 04-098-1, 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. 04-098-1.
• E-mail: Address your comment to
• Agency Web Site: Go to
For information regarding environmental monitoring, contact Mr. Ronald Berger, Environmental Monitoring, Pest Detection and Management Programs, PPQ, APHIS, 4700 River Road Unit 150, Riverdale, MD 20737;
(301) 734-5105. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
In accordance with the National Environmental Policy Act (42 U.S.C. 4321
APHIS field personnel and State cooperators jointly use APHIS Form 2060, Environmental Monitoring Form, to collect information concerning the effects of pesticide use in these sensitive habitats. The goal of environmental monitoring is to track the potential impact that APHIS activities may have on the environment and to use this knowledge in making any necessary adjustments in future program actions.
We are asking the Office of Management and Budget (OMB) to approve our use of APHIS Form 2060 for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the 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 are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Animal and Plant Health Inspection Service, USDA.
Extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with accrediting nongovernment facilities to perform services related to the export certification of plants or plant products.
We will consider all comments that we receive on or before December 3, 2004.
You may submit comments by any of the following methods:
• EDOCKET: Go to
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 04-097-1, 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. 04-097-1.
• E-mail: Address your comment to
• Agency Web Site: Go to
For information regarding the accreditation program, contact Mr. Michael Ward, Accreditation Program Manager, Phytosanitary Issues Management, PPQ, APHIS, 4700 River Road, Unit 140, Riverdale, MD 20737; (301) 734-8262. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
The export certification regulations, which are contained in 7 CFR part 353, describe the procedures for obtaining certification for plants and plant products offered for export or reexport. Our regulations do not require that we engage in export certification activities; however, we perform this work as a service to exporters who are shipping plants or plant products to countries that require phytosanitary certification as a condition of entry.
After assessing the condition of the plants or plant products intended for export (
The regulations allow nongovernment facilities (such as commercial laboratories and private inspection services) to be accredited by APHIS to perform specific laboratory testing or phytosanitary inspections that could serve as the basis for issuing Federal phytosanitary certificates, phytosanitary certificates for reexport, or export certificates for processed plant products.
The accreditation process requires the use of several information collection activities to ensure that nongovernment facilities applying for accreditation possess the necessary qualifications.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the 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 are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that an environmental assessment and finding of no significant impact have been prepared by the Animal and Plant Health Inspection Service relative to issuing a permit for the environmental release of the nonindigenous weevil
Copies of the environmental assessment and finding of no significant impact are available for public inspection 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.
Dr. Robert Flanders, Branch Chief, Biological and Technical Services, Pest Permit Evaluations, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236; (301) 734-5930.
Mile-a-minute weed (
Large, dense patches of mile-a-minute weed develop during the summer. As the vines climb over and cover other plants, they block available sunlight, which can reduce the population of native plant species in affected areas. Mile-a-minute weed can also interfere with Christmas tree farms, pine plantations, and reforestation projects by smothering tree seedlings. Nursery and horticultural crops that are not regularly tilled can also be affected by mile-a-minute weed. The Animal and Plant Health Inspection Service (APHIS) and several States list mile-a-minute weed as a noxious weed.
On June 1, 2004, we published in the
We solicited comments on the environmental assessment for 30 days ending on July 1, 2004. We received one comment by that date, from a private citizen. The commenter objected to APHIS programs and activities in general, but did not address the environmental assessment. Therefore, we are making no changes to the environmental assessment based on this comment.
The environmental assessment and finding of no significant impact may be viewed on the Internet at
The environmental assessment and finding of no significant impact have been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Monsanto Company seeking a determination of nonregulated status for cotton designated as MON 88913, which has been genetically engineered for tolerance to the herbicide glyphosate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, we are soliciting public comments on whether this cotton presents a plant pest risk. We are also making available for public comment an environmental assessment for the proposed determination of nonregulated status.
We will consider all comments we receive on or before December 3, 2004.
You may submit comments by any of the following methods:
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 04-076-1, 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. 04-076-1.
• E-mail: Address your comment to
• Agency Web Site: Go to
• Federal eRulemaking Portal: Go to
Mr. Michael Blanchette, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5141. To obtain copies of the petition or the environmental assessment, contact Ms. Terry Hampton at (301) 734-5715; e-mail:
The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.”
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
On March 26, 2004, APHIS received a petition from Monsanto Company of St. Louis, MO, (Monsanto), requesting a determination of nonregulated status under 7 CFR part 340 for cotton (
As described in the petition, MON 88913 has been genetically engineered to express a 5-enolpyruvyshikimate-3-phosphate synthase protein from
MON 88913 cotton has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. In the process of reviewing the notifications for field trials of the subject cotton, APHIS determined that the vectors and other elements were disarmed and that the trials, which were conducted under conditions of reproductive and physical confinement or isolation, would not present a risk of plant pest introduction or dissemination.
In § 403 of the Plant Protection Act (7 U.S.C. 7701-7772), plant pest is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing. APHIS views this definition very broadly. The definition covers direct or indirect injury, disease, or damage not just to agricultural crops, but also to plants in general, for example, native species, as well as to organisms that may be beneficial to plants, for example, honeybees, rhizobia, etc.
The U.S. Environmental Protection Agency (EPA) is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136
When the use of the pesticide on the genetically modified plant would result in an increase in the residues in a food or feed crop for which the pesticide is currently registered, or in new residues in a crop for which the pesticide is not currently registered, establishment of a new tolerance or a revision of the existing tolerance would be required. Residue tolerances for pesticides are established by EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301
FDA published a statement of policy on foods derived from new plant varieties in the
To provide the public with documentation of APHIS' review and analysis of the environmental impacts and plant pest risk associated with a proposed determination of nonregulated status for Monsanto's 88913 cotton, an environmental assessment (EA) has been prepared. The EA was prepared in accordance with (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
In accordance with § 340.6(d) of the regulations, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested persons for a period of 60 days from the date of this notice. We are also soliciting written comments from interested persons on the EA prepared to examine any environmental impacts of the proposed determination for the subject cotton. The petition and the EA and any comments received are available for public review, and copies of the petition and the EA are available as indicated in the
After the comment period closes, APHIS will review the data submitted by the petitioner, all written comments received during the comment period, and any other relevant information. After reviewing and evaluating the comments on the petition and the EA and other data and information, APHIS will furnish a response to the petitioner, either approving the petition in whole or in part, or denying the petition. APHIS will then publish a notice in the
7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that an environmental assessment and finding of no significant impact have been prepared by the Animal and Plant Health Inspection Service relative to issuing a permit for the environmental release of the nonindigenous moth
Copies of the environmental assessment and finding of no significant impact are available for public inspection 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.
Dr. Robert Flanders, Branch Chief, Biological and Technical Service, Pest Permit Evaluations, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236; (301) 734-5930.
Old World climbing fern,
The climbing fern is a highly invasive, exotic weed that climbs over plants, including tall trees, to form massive walls of vegetation. It also forms thick mats on the ground that smother native plants. New infestations can arise great distances from existing populations because the weed produces millions of spores that are spread by wind and other physical carriers. A single spore is capable of starting a new infestation.
In Florida, the potential distribution of this weed includes all habitats from Lake Okeechobee south. It also has the potential to invade the Gulf Coast of Mexico and southern Texas.
On July 1, 2004, we published in the
We solicited comments on the environmental assessment for 30 days ending on August 2, 2004. We received five comments by that date. Four of the commenters supported the recommendations of the environmental assessment. The fifth commenter objected to APHIS' performance and programs in general, but did not address the environmental assessment. Therefore, we are making no changes to the environmental assessment in response to this comment.
The environmental assessment and finding of no significant impact may be viewed on the Internet at
The environmental assessment and finding of no significant impact have been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
USDA, Forest Service.
Notice of intent to prepare an environmental impact statement.
The Forest Service gives notice of the intent to prepare an environmental impact statement (EIS) to revise the Payette National Forest Travel Plan. The proposed action would designate a site-specific transportation system and prohibit indiscriminant cross-country traffic. The EIS will analyze the effects of the proposed action and alternatives. The Payette National Forest invites written comments and suggestions on the scope of analysis and the issues to address. The agency gives notice of the National Environmental Policy Act (NEPA) analysis and decision-making process on the proposal so interested and affected members of the public may participate and contribute to the final decision.
Comments need to be received in writing by December 7, 2004.
Send written comments to: Travel Plan Revision, Forest Supervisor's Office, Payette National Forest, P.O. Box 1026, McCall, ID 83638, fax (208) 634-0744.
Questions about the proposed project and scope of analysis should be directed to Ana Egnew, Land Management Planner, Payette National Forest, P.O. Box 1026, McCall, ID 83638, or by phone to (208) 634-0624.
The need for revision of the Travel Plan was identified in the 2003 Payette National Forest Land and Resource Plan (Forest Plan) (p. III-63), and in the Forest Service proposed rule (for Travel Management (July 15, 2004); specifically, to establish a system of roads and trails and areas designated for motor vehicle use and to prohibit the use of motor vehicles off the designated system. The purpose of the revision is to (1) meet Forest Plan and national direction, (2) designate a reasonable system of roads, trails, and over-snow use areas, (3) balance management considerations with recreation demands, (4) reduce impacts to Forest resources, and (5) reduce recreation user conflicts. The analysis will be conducted across the 13 Management Areas that comprise the 1,583,681 acres of the Payette National Forest outside designated Wilderness.
The proposed action would revise the current Travel Plan by designating a site-specific transportation system for snow-free and over-snow travel. Motorized snow-free travel off the transportation system would be prohibited on 1,583,681 acres (an increase of 544,863 acres).
The transportation system for snow-free travel would include:
• 1,505 miles of open roads (reduction of 14 miles)
• 612 miles of seasonally open roads (reduction of 28 miles)
• 76 miles of trail open to All-Terrain Vehicles (ATVs) (increase of 22 miles)
• 546 miles of trail open to 2-wheel motorized use (reduction of 98 miles)
• 621 miles of trail open to non-motorized travel (increase of 87 miles)
• 2.7 miles of undetermined road added to the system.
The transportation system for over-snow travel would include:
• 183 miles of open road (unchanged)
• 1,106,480 acres open to motorized activities (reduction of 17,400 acres)
• 477,801 acres reserved for non-motorized over-snow activities
The responsible official is the Forest Supervisor of the Payette National Forest.
The decision to be made is: whether to adopt the proposed revision to the Travel Plan, in whole, or in part, or to adopt another alternative, and with what mitigation measures and management requirements.
Preliminary issues identified by the Forest Service interdisciplinary team include effects to: water quality and wetlands; threatened, endangered, sensitive, and management indicator fish species and habitat; threatened, endangered, sensitive, and management indicator wildlife species and habitat; rare plants; and recreation opportunities.
A range of reasonable alternatives will be considered. The no-action alternative will serve as a baseline for comparison of alternatives. The proposed action will be considered along with additional alternatives developed that meet the purpose and need and address significant issues identified during scoping. Alternatives may allow different locations, types, and seasons of travel activities.
Public participation will be important at several points during the analysis. This notice of intent initiates the scoping process. The scoping process will identify issues to be analyzed in detail and lead to the development of alternatives to the proposal.
The Forest Service is seeking information and comments from other Federal, State, and local agencies; Tribal governments; organizations; and individuals who may be interested in or affected by the proposed action. Comments received in response to this notice, including the names and addresses of those who comment, will be part of the project record and available for public review.
Public meetings are scheduled during the 60-day scoping period and following issuance of the draft EIS. The public scoping meetings are: September 30, in Riggins, Salmon River High School; October 6 in Weiser, Vendome Conference Center; October 12 in McCall, Forest Supervisor's Office; October 14 in Council, Adams County Fairground Exhibit Hall; and October 21 in New Meadows, New Meadows Ranger District Office. All meetings are 4:30 p.m. to 7 p.m.
The second major opportunity for public input is with the draft EIS. The draft EIS will be filed with the Environmental Protection Agency (EPA) and is anticipated to be available for public review during the summer of 2005. The comment period on the draft EIS will be 60 days. It is important that those interested in travel management on the Payette National Forest participate at that time.
The Forest Service believes it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft EISs 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 (
To assist the Forest Service in identifying and considering issues raised by the proposed action, comments on the draft EIS should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft EIS. Comments may also address the adequacy of the draft EIS 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 40 CFR 1503.3 in addressing these points.)
After the 60-day comment period ends on the draft EIS, the Forest Service will analyze comments received and address them in the final EIS. The final EIS is scheduled to be released in December 2005. In the final EIS, the Forest Service will respond to substantive comments received during the comment period. The Responsible Official (Forest Supervisor, Payette National Forest) will document the decision and rationale in a Record of Decision (ROD). The decision will be subject to review under Forest Service appeal regulations at 36 CFR part 215.
Forest Service, USDA.
Notice of meeting.
The Land Between the Lakes Advisory Board will hold a meeting on Thursday, October 28, 2004. Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. App. 2.
The meeting agenda includes the following:
(1) Welcome/Introductions/Agenda;
(2) Advisory Board Membership;
(3) Land and Resource Management Plan Update;
(4) Conservation Education;
(5) Four Threats;
(6) Tour of Turkey Bay;
(7) Board Discussion of Comments Received;
(8) LBL Updates.
The meeting is open to the public. Written comments are invited and may be mailed to: William P. Lisowsky, Area Supervisor, Land Between The Lakes, 100 Van Morgan Drive, Golden Pond, Kentucky 42211. Written comments must be received at Land Between The Lakes by October 20, 2004, in order for copies to be provided to the members at the meeting. Board members will review written comments received, and at their request, oral clarification may be requested at a future meeting.
The meeting will be held on Thursday, October 28, 2004, 8:30 a.m. to 3:15 p.m., c.s.t.
The meeting will be held at the USDA Forest Service Administrative Building, Land Between the Lakes, and will be open to the public.
Sharon Byers, Advisory Board Liaison, Land Between the Lakes, 100 Van Morgan Drive, Golden Pond, Kentucky 42211, (270) 924-2002.
None.
Forest Service, USDA.
Notice of meeting.
Pursuant to the authorities in the Federal Advisory Committee Act (Public Law 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Public Law 106-393), the Boise and Payette National Forests' Southwest Idaho Resource Advisory Committee will conduct a business meeting, which is open to the public.
Wednesday, October 20, 2004, beginning at 10:30 a.m.
Idaho Counties Risk Management Program Building, 3100 South Vista Avenue, Boise, Idaho.
Agenda topics will include review and approval of project proposals, and it is an open public forum.
Doug Gochnour, Designated Federal Officer, at (202) 392-6681 or e-mail
Rural Business-Cooperative Service, USDA.
Notice.
As set forth in 7 CFR 4279.107 (b) and 4279.119 (b)(4), each fiscal year the Agency shall establish a limit on the maximum portion of guarantee authority available for that fiscal year that may be used to guarantee loans with a guarantee fee of 1 percent or guaranteed loans with a guarantee percentage exceeding 80 percent.
Allowing the guarantee fee to be reduced to 1 percent or exceeding the 80 percent guarantee on certain guaranteed loans that meet the conditions set forth in 7 CFR 4279.107 and 4279.119 will increase the Agency's ability to focus guarantee assistance on projects which the Agency has found particularly meritorious, such as projects in rural communities that remain persistently poor, which experience long-term population decline and job deterioration, are experiencing trauma as a result of natural disaster, or are experiencing fundamental structural changes in the economic base.
Not more than 12 percent of the Agency's quarterly apportioned guarantee authority will be reserved for loan requests with a guarantee fee of 1 percent, and not more than 15 percent of the Agency's quarterly apportioned guarantee authority will be reserved for guaranteed loan requests with a guaranteed percentage exceeding 80 percent. Once the above quarterly limits have been reached, all additional loans guaranteed during the remainder of that quarter will require a 2 percent guarantee fee and not exceed an 80 percent guarantee limit. As an exception to this paragraph and for the purposes of this notice, loans developed by the North American Development Bank (NADBank) Community Adjustment and Investment Program (CAIP) will not count against the 15 percent limit. Up to 50 percent of CAIP loans may have a guaranteed percentage exceeding 80 percent. The funding authority for CAIP loans is not derived carryover or recovered funding authority of the B&I Guaranteed Loan Program.
Written requests by the Rural Development State Office for approval of a guaranteed loan with a 1 percent guarantee fee or a guaranteed loan exceeding 80 percent must be forwarded to the National Office, Attn: Director, Business and Industry Division, for review and consideration prior to obligation of the guaranteed loan. The Administrator will provide a written response to the State Office confirming approval or disapproval of the request.
October 4, 2004.
Fred Kieferle, Processing Branch Chief, Business and Industry Division, Rural Business-Cooperative Service, USDA, Stop 3224, 1400 Independence Avenue, SW., Washington, DC 20250-3224, telephone (202) 720-7818.
This action has been reviewed and determined not to be a rule or regulation as defined in Executive Order 12866.
Committee for Purchase from People Who Are Blind or Severely Disabled.
Notice; request for comments.
The Committee for Purchase from People Who Are Blind or Severely Disabled (The Committee) will submit the collection of information listed below to OMB for approval under the provisions of the Paperwork Reduction Act. This notice solicits comments on that collection of information.
Submit your written comments on the information collection on or before December 3, 2004.
Mail your comments on the requirement to Janet Yandik, Information Management Specialist, Committee for Purchase from People Who Are Blind or Severely Disabled, 1421 Jefferson Davis Highway, Jefferson Plaza 2, Suite 10800, Arlington, VA, 22202-3259; fax (703) 603-0655; or e-mail
Anissa Craghead, Regulatory Affairs Specialist, Committee for Purchase from People Who Are Blind or Severely Disabled, 1421 Jefferson Davis Highway, Jefferson Plaza 2, Suite 10800, Arlington, VA, 22202-3259; phone (703) 603-0033; fax (703) 603-0655; or e-mail
The Office of Management and Budget (OMB) regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Federal agencies may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this collection of information is 3037-0005.
The Javits-Wagner-O'Day (JWOD) Act of 1971 (41 U.S.C. 46-48c) is the authorizing legislation for the JWOD Program. The JWOD Program creates jobs and training opportunities for people who are blind or who have other severe disabilities. Its primary means of doing so is by requiring Government agencies to purchase selected products and services from nonprofit agencies employing such individuals. The JWOD Program is administered by the Committee. Two national, independent organizations, National Industries for the Blind (NIB) and NISH, help State and private nonprofit agencies participate in the JWOD Program.
The implementing regulations for the JWOD Act, which are located at 41 CFR Chapter 51, detail the recordkeeping requirements imposed on nonprofit agencies participating in the JWOD
In addition, § 51-4.3 of the regulations requires that nonprofit agencies keep records on direct labor hours performed by each worker and keep an individual record or file for each blind or severely disabled individual documenting that individual's disability and capabilities for competitive employment. The records that nonprofit agencies must keep in accordance with § 51-4.3 of the regulations constitute the bulk of the hour burden associated with this OMB control number.
This information collection renewal request seeks approval for the Committee to continue to ensure compliance with recordkeeping requirements established by the authority of the JWOD Act and set forth in the Act's implementing regulations and to ensure that the Committee has the ability to confirm the suitability of products and services on its Procurement List. The recordkeeping requirements described in this document are the same as those currently imposed on nonprofit agencies participating in the JWOD Program.
We invite comments concerning this renewal on: (1) Whether the collection of information is necessary for the proper performance of our agency's functions, including whether the information will have practical utility; (2) the accuracy of our estimate of the burden of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights that a briefing by conference call of the Connecticut, Delaware, District of Columbia, Maryland, Pennsylvania, Rhode Island, Vermont, Virginia, and West Virginia Advisory Committees will convene at 11 a.m. and adjourn at 11:45 a.m., Friday, October 8, 2004. The purpose of the briefing is to listen to a presentation by Professor Gavin Clarkson on the use of Native American racial imagery for sports mascots.
This conference call is available to the public through the following call-in number: 1-800-497-7708, access code: 26575717. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls not initiated using the supplied call-in number or over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls using the call-in number over land-line connections. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and access code.
To ensure that the Commission secures an appropriate number of lines for the public, persons are asked to register by contacting Barbara de La Viez of the Eastern Regional Office at (202) 376-7533 by 4 p.m. on Wednesday, October 6, 2004.
The meeting will be conducted pursuant to the provisions of the rules and regulations of the Commission.
U.S. Commission on Civil Rights.
Friday, October 8, 2004, 9:30 a.m.
U.S. Commission on Civil Rights, 624 9th Street, NW., Room 540, Washington, DC 20425.
Les Jin, Press and Communications (202) 376-7700.
Bureau of the Census, Department of Commerce.
Notice of determination.
The Bureau of the Census (Census Bureau) will provide certain business data from its Business Register and its 2002 Economic Census to the Bureau of Economic Analysis (BEA) for statistical purposes exclusively. Through the use of these shared data, the BEA expects to improve the quality of data collected by the Census Bureau
The Census Bureau will make certain business data collected from the 2002 Economic Census, as discussed in this notice, available to BEA on October 4, 2004.
Requests for additional information on this proposed program should be directed to Mr. Julius Smith, Jr., Chief, Special Studies Branch, Manufacturing and Construction Division, U.S. Census Bureau, 4700 Silver Hill Road, Washington, DC 20233-6900, by phone at (301) 763-7662, by fax at (301) 457-1318 or by e-mail at
The CIPSEA (Pub. L. 107-347, Subtitle V; 44 U.S.C. 3501
The Census Bureau will provide the BEA with certain business data from its Business Register and collected from the 2002 Economic Census. The BEA also will share data from its 2002 Foreign Direct Investment in the United States survey. The BEA issued a separate notice addressing this issue.
The BEA will use these data for statistical purposes exclusively. Through record linking, the BEA expects to improve the quality of data collected under the authority of Title 13 of the U.S.C. and the International Investment and Trade in Services Survey Act by identifying data-quality issues arising from reporting differences in the Census Bureau and the BEA surveys.
The data from the Business Register and from the 2002 Economic Census are used to estimate employment, payroll, and receipt data of U.S. companies. Statistics from the census are published in separate data publications. All data are collected under Sections 131 and 224 of Title 13 of the U.S.C.
Title 13 of the U.S.C. protects the confidentiality of these data. The data may be seen only by persons sworn to uphold the confidentiality of the information. Access to the shared data will be restricted to specifically authorized personnel and will be provided for statistical purposes only. All BEA employees with access to these data will become Census Bureau Special Sworn Status Employees-meaning that they, under penalty of law, must uphold the data's confidentiality. To further safeguard the confidentiality of the data, the Census Bureau has conducted an Information Technology Security Review of the BEA. The results of this project are subject to disclosure review. Disclosure review is a process conducted to verify that the data to be released do not reveal any confidential information.
Import Administration, International Trade Administration, Department of Commerce.
Correction to final results of antidumping duty administrative review.
October 4, 2004.
Brian J. Sheba or Robert M. James, Antidumping and Countervailing Duty Operations Office Seven, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230, telephone: (202) 482-0145 or (202) 482-0649, respectively.
On May 27, 2004, the Department of Commerce (the Department) published in the
We now correct the final results of the 2001-2002 antidumping duty administrative review of honey from Argentina as noted above. As a result of this correction, the “all others” cash deposit rate is 30.24 percent
These amended final results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act.
Import Administration, International Trade Administration, Department of Commerce.
October 4, 2004.
Lilit Astvatsatrian or Laurel LaCivita, Import Administration, International Trade
We preliminarily determine that magnesium metal from the People's Republic of China (“PRC”) is being, or is likely to be, sold in the United States at less than fair value (“LTFV”), as provided in section 733 of the Tariff Act of 1930, as amended (“the Act”). The estimated margins of sales at LTFV are shown in the “Suspension of Liquidation” section of this notice.
On February 27, 2004, the Department of Commerce (“Department”) received a petition on imports of magnesium metal from the PRC, filed in proper form by the U.S. Magnesium Corporation LLC, United Steelworkers of America, Local 8319, and Glass, Molders, Pottery, Plastics & Allied Workers International, Local 374 (collectively, “Petitioners”) on behalf of the domestic industry and workers producing magnesium metal.
On April 16, 2004, and April 26, 2004, the Department requested quantity and value (“Q&V”) information from a total of one hundred and forty-two producers of magnesium metal in the PRC which were identified in the petition and for which the Department was able to locate contact information. On April 16, 2004, the Department also sent the Government of the PRC a letter requesting assistance in locating all known Chinese producers/exporters of magnesium metal who exported magnesium metal to the United States during the period of investigation (“POI”), July 1, 2003, through December 31, 2003.
On April 26, 2004, the Department received Q&V responses from two Chinese producers/exporters of magnesium metal, the RSM companies (“RSM”) and Tianjin Magnesium International Co., Ltd. (“Tianjin”). The Government of the PRC did not respond to the Department's April 16, 2004, letter requesting assistance in identifying producers and exporters of the subject merchandise in the PRC.
On April 30, 2004, the Department determined that India, Pakistan, Indonesia, Sri Lanka, the Philippines, Morocco, and Egypt are countries comparable to the PRC in terms of economic development.
On May 6, 2004, we issued Sections A, C, D, and E of our questionnaire to Tianjin and RSM, the only two companies that responded to our request for Q&V information. In addition, on May 6, 2004, we issued a Section A, C, D, and E questionnaire to the Government of the PRC through the Ministry of Commerce and the Chinese Embassy in Washington, DC.
On May 17, 2004, the United States International Trade Commission (“ITC”) issued its affirmative preliminary determination that there is a reasonable indication that an industry in the United States is materially injured by reason of imports from China and Russia of pure magnesium and magnesium alloy. The ITC's determination was published in the
On May 19, 2004, the Department issued its respondent selection memorandum, officially selecting RSM and Tianjin as the two mandatory respondents in this investigation.
On May 10, 2004, the Department requested that the parties submit comments on surrogate country selection. On May 24, 2004, we received comments regarding our selection of a surrogate country from the Petitioners. On June 2, 2004, we received comments regarding our selection of a surrogate country from RSM and Tianjin. Petitioners argued that India is the appropriate surrogate country for this investigation because India is at a comparable level of economic development with the PRC based on gross national income (“GNI”) and contains the only producer of primary magnesium located in any of the countries identified by the Department as surrogate countries.
RSM and Tianjin provided information identifying Kazakhstan, Russia, and Brazil as potential surrogate countries in this investigation and contended that, according to the World Bank, Kazakhstan, Russia, and Brazil each have a per-capita GNI comparable to that of the PRC. RSM and Tianjin stated further that, according to the World Bank, neither India nor any of the other countries named in the
We received rebuttal comments concerning the selection of a surrogate country from Petitioners and respondents on June 14, 2004, June 28, 2004, and July 9, 2004.
We provided a one-week extension until June 1, 2004 to all interested parties that requested an extension for submitting a response to our Section A questionnaire. Additionally, we provided an extension until June 16, 2004, to all mandatory respondents to respond to sections C, D, and E of the questionnaire. For a detailed discussion on specific mandatory respondent extensions, please see the company-specific section for each mandatory respondent below.
On June 3, 2004, we received a Section A questionnaire response from Beijing Guangling Jinghua Science & Technology Co., Ltd. (“Guangling”), which requested a separate rate.
On June 2, 2004, and June 4, 2004, we received a request from Petitioners, RSM, and Tianjin, respectively, to extend the deadline for supplying surrogate-value information until two weeks after the submission of Section D data. On July 6, 2004, we extended the time period for interested parties to provide surrogate values for factors of production until July 12, 2004. On July 8, 2004, RSM and Tianjin requested an extension until two weeks after the Department decided the surrogate country to submit their surrogate-value information.
On June 17, 2004, RSM requested that the Department excuse it from reporting certain U.S. further-manufacturing activities. On June 21, 2004, we informed RSM that we did not have sufficient information on the record to exempt it from reporting sales and cost for merchandise further manufactured in the United States and requested RSM to report the further-manufactured
On June 28, 2004, Petitioners made a timely request pursuant to 19 CFR 351.205(e) for a fifty-day postponement of the preliminary determination or until September 24, 2004. On July 21, 2004, the Department published a postponement of the preliminary antidumping duty determination on magnesium metal from the PRC.
On August 3, 2004, the Department determined that India was the appropriate surrogate country to use in this investigation.
As described above, the Department staggered its issuance of sections of the antidumping questionnaire to the mandatory respondents. Upon receipt of the various responses, the Petitioners provided comments and the Department issued supplemental questionnaires. The chronology of this stage of the investigation varies by respondent. Therefore, the Department has separated by company the following discussion of its information-gathering process after issuance of the questionnaire.
RSM submitted its Section A questionnaire response on June 4, 2004. On June 17, 2004, RSM requested that the Department excuse it from reporting certain further-manufacturing activities in the United States, arguing that the value added in the United States “exceeds substantially” the value of the imported subject merchandise and that there were sufficient sales to unaffiliated U.S. customers upon which to conduct a constructed-export-price (“CEP”) analysis. On June 21, 2004, the Department responded that it did not have sufficient information to exempt RSM from reporting its sales of further-manufactured merchandise in the United States. On June 22, 2004, RSM requested further guidance concerning the types of information that the Department needed to grant its request. Petitioners submitted comments concerning RSM's June 22, 2004, request on June 23, 2004, claiming that RSM did not explain fully its affiliations with Toyota Tsusho America, Inc. (“TAI”), its affiliated reseller in the United States, and its further-manufacturer in the United States. Petitioners claimed further that RSM applied an incorrect methodology to determine the value added in the United States. On June 25, 2004, RSM responded that it need only address the value-added arguments in Petitioners' June 23, 2004, submission. RSM submitted its Section C and D questionnaire responses on June 21, 2004. On June 25, 2004, Petitioners submitted comments on RSM's Section A response. RSM submitted its Section E questionnaire response on June 29, 2004. Petitioners submitted deficiency comments on RSM's Section C and D questionnaire responses on July 2, 2004, and on RSM's Section E questionnaire response on July 13, 2004. The Department issued a supplemental questionnaire concerning Sections A-E of RSM's questionnaire responses on July 23, 2004. RSM submitted a supplemental section A through E questionnaire response on August 20, 2004. The Department issued a second supplemental questionnaire covering RSM on September 2, 2004. RSM provided its second supplemental questionnaire response on September 15, 2004. On September 21, 2004, the Department provided a memorandum to the file explaining that, although it was not rejecting RSM's September 15, 2004, submission, it would not be able to use the information provided in its second supplemental questionnaire response for the preliminary determination.
On June 4, 2004, Tianjin submitted its Section A questionnaire response. On June 18, 2004, Tianjin submitted its response to Section C of the Department's May 6, 2004, questionnaire. On June 21, 2004, Tianjin submitted its response to Section D of the Department's questionnaire. On July 2, 2004, Petitioners submitted deficiency comments on Tianjin's responses to Sections A, C, and D of the questionnaire. On July 23, 2004, the Department issued a supplemental Sections A, C, and D questionnaire. On August 13, 2004, Tianjin submitted its response to the supplemental Sections A, C, and D questionnaire. On August 23, 2004, the Department issued a second supplemental Sections A, C, and D questionnaire. On September 2, 2004, Tianjin submitted its response to the second supplemental Sections A, C, and D questionnaire. On September 3, 2004,
Guangling Jinghua submitted its Section A response on June 3, 2004. Petitioners provided comments on Guangling Jinghua's Section A response on July 8, 2004. The Department issued a supplemental Section A questionnaire on August 12, 2004. Guangling provided its supplemental Section A response on August 26, 2004.
Section 735(a) of the Act provides that a final determination may be postponed until no later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise or, in the event of a negative preliminary determination, a request for such postponement is made by the Petitioners. The Department's regulations at 19 CFR 351.210(e)(2) require that requests by respondents for postponement of a final determination be accompanied by a request for an extension of the provisional measures from a four-month period to not more than six months.
On September 14, 2004, RSM requested that, in the event of an affirmative preliminary determination in this investigation, the Department postpone its final determination by 60 days until 135 days after the publication of the preliminary determination. Accordingly, because we have made an affirmative preliminary determination and the requesting parties account for a significant proportion of the exports of the subject merchandise, we have postponed the final determination until no later than 135 days after the date of publication of the preliminary determination and are extending the provisional measures accordingly.
The period of investigation (“POI”) is July 1, 2003, through December 31, 2003. This period corresponds to the two most recent fiscal quarters prior to the month of the filing of the petition (February 27, 2003).
The products covered by this investigation are primary and secondary alloy magnesium metal, regardless of chemistry, raw material source, form, shape, or size. Magnesium is a metal or alloy containing by weight primarily the element magnesium. Primary magnesium is produced by decomposing raw materials into magnesium metal. Secondary magnesium is produced by recycling magnesium-based scrap into magnesium metal. The magnesium covered by this investigation includes blends of primary and secondary magnesium.
The subject merchandise includes the following alloy magnesium metal products made from primary and/or secondary magnesium including, without limitation, magnesium cast into ingots, slabs, rounds, billets, and other shapes, and magnesium ground, chipped, crushed, or machined into raspings, granules, turnings, chips, powder, briquettes, and other shapes: products that contain 50 percent or greater, but less than 99.8 percent, magnesium, by weight, and that have been entered into the United States as conforming to an “ASTM Specification for Magnesium Alloy”
The scope of this investigation excludes the following merchandise: (1) All forms of pure magnesium, including chemical combinations of magnesium and other material(s) in which the pure magnesium content is 50 percent or greater, but less that 99.8 percent, by weight, that do not conform to an “ASTM Specification for Magnesium Alloy”
The merchandise subject to this investigation is classifiable under items 8104.19.00 and 8104.30.00 of the Harmonized Tariff Schedule of the United States (“HTSUS”). Although the HTSUS items are provided for convenience and customs purposes, the written description of the merchandise under investigation is dispositive.
Section 777A(c)(1) of the Act directs the Department to calculate individual dumping margins for each known exporter and producer of the subject merchandise. Section 777A(c)(2) of the Act gives the Department discretion, when faced with a large number of exporters/producers, to limit its examination to a reasonable number of such companies if it is not practicable to examine all companies. Where it is not practicable to examine all known producers/exporters of subject merchandise, this provision permits the Department to investigate either (1) a sample of exporters, producers, or types of products that is statistically valid based on the information available to the Department at the time of selection or (2) exporters/producers accounting for the largest volume of the merchandise under investigation that can reasonably be examined. Only two of the twenty-four exporters identified in the petition responded to the Department's questionnaire. Therefore, the Department determined that it has the resources available to investigate all responding parties in this investigation and that there is no reason to limit the number of respondents to be examined in this investigation pursuant to section 777A(c)(2) of the Act.
For purposes of initiation, the Petitioners submitted LTFV analyses for the PRC as a non-market economy.
When the Department is investigating imports from an NME, section 773(c)(1) of the Act directs it to base normal value (“NV”), in most circumstances, on the NME producer's factors of production valued in a surrogate market-economy country or countries considered to be appropriate by the Department. In accordance with section 773(c)(4) of the Act, in valuing the factors of production, the Department shall utilize, to the extent possible, the prices or costs of factors of production in one or more market-economy countries that are at a level of economic development comparable to that of the NME country and are significant producers of comparable merchandise. The sources of the surrogate values we have used in this investigation are discussed under the NV section below.
The Department determined that India, Pakistan, Indonesia, Sri Lanka, the Philippines, Morocco, and Egypt are countries comparable to the PRC in terms of economic development.
The Department received arguments from interested parties on the surrogate country. Petitioners argue that India is the appropriate surrogate country for this investigation because India is at a comparable level of economic development with the PRC based on gross national income (“GNI”). Petitioners contend that the Department has consistently found that India meets these statutory requirements for a surrogate country for the PRC, citing
Respondents identified Kazakhstan, Russia, and Brazil as potential surrogate countries for the PRC in this investigation. Respondents argue that neither India nor the other countries identified in the Office of Policy's List of Surrogate Countries produce the subject merchandise nor comparable merchandise. Respondents claim further that, among the developing countries other than China, only Kazakhstan, Russia, and Brazil are significant producers and exporters of magnesium and magnesium alloys.
The Department found that none of the countries on the List of Surrogate Countries are significant producers of the subject merchandise, magnesium metal. In past cases, the Department has determined that aluminum is comparable merchandise to magnesium.
Consequently, we have made the following determination about the use of India as a surrogate country: (1) It is a significant producer of comparable merchandise, aluminum; (2) it is at a similar level of economic development pursuant to 733(c)(4) of the Act; and (3) we have reliable data from India that we can use to value the factors of production.
In accordance with 19 CFR 351.301(c)(3)(i), for the final determination in an antidumping investigation, interested parties may submit publicly available information to value the factors of production within 40 days after the date of publication of the preliminary determination.
Section 771(33) of the Act states that the Department considers the following entities to be affiliated: (A) Members of a family, including brothers and sisters (whether by whole or half blood), spouse, ancestors, and lineal descendants; (B) Any officer or director of an organization and such organization; (C) Partners; (D) Employer and employee; (E) Any person directly or indirectly owning, controlling, or holding with power to vote, 5 percent or more of the outstanding voting stock or shares of any organization and such
For purposes of affiliation, section 771(33) of the Act states that a person shall be considered to control another person if the person is legally or operationally in a position to exercise restraint or direction over the other person. In order to find affiliation between companies, the Department must find that at least one of the criteria listed above is applicable to the respondents.
The Statement of Administrative Action accompanying the Uruguay Round Agreements Act (“SAA”), H.R. Doc. 103-316 (1994), indicates that stock ownership is not the only evidentiary factor that the Department may consider to exercise restraint or direction to determine whether a person is in a position to control and that control may be established through corporate or family groupings.
To the extent that the affiliation provisions in section 771(33) of the Act do not conflict with the Department's application of separate rates and the statutory NME provisions in section 773(c) of the Act, the Department will determine that exporters and/or producers are affiliated if the facts of the case support such a finding.
Following these guidelines, we have considered whether we should determine that the seven members of the RSM Group (“RSM”): Nanjing Yunhai Special Metals Co., Ltd. (“Yunhai Special”), Nanjing Welbow Metals Co., Ltd. (“Welbow”), Nanjing Yunhai Magnesium Co., Ltd. (“Yunhai Magnesium”), Shanxi Wenxi Yunhai Metals Co., Ltd. (“Wenxi Yunhai”), Shanxi Wenxi Bada Magnesium Co., Ltd. (“Bada Magnesium”), Yuncheng Wenxi Welfare Magnesium Plant (“Welfare Magnesium”), and Nanjing Yunhai Metals Plant (“Yunhai Metals”) are affiliated and should be collapsed. Moreover, we considered whether these companies should be collapsed with China National Nonferrous Metals I/E Corp., Jiangsu Branch (“Jiangsu Metals”), and TAI, thus considering these companies as a single entity for the purposes of the antidumping investigation of magnesium metal from the People's Republic of China (“PRC”).
In its original questionnaire responses, RSM also reported that its affiliated reseller in the United States made sales of subject merchandise to an affiliated further-manufacturer in the United States that incorporated the subject merchandise into steering wheel armatures. In its supplemental questionnaire response, RSM argued that TAI was not affiliated with its downstream further-manufacturer. Therefore, we considered whether TAI and its downstream further-manufacturer are affiliated for the purposes of this investigation.
RSM reported that the members of RSM Group that produced or exported the subject merchandise are Yunhai Special, Welbow, Yunhai Magnesium, Wenxi Yunhai, Bada Magnesium, Welfare Magnesium, and Yunhai Metals. In addition, in its original questionnaire response, RSM claimed that it was affiliated with its U.S. reseller, TAI, during the POI and that all of the U.S. sales made through TAI should be treated as CEP sales. In its supplemental response, however, RSM argued that TAI was affiliated with only one member of the RSM group, Yunhai Magnesium, through TAI's parent company. Consequently, RSM reclassified all of its U.S. sales, except those originating with Yunhai Magnesium, as export-price (“EP”) sales.
Based on our examination of the evidence presented in RSM's questionnaire responses, we have determined that Yunhai Special, Wenxi Yunhai, Welbow, Yunhai Magnesium, Bada Magnesium, Welfare Magnesium, and Yunhai Metals are affiliated under sections 771(33)(B), (E), (F), and (G) of the Act. We found, however, that only Yunhai Special, Welbow, Yunhai Magnesium, and Wenxi Yunhai either produced the subject merchandise during the POI, or were capable of producing the subject merchandise. Thus, we determined that Yunhai Special, Welbow, Wenxi Yunhai, and Yunhai Magnesium are affiliated and should be collapsed and treated as a single entity for purposes of calculating a dumping margin in this investigation for the following reasons: (1) Yunhai Special controls a majority or near-majority of Welbow, Wenxi Yunhai, and Yunhai Magnesium based on stock-ownership; (2) Yunhai Special, Welbow, Wenxi Yunhai, and Yunhai Magnesium share the same general manager and a common board member; and (3) RSM reported that the operations of Yunhai Special and Welbow cannot be distinguished since the two companies share the same general manager, production facilities, and employees.
We also determined that Jiangsu Metals is affiliated with the RSM Group, under sections 771(33)(E) and (F) of the Act, because RSM reported that Jiangsu Metals, an exporter of the subject merchandise, held more than 5 percent of the outstanding stock in Yunhai Magnesium and is therefore affiliated with Yunhai Magnesium pursuant to section 771(33)(E) of the Act. In addition, we found that Jiangsu Metals and Yunhai Special both own shares of Yunhai Magnesium as joint-venture partners. Consequently, we determined that Jiangsu Metals and Yunhai Special are affiliated in accord with section 771(33)(F) of the Act.
We determined further that, in contrast to RSM's arguments in its supplemental questionnaire response, TAI is also affiliated with the RSM Group under sections 771(33)(E) and (F) of the Act because the role that TAI and its parent corporation play in RSM's sales process indicates that TAI is
We did not analyze whether Jiangsu Metals, an affiliated exporter, meets the criteria for collapsing with the RSM group because the company did not produce the subject merchandise during the POI. As a result, we have not collapsed Jiangsu Metals with the members of the RSM group for the purposes of calculating the antidumping duty margin. We have considered Jiangsu Metals for a separate rate in its own right.
We examined the information on the record with respect to TAI and its further-manufacturer and determined that TAI was affiliated with its downstream further-manufacturer, under section 771(33)(E) and (F) of the Act, for several reasons. RSM reported that TAI and its further-manufacturer are both subsidiaries of the same parent corporation in Japan and, thus, are affiliated in accord with section 771(33)(E) of the Act.
In proceedings involving NME countries, the Department begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is the Department's policy to assign all exporters of merchandise subject to investigation in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate. The two mandatory respondents and the Section A respondent have provided company-specific information and each has stated that it meet the standards for the assignment of a separate rate.
We have considered whether each company based in the PRC is eligible for a separate rate. The Department's separate-rate test to determine whether the exporters are independent from government control does not consider, in general, macroeconomic/border-type controls,
To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, the Department analyzes each entity exporting the subject merchandise under a test arising from the
The Department considers the following
Our analysis shows that the evidence on the record supports a preliminary finding of
Typically the Department considers the following four factors in evaluating whether each respondent is subject to de facto governmental control of its export functions: (1) Whether the export prices are set by or are subject to the approval of a governmental agency; (2) whether the respondent has authority to negotiate and sign contracts and other agreements; (3) whether the respondent has autonomy from the government in making decisions regarding the selection of management; and (4) whether the respondent retains the proceeds of its export sales and makes independent decisions regarding disposition of profits or financing of losses.
We determine that, for Tianjin, Guangling Jinghua, Jiangsu Metals, and the RSM companies consisting of Yunhai Special, Welbow, Wenxi Yunhai, and Yunhai Magnesium, the evidence on the record supports a preliminary finding of
Therefore, the evidence placed on the record of this investigation by Tianjin, Guangling Jinghua, Jiangsu Metals, and the RSM companies consisting of Yunhai Special, Welbow, Wenxi Yunhai, and Yunhai Magnesium demonstrates an absence of government control, both in law and in fact, with respect to each of the exporter's exports of the merchandise under investigation in accordance with the criteria identified in
The Department has data that indicates there were more exporters of magnesium metal from the PRC during the POI than those which responded to the Q&V questionnaire.
Section 776(a)(2) of the Act provides that, if an interested party (A) withholds information that has been requested by the Department, (B) fails to provide such information in a timely manner or in the form or manner requested, subject to subsections 782(c)(1) and (e) of the Act, (C) significantly impedes a proceeding under the antidumping statute, or (D) provides such information but the information cannot be verified, the Department shall, subject to subsection 782(d) of the Act, use facts otherwise available in reaching the applicable determination.
Pursuant to section 782(e) of the Act, the Department shall not decline to consider submitted information if all of the following requirements are met: (1) The information is submitted by the established deadline; (2) the information can be verified; (3) the information is not so incomplete that it cannot serve as a reliable basis for reaching the applicable determination; (4) the interested party has demonstrated that it acted to the best of its ability; and (5) the information can be used without undue difficulties.
Information on the record of this investigation indicates that there are numerous producers/exporters of magnesium metal in the PRC. As described above, all exporters were given the opportunity to respond to the Department's questionnaire. Based upon our knowledge of the volume of imports of subject merchandise from the PRC and the fact that information indicates that the responding companies did not account for all imports into the United States from the PRC, we have preliminarily determined that certain PRC exporters of magnesium metal failed to respond to our questionnaires. As a result, use of adverse facts available (“AFA”) pursuant to section 776(a)(2)(A) of the Act is appropriate. Additionally, in this case, the Government of the PRC did not respond to the Department's questionnaire, thereby necessitating the use of AFA to determine the PRC-wide rate.
Section 776(b) of the Act provides that, in selecting from among the facts available, the Department may employ adverse inferences if an interested party fails to cooperate by not acting to the best of its ability to comply with requests for information.
Section 776(b) of the Act authorizes the Department to use AFA information derived from the petition, the final determination from the LTFV investigation, a previous administrative review, or any other information placed on the record. As AFA, we have assigned to the PRC-wide entity a margin based on a calculated margin derived from information obtained in the course of the investigation and placed on the record of this proceeding. In this case, we have applied a rate of 177.62 percent.
Consequently, we are applying a single antidumping rate—the PRC-wide rate—to producers/exporters that failed to respond to the Q&V questionnaire or Section A questionnaire. This rate will also apply to exporters which did not demonstrate entitlement to a separate rate.
Because this is a preliminary margin, the Department will consider all margins on the record at the time of the final determination for the purpose of determining the most appropriate final PRC-wide margin.
Guangling Jinghua, the only exporter which submitted a response to Section A of the Department's antidumping questionnaire and had sales of the subject merchandise to the United States during the POI but was not selected as mandatory respondent in this investigation (“Section A respondent”), has applied for a separate rate and provided information for the Department to consider for this purpose. Therefore, we have established a weighted-average margin based on the rate we have calculated for the two mandatory respondents, excluding any
Section 351.401(I) of the Department's regulations state that, “in identifying the date of sale of the subject merchandise or foreign like product, the Secretary normally will use the date of invoice, as recorded in the exporter or producer's records kept in the normal course of business.” After examining the sales documentation placed on the record by the mandatory respondents, we preliminarily determine that date of purchase order is the most appropriate date of sale for RSM and Tianjin. In their submissions, RSM and Tianjin stated that they establish the date of sale on their purchase order date because all of their sales terms are finalized by the purchase order date. Additionally, RSM and Tianjin provided no evidence to suggest that their sales terms changed after the purchase order was established. Based on record evidence, we have determined that RSM's and Tianjin's sales terms did not change after the purchase-order date, and thus we have used purchase order date as the date of sale for the preliminary determination for RSM and Tianjin.
The Department intends to examine the date-of-sale issue at verification thoroughly and may reconsider its position for the final determination based on the results of verification.
To determine whether sales of magnesium metal to the United States by the two mandatory respondents were made at less than fair value, we compared EP or CEP to NV, as described in the “Export Price,” “U.S. Price,” and “Normal Value” sections of this notice.
In accordance with section 772(a) of the Act, we used EP for Tianjin, as appropriate, because the subject merchandise was first sold (or agreed to be sold) before the date of importation by the producer or exporter of the subject merchandise outside the United States to an unaffiliated purchaser in the United States or to an unaffiliated purchaser for exportation to the United States and because the use of CEP was not otherwise indicated. In accordance with section 772(b) of the Act, we used CEP for RSM and Jiangsu Metals because the subject merchandise was sold in the United States after the date of importation by a U.S. reseller affiliated with the producer. In addition, we did not use sales made by the U.S. reseller to an affiliated further-manufacturer because RSM reported that all of those sales were destined for further manufacturing in the United States where the value added substantially exceeded the value of the merchandise imported.
We calculated EP and CEP based on the packed F.O.B., C.I.F., or delivered price to unaffiliated purchasers in, or for exportation to, the United States. We made deductions, as appropriate, for any movement expenses (
In accordance with section 772(d)(1) of the Act and the
We compared NV to weighted-average EPs and CEPs in accordance with section 777A(d)(1) of the Act. For RSM, in accordance with sections 772(d)(3) and 772(f) of the Act, we deducted CEP profit. For a detailed description of all adjustments,
Section 773(c)(1) of the Act provides that the Department shall determine the NV using a factors-of-production methodology if the merchandise is exported from an NME and the information does not permit the calculation of NV using home-market prices, third-country prices, or constructed value under section 773(a) of the Act. The Department bases NV on the factors of production because the presence of government controls on various aspects of these economies renders price comparisons and the calculation of production costs invalid under its normal methodologies.
The Department's questionnaire requires that the respondent provide information regarding the weighted-average factors of production across all of the company's plants that produce the subject merchandise, not just the factors of production from a single plant. This methodology ensures that the Department's calculations are as accurate as possible.
In accordance with section 773(c) of the Act, we calculated NV based on factors of production reported by respondents for the POI. To calculate NV, we multiplied the reported per-unit factor-consumption rates by publicly available Indian surrogate values (except as discussed below). In selecting the surrogate values, we considered the quality, specificity, and contemporaneity of the data. As appropriate, we adjusted input prices by including freight costs to make them delivered prices. Specifically, we added to Indian import surrogate values a surrogate freight cost using the shorter of the reported distance from the domestic supplier to the factory or the distance from the nearest seaport to the factory where appropriate. This adjustment is in accordance with the
For this preliminary determination, in accordance with past practice, we used data from the Indian Import Statistics in order to calculate surrogate values for the mandatory respondents' material inputs. In selecting the best available information for valuing factors of production in accordance with section 773(c)(1) of the Act, the Department's practice is to select, to the extent practicable, surrogate values which are non-export average values, most contemporaneous with the POI, product-specific, and tax-exclusive. The record shows that data in the Indian Import Statistics represents import data, is contemporaneous with the POI, is product-specific, and is tax-exclusive.
Furthermore, with regard to both the Indian import-based surrogate values and the market-economy input values, we have disregarded prices that we have reason to believe or suspect may be subsidized. We have reason to believe or suspect that prices of inputs from Indonesia, South Korea, and Thailand may have been subsidized. We have found in other proceedings that these countries maintain broadly available, non-industry-specific export subsidies and, therefore, it is reasonable to infer that all exports to all markets from these countries are subsidized.
We used the Indian Import Statistics to value the following raw material inputs, energy, by-products, and packing materials that RSM and Tianjin used to produce the subject merchandise during the POI: Ferrosilicon, dolomite, No.2 flux, fluorite powder, sulfur powder, primary magnesium, magnesium scrap, zinc, AlBe5, AlBe1, manganese powder, magnesium, aluminum-magnesium alloy, sulfuric acid manganese chip, magnesium chloride, potassium chloride, barium chloride, aluminum, sulfur dioxide, nitrogen, argon, coal, bituminous coal, anthracite, liquified petroleum gas (“LPG”), propane, steel strap, LDPE sheet, printing ink, printing ink solvent, particle board, pallet, little steel sheet, steel band, and plastic bags. For a detailed description of all surrogate values used for respondents,
To value electricity, we used data from the International Energy Agency (“IEA”)
To value heavy oil and diesel fuel, we used data from IEA's
For direct, indirect, and packing labor, consistent with 19 CFR 351.408(c)(3), we used the PRC regression-based wage rate as reported on Import Administration's home page, Import Library, Expected Wages of Selected NME Countries, revised in September 2003,
The respondents also reported packing inputs. We used Indian Import Statistics data from the period July 2003 to December 2003 to value these inputs.
RSM reported magnesium alloy slag as by-product of the production process. We used Indian Import Statistics data from the period July 2003 to December 2003 to value this by-product.
We used Indian transport information in order to value the transportation of raw materials. To calculate domestic inland freight for trucking services, we selected freight values from
We used Indian rail freight information in order to value the transportation of raw materials. To value the rail freight, we used two price quotes from November 1999 for steel shipments within India. Because the value was not contemporaneous with the POI, we adjusted the rate for inflation.
To value factory overhead, selling, general, and administrative expenses, and profit, we used the audited financial statements for the fiscal year ending March 31, 2003, from the following aluminum producers in India: National Aluminium Company Limited;
We made currency conversions into U.S. dollars, in accordance with section 773A(a) of the Act, based on the exchange rates in effect on the dates of the U.S. sales as certified by the Federal Reserve Bank.
As provided in section 782(I)(1) of the Act, we intend to verify the information upon which we will rely in making our final determination.
The weighted-average dumping margins are as follows:
We will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
In accordance with section 733(d) of the Act, we will instruct U.S. Customs and Border Protection (“CBP”) to suspend liquidation of all entries of subject merchandise, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
In accordance with section 733(f) of the Act, we have notified the ITC of our preliminary affirmative determination of sales at less than fair value. Because we have postponed the deadline for our final determination to 135 days from the date of publication of this preliminary determination, section 735(b)(2) of the Act requires the ITC to make its final determination as to whether domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of wooden bedroom furniture, or sales (or the likelihood of sales) for importation, of the subject merchandise within 45 days of our final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Import Administration no later than seven days after the date of the final verification report is issued in this proceeding and rebuttal briefs limited to issues raised in case briefs no later than five days after the deadline date for case briefs. A list of authorities used and an executive summary of issues should accompany any briefs submitted to the Department. This summary should be limited to five pages total, including footnotes.
In accordance with section 774 of the Act, we will hold a public hearing, if requested, to afford interested parties an opportunity to comment on arguments raised in case or rebuttal briefs. If a request for a hearing is made, we intend to hold the hearing three days after the deadline of submission of rebuttal briefs at the U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230, at a time and location to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Import Administration, U.S. Department of Commerce, Room 1870, within 30 days after the date of publication of this notice.
We will make our final determination no later than 135 days after the date of publication of this preliminary determination, pursuant to section 735(a)(2) of the Act.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
In response to a petition filed by U.S. Magnesium LLC (U.S. Magnesium), United Steelworkers of America, Local 8319, Glass, Molders, Pottery, Plastics and Allied Workers International, Local 374 (collectively, the Petitioners), the U.S. Department of Commerce (the Department) initiated and is conducting an investigation of sales of magnesium metal from the Russian Federation for the period January 1, 2003, through December 31, 2003.
October 4, 2004.
Joshua Reitze or Sebastian Wright at (202) 482-0666 or (202) 482-5254, respectively; Office of AD/CVD Operations VI, Import Administration, Room 1870, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230.
This investigation was initiated on March 18, 2004.
On March 26, 2004, the Department issued a letter providing interested parties an opportunity to comment on a proposed set of model-match criteria. We received comments in response to this letter from the Petitioners and JSC Avisma Magnesium-Titanium Works and VSMPO-Tirus, U.S. (Avisma) on April 1, 2004. Based on these submissions, we determined the appropriate model-match characteristics and included them in the antidumping questionnaire issued to Avisma and Solikamsk Magnesium Works (SMW), Respondents in this investigation, on April 24, 2004.
On March 31, 2004, the Department set aside a period for all interested parties to raise issues regarding the scope of this investigation. On April 16, 2004, the following companies submitted timely comments: Reade Manufacturing Company, Magnesium Elektron North America, Inc., and Hart Metals, Inc. (collectively, Reade) and Avisma. On April 26, 2004, the Department received rebuttal comments from the Petitioners, and additional comments from Northwest Alloys, Inc. (Northwest) and Alcoa, Inc. (Alcoa). On June 25, June 28, and July 9, 2004, we received additional comments on the scope of this investigation from Petitioners, Alcoa, Reade, and Avisma, in response to questions that we issued to all interested parties on June 9, 2004.
On May 17, 2004, the United States International Trade Commission (ITC) preliminarily determined that there is a reasonable indication that imports of the products subject to this investigation are materially injuring an industry in the United States producing the domestic like products.
On June 28, 2004, the Petitioners requested that the Department extend the preliminary determination in this investigation from August 5, 2004, to September 24, 2004.
In their petition, the Petitioners alleged that Russian energy costs were distorted by excessive involvement by the Russian government in the energy sector, and requested that the Department make adjustments to energy costs to account for the effects of this involvement. In the
Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise. Section 351.210(e)(2) of the Department's regulations requires that exporters requesting postponement of the final determination must also request an extension of the provisional measures referred to in section 733(d) of the Act from a four-month period until not more than six months. On September 14 and September 21, 2004, we received requests to postpone the final determination from SMW and Avisma, respectively. Both requests consented to the extension of provisional measures from four months to no longer than six months. Since this preliminary determination is affirmative, the requests for postponement are made by exporters that account for a significant proportion of exports of the subject merchandise, and since there is no compelling reason to deny the Respondents' requests, we have extended the deadline for issuance of the final determination until the 135th day after the date of publication of this preliminary determination in the
Section 777A(c)(1) of the Act directs the Department to calculate individual dumping margins for each known exporter and producer of the subject merchandise. Where it is not practicable to examine all known producers/exporters of subject merchandise, section 777A(c)(2) of the Act permits the Department to investigate either: (1) A sample of exporters, producers, or types of products that is statistically valid, based on the information available at the time of selection; or (2) exporters and producers accounting for the largest volume of the subject merchandise that can reasonably be examined. In the petition, the Petitioners identified two potential producers and exporters of magnesium metal in the Russian Federation: Avisma and SMW. This was confirmed by the Department's analysis of data collected by U.S. Customs and Border Protection (CBP), which was placed on the record on June 17, 2004.
On May 21, 2004, the Department received an e-mail message from another Russian producer of magnesium. In a subsequent e-mail message, the producer informed the Department that it had sold a small amount of subject merchandise to the United States during the period of investigation (POI). It also informed the Department that it is unrelated to the other Respondents. The sales amount reported by this producer is extremely small in comparison to the import statistics on the ITC Web site. As discussed in the memorandum for selection of Respondents, the Department found that it was not practical to examine all known exporters and producers of the subject merchandise.
The period of investigation (POI) is January 1, 2003, through December 31, 2003. This period corresponds to the four most recent fiscal quarters prior to the month of filing of the petition (
For the purpose of this investigation, the product covered is magnesium metal (also referred to as magnesium). The products covered by this investigation are primary and secondary pure and alloy magnesium metal, regardless of chemistry, raw material source, form, shape, or size. Magnesium is a metal or alloy containing by weight primarily the element magnesium. Primary magnesium is produced by decomposing raw materials into magnesium metal. Secondary magnesium is produced by recycling magnesium-based scrap into magnesium metal. The magnesium covered by this investigation includes blends of primary and secondary magnesium.
The subject merchandise includes the following pure and alloy magnesium metal products made from primary and/or secondary magnesium, including, without limitation, magnesium cast into ingots, slabs, rounds, billets, and other shapes, and magnesium ground, chipped, crushed, or machined into raspings, granules, turnings, chips, powder, briquettes, and other shapes: (1) Products that contain at least 99.95 percent magnesium, by weight (generally referred to as “ultra-pure” magnesium); (2) products that contain less than 99.95 percent but not less than 99.8 percent magnesium, by weight (generally referred to as “pure” magnesium); and (3) chemical combinations of magnesium and other material(s) in which the magnesium content is 50 percent or greater, but less that 99.8 percent, by weight, whether or not conforming to an “ASTM Specification for Magnesium Alloy.”
The scope of this investigation excludes: (1) Magnesium that is in liquid or molten form; and (2) mixtures containing 90 percent or less magnesium in granular or powder form by weight and one or more of certain non-magnesium granular materials to make magnesium-based reagent mixtures, including lime, calcium metal, calcium silicon, calcium carbide, calcium carbonate, carbon, slag coagulants, fluorspar, nephaline syenite, feldspar, alumina (Al203), calcium aluminate, soda ash, hydrocarbons, graphite, coke, silicon, rare earth metals/mischmetal, cryolite, silica/fly ash, magnesium oxide, periclase, ferroalloys, dolomite lime, and colemanite.
The merchandise subject to this investigation is classifiable under items 8104.11.00, 8104.19.00, 8104.30.00, and 8104.90.00 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS items are provided for convenience and customs purposes, the written description of the merchandise under investigation is dispositive.
On March 31, 2004, the Department set aside a period for all interested parties to raise issues regarding the scope of this investigation. As discussed above, we received comments from Reade, Northwest, Alcoa, and Avisma, as well as rebuttal comments from Petitioners. These comments are summarized in the Department's September 24, 2004 memorandum
To determine whether sales of magnesium metal were made in the United States at LTFV, we compared the constructed export price (CEP) to the normal value (NV), as described in the “Constructed Export Price” and “Normal Value” sections below. In accordance with section 777A(d)(1)(A)(i) of the Act, we calculated weighted-average CEPs. We then compared these to weighted-average home market prices in Russia.
Avisma reported invoice date as the date of sale for both the home and U.S. markets. Avisma issues invoices at the time of shipment, which, in the home market, may come after payment. For contract sales, the invoice establishes the price and quantity of the sale, as well as the parameters by which price and quantity may change under the contract. Invoices also set the price and quantity for spot sales. Because the material terms of sale are established when the invoice is issued, and because of our presumption that invoice date is the date of sale, as stated in section 351.401(i) of our regulations, we are using invoice date as the date of sale for all Avisma transactions in both markets.
For both the home and U.S. markets, SMW reported contract date as the date of sale. The contract date is the date when the material terms of sale (
Because the material terms of SMW's contracts are susceptible to amendment, and in fact are amended, we are using invoice date as the date of sale for this preliminary determination for both the home and U.S. markets. As noted above, the Department's regulations presume that invoice date is the date of sale.
For U.S. price, we used CEP, as defined in section 772(b) of the Act. Section 772(b) of the Act defines CEP as the price at which the subject merchandise is first sold in the United States before or after the date of importation by or for the account of the producer or exporter of such merchandise or by a seller affiliated with the producer or exporter, to a purchaser not affiliated with the
In its questionnaire responses, Avisma identified all of its sales to the United States as CEP sales. All of Avisma's sales are properly classified as CEP sales because they were made for the account of Avisma, by Avisma's U.S. affiliate, VSMPO-Tirus, U.S., Inc. (Tirus US), to unaffiliated purchasers in the United States. U.S. sales to the first unaffiliated party were made in the United States, by the U.S. affiliate, thus satisfying the Department's requirements for treating sales as CEP sales. Avisma and Tirus US are affiliated through common ownership.
In accordance with Section 772(c)(2) of the Act, for Avisma's CEP sales we made deductions from price for movement expenses and discounts, and additions for billing adjustments, where appropriate. More specifically, after reviewing the terms of delivery for Avisma's CEP sales to the United States, we deducted early payment discounts, added billing adjustments, and deducted foreign inland freight from plant to port, international freight and insurance, U.S. customs duties, U.S. brokerage and handling, and U.S. inland freight.
Section 772(d)(1) of the Act provides for additional adjustments to calculate CEP. Accordingly, we deducted direct selling expenses and indirect selling expenses related to commercial activity in the United States. Pursuant to section 772(d)(3) of the Act, we made an adjustment for CEP profit.
SMW also identified all of its U.S. sales as CEP sales in its questionnaire responses. During the POI, all sales of SMW's subject merchandise to the United States were made through its U.S. affiliates, Solimin and Cometals. We find that Cometals is affiliated with SMW by virtue of an agency agreement, in which Cometals acts as a North American distributor of pure and alloy magnesium products.
In accordance with section 772(c)(2) of the Act, for SMW's CEP sales, we made deductions from price for movement expenses and billing adjustments, where appropriate. More specifically, after reviewing the terms of delivery for SMW's CEP sales, we deducted foreign inland freight from plant to port; foreign brokerage, handling, and port charges; international freight and insurance; U.S. brokerage, handling, and port charges; U.S. warehousing; U.S. and foreign customs duties; and U.S. inland freight.
In accordance with section 772(d)(1) of the Act, we deducted direct selling expenses and indirect selling expenses related to commercial activity in the United States. Pursuant to section 772(d)(3) of the Act, we made an adjustment for CEP profit.
Section 773(a)(1) of the Act directs the Department to calculate NV based on the price at which the foreign like product is sold in the home market, provided that the merchandise is sold in sufficient quantities (or value, if quantity is inappropriate), and that there is no particular market situation that prevents a proper comparison with the EP or CEP. Under the statute, the Department will normally consider quantity (or value) insufficient if it is less than five percent of the aggregate quantity (or value) of sales of the subject merchandise to the United States.
We used sales to affiliated customers in the home market only where we determined such sales were made at arm's-length prices (
On June 29, 2004, Petitioners alleged that Avisma and SMW made sales in the home market at less than the COP. On July 15, 2004, Petitioners amended this allegation and revised their methodology. Based on these allegations, and in accordance with section 773(b)(2)(A)(i) of the Act, we found reasonable grounds to believe or suspect that magnesium sales were made in Russia at prices below the cost of production (COP).
In accordance with section 773(b)(3) of the Act, we calculated a weighted-average COP based on the sum of the cost of materials and fabrication for the foreign like product, plus amounts for the home market selling, general, and administrative (SG&A) expenses, including interest expenses and packing expenses. We relied on the COP data submitted by Avisma and SMW in their cost questionnaire responses, with the following changes.
We adjusted Avisma's financial expense ratio to include the total net foreign exchange gains and losses from Avisma's 2003 audited financial statements.
As noted above under “Case History,” Petitioners have alleged that Russian energy costs are distorted by excessive government involvement, and have requested that the Department make adjustments to Respondents' reported energy costs to account for the effects of this involvement. In their various submissions (identified in the “Case History” section above). Petitioners argue such adjustments are allowed under section 773(f) of the Act, which states:
Petitioners argue the use of the word “normally” in section 773(f) of the Act gives the Department the discretion to disregard reported costs in certain circumstances. According to Petitioners, energy is a cost “associated with” the production and sale of magnesium. Petitioners argue that non-market forces pervade the Russian energy sector, and that Russian energy prices do not reflect the true cost of energy production. In support of their position, Petitioners submitted documents from various organizations examining the Russian energy sector, and based on their analysis of these documents, they proposed options for the requested adjustment. Petitioners also noted that the Department's 2002 memorandum granting Russia market economy status, and the suspension agreement signed in 2002 in the antidumping investigation of cut-to-length carbon steel plate from Russia, alluded to the fact that prices in the Russian energy sector would merit particular scrutiny in future antidumping proceedings. In Petitioners' view, therefore, there is a sufficient legal and factual basis to reject Respondents' reported energy costs.
Respondents, on the other hand, argue that the Department has no authority to disregard their reported energy costs. Respondents note that, in a case involving a market economy, the Department is required to use the companies' reported energy costs unless one of the exceptions specified in the statute exists. Respondents argue that the statute focuses on the costs to the respondent, not the costs of an unaffiliated energy supplier, and there is no statutory authority to disregard a company's costs due to alleged government action. Rather, Respondents argue, there is a long line of precedent from both the Department and the courts holding that a company's reported costs may not be adjusted due to the receipt of government subsidies.
We believe that the legal arguments raised by both Petitioners and Respondents have merit, but we do not reach this legal issue in this preliminary determination. For the reasons discussed below, we have preliminarily concluded that the factual record of this investigation, to date, does not lead us to conclude that the Department should disregard Respondents' reported energy costs at this time.
We have carefully reviewed Petitioners' allegations regarding energy prices in Russia, as well as all relevant facts and information on the record, particularly since the Department has, in other contexts, expressed concerns about Russian energy pricing and pricing policies. Because, in the production of magnesium, gas costs are less important than electricity costs, our discussion focuses on electricity costs.
The analysis submitted by Petitioners to support their allegation that there is a significant price distortion compares retail-level cost (of sales off the low-voltage grid) to electricity prices Respondents paid, which, as reported by Respondents in their questionnaire responses, reflect sales off the high-voltage grid,
Finally, Petitioners argue that a meaningful measure of cost recovery for the electricity sector must include a price for gas used to make electricity that itself reflects full cost recovery. With respect to this argument, we have identified a number of issues that require further consideration. For example, one would need to assess the role of other non-gas based electricity supply sources in determining whether a significant distortion exists and the extent to which it is appropriate to employ estimates of future prices in calculating any adjustment to electricity prices. In addition, assuming,
Given these questions and reservations, the Department considers that it is appropriate to use Respondents' reported energy costs for purposes of the preliminary determination. We will, however, continue examining this issue in preparation for our final determination. We encourage the parties to submit additional information and arguments on this issue, inviting them in particular to comment on the concerns that we have outlined above. We also will be verifying Respondents' questionnaire responses including the information about their energy purchases that we have relied upon in this preliminary analysis. In order to allow proper review by the Department and all interested parties, we request that any additional arguments and factual information concerning this issue be filed as early as possible during the remainder of the proceeding. With respect to factual information, the following deadlines will apply. Any new, revised or updated factual information concerning Respondents' actual energy costs and all aspects of their energy usage and their relationships (if any) with energy suppliers must be submitted no later than the deadlines specified in any future questionnaires issued by the Department and in accordance with 19 CFR 351.301(c)(2)(ii), since such information is part of the questionnaire responses which must be verified. Any new factual information and arguments pertaining to the broader issue of whether electricity prices in Russia are or are not significantly distorted and whether an adjustment to such prices is or is not warranted must be submitted no later than November 8, 2004, and rebuttals of any such factual information and rebuttal comments no later than November 18, 2004, in accordance with 19 CFR 351.301(c)(1) and (c)(2)(ii). If the Department finds that an adjustment may be warranted after further review, we will issue for comment a memorandum outlining our preliminary analysis of why such an adjustment is warranted and the type of adjustment we are proposing, in order to ensure that all aspects of such an adjustment are carefully considered in time for the final determination.
We compared the weighted-average COP for Avisma and SMW to their home market sales prices of the foreign like product, as required under section 773(b) of the Act, to determine whether these sales had been made at prices below the COP within an extended period of time (
We disregarded below-cost sales where (1) 20 percent or more of either Respondent's sales of a given product during the POI were made at prices below the COP, and thus such sales were made within an extended period of time in substantial quantities in accordance with sections 773(b)(2)(B) and (C) of the Act, and (2) based on comparisons of price to weighted-average COPs for the POI, we determined that the below-cost sales of the product were at prices which would not permit recovery of all costs within a reasonable time period, in accordance with section 773(b)(2)(D) of the Act. We found that both Avisma and SMW made sales below cost and we disregarded such sales where appropriate.
Where appropriate, we determined NV for Avisma and SMW based on home market prices. However, both Respondents reported a significant number of “barter” sales in the home market. As this is the first investigation of Russian exporters conducted since the Department determined Russia to be a market economy,
We have examined barter sales in the Argentinian and Japanese markets in two cases decided prior to the effective date of the amendments made by the Uruguay Round Agreements Act (URAA). In
In
Therefore, the Department will need to examine this issue in greater detail. Questions we will need to examine further concerning these sales include, but are not limited to: the alignment of barter prices with non-barter prices charged for similar goods sold; the linkage of the price charged with the goods received, including any internal and external procedures for ensuring reasonable compensation is received in exchange for magnesium; and how these sales are recorded in Respondents' books and records. Of particular concern in this case, is the apparent discrepancy between prices charged on average for products sold on a barter basis compared to prices charged for the identical or most similar products when sold on a cash basis. While the Department has issued questionnaires concerning these sales in general, given the novelty of this issue for the Russian market, noted above, we do not currently have enough information concerning these sales on the record, and therefore have concluded that we should disregard the barter sales in our calculations for this preliminary determination.
For all remaining sales, we deducted home market movement expenses, pursuant to section 773(a)(6)(A) of the Act. We made circumstances of sale (COS) adjustments for Avisma's and SMW's transactions by deducting direct selling expenses incurred for home
Section 773(a)(4) of the Act provides that, where NV cannot be based on comparison-market sales, NV may be based on constructed value (CV). Accordingly, for sales of magnesium for which we could not determine the NV based on comparison-market sales, either because there were no useable sales of a comparable product or all sales of the comparable products failed the COP test, we based NV on CV.
Section 773(e) of the Act provides that CV shall be based on the sum of the cost of materials and fabrication for the imported merchandise, plus amounts for SG&A expenses, profit, and U.S. packing costs. We calculated the cost of materials and fabrication based on the methodology described in the “Cost of Production Analysis” section, above. We based SG&A and profit on the actual amounts incurred and realized in connection with the production and sale of the foreign like product in the ordinary course of trade for consumption in the comparison market, in accordance with section 773(e)(2)(A) of the Act.
We made adjustments to CV for differences in COS in accordance with section 773(a)(8) of the Act and 19 CFR 351.410. For comparisons to CEP, we made COS adjustments by deducting from CV direct selling expenses incurred on home-market sales.
In accordance with section 773(a)(1)(B)(i) of the Act, to the extent practicable, we determine NV based on sales in the comparison market at the same LOT as U.S. sales.
To determine whether NV sales are at a different LOT than EP or CEP sales, we examine stages in the marketing process and selling functions along the chain of distribution between the producer and the unaffiliated customer in the home market. If the comparison-market sales are at a different LOT, and the difference affects price comparability, as manifested in a pattern of consistent price differences between the sales on which NV is based and comparison-market sales at the LOT of the export transaction, we make an LOT adjustment under section 773(a)(7)(A) of the Act. Finally, for CEP sales, if the NV level is more remote from the factory than the CEP level and there is no basis for determining whether the difference in the levels between NV and CEP affects price comparability, we adjust NV under section 773(a)(7)(B) of the Act (the CEP offset provision).
In the current investigation, SMW claimed that sales in the home market and the United States market were made at different LOTs, but did not claim a LOT adjustment. Based on the selling functions performed, we preliminarily determine that SMW did not sell at different LOTs in the home and U.S. markets. After examining the selling functions for the one LOT reported in the United States, and the two claimed LOTs reported in the home market, we determine that these sale are, in fact, all made at one LOT. While SMW claimed that there were some differences between these various distribution channels, which it claimed to constitute separate LOTs, we have preliminarily determined that some of these differences do not constitute differences in selling functions. Differences between other functions,
In conducting this analysis, we examined the U.S. LOT after excluding the selling functions performed by SMW's U.S. affiliates (
Avisma reported one LOT in the home market and one LOT in the United States. It did not claim a LOT adjustment. After examining the selling functions performed in the home market and the United States (excluding those functions performed by the U.S. affiliate) we have preliminarily determined that the LOT for home market and U.S. sales is the same.
We made currency conversions into U.S. dollars in accordance with section 773A of the Act based on exchange rates in effect on the dates of the U.S. sales, as obtained from the Federal Reserve Bank (the Department's preferred source for exchange rates).
In accordance with section 782(i) of the Act, we will verify the questionnaire responses of Avisma and SMW before making our final determination.
In accordance with section 733(d)(2) of the Act, we are directing CBP to suspend liquidation of all entries of magnesium from Russia that are entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
In accordance with 19 CFR 351.224(b), the Department will disclose to interested parties the calculations performed in this preliminary determination within five days of the date of public announcement.
Interested parties are invited to comment on the preliminary determination. Interested parties may submit case briefs on the later of 50 days after the date of publication of this notice or ten days after the issuance of the verification reports.
In accordance with section 774 of the Act, we will hold a public hearing, if requested, to afford interested parties an opportunity to comment on arguments raised in case or rebuttal briefs. If a request for a hearing is made, we will tentatively hold the hearing two days after the deadline for submission of rebuttal briefs at the U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230, at a time and in a room to be determined. Parties should confirm by telephone the date, time, and location of the hearing 48 hours before the scheduled date.
Interested parties who wish to request a hearing, or to participate in a hearing if one is requested, must submit a written request to the Assistant Secretary for Import Administration, U.S. Department of Commerce, Room 1870, within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. At the hearing, oral presentations will be limited to issues raised in the briefs.
In accordance with section 733(f) of the Act, we have notified the ITC of the Department's preliminary affirmative determination. If the final determination in this proceeding is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether imports of magnesium metal from the Russian Federation are materially injuring, or threatening material injury to, the U.S. industry.
This determination is issued and published pursuant to sections 733(f) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
October 4, 2004.
Susan Lehman or Richard Rimlinger, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-0180 or (202) 482-4477, respectively.
On September 7, 2004, the Department of Commerce (the Department) received a petition on imports of polyvinyl alcohol (PVA) from Taiwan filed in proper form by Celanese Chemicals Ltd. (the petitioner). On September 9, 2004, and September 15, 2004, the Department issued supplemental questionnaires requesting additional information and clarification of certain areas of the petition. The Department also requested additional information in September 17, 2004, and September 24, 2004, conference telephone calls with the petitioner.
On September 23, 2004, E.I. DuPont de Nemours & Co. (DuPont), a domestic producer of PVA, upon the request of the Department, filed a statement detailing DuPont's total production of PVA for the calendar year 2003. On September 24, 2004, DuPont submitted two challenges to the petition. On September 27, 2004, Solutia Inc. (Solutia), a domestic producer of PVA, submitted a document informing the Department that it “neither supports nor opposes the antidumping duty petition” on PVA from Taiwan.
In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of PVA from Taiwan are being, or are likely to be, sold in the United States at less than fair value within the meaning of section 731 of the Act and that such imports are materially injuring and threaten to injure an industry in the United States.
The Department finds that the petitioner filed this petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(c) of the Act and the petitioner has demonstrated sufficient industry support with respect to the investigation that the petitioner is requesting the Department to initiate (
The merchandise covered by this investigation is PVA. This product consists of all PVA hydrolyzed in excess of 80 percent, whether or not mixed or diluted with commercial levels of defoamer or boric acid. PVA in fiber form is not included in the scope of this investigation. The merchandise under investigation is currently classifiable under subheading 3905.30.00 of the
During our review of the petition, we discussed the scope with the petitioner to ensure that it is an accurate reflection of the products for which the domestic industry is seeking relief. Moreover, as discussed in the preamble to the regulations (
Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (1) At least 25 percent of the total production of the domestic like product; and (2) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition.
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether the petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While the Department and the ITC must apply the same statutory definition regarding the domestic like product they do so for different purposes and pursuant to separate and distinct authority.
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this subtitle.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation,”
With regard to the definition of domestic like product, the petitioner does not offer a definition of domestic like product distinct from the scope of the investigation. Based on our analysis of the information presented by the petitioner, we have determined that there is a single domestic like product, PVA, which is defined in the “Scope of Investigation” section above, and we have analyzed industry support in terms of the domestic like product.
On September 24, 2004, the Department received opposition to the petition from DuPont, a producer of the domestic like product. Also, on September 27, 2004, the Department received a submission from Solutia, a producer of the domestic like product, expressing that it takes neither an affirmative nor a negative position with regard to this proceeding. However, the Department confirmed the necessary industry support based on the actual 2003 production figures which each domestic producer provided (
On September 24, 2004, the same producer of the domestic like product that filed an opposition to the petition (DuPont) filed a submission in which it urged the Department to reject the petition “because the petitioner has engaged in improper conduct” with respect to the establishment of industry support. Because the petitioner represents over 50 percent of total U.S. production, notwithstanding the allegations contained in DuPont's September 24, 2004, submission, it is not appropriate to reject the petition.
Accordingly, the Department determines that the petition was filed on behalf of the domestic industry within the meaning of section 732(b)(1) of the Act.
The anticipated period of investigation is July 1, 2003, through June 30, 2004.
The following is a description of the allegation of sales at less than fair value upon which the Department based its decision to initiate this investigation. The sources of data for the deductions and adjustments relating to U.S. price and normal value (NV) are discussed in greater detail in the Initiation Checklist. Should the need arise to use any of this information as facts available under section 776 of the Act, we may reexamine the information and revise the margin calculation, if appropriate.
The petition identified one producer of PVA in Taiwan.
The petitioner calculated EP by deducting an amount for foreign inland freight from factory to port. We reviewed the information provided regarding EP and have determined that it represents information reasonably available to the petitioner and have reviewed it for adequacy and accuracy. See Initiation Checklist.
To calculate NV, the petitioner obtained contemporaneous home-market prices for PVA sold in Taiwan from a Web site sponsored by the Taiwan Institute of Chemical Industry. The petitioner made an adjustment to home-market price by deducting amounts for inland freight and imputed credit expense. The petitioner compared home-market prices to its own cost of production (COP), adjusted for known cost differences between Taiwan and
The Statement of Administrative Action (SAA), accompanying the URAA, states that an allegation of sales below COP need not be specific to individual exporters or producers. See SAA, H.R. Doc. No. 103-316 at 833 (1994). The SAA states that “Commerce will consider allegations of below-cost sales in the aggregate for a foreign country, just as Commerce currently considers allegations of sales at less than fair value on a country-wide basis for purposes of initiating an antidumping investigation.”
Further, the SAA provides that the “new section 773(b)(2)(A) retains the current requirement that Commerce have ‘reasonable grounds to believe or suspect' that below cost sales have occurred before initiating such an investigation. ‘Reasonable grounds’ * * * exist when an interested party provides specific factual information on costs and prices, observed or constructed, indicating that sales in the foreign market in question are at below-cost prices.”
Pursuant to section 773(b)(3) of the Act, COP consists of the COM and SG&A (including financial expenses). The petitioner calculated COP based on its own experience as a U.S. producer during 2003, adjusted for known differences between costs incurred to manufacture PVA in the United States and in Taiwan. With the exception of labor, the publicly available data the petitioner used was contemporaneous with the prospective POI.
Based upon a comparison of the home-market prices of the foreign like product to the calculated COP of the product, we find reasonable grounds to believe or suspect that sales of the foreign like product were made below the COP, within the meaning of section 773(b)(2)(A)(i) of the Act. Accordingly, the Department is initiating a country-wide cost investigation.
As such, pursuant to sections 773(a)(4) and 773(e) of the Act, the petitioner calculated NV based on constructed value (CV). Consistent with section 773(e)(2)(B)(iii) of the Act, the petitioner included in CV an amount for profit. For profit, the petitioner relied upon amounts reported in Chang Chun Petrochemical Ltd.'s (CCP's), the potential respondent's, 2003 financial statements.
We adjusted the petitioner's calculated margin because the petitioner subtracted inland freight expenses from the CV and we do not normally deduct such expenses from CV. Therefore, we added the inland freight expense of 0.30 New Taiwan dollars per kilogram to the CV calculated by the petitioner and then converted the recalculated CV to a U.S. dollars per pound figure using the same methodology as the petitioner used. This results in a CV of US$ 0.8418 per pound and a U.S. price that is US$ 0.2398 per pound lower than CV. We reviewed the NV and CV information provided and have determined that it represents information reasonably available to the petitioner and have reviewed it for adequacy and accuracy.
Based on a comparison of EP derived from U.S. average unit values (AUVs) to adjusted CV, the dumping margin is 39.83 percent for PVA from Taiwan.
As indicated above, the petitioner also provided information demonstrating reasonable grounds to believe or suspect that sales of PVA in the home market were made at prices below the COP, within the meaning of section 773(b) of the Act, and requested that the Department conduct a country-wide sales-below-cost investigation.
Based on the data provided by the petitioner, there is reason to believe that imports of PVA from Taiwan are being, or are likely to be, sold in the United States at less than fair value.
The petitioner alleges that the U.S. industry producing the domestic like product is being materially injured and is threatened with material injury by reason of the imports of the subject merchandise sold at less than normal value. The petitioner contends that the industry's injured condition is evidenced by the volume of lost sales, declining profitability, reductions in employment, and stagnant capacity utilization. Furthermore, the petitioner contends that injury and threat of injury is evidenced by negative effects on its revenue, market share, and growth.
These allegations are supported by relevant evidence including import data, lost sales, and pricing information. The Department assessed the allegations and supporting evidence regarding material injury and causation and determined that these allegations are supported by accurate and adequate evidence and meet the statutory requirements for initiation.
Based upon the examination of the petition on PVA from Taiwan, and other information reasonably available to the Department, we find that the petition meets the requirements of section 732 of the Act. Therefore, we are initiating an antidumping duty investigation to determine whether imports of PVA from Taiwan are being, or are likely to be, sold in the United States at less than fair value. Unless postponed, we will make our preliminary determination no later than 140 days after the date of this initiation.
In accordance with section 732(b)(3)(A) of the Act, a copy of the public version of the petition has been provided to the representatives of the government of Taiwan. We will attempt to provide a copy of the public version of the petition to the producer named in the petition.
We have notified the ITC of our initiation, as required by section 732(d) of the Act.
The ITC will preliminarily determine, no later than October 22, 2004, whether there is a reasonable indication that imports of PVA from Taiwan are causing material injury, or threatening to cause material injury, to a U.S. industry. A negative ITC determination will result in the investigation being terminated; otherwise, this investigation will proceed according to statutory and regulatory time limits.
This notice is issued and published pursuant to section 777(i) of the Act.
Committee for the Implementation of Textile Agreements (CITA).
Issuing a directive to the Commissioner, Bureau of Customs and Border Protection adjusting limits.
October 4, 2004.
Naomi Freeman, 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 Bureau of Customs and Border Protection website at http://www.cbp.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 special shift.
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 October 14, 2003, 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 Hong Kong and exported during the twelve-month period which began on January 1, 2004 and extends through December 31, 2004.
Effective on October 4, 2004, 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).
Sincerely,
Committee for the Implementation of Textile Agreements (CITA).
Issuing a directive to the Commissioner, Bureau of Customs and Border Protection adjusting limits.
October 4, 2004.
Ross Arnold, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 344-2650. 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 Bureau of Customs and Border Protection website at http://www.cbp.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.
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 13, 2003, 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 Indonesia and exported during the twelve-month period which began on January 1, 2004 and extends through December 31, 2004.
Effective on October 4, 2004, you are directed to adjust the limits for the categories listed below, 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).
Sincerely,
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.
Ms. J. Hurd, DSCA/OPS-ADMIN, (703) 604-6575.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 04-33 with attached transmittal, policy justification, and Sensitivity of Technology.
Office of the Secretary, DoD.
Notice of DRG revised rates.
This notice describes the changes made to the TRICARE DRG-based payment system in order to conform to changes made to the Medicare Prospective Payment System (PPS).
It also provides the updated fixed loss cost outlier threshold, cost-to-charge ratios and the Internet address for accessing the updated adjusted standardized amount and DRG relative weights to be used for FY 2005 under the TRICARE DRG-based payment system.
The rates, weights and Medicare PPS changes which affect the TRICARE DRG-based payment system contained in this notice are effective for admissions occurring on or after October 1, 2004.
TRICARE Management Activity (TMA), Medical Benefits and Reimbursement Systems, 16401 East Centretech Parkway, Aurora, CA 80011-9066.
Marty Maxey, Medical Benefits and Reimbursement Systems, TMA, telephone (303) 676-3627. Questions regarding payment of specific claims under the TRICARE DRG-based payment system should be addressed to the appropriate contractor.
The final rule published on September 1, 1987 (52 FR 32992) set forth in basic procedures used under the CHAMPUS DRG-based payment system. This was subsequently amended by final rules published August 31, 1988 (53 FR 33461), October 21, 1988 (53 FR 41331), December 16, 1988 (53 FR 50515), May 30, 1990 (55 FR 21863), October 22, 1990 (55 FR 42560), and September 10, 1998 (63 FR 48439). An explicit tenet of these final rules, and one based on the statute authorizing the use of DRGs by TRICARE, is that the TRICARE DRG-
In addition, this notice updates the rates and weights in accordance with our previous final rules. The actual changes we are making, along with a description of their relationship to the Medicare PPS, are detailed below.
Following is a discussion of the changes CMS has made to the Medicare PPS that affect the TRICARE DRG-based payment system.
Under both the Medicare PPS and the TRICARE DRG-based payment system, cases are classified into the appropriate DRG by a Grouper program. The Grouper classifies each case into a DRG on the basis of the diagnosis and procedure codes and demographic information (that is, sex, age, and discharge status). The Grouper used for the TRICARE DRG-based payment system is the same as the current Medicare Grouper with two modifications. The TRICARE system has replaced Medicare DRG 435 with two age-based DRGs (900 and 901), and has implemented thirty-four (34) neonatal DRGs in place of Medicare DRGS 385 through 390. For admission occurring on or after October 1, 2001, DRG 435 has been replaced by DRG 523. The TRICARE system has replaced DRG 523 with the two age-based DRGs (900 and 901). For admissions occurring on or after October 1, 1995, the CHAMPUS grouper hierarchy logic was changed so the age split (age <29 days) and assignments to MDC 15 occur before assignment of the PreMDC DRGs. This resulted in all neonate tracheostomies and organ transplants to be grouped to MDC 15 and not to DRGs 480-483 or 495. For admissions occurring on or after October 1, 1998, the CHAMPUS grouper hierarchy logic was changed to move DRG 103 to the PreMDC DRGs and to assign patients to PREMDC DRGs 480, 103 and 495 before assignment to MDC 15 DRGs and the neonatal DRGs. For admissions occurring on or after October 1, 2001, DRGs 512 and 513 were added to the PREMDC DRGs, between DRGs 480 and 103 in the TRICARE grouper hierarchy logic. For admissions occurring on or after October 1, 2004, DRG 483 was deleted and replaced with DRGs 541 and 542, splitting the assignment of cases on the basis of the performance of a major operating room procedure. The description for DRG480 was changed to “Liver Transplant and/or Intestinal Transplant”, and the description for DRG 103 was changed to “Heart/Heart Lung Transplant or Implant of Heart Assist System”.
For FY 2005, CMS will implement classification changes, including surgical hierarchy changes. The TRICARE Grouper will incorporate all changes made to the Medicare Grouper, with the exception of the changes made to MDC 11, DRG 315 to accommodate the congressional mandate to cover the pancreatic inlet cell transplantation clinical trial for Medicare patients.
TRICARE will continue to use the same wage index amounts used for the Medicare PPS. In addition, TRICARE will duplicate all changes with regard to the wage index for specific hospitals that are redesignated by the Medicare Geographic Classification Review Board.
TRICARE is adopting the out commuting wage index adjustment used in the Medicare PPS due to the passage of the Medicare Modernization Act of 2003 (MMA) P.L. 108-173.
TRICARE is adopting the new labor market areas used in the Medicare PPS.
TRICARE is adopting CMS' permanent equalization of the ASA rate for large urban and other areas due to the passage of the MMA of 2003. Under TRICARE, children's hospitals are reimbursed under the TRICARE DRG-based payment system and are entitled to receive the children's hospital differential. The differential amount is based on large urban and other areas. With the elimination of the other area ASA rate for hospitals subject to the TRICARE DRG-based payment, TRICARE is also eliminating the other area children's hospital differential rate and adopting the large urban differential rate for all children's hospitals.
TRICARE is adopting CMS' percentage of labor related share of the standardized amount. For wage index values greater than 1.0, the labor related portion of the ASA shall equal 71.1 percent. For wage index values less than or equal to 1.0 the labor related portion of the ASA shall equal 62 percent.
TRICARE will update the adjusted standardized amounts according to the final updated hospital market basket used for the Medicare PPS for all hospitals subject to the TRICARE DRG-based payment system according to CMS's August 11, 2004, final rule.
Since TRICARE does not include capital payments in our DRG-based payments, we will use the fixed loss cost outlier threshold calculated by CMS for paying cost outliers in the absence of capital prospective payments. For FY 2005, the fixed loss cost outlier threshold is based on the sum of the applicable DRG-based payment rate plus any amounts payable for IDME plus a fixed dollar amount. Thus, for FY 2005, in order for a case to qualify for cost outlier payments, the costs must exceed the TRICARE DRG based payment rate (wage adjusted) for the DRG plus the IDME payment plus $23,762 (wage adjusted). The marginal cost factor for cost outliers continues to be 80 percent.
The FY 2005 TRICARE National Operating Standard Cost as a Share of Total Costs used in calculating the cost outlier threshold is 0.921.
Passage of the MMA of 2003 modified the formula multipliers to be used in the calculation of the indirect medical education IDME adjustment factor. Since the IDME formula used by TRICARE does not include disproportionate share hospitals (DSHs), the variables in the formula are different than Medicare's, however; the percentage reduction that will be applied to Medicare's, formula will also be applied to the TRICARE IDME formula. The new multiplier for the IDME adjustment factor for TRICARE for FY 2005 is 1.07.
For FY 2005 TRICARE is adopting CMS' expanding post acute care transfer policy according to CMS' final rule published August 11, 2004.
For FY 2005, the cost-to-charge ratio used for the TRICARE DRG-based payment system will be 0.4438, which is increased to 0.4508 to account for bad debts. This shall be used to calculate the adjusted standardized amounts and to calculate cost outlier payments, except for children's hospitals. For children's hospital cost outliers, the cost-to charge ratio used is 0.4887.
The updated rates and weights are accessible through the Internet at
Notice of meeting.
PITAC's Subcommittee on Cyber Security will provide a status update of its activities and present its draft findings and recommendations. PITAC will discuss the Subcommittee's presentation and provide guidance for use in the completion of the report. In addition, an update of the activities of PITAC's Subcommittee on Computational Science will be presented and discussed. Each of the sessions for the two Subcommittees will conclude with a public comment period. A small fraction of the meeting time will be allocated for other PITAC updates at the discretion of the co-hairs and designated Federal officer.
Wednesday, October 20, 2004, 10 a.m. to 3 p.m.
National Science Foundation, Stafford II Building—Room 555, 4201 Wilson Boulevard, Arlington, Virginia 22230.
Members of the public are invited to attend this meeting in-person at the National Science Foundation. Remote participation by teleconference and the Internet (through the Webex application) will also bed supported. Detailed information about this meeting, including the agenda and details concerning registration for in-person or remote participation, will be posted at PITAC's Web site (
Alan Inouye at the National Coordination Office for Information Technology Research and Development at 703-292-4873 or by email at
Department of Defense.
Notice of Advisory Committee Meetings.
The Defense Science Board Task Force on Missile Defense, Phase IV (Information Policy) will meet in closed session on October 15, 2004 and December 9-10, 2004, at the Institute for Defense Analyses, 1801 N. Beauregard Street, Alexandria, VA. The Task Force will assess: the scope of the modeling and simulation effort; the appropriateness of the level of fidelity of classes of simulations; the impact of communications in the end-to-end models; the approaches to ensuring the validity of simulations for all uses, including exercises and wargaming done for training and operations concept development; and additional opportunities for modeling and simulation contribution to Ballistic Missile Defense Systems development and evaluation.
The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At this meeting, the Defense Science Board Task Force will address the above mentioned issues in a system of systems context with particular emphasis on battle management systems, command and control systems, and the global sensor system. The Task Force will provide advice on the state of modeling and simulation for use in assessing overall performance of segments of the Ballistic Missile Defense Systems; e.g., ground-based midcourse intercept system, space-based interceptor system.
In accordance with Section 10(d) of the Federal Advisory Committee Act, Pub. L. 92-463, as amended (5 U.S.C. App. II), it has been determined that this Defense Science Board Task Force meeting concerns matters listed in 5 U.S.C. 552b(c)(1) and that, accordingly, the meeting will be closed to the public.
Department of Defense.
Notice of Advisory Committee Meeting.
The Defense Science Board Task Force on Mobility will meet in closed session on October 14-15, 2004; November 17-18, 2004; and December 14-15, 2004, in Arlington, VA. This task Force will identify the acquisition issues in improving our strategic mobility capabilities.
The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At this meeting, the Defense Science Board Task Force will review: The part transport plays in our present-day military capability—the technical strengths and weaknesses the operational opportunities and constraints; the possible advantage of better alignment of current assets with those in production and those to be delivered in the very near future; how
In accordance with Section 10(d) of the Federal Advisory Committee Act, Pub. L. 92-463, as amended (5 U.S.C. App. II), it has been determined that this Defense Science Board Task Force meeting concerns matters listed in 5 U.S.C. 552b(c)(1) and that, accordingly, the meeting will be closed to the public.
Department of Defense, Defense Threat Reduction Agency.
Notice of PRB membership.
This notice announces the appointment of DTRA's PRB membership. The publication of the PRB membership is required by 5 U.S.C. 4314(c)(4). The PRB shall provide fair and impartial review of Senior Executive Service performance appraisals and make recommendations regarding performance ratings and performance awards to the Acting Director, Defense Threat Reduction Agency.
The effective date of service for the appointees of the DTRA PRB is on or about October 1, 2004.
Tana Farrell, Operations Office, Business Directorate, (703) 767-5759, Defense Threat Reduction Agency, 8725 John J. Kingman Road, Stop 6201, Ft. Belvoir, VA 22060-6201.
In accordance with 5 U.S.C. 4314(c)(4), the officials appointed to serve as members of the DTRA PRB are set forth below:
The following DTRA officials will serve as alternate members of the DTRA PRB, as appropriate.
DoD, Per Diem, Travel and Transportation Allowance Committee.
Notice of Revised Non-Foreign Overseas Per Diem Rates.
The Per Diem, Travel and Transportation Allowance Committee is publishing Civilian Personnel Per Diem bulletin Number 236. This bulletin lists revisions in the per diem rates prescribed for U.S. Government employees for official travel in Alaska, Hawaii, Puerto Rico, the Northern Mariana Islands and Possessions of the United States. AEA changes announced in Bulletin Number 194 remain in effect. Bulletin Number 236 is being published in the
October 1, 2004.
This document gives notice of revisions in per diem rates prescribed by the Per Diem Travel and Transportation Allowance Committee for non-foreign areas outside the continental United States. It supersedes Civilian Personnel Per Diem Bulletin Number 235. Distribution of Civilian Personnel Per Diem Bulletins by mail was discontinued. Per Diem Bulletins published periodically in the
The following notice of meeting is published pursuant to section 3(a) of the Government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:
Federal Energy Regulatory Commission, DOE.
September 15, 2004, 10 a.m.
Room 2C, 888 First Street, NE., Washington, DC 20426.
Open.
Agenda.
*Note—Items listed on the Agenda may be deleted without further notice.
Magalie R. Salas, Secretary, Telephone (202) 502-8400. For a recording listing items stricken from or added to the meeting, call (202) 502-8627.
This is a list of matters to be considered by the commission. It does not include a listing of all papers relevant to the items on the Agenda;
The Capitol Connection offers the opportunity for remote listening and viewing of the meeting. It is available for a fee, live over the Internet, via C-Band Satellite. Persons interested in receiving the broadcast, or who need information on making arrangements should contact David Reininger or Julia Morelli at the Capitol Connection (703-993-3100) as soon as possible or visit the Capitol Connection website at
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before November 3, 2004.
Submit your comments, referencing docket ID number OECA-2004-0027, to: (1) EPA online using EDOCKET (our preferred method), by e-mail to
Maureen Lydon, Office of Compliance, Mail Code 2221A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-4046; fax number: (202) 564-0027; e-mail address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On May 13, 2004 (69 FR 26598), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.
EPA has established a public docket for this ICR under Docket ID No. OECA-2004-0027, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is (202) 566-1752. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at
Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket,
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/or instrument, if applicable.
Environmental Protection Agency.
Notice of public meeting.
The U.S. Environmental Protection Agency (EPA) is convening an expert panel workshop to discuss issues associated with the Lead and Copper Rule (LCR). This workshop will examine and discuss potential issues associated with lead service line replacement including full and partial replacement programs, techniques, testing, sampling protocols, identification of lead service lines, and managing inventory.
The workshop on Lead Service Line Replacement will be held on Tuesday, October 26, 2004, from 8 a.m. to 5 p.m., Eastern time (ET) and Wednesday, October 27, 2004, from 8 a.m. to 1 p.m., ET.
The workshop will be held at the Atlanta Airport Marriott, 4711 Best Road College Park, GA 30337 USA.
To attend this workshop as an observer, please contact Donna Strahm at 503-223-3033 between 11 a.m. and 7 p.m. (ET), or by e-mail:
Members of the public may attend as observers at the workshop and provide comments during 30-minute periods each on Tuesday and Wednesday. Individual comments should be limited to no more than 5 minutes. There is no charge for attending this workshop as an observer, but seats are limited, so register as soon as possible. Any person needing special accommodations at any of these meetings, including wheelchair access, should make this known at the time of registration.
Environmental Protection Agency (EPA).
Notice.
EPA's Pesticide Program Dialogue Committee (PPDC) will hold a public meeting on October 21 and 22, 2004. An agenda is being developed and will be posted on EPA's website by October 7. Agenda topics will include a report from PPDC's Registration Review Work Group; a preview of the pesticide program's budget; the Pesticide Safety Education Program; endangered species; brief updates on human testing, anticipated residue policy, termiticide bait draft Pesticide Registration Notice, and activity-based re-entry intervals (REI's). There will also be brief reports from the Committee's other Work Groups, the PRIA (Pesticide Registration Improvement Act) Process Improvements Work Group and the Consumer Pesticide Label Improvement Work Group, as well as a presentation on tribal pesticide program issues. On October 20, the day preceding the PPDC meeting, there will be an Endangered Species Workshop which is also open to the public. The Workshop will involve discussion of a case study using a specific pesticide to demonstrate how the Agency conducts screening level and species-specific assessments following the Technical Overview document which can be found at:
The PPDC meeting will be held on Thursday, October 21, 2004, from 9 a.m. to 5:15 p.m. and on Friday, October 22, 2004, from 9 a.m. to 12:45 p.m.
The Endangered Species Workshop will be held on Wednesday, October 20, 2004, from 9 a.m. to 5 p.m.
Both the PPDC meeting and Workshop will be held at the Radisson Hotel Old Town, 901 N Fairfax St., Alexandria, VA 22314. The hotel telephone number is (703) 683-6000. The Radisson is 12 blocks from the Braddock Road Metro station (on the blue and yellow lines) and two miles from Ronald Reagan National Airport, with courtesy transportation available from the airport and its Metro station.
Margie Fehrenbach, Office of Pesticide Programs, Mail code 7501C, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-4775; fax number: (703) 308-4776; e-mail address:
This action is directed to the public in general, and may be of particular interest to persons who work in agricultural settings or persons who are concerned about implementation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the Federal Food, Drug, and Cosmetic Act (FFDCA); and the amendments to both of these major pesticide laws by the Food Quality Protection Act (FQPA) of 1996. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this
1.
2.
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at
EPA's Office of Pesticide Programs is entrusted with responsibility to help ensure the safety of the American food supply, the education and protection from unreasonable risk of those who apply or are exposed to pesticides occupationally or through use of products, and general protection of the environment and special ecosystems from potential risks posed by pesticides.
PPDC was established under the Federal Advisory Committee Act (FACA), Public Law 92-463, in September 1995, for a 2-year term and has been renewed every 2 years since that time. PPDC provides advice and recommendations to the Office of Pesticide Programs on a broad range of pesticide regulatory, policy, and program implementation issues that are associated with evaluating and reducing risks from use of pesticides. The following sectors are represented on the PPDC: Pesticide industry and trade associations; environmental/public interest and consumer groups; farm worker organizations; pesticide user, grower, and commodity groups; Federal and State/local/Tribal governments; the general public; academia; and public health organizations.
Copies of the PPDC Charter are filed with appropriate committees of Congress and the Library of Congress and are available upon request.
Environmental protection, Agricultural workers, Agriculture, Chemicals, Foods, Pesticides, Pests, Public health, Risk assessment, Tolerance reassessment.
Environmental Protection Agency (EPA).
Notice.
EPA is announcing the meeting of the Forum on State and Tribal Toxics Action (FOSTTA) to collaborate on environmental protection and pollution prevention issues. Representatives and invited guests of the Chemical Information and Management Project, the Pollution Prevention Project, and the Tribal Affairs Project (TAP), components of FOSTTA, will be meeting October 18-19, 2004. The meeting is being held to provide participants an opportunity to have in-depth discussions on the environment and human health issues. This notice announces the location and times for the meeting and sets forth some tentative agenda topics. EPA invites all interested parties to attend the public meeting.
The three projects will meet on Monday, October 18, 2004, from 9:45 a.m. to 5:00 p.m., and on Tuesday, October 19, 2004, from 8 a.m. to noon. A plenary session is being planned for the participants on the Integrated Toxics Management Project on Monday, October 18, 2004, from 8 a.m. to 9:30 a.m.
Requests to participate in the meeting, identified by docket identification (ID) number OPPT-2004-0115, must be received on or before October 14, 2004.
The meeting will be held at the Phoenix Park Hotel, 520 North Capitol Street, NW., Washington, DC.
Requests to participate in the meeting may be submitted to the technical person listed under
Margaret Sealey, Environmental Council of the States, 444 North Capitol Street, NW., Suite 445, Washington, DC 20001; telephone number: (202) 624-3661; fax number: (202) 624-3662; e-mail address:
You may be potentially affected by this action if you are interested in FOSTTA and hearing about the perspectives of the states and tribes on EPA programs and information exchange regarding important issues related to human health and environmental exposure to toxic chemicals. Potentially affected entities may include, but are not limited to:
• States and federally recognized tribes
• State, federal, and local environmental and public health organizations
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
1.
2.
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at
The Toxic Substances Control Act, 15 U.S.C. 2609, section 10(g), authorizes EPA and other federal agencies to establish and coordinate a system for exchange among federal, state, and local authorities of research and development results respecting toxic chemical substances and mixtures, including a system to facilitate and promote the development of standard data format and analysis and consistent testing procedures. Through FOSTTA, the Chemical Information and Management Project (CIMP) focuses on EPA's chemical program and works to develop a more coordinated effort involving federal, state, and tribal agencies. The Pollution Prevention (P2) Project promotes the prevention ethic across society, helping companies incorporate P2 approaches and techniques and integrating P2 into mainstream environmental activities at both the federal level and among the states and tribes. The TAP concentrates on chemical and pollution prevention issues that are most relevant to the tribes, including lead control and abatement, tribal traditional/subsistence lifeways, and hazard communications and outreach. FOSTTA's vision is to focus on major policy-level issues of importance to states and tribes, recruit more senior state and tribal leaders, increase outreach to all 50 states and some 560 federally recognized tribes, and vigorously seek ways to engage the states and tribes in ongoing substantive discussions on complex and oftentimes controversial environmental issues.
In January 2002, the Environmental Council of the States (ECOS), in cooperation with the National Tribal Environmental Council (NTEC), was awarded the new FOSTTA cooperative agreement. ECOS, NTEC, and EPA's Office of Pollution Prevention and Toxics (OPPT) are co-sponsoring the meetings. As part of a cooperative agreement, ECOS facilitates ongoing efforts of the state and tribal leaders and OPPT to increase understanding and improve collaboration on toxic chemicals and pollution prevention issues, and to continue a dialogue on how federal environmental programs can best be implemented among the states, tribes, and EPA.
You may submit a request to participate in this meeting to the technical person listed under
In the interest of time and efficiency, the meetings are structured to provide maximum opportunity for state, tribal, and EPA participants to discuss items on the predetermined agenda. At the discretion of the chair, an effort will be made to accommodate participation by observers attending the proceedings. The FOSTTA representatives and EPA will collaborate on environmental protection and pollution prevention issues. The tentative agenda items identified by the states and the tribes follow:
1. High Production Volume (HPV) Challenge Program database demonstration
2. Moving the HPV outreach plan from strategy to implementation
3. Multimedia Pollution Prevention Forum (M2P2) presentation
4. Performance Partnership Grants (PPG) guidance for FY 2005
5. TAP working plan
6. Tribal college Interagency Personnel Agreement (IPA) proposal
Environmental protection, Pollution prevention, Chemical information and management.
Environmental Protection Agency.
Notice of availability.
The Environmental Protection Agency (EPA) today announces the availability of five scientific papers on metals risk assessment. The papers include: (1) Issue Paper on the Environmental Chemistry of Metals; (2) Issue Paper on Metal Exposure Assessment; (3) Issue Paper on the Ecological Effects of Metals; (4) Issue Paper on the Human Health Effects of Metals; and (5) Issue Paper on the Bioavailability and Bioaccumulation of
The scientific papers will be available on or about October 4, 2004.
The issue papers are available primarily via the Internet on the Risk Assessment Forum's Web page
For technical information, contact Dr. William P. Wood, Executive Director, Risk Assessment Forum, National Center for Environmental Assessment, Office of Research and Development; telephone: (202) 564-3361; facsimile: (202) 565-0062; or e-mail:
EPA has recognized the need for consistent application of methods and data to metals risk assessment in consideration of the unique properties of metals. Early in 2002, the Agency's Science Policy Council initiated the development a framework to assess the risks of metals to humans and the environment. An Agency Action Plan was developed and reviewed by EPA's Science Advisory Board (SAB) in September 2002. The SAB emphasized the importance of focusing on the unique properties of metals as they relate to environmental chemistry, bioavailability, bioaccumulation, exposure, and toxicity. The SAB also emphasized the importance of engaging the outside community so as to contribute to the knowledge base the Agency would draw from in developing guidance on the risk assessment of metals.
To inform the consideration of metals properties, and to engage the external scientific community, the Agency commissioned external experts to lead the development of a series of issue papers. (Some individual EPA experts contributed specific discussions on topic(s) for which he or she has scientific expertise or knowledge of current Agency practice.) A public comment period was held on the draft papers from September 22 through November 7, 2003, wherein comments were collected utilizing the Agency's on-line commenting system (E-Docket). Additionally, comment was received via a public meeting held October 28, 2003, in Washington, DC (comments remain available for viewing at
Having engaged the external community to broaden our knowledge base, the Agency is working to develop a framework for metals risk assessment. The framework will be provided for public comment, and SAB review.
Notice.
The Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction (“Commission”) will meet in closed session on Wednesday, October 20, 2004, and Thursday, October 21, 2004, in its offices in Arlington, Virginia.
Executive Order 13328 established the Commission for the purpose of assessing whether the Intelligence Community is sufficiently authorized, organized, equipped, trained, and resourced to identify and warn in a timely manner of, and to support the United States Government's efforts to respond to, the development of Weapons of Mass Destruction, related means of delivery, and other related threats of the 21st Century. This meeting will consist of briefings and discussions involving classified matters of national security, including classified briefings from representatives of agencies within the Intelligence Community; Commission discussions based upon the content of classified intelligence documents the Commission has received from agencies within the Intelligence Community; and presentations concerning the United States' intelligence capabilities that are based upon classified information. While the Commission does not concede that it is subject to the requirements of the Federal Advisory Committee Act (FACA), 5 United States Code Appendix 2, it has been determined that the October 20-21 meeting would fall within the scope of exceptions (c)(1) and (c)(9)(B) of the Sunshine Act, 5 United States Code, Sections 552b(c)(1) & (c)(9)(B), and thus could be closed to the public if FACA did apply to the Commission.
Wednesday, October 20, 2004 (9 a.m. to 5 p.m.) and Thursday, October 21, 2004 (9 a.m. to 1 p.m.).
Members of the public who wish to submit a written statement to the Commission are invited to do so by facsimile at (703) 414-1203, or by mail at the following address: Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction, Washington, DC 20503. Comments also may be sent to the Commission by e-mail at
Brett C. Gerry, Associate General Counsel, Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction, by facsimile, or by telephone at (703) 414-1200.
The Federal Communications Commission, as part of its continuing
Written comments should be submitted on or before November 3, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.
Direct all comments to Kristy L. LaLonde, Office of Management and Budget (OMB), Room 10236 NEOB, Washington, DC 20503, (202) 395-3087 or via the Internet at
For additional information or copies of the information collections contact Les Smith at (202) 418-0217 or via Internet at
The Commission has requested approval of these two information collections under the emergency processing provisions of the PRA by September 28, 2004.
On June 24, 2004, the U. S. Court of Appeals for the Third Circuit (the “Court”) issued an Opinion and Judgment (“
This collection also includes the third party disclosure requirement of 47 CFR 73.3580. This section requires local public notice in a newspaper of general circulation of the filing of all applications for assignment of license/permit. This notice must be completed within 30 days of the tendering of the application. This notice must be published at least twice a week for two consecutive weeks in a three-week period. A copy of this notice must be placed in the public inspection file along with the application. Additionally, an applicant for assignment of license must broadcast the same notice over the station at least once daily on four days in the second week immediately following the tendering for filing of the application.
On June 24, 2004, the U.S. Court of Appeals for the Third Circuit (the “Court”) issued an Opinion and Judgment (“
This collection also includes the third party disclosure requirement of 47 CFR 73.3580. This section requires local public notice in a newspaper of general circulation of the filing of all applications for transfer of control of license/permit. This notice must be completed within 30 days of the tendering of the application. This notice must be published at least twice a week for two consecutive weeks in a three-week period. A copy of this notice must be placed in the public inspection file along with the application. Additionally, an applicant for transfer of control of license must broadcast the same notice over the station at least once daily on four days in the second week immediately following the tendering for filing of the application.
On June 24, 2004, the U. S. Court of Appeals for the Third Circuit (the “Court”) issued an Opinion and Judgment (“
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 28, 2004.
Board of Governors of the Federal Reserve System, September 28, 2004.
The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR Part 225) to engage
Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center website at
Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 18, 2004.
Board of Governors of the Federal Reserve System, September 28, 2004.
In accordance with § 271.25 of its rules regarding availability of information (12 CFR part 271), there is set forth below the domestic policy directive issued by the Federal Open Market Committee at its meeting held on August 10, 2004.
The Federal Open Market Committee seeks monetary and financial conditions that will foster price stability and promote sustainable growth in output. To further its long-run objectives, the Committee in the immediate future seeks conditions in reserve markets consistent with increasing the federal funds rate to an average of around 1-1/2 percent.
By order of the Federal Open Market Committee, September 27, 2004.
Office of the Chief Acquisition Officer, GSA.
Notice of Industry Day.
The Federal Acquisition Institute (FAI) intends to hold an Industry Day for interested vendors to provide information related to FAI's initiatives and activities under the Acquisition Workforce Training Fund (AWTF). FAI will describe our plans and requirements for training related services. DAU will present information on recent contracting curriculum changes.
Industry Day is scheduled for October 13, 2004, from 10:00 a.m. to 12:00 noon at the following location: SRA's Fair Lakes North-C Presentation Center, 4350 Fair Lakes Court (Receptionist, 2nd Floor), Fairfax, Virginia 22033.
Interested parties may register by e-mail at Jamie.ready@gsa.gov, or telephone (202) 219-3454.
Ms. Jamie Ready, Federal Acquisition Institute, General Services Administration, via telephone at (202) 703-219-3454; e-mail at Jamie.ready@gsa.gov; or fax at (202) 501-3341.
FAI works in partnership with the Defense Acquisition University (DAU). DAU provides mandatory, assignment-specific, and continuing education courses for military and civilian acquisition personnel within the Department of Defense. As part of Industry Day, DAU will present information on recent contracting curriculum changes.
FAI's mission is to foster and promote the development of a professional acquisition workforce into effective business leaders. Section 1412 of the National Defense Authorization Act for Fiscal Year 2004 (H.R. 1588) authorized an Acquisition Workforce Training Fund (AWTF) “to ensure that the Federal acquisition workforce adapts to fundamental changes in the nature of Federal Government acquisition of property and services associated with the changing roles of the Federal Government; and acquires new skills and a new perspective to enable it to contribute effectively in the changing environment of the 21st century.” FAI will use the fund to develop training resources needed to enable federal acquisition professionals to transition to a service oriented and technology driven federal market.
FAI coordinates with the Office of Federal Procurement Policy (OFPP), the FAI Board of Directors and the Chief Acquisition Officers (CAO) Council, and DAU to identify training needs and set priorities for use of the fund. OFPP provides guidance on Administration initiatives and new issues in acquisition.
Office of Government Ethics (OGE).
Notice.
Notice is hereby given of the appointment of members of the updated OGE Senior Executive Service (SES) Performance Review Board.
October 4, 2004.
Daniel D. Dunning, Deputy Director for Administration and Information Management, Office of Government Ethics, Suite 500, 1201 New York Avenue, NW., Washington, DC 20005-3917; Telephone: (202) 482-9300; TDD: (202) 208-9293; FAX: (202) 482-9237.
5 U.S.C. 4314(c) requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management at 5 CFR part 430, subpart C and § 430.310 thereof in particular, one or more Senior Executive Service performance review boards. As a small executive branch agency, OGE has just one board. In order to ensure an adequate level of staffing and to avoid a constant series of recusals, the designated members of OGE's SES Performance Review Board are being drawn, as in the past, largely from the ranks of other agencies. The board shall
The following have been selected as regular members of the SES Performance Review Board of the Office of Government Ethics:
John J. Covaleski [Chair], Deputy Director for Agency Programs, Office of Government Ethics;
Stuart D. Rick [Alternate Chair], Deputy General Counsel, Office of Government Ethics;
Joseph E. Gangloff, Senior Counsel, Office of International Affairs, Department of Justice;
Rosalind A. Knapp, Deputy General Counsel, Department of Transportation;
Steven Y. Winnick, Deputy General Counsel, Department of Education.
Diabetes is a serious and costly public health problem in the United States. In November 2003, the number of Americans with diabetes rose to an all time high with an estimated 18.2 million people. Diabetes continues to be the sixth leading cause of death in the United States. An estimated 13 million Americans have been diagnosed with diabetes and about 5.2 million additional Americans have the disease but have not been diagnosed. Diabetes disproportionately affects some ethnic populations such as American Indians/Alaskan Natives, blacks or African Americans, Hispanics or Latinos, Asian Americans, Native Hawaiians and other Pacific Islanders. The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) joined forces in 1995 to develop the National Diabetes Education Program (NDEP). The NDEP is a collaborative effort based on a partnership of public and private organizations that are concerned about the health status of their constituents. The NDEP is designed to improve treatment and outcomes for people with diabetes, to promote early diagnosis and to prevent the onset of diabetes. The NDEP aims to change the way diabetes is treated by working through its Partnership Network to increase awareness via media campaigns, create tools for community interventions, and promote health systems change for better diabetes management and prevention. It is through this commitment that the NDEP focuses on working with national and regional organizations that demonstrate the ability to reach populations disproportionately affected by diabetes. These organizations are critical partners of the NDEP, and it is through them and other partners that partnerships are formed to extend the reach of NDEP and its impact on reducing the burden of diabetes among racial and ethnic minority populations.
This program is authorized under Sections 301(a) and 317(k)(2) of the Public Health Service (PHS) Act, [42 U.S.C. 241(a) and 247b(k)(2)] as amended. Applicable program regulations are found in 45 CFR part 74.
The purpose of this program announcement is to support the National Diabetes Education Program (NDEP) activities that strengthen the capacity of national and regional organizations to reduce the disproportionate burden of diabetes among high-risk populations (
Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) that relates to the NDEP: Increase the capacity of national and regional organizations to address the prevention of diabetes for those at risk and prevention of complications and premature mortality among people with diabetes through awareness and education efforts, including identification and dissemination of lifestyle interventions proven to be effective in preventing or delaying type 2 diabetes.
Recipient activities for this program are as follows:
A. Implement strategies for promoting diabetes awareness and delivering diabetes education messages, interventions and products to targeted populations using a variety of culturally effective community-based approaches that increase and improve health care utilization within communities. This should include but is not limited to presentations at CDC conferences/meetings and having CDC present at the recipient's conferences/meetings.
B. Establish coalitions and partnerships with community-based organizations (CBOs), State and local health departments, other national and regional organizations and other appropriate organizations. Partner with and engage State diabetes prevention and control programs (DPCPs) to expand programs that capitalize on current diabetes education efforts. Actively bring together members to identify community needs, barriers to care and resources using community mobilization models such as Diabetes Today and Racial and Ethnic Approaches to Community Health (REACH). More information on these programs can be found at
C. Develop program activities that are consistent with those proven to be effective for diabetes education within community settings such as Diabetes Today. Include the development of action plans and identify activities to engage affiliates, chapters and community-based organization (CBO)
D. Identify and address the capacity-building needs of your program with the goal of long-term sustainability of activities.
E. Attend and participate in CDC sponsored training and meetings and serve as an active participant on NDEP Workgroups.
F. Develop and implement community-based intervention strategies which include lifestyle interventions to prevent or delay diabetes that can be designed to improve the knowledge, attitude, skills and behaviors related to the prevention, early detection and control of diabetes complications. These intervention strategies can include new and creative approaches that are coordinated with NDEP Workgroups, supportive of the NDEP Strategic Plan, workgroup goals and objectives. The materials and messages should be linguistically and culturally appropriate.
G. Describe the activities that will be conducted to ensure that proposed activities with partners will work synergistically with existing effective diabetes intervention and strategies.
H. Promote and disseminate NDEP and local diabetes health care resources and educational materials, translate and/or tailor materials into specific languages and utilize existing diabetes awareness messages, interventions, products and strategies that are culturally and linguistically appropriate for the targeted population based on current science.
I. Develop strategies that strengthen relationships with health care providers and assist them in providing culturally and linguistically appropriate diabetes education and support to diverse racial and ethnic minority populations. This may include the production of materials providing current scientific information regarding diabetes (if these materials do not already exist), other chronic diseases linked to diabetes such as cardiovascular disease (heart disease and stroke), high blood pressure and high cholesterol. Provide up-to-date, comprehensive diabetes resource guides, as well as general information on the populations served (
J. Develop a well-designed evaluation plan to monitor the progress and to evaluate the impact of activities and strategies and to measure the accomplishments of the applicant and funded partner CBOs. The evaluation plan should include (but need not be limited to) the following:
1. Identify existing data sources that can be used to establish baseline and evaluate the impact of interventions, possibly including Behavioral Risk Factor Surveillance System (BRFSS) data; hospital discharge data; medical care practice data; vital statistics data; Women, Infants, and Children (WIC) data; community health center data; Medicaid and Medicare data; and other sources of information about community health status, needs, and resources relevant to the NDEP Strategic Plan.
2. Participate in the evaluation of NDEP. The cooperative agreement recipients will be involved in gathering and submitting information on process and impact measures surrounding NDEP initiatives. Recipients will also contribute to other evaluation activities that may include development of tools to assess individual workgroup products and share success stories to support evaluation capacity building within NDEP.
3. Evidence-Based Decisionmaking. Recipients are expected to use all the information above to design and modify program objectives and intervention strategies; participate in pilot testing and implement and evaluate revised materials and interventions created in conjunction with NDEP Workgroups; revise budgets and work plans as needed; and recruit new members to the NDEP Partnership Network.
K. Disseminate pertinent program information to appropriate partner organizations and other agencies at the national, regional, State and local levels.
1. Identify and share promising practices and results including successful strategies for building community engagement, mobilization, ownership, and organization with other NDEP partner organizations in an effort to sustain the program in lieu of NDEP funding.
2. Ensure effective, timely communication and exchange of information, experiences, and results through the use of the Internet (
L. Respond to public inquiries regarding program activities as appropriate.
M. Management Information System (MIS): The MIS will be used to assist in the post award administration, technical assistance and programmatic decisionmaking processes. Programs will be expected to ensure that information is entered into the MIS in a timely manner.
N. Demonstrate quality activities linked to two or more of the CDC Division of Diabetes Translation's (DDT) National Objectives (
In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
A. Ensure that successful prevention interventions, program models and lessons learned are shared between grantees and others through meetings, workshops, conferences, newsletters, Internet and other avenues of communication.
B. Provide periodic updates of national activities related to the prevention and control of diabetes in targeted populations. Provide linkage to communities funded through other mechanisms (
C. Assist in identifying and developing culturally and linguistically appropriate diabetes educational materials for community based programs that reach the targeted populations.
D. Provide programmatic consultation and guidance related to the development, implementation, and evaluation and monitoring of proposed program activities. This includes access to an Evaluation Tool Kit (ETK) developed by CDC DDT personnel to
E. Provide technical assistance relative to the coordination of activities between recipients and other national and community programs including State and local health departments to facilitate effective communication and integration between state DPCPs and national and regional organizations.
F. Provide support in the maintenance of an information system for funded organizations to input information for the purpose of planning and sharing. This includes initial training in the use of the MIS and ongoing training updates as needed for new staff or when additional features are installed.
• Applications may only be submitted by national, regional, State, multi-State, and faith based organizations and institutions that are private health, education or social service organizations (professional or voluntary); qualify as a non-profit 501(c)(3) entity; have affiliate offices or chapters at the local, State and/or regional level in five or more geographically distinct communities serving a high concentration of the targeted population and have the capacity and experience to assist their affiliate offices and chapters. Geographically distinct communities must be located in different areas. Applicants should consider available resources when determining the population size and the number of geographically distinct communities to include in their proposal. Affiliate and chapter offices may not apply in lieu of or on behalf of their parent national office. However, this does not exclude affiliates from assisting with the development of the application.
Matching funds are not required for this program.
If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.
If your application is incomplete or non-responsive to the requirements listed in section IV. Application and Submission Information, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.
Title 2 of the United States Code section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
To apply for this funding opportunity, use application form PHS 5161. Application forms and instructions are available on the CDC Web site, at the following Internet address:
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•
• Double spaced.
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• Printed only on one side of page.
• Written in plain language, avoid jargon.
Your LOI must contain the following information:
• Your organization name, address, executive director and contact information.
• A description of the population your organization plans to target.
• A statement of your intent to apply.
• Indicate whether your agency is a national or regional organization.
• Your application should not accompany your LOI.
• Maximum number of pages: 35.
If your narrative exceeds the page limit, only the first 35 pages will be reviewed.
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• Doubled spaced.
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• Printed only on one side of page.
• Held together only by rubber bands or metal clips; not bound in any other way.
Your narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed:
• Justification of Need—Describe the problem(s) being addressed by the proposed activities. Describe the need for the proposed activities in the geographical area(s) within which the activities will be implemented. Who is your proposed target population? Describe the characteristics of the targeted population relative to their racial and ethnic diversity and knowledge, attitudes, beliefs and health practices relative to diabetes.
• Organization Capacity—The purpose of this section is to assess your organization's ability to effectively sustain your proposed program. Describe the organization's mission, structure and function to include:
1. Describe past experience serving racial and ethnic minority populations through its offices, affiliates, chapters or participating organizations at the national/regional level for at least 12 months prior to submission of the application. Please include outcomes or expected outcomes if the project/intervention is ongoing.
2. Number of affiliate or chapter organizations, location of affiliate or chapter organizations, and how affiliates or chapters work with the national and/or regional organization decisions makers, methods of routine communication with affiliates or chapters and description of how the infrastructure will be used to support
3. Describe the organization's past and present abilities to work with affiliates, chapters, CBOs and other governmental and non-governmental organizations including other national or local diabetes related agencies, State diabetes prevention and control programs (DPCPs) and local health departments. Explain how existing effective diabetes messages, interventions and products will be incorporated and how the proposed activities will expand rather than duplicate present activities.
4. Include the nature and extent of affiliates, chapters, etc. support for past and present activities relative to awareness and/or educational activities or describe how affiliates, chapters, etc. support will be obtained for the proposed program activities.
5. Provide a copy of a letter of commitment from the organization's board president or appropriate designee acknowledging their support of the applicant's activities and organization. The letter should address the organization's support and commitment to develop a plan and policy that will be adopted by affiliates, chapter membership organizations and CBO partners. If a diabetes control policy and plan currently exists within the organization's office, it should be submitted in lieu of a letter of commitment.
• Objectives
Objectives are tangible statements that describe the activities the program is attempting to achieve. Objectives should be written in a manner to be evaluated at the conclusion of a project to determine if they were achieved. Relative to objectives the applicant should:
1. Describe the five year (long term) specific, measurable, achievable, relevant, time-phased objectives for the program consistent with the purpose of this program announcement.
2. Describe specific, measurable, achievable, relevant, time-phased objectives for each budget year (short term).
• Program Activities
1. Describe how the affiliates, chapters or CBOs will be involved in the implementation of the proposed program activities.
2. Describe the specific activities that will be undertaken to achieve each of the program's objectives during the first year consistent with the recipient activities.
3. Briefly describe the activities planned for budget years two through five. Include the linkages to the Division of Diabetes Translation (DDT) National Objectives.
• Project Management
1. Submit a work plan that outlines the main implementation steps and activities to be completed by recipient and affiliates, chapters, or partner CBOs by specified targeted dates to achieve the objectives for the budget year. Identify the name(s) or position(s) responsible for carrying out the activities.
2. Describe each proposed position for this program that will support this work plan by job title, function, general duties and the responsibilities of the position.
3. Describe the qualifications for the project coordinator position in terms of education, experience and desired skills.
4. Include the level of effort and allocation of time for each project activity by staff position.
Minimal staffing should include a full-time project coordinator and one program assistant.
• Program Evaluation Plan
This section should be described in terms of how the recipient will engage in the six-step CDC Framework for Evaluation: engage stakeholders, describe the program, spotlight the evaluation design, gather credible evidence, justify conclusions and ensure use and share lessons learned. More information on this evaluation framework can be found at:
1. Identify methods for attaining measurable, time phased short and long term objectives. Identify methods for accomplishing program activities and monitoring program quality. The evaluation plan should include qualitative and quantitative data collection and assessment methods. As appropriate, this plan should include baseline data for the proposed objectives or the methods that will be used to establish the baseline data; the minimum data to be collected to evaluate the achievement of proposed program objectives; and the systems for collecting and analyzing the data. Data to be reported will be dependent on the proposed program objectives and activities; however, examples of potential data include, but are not limited to the following:
a. The number of individuals expected to be reached in the targeted population and the plan for evaluating the number actually reached.
b. Information about the national, regional, state and local health organizations, providers reached and populations served.
c. Number and types of community activities implemented (when, where, and how activities are conducted).
d. Information on the change in knowledge, attitudes and self-management and/or care utilization practices among people with diabetes.
e. Information on the number of affiliates, chapters, organizations, coalitions and partnerships that are participating in program activities and how activities complement national education efforts.
• Budget and Narrative Justification
1. Provide a detailed line-item budget and justification for all operating expenses consistent with the proposed objectives and activities. Provide precise information regarding the purpose of each budget item and provide itemized calculations when appropriate.
2. Applicants should budget for the following cost: Out-of-state travel, participation in CDC sponsored trainings, workshops and meetings. Travel funds should be budgeted for:
a. Two persons to attend the CDC Diabetes Translation Conference held during the spring (4 days).
b. At least one person to attend one NDEP Minority Workgroup face-to-face meeting (2 days).
c. At least one person to attend NDEP Steering Committee meetings (twice a year: 1-2 days).
d. At least one person to attend the Division of Diabetes Translation Annual Program Director's meeting. (3 days).
e. Two persons to attend the first year program orientation meeting, preferably attended by the program coordinator and evaluation lead (2 days).
f. Organizations are also encouraged to attend and participate in non-conference training such as Diabetes Today and the Diabetes Collaborative which is relevant to the goals and objectives of NDEP.
3. Local travel as necessary to meet program objectives and activities.
• Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes curriculum vitaes, resumes, organizational charts, letters of support, etc. Please include the following information as appendices:
1. Provide an organization chart and one page resume of each current staff member who will work on this project. Include a one-page job description of proposed staff. This must include the identification of a lead person for
2. A list of applicant's affiliates/chapters by regional, state and local organizations or a description of each CBO partner.
3. Evidence of collaboration with other organizations that serve the same targeted populations. Include Memoranda of Agreement and letters of support.
4. A description of funding from other sources to conduct similar activities.
a. Describe how funds requested under this announcement will be used differently or in ways that will expand on the funds already received, applied for or being received.
b. Identify proposed personnel devoted to this project who are supported by other funding sources and the activities they support.
c. Written statement that the funds being requested will not duplicate or supplant funds received from any other sources.
5. Proof of eligibility (
You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access
Additional requirements that may require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”
CDC requests that you send a LOI if you intend to apply for this program. Although the LOI is not required, not binding, and does not enter into the review of your subsequent application, the LOI will be used to gauge the level of interest in this program, and to allow CDC to plan the application review.
This announcement is the definitive guide on application submission address and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that your application did not meet the submission requirements.
CDC will not notify you upon receipt of your application. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at (770) 488-2700. Before calling, please wait two to three days after the application deadline. This will allow time for applications to be processed and logged.
Executive Order 12372 does not apply to this program.
Restrictions, which must be taken into account while writing your budget, are as follows:
• Funding may not be expended for the purchase or lease of land or buildings, construction of facilities, renovation of existing space, or the delivery of clinical and therapeutic services. The purchase of equipment is discouraged but will be considered for approval if justified on the basis of being essential to the program and not available from any other source.
If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.
Awards will not allow reimbursement of pre-award costs. Guidance for completing your budget can be found on the CDC Web site, at the following Internet address:
Applications may not be submitted electronically by e-mail or faxed at this time.
You are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.
Your application will be evaluated against the following criteria:
Extent to which the applicant describes:
1. The capacity of the applicant's infrastructure to support successful implementation of the proposed program activities in high risk populations.
2. Applicant's relationship with target population; a primary or direct relationship is preferred. Secondary relationships that are limited to fundraising or philanthropy have less preference.
3. The success of the applicant's past and present experiences in working with the high risk populations, conducting awareness and/or other educational activities, collaborating
4. The success of the applicant in generating affiliate or chapter support for past and present organizational activities and the likelihood that strong support can be secured for the proposed program activities.
5. The reach of affiliates and chapters, national and regional organizations and number of states or jurisdictions covered.
Extent to which proposed activities are appropriate for the targeted population, achievable and that implementation will lead to accomplishment of the proposed objectives within the project period.
1. Extent to which the work plan outlined is adequate to implement the program within the time lines described by the positions and and individuals identified.
2. Extent to which the proposed personnel time allocation is sufficient to accomplish the program activities.
Extent to which the proposed objectives are specific, measurable, achievable, appropriate and relevant for the targeted audience and consistent with the stated purpose of this program announcement. The objectives must also be time related.
Extent to which the applicant describes an evaluation plan for monitoring the program's progress, quality, accomplishments relative to achieving the objectives and completing the proposed program activities within the project period.
Extent to which the applicant demonstrates an understanding of the program's purpose, objectives, describes the target population characteristics, diabetes burden, needs of the targeted population and justify the need for the proposed activities.
Extent to which the budget is reasonable and consistent with the purpose of the program announcement and proposed objectives and activities.
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness by the National Center for Chronic Disease Prevention and Health Promotion. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.
An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above.
In addition, the following factors may affect the funding decision: Preference for funding will be given to ensure that:
• Funded organizations are balanced in terms of the racial/ethnic minority groups they target. The number of funded national and regional organizations serving each racial/ethnic minority group may be adjusted based on the burden of diabetes in that target group as measured by U.S. Department of Health and Human Services (HHS)reporting sources.
• Funded national and regional organizations are balanced in terms of geographic distribution within the United States, including the District of Columbia and United States Territories. Consideration will be given to high prevalence areas; the number of funded organizations may be adjusted based on the burden of diabetes in the jurisdiction as measured by HHS reporting sources.
It is expected that the awards will begin on or about February 27, 2005, and will be made for a 12 month budget period within a project period of up to five years. Funding estimates may vary depending on availability of funds.
Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient's fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of the application review by mail.
45 CFR Part 74 and Part 92
The following additional requirements apply to this project:
• AR-9 Paperwork Reduction Act Requirements
• AR-10 Smoke-Free Workplace Requirements
• AR-11 Healthy People 2010
• AR-12 Lobbying Restrictions
• AR-14 Accounting System Requirements
• AR-15 Proof of Non-Profit Status
• AR-21 Small, Minority, and Women-Owned Business Additional information on these requirements can be found on the CDC Web site at the following Internet address:
You must provide CDC with an original, plus two hard copies of the following reports:
1. Interim progress report, no later than September 27 of each year. The progress report will serve as your non-competing continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Financial status report and annual progress report no more than 90 days after the end of the budget period.
3. Final financial and performance reports, no more than 90 days after the end of the project period.
These reports must be mailed to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.
For general questions about this announcement, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, telephone: (770) 488-2700.
For program technical assistance, contact: Shirl Ellis, Project Officer, CDC, National Center for Chronic Disease Prevention and Health Promotion, Division of Diabetes Translation, National Diabetes Education Program,
For financial, grants management, or budget assistance, contact: Tiffney Esslinger, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, telephone: (770) 488-2686, e-mail:
Workgroup members serve as advisors/consultants for the development of NDEP materials, and implement strategic intervention activities for the NDEP program through their NDEP partner organizations. In addition, workgroup members serve as conduits for promoting the NDEP messages and the principles of NDEP. Workgroup members participate on conference calls, face-to-face meetings and the annual Partnership Network conference.
Workgroup membership roles and responsibilities include a commitment to do the following:
• Represent an organization invited to participate as an NDEP partner.
• Notify the workgroup chair if the workgroup member no longer represents the NDEP partner organization or if the organization selects another representative.
• Communicate with the organization which the member represents about NDEP campaigns and activities.
• Communicate with NDEP about members' organizational activities in support of the NDEP goals and objectives.
• Participate in workgroup conference calls. In most workgroups this represents a commitment of one hour monthly.
• Participate in face-to-face meetings, which usually will include one workgroup meeting and one Partnership Network meeting annually. It is not acceptable to invite a substitute to participate on a call or at a meeting if the NDEP member is not available.
• Facilitate partnerships that promote NDEP activities.
• Serve as a spokesperson for NDEP.
• Encourage networking in professional associations and organizations to promote NDEP.
• Assist with language translation or review of translated materials (if needed and applicable).
• Provide feedback and input for materials development.
• Contribute to NDEP's overall evaluation effort by reporting back to NDEP staff about activities promoting, disseminating or implementing NDEP campaigns and interventions.
1. By 2008, demonstrate success in achieving an increase in the percentage of people with diabetes in your jurisdiction who receives the recommended foot exams.
2. By 2008, demonstrate success in achieving an increase in the percentage of people with diabetes in your jurisdiction who receives the recommended eye exams.
3. By 2008, demonstrate success in achieving an increase in the percentage of people with diabetes in your jurisdiction who receive the recommended vaccinations (influenza and pneumococcal).
4. By 2008, demonstrate success in achieving an increase in the percentage of people with diabetes in your jurisdiction who receives the recommended A1C tests.
5. By 2008, demonstrate success in reducing health disparities for high-risk populations with respect to diabetes prevention and control.
6. By 2008, demonstrate success in linking to programs for promotion of wellness and physical activity, weight and blood pressure control and smoking cessation for people with diabetes.
To find out more about the National Diabetes Education Program (NDEP), visit the following Web sites at:
To find out more about the CDC Division of Diabetes Translation, visit the Web site at:
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of annual update of list of infectious and communicable diseases that are transmitted through handling the food supply and the methods by which such diseases are transmitted.
Section 103(d) of the Americans with Disabilities Act of 1990, Pub. L. 101-336, requires the Secretary to publish a list of infectious and communicable diseases that are transmitted through handling the food supply and to review and update the list annually. The Centers for Disease Control and Prevention (CDC) published a final list on August 16, 1991 (56 FR 40897) and updates on September 8, 1992 (57 FR 40917); January 13, 1994 (59 FR 1949); August 15, 1996 (61 FR 42426); September 22, 1997 (62 FR 49518-9); September 15, 1998 (63 FR 49359), September 21, 1999 (64 FR 51127); September 27, 2000 (65 FR 58088), September 10, 2001 (66 FR 47030), September 27, 2002 (67 FR 61109) and November 6, 2003 (68 FR 62809). No new information that would warrant additional changes has been received; therefore the list, as set forth in the last update and below, remains unchanged.
October 4, 2004.
Dr. Art Liang, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop G-24, Atlanta, Georgia 30333, telephone (404) 639-2213
Section 103(d) of the Americans with Disabilities Act of 1990, 42 U.S.C. 12113(d), requires the Secretary of Health and Human Services to:
1. Review all infectious and communicable diseases which may be transmitted through handling the food supply;
2. Publish a list of infectious and communicable diseases which are transmitted through handling the food supply;
3. Publish the methods by which such diseases are transmitted; and,
4. Widely disseminate such information regarding the list of diseases and their modes of transmissibility to the general public.
Additionally, the list is to be updated annually.
Since the last publication of the list on November 6, 2003 (68 FR 62809), CDC has received no information to indicate that additional unlisted diseases are transmitted through handling the food supply. Therefore, the list set forth below is unchanged from
The contamination of raw ingredients from infected food-producing animals and cross-contamination during processing are more prevalent causes of foodborne disease than is contamination of foods by persons with infectious or contagious diseases. However, some pathogens are frequently transmitted by food contaminated by infected persons. The presence of any one of the following signs or symptoms in persons who handle food may indicate infection by a pathogen that could be transmitted to others through handling the food supply: diarrhea, vomiting, open skin sores, boils, fever, dark urine, or jaundice. The failure of food-handlers to wash hands (in situations such as after using the toilet, handling raw meat, cleaning spills, or carrying garbage, for example), wear clean gloves, or use clean utensils is responsible for the foodborne transmission of these pathogens. Non-foodborne routes of transmission, such as from one person to another, are also major contributors in the spread of these pathogens. Pathogens that can cause diseases after an infected person handles food are the following:
Other pathogens are occasionally transmitted by infected persons who handle food, but usually cause disease when food is intrinsically contaminated or cross-contaminated during processing or preparation. Bacterial pathogens in this category often require a period of temperature abuse to permit their multiplication to an infectious dose before they will cause disease in consumers. Preventing food contact by persons who have an acute diarrheal illness will decrease the risk of transmitting the following pathogens:
1. World Health Organization. Health surveillance and management procedures for food-handling personnel: report of a WHO consultation. World Health Organization technical report series; 785. Geneva: World Health Organization, 1989.
2. Frank JF, Barnhart HM. Food and dairy sanitation. In: Last JM, ed. Maxcy-Rosenau public health and preventive medicine, 12th edition. New York Appleton-Century-Crofts, 1986:765-806.
3. Bennett JV, Holmberg SD, Rogers MF, Solomon SL. Infectious and parasitic diseases. In: Amler RW, Dull HB, eds. Closing the gap: the burden of unnecessary illness. New York: Oxford University Press, 1987:102-114.
4. Centers for Disease Control and Prevention. Locally acquired neurocysticercosis—North Carolina, Massachusetts, and South Carolina, 1989-1991. MMWR 1992; 41:1-4.
5. Centers for Disease Control and Prevention. Foodborne Outbreak of Cryptosporidiosis-Spokane, Washington, 1997. MMWR 1998; 47:27.
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Hilda Scharen at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Current Good Manufacturing Practices for Combination Products.” Once finalized, this guidance will provide guidance to industry and FDA staff on the applicability of current good manufacturing practices (CGMP) for combination products.
Submit written or electronic comments on the draft guidance by December 3, 2004. General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies of the draft guidance to the Office of Combination Products (HFG-3), 15800 Crabbs Branch Way, suite 200, Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
Patricia Y. Love, Office of Combination Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD 20855, 301-427-1934, FAX 301-427-1935, e-mail:
FDA is announcing the availability of a draft guidance for industry entitled “Current Good Manufacturing Practices for Combination Products.” Combination products are defined under 21 CFR 3.2(e). This draft guidance document makes recommendations for achieving compliance with applicable CGMPs for the drug, device, or biological product constituent parts of a combination product. In addition, the draft guidance document makes recommendations for achieving compliance with applicable CGMPs for combination products where the constituent parts of a combination product are joined together. The applicable regulations include the CGMP regulations for finished pharmaceuticals, or drug products, and most biological products (21 CFR parts 210 and 211); the biological product regulations for biological products (21 CFR parts 600-680); and the quality system regulations for devices (21 CFR part 820).
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 CGMP for combination products. 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 Division of Dockets Management (see
Persons with access to the Internet may obtain the draft guidance document at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Computerized Systems Used in Clinical Trials.” This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to FDA. This draft guidance, when finalized, will supercede the guidance of the same name issued in April 1999.
Submit written or electronic comments on the draft recommendations by January 3, 2005. General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies of the draft guidance to the Office of Training and Communications, Division of Communications Management, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857; to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448; to the Office of Health and Industry Programs,
FDA is announcing the availability of a draft guidance for industry entitled “Computerized Systems Used in Clinical Trials.” This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to FDA. These data form the basis for the agency's decisions regarding the safety and effectiveness of new human and animal drugs, biological products, medical devices, and certain food and color additives. As such, these data have broad public health significance and are expected to be of the highest quality and integrity.
This draft guidance, when finalized, will supercede the guidance of the same name issued in April 1999. This draft guidance is being revised to make it consistent with agency policy as reflected in the guidance for industry on “Part 11, Electronic Records; Electronic Signatures—Scope and Application,” which issued in August 2003. It also reflects policy consistent with regard to the agency's international harmonization efforts.
This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This draft guidance, when finalized, will represent the agency's current thinking on computerized systems used in clinical trials. 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 the approach satisfies the requirements of the applicable statute and regulations.
Interested persons may submit to the Division of Dockets Management (see
Copies of this draft guidance for industry are available on the Internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 011” (Recognition List Number: 011), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.
Submit written requests for single copies on a 3.5″ diskette of “Modifications to the List of Recognized Standards, Recognition List Number: 011” to the Division of Small Manufacturers Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see
Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and
Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards, developed by international and national organizations, for use in satisfying portions of device premarket review submissions or other requirements.
In a notice published in the
In
FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA recognized consensus standards in the agency's searchable database. FDA will use the term “Recognition List Number: 011” to identify these current modifications.
In table 1 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, (2) the correction of errors made by FDA in listing previously recognized standards, and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.
In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA.
The listing of new entries and consensus standards added as modifications to the list of recognized standards, under Recognition List Number: 011, follows:
FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at
FDA will incorporate the modifications and minor revisions described in this document into the database and, upon publication in the
Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see
In order to receive “Guidance on the Recognition and Use of Consensus Standards” via your fax machine, call the Center for Devices and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number 321 followed by the pound sign. Follow the remaining voice prompts to complete your request.
You may also obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the
You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for FDA recognized consensus standards, through the hyperlink at
This
Interested persons may submit to the contact person (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is revising the criteria the agency will use to accredit persons for the purpose of conducting inspections of eligible device manufacturers under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which established an “inspection by accredited persons” program. FDA is also announcing the availability of a revised guidance document that will provide information for those interested in participating in this program. The guidance is entitled “Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria.” This revised guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices. FDA is taking these actions to implement recent technical amendments to MDUFMA.
Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies on a 3.5″ diskette of the guidance document entitled “Implementation of the Inspection by
Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
John F. Stigi, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 124.
MDUFMA (Public Law 107-250) was signed into law on October 26, 2002. Section 201 of MDUFMA adds a new paragraph “g” to section 704 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons or APs) to perform inspections of eligible manufacturers of class II or class III devices. This is a voluntary program; eligible manufacturers have the option of being inspected by an AP or by FDA. In the
On April 1, 2004, the Medical Devices Technical Corrections Act (Public Law 108-214) was signed into law by the President. This law made changes to several sections of the act, including section 704(g). Most significantly, section 704(g) of the act as amended permits an establishment that markets at least one class II or III device in the United States and markets or intends to market at least one such device in one or more foreign countries to use an accredited third party if one or both of the following conditions are met: (1) One of the foreign countries certifies, accredits, or recognizes the AP as a person authorized to conduct inspections of device establishments or (2) the establishment submits a statement that the law of a country where the device is marketed or intended to be marketed recognizes an inspection by FDA or an AP. Before the technical correction, it was necessary that both of these conditions be met before an establishment would be eligible to use an AP under this program. FDA is now issuing revised criteria as set out in section II of this document and a revised guidance document that incorporates the changes made by the Medical Device Technical Corrections Act.
This guidance document supersedes the guidance document that FDA issued on April 28, 2003. FDA received three comments on the April 28, 2003, guidance. FDA reviewed those comments and has addressed them as appropriate in this revised guidance.
FDA is making this guidance document immediately available because prior public participation is not feasible. MDUFMA requires that FDA implement this program immediately and this guidance is needed to help effect such implementation.
This section describes the criteria FDA will apply when making decisions about whether to accredit persons who request to conduct inspections of eligible class II and class III device manufacturers in lieu of an FDA inspection. The guidance document entitled ``Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria” repeats these criteria and provides suggestions on how applicants may address them in their application.
Section 704(g)(3) of the act describes the minimum requirements that an AP must meet in order to be accredited by FDA. These requirements are that an AP:
• May not be a Federal Government employee;
• Shall be an independent organization not owned or controlled by a manufacturer, supplier, or vendor of articles regulated under the act and have no organizational, material, or financial affiliation (including a consultative affiliation) with such a manufacturer, supplier, or vendor;
• Shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation;
• Shall not engage in the design, manufacture, promotion, or sale of articles regulated under the act;
• Shall operate in accordance with generally accepted professional and ethical business practices and agree in writing that, at a minimum, it will:
Certify that the reported information accurately reflects data reviewed, inspection observations made, other matters that relate to or may influence compliance with the act, and recommendations made during an inspection or at an inspection's closing meeting;
Limit work to that for which competence and capacity are available;
Treat information received, records, reports, and recommendations as confidential commercial or financial information or trade secret information, except such information may be made available to FDA;
Respond promptly and attempt to resolve complaints regarding its activities for which it is accredited;
Protect against the use of any officer or employee of the AP to conduct inspections who has a financial conflict of interest regarding any product regulated under the act, and annually make available to the public disclosures of the extent to which the AP, and the officers and employees of the person, have maintained compliance with requirements relating to financial conflicts of interest.
In addition to the minimum requirements specified in section 704(g)(3) of the act for becoming an AP, this document also establishes the following additional criteria:
FDA expects APs to have sufficient personnel, with the necessary education, training, skills, and experience to review records and perform inspections. FDA will consider several factors when accrediting applicants. These factors include:
• Whether personnel have knowledge of the following:
The act (21 U.S.C. 321
The Public Health Service Act (42 U.S.C. 201
Regulations implementing these statutes, particularly parts 11 and 800-1271 (21 CFR parts 11 and 800-1271), with special emphasis on parts 11, 801, 803, 806, 807, 809, 814, 820, and 821;
FDA Compliance Program 7382.845, Inspection of Medical Device Manufacturers;
Guide to Inspection of Quality Systems (QS): Quality System Inspection Technique (QSIT); and
FDA Investigations Operations Manual, Chapter 5 “Establishment Inspection.”
Whether the applicant:
Has established, documented, and executed policies and procedures to ensure that inspections are performed by qualified personnel, and will maintain records on the relevant education, training, skills, and experience of all personnel who contribute to the performance of inspections;
Has available to its personnel clear, written instructions for duties and responsibilities with respect to inspections;
Has identified personnel who, as a whole, are qualified in all of the quality system disciplines for the inspections under the AP scope of work; and
Has identified at least one individual who is responsible for providing supervision over inspections and who has sufficient authority and competence to assess the quality and acceptability of inspection reports.
APs need the capability to interface with FDA's electronic data systems, including FDA's Internet Web sites and the Center for Devices and Radiological Health (CDRH) Facts-On-Demand system. At a minimum, this would entail a computer system with a modem and an independent fax machine. FDA will rely extensively on the use of our electronic systems for timely dissemination of guidance documents to APs and other interested parties. APs must also have physical security and safeguards to protect trade secret and confidential commercial or financial information, as well as personal identifier information in medical records, such as adverse event reports, that would reveal the identity of individuals if disclosed.
An AP must be impartial and free from any commercial, financial, and other pressures that might present a COI or an appearance of a COI. To that end, when deciding whether to accredit a person, we will consider whether they have established, documented, and executed policies and procedures to prevent any individual or organizational COI, including conflicts that their contractors or individual contract employees may have.
Although it is not feasible to identify all of the circumstances that would raise concerns about COI in this document, the most common conditions that indicate an actual or a potential COI are as follows:
• The AP is owned, operated, or controlled by a manufacturer, supplier, or vendor of any article regulated under the act. Please see
• The AP has any ownership or financial interest in any product, manufacturer, supplier or vendor regulated under the act (see section II.B.3 of this document);
• Any personnel of the AP involved in inspections or their spouse or minor children have an ownership or other financial interest regarding any product regulated under the act (see link at section II.B.3 of this document);
• The AP or any of its personnel involved in inspections participates in the design, manufacture, promotion or sale of any product regulated under the act;
• The AP or any of its personnel involved in inspections provides consultative services to any manufacturer, supplier or vendor of products regulated under the act (see link at section II.B.3 of this document);
• Any personnel of the AP involved in the inspection process participate in an inspection of a firm they were employed by within the last 12 months; and
• The fees charged or accepted are contingent or based upon the report made by the AP.
When the AP uses the services of a contractor in connection with an inspection, it is responsible for the work of the contractor and its personnel. It will be the AP's responsibility to assure that the contractor meets the same criteria for freedom from COI as the AP and its personnel.
In addition to conducting inspections as an AP, an AP may also conduct other activities, such as objective laboratory testing of products regulated under the act or assessment of conformance to standards, if those other activities do not affect the impartiality of inspections. Examples of conflicted laboratory testing, i.e., activities an AP may not perform, are those tests linked to the manufacturing process that are usually performed by manufacturers, such as routine quality production tests, validation/verification studies, and quality assurance related testing.
Information on the COI standards FDA applies to its own personnel is included in appendix 1 of the guidance entitled “Standards for Ethical Conduct for Employees of the Executive Branch.” An AP may adopt these standards, utilize the model COI policy FDA has provided as another appendix to the guidance, or demonstrate how alternative equivalent procedures will safeguard against COI.
An AP will not be eligible to conduct independent inspections until they have successfully completed the classroom training required by FDA and conducted a satisfactory performance inspection under FDA observation. Firms identified on FDA's list of APs to perform inspections will designate employees to participate in the classroom training and joint qualifying inspections.
Training for APs will be “modeled” after training of European Union Conformity Assessment Bodies (EU CABs) under the Mutual Recognition Agreement (MRA) Implementation Plan. (See
The FDA training will consist of a two-tiered program.
Tier one will include formal classroom training for AP inspectional staffers (trainees). At a minimum, this will include:
• The Association for the Advancement of Medical Instrumentation (AAMI) Good Manufacturing Practice (GMP)/Quality System: Requirements and Industry Practice (or equivalent). AAMI will be conducting this training throughout the United States and in foreign countries. (See the AAMI Web site at
• FDA's QSIT training module.
• FDA investigator training, which will include training on:
Food and Drug Law,
Advanced QSIT,
FDA inspectional procedures,
FDA policies and device regulations, and
Evidence development.
FDA will periodically provide either “face to face” or electronic training for AP inspectors. Each applicant to this program should make tentative plans to send appropriate representatives to the FDA investigator training. However, only those applicants whose applications are approved will be eligible to nominate employees to attend the training. Applicants should advise FDA in their AP application of the names of the employee(s) who have either successfully completed this training or those who will be nominated to participate in this training. AP trainees will not qualify to enter the second tier unless they successfully pass a test at the end of each tier, which is one training session.
The second tier will involve the completion of three joint inspections, during which FDA and the AP will address the relevant parts of Compliance Program 7382.845—Inspection of Medical Device Manufacturers and the QSIT guidance—Guide to Inspection of Quality Systems. The three joint inspections will include:
• Collaborative inspection—The FDA investigator will be the lead inspector and the AP trainee will act primarily as an observer. The FDA investigator will prepare a list of any nonconformities and an inspection report. The trainee will prepare a “practice” list of nonconformities and an inspection report.
• Modified performance inspection—Using established criteria, the FDA investigator will observe and evaluate the trainee performance of an inspection and may provide assistance. The trainee will prepare a list of any nonconformities to be presented to the facility and an inspection report. The FDA investigator will review the list of nonconformities and provide feedback before it is presented. In addition, the FDA investigator will review the inspection report and, if necessary, write an addendum to supplement the inspection report.
• Full performance inspection—The AP trainee will perform an independent inspection and will be observed and evaluated by the FDA investigator using established criteria. The FDA investigator may not provide assistance to the trainee. The trainee will prepare a list of any nonconformities to be presented to the facility and an inspection report. The FDA investigator will review the list of nonconformities and provide feedback before it is presented. In addition, the FDA investigator will review the inspection report and, if necessary, write an addendum to supplement the inspection report. The FDA investigator's evaluation of the trainee and report will be presented to FDA's Office of Regulatory Affairs (ORA) certifier in FDA's Division of Human Resource Development who will determine if the trainee is qualified to perform independent inspections.
The criteria FDA will use to evaluate the joint inspections will be addressed at FDA's training sessions.
After FDA receipt of the AP application
:• The third party recognition board (TPRB) Chairman will e-mail the applicant's contact person within 24 hours of receipt of the AP application, acknowledging receipt.
• Members of the TPRB will perform an initial review to determine if the request for accreditation addresses the information set forth in section II.B.6 of this document and is adequate for review by the full TPRB.
• The TPRB Chairman will advise the contact individual, via e-mail, within 60 days after the receipt of such request for accreditation, whether the request is adequate for review by the TPRB or whether additional information is needed.
• If the application is deficient, FDA will identify its shortcomings and advise the applicant to submit additional information within the designated time period. FDA may deem the application incomplete and deny the request for accreditation if the applicant fails to respond to a request for additional information in a timely manner. All information submitted to FDA in response to any requests for additional information should be received by the date indicated in FDA's request. Once such information is received, FDA will file the application for full review, rating, and ranking by the TPRB.
A rating criteria checklist will be used to assess the relevant qualifications and competence of persons applying to become APs. The agency has assigned a weight (5, 15 or 20) to each of eight elements. The eight elements are addressed in section II.B.6 of this document. The weight of the element is based on how essential the information is in determining if the applicant is suitable to perform QS/GMP inspections on behalf of FDA. Each member of the TPRB will assess each of the eight elements and will vote a “quality level” score from 0 to 4 (0 = unsatisfactory, 2 = satisfactory, 4 = exceeds) for each element. The final quality level score will be determined by a majority vote of the TPRB (quality level score x weight = element score). The eight element scores will be totaled to yield an “Application Rating” (maximum rating attainable is 400). Any application with one or more elements rated as unsatisfactory will be deemed to have failed to meet the criteria established by the AP.
• FDA may deny the request for accreditation if we determine that the application does not meet the criteria established for APs.
Applicants should include the following information:
• Administrative information;
• Application in English;
• Name and address of the organization seeking accreditation;
• Telephone number and e-mail address of the contact person. The contact person should be the individual to whom questions about the content of the application may be addressed and to whom a letter of determination and general correspondence will be directed;
• Name and title of the most responsible individual at the AP. Foreign applicants may wish to identify an authorized representative located within the United States who will serve as the AP's contact with FDA;
• Name and title of the most responsible individual at the parent organization, if applicable;
• Brief description of the applicant, including: Type of organization (e.g., not-for-profit institution, commercial business); size of organization (number of employees); organizational charts showing the relationship of the organization involved in the AP inspection program and its relationship with parent or affiliate companies; number of years in operation; nature of work (e.g., conformity assessment testing or certification laboratory); and sufficient information regarding ownership, operation, and control of the
• List of countries that have certified, accredited or recognized the applicant for quality system or GMP inspections/auditing of medical devices, and the date of such certification, accreditation, or recognition;
• Specification of any accreditation for assessment of quality systems that you may have, such as accreditation to ISO/IEC Guide 62. If you are accredited to standards other then Guide 62, please provide copies of the standards in English.
• Activities for which the AP seeks accreditation. This includes a list identifying the devices the applicant seeks to inspect. Applicants may simply state “all devices” or identify the devices they wish removed from their scope of work by classification panel or by classification name (e.g., all devices except cardiovascular devices under part 870 or except §§ 870.3620, 870.3630, 870.3640, and 870.3670).
The applicant should submit a copy of the written policies, procedures, and sample certification/compliance statements established to prevent conflicts of interest. MDUFMA requires that the AP and its employees (including contract employees) involved in the performance of inspections and the preparation and approval of reports be free from conflicts of interest and the appearance of conflicts of interest that might affect the inspection process. No personnel of an AP involved in inspections, nor their spouses or minor children, may have ownership of or other financial interest in any product regulated under the act. In accordance with section 704(g)(3)(E) of the act, APs will annually make available to the public the extent to which the AP complies with conflict of interest requirements.
FDA will consider several factors with respect to personnel qualifications and the preparedness of the applicant to conduct technically competent inspections. The applicant should document these factors in its application and include:
• The written policies and procedures established to ensure that manufacturers are inspected by qualified personnel;
• The written instructions for the duties and responsibilities of personnel, including inspectors, with respect to the inspection of device manufacturing facilities;
• The written personnel qualification standards established to ensure that inspectors and other designated personnel are qualified in all of the regulatory and technical disciplines needed to effectively inspect for compliance with FDA's regulatory requirements for medical devices;
• The documentation (e.g., CVs) to establish that the inspectors and other involved nonsupervisory personnel meet the established criteria for qualified personnel. This includes documentation of knowledge, education, training, skills, abilities and experience, including specialized education and experience needed for the inspection of medical device manufacturing facilities;
• The documentation (e.g., CVs) to establish that the supervisor(s) of inspectors have sufficient authority and meet the established criteria for qualified supervisory personnel. This includes documentation of knowledge, education, training, skills, abilities and experience, including any specialized education and experience needed to supervise the inspection and review records prepared by inspectors;
• A description of the applicant's management structure and that of any contractor used for inspection work. The application should describe the position of the individual(s) providing supervision within the management structure and explain how that structure provides for the supervision of the inspectors and other personnel involved in the inspection process. (If the applicant plans to utilize contractors, please address the additional information described at section II.B.6 of the document);
• A description of the inspection team. This includes documentation for any members of the team who may already have training and experience relevant to the assessment of compliance with FDA's regulatory requirements for medical devices (e.g., compliance programs, the QS regulation, and general auditing principles). The description should include documentation of the ability of the team to recognize, collect, and identify evidence of noncompliance and adequately communicate with the manufacturer regarding the inspection;
• Documentation that personnel involved in inspections have basic quality systems knowledge and are qualified in accordance with generally accepted quality assurance standards, (e.g., ISO 13485 or part 820) and capable of functioning in accordance with the relevant parts of these standards;
• Documentation of training plan to assure technical competence;
• Documentation of records that demonstrate the appropriate experience and training of each inspector.
The applicant should identify what reference materials are available to inspectors and other personnel involved in inspections, (e.g., the act, regulations, manuals, standards). Also, the application should identify equipment and resources available that will enable the inspector to perform technical and administrative tasks. At a minimum, this should include a computer system with a modem and an independent facsimile machine. FDA will rely extensively on the use of our electronic systems for timely dissemination of guidance documents to APs and other interested parties.
APs should have physical security and safeguards in place to protect trade secret and confidential commercial and financial information, as well as personal identifier information in medical records, such as adverse event reports, that would reveal the identity of individuals if disclosed.
The applicant should include established procedures to ensure confidentiality of reports and all information obtained during an inspection. These should address aspects of authorized disclosure and the procedures by which the applicant maintains confidentiality between itself and the manufacturer. In addition, the applicant should describe the procedures through which the applicant's personnel and any contractors are made aware of confidentiality requirements.
FDA will consider several factors to determine whether the applicant ensures that contractors are properly qualified, utilized, and monitored. Special emphasis will be placed on personnel qualifications and preparedness to conduct technically competent inspections, and on conflict of interest controls. The applicant should document these factors in the application and include:
• The written policies and procedures established to ensure that contractors conform to the same requirements (e.g., education, training, and experience) that would apply to the applicant if it were performing the inspection or aspects of the inspection contracted. These policies and procedures should ensure that the contractor conducts inspections in accordance with the same procedures under which the applicant operates. The applicant should include assurances that it will maintain documentary evidence that the contractor has the necessary technical competence and resources to carry out contracted activities;
• Written policies and procedures documenting that the applicant will not contract the overall responsibility for reviewing the results of the inspections;
• Documentation of an agreement delineating the duties, responsibilities, and accountability of the contractor; and
• The written policies and procedures for establishing a register of qualified contractors.
FDA will consider the following factors to determine whether the applicant has established an adequate quality system to ensure compliance with FDA policies and procedures relevant to inspections:
• The applicant should establish a documented quality system to ensure that there are processes and procedures in place to demonstrate compliance with section 704(g) of the act;
• The policies and procedures the applicant follows are adequate to maintain control of all quality system documentation and to ensure that a current version is available at all locations; and
• The policies and procedures for internal auditing to ensure the quality system is implemented effectively and that resources are available for conducting such audits.
The applicant should provide a copy of a documented statement, which will be signed by the most responsible individual, certifying that:
• The AP has appropriate policies and procedures to meet FDA's conflict of interest provisions, has the appropriate staff and procedures in place to ensure technical competence for conducting inspections under section 704(g) of the act, and has the quality system in place to ensure acceptable and consistent inspections;
• Where the AP uses the services of a contractor for QS/GMP inspections, the AP should also certify that its contractor(s) meets the APs established criteria for freedom from conflicts of interest and technical competence;
• The AP consents to FDA inspection and copying of all records, correspondence, and other materials relating to any inspections conducted by the AP under this program, including records on personnel, education, training, skills, and experience and all documentation on prevention of conflicts of interest, including certification/compliance statements; and
• The AP will protect trade secret and confidential commercial or financial information, and will treat as private information about specific patient identifiers in records such as adverse event reports, except that such information may be made available to FDA.
We are issuing a revised guidance entitled “Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria,” which repeats the AP criteria set out in section II of this document. In addition, the guidance provides other useful information such as suggestions about the format and content of the accreditation applications. The revised guidance reflects changes to the law made by the Medical Device Technical Corrections Act.
The guidance represents the agency's current thinking on the “Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria.” The issuance of this guidance is consistent with FDA's good guidance practices regulation (21 CFR 10.115). 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.
To receive “Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria” by fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1200) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts,
This document and the guidance entitled “Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria” contain a proposed collection of information that requires clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information addressed in the guidance document have been approved by OMB in accordance with the PRA under OMB control number 0910-0510.
Interested persons may submit to the Division of Dockets Management (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations.” The draft guidance describes the key elements of a robust quality systems model and shows how persons implementing such a model can achieve compliance with the CGMP regulations.
Submit written or electronic comments on the draft guidance by December 3, 2004. 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; or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
FDA is announcing the availability of a draft guidance for industry entitled “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations.” The draft guidance illustrates where FDA can harmonize across agency centers and with other non-U.S. pharmaceutical quality management requirements. This draft guidance was developed by the quality systems group formed as part of the CGMP for the 21st Century initiative. The draft guidance is intended to encourage the use of modern quality management system principles by the regulated industry and foster innovation and continuous improvements in pharmaceutical manufacturing.
The Pharmaceutical CGMPs for the 21st Century: A Risk Based Approach initiative was announced in August 2002 (
At the outset, the agency established a set of guiding principles for the initiative:
• Maintain a risk-based orientation;
• Policies and standards must be science based;
• The agency's orientation must be toward integrated quality systems;
• International cooperation is very important; and
• Protection of the public health must remain top priority.
The initiative's announcement stated that 21 CFR parts 210, 211, and parts 600 and 610 are flexible and will allow the agency to embark on a science-based risk management approach to CGMPs. This draft guidance, developed by a cross-center working group established by the initiative, is key in achieving the agency's goals. By showing how modern quality systems approaches relate to the existing CGMP regulation, the agency can help manufacturers meet the requirements of the agency's CGMP while using a robust quality systems approach to the production of human and animal medical products. Such a comprehensive approach should foster flexibility and allow for continued innovation, while maintaining the principles of the CGMP regulations.
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 this topic. 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 Division of Dockets Management (see
Persons with access to the Internet may obtain the document at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.” The guidance explains a science-based, risk-based framework, “Process Analytical Technology, or PAT,” to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. This framework is founded on process understanding, with the goal of facilitating innovation and risk-based regulatory decisions by industry and the agency. Working with existing regulations, this guidance describes a regulatory approach that will enable the agency and the pharmaceutical industry to address technical and regulatory issues and questions anticipated during the implementation of PAT.
General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies of the 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 guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
FDA is announcing the availability of a guidance entitled “Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.” The guidance explains a science-based, risk-based framework, “Process Analytical Technology, or PAT,” that supports innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. The framework is founded on process understanding, which can be used to facilitate innovation and risk based regulatory decisions by industry and the agency.
Conventional pharmaceutical manufacturing is generally accomplished using batch processing with laboratory testing conducted on collected samples to evaluate quality. This conventional approach has been successful in providing quality pharmaceuticals to the public. However, today significant opportunities exist for improving pharmaceutical development, manufacturing, and quality assurance through innovation in product and process development, process analysis, and process control. Unfortunately, the pharmaceutical industry generally has been hesitant to introduce innovative systems into the manufacturing sector for a number of reasons. One reason often cited is regulatory uncertainty, which may result from the perception that the existing regulatory system is rigid and unfavorable to the introduction of innovative systems. In August 2002, recognizing the need to eliminate the hesitancy to innovate, FDA launched a new initiative entitled “Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach.” Development of this guidance was part of that initiative.
Pharmaceutical development and manufacturing is evolving with increased emphasis on science and engineering principles. Effective use of pharmaceutical science and engineering principles and knowledge, throughout the life cycle of a product, can improve the efficiencies of both manufacturing and regulatory processes. FDA's initiative is designed to do just that using an integrated systems approach to regulating pharmaceutical product quality. This approach is based on science and engineering principles for assessing and mitigating risks related to poor product and process quality. The desired future state of pharmaceutical manufacturing may be characterized as the following: (1) Product quality and performance achieved and ensured through the design of effective and efficient manufacturing processes, (2) product and process specifications based on a mechanistic understanding of how formulation and process factors affect product performance, (3) continuous real time quality assurance, (4) regulatory policies and procedures tailored to recognize the level of scientific knowledge supporting products and processes, (5) risk-based regulatory approaches that recognize the level of scientific understanding of how formulation and manufacturing process factors affect product quality and performance, as well as, the capability of process control strategies to prevent or mitigate the risk of producing a poor quality product. This guidance is intended to facilitate progress to this desired state.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on this topic. 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
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.” This guidance explains FDA's current thinking on manufacturing of sterile drug products produced by aseptic processing in the context of complying with certain sections of the current good manufacturing practice (CGMP) regulations for drug and biological products. This guidance is issued with the goal of providing clear and consistent communication of regulatory expectations to promote voluntary compliance with current FDA requirements.
General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies of the 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; or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
FDA is announcing the availability of a guidance for industry entitled “Sterile Drug Products Produced by Aseptic Processing— Current Good Manufacturing Practice.” This guidance explains FDA's current thinking on manufacturing of sterile drug products produced by aseptic processing in the context of complying with certain sections of the CGMP regulations for drug and biological products (21 CFR parts 210, 211, and 600 through 680, respectively).
In the
Sterile drug products are a high priority in FDA's risk-based inspectional program. These drug products are generally of high therapeutic significance. Clarifying relevant regulatory standards for sterile drug products will help reduce the incidence of manufacturing problems with this class of pharmaceuticals, thus facilitating the ready availability of these therapeutically significant pharmaceuticals and avoiding drug shortages.
This guidance document is the product of extensive public input. FDA first published a preview of its current thinking in the form of a concept paper on September 23, 2003. We presented our CGMP approach for aseptic processing at the Advisory Committee for Pharmaceutical Science on October 22, 2002. At this meeting, the concept paper was discussed in a public forum and critiqued by the advisory committee's members as well as a panel of invited aseptic processing experts. The advisory committee meeting yielded a number of issues that provided impetus for further discussion. In December 2002, an aseptic processing working group was formed under Product Quality Research Institute (PQRI) to address these issues. The working group, composed of 41 prominent aseptic processing experts from industry, academia, and FDA, prepared technical recommendations on the guidance document. The PQRI Steering Committee forwarded the working group's final report to FDA on March 19, 2003, and it was subsequently posted on PQRI's Web site (
The advisory committee and PQRI Working Group recommendations provided valuable contributions and many of these recommendations have been adopted in the guidance.
A number of comments were received on the draft guidance, most of which concerned the need to further enhance the precision of guidance provided on certain topics. As a result, many clarifying changes were made. Major changes include the revision of the Sterility Testing section of the guidance to clearly emphasize and reference the United States Pharmacopeial Sterility Test <71>. In the guidance, table 1 entitled “Air Classifications,” which
This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking. 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 the approach satisfies the requirements of the applicable statute and regulations.
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0139, until August 31, 2005.
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a document entitled “Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information,” dated September 2004. The guidance document provides to vaccine manufacturers, medical practitioners, and consumers an overview of the vaccine labeling review process, a description of FDA's review of childhood vaccine labeling, and a discussion of the type of data FDA examines when determining the adequacy of vaccine labeling.
Submit written or electronic comments on agency guidances at any time.
Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800. See the
Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
Astrid Szeto, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.
FDA is announcing the availability of a document entitled “Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information,” dated September 2004. The guidance document provides to vaccine manufacturers, medical practitioners, and consumers an overview of the vaccine labeling review process, a description of FDA's review of childhood vaccine labeling under section 314 of the National Childhood Vaccine Injury Act (NCVIA), and a discussion of the type of data FDA examines when determining the adequacy of vaccine labeling. The processes described represent current FDA practices and do not represent any new interpretation of existing labeling statutes, regulations, or guidances.
The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on this topic. 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 requirement of the applicable statutes and regulations.
In accordance with 21 CFR 10.115(g)(4)(i), FDA is immediately implementing this guidance. Interested persons may, at any time, submit written or electronic comments to the Division of Dockets Management (see
Persons with access to the Internet may obtain the guidance at either
Health Resources and Services Administration, HHS.
Notice of Children's Hospitals Graduate Medical Education Payment Program (CHGME PP) conference call.
This document announces a scheduled CHGME PP conference call for Federal fiscal year (FY) 2005. The
The conference call will be held on Wednesday, October 20, 2004 from 1:30 p.m. to 3:30 p.m. EST.
Ayah E. Johnson, Ph.D., telephone: (301) 443-1058; Division of Medicine and Dentistry, Bureau of Health Professions, Health Resources and Services Administration, Parklawn Building, 5600 Fishers Lane, Room 9A-05, Rockville, Maryland 20857; or by e-mail at:
The CHGME PP, as authorized by section 340E of the Public Health Service (PHS) Act (the Act) (42 U.S.C. 256e), provides funds to children's hospitals to address disparity in the level of Federal funding for children's hospitals that result from Medicare funding for graduate medical education (GME). Pub. L. 106-310 amended the CHGME statute to extend the program through FY 2005.
The statute authorized $280 million for both direct and indirect medical education payments in FY 2000, $285 million in FY 2001, and for each of the FY 2002 through FY 2005 such sums as necessary. Congress appropriated $303 million in FY 2004 for the CHGME PP. These funds have supported over 4,000 residents receiving training in children's teaching hospitals in 31 States.
The agenda for the conference calls will include but not be limited to: (1) Welcome and opening comments; (2) news releases/updates; (3) reminders; and (4) “on the horizon” topics of interest. Time will also be available for a question and answer period. Agenda items will be determined as priorities dictate.
Interested parties must register, in advance, but not later than 5 days prior to the scheduled conference call. Conference call registration forms and information about the Program can be found on the CHGME PP Web site. The Web site address is
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), notice is hereby given of the following meeting:
Anyone requiring information regarding the Committee should contact Peter C. Van Dyck, M.D., M.P.H., Executive Secretary, ACIM, Health Resources and Services Administration (HRSA), Room 18-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, telephone: (301) 443-2170.
Individuals who are interested in attending any portion of the meeting or who have questions regarding the meeting should contact Ann M. Koontz, C.N.M., Dr.P.H., HRSA, Maternal and Child Health Bureau, telephone: (301) 443-6327.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), notice is hereby given of the following meeting:
On Friday, October 22, the Advisory Committee will continue work on the report. An opportunity will be provided for public comment.
National Institutes of Health, Public Health Service, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
Available for licensing for industrial scale-up production and commercial distribution is an improved countercurrent chromatography apparatus comprising a disk having a series of interconnected and elongated compartments coupled by ducts that form a portion of a groove in a surface of the disk. At least some of the elongated compartments have an aspect ratio of at least greater than two and a width greater than twice the width of the connecting ducts and a length of about 10 to 20 times the length of the connecting ducts. This apparatus may also be used for a large-scale industrial separation by coaxially rotating in centrifugal or gravitational fields.
Available for licensing and commercial distribution is an assay method and kit having diagnostic peptide fragments derived from human immunodeficiency virus-1 (HIV-1). The new serology assay includes HIV-1 peptide fragments epitopes that map to HIV-1 GAG-p6, and gp41 genes. These epitopes are broadly reactive with early sera from HIV infected individuals, do not illicit protective antibodies, do not illicit immunologic cytotoxicity and are readily removable from current and future HIV-1 candidates. The assay is advantageous in detecting HIV-1 early breakthrough infections in seroconverted vaccine recipients while being able to distinguish between individuals with bonafide breakthrough infections versus non-HIV infected vaccine recipients presenting only vaccine borne antibodies. For example, 90% of vaccine recipients receiving a Canarypox construct expressing a plurality of HIV antigens (Env, Gag, Pol, HIV Protease, Nef) followed by an envelope protein boost, scored positive in FDA licensed enzyme immunoassay, rapid test, and Western blot (Marta-Louise Ackers
Available for licensing and commercial distribution are optical cells that are spectroscopically, thermally and mechanically stable and can be used for spectroscopic measurement in transmission, reflection, transmission-reflection, emission, or scattering modes without modification of standard spectrometers. The cell handles liquid samples and biological or solid samples equilibrated with bathing fluid which does not interfere with the light beam, allows liquid sample or bathing fluid to be exchanged without cell reassembly, requires only a small amount of sample (down to 0.1μl), allows for different sample gaps (0.2-1000μm) to be easily and inexpensively set, and allows spectral measurements to be taken over wavelengths ranging at least from the mid-infrared to the vacuum ultraviolet. The inventive cell and methods allows sensitive and reproducible monitoring spectra and their changes (down to at least 10
This research is described, in part, in Mertz E.L., Leikin S. “Interactions of Inorganic Phosphate and Sulfate Anions with Collagen”, Biochemistry, in press.
Available for licensing and commercialization is a device for sequentially eluting proteins and peptides. The device comprises a separation medium having an outlet, and a collector having a first receptacle and second receptacle that can be sequentially brought into contact with the outlet of the separation medium by translating (rotating) the first receptacle and the second receptacle in relation to the outlet of the separation medium. The invention is adaptable to capillary electrophoresis as well. Multiple sequential protein transfer from SDS-PAGE gel to a mass spectrometer is made possible. Separated protein bands sequentially electrophorese into low melting agarose plugs distributed along the surface of a plastic drum. The effective electroelution of a protein from a gel band to an agarose filled slot. The drum is rotated to receive each band individually. Migrating SDS linearized proteins are electrophoresed into the receptacle slot drum. The drum is rolled until each protein of interest is separated. Agarose plugs are lifted from the drum slots; enzymatically dissolved, and loaded directly onto a MALDI spectrometer. Between two agarose layers, gel free collection chambers can be formed inside the drum providing solution phase fraction collection.
This research is described in: Buzas Z, Antal J, Gilligan JJ, Backlund PS, Yergey AL, Chrambach A. An electroelution apparatus for sequential transfer of sodium dodecyl sulfate-proteins into agarose and mass spectrometric identification of Li-Na-dodecyl sulfate-proteins from solubilized agarose. Electrophoresis. 2004 Apr;25(7-8):966-9.
Available for licensing is an invention in which a single tube assay is used for determining high-density lipoprotein HDL-cholesterol (HDL-C), low density lipoprotein (LDL-C) and total cholesterol (total-C), from a single serum sample. This assay is an efficient tool for use in determining patient risk factors for heart disease. Previously, multiple costly tests were performed in order to determine low-density lipoprotein LDL-C and HDL-C by measuring total-C, total triglyceride, and HDL-C. That method of testing had limitations and was complex. Using this methodology, the homogeneous assay for HDL-C does not require physically separating HDL. The new assay developed is efficient, less costly, and compares favorably to current assays for HDL-C, total cholesterol, and triglyceride. This technology may also be used to simplify the procedure for the point of care testing of hyperlipidemia.
Pursuant to Pub. L. 92-463, notice is hereby given of a correction of a notice of a meeting of the Substance Abuse Prevention (CSAP) National Advisory Council to be held in October 2004.
Public notice was given in the
Fish and Wildlife Service, Interior.
Notice of availability.
The U.S. Fish and Wildlife Service announces that a Comprehensive Conservation Plan (CCP) and Summary for Fish Springs National Wildlife Refuge is available. This CCP, prepared pursuant to the National Wildlife Refuge System Improvement Act of 1997 and the National Environmental Policy Act of 1969, describes how the U.S. Fish and Wildlife Service intends to manage this Refuge for the next 15 years.
A copy of the Plan or Summary may be obtained by writing to U.S. Fish and Wildlife Service, Fish Springs National Wildlife Refuge, PO Box 568, Dugway, Utah, 84022; or download from
Jay Banta, Refuge Manager, U.S. Fish and Wildlife Service, Fish Springs National Wildlife Refuge, PO Box 568, Dugway, Utah, 84022. Phone 435-831-5353; fax 435-831-5354; or e-mail:
Background
Fish Springs National Wildlife Refuge (NWR), comprised of 17,992 acres, is located in western Utah in Juab County. Springs flowing from the eastern base of the Fish Springs Range feed a 10,000-acre saline marsh divided into nine impoundments. The remaining portion comprises 6,000 acres of mud and alkali flat and 2,000 acres of semidesert upland. The Refuge provides the only important wetland habitat for a 70-mile radius, attracting hundreds of wetland-dependent species during migration. Since Refuge establishment, more than 278 species of birds have been seen at Fish Springs NWR, 61 of which nest on the Refuge. Fish Springs NWR was established by the Migratory Bird Conservation Commission in 1959 “* * * for use as an inviolate sanctuary, or for any other management purpose, for migratory birds.”
The availability of the Draft CCP and Environmental Assessment (EA) for 30-day public review and comment was announced in the
Based on this assessment and comments received, the preferred Alternative C was selected for implementation. The preferred alternative was selected because it best meets the purpose and goals of the Refuge, as well as the goals of the National Wildlife Refuge System. The preferred alternative will also benefit migratory birds and native mammal, mollusk, invertebrate, and amphibian communities. Increased efforts in visitor services and the addition of a goose hunt will result in improved wildlife-dependent recreational opportunities. Cultural and historical resources will be protected.
Fish and Wildlife Service, Interior.
Notice of availability.
We, the Fish and Wildlife Service, have received an application from Southern Conservation Corporation (Applicant) for an enhancement of survival permit (ESP) pursuant to section 10(a)(1)(A) of the Endangered Species Act of 1973 (U.S.C. 1531
Written comments on the CCAA and ESP application should be sent to the Service's Regional Office (see
Persons wishing to review the CCAA and ESP application may obtain copies by writing the Service's Southeast Regional Office, Atlanta, Georgia at the address below. Documents will also be available for public inspection by appointment during normal business hours at the Regional Office, 1875 Century Boulevard, Suite 200, Atlanta, Georgia 30345 (Attn: Endangered Species Permits), or Field Supervisor, Fish and Wildlife Service, 3761 Georgetown Road, Frankfort, Kentucky 40601. Written data or comments concerning the CCAA or ESP application should be submitted to the Regional Office at the address listed above and must be submitted in writing to be adequately considered in the Service's decision-making process. Please reference permit number TE-088168-0 in your comments, or in requests of the documents discussed herein.
Mr. Rick Gooch, Regional CCAA Coordinator, (see
Individuals wishing copies of the ESP application and/or copies of the full text of the proposed Agreement should contact the office and personnel listed in the
The greater Adams Cave beetle (
Historically, Adams Cave has experienced extensive vandalism and was littered with trash and other debris, affecting the quality of available habitat for cave beetles. In 2002, a specially designed cave gate was installed to prevent unwanted human entry. Under the CCAA, Southern Conservation Corporation has agreed to implement several conservation measures that will reduce and/or eliminate potential threats to the species. Southern Conservation Corporation will: (1) Maintain the Adams Cave property in a natural state; (2) maintain the metal gate at the entrance to Adams Cave; and (3) control and limit access to Adams Cave and the enrolled property. Implementation of the CCAA is expected to protect and conserve habitat for the covered species, eliminate unauthorized human disturbances within Adams Cave that are believed to impact the covered species, and provide important monitoring data that can be used to develop and/or improve management strategies for the covered species and other cave-dependent species. These benefits will be obtained through restoration and protection of the above- and below-ground habitats on the enrolled property.
We will make our final determination after the end of the 30-day comment period and will fully consider all comments received during the comment period. If the final analysis shows the CCAA to be consistent with our policies and applicable regulations, we will sign the CCAA and issue the ESP. The proposed ESP would, in compliance with the CCAA Policy, only become valid on such date as the greater Adams Cave beetle and/or lesser Adams Cave beetle is listed as a threatened or endangered species under the Act.
This notice also advises the public that we have made a preliminary determination that issuance of the ESP will not result in significant environmental, economic, social, historical, or cultural impacts and is, therefore, categorically excluded from review under NEPA, pursuant to 516 Departmental Manual 2, Appendix 1 and 516 Departmental Manual 6, Appendix 1. We specifically request information, views, and opinions from the public via this notice. Further, we specifically solicit information regarding the adequacy of the CCAA as measured against our CCAA Policy.
The primary author of this notice is Rick Gooch (see
The authority for this action is the Endangered Species Act, (16 U.S.C. 1531
The proposal for the information collection described below will be submitted to the Office of Management and Budget for approval under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35). Copies of the proposed collection of information may be obtained by contacting the Bureau's clearance officer at the phone number listed below. Comments on the proposal should be made within 60 days to the Bureau Clearance Officer, U.S. Geological Survey, 807 National Center, 12201 Sunrise Valley Drive, Reston, Virginia, 20192, telephone (703) 648-7313.
As required by OMB regualtions at 5 CFR 1320.8(d)(1), the U.S. Geological Survey solicits specific public comments as to:
1. Whether the collection of information is necessary faor the proper performance of the functions on the bureaus, including whether the information will have practical utility;
2. The accuracy of the bureau's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
3. The quality, utility, and clarity of the information to be collected; and
4. How to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other forms of information technology.
Bureau of Indian Affairs, Interior.
Notice.
This notice announces that the Bureau of Indian Affairs (BIA) has submitted the proposed renewal of the information collection request for the Housing Assistance Application, to the Office of Management and Budget (OMB) for approval under the Paperwork Reduction Act.
Comments must be submitted on or before November 3, 2004.
Your comments and suggestions on the requirements should be made directly to the attention: Desk Officer for the Department of the Interior, Office of Information and Regulatory Affairs, Office of Management and Budget, either by facsimile at 202-395-6566, or by e-mail to
Copies of the collection of information form may be obtained by contacting Frank Joseph, Bureau of Indian Affairs, Department of the Interior, 1951 Constitution Avenue, NW., MS-335B-SIB, Washington, DC 20240. Telephone: (202) 513-7620.
This information collection has been re-evaluated and our estimates of the burden have been revised based on field experience. We have added the time the tribes spend in reviewing applications, the cost of soliciting applications and the cost of house inspection for each possible recipient. This additional cost is incurred regardless of whether or not the applicant is awarded a home improvement grant. These changes are an adjustment to the burden because the added burden was there before.
The information is needed to establish an applicant's eligibility to receive services under the Housing Improvement Program and to establish the priority order in which eligible applicants may receive services under the program. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
We specifically request your comments be submitted to OMB at the address provided above with a copy to the Bureau of Indian Affairs within 30 days concerning the following:
1. Whether the collection of information is necessary for the proper performance of the functions of the BIA, including whether the information will have practical utility;
2. The accuracy of the BIA's estimate of the burden to collect the information, including the validity of the methodology and assumptions used;
3. The quality, utility and clarity of the information to be collected;
4. How to minimize the burden of the information collection on those who are to respond, including the use of appropriate automated electronic, mechanical or other forms of information technology.
5. OMB is required to respond to this request within 60 days after publication of this notice in the
Bureau of Reclamation, Interior.
Notice.
Notice is hereby given of contractual actions that have been proposed to the Bureau of Reclamation (Reclamation) and are new, modified, discontinued, or completed since the last publication of this notice on July 26, 2004. This notice is one of a variety of means used to inform the public about proposed contractual actions for capital recovery and management of project resources and facilities consistent with section 9(f) of the Reclamation Project Act of 1939. Additional announcements of individual contract actions may be published in the
The identity of the approving officer and other information pertaining to a specific contract proposal may be obtained by calling or writing the appropriate regional office at the address and telephone number given for each region in the
Sandra L. Simons, Manager, Contract Services Office, Bureau of Reclamation, PO Box 25007, Denver, Colorado 80225-0007; telephone (303) 445-2902.
Consistent with section 9(f) of the Reclamation Project Act of 1939 and the rules and regulations published in 52 FR 11954, April 13, 1987 (43 CFR 426.22), Reclamation will publish notice of proposed or amendatory contract actions for any contract for the delivery of project water for authorized uses in newspapers of general circulation in the affected area at least 60 days prior to contract execution. Announcements may be in the form of news releases, legal notices, official letters, memorandums, or other forms of written material. Meetings, workshops, and/or hearings may also be used, as appropriate, to provide local publicity. The public participation procedures do
Public participation in and receipt of comments on contract proposals will be facilitated by adherence to the following procedures:
(1) Only persons authorized to act on behalf of the contracting entities may negotiate the terms and conditions of a specific contract proposal.
(2) Advance notice of meetings or hearings will be furnished to those parties that have made a timely written request for such notice to the appropriate regional or area office of Reclamation.
(3) Written correspondence regarding proposed contracts may be made available to the general public pursuant to the terms and procedures of the Freedom of Information Act, as amended.
(4) Written comments on a proposed contract or contract action must be submitted to the appropriate regional officials at the locations and within the time limits set forth in the advance public notices.
(5) All written comments received and testimony presented at any public hearings will be reviewed and summarized by the appropriate regional office for use by the contract approving authority.
(6) Copies of specific proposed contracts may be obtained from the appropriate regional director or his designated public contact as they become available for review and comment.
(7) In the event modifications are made in the form of a proposed contract, the appropriate regional director shall determine whether republication of the notice and/or extension of the comment period are necessary.
Factors considered in making such a determination shall include, but are not limited to: (i) The significance of the modification; and (ii) the degree of public interest which has been expressed over the course of the negotiations. At a minimum, the regional director shall furnish revised contracts to all parties who requested the contract in response to the initial public notice.
The February 27, 2004, notice should be used as a reference point to identify changes. The numbering system in this notice corresponds with the numbering system in the February 27, 2004, notice.
Bureau of Reclamation, 1150 North Curtis Road, Suite 100, Boise, Idaho 83706-1234, telephone (208) 378-5223.
15. Vale and Warmsprings IDs, Vale Project, Oregon: Repayment contract for reimbursable cost of SOD modifications to Warm Springs Dam.
Bureau of Reclamation, 2800 Cottage Way, Sacramento, California 95825-1898, telephone (916) 978-5250.
41. PacifiCorp, Klamath Basin Area Office, Klamath Project, Oregon: Execution of long-term agreement for lease of power privilege and the O&M of Link River Dam. This agreement will provide for operations of Link River Dam, coordinated operations with the non-Federal Keno Dam, and provision of power by PacifiCorp for Klamath Project purposes to ensure project water deliveries and to meet Endangered Species Act requirements.
7. City of Roseville, CVP, California: Execution of long-term Warren Act contract for conveyance of nonproject water provided from the Placer County Water Agency. The contract will allow CVP facilities to be used to deliver nonproject water to the City of Roseville for use within its service area.
9. El Dorado ID, CVP, California: Execution of long-term Warren Act contracts for conveyance of nonproject water (one contract for ditch rights in the amount of 3,344 acre-feet, and one contract for Project 184 in the amount of 11,000 acre-feet). The contracts will allow CVP facilities to be used to deliver nonproject water to El Dorado ID for use within its service area.
25. Sacramento Suburban WD, CVP, California: Execution of long-term Warren Act contract for conveyance of nonproject water. The contract will allow CVP facilities to be used to deliver nonproject water to the Sacramento Suburban WD for use within its service area.
39. Pershing County Water Conservation District, Pershing County, Lander County, and the State of Nevada; Humboldt Project; Nevada: Title transfer to lands and features of the Humboldt Project.
Bureau of Reclamation, PO Box 61470 (Nevada Highway and Park Street), Boulder City, Nevada 89006-1470, telephone (702) 293-8536.
30. Harquahala Valley ID, CAP, Arizona: The District has requested that Reclamation transfer title to the District's CAP distribution system and to assign to the District permanent easements acquired by the United States. Title transfer of the District's CAP distribution system is authorized by Pub. L. 101-628 and contract No. 3-07-30-W0289 between the District and Reclamation, dated December 8, 1992.
Bureau of Reclamation, 125 South State Street, Room 6107, Salt Lake City, Utah 84138-1102, telephone (801) 524-3864.
1.(f) Oxbow Mining, LLC, Aspinall Storage Unit, CRSP: Oxbow Mining, LLC has requested 242 acre-feet of M&I water out of Blue Mesa Reservoir, which requires submission of a Plan of Augmentation to the Division 4 Water Court.
1.(g) United Companies, Aspinall Storage Unit, CRSP: United Companies has requested 7 acre-feet of M&I water out of Blue Mesa Reservoir for the Delta No. 1 Gravel Pit.
1.(h) Mountain View Amish-Mennonite Church, Aspinall Storage Unit, CRSP: The Church has requested 1 acre-foot of M&I water out of Blue
28. U.S. Fish and Wildlife Service, San Juan River Basin Recovery Implementation Program, Aspinall Storage Unit, CRSP: The U.S. Fish and Wildlife Service has requested 14 acre-feet of water out of Blue Mesa Reservoir to be used at the Chipeta Unit ponds at the Hotchkiss National Fish Hatchery. The ponds are to be used to grow out the two San Juan River Basin endangered fish species.
29. Town of Palisade, Palisade ID, Mesa County ID, Reclamation, and the U.S. Fish and Wildlife Service; CRSP: The Colorado River is critical habitat for four endangered fish species. These agencies are entering into an agreement for each to provide the following: Reclamation shall provide cost-share funding for the recovery monitoring and research and O&M (October 30, 2000, 114 Stat. 1602, Pub. L. 106-392); the Districts are willing to allow the U.S. Fish and Wildlife Service and Reclamation to construct the fish passage; and the Town proposes to provide recreational opportunities on or near the fish passage.
30. Public Service Company of New Mexico, Reclamation, and the U.S. Fish and Wildlife Service; San Juan River Basin Recovery Implementation Program: The agreement identifies that Reclamation may provide cost-share funding for the recovery monitoring and research and O&M (October 30, 2000, 114 Stat. 1602, Pub. L. 106-392) of the constructed fish passage.
31. Reclamation, U.S. Fish and Wildlife Service, and the Colorado River Water Conservation District; the Recovery Implementation Program for Endangered Fish Species in the Upper Colorado River Basin: Reclamation will provide cost-share funding for enlargement of Elkhead Reservoir (October 30, 2000, 114 Stat. 1602, Pub. L. 106-392) in a separate grant agreement.
27. South Cache Water Users Association, Hyrum Project, Utah: Contract for repayment of 15 percent of SOD costs at Hyrum Dam. Contract executed June 16, 2004.
Bureau of Reclamation, PO Box 36900, Federal Building, 316 North 26th Street, Billings, Montana 59107-6900, telephone (406) 247-7730.
49. City of Fountain, Colorado; Fryingpan-Arkansas Project; Colorado: Consideration of a request for a long-term contract for the use of excess capacity in the Fryingpan-Arkansas Project.
50. Colorado Springs Utilities; Colorado Springs, Colorado; Colorado-Big Thompson Project: Consideration of a request for a long-term agreement for water substitution and power interference in the Colorado-Big Thompson Project.
51. Pueblo West Metropolitan District; Pueblo West, Colorado; Fryingpan-Arkansas Project, Colorado: Consideration of a request for a 5-to 10-year contract for the use of excess capacity in the Fryingpan-Arkansas Project.
4. Garrison Diversion Unit, P-SMBP, North Dakota: Renegotiation of the master repayment contract with Garrison Diversion Conservancy District to conform with the Dakota Water Resources Act of 2000; negotiation of repayment contracts with irrigators and M&I users.
34. Debbie A. Axtell (Individual), Boysen Unit, P-SMBP, Wyoming. Renew long-term contract for up to 100 acre-feet of irrigation water to service 17.2 acres. Contract executed July 2, 2004.
38. Kansas-Bostwick ID No. 2 (KBID); Franklin, Superior-Courtland, and Courtland Units; Bostwick Division; P-SMBP; Courtland, Kansas: The District requested a deferment of its 2004 repayment obligation. A request was prepared to amend contract No. 009D6B0120 to defer payments in accordance with the Act of September 21, 1959. Amendatory contract executed August 27, 2004.
Notice is hereby given that, on September 10, 2004, pursuant to section 6(a) of the National Cooperative Research and Production act of 1993, 15 U.S.C. 4301
Pursuant to section 6(b) of the Act, the name and principal place of business of the standards development organization is American Society for Blood and Marrow Transplantation (“ASBMT”) Arlington Heights, IL 60005-4460. The nature and scope of ASBMT's standards development activities are to develop, plan, establish, coordinate, and publish voluntary consensus standards applicable to the field of cellular therapy and blood and marrow transplantation. Specifically, ASBMT develops, plans, establishes coordinates, and publishes voluntary consensus standards in the form of: Policy statements relating to the effectiveness of transplant therapies; transplant center guidelines; physician training guidelines; and clinical practice guidelines in the form of evidence-based reviews. Through its standard development activities, ASBMT seeks to ensure the highest quality of medical practice, define commonly accepted medical practice, and develop standards of medical care as related to the field of cellular therapy and blood and marrow transplantation. ASBMT's standards development activities are ongoing in nature, and existing guidelines and policy statements may be updated and/or amended from time to time.
Notice is hereby given that, on August 24, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and CableLabs intends to file additional written notifications disclosing all changes in membership.
On August 8, 1988, CableLabs filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on April 21, 2004. A notice was published in the
Notice is hereby given that, on July 26, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and EFMA intends to file addiltional written notifications disclosing all changes in membership.
On January 16, 2002, EFMA filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on September 3, 2002. A notice was published in the
Notice is hereby given that, on August 16, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and GSA intends to file additional written notification disclosing all changes in membership.
On March 6, 2003, GSA filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on May 7, 2004. A notice was published in the
Notice is hereby given that, on August 30, 2004, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Notice is hereby given that, on September 2, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to section 6(b) of the Act, the name and principal place of business of the standards development organization is: NACE International, Houston, TX. The nature and scope of NACE's standards development activities are: to prepare consensus standards to serve as voluntary guidelines in the field of prevention and control of corrosion; to provide information to aid in reducing the economic losses resulting from corrosion; and to promote the optimal use of natural resources and materials and to prevent their wastage as a result of corrosion.
Additional information concerning NACE's standards development activities may be obtained from Linda Goldberg, Director, Technical Activities, NACE International, at (281) 228-6221.
Notice is hereby given that, on August 27, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Notice is hereby given that, on July 13, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and National Center for Manufacturing Sciences intends to file additional written notification disclosing all changes in membership.
On February 20, 1987, National Center for Manufacturing Sciences filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on April 28, 2004. A notice was published in the
Notice is hereby given that, on August 30, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Notice is hereby given that, on august 18, 2004, pursuant to section 6(a) of the National Cooperative Research and Production act of 1993, 15 U.S.C. 4301
Pursuant to section 6(b) of the Act, the name and principal place of business of the standards development organization is: Portland Cement Association, Skokie, IL. The nature and scope of Portland Cement Association's standards development activities are for the design and construction of assemblies using cement, cement-based products, and associated products.
Additional information concerning the Portland Cement Association may be obtained from Stephen Szoke, P.E., Director, Codes and Standards, Portland Cement Association, 5420 Old Orchard Road, Skokie, IL 60077.
Notice is hereby given that, on August 31, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Memberships in this group research project remains open, and PXI Systems Alliance, Inc. intends to file additional written notification disclosing all changes in membership.
On November 22, 2000, PXI Systems Alliance, Inc. filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on June 2, 2004. A notice was published in the
Notice is hereby given that, on August 18, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to section 6(b) of the Act, the name and principal place of business of the standards development organization is: Sheet Metal and Air Conditioning Contractors' National Association (SMACNA), Chantilly, VA. The nature and scope of SMACNA's standards development activities are to promulgate industry standards to the general public and to initiate, promote and document studies directed toward the solution of present and future problems in the heating, ventilation and air conditioning (HVAC) industry and all facets of the sheet metal industry.
Additional information concerning SMACNA may be obtained from Sue Baker at (703) 803-2980.
Notice is hereby given that, on September 1, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Notice is hereby given that, on September 8, 2004, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Legal Services Corporation.
Announcement of intention to make FY 2005 Competitive Grant Awards.
The Legal Services Corporation (LSC) hereby announces its intention to award grants and contracts to provide economical and effective delivery of high quality civil legal services to eligible low-income clients, beginning January 1, 2005.
All comments and recommendations must be received on or before the close of business on November 3, 2004.
Legal Services Corporation—Competitive Grants, Legal Services Corporation; 3333 K Street, NW., Third Floor; Washington, DC 20007.
Reginald Haley, Office of Program Performance, (202) 295-1545.
Pursuant to LSC's announcement of funding availability on April 16, 2004 (69 FR 20650), July 20, 2004 (69 FR 43456), and Grant Renewal applications due on August 9, 2004, LSC intends to award funds to the following organizations to provide civil legal services in the indicated service areas. Amounts are estimates and are subject to change.
These grants and contracts will be awarded under the authority conferred on LSC by the Legal Services Corporation Act, as amended (42 U.S.C. 2996e(a)(1)). Awards will be made so that each service area is served. None of the listed organizations is guaranteed an award or contract. This public notice is issued pursuant to the LSC Act (42 U.S.C. 2996f(f)), with a request for comments and recommendations concerning the potential grantees within a period of thirty (30) days from the date of publication of this notice. Grants will be distributed on or about January 1, 2005.
U.S. Institute for Environmental Conflict Resolution, Morris K. Udall Foundation.
Notice.
5 U.S.C. Appendix 2; 20 U.S.C. 5601-5609.
This notice is published in accordance with section 9(a) of the Federal Advisory Committee Act of 1972 (Public Law 92-463). The executive director of the Morris K. Udall Scholarship and Excellence in National Environmental Policy Foundation has determined that the renewal of the National ECR Advisory Committee is necessary and in the public interest in connection with the performance of duties imposed upon the U.S. Institute for Environmental Conflict Resolution (U.S. Institute) by 20 U.S.C. 5601
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.
Thursday, October 21, 2004, 1 p.m. to 3 p.m. central time.
This meeting will be conducted via teleconference; hence participation will require contacting Ms. Susan M. Burch on (202) 358-0914 before noon eastern, October 20, 2004, and providing your name, affiliation, and phone number.
Mr. Mark D. Erminger, Aerospace Safety Advisory Panel Executive Director, Code Q-1, National Aeronautics and Space Administration, Washington, DC 20546, (202) 358-0914.
The Aerospace Safety Advisory Panel will hold its Quarterly Meeting. This meeting will be open to the public up to the capability of the teleconferencing system. This discussion is pursuant to carrying out its statutory duties for which the Panel reviews, identifies, evaluates, and advises on those program activities, systems, procedures, and management activities that can contribute to program risk. Priority is given to those programs that involve the safety of human flight. The major subjects covered will be: Space Shuttle Program, International Space Station Program, and Cross-Program Areas. The Aerospace Safety Advisory Panel is composed of nine members and one ex-officio member.
Any member of the public is permitted to file a written statement with the Panel at the time of the meeting. Presentations and written comments should be limited to the subject of safety in NASA. To do so, please contact Ms. Susan Burch on (202) 358-0914 at least 24 hours in advance.
In accordance with the Federal Advisory Committee Act (Public Law 92-463, as amended), the National Science Foundation announces the following meeting:
In accordance with the Federal Advisory Committee Act (Public Law 92-463, as amended), the National Science Foundation announces the following meeting:
In accordance with the Federal Advisory Committee Act (Public law 92-463, as amended), the National Science Foundation announces the following meeting:
In accordance with Federal Advisory Committee Act (Public Law 92-463, as amended), the National Science Foundation announces the following meeting:
The U.S. Nuclear Regulatory Commission (NRC) is authorizing the University of Pittsburgh, License No. 37-00245-09, an exemption to 10 CFR 35.615(f)(3), to permit the licensee to have a qualified neurosurgeon physically present in place of an Authorized User (AU) during the use of its gamma stereotactic radiosurgery (GSR) units.
The University of Pittsburgh has a NRC license (License No. 37-00245-09) which authorizes the medical use of three GSR units. The licensee has requested, in a letter dated April 9, 2004, that NRC grant a exemption to 10 CFR 35.615(f)(3), which requires an AU and Authorized Medical Physicist (AMP) to be physically present throughout all patients treatments with a GSR unit.
The licensee has three GSR units located in the same wing of the hospital. Because of its expanding patient workload, the licensee states that there will be times when it will need to be able to perform simultaneous treatments with the GSR units. The licensee is requesting an exemption to 10 CFR 35.615(f)(3) to allow the use of a qualified neurosurgeon, instead of an AU, to be present throughout patients treatments involving the GSR units, in addition to the presence of the AMP. The AU will be immediately available to respond to an emergency at any of the units.
The exemption is needed so that University of Pittsburgh can continue to provide optimum medical treatment to its patients. The exemption would allow the University of Pittsburgh to perform simultaneous treatments with the GSR units. The exemption would allow better participation of the AU in dose treatment planning and patient set-up, without requiring the addition of a second AU. In evaluating the licensee's performance conforming to the current requirements in 10 CFR 35.615(f)(3), NRC inspections since April 2000 have not identified any violations nor medical events associated with the use of the GSR units.
The gamma stereotactic radiosurgery sources are sealed sources and no material will be released to the environment. All the sources are contained within the unit, as verified by periodic spot checks performed by the licensee. The proposed action does not increase public radiation exposure. There will be no impact on the environment as a result of the proposed action.
As required by Section 102(2)(E) of NEPA (42 USC 4322(2)(E)), a possible alternative to the final action has been considered. The alternative is to deny the exemption request, which would require the licensee to have at least two AUs and two AMPs physically present when simultaneous treatments are conducted at the licensed facility, which would significantly increase the cost of patient care. The alternative option would not produce a gain in protecting the human environment, and it would negatively impact the licensee's provision of medical care to it patients.
No alternative use of resources was considered because of the reasons stated above.
The Advisory Committee on the Medical Uses of Isotopes (ACMUI) has been consulted to evaluate this exemption request. ACMUI's recommendation has been considered in responding to the licensee's request.
Letters from the University of Pittsburgh, to NRC, Region I, dated April 9, 2004, and June 3, 2004.
Based on the above environmental assesment, the Commission has concluded that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, NRC has determined that a Finding of No Significant Impact is appropriate and preparation of an environmental impact statement is not warranted.
The licensee's letters are available for inspection, and/or copying for a fee, in the NRC Region I, Public Document Room, 475 Allendale Road, King of Prussia, PA 19406. The documents are available electronically for public inspection from the Publicly Available Records (PARS) component of NRC's Documents Access and Management System (ADAMS), accession numbers ML041190282 and ML041620397, respectively. ADAMS is accessible from the NRC Web site at:
For the Nuclear Regulatory Commissinon.
Nuclear Regulatory Commission.
Week of October 4, 2004.
Commissioner's Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
The schedule for Commission meetings is subject to change on short notice. To verify the status of meetings call (recording)—(301) 415-1292. Contact person for more information: Dave Gamberoni, (301) 415-1651.
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
This notice is distributed by mail to several hundred subscribers; if you no longer wish to receive it, or would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301-415-1969). In addition, distribution of this meeting notice over the Internet system is available. If you are interested in receiving this Commission meeting schedule electronically, please send an electronic message to
Overseas Private Investment Corporation.
Request for comments.
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to publish a Notice in the
Comments must be received within 30-calendar days of this Notice.
Copies of the subject form and the request for review submitted to OMB may be obtained from the Agency Submitting Officer. Comments on the form should be submitted to the OMB Reviewer.
Overseas Private Investment Corporation.
Notice to add new Privacy Act system of records.
The Overseas Private Investment Corporation (OPIC) is giving notice that it proposes to add a new system of records, Staff Central (OPIC-4), to its existing inventory of systems subject to the privacy Act of 1974 (5 U.S.C. 552a), as amended. This system of records incorporates and replaces OPIC-4, Employee Exit Forms, which OPIC is deleting from its inventory of systems of records. Staff Central is an electronic workflow and information tracking system employed in connection with the administration and handling of OPIC personnel. The system automates administrative tasks associated with the processing of new employees, moving personnel between offices, and processing employees through OPIC's employment exit procedures. Staff Central also transfers staff in formation to various directories and applications, and provides a central location for other OPIC systems to link to and pull information from as needed.
The new system will be effective without further notice on November 15, 2004, unless comments on or before the date cause a contrary decision.
Written comments may be addressed and mailed or hand-delivered to Christopher Astriab, Overseas Private Investment Corporation, 1100 New York Avenue, NW., Washington, DC 20527. Faxes may be sent to Christopher Astriab at (202) 842-8413. Submit electronic comments to
Christopher Astriab, Overseas Private Investment Corporation, 1100 New York Avenue, NW., Washington, DC 20527, telephone (202) 336-8633.
OPIC last published a comprehensive set of Privacy Act system notices in the
Section 552a(e)(4) and (11) of Title 5, United States Code, provides that the public be afforded a 30-day period in which to comment on this addition to OPIC's existing record systems. Additionally, a copy of this notice has been submitted to the Chair of the Committee on Government Reform and Oversight of the House of Representatives, the Chair of the Committee on Governmental Affairs of the Senate, and the Office of Management and Budget, pursuant to 5 U.S.C. 552a(r).
Staff Central, an electronic workflow and information tracking system, enables OPIC to automate the processes associated with the administration and handling of OPIC personnel. This includes such tasks as processing new employees, moving personnel between offices, and processing employees through OPIC's employment exit procedures. Staff Central also transfers staff information to various directories and applications, and provides a central location for other OPIC systems to link to and pull information from as needed. The system cross-references, indexes, and tracks a number of administrative work processes in a centralized, paper-less environment. Records maintained in Staff Central are primarily accessed by employee name. In addition, records may be accessed by reference to any information entered into the system, including address, phone number, certification in CPR, etc.
Staff Central
Sensitive But Unclassified
Overseas Private Investment Corporation, 1100 New York Avenue, NW., Washington, DC 20527.
Current and former employees of the Corporation (including personal services contractors) and industrial contractors.
(1) Security records, including records indicating level of building and network access, security badge number, and security clearance level and adjudication date; (ii) emergency contract information records, including home address, phone number and e-mail, emergency contact person information, and information on the individual's home computer operating system, home Internet access, and whether they possess first-aid or CPR certification; and (iii) employee exit process records, including signatures and date stamps reflecting whether department employees have been debriefed on the government's classified information program, the Corporation's security program, and the Corporation's records policies and procedures; have been advised if and fully understand provisions on post employment conflicts of interest; and certifying that all required clearances for release of the employee's final pay check have been obtained. Authority for maintenance of the system: General authority for agency records management is provided by 5 U.S.C. 301, Departmental Regulations, and 44 U.S.C. 3101, Records Management by Agency Heads. Additional authority to maintain security records is provided by 5 U.S.C. 3301, Examination, Selection and Placement, E.O. 10450, Clearance for Federal Employment, April 17, 1953, as amended; E.O. 12968, Access to Classified Information, August 4, 1995. Additional authority to maintain emergency contact information records is provided by Federal Preparedness Circular 65, Federal Executive Branch Continuity of Operations (COOP), July 26, 1999; E.O. 12656, Assignment of Emergency Preparedness Responsibilities, November 18, 1988, as amended; and Presidential Decision Directive 67, Enduring Constitutional Government and Continuity of Government Operations, October 21, 1998. Additional authority to maintain employee exit process records is provided by E.O. 12958, Classified National Security Information, April 17, 1995; 32 CFR 2003.20, Classified Information Non-Disclosure Agreement: SF-312; 5 CFR part 2637, Regulations Concerning Post Employment Conflicts of Interest; and Pub. L. l104-134, Debt Collection Improvement Act of 1996.
These records are used (i) as an easy-reference record to determine the suitability and/or eligibility of employees and contractors for access to facilities, information systems, and classified information; (iii) to account for and/or communicate with employees and contractors or their designees in the event of an emergency or disaster; (iii) to process existing employees and contractors when their tenure with OPIC ends; and (iv) to maintain a record of all debriefings and completed exit procedures for former employees.
Security records are used (i) by OPIC human resources and security managers to check the status, level, and date received of security clearances, and (ii) by OPIC departmental security officers to confirm that employees who require access to classified information have the appropriate level of security clearance. Emergency contact information records are used (i) by OPIC human resources and security managers to notify an employee's designee of an emergency that affects the employee or to account for an employee's whereabouts, especially in the event of a disaster; (ii) by OPIC human resources managers to communicate with an employee's designee regarding survivor benefits or other benefits or employment information in the event an employee becomes incapacitated or dies; and (iii) by OPIC security managers for emergency management or continuity of operations purposes. Employee exist process records are used by OPIC agency managers (i) to verify that all departing employees have completed the checkout process and returned government property to OPIC, (ii) to ensure the security of OPIC-related information, (iii) to ensure that employees are briefed concerning post-employment restrictions; and (iv) to certify that all required clearances for release of the employee's final pay check have been obtained.
OPIC may disclose information contained in a record in this system of records under the routine uses listed in this notice without the consent of the individual if the disclosure is compatible with the purposes for which the record was collected. Disclosures may be made:
(i) In the event that information in this system of records indicates, either on its face or in connection with other information, a violation or potential violation of any applicable statute, regulation, or order of a competent authority, OPIC may disclose the relevant records to the appropriate agency, whether Federal, State, or local, charged with the responsibility of
(ii) In a proceeding before a court or adjudicative body before which OPIC is authorized to appear when any of the following is a party to litigation or has an interest in litigation and information in this system is determined by OPIC to be arguably relevant to the litigation: OPIC; any OPIC employee in his or her official capacity, or in his or her individual capacity where the Department of Justice agrees to represent the employee; or the United States where OPIC determines that the litigation is likely to affect it.
(iii) To a court, a magistrate, administrative tribunal, or other adjudicatory body in the course of presenting evidence or argument, including disclosure to opposing counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations, or in connection with criminal law proceedings.
(iv) To a Member of Congress or staff acting upon the Member's behalf when the Member or staff requests the information on behalf of and at the written request of the individual who is the subject of the record.
(v) To another Federal agency or other public authority, in connection with the hiring or retention of an employee or other personnel action, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of a license, grant, or other benefit, to the extent that the record is relevant and necessary to the receiving entity's decision on the matter.
(vi) To the National Archives and Records Administration and to the General Services Administration in records management inspections conducted under the authority of 44 U.S.C. 2904 and 2906.
(vii) To the employees of entities with which OPIC contracts for the purposes of performing any function that requires disclosure of records in this system. Before entering into such a contract, OPIC shall require the contractor to maintain Privacy Act safeguards as required under 5 U.S.C. 552a(m) with respect to the records in the system.
None.
Records are stored electronically on OPIC's computer network or on backup media such as tape and/or CD-ROM. Copies of records may be stored in hard copy format in file folders in secure file cabinets accessible only by authorized individuals either onsite at OPIC or at approved offsite locations.
Records are retrieved by the names of the individuals covered by the system and may be searched and indexed by any field within the record.
Access to and use of each of the records in the system are limited to persons whose official duties require such access. Information contained in the system is safeguarded and protected through physical and system-based safeguards, including system access controls. Retention and disposal: Records related to post-employment conflict of interest debriefings are retained for six years following separation from employment. All other records are retained for two years following separation from employment or contractual relationship with OPIC. All records are destroyed pursuant to existing General Records Schedules and OPIC records disposition schedules.
Director of Operations, Overseas Private Investment Corporation, 1100 New York Avenue, NW., Washington, DC 20527.
Requests by individuals concerning the existence of a record may be submitted in writing, addressed to the system manager above. The request must comply with the requirements of 22 CFR 707.21(b).
Same as notification procedure.
Requests by individuals to amend their record must be submitted in writing, addressed to the system manager above. Requests for amendments to records and requests for review of a refusal to amend a record must comply with the requirements of 22 CFR 707.22.
Federal agencies conducting background investigations under agreements with OPIC or under agreements with contracting agencies with whom OPIC has a contractual relationship; individuals on whom the records are maintained; and OPIC staff involved in the employee exit process.
None.
Postal Service.
Notice of change to the Retirement Plan for Manually Set Postage Meters.
By this notice, the Postal Service
This notice is effective on October 4, 2004.
Wayne A. Wilkerson, manager of Postage Technology Management, at (703) 292-3691 or by fax at (703) 292-4073.
A notice was published in the
An exception was taken to the proposed restriction on replacing a malfunctioning manually set meter with a functional meter of the same model. The Postal Service reconsidered its proposal and removed this restriction. Replacement meters will be permitted up to February 28, 2005.
You can review the comments received by submitting a request to the office of Postage Technology Management at (703) 292-3691 or by fax at (703) 292-4073.
The final plan follows.
The Postal Service retirement date for manually set electronic meters with lease expiration dates on or after October 1, 2004, will be May 31, 2005. The Postal Service will no longer reset electronic manually set meters after February 28, 2005. Anyone in possession of a manually set meter must return it to the meter provider on or before May 31, 2005. The meter provider will withdraw the meter from service.
Any manually set electronic postage meter that is capable of remote meter setting must be either converted to remote meter setting or retired from service and returned to the meter provider. The function that allows manual setting must be disabled.
The manager of Postage Technology Management, Postal Service Headquarters, will send official notification to those affected users with an explanation of this plan. Any other explanation received by users may not accurately represent the position of the Postal Service.
Notice is hereby given that the following filing(s) has/have been made with the Commission pursuant to provisions of the Act and rules promulgated under the Act. All interested persons are referred to the application(s) and/or declaration(s) for complete statements of the proposed transaction(s) summarized below. The application(s) and/or declaration(s) and any amendment(s) is/are available for public inspection through the Commission's Branch of Public Reference.
Interested persons wishing to comment or request a hearing on the application(s) and/or declaration(s) should submit their views in writing by October 20, 2004, to the Secretary, Securities and Exchange Commission, Washington, DC 20549-0609, and serve a copy on the relevant applicant(s) and/or declarant(s) at the address(es) specified below. Proof of service (by affidavit or, in the case of an attorney at law, by certificate) should be filed with the request. Any request for hearing should identify specifically the issues of facts or law that are disputed. A person who so requests will be notified of any hearing, if ordered, and will receive a copy of any notice or order issued in the matter. After October 20, 2004, the application(s) and/or declaration(s), as filed or as amended, may be granted and/or permitted to become effective.
Allegheny Energy, Inc. (“Allegheny”), a registered holding company under the Act, 800 Cabin Hill Drive, Greensburg, Pennsylvania 15601, has filed a declaration (“Declaration”) under section 12(d) and rule 44 of the Act.
Allegheny requests authorization to sell its nine percent ownership interest in Ohio Valley Electric Corporation (“OVEC”) to Buckeye Power Generating, LLC (“Buckeye Power”), an affiliate of Buckeye Power Inc. OVEC is a public utility company under the Act.
OVEC was formed in the early 1950s by a group of holding companies and utilities located in the Ohio Valley region in response to the request of the United States Atomic Energy Commission (“AEC”) to supply the electric power and energy necessary to meet the needs of a uranium enrichment plant being built by the AEC in Pike County, Ohio. The holding companies that directly or indirectly own 10 percent or more of OVEC's stock, each of which is a registered holding company, are: Allegheny (12.5%),
OVEC owns two coal-fired generating stations: (1) The Kyger Creek Plant in Cheshire, Ohio, which has a generating capacity of 1,075 megawatts, and (2) the Clifty Creek Plant in Madison, Indiana, which has a generating capacity of 1,290 megawatts and is owned by OVEC's wholly-owned subsidiary, Indiana-Kentucky Electric Corporation. Originally, the Department of Energy (“DOE”) purchased essentially all of the generating capacity of OVEC's generating facilities. However, DOE terminated its purchase agreement on April 30, 2003, and each of the Sponsoring Companies currently is entitled to its specified share of all net power and energy produced by OVEC's two generating stations.
Buckeye Power, Inc., is a member-owned generation and transmission cooperative based in Columbus, Ohio that supplies power and energy to all the electric distribution cooperatives that serve customers in Ohio. The certified service territory of these distribution cooperatives covers nearly 40 percent of the land area in the State and encompasses 77 of Ohio's 88 counties.
On May 17, 2004, Allegheny signed a purchase agreement (“Purchase Agreement”) under which Allegheny will sell a nine percent equity interest in OVEC, and Allegheny Energy Supply Company, LLC (“AE Supply”), will assign its rights to nine percent of the power generated by OVEC, to Buckeye Power for $102 million in cash and the assumption of approximately $37 million in debt by Buckeye Power (“Purchase Price”). Of the total cash component of the Purchase Price, $7,140,000 represents the price for the transfer of Allegheny's nine percent equity interest in OVEC, the transaction for which authority is being sought in this Application. The remainder represents the price for the assignment of AE Supply's rights under the OVEC Inter-Company Power Agreement (“OVEC Power Agreement”) to nine percent of the power generated by OVEC.
Allegheny maintains that the sale and assignment of these various interests is consistent with Allegheny's strategic goals of improving its financial strength
Allegheny states that the Purchase Price and other definitive terms for the sale of OVEC reflected in the Purchase Agreement—negotiated by representatives of the parties over a number of months—are the result of arm's-length bargaining, and the Purchase Price constitutes fair and adequate consideration for the sale and assignment of Allegheny's interests in OVEC.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FICC is seeking to amend the rules of its Government Securities Division (“GSD”) to modify the penalty assessment process for violations of minimum financial standards and for failures to submit requisite financial reports on a timely basis.
In its filing with the Commission, FICC 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. FICC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
The proposed rule change would amend the rules of the GSD by modifying the penalty assessment process for violations of minimum financial standards and failure to submit requisite financial reports on a timely basis.
The rules of the GSD require netting members and clearing members to meet and maintain certain minimum financial standards at all times. While the majority of GSD members consistently satisfy their minimum financial requirements, occasionally members do breach these requirements and create undue risk for FICC and its GSD members. FICC has decided that a more uniform system of enforcing minimum financial requirements within the GSD would enhance the ability of FICC to minimize risk to itself and its members in a fair and effective manner.
Currently, the GSD Rules provide clearing fund consequences for the various categories of netting members that fall out of compliance with minimum financial requirements as follows:
Under the proposed rule change, a violation of a minimum financial requirement by a member
Certain members that are required to provide monthly or quarterly financial data to FICC at times have violated GSD's membership requirements by not timely providing such financial data. In such instances, management contacts each offending member and follows up with a letter.
Failure to timely receive required information creates risk to FICC and as a result hinders FICC's ability to appropriately assess the financial condition of such members. To encourage timely submission of required financial data, FICC has established a mechanism to fine delinquent members.
First, FICC proposes to subject delinquent members to a more stringent clearing fund requirement. Specifically, under the proposed rule filing FICC would automatically impose a margin premium equal to the greater of (1) 25 percent of the member's unadjusted clearing fund requirement or (2) $1,000,000. The margin premium would be applied until appropriate financial data is submitted to FICC and is reviewed for compliance purposes. In addition, delinquent members would be precluded from taking back any excess clearing fund collateral to which they might ordinarily be entitled.
Second, members that fail to submit requisite financial reports on a timely basis would also automatically be placed on FICC's “watch list” and subject to more frequent and thorough monitoring.
FICC believes that the proposed rule change is consistent with the requirements of Section 17A of the Act
FICC does not believe that the proposed rule change will have any impact or impose any burden on competition.
Written comments relating to the proposed rule change have not yet been solicited or received. FICC will notify the Commission of any written comments received by FICC.
Within thirty-five 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. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-FICC-2004-11. This file
For the Commission by the Division of Market Regulation, pursuant to delegated authority.
On June 25, 2004, the National Association of Securities Dealers (“NASD”) filed with the Securities and Exchange Commission (“Commission” or “SEC”) a proposed rule change, pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
NASD Rule 1120(a) currently provides, in part, that no member shall permit any registered person to continue to, and no registered person shall continue to, perform duties as a registered person, unless such person has complied with the Regulatory Element of the CE requirement set forth in this Rule.
Currently, two classes of persons are exempt from Regulatory Element requirements under NASD Rule 1120(a). The first class of persons come within the “grandfathered” exemption which applies to persons who were continuously registered, without serious disciplinary action,
However, in response to recommendations made by the Securities Industry/Regulatory Council on Continuing Education (the “Council”), NASD submitted a proposed rule change to eliminate all currently effective exemptions from required participation in Regulatory Element programs.
NASD will announce the effective date of the proposed rule change in a Notice to Members to be published no later than 60 days following Commission approval. Proposed amendments are expected to become effective (1) not more than 30 days following publication of the Notice to Members announcing Commission approval, (2) not more than 30 days following the implementation of necessary changes to Web Central Registration Depository (“Web CRD”), or (3) April 4, 2005, whichever date is latest to occur.
The Commission finds that the proposed rule change, as amended, is consistent with the requirements of section 15A of the Act,
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
On July 15, 2004, 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 proposed rule change was published for comment in the
The Commission finds that the proposed rule change is consistent with the provisions of Section 15A 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)(7) of the Securities Exchange Act of 1934 (“Act”)
NFA proposes to adopt NFA Bylaw 1508 regarding securities futures agreements. The text of the proposed rule change appears below. New language is in italics.
NFA has prepared statements concerning the purpose of, and basis for, the proposed rule change, burdens on competition, and comments received from members, participants and others. The text of these statements may be examined at the places specified in Item IV below. NFA has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Under the Act, NFA is required, as a limited purpose national securities association, to adopt and enforce SFP sales practice rules for notice-registered broker-dealers. Pursuant to CFTC Regulation 1.52(b),
NFA is, however, responsible under the Act for auditing the security futures activities of these notice-registered broker-dealers. In order to minimize the number of audits these firms are subject to, NFA Bylaw 1508 authorizes the NFA to enter into a regulatory services agreement with the futures exchanges that audit them. The bylaw also provides that NFA retains full responsibility for its obligations under the Exchange Act. If the futures exchanges do not conduct the appropriate audit steps or report potential violations to NFA, then NFA will be responsible to the Commission for those failures.
The rule change is authorized by, and consistent with Section 15A(k) of the Act.
NFA believes that the proposed rule change will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act and the CEA. In fact, NFA believes that the rule change will lessen the burdens on competition by avoiding duplicative examinations of notice-registered broker-dealers.
NFA did not publish the rule change to the membership for comment. NFA did not receive comment letters concerning the rule change.
The proposed rule change became effective on September 17, 2004. Within 60 days of the date of effectiveness of the proposed rule change, the Commission, after consultation with the CFTC, may summarily abrogate the proposed rule change and require that the proposed rule change be refiled in accordance with the provisions of Section 19(b)(1) 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. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-NFA-2004-01. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
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 PCXE Rule 7.37 (“Order Execution”), which governs the Archipelago Exchange (“ArcaEx”), an equities trading facility of PCXE, to apply the restriction on the size of an order routed outside ArcaEx only to Intermarket Trading System “ITS” Eligible Listed securities, and not to over-the-counter “OTC” securities. The text of the proposed rule change appears below. New text is in italics. Deleted text is in brackets.
Rule 7.37. (a)-(c) No change.
(d) Step 5: Routing Away.
(1)-(2)—No change.
(A)(i) The order shall be routed, either in its entirety or as component orders, to another market center or market participant as a limit order
The remaining portion of the order, if any, shall be ranked and displayed in the Arca Book in accordance with the terms of such order under Rule 7.36 and such order shall be eligible for execution under Rule 7.37.
(ii)—No change.
(B)—(E)—No change.
In its filing with the Commission, the PCX 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 PCX has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Commission recently approved a rule change to PCXE Rule 7.37 that clarified ArcaEx's execution rules related to routing to away markets.
The Exchange believes that the proposed rule change is consistent with Section 6(b)
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 purposes of the Act.
Written comments were neither solicited nor received with respect to the proposed rule change.
Because the foregoing proposed rule change does not:
(i) Significantly affect the protection of investors or the public interest;
(ii) Impose any significant burden on competition; and
(iii) Become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, it 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
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. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-PCX-2004-77. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Small Business Administration.
Notice of reporting requirements submitted for OMB review.
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before November 3, 2004. If you intend to comment but cannot prepare comments promptly, please advise the OMB Reviewer and the Agency Clearance Officer before the deadline.
Address all comments concerning this notice to:
Jacqueline White, Agency Clearance Officer, (202) 205-7044.
The U.S. Small Business Administration Region II Advisory Council located in the geographical area of Buffalo, New York, will hold a public meeting at 10 a.m. eastern time on Wednesday, October 20, 2004, at the Buffalo Club, 388 Delaware Avenue, Buffalo, New York, to discuss such matters that may be presented by members, and staff of the U.S. Small Business Administration, or others present. Anyone wishing to make an oral presentation to the Board must contact Franklin J. Sciortino, District Director, in writing by letter or fax no later than Friday, October 15, 2004, in order to be put on the agenda. Franklin J. Sciortino, District Director, U.S. Small Business Administration, 1311 Federal Building, 111 West Hurton Street, Buffalo, NY 14202. Telephone (716) 551-4301 or Fax (716) 551-4418.
U.S. Small Business Administration (SBA).
Notice of proposed change in procedures; notice of extension of comment period.
SBA published a Notice of a proposed change in procedures on August 6, 2004 seeking comments on its proposed revisions to its procedures implementing the National Environmental Policy Act (NEPA) specifically relating to loans made
The comment period for the Notice of proposed change in procedures published August 6, 2004 (69 FR 47971) is extended through December 15, 2004.
You may submit comments, identified by a reference to “NEPA Procedures Public Comments,” by any of the following methods: Through the Federal eRulemaking portal at
Eric S. Benderson, Associate General Counsel (202) 205-6636;
The Social Security Administration (SSA) publishes a list of information collection packages that will require clearance by the Office of Management and Budget (OMB) in compliance with Pub. L. 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. The information collection packages that may be included in this Notice are for revisions to OMB-approved information collections and extensions (no change) of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and on ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Written comments and recommendations regarding the information collection(s) should be submitted to the OMB Desk Officer and the SSA Reports Clearance Officer. The information can be mailed and/or faxed to the individuals at the addresses and fax numbers listed below:
(OMB), Office of Management and Budget, Attn: Desk Officer for SSA, New Executive Building, Room 10235, 725 17th St., NW., Washington, DC 20503, Fax: 202-395-6974.
(SSA), Social Security Administration, DCFAM, Attn: Reports Clearance Officer, 1338 Annex Building, 6401 Security Blvd., Baltimore, MD 21235, Fax: 410-965-6400.
I. The information collections listed below are pending at SSA and will be submitted to OMB within 60 days from the date of this notice. Therefore, your comments should be submitted to SSA within 60 days from the date of this publication. You can obtain copies of the collection instruments by calling the SSA Reports Clearance Officer at 410-965-0454 or by writing to the address listed above.
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Section 205(r) of the Social Security Act requires SSA to contract with the States to obtain death certificate information in order to compare it to SSA's payment files. This match ensures the accuracy of our payment files by detecting unreported or inaccurate deaths of beneficiaries.
Entitlement to retirement, disability, wife's, husband's or parent's benefits under the provisions of the Social Security Act terminates when the beneficiary dies. About 2.5 million people die in the United States each year. Approximately 2.0 million are SSA beneficiaries. Therefore, the information is instrumental in maintaining payment integrity.
SSA is seeking clearance of both the current state death match reporting process and the new Web-based Electronic Death Registration (EDR) process described below:
The first participants in the death registration process, usually funeral directors, are charged by State law to complete the demographic information on the decedent and obtain necessary physicians' signatures to complete the death registration. Once the death registration information is completed, the first participant sends the information to the State's bureaus of vital statistics (SBVS). The SBVS officially registers the death and is the official keeper of the death record. Each State then furnishes this information to SSA, using current technology including Vital Information Systems Network (VISN), electronic Vital Information Systems Network (eVISN), and ConnectDirect. Under this process SSA must independently verify the State death data before taking a termination action. The respondents are the SBVS.
The States are now updating and further automating the death registration processes. This State reengineering effort is widely known as the Electronic Death Registration (EDR) initiative. The EDR system permits electronic transfer of the death certificate. Under EDR the first participant completes a portion and electronically sends the document to the next participant for completion and submission to the BVS.
An additional feature of EDR is the Online Verification System (OVS) developed by the National Association for Public Health Statistics and Information System (NAPHSIS) in conjunction with SSA. The process allows the first participants in the death registration process to enter the decedent's demographic information including the social security number (SSN) into the EDR system. The system will verify the SSN online in real time and creates an electronic death certificate as well as a fact of death report. The States have agreed that the on-line verification of the SSN at the first point of collection in the registration process will satisfy the requirement to independently verify the SSN.
EDR reduces the processing time needed to register deaths and greatly improves the business practices of the various participants in death registration process. EDR will result in the State's ability to send SSA the report with a verified SSN within 5 days of the date of death and within 24 hours of receipt in the State repository. SSA is using a phased-in approach to EDR. When fully implemented, SSA will save significant program dollars and work years annually. The respondents are the SBVS.
Your comments on the information collection would be most useful if received by OMB and SSA within 30 days from the date of this publication. You can obtain a copy of the OMB clearance package by calling the SSA Reports Clearance Officer at 410-965-0454, or by writing to the address listed above.
Section 251 of the Foster Care Independence Act of 1999, Pub. L. 106-169, added Title VIII (Special Benefits for Certain World War II veterans) to the Social Security Act. Title VIII allows for the payments of monthly benefits to qualified World War II veterans who reside outside the United States. When an overpayment in SVB occurs, the beneficiary can request a waiver of recovery of the overpayment or a change in the overpayment rate.
Form SSA-2032-BK will be used by SSA to obtain the information necessary to determine whether the provisions of the Act regarding waiver of recovery of the overpayment are met. The information on the form is needed to determine a repayment rate if repayment cannot be waived. The information will be collected by personnel in SSA field offices, U.S. Embassies or consulates, or the Veterans Affairs Regional Office in the Philippines. Respondents to the SSA-2032 are beneficiaries who have overpayments on their Title VIII record and wish to file a claim for waiver of recovery or change in repayment rate.
Department of State, Office of International Energy and Commodities Policy.
Notice.
The proposed action is to issue a Presidential Permit to Express Pipeline LLC (“Express”) to authorize it to construct, connect, operate and maintain six new pump stations for an existing 24-inch outer diameter pipeline to convey crude petroleum from Hardisty, Alberta in Canada, to Casper, Wyoming. The Department of State (the “Department”) issued a Presidential Permit on August 30, 1996 to construct, connect, operate, and maintain the 24-inch-diameter buried steel pipeline that is currently capable of transporting 172,000 bpd of petroleum from Hardisty, Alberta, Canada to Casper, Wyoming. On behalf of Express, Westech Environmental Services of Helena, Montana, prepared a draft environmental assessment (“EA”) for the proposed action under the guidance and supervision of the Department. The Department placed a notice in the
Numerous Federal and State agencies independently reviewed the Express Permit application and the draft environmental assessment. They include: the Environmental Protection Agency, the Department of Transportation, the Department of the Interior, the U.S. Fish and Wildlife Service, the U.S. Department of Homeland Security, the Department of Defense, the Department of Commerce and the Department of Energy.
Comments received from the Federal and State agencies were either responded to directly, or addressed directly by incorporation into the analysis contained in the draft environmental assessment. In addition to inclusion in the analyses of impacts and risks, Federal and State agency comments were used to develop measures to be undertaken by Express to prevent or mitigate potentially adverse environmental impacts, which were included as commitments by Express and its operator Terasen Pipelines, Inc., in the EA and are to be included in the permit to be issued.
The summary environmental assessment, comments submitted by the Federal and State agencies, responses to those comments, and the draft environmental assessment, as amended, together constitute the Final Environmental Assessment of the proposed action.
The Express Pipeline is a 24-inch-diameter buried steel pipeline currently capable of transporting approximately 172,000 bpd of petroleum from Hardisty, Alberta, Canada to Casper, Wyoming. The U.S. portion of the Express Pipeline was authorized by a Presidential Permit issued by the Department on August 30, 1996 which permitted the operation of five pump stations, several mainline valves and other pipeline related facilities on the basis of an environmental impact statement that is an annex to this environmental assessment. The Express Pipeline was constructed in the fall and winter of 1996-1997, and became operational in early 1997.
The 1996 Presidential Permit was issued to Express Pipeline partnership, a Delaware partnership. On August 1, 2001, Express Pipeline partnership filed a certificate of conversion to a limited liability company with the Delaware Secretary of State, thereby automatically converting to a domestic limited liability company, Express Pipeline LLC. On January 9, 2003, Encana Corporation of British Columbia sold Express Pipeline LLC to a consortium comprised of Terasen, Inc., of British Columbia, the Ontario Municipal Employees Retirement System and the Ontario Teachers Pension Plan Board, each holding an equal one-third interest. Terasen Pipelines (USA) Inc., (“Terasen”) operates and maintains the existing system on behalf of Express Pipeline LLC.
Express Pipeline LLC (“Express”) owns the portion of the Express Pipeline system from the Canada/U.S. border to Casper, Wyoming. Express is now applying for a Presidential Permit from the U.S. Department of State to construct, operate and maintain six additional pump stations on the Express Pipeline in Montana and Wyoming and to transfer the existing Presidential Permit from Express Pipeline partnership to Express (the “Proposed Action”). This expansion of the capacity of the Express Pipeline in the United States would enable Express to respond to the market demand of Rocky Mountain and Midwest refiners for
Subsequent engineering and operational analysis demonstrated that, in conjunction with the Proposed Action, two new 150,000 barrel storage tanks would be needed at the existing Casper Station Tank Farm located in Casper, Wyoming to accommodate the additional volumes of petroleum. The Casper Station Tank Farm is owned by Platte Pipe Line Company (“Platte”), an affiliate of Express. Because, according to Express, these storage tanks would be located beyond the terminus of the Express Pipeline system (
The Express Pipeline was constructed to meet the requirements of refiners in the U.S., particularly in the Rocky Mountain and Midwest regions, by providing new sources of Canadian petroleum to numerous markets including Montana, Wyoming, Utah, Colorado, Kansas and Illinois. The Express Pipeline system is consistently operating at or near its maximum capacity in its current configuration. Market demand for additional Canadian petroleum supplies continues to grow. The Express Pipeline cannot meet the increased demand in its current configuration. The construction of additional pump stations along the existing, permitted Express Pipeline right-of-way (“ROW”), along with construction of two new storage tanks at the Casper Station Tank Farm, would result in the expansion of capacity necessary to enable Express Pipeline to transport additional petroleum to these markets. Without greater supply diversity and reliability of access to additional supply, the potential that the consumer will enjoy the availability of more competitively priced refined products could be substantially reduced and the refiners' ability to comply with more rigorous refined product specifications could be hindered.
The increased demand for Canadian petroleum was anticipated at the time the Express Pipeline was originally proposed in 1993. The entire Express Pipeline system from Hardisty, Alberta to Casper, Wyoming was originally designed for an ultimate capacity of approximately 280,000 barrels per day (“bpd”), depending on the characteristics of the petroleum being transported. Accordingly, the original design of the Express Pipeline system called for 11 pump stations to be located in the United States.
Although the Express Pipeline system was designed for an ultimate capacity of approximately 280,000 bpd, it was originally constructed to transport approximately 172,000 bpd, in response to the anticipated market demand in 1996. Consequently, only five of the 11 pump stations planned for location in the U.S. were needed when the pipeline was constructed.
Mainline valves were installed at the locations of the six remaining pump stations in order to allow the future addition of the remaining pump stations without requiring substantial alteration or reconstruction of the pipeline itself.
To maintain the hydraulic efficiency of the pipeline system as currently designed, the remaining six pump stations in the U.S. would need to be placed at the locations originally planned. Three of the six new pump stations will be located on public land administered by the U.S. Department of the Interior, Bureau of Land Management (“BLM”). The BLM evaluated the environmental consequences of constructing and operating pipeline facilities in the Express Crude Oil Draft Environmental Impact Statement. Since environmental conditions at the three BLM-administered sites have not materially changed from those reflected in the DEIS, BLM issued a “Notice to Proceed” with construction of these pump stations on October 14, 2003.
The three pump stations on non-federal land would all be constructed within the certified 500-foot-wide Express Pipeline corridor. Express owns or has obtained easements on the land at these three proposed pump stations. The general discussion of impacts and mitigation measures for the pump stations on non-federal land set forth below would also be relevant to the pump stations on Federal land.
Three action alternatives were considered but eliminated from further analysis for the reasons discussed below.
“Looping” allows an existing pipeline system to expand its capacity by constructing a second, generally parallel pipeline alongside the existing pipeline. Looping is utilized when the existing pipeline does not have the potential capacity to transport additional petroleum. The two pipelines could be located in the same ROW, although they would be offset far enough so that construction activities on the second pipeline would not disturb the existing pipeline. The two pipelines may share certain facilities, such as an operations center.
Looping is a major construction activity that has the potential for environmental impacts equal to those encountered during construction of the original pipeline. For example, if the Express Pipeline was looped only along the U.S. portion of the pipeline, approximately 515 miles of new pipeline along with pump stations, mainline valves and other facilities would have to be constructed. The pipeline would have to cross 137 named perennial, intermittent or ephemeral rivers and streams, as well as 354 named or unnamed drainages, irrigations canals or ditches. There could be potential impacts to land use activities along the pipeline, to wildlife and fisheries habitat (including endangered or threatened species), to soils and cultural resources, as well as socioeconomic burdens on the existing infrastructure, such as temporary housing and road systems. Looping would require a minimum of two years to design the new pipeline and facilities, conduct a thorough environmental impact analysis, obtain construction easements and other permits, acquire the pipe and other materials, hire pipeline contractors, construct the pipeline and rehabilitate disturbed areas after construction.
In the case of the Express Pipeline, looping would not be necessary because the Express Pipeline system was conceived and designed for an ultimate capacity of approximately 280,000 bpd, assuming 18 pump stations in Canada and the U.S. In other words, the Express Pipeline system could be expanded simply by adding nine pump stations (three in Canada and six in the U.S.) at sites where mainline valves were placed
The Express Pipeline system transports petroleum from Hardisty, Alberta, Canada to Casper, Wyoming, crossing the Canada/U.S. border near the Port of Wild Horse. As part of the pre-construction environmental impact analysis for the Express Pipeline, the Express Crude Oil Draft Environmental Impact Statement evaluated three alternative points of entry into the U.S.: one located approximately 120 miles west of Wild Horse, and the other two located approximately 65 and 120 miles east of Wild Horse respectively. The Express Crude Oil Draft Environmental Impact Statement concluded that these alternative routes would add additional length and cost to the Express Pipeline system without providing any environmental or engineering benefits.
These same three entry points are still potentially available for an alternative pipeline route. However, use of any of these entry points would require construction of a new pipeline on the Canada portion of the Express Pipeline system as well as a new pipeline on the U.S. portion (in effect, construction of an entirely new Express Pipeline system). Any such pipeline system would be longer than the existing pipeline, would require substantial engineering and environmental study and design in both Canada and the U.S. that would delay construction of the project for several years, and (as stated in the Express Crude Oil Draft Environmental Impact Statement) would not provide any environmental or engineering benefits on the U.S. portion of the project. In addition, as discussed previously, a new pipeline would not be necessary to obtain the additional petroleum supplies for U.S. refiners, since the existing Express Pipeline system could provide those supplies by the simple addition of nine pump stations (three in Canada and six in the U.S.). Therefore, a new pipeline on an alternative route was also eliminated as an alternative from further analysis.
The original Express Pipeline was designed for an ultimate capacity of approximately 280,000 bpd, which would require a total of 18 pump stations in Canada and the U.S. The location of each of the 18 pump stations was selected when the Express Pipeline was originally designed to minimize environmental impact and maximize both the capacity and efficiency of the system. To achieve the initial capacity of approximately 172,000 bpd, nine of the 18 pump stations were constructed in 1996, four pump stations in Canada and five pump stations in the United States. To maintain the hydraulic efficiency of the pipeline system as it was originally designed, the remaining nine pump stations (three in Canada, six in the U.S.) must be placed at the intervals as originally planned.
The proposed pump station sites addressed in the Proposed Action were selected not only for their hydraulic efficiency but to minimize environmental impacts. The pump stations locations were deliberately selected to avoid impacts to the following land uses:
Because of the placement of the existing pump stations, any change in the locations of the proposed pump stations would interfere with the hydraulics and performance of the entire pipeline system. Changing the locations of the proposed pump stations would not provide any engineering or environmental benefits. Consequently, use of alternative pump station locations were eliminated as an alternative from further analysis.
In sum, there do not appear to be any alternatives other than the Proposed Action and a No Action alternative. The design of the pump stations as described in the Proposed Action represents the most efficient use of the available site lands and minimizes environmental impacts associated with construction, operation and maintenance of the pump stations. Other alternatives that would increase pipeline capacity are less desirable from an environmental standpoint. Putting the six pump stations at new locations would entail much more invasive construction than that required at the locations already identified and moving the pipeline would be even more environmentally disruptive. Accordingly, there are no other alternatives that would meet the requirements of the Proposed Action and therefore this EA considers only the Proposed Action and a No Action alternative.
The physical design of the pump station facilities would be similar to the originally constructed stations, although the footprint of the new pump stations would be smaller than that of the
The stations would be constructed adjacent to existing mainline valves, in fenced and graveled station yards. Electrical supply lines and substations would provide the power required for the pump stations and would be permitted, constructed and maintained by local electrical utility companies.
Each pump station would have two 5,000 horsepower electric motor-driven pumps located above ground on concrete pads, and coated at the factory with protective paint to prevent corrosion. Each pump would have a pump seal. Additional equipment at each station would include piping, a double-walled sump tank, electrical controls, process instrumentation, data collection and communication equipment. An electrical building would be constructed at each pump station to house electrical equipment including switchgear, motor controls and Supervisory Control and Data Acquisition (“SCADA”) equipment. Each of the proposed pump stations would be equipped with a SCADA system to control and monitor the station. A satellite dish would be installed to maintain the communication link with the Edmonton Control Center. Collected data would be relayed to the Control Center in Edmonton, Alberta where Control Center Operators monitor the status of the stations and pipeline. The Edmonton Control Center is a 24-hour staffed facility, and has full control of all the station equipment including the capability to start and stop station pumps, and close and open station valves.
Express and Terasen have agreed to test each pump station hydrostatically to ensure system integrity prior to operation. The pump stations would be maintained and operated in accordance with the standards set forth in the General Operations Management Plan that are applicable to the existing stations. All manuals, including the Express/Platte Emergency Response Plan (“ERP”) required by the U.S. Department of Transportation (“U.S. DOT”), would be updated to reflect the addition of these proposed stations.
In addition, the storage tanks would be constructed at the Casper Station Tank Farm. Other possible locations outside the Casper Tank Farm boundary would reduce the efficiency of the transfer of petroleum from the Express Pipeline system to the Platte Pipeline system because it would lengthen the distance to the refineries as well as increase costs and opportunities for system failure. In addition, locating the storage tanks within the Casper Tank Farm, which has been disturbed by past and on-going activities with the existing tanks, would minimize potential environmental impacts from construction and operation of the tanks while allowing quick response from Terasen personnel and equipment in the event of an emergency.
The project facilities would consist of two 150,000-barrel storage tanks, leak detection system, spill-containment dikes, impervious liners, piping, control valves, manifold piping and site lighting. Electrical service would be provided by an extension from the distribution center in Platte's station yard, or from an adjacent transmission line. Other facilities such as an access road, control and quality assurance buildings and satellite dish are already in place in the Casper Station Tank Farm. A secure 6-foot chain link fence surrounds the entire complex.
Like the pump stations, Express and Terasen have agreed to hydrostatically test the storage tank facilities prior to operation to ensure system integrity. According to Express and Terasen, the new storage tanks would be operated in accordance with appropriate manuals and procedures for the Casper Station Tank Farm. Further they state that all manuals, including the Express/Platte ERP required by the U.S. DOT, would be updated to reflect the addition of these additional storage tanks.
The No Action Alternative would mean that the additional pump stations and storage tanks would not be constructed. There would be no additional environmental impacts under the No Action alternative. However, there would be no beneficial economic effects because the pipeline capacity would remain unchanged.
Construction and normal operation of the Proposed Action would have beneficial economic impacts. Temporary socioeconomic benefits would flow to the local economy during the construction period and would result in a temporary increase in local personal income. Local motels, restaurants, retail outlets and recreation providers would be the primary recipients of these benefits.
Over the long-term, the state of Montana and respective counties would receive additional tax benefits as a result of the ad valorem tax that would be assessed on the three proposed stations on private land. It is estimated that the ad valorem tax would be approximately $225,000 per station per year.
The construction of the proposed pump stations would increase the throughput capacity of the Express Pipeline, increasing the pipeline's ability to deliver high quality Canadian petroleum to refiners in PADD II and PADD IV including Montana, Wyoming, Utah, Colorado, Kansas and Illinois. This would enable these refiners to access additional quantities of specialized petroleum, enhancing their ability to meet increasingly stringent refined product quality requirements. The Proposed Action would also provide the refiners access to an increased number of potential suppliers, and potentially longer-term supply sources at tolls that would be competitive with alternative routes.
Based on the draft environmental assessment prepared by Westech Environmental Services on behalf of Express, normal operation of the Proposed Action would have no significant adverse impacts on climate, air quality noise, geology, wetlands and riparian areas, navigable waters, floodplains, plant species of special concern/sensitive communities, noxious weeds, threatened or endangered species, land use, transportation, socioeconomics, population and housing, recreation, and cultural and paleontological resources. This document lays out the minimal impacts that have been identified in the environmental assessment.
• During construction, drainage control structures (ditches, ponds, sediment fence) would be designed, built and maintained to transport surface runoff from the affected area but prevent discharge to drainages or areas outside the 5.74-acre site.
• A detailed hydrostatic test plan would be prepared before mechanical construction of the pump stations would begin.
• Any necessary permits or approvals would be obtained prior to hydrostatic testing.
• During construction, drainage control structures (ditches, ponds, sediment fence) would be designed, built and maintained to transport surface runoff off the affected area but to prevent discharge to drainages or areas outside the 5.74-acre site.
• With the potential exception of the proposed Faulkners Coulee pump station, salvaged topsoil would be spread to blend with the landforms on undisturbed portions of the site.
• At the proposed Faulkners Coulee pump station, it may be necessary to retain a small topsoil stockpile for the life of the project, due to the active cultivation of portions of the site that would make it difficult to maintain (and eventually salvage) a uniform soil depth. Unless otherwise requested by the landowner, the topsoil would be seeded in the first appropriate season with “Sodar” streambank wheatgrass.
• After construction is completed, temporary workspace and other portions of the affected area where long-term disturbance is not required would be rehabilitated using the topsoil spreading and revegetation mixtures recommended in the applicable discussion for each pump station in the EA.
• Ultimate reclamation of the three pump stations would be addressed in the abandonment plan.
• Noxious weeds at each station would be monitored and controlled.
• Implement the surface runoff control mitigation measures recommended above to reduce the potential for surface runoff and sedimentation to reach drainages.
• Any transmission line poles erected on the site would provide raptor protection in accordance with Suggested Practices for Raptor Protection on Power Lines: the State of the Art in 1996 (APLIC 1996).
• Facilities would be painted similar to the paint scheme used at the existing pump stations.
• As soon as practicable after construction, temporary workspace that is not needed for the life of the project would be revegetated.
The potential for a petroleum release during normal operations would be driven by the age of the pipeline rather than its operating capacity. The Express Crude Oil Draft Environmental Impact Statement presented a risk analysis for petroleum release in or near riverbeds, based on pipeline industry statistics. That analysis concluded that, over a potential 25-year life of the project, two releases of 50 barrels or less and one release of over 50 barrels could statistically occur. If the life of the project were extended an additional 25 years (
The statistical potential for a major release (
For example, a 15-minute recognition and shut down time of a major rupture of the Express Pipeline at 280,000 bpd (release volumes were calculated in accordance with 49 CFR 194.105(b)(1)), would result in a
In comparison,
Terasen has an Integrity Management Program, developed as a result of the requirements of 49 CFR 195.452. When constructed, the Express Pipeline employed “state-of-the-art” technology, including the most recent SCADA and leak detection systems.
The sensitivity of leak detection is a function of the uncertainty in the flow rate of fluid entering and delivered from the pipeline system, and the uncertainty in the line pack within the pipeline. These uncertainties are dependent on a number of parameters including instrumentation accuracy and repeatability, fluid properties and SCADA system characteristics. The proposed Action would not fundamentally change the type or level of instrumentation, the fluids being transported or the SCADA system. Therefore the leak detection system would continue to operate at the same sensitivity, as a percentage of flow rate, at the ultimate capacity of approximately 280,000 bpd as it does at the current rate of 172,000 bpd.
Upon regulatory approval of the Proposed Action, as required by the U.S. DOT, Terasen would update the Express/Platte ERP to consider the worst-case scenario based on the throughput under the Proposed Action. Although the worst-case scenario would not likely represent a “real world” occurrence, Terasen's response planning is based on this scenario. For example, additional manpower and spill response equipment might be needed as a result of these calculations; if so, Terasen would obtain these resources through local contractors and the Montana-Wyoming Spill Cooperative.
As discussed in the Express Crude Oil Draft Environmental Impact Statement, in the event of a release anywhere on the Express Pipeline, the magnitude and duration of environmental damage would be influenced by a number of factors. The kind, magnitude and duration of these effects would not be expected to materially change under the Proposed Action, although the released volume could be greater in some locations and smaller in others.
The U.S. Department of Transportation (“DOT”) regulates all aspects of pipeline design, construction, operations, maintenance and emergency and spill response. Pipeline safety regulations are designed to protect the public, environmentally sensitive areas, cultural resources and economic resources. Emergency and spill response planning regulations require the identification of environmentally important areas, and require that operators have response capabilities in place to minimize a pipeline release and the impact of such a release on the environment, the public and other resources.
In the event of a release, the Federal regulatory programs define the notification requirements and required response actions. These programs include: The National Oil and Hazardous Substances Pollution Contingency Plan (NCP: 40 CFR part 300); the Clean Water Act; the Oil Pollution Act; and the Superfund Amendment and Reauthorization Act. U.S. DOT NEPA regulations allow for coordinated implementation of these federal requirements. The U.S. DOT requires Terasen to develop, maintain and update an approved ERP. The ERP defines notification and initiation of response actions in a timeframe and on a scale appropriate to the extent of the release. The ERP establishes a required endpoint for response actions, that being the mitigation of any unacceptable threat to human health or the environment. The ERP includes a mechanism for providing compensation for short- or long-term damages to any natural resources and for restoration costs. The cumulative result of these regulatory constraints is that the adverse impacts of a release will be temporary and that baseline conditions will be restored.
In summary, although the throughput of the Express Pipeline system would be greater under the Proposed Action than under the currently certificated capacity, the kind, magnitude, duration and result of environmental impacts are not expected to be significant under the Proposed Action because:
(1) The range of these impacts was identified and discussed in the Express Crude Oil Draft Environmental Impact Statement and would not be expected to change as a result of the Proposed Action;
(2) The Express Pipeline was designed and constructed to operate at the volumes contemplated by the Proposed Action, and can safely accommodate these volumes;
(3) The petroleum release detection system currently in place on the Express Pipeline would continue to work at the same efficiency as at the current certificated volume, and continues to be “state-of-the-art” technology; and
(4) Procedures for design, construction, operation and maintenance of the Express and Platte Pipeline systems are covered by a variety of Federal regulations under the oversight of the U.S.DOT. The ERP required by the U.S. DOT mandates the mechanisms of Terasen's response to a petroleum release and would be updated to reflect the pipeline capacities under the Proposed Action.
Accidental release of petroleum at any of the proposed pump stations would not affect most environmental disciplines. The disciplines most likely to be affected would be surface water, groundwater, wildlife and fish. The following measures are proposed to minimize the potential impacts as a result of a petroleum spill:
• Sump tanks will be constructed to incorporate a double wall with integrity monitoring instrumentation, to enable Terasen to know of any leak in either sump tank wall.
• In accordance with U.S. DOT requirements, Terasen has developed an ERP that is updated as necessary. In accordance with the ERP, sufficient petroleum spill response equipment and other resources, such as contractors and equipment, are provided to respond to any emergency along the Express pipeline within a specified timeframe. Therefore response times in the event of major petroleum spill at any of the
• In the event of a petroleum release, Terasen is committed to remediating impacted areas so that vegetation can be reestablished. Implementing the ERP and reestablishing vegetation will remediate impacts to surface water, groundwater, fish and wildlife.
As noted above, implementation of the Proposed Action would require the construction and normal operation of the two storage tanks at the Casper Station Tank Farm. Construction and operation of the storage tanks would contribute to the local and State (Wyoming) economic benefits described above.
Based on the draft environmental assessment prepared by Westech Environmental Services on behalf of Express, construction and normal operation of the storage tanks would have no significant adverse environmental impacts on climate, air quality noise, geology, wetlands and riparian areas, navigable waters, floodplains, plant species of special concern/sensitive communities, noxious weeds, threatened or endangered species, land use, transportation, socioeconomics, population and housing, recreation, and cultural and paleontological resources, given that they are additions to an existing tank farm.
Construction and operation of the storage tanks could affect surface water as a result of runoff and sedimentation during construction or hydrostatic testing. Express and Terasen have agreed to undertake the following measures to mitigate impacts to surface water from the two storage tanks:
• During construction, drainage control structures (ditches, ponds, sediment fence) would be designed, built and maintained to transport surface runoff from the affected area but prevent discharge to drainages or areas outside the Casper Station Tank Farm.
• Terasen would prepare a detailed hydrostatic test plan before mechanical construction of the storage tanks and piping would begin.
• Terasen would obtain any necessary permits or approvals prior to hydrostatic testing.
Groundwater at the Casper Station Tank Farm consists of shallow, fractured aquifers that could be affected by construction of the proposed storage tanks. Express and Terasen have agreed to undertake the following measures to mitigate impacts to groundwater at the storage tank site:
• An impervious liner would be installed beneath the storage tanks and berm.
• A leak detection system would be installed below the tanks.
There could be impacts to soil resources at the Casper Station Tank Farm as a result of salvage and storage, clearing and grading, compaction, and wind or water erosion. Express and Terasen have agreed to undertake the following measures to mitigate any such impacts to upland soil resources:
• During construction, drainage control structures (ditches, ponds, sediment fence) would be designed, built and maintained to transport surface runoff off the affected area but to prevent discharge outside the Casper Station Tank Farm.
• After construction, any remaining subsoil would be spread onto the 2-4 acres used for temporary workspace, and the salvaged topsoil would be placed over the subsoil. The topsoil would be seeded with “Ephraim” crested wheatgrass (
• Ultimate reclamation of the proposed storage tank site would be addressed in the abandonment plan to be submitted to the DOT Office of Pipeline Safety at least one year prior to abandonment.
Because soils would be disturbed, there could be impacts to upland vegetation as a result of construction and normal operation of the storage tanks. Express and Terasen have agreed to undertake the following measures to mitigate impacts to vegetation resources:
• After construction is completed, temporary workspace and other portions of the affected area where long-term disturbance is not required would be rehabilitated using the topsoil spreading and revegetation mixtures recommended above.
• Ultimate reclamation of the site would be addressed in the abandonment plan.
• Noxious weeds would be monitored and controlled.
Similarly, there could be impacts from construction and operation of the storage tanks to wildlife and fisheries. Express and Terasen have agreed to undertake the following measures to mitigate these impacts:
• Terasen would implement the surface runoff control mitigation measures recommended above to reduce the potential for surface runoff and sedimentation to reach drainages.
• Wildlife habitat would be considered in the abandonment plan.
• Terasen would prepare a detailed hydrostatic test plan before mechanical construction of the storage tanks and piping would begin.
• Terasen would obtain any necessary permits or approvals prior to hydrostatic testing.
Because the storage tanks would be constructed in the existing Casper Station Tank Farm, they would not detract from the visual impression of the site or surrounding area. However, Express and Terasen have agreed to undertake the following measures to minimize impacts to visual resources from the two storage tanks:
• Facilities would be painted similar to the paint scheme used at the existing Casper Station Tank Farm.
• As soon as practicable after construction, temporary work space that is not needed for the life of the project would be revegetated.
If no action were taken, there would be no environmental impacts from the Proposed Action or associated facilities. Any environmental impacts currently occurring at these sites would continue to occur.
Under the No Action Alternative, economic benefits to the U.S. from additional petroleum supplies via the Express Pipeline would not be realized. Economic benefits to the States of Montana and Wyoming from additional taxes, and construction and operation benefits to local power providers and communities, would not materialize.
If the Express Pipeline were not expanded, three potential scenarios would be reasonably foreseeable:
(1) Existing pipelines other than Express would expand by looping or building entirely new pipelines;
(2) Some smaller refineries could be forced to reduce throughput or close if they were unable to access specialized petroleum and maintain the quality of their petroleum via transportation on a batch pipeline system such as Express; and
(3) A refined products pipeline could be built that would serve the Rocky Mountain region thereby causing the closure of smaller refineries because of competing lower-priced refined products from larger refineries.
Under the first scenario, the market responses to the Express Pipeline's inability to deliver additional petroleum
Under the second scenario, one or more Rocky Mountain refineries could close. These refineries are currently evaluating their ability to comply with new environmental requirements. To comply they must either invest in facility upgrades or obtain a source of higher quality petroleum that enables them to comply without major capital investment. The Proposed Action would expand access to a wide variety of high quality petroleum supply that complies with the new environmental objectives. The Express Pipeline also transports petroleum on a batched basis, which meets the smaller refiners' need for specialized petroleum. It is possible that one or more of these refineries could close under the No Action alternative.
Under the third scenario, an entirely new refined product pipeline could be constructed from Canada to the United States. The construction of an entirely new pipeline would likely result in more extensive environmental impacts than the installation of additional pump stations on the existing Express Pipeline. The specific impacts would be speculative and would have to be identified and evaluated during the regulatory process for these other projects.
Cumulative effects are the impacts on the environment that result from an incremental impact of the Proposed Action when added to other past, present and reasonably foreseeable actions. Examples of such actions would include the past construction and operation of the Express Pipeline; other pipelines proposed for construction near the Express Pipeline; upgrades of existing highways in the vicinity of the proposed pump stations; and construction or upgrades of transmission lines in the vicinity of the proposed pump stations.
The Express Pipeline was constructed in 1996 and has been in operation since 1997. The Express Pipeline has provided positive economic benefits to local communities, local power providers, the States of Montana and Wyoming through ad valorem taxes, and improved petroleum supply to Montana refiners. Environmental impacts from construction of the pipeline have been largely mitigated, and there have been no major operational problems with the pipeline.
No other petroleum pipelines are known to be proposed for construction in the vicinity of the Express Pipeline. No substantial upgrades (
There are no known proposals to construct or upgrade electric transmission lines in the vicinity of the proposed pump stations, except for the transmission lines that would directly supply the proposed pump stations. It is assumed that environmental impacts of any transmission line projects would be addressed by separate analysis documents. If it assumed that the transmission lines that would supply electrical power to the proposed pump stations were constructed in the same time frame as the proposed pump stations, there could be increased short-term socioeconomic benefits to the States of Montana and Wyoming, as well as counties and local communities, but there could also be shortages of temporary housing for construction workers, depending on the number of workers employed for transmission line construction, and the season of construction.
Construction of the Proposed Action would result in some short-term direct and indirect unavoidable impacts. Temporary impacts to wildlife and visual resources during construction could not be avoided. Soil and vegetation would be removed, and agricultural productivity would be lost, on a maximum of 1.24 acres at each proposed pump station over the life of the project, but restored per the mitigation measures described here-in. All such impacts would be mitigated as described above.
On the basis of the Final Environmental Assessment submitted by the sponsor, the Department's independent review of that assessment, information developed during the review of the application and Environmental Assessment, comments received by the Department from Federal and State agencies, and measures that Express and Terasen are prepared to undertake to prevent or mitigate potentially adverse environmental impacts, the Department has concluded that issuance of a Presidential Permit authorizing construction and operation of the proposed Express Pipeline capacity increase would not have a significant impact on the quality of the human environment within the United States. Accordingly, a Finding of No Significant Impact is adopted and an Environmental Impact Statement will not be prepared.
The Final Environmental Assessment addressing this action is incorporated by reference and is on file and may be reviewed by interested parties at the Department of State, 2201 C Street NW., Room 3535, Washington, DC 20520 (Attn: Mr. Pedro Erviti, Tel. 202-647-1291).
Federal Aviation Administration (FAA), DOT.
Notice of Commercial Space Transportation Advisory Committee open meeting.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App. 2), notice is hereby given of a meeting of the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on Wednesday, October 27, 2004, starting at 8 a.m. at the Federal Aviation Administration Headquarters Building, 800 Independence Avenue, SW., Washington, DC, in the Bessie Coleman Conference Center, 2nd Floor. This will be the fortieth meeting of the COMSTAC.
The proposed agenda for the meeting will include updates on current
Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the Contact Person listed below in advance of the meeting.
Brenda Parker (AST-200), Office of the Associate Administrator for Commercial Space Transportation (AST), 800 Independence Avenue, SW., Room 331, Washington, DC 20591, telephone (202) 385-4713; e-mail
Federal Highway Administration (FHWA), Department of Transportation.
Notice of intent.
The FHWA is issuing this notice to advise the public that an Environmental Impact Statement will be prepared for a proposed highway project in Etowah County, Alabama. This Notice of Intent (NOI) supersedes a NOI for this proposed project that was issued by the FHWA in the
Mr. Joe D. Wilkerson, Division Administrator, Federal Highway Administration, 500 Eastern Boulevard, Suite 200, Montgomery, Alabama 36117, Telephone: (334) 223-7370.
The FHWA, in cooperation with the State of Alabama Department of Transportation, will prepare an Environmental Impact Statement (EIS) for Alabama Project HPP-1602 (539), old project number NHF-PE 94 (2). The proposal is to construct a limited access facility from the eastern terminus of Interstate Highway 759 (I-759) near George Wallace Drive to an interchange with U.S. Highway 431 and U.S. Highway 278 in the city of Gadsden, Alabama. The project will be a multi-lane roadway on new location. The proposal will allow traffic from I-759 to flow through the city of Gadsden.
Alternatives under consideration include (1) alternate route locations, (2) a no-action alternative, and (3) postponing the action.
Letters describing the proposed action and soliciting comments will be sent to appropriate Federal, State, and local agencies and to private organizations and citizens that have previously expressed or are known to have an interest in this proposal. A public involvement meeting and a public hearing will be held in the city of Gadsden. Public notice with be given of the time and place for the meeting and hearing. A formal scoping meeting will not be held.
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 FHWA at the address provided above.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition for exemption.
This notice grants in full the petition of Nissan North America, Inc., (Nissan) for an exemption of a high-theft vehicle line, [whose nameplate is confidential], from the parts-marking requirements of the Federal motor vehicle theft prevention standard. This petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the Theft Prevention Standard. Nissan requested confidential treatment for the information and attachments it submitted in support of its petition. In a letter dated July 23, 2004, the agency granted the petitioner's request for confidential treatment of most aspects of its petition.
The exemption granted by this notice is effective beginning with the [confidential] model year.
Ms. Rosalind Proctor, Office of International Policy, Fuel Economy and Consumer Programs, NHTSA, 400 Seventh Street, SW., Washington, DC 20590. Ms. Proctor's telephone number is (202) 366-0846. Her fax number is (202) 493-2290.
In a petition dated June 23, 2004, Nissan North America, Inc. (Nissan), requested exemption from the parts-marking requirements of the theft prevention standard (49 CFR Part 541) for a vehicle line. The nameplate of the line and the model year of introduction are confidential. The petition has been filed pursuant to 49 CFR Part 543,
Section 33106(b)(2)(D) of Title 49, United States Code, gave the Secretary of Transportation the authority to grant a manufacturer
Nissan's submittal is considered a complete petition, as required by 49 CFR 543.7, in that it meets the general requirements contained in “543.5 and the specific content requirements of “543.6. In its petition, Nissan provided a detailed description and diagram of the identity, design, and location of the components of the antitheft device for the new line. Nissan requested confidential treatment for the information it submitted in support of its petition. In a letter dated July 23, 2004, the agency granted the petitioner's request for confidential treatment of most aspects of its petition.
In order to ensure reliability and durability of the device, Nissan conducted tests based on its own specified standards. Nissan provided a detailed list of the tests conducted and believes that the device is reliable and durable since the device complied with its specified requirements for each test.
Nissan compared the device proposed for its vehicle line with devices which NHTSA has determined to be as effective in reducing and deterring motor vehicle theft as would compliance with the parts-marking requirements. Nissan stated that its proposed device, as well as other comparable devices that have received full exemptions from the parts-marking requirements, lack an audible and visible alarm. Therefore, these devices cannot perform one of the functions listed in 49 CFR 542.6(a)(3), that is, to call attention to unauthorized attempts to enter or move the vehicle. However, theft data have indicated a decline in theft rates for vehicle lines that have been equipped with antitheft devices similar to that which Nissan purposes. In these instances, the agency has concluded that the lack of a visual or audible alarm has not prevented these antitheft devices from being effective protection against theft.
On the basis of this comparison, Nissan has concluded that the antitheft device proposed for its vehicle line is no less effective than those devices in the lines for which NHTSA has already granted full exemption from the parts-marking requirements.
Based on the evidence submitted by Nissan, the agency believes that the antitheft device for the Nissan vehicle line is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the Theft Prevention Standard.
The agency concludes that the device will provide four of the five types of performance listed in § 543.6(a)(3): Promoting activation; preventing defeat or circumvention of the device by unauthorized persons; preventing operation of the vehicle by unauthorized entrants; and ensuring the reliability and durability of the device.
As required by 49 U.S.C. 33106 and 49 CFR 543.6 (a)(4) and (5), the agency finds that Nissan has provided adequate reasons for its belief that the antitheft device will reduce and deter theft. This conclusion is based on the information Nissan provided about its device, much of which is confidential. This confidential information included a description of reliability and functional tests conducted by Nissan for the antitheft device and its components.
For the foregoing reasons, the agency hereby grants in full Nissan's petition for exemption for the vehicle line from the parts-marking requirements of 49 CFR Part 541. The agency notes that 49 CFR Part 541, Appendix A-1, identifies those lines that are exempted from the Theft Prevention Standard for a given model year. Advanced listing, including the release of future product nameplates, is necessary in order to notify law enforcement agencies of new vehicle lines exempted from the parts marking requirements of the Theft Prevention Standard. Since Nissan has been granted confidential treatment for its vehicle line, the confidential status of its nameplate will be protected until the introduction of its vehicle line into the market place. At that time, Appendix A-1 will be revised to reflect the nameplate of Nissan's exempted vehicle line.
If Nissan decides not to use the exemption for this line, it must formally notify the agency, and, thereafter, the line must be fully marked as required by 49 CFR 541.5 and 541.6 (marking of major component parts and replacement parts).
NHTSA notes that if Nissan wishes in the future to modify the device on which this exemption is based, the company may have to submit a petition to modify the exemption. Part 543.7(d) states that a Part 543 exemption applies only to vehicles that belong to a line exempted under this part and equipped with the anti-theft device on which the line's exemption is based. Further, § 543.9(c)(2) provides for the submission of petitions to modify an exemption to permit the use of an antitheft device similar to but differing from the one specified in that exemption.
The agency wishes to minimize the administrative burden that § 543.9(c)(2) could place on exempted vehicle manufacturers and itself. The agency did not intend Part 543 to require the submission of a modification petition for every change to the components or design of an antitheft device. The significance of many such changes could be
49 U.S.C. 33106; delegation of authority at 49 CFR 1.50.
Baby Trend, Inc. (Baby Trend) has determined that certain child restraint seats that it produced and sold between approximately June 2002 and June 2003 do not comply with S5.2.3.2(a) of 49 CFR 571.213, Federal Motor Vehicle Safety Standard (FMVSS) No. 213, “Child restraint systems.” Pursuant to 49 U.S.C. 30118(d) and 30120(h), Baby Trend has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety. Notice of receipt of Baby Trend's petition was published, with a 30 day comment period, on July 29, 2004, in the
S5.2.3.2 of FMVSS No. 213 requires that:
Each system surface * * * which is contactable by the dummy head when the system is tested in accordance with S6.1 shall be covered with slow recovery, energy absorbing material with the following characteristics: (a) A 25 percent compression-deflection resistance of not less than 0.5 and not more than 10 pounds per square inch when tested in accordance with S6.3.
Baby Trend produced a total of approximately 150,730 Latch-Loc infant car seats whose foam covering as molded onto the seat back of these seats has a compression-deflection resistance of 0.3 pounds per square inch, and therefore does not meet the compression-deflection resistance required by S5.2.3.2(a).
Baby Trend does not believe that the product presents any real world safety hazard as verified by highly sensitive testing with calibrated dummies on actual production product. In June 2003, FMVSS No. 213 underwent a number of revisions including amendments to incorporate advanced test dummies and updated test procedures (68 FR 37620, June 24, 2003). This included amending S5.2.3.1 to eliminate subjecting child restraint systems to the compression-deflection resistance requirements if they are tested to the revised standard using the advanced Part 572 Subpart R test dummy.
The revised S5.2.3.1 of FMVSS No. 213 states:
Each child restraint system other than a child harness, manufactured before August 1, 2005, that is recommended under S5.5.2 for a child whose mass is less than 10 kg and that is not tested with the Part 572 Subpart R dummy, shall comply with S5.2.3.
As stated in its petition, Baby Trend conducted testing of the subject child restraint systems in accordance with the revised FMVSS No. 213. Its testing included dynamic sled testing with the 12-month-old size CRABI test dummy (Part 572 Subpart R dummy). The test results yielded head injury criterion (HIC36) values of approximately 500 to 600, which are well within the maximum HIC36 requirement of 1000.
NHTSA agrees that the noncompliance is inconsequential to motor vehicle safety. Based on the successful dynamic testing conducted by Baby Trend on the non-compliant child restraint systems using the Part 572 Subpart R dummy in accordance with the revised FMVSS No. 213, the head foam material appears to provide adequate head impact protection given the low HIC36 values measured.
In consideration of the foregoing, NHTSA has decided that the petitioner has met its burden of persuasion that the noncompliance described is inconsequential to motor vehicle safety. Accordingly, Baby Trend's petition is granted and the petitioner is exempted from the obligation of providing notification of, and a remedy for, the noncompliance.
(Authority: 49 U.S.C. 30118, 30120; delegations of authority at CFR 1.50 and 501.8)
Spokane County, Division of Engineering and Roads (Spokane), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to acquire from The Burlington Northern and Santa Fe Railway Company (BNSF), a line of railroad known as the Geiger Spur from milepost 1493.95, on its Columbia River Subdivision, to milepost 4.93, on the Geiger Spur, a total distance of 4.93 miles.
This transaction is related to a verified notice of exemption in STB Finance Docket No. 34546,
Spokane certifies that its projected annual revenues as a result of this transaction will not exceed $5 million, and the transaction will not result in the creation of a Class I or Class II rail carrier.
The transaction was scheduled to be consummated on October 1, 2004.
If the notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 34541, must be filed with the Surface Transportation Board, 1925 K Street NW., Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Martin Rollins, Spokane County Prosecuting Attorney's Office, Civil Division, 1115 West Broadway Avenue, Spokane, WA 99260.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
In rule document 04-21837 beginning on page 58049 in the issue of September 29, 2004, make the following correction:
1. On page 58050, under the table “SUPPLEMENT No. 4 TO PART 744-ENTITY LIST-Continued”, in the first column “Country/Entity”, in the first line “Dpeartment” should read “Department”
2. On the same page, under the same table, in the same column, in the 11th line “subjet” should read “subject ”.
3. On the same page, under the same table, in the third column “License review policy”, in the second paragraph, in the eighth line “(NPI)” should read “(NP1)”.
In rule document 04-21553 beginning on page 57651 in the issue of Monday, September 27, 2004, make the following correction:
On page 57652, in the first column, in the fourth line, the date “October 7, 2004” should read, “October 12, 2004.”
In rule document 04-21528 beginning on page 57170 in the issue of September 24, 2004, make the following correction:
On page 57171, in the third column, in § 71.1, under the heading “
In rule document 04-21529 beginning on page 57169 in the issue of September 24, 2004, make the following correction:
On page 57170, in the second column, in § 71.1, under the heading “
Occupational Safety and Health Administration (OSHA), Department of Labor.
Proposed rule; request for comments and scheduling of informal public hearings.
The Occupational Safety and Health Administration (OSHA) proposes to amend its existing standard for employee exposure to hexavalent chromium (Cr(VI)). The basis for issuance of this proposal is a preliminary determination by the Assistant Secretary that employees exposed to Cr(VI) face a significant risk to their health at the current permissible exposure limit and that promulgating this proposed standard will substantially reduce that risk. The information gathered so far in this rulemaking indicates that employees exposed to Cr(VI) well below the current permissible exposure limit are at increased risk of developing lung cancer. Occupational exposures to Cr(VI) may also result in asthma, and damage to the nasal epithelia and skin.
This document proposes an 8-hour time-weighted average permissible exposure limit of one microgram of Cr(VI) per cubic meter of air (1 mg/m
Please note that security-related problems may result in significant delays in receiving comments and other materials by regular mail. Telephone the OSHA Docket Office at (202) 693-2350 for information regarding security procedures concerning delivery of materials by express delivery, hand delivery, and messenger service.
All comments and submissions will be available for inspection and copying in the OSHA Docket Office at the address above. Most comments and submissions will be posted on OSHA's Web page (
For general information and press inquiries, contact Mr. George Shaw, Office of Communications, Room N-3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-1999. For technical inquiries, contact Ms. Amanda Edens, Directorate of Standards and Guidance, Room N-3718, OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-2093 or
For additional copies of this
The preamble to the proposed standard on occupational exposure to chromium (VI) discusses events leading to the proposal, health effects of exposure, the degree and significance of the risk presented, a summary of the analysis of technological and economic feasibility, regulatory impact, and regulatory flexibility, and the rationale behind the specific provisions set forth in the proposed standard. The discussion follows this outline:
OSHA requests comment on all relevant issues, including health effects, risk assessment, significance of risk determination, technological and economic feasibility, and the provisions of the proposed regulatory text. OSHA is especially interested in responses, supported by evidence and reasons, to the following questions:
1. OSHA has described a variety of studies addressing the major adverse health effects that have been associated with exposure to Cr(VI). Has OSHA adequately identified and documented all critical health impairments associated with occupational exposure to Cr(VI)? Are there any additional studies or other data that would controvert the information discussed or significantly enhance the determination of material health impairment or the assessment of exposure-response relationships? Submit any relevant information, and explain your reasoning for recommending the inclusion of any studies you suggest.
2. Using currently available epidemiologic and experimental studies, OSHA has made a preliminary determination that all Cr(VI) compounds (
3. In its preliminary assessment of risk, OSHA has relied primarily on two epidemiologic cohort studies of chromate production workers to estimate the lung cancer risk to workers exposed to Cr(VI) (Exs. 31-22-11; 33-10). Are there any other studies that you believe are better suited to estimating the risk to exposed workers; if so, please provide the studies and explain why you believe they are better.
4. OSHA is aware of two cohorts (i.e., Alexander cohort, Ex. 31-16-3, and Pastides cohort, Ex. 35-279) in which a sizable number of workers were probably exposed to low Cr(VI) air levels (
5. OSHA has relied upon a linear relative risk model and cumulative Cr(VI) exposure for estimating the lifetime occupational lung cancer risk among Cr(VI)-exposed workers. In particular, OSHA has made a preliminary determination that a threshold model is not appropriate for estimating the lung cancer risk associated with Cr(VI). However, there is some evidence that pathways (
6. OSHA's estimates of lung cancer risk are based on workers primarily exposed to highly water-soluble sodium chromate and sodium dichromate. OSHA has preliminarily concluded that the risk for workers exposed to equivalent levels of other Cr(VI) compounds will be of a similar magnitude or, in the case of some Cr(VI) compounds, possibly greater than the risks projected in the OSHA quantitative risk assessment. Is this determination appropriate? Are there sufficient data to reliably quantify the risk from occupational exposure to specific Cr(VI) compounds? If so, explain how the risk could be estimated.
7. The preliminary quantitative risk assessment relies on two (Gibb and Luippold) cohort studies in which most workers were exposed higher Cr(VI) levels than the PEL proposed by OSHA, for shorter durations than a working lifetime exposure. The risks estimated by OSHA for lifetime exposure to the proposed PEL, therefore, carry the assumption that a cumulative exposure achieved by short duration exposure to higher Cr(VI) air levels (
8. OSHA has made a preliminary determination that suitable data are not available for making quantitative risk estimates for the non-cancer adverse health effects associated with exposure to Cr(VI) (
9. Are there other factors OSHA should take into consideration in its final quantitative risk assessment to better characterize the risks associated with exposure to Cr(VI)?
10. In its Preliminary Economic Analysis of the proposed standard, OSHA presents a profile of the affected worker population. In that profile are estimates of the number of affected workers by application group and job category and the distribution of exposures by job category. Are there additional data that will enable the Agency to refine its profile of the worker population exposed to Cr(VI)? If so, how should OSHA use these data in making such revisions?
11. What are the job categories in which employees are potentially exposed to Cr(VI) in your company or industry? For each job category, provide a brief description of the operation and describe the job activities that may lead to Cr(VI) exposure. How many employees are exposed, or have the potential for exposure, to Cr(VI) in each job category in your company or industry? What are the frequency, duration and levels of exposures to Cr(VI) at each job category in your company or industry? Where commenters are able to provide exposure data, OSHA requests that, where possible, exposure data be personal samples with clear descriptions of the length of the sample and analytical method. Exposure data that provide information concerning the controls in place are more valuable than exposure data without such information.
12. Have there been technological changes within your industry that have influenced the magnitude, frequency, or duration of exposure to Cr(VI) or the means by which employers attempt to control exposures? Describe in detail these technological changes and their effects on Cr(VI) exposures and methods of control.
13. Has there been a trend within your industry to eliminate Cr(VI) from production processes, products and services? If so, comments are requested on the success of substitution efforts. Commenters should estimate the percentage reduction in Cr(VI), and the extent to which Cr(VI) is still necessary in their processes within product lines or production activities. OSHA also requests that commenters describe any technical, economic or other deterrents to substitution.
14. Does any job category or employee in your workplace have exposures to Cr(VI) that raw air monitoring data do not adequately portray due to the short duration, intermittent or non-routine nature, or other unique characteristics of the exposure? Please explain your response and indicate peak levels, duration and frequency of exposures for employees in these job categories.
15. OSHA requests the following information regarding engineering and work practice controls in your workplace or industry:
a. Describe the operations in which the proposed PEL is being achieved most of the time by means of engineering and work practice controls.
b. What engineering and work practice controls have been implemented in these operations?
c. For all operations in facilities where Cr(VI) is used, what engineering and work practice controls have been implemented? If you have installed engineering controls or adopted work practices to reduce exposure to Cr(VI), describe the exposure reduction achieved and the cost of these controls. Where current work practices include the use of regulated areas and hygiene facilities, provide data on the implementation of these controls, including data on the costs of installation, operation, and maintenance associated with these controls.
d. Describe additional engineering and work practice controls which could be implemented in each operation where exposure levels are currently above the proposed PEL to further reduce exposure levels.
e. When these additional controls are implemented, to what levels can exposure be expected to be reduced, or what per cent reduction is expected to be achieved?
f. What are the costs and amount of time needed to develop, install and implement these additional controls? Will the added controls affect productivity?
g. Are there any processes or operations for which it is not reasonably possible to implement engineering and work practice controls within two years to achieve the proposed PEL? If so, would allowing additional time for employers to implement engineering and work practice controls make compliance possible? How much additional time would be necessary?
16. OSHA requests information on whether there are any limited or unique conditions or job tasks in Cr(VI) manufacture or use where engineering and work practice controls are not available or are not capable of reducing exposure levels to or below the proposed PEL most of the time. Provide data and evidence to support your response.
17. In its Preliminary Economic Analysis, OSHA presents estimated baseline levels of use of personal protective equipment (PPE) and the incremental costs associated with the proposed standard. Are OSHA's estimated compliance rates reasonable? Are OSHA's estimates of PPE costs, and the assumptions underlying these estimates, consistent with current industry practice? Comments are solicited on OSHA's analysis of PPE costs.
18. In its Preliminary Economic Analysis, OSHA presents estimated baseline levels of communication of Cr(VI)-related hazards and the incremental costs associated with the additional requirements for communication in the proposed standard. OSHA requests information on hazard communication programs addressing Cr(VI) that are currently being implemented by employers and any necessary additions to those programs that are anticipated in response to the proposed standard. Are OSHA's baseline estimates and unit costs for training reasonable and consistent with current industry practice?
19. Will difficulties be encountered by small entities when attempting to comply with requirements of the proposed standard? Can any of the
20. OSHA, in its Preliminary Economic Analysis, has estimated, by application group, compliance costs per affected entity and the likely impacts on revenues and profits under alternative market scenarios. OSHA requests that affected employers provide comment on OSHA's estimate of revenue, profit, and the impacts of costs for their industry or application group. Are there special circumstances—such as unique cost factors, foreign competition, or pricing constraints—that OSHA needs to consider when evaluating economic impacts for particular application groups? Comments are requested on OSHA's analysis of economic feasibility in the PEA.
21. Do any federal regulations duplicate, overlap, or conflict with the proposed Cr(VI) standard?
22. In some facilities, adjustments in ventilation systems to comply with the proposed PEL may require additional time and expense to retest these systems to ensure compliance with EPA requirements or state requirements. OSHA requests information and comment indicating how frequently retesting would be required, and the time and costs involved in such retesting.
23. Submit any data, information, or comments pertaining to possible environmental impacts of adopting this proposal, such as the following:
a. Any positive or negative environmental effects that could result;
b. Any irreversible commitments of natural resources which could be involved; and
c. Estimates of the effect of the proposed standard on the levels of Cr(VI) in the environment.
In particular, consideration should be given to the potential direct or indirect impacts of the proposal on water and air pollution, energy use, solid waste disposal, or land use.
d. Some small entity representatives noted that OSHA PELs are sometimes used to set “fence line” standards for air pollutants. OSHA is unable to find evidence of states formally using this procedure, though some states may use such a procedure informally. Do any states or other air pollution authorities base standards on OSHA PELs? What effects might this have on the environment and on environmental compliance?
24. OSHA's safety and health advisory committees for Construction and Maritime advised the Agency to take into consideration the unique nature of their work environments by either settings separate standards or making accommodations for the differences in work environments in construction and maritime. To account for differences in the workplace environment for these different sectors OSHA has proposed separate standards for general industry, construction, and shipyards. Is this approach appropriate? What other approaches should the Agency consider? Please provide a rationale for your response.
25. OSHA has not proposed to cover agriculture, because the Agency is not aware of significant exposures to Cr(VI) in agriculture. Is this determination correct?
26. OSHA has proposed to regulate exposures to all Cr(VI) compounds. As discussed in the health effects section of this preamble, the Agency has made a preliminary determination that the existing data support coverage of all Cr(VI) compounds in the scope of the proposed standard. Is this an appropriate determination or are there additional data that support the exclusion of certain compounds from the scope of the final standard? If so, describe specifically how these data would support a decision to exclude certain compounds from the scope of the final rule.
27. OSHA has made a preliminary determination to exclude Cr(VI) exposures due to work with portland cement from the scope of the construction standard. OSHA believes that guidance efforts by the Agency may be more suitable for addressing the dermal hazards associated with portland cement use in construction settings. OSHA's Advisory Committee for Construction Safety and Health (ACCSH) advised OSHA to include construction cement work under the proposed standard because of the known hazards associated with wet cement and the large number of workers exposed to wet cement in construction work settings. In particular ACCSH advised OSHA that only certain provisions might be necessary for workers exposed to wet cement (
28. OSHA has proposed to include exposure to Cr(VI) from portland cement in the scope of the standard for general industry. The Agency believes that the potential for airborne exposure to Cr(VI) in general industry due to work with portland cement, as indicated by the profile of exposed workers presented in Table IX-2 of this preamble, is higher than in the construction industry. OSHA acknowledges, however, that the exposure profile indicates that no workers are exposed to Cr(VI) at levels over the proposed action level. Given the low level of airborne exposure among cement workers in general industry, should OSHA exclude exposures to Cr(VI) from portland cement from the scope of the general industry standard? OSHA seeks data to help inform this issue, and solicits comments on particular provisions of the general industry and construction standards that may or may not be appropriate for cement workers.
29. OSHA has proposed to exempt from coverage Cr(VI) exposures occurring in the application of pesticides in general industry (such as the treatment of wood with chromium copper arsenate (CCA)) because pesticide application is regulated by EPA, and section 4(b)(1) of the OSH Act precludes OSHA from regulating where other Federal agencies exercise their statutory authority to do so. OSHA has proposed to cover exposures resulting from use of treated materials. Is this approach appropriate? Are there any instances where EPA-regulated pesticide application occurs in construction or shipyard workplaces?
30. Describe any additional industries, processes, or applications that should be exempted from the Cr(VI) standard and provide detailed reasons for any requested exemption. In
31. Can the proposed Cr(VI) standard for the construction industry be modified in any way to better account for the workplace conditions in that industry, while still providing appropriate protection to Cr(VI)-exposed workers in that industry? Would an alternative approach similar to that used in OSHA's asbestos standard, where the application of specified controls in certain situations would be considered adequate to meet the requirements of the standard, be useful? Is there enough information available to define such technology specifications?
32. Can the proposed Cr(VI) standard for shipyards be modified in any way to better account for the workplace conditions in that industry, while still providing appropriate protection to Cr(VI)-exposed workers in that industry?
33. OSHA has proposed a TWA PEL for Cr(VI) of 1.0 μg/m
34. Should different PELs be established for different Cr(VI) compounds? If so, how should they be established? Where possible, provide specific detail about how different PELs could be established and how the Agency should apply those PELs in instances where workers may be exposed to more than one Cr(VI) compound.
35. OSHA has proposed an action level for Cr(VI) exposure in general industry, but not in construction or shipyards. Is this an appropriate approach? Should OSHA set an action level for exposure to Cr(VI) in construction and shipyards? Should the proposed action level in general industry be retained in the final rule?
36. If an action level is included in the final rule, is the proposed action level for general industry (0.5 μg/m
37. If an action level is included in the final rule, which provisions should be triggered by exposure above the action level? Indicate the basis for your position and include any supporting information.
38. If no action level is included in the final rule, which provisions should apply to all Cr(VI)-exposed workers? Which provisions should be triggered by the PEL? Are there any other appropriate triggers for the requirements of the standard?
39. Should OSHA set a short-term exposure limit (STEL) or ceiling for exposure to Cr(VI)? If so, please specify the appropriate air concentration and the rationale for its selection.
40. Do you conduct initial air monitoring or do you rely on objective data to determine Cr(VI) exposures? Describe any other approaches you have implemented for assessing an employee's initial exposure to Cr(VI).
41. Describe any follow-up or subsequent exposure assessments that you conduct. How often do you conduct such follow-up or subsequent exposure assessments? Please comment on OSHA's estimate of baseline industry practice and the projected costs for initial and periodic exposure assessment. Are OSHA's estimates consistent with current industry practice?
42. Do shipyard employers presently measure their employees' exposure to Cr(VI)? If not, do they use some alternative method of identifying which employees may be over-exposed to Cr(VI)?
43. OSHA has proposed specific requirements for exposure assessment in general industry, but has not proposed that these requirements apply to construction or shipyard employers. Should requirements for exposure assessment in construction or shipyards be included in the final Cr(VI) standard? Are there any advantages to requiring construction or shipyard employers to measure their employees' exposures to Cr(VI)? If so, would the exposure assessment requirements proposed for general industry be appropriate? Would construction or shipyard employers encounter situations where monitoring would be infeasible if they were required to follow the exposure assessment requirements proposed for employers in general industry? Indicate the basis for your position and include any supporting information. What types of exposure assessment strategies are effective for assessing worker exposures at construction and shipyard worksites?
44. Should requirements for exposure assessment in general industry be included in the final Cr(VI) standard, or would the performance-oriented requirement proposed for construction and shipyards be more appropriate? Indicate the basis for your position and include any supporting information.
45. OSHA has proposed that exposure monitoring in general industry be conducted at least every six months if exposures are above the action level but below the PEL, and at least every three months if exposures are at or above the PEL. Are these proposed frequencies appropriate? If not, what frequency of monitoring would be more appropriate, and why?
46. OSHA has proposed that regulated areas be established in general industry wherever an employee's exposure to airborne concentrations of Cr(VI) is, or can reasonably be expected to be, in excess of the PEL. OSHA seeks comments on this provision and in particular:
a. Describe any work settings where establishing regulated areas could be problematic or infeasible. If establishing regulated areas is problematic, what approaches might be used to warn employees in such work settings of high risk areas (i.e., areas where the airborne concentrations of Cr(VI) exceed the PEL?).
b. Should OSHA add hazards from eye or skin contact as a trigger for establishing regulated areas? Explain the basis for your position, and include any supporting information. c. Describe any methods currently used that have been found to be effective in establishing regulated areas.
47. OSHA has not proposed requirements for establishment of regulated areas in construction or shipyards. Should requirements for regulated areas for construction or shipyards be included in the final Cr(VI) standard? If so, would the requirements for regulated areas proposed for general industry be appropriate? Are there any particular problems in construction or shipyard settings that make regulated areas problematic or infeasible? If requirements for regulated areas for construction or shipyards are not included in the final Cr(VI) standard, should OSHA include requirements for warning signs or other measures to alert employees of the presence of Cr(VI)? If so, what practical means could be used to determine where and when such labeling would be required? What potential difficulties might be encountered by using such an approach? Indicate the basis for your position and include any supporting information.
48. Under the proposed standard, employers are required to use engineering and work practice controls
49. In OSHA's Cadmium standard (29 CFR 1010.1027), the Agency established separate engineering control air limits (SECALs) for certain processes in selected industries. SECALs were established where compliance with the PEL by means of engineering and work practice controls was infeasible. For these industries, a SECAL was established at the lowest feasible level that could be achieved by engineering and work practice controls. The PEL was set at a lower level, and could be achieved by any allowable combination of controls. SECALs thus allowed OSHA to establish a lower PEL for cadmium than would otherwise have been possible, given technological feasibility constraints. Should OSHA establish SECALs for Cr(VI) in any industries or processes? If so, in what industries or processes, and at what levels? Provide rationale to support your position.
50. The proposed standard prohibits the use of job rotation for the sole purpose of lowering employee exposures to Cr(VI). Are there any circumstances where this practice should be allowed in order to meet the proposed PEL?
51. OSHA is proposing that employers provide appropriate protective clothing and equipment when a hazard is present or is likely to be present from skin or eye contact with Cr(VI). OSHA would expect an employer to exercise common sense and appropriate expertise to determine if a hazard is present or likely to be present. Is this approach appropriate? Are there other approaches that would be better for characterizing eye and skin contact with Cr(VI)? For example, are there methods to measure dermal exposure that could be used to routinely monitor worker exposure to Cr(VI) that OSHA should consider including in the final standard?
52. For employers whose employees are exposed to Cr(VI), what approaches do you currently use to assess potential hazards from eye or skin contact with Cr(VI)? What protective clothing and equipment do you use to protect employees from eye or skin contact with Cr(VI)? What does this protective clothing and equipment cost? Who pays for the protective clothing and equipment?
53. Should OSHA require the use of protective clothing and equipment for those employees who are exposed to airborne concentrations of Cr(VI) in excess of the PEL? If so, what type of protective clothing and equipment might be necessary?
54. OSHA has proposed to require that employers pay for protective clothing and equipment provided to employees. The Agency seeks comment on this provision, in particular:
a. Should OSHA refrain from requiring employer payment, and follow the outcome of the rulemaking addressing employer payment for personal protective equipment (64 FR 15401 (3/31/99))?
b. Are there circumstances where employers should not be required to pay for clothing and equipment used to protect employees from Cr(VI) hazards, such as situations where it is customary for employees to provide their own protective clothing and equipment (i.e., “tools of the trade”)?
c. OSHA realizes that there is frequent turnover in the construction industry, where employees frequently move from jobsite to jobsite. This is an important factor because an employer with a high-turnover workplace would have to buy protective clothing and equipment for more employees if the protective clothing and equipment could only be used by one employee. The Agency requests comment on whether this proposal's requirement for employer payment for protective clothing and equipment is appropriate in the construction industry. Are there any alternative approaches that would be responsive to the turnover situation and would also be protective of construction workers? Are there any other issues specific to the construction industry that OSHA should be consider in this rulemaking?
d. At some ports, employees are hired for jobs in shipyards, longshoring, and marine terminals through a labor pool, and a single employee may work for five different employers in the same week. How do these factors affect who is required to pay for protective clothing and equipment? Are there any other issues specific to shipyards, longshoring, or marine terminals that OSHA should consider in this rulemaking?
55. OSHA is proposing that washing facilities capable of removing Cr(VI) from the skin be provided to affected employees, but does not propose that showers be required. Should OSHA include requirements to provide showers to employees exposed to Cr(VI)? If so, under what circumstances should showers be required? Describe work situations where showers are either unnecessary for employee protection or that present obstacles to their implementation and describe any such obstacles.
56. OSHA has not included housekeeping provisions in the proposed Cr(VI) standard for construction or shipyards. The Agency has made a preliminary determination that the housekeeping requirements proposed for general industry are likely to be difficult to implement in the construction and shipyard environments. Is this an appropriate determination? If not, what practicable housekeeping measures can construction and shipyard employers take to reduce employee exposure to Cr(VI) at the work site? What housekeeping activities are currently being performed?
57. Is medical surveillance being provided to Cr(VI)-exposed employees at your worksite? If so,
a. What exposure levels or other factors trigger medical surveillance?
b. What tests or evaluations are included in the medical surveillance program?
c. What benefits have been achieved from the medical surveillance program?
d. What are the costs of the medical surveillance program? How do your current costs compare with OSHA's estimated unit costs for the physical examination and employee time involved in the medical surveillance program? Please comment on OSHA's baseline assumptions and cost estimates for medical surveillance.
e. How many employees are included in your medical surveillance program?
f. In what North American Industry Classification System (NAICS) code does your workplace fall?
58. OSHA has proposed that medical surveillance be triggered in general industry in the following circumstances: (1) When exposure to Cr(VI) is above the PEL for 30 days or more per year; (2) after an employee experiences signs or symptoms of the adverse health effects associated with Cr(VI) exposure (
59. OSHA has proposed that medical surveillance be triggered in construction and shipyards in the following circumstances: (1) after an employee experiences signs or symptoms of the adverse health effects associated with Cr(VI) exposure (
60. OSHA has not included certain biological tests (
61. OSHA has not included requirements for medical removal protection (MRP) in the proposed standard. OSHA has made a preliminary determination that there are few instances where temporary worker removal and MRP will be useful. The Agency seeks comment as to whether the final Cr(VI) standard should include provisions for the temporary removal and extension of MRP benefits to employees with certain Cr(VI)-related health conditions. In particular, what endpoints should be considered for temporary removal and for what maximum amount of time should MRP benefits be extended? OSHA also seeks information on whether or not MRP is currently being used by employers with Cr(VI)-exposed workers, and the costs of such programs.
62. OSHA has proposed that employers provide hazard information to employees in accordance with the Agency's Hazard Communication standard (29 CFR 1910.1200), and has also proposed additional requirements regarding signs, labels, and additional training specific to work with Cr(VI). Should OSHA include these additional requirements in the final rule, or are the requirements of the Hazard Communication standard sufficient?
63. OSHA has proposed that bags or containers of laundry contaminated with Cr(VI) bear warning labels. Will this cause you to alter your current laundry practices? Are there laundries in your area that would accept such laundry? Would laundering costs increase? If so, by how much?
64. OSHA requests comment on the time allowed for compliance with the provisions of the proposed standard. Is the time proposed sufficient, or is a longer or shorter phase-in of requirements appropriate? Identify any industries, processes, or operations that have special needs for additional time, the additional time required and the reasons for the request.
65. Some other OSHA health standards have included appendices that address topics such as the hazards associated with the regulated substance, health screening considerations, occupational disease questionnaires, and PLHCP obligations. OSHA has not proposed to include any appendices with the Cr(VI) rule because the Agency has made a preliminary determination that such topics would be best addressed with guidance materials. What would be the advantage of including such appendices in the final rule? If you believe they should be included, what information should be included? What would be the disadvantage of including these appendices in the final rule?
The purpose of the Occupational Safety and Health Act, 29 U.S.C. 651 et seq. (“the Act”) is to “assure so far as possible every working man and woman in the nation safe and healthful working conditions and to preserve our human resources.” 29 U.S.C. 651(b). To achieve this goal Congress authorized the Secretary of Labor to promulgate and enforce occupational safety and health standards. 29 U.S.C. 655(a)(authorizing summary adoption of existing consensus and federal standards within two years of Act's enactment), 655(b)(authorizing promulgation of standards pursuant to notice and comment), 654(b)(requiring employers to comply with OSHA standards).
A safety or health standard is a standard “which requires conditions or the adoption of or use of one or more practices, means, methods, operations or processes, reasonably necessary or appropriate to provide safe or healthful employment or places of employment 29 U.S.C. 652(8).
A standard is reasonably necessary or appropriate within the meaning of Section 652(8) if it substantially reduces or eliminates significant risk, and is economically feasible, technologically feasible, cost effective, consistent with prior Agency action or supported by a reasoned justification for departing from prior Agency actions, supported by substantial evidence, and is better able to effectuate the Act's purpose than any national consensus standard it supersedes. See 58 Fed. Reg. 16612-16616 (March 30, 1993).
OSHA has generally considered, at minimum, fatality risk of 1/1000 over a 45-year working lifetime to be a significant health risk.
A standard is technologically feasible if the protective measures it requires already exist, can be brought into existence with available technology, or can be created with technology that can reasonably be expected to be developed.
A standard is economically feasible if industry can absorb or pass on the costs of compliance without threatening its long-term profitability or competitive structure.
A standard is cost effective if the protective measures it requires are the least costly of the available alternatives that achieve the same level of protection. ATMI, 453, U.S, at 514 n. 32; International
All standards must be highly protective. See 58 FR 16614-16615; LOTO III, 37 F. 3d at 669. However, health standards must also meet the “feasibility mandate” of Section 6(b)(7) of the Act, 29 U.S.C. 655(b)(5). Section 6(b)(5) requires OSHA to select “The most protective standard consistent with feasibility” that is needed to reduce significant risk when regulating health standards. ATMI, 452 U.S. at 509.
Section 6(b)(5) also directs OSHA to base health standard on “the best available evidence,” including research, demonstrations, and experiments. 29 U.S.C. 655(b)(5). OSHA shall consider “in addition to the attainment of the highest degree of health and safety protection * * * feasibility and experience gained under this and other health and safety laws.”
Section 6(b)(7) authorizes OSHA to include among a standard's requirements labeling, monitoring, medical testing and other information gathering and transmittal provisions. 29 U.S.C. 655(b)(7).
Finally, whenever practical, standards shall “be expressed in terms of objective criteria and of the performance desired.”
OSHA's present standards for workplace exposure to Cr(VI) were adopted in 1971, pursuant to section 6(a) of the OSH Act, from a 1943 American National Standards Institute (ANSI) recommendation originally established to control irritation and damage to nasal tissues (Ex. 20-3). OSHA's general industry standard set a permissible exposure limit (PEL) of 1 mg chromium trioxide per 10 m
Following the ANSI standard of 1943, other occupational and public health organizations evaluated Cr(VI) as a workplace and environmental hazard and formulated recommendations to control exposure. The ACGIH first recommended control of workplace exposures to chromium in 1946, recommending a time-weighted average Maximum Allowable Concentration (later called a Threshold Limit Value) of 100 μg/m
During the 1980s, regulatory and standards organizations came to recognize Cr(VI) compounds in general as carcinogens. The Environmental Protection Agency (EPA) Health Assessment Document of 1984 stated that “using the IARC [International Agency for Research on Cancer] classification scheme, the level of evidence available for the combined animal and human data would place hexavalent chromium Cr(VI) compounds into Group 1, meaning that there is decisive evidence for the carcinogenicity of those compounds in humans” (Ex. 19-1, p. 7-107). In 1988 IARC evaluated the available evidence regarding Cr(VI) carcinogenicity, concluding in 1990 that “There is sufficient evidence in humans for the carcinogenicity of chromium[VI] compounds as encountered in the chromate production, chromate pigment production and chromium plating industries”, and “sufficient evidence in experimental animals for the carcinogenicity of calcium chromate, zinc chromates, strontium chromate and lead chromates'(Ex. 18-3, p. 213). In September 1988, NIOSH advised OSHA to consider all Cr(VI) compounds as potential occupational carcinogens (Ex. 31-22-22, p. 8). ACGIH now classifies water-insoluble and water-soluble Cr(IV) compounds as class A1 carcinogens (Ex. 35-207). Current ACGIH standards include specific 8-hour time-weighted average TLVs for calcium chromate (1 μg/m
In July 1993, OSHA was petitioned for an emergency temporary standard to reduce occupational exposures to Cr(VI) compounds (Ex. 1). The Oil, Chemical, and Atomic Workers International Union (OCAW) and Public Citizen's Health Research Group (HRG), citing evidence that occupational exposure to Cr(VI) increases workers' risk of lung cancer, petitioned OSHA to promulgate an emergency temporary standard to lower the PEL for Cr(VI) compounds to 0.5 μg/m
OSHA initiated Small Business Regulatory Enforcement Act (SBREFA) proceedings in 2003, seeking the advice of small business representatives on the proposed rule. The SBREFA panel, including representatives from OSHA, the Small Business Administration (SBA), and the Office of Management and Budget (OMB), was convened on December 23, 2003. The panel conferred with representatives from small entities in chemical, alloy, and pigment manufacturing, electroplating, welding, aerospace, concrete, shipbuilding, masonry, and construction on March 16-17, 2004, and delivered its final report to OSHA on April 20, 2004. The Panel's report, including comments from the small entity representatives (SERS) and recommendations to OSHA for the proposed rule, is available in the Cr(VI) rulemaking docket (Ex. 34).
OSHA provided the Advisory Committee on Construction Safety and Health (ACCSH) and the Maritime Advisory Committee on Occupational Safety and Health (MACOSH) with copies of the draft proposed rule for review in early 2004. OSHA representatives met with ACCSH in February 2004 and May 2004 to discuss the rulemaking and receive their comments and recommendations. On February 13, ACCSH recommended that portland cement should be included
Chromium is a metal that exists in several oxidation or valence states, ranging from chromium (−II) to chromium (+VI). The elemental valence state, chromium (0), does not occur in nature. Chromium compounds are very stable in the trivalent state and occur naturally in this state in ores such as ferrochromite, or chromite ore (FeCr
Chromium compounds in higher valence states are able to undergo “reduction” to lower valence states; chromium compounds in lower valence states are able to undergo “oxidation” to higher valence states. Thus, Cr(VI) compounds can be reduced to Cr(III) in the presence of oxidizable organic matter. Chromium can also be reduced in the presence of inorganic chemicals such as iron.
Chromium does exist in less stable oxidation (valence) states such as Cr(II), Cr(IV), and Cr(V). Anhydrous Cr(II) salts are relatively stable, but the divalent state (II, or chromous) is generally relatively unstable and is readily oxidized to the trivalent (III or chromic) state. Compounds in valence states such as (IV) and (V) usually require special handling procedures as a result of their instability. Cr(IV) oxide (CrO
Chromium (III) is also an essential nutrient that plays a role in glucose, fat, and protein metabolism by causing the action of insulin to be more effective. Chromium picolinate, a trivalent form of chromium combined with picolinic acid, is used as a dietary supplement, because it is claimed to speed metabolism.
Elemental chromium and the chromium compounds in their different valence states have various physical and chemical properties, including differing solubilities. Most chromium species are solid. Elemental chromium is a steel gray solid, with high melting and boiling points (1857 °C and 2672 °C, respectively), and is insoluble in water and common organic solvents. Chromium (III) chloride is a violet or purple solid, with high melting and sublimation points (1150 °C and 1300 °C, respectively), and is slightly soluble in hot water and insoluble in common organic solvents. Ferrochromite is a brown-black solid; chromium (III) oxide is a green solid; and chromium (III) sulfate is a violet or red solid, insoluble in water and slightly soluble in ethanol. Chromium (III) picolinate is a ruby red crystal soluble in water (1 part per million at 25 °C). Chromium (IV) oxide is a brown-black solid that decomposes at 300 °C and is insoluble in water.
Cr(VI) compounds have mostly lemon yellow to orange to dark red hues. They are typically crystalline, granular, or powdery although one compound (chromyl chloride) exists in liquid form. They range from very soluble to insoluble in water. For example, chromyl chloride is a dark red liquid that decomposes into chromate ion and hydrochloric acid in water. Chromic acids are dark red crystals that are very soluble in water. Other examples of soluble chromates are potassium chromate (lemon yellow crystals), sodium chromate (yellow crystals), and sodium dichromate (reddish to bright orange crystals). Nickel chromate, lead chromate oxide, and zinc chromate are completely insoluble in water. The nickel chromate (black crystals) dissolves in nitric acid and hydrogen peroxide. Lead chromate oxide is a red crystalline powder. The zinc chromate (lemon yellow crystals) decomposes in hot water and is soluble in acids and liquid ammonia. Examples of slightly soluble Cr(VI) compounds are barium (light yellow), calcium (yellow), lead (yellow to orange-yellow), and strontium (yellow) chromates, and zinc chromate hydroxide (yellow). They all exist in solid form as crystals or powder. Potassium zinc chromate hydroxide (greenish-yellow crystals) is also slightly soluble in water.
Some major users of chromium are the metallurgical, refractory, and chemical industries. Chromium is used by the metallurgical industry to produce stainless steel, alloy steel, and nonferrous alloys. Chromium is alloyed with other metals and plated on metal and plastic substrates to improve corrosion resistance and provide protective coatings for automotive and equipment accessories. Welders use stainless steel welding rods when joining metal parts.
Cr(VI) compounds are widely used in the chemical industry in pigments, metal plating, and chemical synthesis as ingredients and catalysts. Chromates are used as high quality pigments for textile dyes, paints, inks, glass, and plastics. Cr(VI) can be produced during welding operations even if the chromium was originally present in another valence state. While Cr(VI) is not intentionally added to portland cement, it is often present as an impurity.
Occupational exposures to Cr(VI) can occur from inhalation of mists (
There are about thirty major industries and processes where Cr(VI) is used. These include producers of chromates and related chemicals from chromite ore, electroplating, welding, painting, chromate pigment production and use, steel mills, and iron and steel foundries. A detailed discussion of the uses of Cr(VI) in industry is found in Section IX of this preamble.
The studies of adverse health effects resulting from exposure to hexavalent chromium (Cr(VI)) in humans and experimental animals are summarized in the section below. Section VI includes information on the fate of Cr(VI) in the body and laboratory research that relates to its toxic mode of action. The primary health impairments from workplace exposure to Cr(VI) are lung cancer, asthma, and damage to the nasal epithelia and skin. This chapter on health effects will not attempt to describe every study ever conducted on Cr(VI) toxicity. Instead, only the most important articles and reviews of studies will be evaluated.
Chromium can exist in a number of valence states from −2 to +6 valence. The most common forms are the elemental metal Cr(0), trivalent Cr(III), and hexavalent Cr(VI). Chromium exists naturally in the environment in
Various anatomical, physical and physiological factors determine both the fractional and regional deposition of inhaled particulate matter. Due to the airflow patterns in the lung more particles tend to deposit at certain preferred regions in the lung. Schlesinger and Lippman have shown a high degree of correlation between sites of greatest particle deposition in the tracheobronchial airways and increased incidence of bronchial tumors (Ex. 35-102). It is possible to have a buildup of chromium at certain sites in the bronchial tree that could create areas of very high chromium concentration. This would especially be true for occupational environments that are particularly dusty or contain other irritating aerosols.
Large inhaled particles (>5 μm) are efficiently removed from the air-stream in the extrathoracic region (Ex. 35-175). Particles greater than 2.5 μm are generally deposited in the tracheobronchial regions, whereas particles less than 2.5 μm are generally deposited in the pulmonary region. Some larger particles (>2.5 μm) can reach the pulmonary region. The mucociliary escalator predominantly clears particles that deposit in the extrathoracic and the tracheobronchial region of the lung. Individuals exposed to high particulate levels of Cr(VI) may also have altered respiratory mucociliary clearance. Particulates that reach the alveoli can be absorbed into the bloodstream cleared by phagocytosis.
The absorption of inhaled chromium compounds depends on a number of factors, including physical and chemical properties of the particles (oxidation state, size, solubility) and the activity of alveolar macrophages (Ex. 35-41). The hexavalent chromate anion (CrO
Once the Cr(VI) particles reach the alveoli, absorption into the bloodstream is greatly dependent on solubility. Bragt and van Dura demonstrated that more soluble chromates are absorbed faster than less soluble chromates (Ex. 35-56). Insoluble chromates are poorly absorbed and therefore have longer resident time in the lungs. They studied the kinetics of three Cr(VI) compounds: Sodium chromate, zinc chromate and lead chromate. They instilled
The studies by Langard
Several other studies have reported absorption of chromium from the lungs after intratracheal instillation (Exs. 7-9; 9-81; Visek
Evidence indicates that even chromates that are encapsulated in a paint matrix may be released in the lungs (Ex. 31-15, p. 2). LaPuma
A number of questions remain unanswered regarding encapsulated Cr(VI) and bioavailability from the lung. There is a lack of detailed information on the encapsulation process. The efficiency of encapsulation and whether all of the chromate molecules are
Both human and animal studies demonstrate that Cr(VI) compounds are absorbed after dermal exposure. Dermal absorption depends on the oxidation state of chromium, the vehicle and the integrity of the skin. Cr(VI) readily traverses the epidermis to the dermis (Exs. 9-49; 309). The histological distribution of Cr(VI) within intact human skin was studied by Liden and Lundberg (Ex. 35-80). They applied test solutions of potassium dichromate in petrolatum or in water as occluded circular patches of filter paper to the skin. Results with potassium dichromate in water revealed that Cr(VI) penetrated beyond the dermis and penetration reached steady state with resorption by the lymph and blood vessels by 5 hours. About 10 times more chromium penetrated when potassium dichromate was applied in petrolatum than when applied in water, indicating that organic solvents facilitate the absorption of Cr(VI) from the skin. Baranowska-Dutkiewicz also demonstrated that the absorption rates of sodium chromate solutions from the occluded forearm skin of volunteers increase with increasing concentration (Ex. 35-75). The rates were 1.1 μg Cr(VI)/cm
Using volunteers, Mali found that potassium dichromate penetrates the intact epidermis (Exs. 9-49; 35-41). Wahlberg and Skog demonstrated the presence of chromium in the blood, spleen, bone marrow, lymph glands, urine and kidneys of guinea pigs exposed to
Inhaled Cr(VI) can enter the digestive tract as a result of mucocilliary clearance and swallowing. Studies indicate Cr(VI) is absorbed from the gastrointestinal tract. The six-day fecal and 24-hour urinary excretion patterns of radioactivity in groups of six volunteers given Cr(VI) as sodium chromate labeled with
In the gastrointestinal tract, Cr(VI) can be reduced to Cr(III) by gastric juices, which is then poorly absorbed (Underwood, 1971 as cited in Ex. 19-1; Ex. 35-85). The mechanism by which Cr(VI) is carried across the intestinal wall and the site of absorption are not known and may well depend upon the efficiency of defense mechanisms (Mertz, 1969 as cited in Ex. 19-1).
Kuykendall
Studies with
Treatment of rats by gavage with an unencapsulated lead chromate pigment or with a silica-encapsulated lead chromate pigment resulted in no measurable blood levels of chromium (measured as Cr(III), detection limit=10 μg/L) after two or four weeks of treatment or after a two-week recovery period. However, kidney levels of chromium (measured as Cr(III)) were significantly higher in the rats that received the unencapsulated pigment when compared to the rats that received the encapsulated pigment, indicating that silica encapsulation may reduce the gastrointestinal bioavailability of chromium from lead chromate pigments (Ex. 11-5). This study does not address the bioavailability of encapsulated chromate pigments from the lung where residence time could be different.
Once in the bloodstream, Cr(VI) is taken up into erythrocytes, where it is reduced to lower oxidation states and forms chromium protein complexes during reduction (Ex. 35-41). Once complexed with protein, chromium cannot leave the cell. The binding of chromium compounds by proteins in the blood has been studied in some detail (Exs. 5-24; 35-41; 35-52). It was found that intravenously injected anionic Cr(VI) passes through the membrane of red blood cells and binds to the globin fraction of hemoglobin. It has been hypothesized that before Cr(VI) is bound by hemoglobin, it is reduced to Cr(III) by an enzymatic reaction within red blood cells. Once inside the blood cell, chromium ions are unable to repenetrate the membrane and move back into the plasma (Exs. 7-6; 7-7; 19-1; 35-41; 35-52). According to Aaseth
Examination of autopsy tissues from chromate workers who were occupationally exposed to Cr(VI) showed that the highest chromium levels were in the lungs. The liver, bladder, and bone also had chromium levels above background. Mancuso examined tissues from three individuals with lung cancer who were exposed to chromium in the workplace (Ex. 124). One was employed for 15 years as a welder, the second and third worked for 10.2 years and 31.8 years, respectively, in ore milling and preparations and boiler operations. The cumulative
Animal studies have shown similar distribution patterns after inhalation exposure. The distribution of Cr(VI) compared with Cr(III) was investigated in guinea pigs after intratracheal instillation of potassium dichromate or chromium trichloride (Ex. 7-8). At 24 hours after instillation, 11% of the original dose of chromium from potassium dichromate remained in the lungs, 8% in the erythrocytes, 1% in plasma, 3% in the kidney, and 4% in the liver. The muscle, skin, and adrenal glands contained only a trace. All tissue concentrations of chromium declined to low or nondetectable levels in 140 days, with the exception of the lungs and spleen. After chromium trichloride instillation, 69% of the dose remained in the lungs at 20 minutes, while only 4% was found in the blood and other tissues, with the remaining 27% cleared from the lungs and swallowed. The only tissue that contained a significant amount of chromium two days after instillation of chromium trichloride was the spleen. After 30 and 60 days, 30 and 12%, respectively, of the Cr(III) was retained in the lungs, while only 2.6 and 1.6%, respectively, of the Cr(VI) dose was retained in the lungs.
Cr(VI) is reduced to Cr(III) in the lungs by a variety of reducing agents. This serves to limit uptake into lung cells and absorption into the bloodstream. Cr(V) and Cr(IV) are transient intermediates in this process. The genotoxic effects produced by the Cr(VI) are related to the reduction process and are further discussed in the section on Mechanistic Considerations.
Excretion of chromium from Cr(VI) compounds is predominantly in the urine, although there is some biliary excretion into the feces. In both urine and feces, the chromium is present as low molecular weight Cr(III) complexes. Absorbed chromium is excreted from the body in a rapid phase representing clearance from the blood and at least two slower phases representing clearance from tissues. Urinary excretion accounts for over 50% of eliminated chromium (Ex. 35-41). Although chromium is excreted in urine and feces, the intestine plays only a minor part in chromium elimination, representing only about 5% of elimination from the blood (Ex. 19-1). Normal urinary levels of chromium in humans have been reported to range from 0.24-1.8 μg/L with a median level of 0.4 μg/L (Ex. 35-79). Humans exposed to 0.05-1.7 mg Cr(III)/m
A half-life of 15-41 hours has been estimated for chromium in urine for four welders using a linear one-compartment kinetic model (Exs. 35-73; 5-52; 5-53). Limited work on modeling the absorption and deposition of chromium indicates that adipose and muscle tissue retain chromium at a moderate level for about two weeks, while the liver and spleen store chromium for up to 12 months. The estimated half-life for whole body chromium retention is 22 days for Cr(VI) and 92 days for Cr(III) (Ex. 19-1). The half-life of chromium in the human lung is 616 days, which is similar to the half-life in rats (Ex. 7-5).
Elimination of chromium was shown to be very slow in rats exposed to 2.1 mg Cr(VI)/m
Information regarding the excretion of chromium in humans after dermal exposure to chromium or its compounds is limited. Fourteen days after application of a salve containing potassium chromate, which resulted in skin necrosis and sloughing at the application site, chromium was found at 8 mg/L in the urine and 0.61 mg/100 g in the feces of one individual (Brieger 1920 as cited in Ex. 19-1). A slight increase over background levels of urinary chromium was observed in four subjects submersed in a tub of chlorinated water containing 22 mg Cr(VI)/L as potassium dichromate for three hours (Ex. 31-22-6). For three of the four subjects, the increase in urinary chromium excretion was less than 1 μg/day over the five-day collection period. Chromium was detected in the urine of guinea pigs after radiolabeled sodium chromate solution was applied to the skin (Ex. 35-81).
O'Flaherty developed physiologically-based pharmacokinetic (PBPK) models that simulate absorption, distribution, metabolism, and excretion of Cr(VI) and Cr(III) compounds in humans (Ex. 35-95) and rats (Exs. 35-86; 35-70). The original model (Ex. 35-86) evolved from a similar model for lead, and contained compartments for the lung, GI tract, skin, blood, liver, kidney, bone, well-
The model was developed from several data sets in which rats were dosed with Cr(VI) or Cr(III) intravenously, orally or by intratracheal instillation, because different distribution and excretion patterns occur depending on the route of administration. In most cases, the model parameters (
A human PBPK model recently developed by O'Flaherty
PBPK models are increasingly used in risk assessments, primarily to predict the concentration of a potentially toxic chemical that will be delivered to any given target tissue following various combinations of route, dose level, and test species. Further development of the respiratory tract portion of the model, specific Cr(VI) rate data on extracellular reduction and uptake into lung cells, and more precise understanding of critical pathways inside target cells would improve the model value for risk assessment purposes.
Based on the studies presented above, evidence exists in the literature that shows Cr(VI) can be systemically absorbed by the respiratory tract. The absorption of inhaled chromium compounds depends on a number of factors, including physical and chemical properties of the particles (oxidation state, size, and solubility), the reduction capacity of the ELF and alveolar macrophages and clearance by the mucocliary escalator and phagocytosis. Soluble Cr(VI) compounds enter the bloodstream more readily than highly insoluble Cr(VI) compounds. However, insoluble compounds may have longer residence time in lung. Absorption of Cr(VI) can also take place after oral and dermal exposure, particularly if the exposures are high.
The chromate (CrO
Inhaled Cr(VI) is reduced to Cr(III)
Absorbed chromium is excreted from the body in a rapid phase representing clearance from the blood and at least two slower phases representing clearance from tissues. Urinary excretion is the primary route of elimination, accounting for over 50% of eliminated chromium. Although chromium is excreted in urine and feces, the intestine plays only a minor part in chromium elimination representing only about 5% of elimination from the blood.
There has been extensive study on the potential for Cr(VI) to cause carcinogenic effects, particularly cancer of the lung. OSHA reviewed epidemiologic data from several industry sectors including chromate production, chromate pigment production, chromium plating, stainless steel welding, and ferrochromium production. Supporting evidence from animal studies and mechanistic considerations are also evaluated in this section.
The epidemiologic literature of workers in the chromate production industry represents the earliest and best-documented relationship between exposure to chromium and lung cancer. The earliest study of chromate production workers in the United States was reported by Machle and Gregorius in 1948 (Ex.7-2). In the United States, two chromate production plants, one in Baltimore, Maryland and one in Painesville, Ohio have been the subject of multiple studies. Both plants were included in the 1948 Machle and Gregorius study and again in the study conducted by the Public Health Service and published in 1953 (Ex. 7-3). Both of these studies reported the results in aggregate. The Baltimore chromate production plant was studied by Hayes
The basic hexavalent chromate production process involves milling and mixing trivalent chromite ore with soda ash, sometimes in the presence of lime (Exs. 7-103; 35-61). The mixture is “roasted” at a high temperature, which oxidizes much of the chromite to hexavalent sodium chromate. Depending on the lime content used in the process, the roast also contains other chromate species, especially calcium chromate under high lime conditions. The highly water-soluble sodium chromate is water-extracted from the water-insoluble trivalent chromite and the less water-soluble chromates (
a.
Hayes divided the production process into three departments: (1) The mill and roast or “dry end” department which consists of grinding, roasting and leaching processes; (2) the bichromate department which consists of the acidification and crystallization processes; and (3) the special products department which produces secondary products including chromic acid. The bichromate and special products departments are referred to as the “wet end”.
The construction of a new mill and roast and bichromate plant that opened during 1950 and 1951 and a new chromic acid and special products plant that opened in 1960 were cited by Hayes as “notable production changes” (Ex. 7-
Plant-related work and health histories were abstracted for each employee from plant records. Each job on the employee's work history was characterized according to whether the job exposure occurred in (1) a newly constructed facility, (2) an old facility, or (3) could not be classified as having occurred in the new or the old facility. Those who ever worked in an old facility or whose work location(s) could not be distinguished based upon job title were considered as having a high or questionable exposure. Only those who worked exclusively in the new facility were defined for study purposes as “low exposure”. Data on cigarette smoking was abstracted from plant records, but was not utilized in any analyses since the investigators thought it “not to be of sufficient quality to allow analysis.”
One thousand one hundred and sixty nine (1,169) cohort members were identified as alive, 494 not individually identified as alive and 438 as deceased. Death certificates could not be located for 35 reported decedents. Deaths were coded to the 8th revision of the
Mortality analysis was limited to the 1,803 hourly employees calculating the standardized mortality ratios (SMRs) for specific causes of death. The SMR is a ratio of the number of deaths observed in the study population to the number that would be expected if that study population had the same specific mortality rate as a standard reference population (
Analysis of lung cancer deaths among hourly workers by year of initial employment (1945-1949; 1950-1959 and 1960-1974), exposure category (low exposure or questionable/high exposure) and duration of employment (short term defined as 90 days-2 years; long term defined as 3 years +) was also conducted. For those workers characterized as having questionable/high exposure, the SMRs were significantly elevated for the 1945-1949 and the 1950-1959 hire periods and for both short- and long-term workers (not statistically significant for the short-term workers initially hired 1945-1949). For those characterized as low exposure, there was an elevated SMR for the long-term workers hired between 1950 and 1959, but based only on three deaths (not statistically significant). No lung cancer cases were observed for workers hired 1960-1974.
Case-control analyses of (1) a history of ever having been employed in selected jobs or combinations of jobs or (2) a history of specified morbid conditions and combinations of conditions reported on plant medical records were conducted. Cases were defined as decedents (both hourly and salaried were included in the analyses) whose underlying or contributing cause of death was lung cancer. Controls were defined as deaths from causes other than malignant or benign tumors. Cases and controls were matched on race (white/non-white), year of initial employment (+/−3 years), age at time of initial employment (+/−5 years) and total duration of employment (90 days-2 years; 3-4 years and 5 years +). An odds ratio (OR) was determined where the ratio is the odds of employment in a job involving Cr(VI) exposure for the cases relative to the controls.
Based upon matched pairs, analysis by job position showed significantly elevated odds ratios for special products (OR = 2.6) and bichromate and special products (OR = 3.3). The relative risk for bichromate alone was also elevated (OR = 2.1, not statistically significant).
The possible association of lung cancer and three health conditions (skin ulcers, nasal perforation and dermatitis) as recorded in the plant medical records was also assessed. Of the three medical conditions, only the odds ratio for dermatitis was statistically significant (OR = 3.0). When various combinations of the three conditions were examined, the odds ratio for having all three conditions was statistically significantly elevated (OR = 6.0).
Braver
Air samples were collected by both midget impingers and high volume samplers. According to the NIOSH/OSHA review, high volume samplers could have led to a “significant” loss of Cr(VI) due to the reduction of Cr(VI) to Cr(III) by glass or cellulose ester filters, acid extraction of the chromate from the filter, or improper storage of samples. The midget impinger was “less subject” to loss of Cr(VI) according to the panel since neither filters nor acid extraction from filters was employed. However, if iron was present or if the samples were stored for too long, conversion from Cr(VI) to Cr(III) may have occurred. The midget impinger can only detect water soluble Cr(VI). The authors noted that, according to a 1949 industrial hygiene survey by the U.S. Public Health Service, very little water insoluble Cr(VI) was found at the Baltimore plant. One NIOSH/OSHA panel member characterized midget impinger results as “reproducible” and “accuracy * * * fairly solid unless substantial reducing agents (
The authors also cite other factors related to the industrial hygiene data that could have potentially influenced the accuracy of their exposure estimates (either overestimating or underestimating the exposure). These include: measurements may have been taken primarily in “problem” areas of the plant; the plants may have been cleaned or certain processes shut down prior to industrial hygiene monitoring by outside groups; respirator use; and periodic high exposures (due to infrequent maintenance operations or failure of exposure control equipment) which were not measured and therefore not reflected in the available data.
The authors estimated exposure indices for cohorts rather than for specific individuals using hire period (1945-1949 or 1950-1959) and duration
Cumulative exposure was calculated as the usual exposure level × average duration. Short-term workers, regardless of length of employment, were assumed to have received 1.6 years of exposure regardless of hire period. For long-term workers, the average length of exposure was 12.3 years. Those hired 1945-1949 were assigned five years at an exposure of 413 μg/m
Gibb
Deaths were coded according to the 8th revision of the
Between 1950 and 1985, approximately 70,000 measurements of airborne Cr(VI) were collected utilizing several different sampling methods. The program of routine air sampling for Cr(VI) was initiated to “characterize ‘typical/usual exposures’ of workers” (Ex. 31-22-11, p.117). Area samples were collected during the earlier time periods, while both area and personal samples were collected starting in 1977. Exposure estimates were derived from the area sampling systems and were adjusted to “an equivalent personal exposure estimate using job-specific ratios of the mean area and personal sampling exposure estimates for the period 1978-1985 * * *.” (Ex. 31-22-11, p.117). According to the author, comparison of the area and personal samples showed “no significant differences” for about two-thirds of the job titles. For several job titles with a “significant point source of contamination” the area sampling methods “significantly underestimated” personal exposure estimates and were adjusted “by the ratio of the two” (Ex. 31-22-11, p.118).
A job exposure matrix (JEM) was constructed, where air sampling data were available, containing annual average exposure for each job title. Data could not be located for the periods 1950-1956 and 1960-1961. Exposures were modeled for the missing data using the ratio of the measured exposure for a job title to the average of all measured job titles in the same department. For the time periods where “extensive” data were missing, a simple straight line interpolation between years with known exposures was employed.
In an attempt to estimate airborne Cr(III) concentrations, 72 composite dust samples were collected at or near the fixed site air monitoring stations about three years after the facility closed. The dust samples were analyzed for Cr(VI) content using ion chromatography. Cr(III) content was determined through inductively coupled plasma spectroscopic analysis of the residue. The Cr(III):Cr(VI) ratio was calculated for each area corresponding to the air sampling zones and the measured Cr(VI) air concentration adjusted based on this ratio. Worker exposures were calculated for each job title and weighted by the fraction of time spent in each air-monitoring zone. The Cr(III):Cr(VI) ratio was derived in this manner for each job title based on the distribution of time spent in exposure zones in 1978. Cr(VI) exposures in the JEM were multiplied by this ratio to estimate Cr(III) exposures.
A total of 855 observed deaths (472 white; 323 nonwhite and 60 race unknown) were reported. SMRs were calculated using U.S. rates for overall mortality. Maryland rates (the state in which the plant was located) were used to analyze lung cancer mortality in order to better account for regional differences in disease fatality.
A statistically significant lung cancer SMR, based on the national rate, was found for whites (O=71; SMR=186; 95% CI: 145-234); nonwhites (O=47; SMR=188; 95% CI: 138-251) and the total cohort (O=122; SMR=180; 95% CI: 149-214). Of the 122 lung cancer cases, 116 were smokers and four were non smokers at the time of hire. Smoking status was unknown for two lung cancer cases. SMRs were not adjusted for smoking.
The ratio of observed to expected lung cancer deaths (O/E) for the entire cohort stratified by race and cumulative exposure quartile were computed. Cumulative exposure was lagged five years (only exposure occurring five years before a given age was counted). The cut point for the quartiles divided the cohort into four equal groups based upon their cumulative exposure at the end of their working history (0-0.00149 mgCrO
Proportional hazards models were used to assess the relationship between chromium exposure and the risk of lung cancer. The lowest exposure quartile was used as the reference group. The median exposure in each quartile was used as the measure of cumulative Cr(VI) exposure. When smoking status was included in the model, relative lung cancer risks of 1.83, 2.48 and 3.32 for the second, third and fourth exposure quartiles respectively were estimated. Smoking, Cr(III) exposure, and work duration were also significant predictors of lung cancer risk in the model.
The analysis attempted to separate the effects into two multivariate proportionate hazards models (one model incorporated the log of cumulative Cr(VI) exposure, the log of cumulative Cr(III) exposure and smoking; the second incorporated the log of cumulative Cr(VI), work duration and smoking). In either regression model, lung cancer mortality remained significantly associated (p < .05) with
Exponent, as part of a larger submission from the Chrome Coalition, submitted comments on the Gibb paper asking that OSHA review methodological issues believed by Exponent to impact upon the usefulness of the Gibb data in a risk assessment analysis. While Exponent states that the Gibb study offers data that “are substantially better for cancer risk than the Mancuso study* * *” they believe that further scrutiny of some of the methods and analytical procedures are necessary (Ex. 31-18-15-1, p. 5).
The issues raised by Exponent and the Chrome Coalition (Ex. 31-18-14) concerning the Gibb paper are: selection of the appropriate reference population for compilation of expected numbers for use in the SMR analysis; inclusion of short term workers (<1 year); expansion of the number of exposure groupings to evaluate dose response trends; analyzing dose response by peak JEM exposure levels; analyzing dose-response at exposures above and below the current PEL and calculating smoking-adjusted SMRs for use in dose-response assessments. Exponent obtained the original data from the Gibb study. The data were reanalyzed to address the issues cited above. Exponent's findings are presented in Exhibit 31-18-15-1 and are discussed below.
Exponent suggests that Gibb's use of U.S. and Maryland mortality rates for developing expectations for the SMR analysis was inappropriate and suggested that Baltimore city mortality rates would have been the appropriate standard to select since those mortality rates would more accurately reflect the mortality experience of those who worked at the plant. Exponent reran the SMR analysis to compare the SMR values reported by Gibb (U.S. mortality rates for SMR analysis) with the results of an SMR analysis using Maryland mortality rates and Baltimore mortality rates. Gibb reported a lung cancer SMR of 1.86 (95% CI: 1.45-2.34) for white males based upon 71 lung cancer deaths using U.S. mortality rates. Reanalysis of the data produced a lung cancer SMR of 1.85 (95% CI: 1.44-2.33) for white males based on U.S. mortality rates, roughly the same value obtained by Gibb. When Maryland and Baltimore rates are used, the SMR drops to 1.70 and 1.25 respectively.
Exponent suggested conducting sensitivity analysis that excludes short-term workers (defined as those with one year of employment) since the epidemiologic literature suggests that the mortality of short-term workers is different than long-term workers. Short-term workers in the Gibb study comprise 65% of the cohort and 54% of the lung cancers. The Coalition also suggested that data pertaining to short-term employee's information are of “questionable usefulness for assessing the increased cancer risk from chronic occupational exposure to Cr(VI)” (Ex. 31-18-15-1, p. 5).
Lung cancer SMRs were calculated for those who worked <1 year and for those who worked one year or more. Exponent defined short-term workers as those who worked a minimum of one year “because it is consistent with the inclusion criteria used by others studying chromate chemical production worker cohorts'' (Ex. 31-18-15-1, p. 12). Exponent also suggested that Gibb's breakdown of exposure by quartile was not the most “appropriate” way of assessing dose-response since cumulative Cr(VI) exposures remained near zero until the 50th to 60th percentile, “so there was no real distinction between the first two quartiles * * *” (Ex. 31-18-15-1, p. 24). They also suggested that combining “all workers together at the 75th quartile * * * does not properly account for the heterogeneity of exposure in this group” (Ex. 31-18-15-1, p. 24). The Exponent reanalysis used six cumulative exposure levels of Cr(VI) compared with the four cumulative exposure levels of Cr(VI) in the Gibb analysis. The lower levels of exposure were combined and “more homogeneous” categories were developed for the higher exposure levels.
Using these re-groupings and excluding workers with less than one year of employment, Exponent reported that the highest SMRs are seen in the highest exposure group (1.5<5.25 mg CrO
Analysis of length of employment and “peak” (i.e., highest recorded mean annual) exposure level to Cr(VI) was conducted. Exponent reported that approximately 50% of the cohort had “only very low” peak exposure levels (<07.2 μg CrO
The Exponent analysis of workers who were ever exposed above the current PEL versus those never exposed above the current PEL produced slightly higher SMRs for those ever exposed, with the SMRs higher using the Maryland standard rather than the Baltimore standard. The only statistically significant result was for all lung cancer deaths combined.
Assessment was made of the potential impact of smoking on the lung cancer SMRs since Gibb did not adjust the SMRs for smoking. Exponent stated that the smoking-adjusted SMRs are more appropriate for use in the risk assessment than the unadjusted SMRs. It should be noted that smoking adjusted SMRs could not be calculated using Baltimore reference rates. As noted by the authors, the smoking adjusted SMRs produced using Maryland reference rates are, by exposure, “reasonably consistent with the Baltimore-referenced SMRs” (Ex. 31-18-15-1, p. 41).
Gibb
Hayes
Gibb's selection of the cut points for the exposure quartiles is accomplished by dividing the workers in the cohort into four equal groups based on their cumulative exposure at the end of their working history. Using the same method but excluding the short-term workers would have resulted in slightly different cumulative exposure quartiles. Exponent expressed a preference for a six-tiered exposure grouping. The impact of using different exposure groupings is further discussed in preamble section VII.C of the preliminary quantitative risk assessment.
The exposure matrix of Gibb
Exponent and the Chrome Coalition also suggested that the SMRs should have been adjusted for smoking. According to Exponent, smoking adjusted SMRs based upon the Maryland mortality rates produced SMRs similar to the SMRs obtained using Baltimore mortality rates (Ex. 31-18-15-1). The accuracy of the smoking data is still questionable since it represents information obtained at the time of hire. Hayes abstracted the smoking data from the plant medical records, but “found it not to be of sufficient quality to allow analysis.” One advantage to using the Baltimore mortality data may be to better control for the potential confounding of smoking.
Despite the potential methodological limitations of the Gibb study, this is one of the better cohort mortality studies of workers in the chromium production industry. The quality of the available industrial hygiene data and its characterization as “typical/usual” makes the Gibb study useful for risk assessment.
b.
Mancuso (Ex. 7-11) updated his 1951 study of 332 chromate production workers employed during the period 1931-1937. Age adjusted mortality rates were calculated by the direct method using the distribution of person years by age group for the total chromate population as the standard. Vital status follow-up through 1974 found 173 deaths. Of the 66 cancer deaths, 41 (62.1%) were lung cancers. A cluster of lung cancer deaths was observed in workers with 27-36 years since first employment.
Mancuso used industrial hygiene data collected in 1949 to calculate weighted average exposures to water-soluble (presumed to be Cr(VI)), insoluble (presumed to be principally Cr(III)) and total chromium (Ex. 7-98). The age-adjusted lung cancer death rate increased from 144.6 (based upon two deaths) to 649.6 (based upon 14 deaths) per 100,000 in five exposure categories ranging from a low of 0.25-0.49 to a high of 4.0+ mg/m
Age-adjusted lung cancer death rates also were calculated by classifying workers by the levels of insoluble Cr(III) and total chromium exposure. From the data presented, it appears that for a fixed level of insoluble Cr(III), the lung cancer risk appears to increase as the total chromium increases (Ex. 7-11).
Mancuso (Ex. 23) updated the 1975 study. As of December 31, 1993, 283 (85%) cohort members had died and 49 could not be found. Of the 102 cancer deaths, 66 were lung cancers. The age-adjusted lung cancer death rate per 100,000 ranged from 187.9 (based upon four deaths) to 1,254.1 (based upon 15 deaths) for insoluble Cr(III) exposure categories ranging from 0.25-0.49 to 4.00-5.00 mg/m
The age-adjusted lung cancer death rate per 100,000 ranged from 99.7 (based upon five deaths) to 2,848.3 (based upon two deaths) for soluble Cr(VI) exposure categories ranging from <0.25 to 4.00+ mg/m
To investigate whether the increase in the lung cancer death rate was due to one form of chromium compound (presumed insoluble Cr(III) or soluble Cr(VI)), age-adjusted lung cancer mortality rates were calculated by classifying workers by the levels of exposure to insoluble Cr(III) and total chromium. For a fixed level of insoluble Cr(III), the lung cancer rate appears to increase as the total chromium increases for each of the six total chromium exposure categories, except for the 1.00-1.99 mg/m
For a fixed level of soluble Cr(VI), the lung cancer death rate increased as total chromium categories of exposure increased for three of the six gradients of soluble Cr(VI). For the fixed exposure categories of total chromium, the increasing exposure to specific levels of
Luippold
Information on potential confounders was limited. Smoking status (yes/no) was available for only 35% of the cohort from surveys administered between 1960 and 1965 or from employee medical files. For those employees where smoking data were available, 78% were smokers (responded yes on at least one survey or were identified as smokers from the medical file). Information on race also was limited, the death certificate being the primary source of information.
Results of the vital status follow-up were: 303 deaths; 132 presumed alive and 47 vital status unknown. Deaths were coded to the 9th revision of the
SMRs were calculated based upon two reference populations: the U.S. (white males) and the state of Ohio (white males). Lung cancer SMRs stratified by year of hire, duration of exposure, time since first employment and cumulative exposure group also were calculated.
Proctor
The production of water-soluble sodium chromate was the primary operation at the Painesville plant. It involved a high lime roasting process that produced a water insoluble Cr(VI) residue (calcium chromate) as byproduct that was transported in open conveyors and likely contributed to worker exposure until the conveyors were covered during plant renovations in 1949. The average airborne
Reductions in Cr(VI) levels over time coincided with improvements in the chromate production process. Industrial hygiene surveys over the period from 1957 to 1964 revealed average Cr(VI) levels of 270 μg/m
The average cumulative Cr(VI) exposure (mg/m
Sixty-three per cent of the study cohort was reported as deceased at the end of the follow-up period (December 31, 1997). There was a statistically significant increase for the all causes of death category based on both the national and Ohio state standard mortality rates (national: O=303; E=225.6; SMR=134; 95% CI: 120-150; state: O=303; E=235; SMR=129; 95% CI: 115-144). Fifty-three of the 90 cancer deaths were cancers of the respiratory system with 51 coded as lung cancer. The SMR for lung cancer is statistically significant using both reference populations (national O=51; E=19; SMR 268; 95% CI: 200-352; state O=51; E=21.2; SMR 241; 95% CI: 180-317).
SMRs also were calculated by year of hire, duration of employment, time since first employment and cumulative Cr(VI) exposure, mg/m
Lung cancer SMRs based upon duration of employment (years) increased as duration of employment increased. For those with one to four years of employment, the lung cancer SMR was 137 based upon nine deaths (E=6.6; 95% CI: 62-260); for five to nine years of employment, the lung cancer SMR was 160 (O=8; E=5.0; 95% CI: 69-314). For those with 10-19 years of employment, the lung cancer SMR was 169 (O=7; E=4.1; 95% CI: 68-349) and for those with 20 or more years of employment, the lung cancer SMR was 497 (O=27; E=5.4; 95% CI: 328-723).
Analyses of cumulative Cr(VI) exposure found the lung cancer SMR (based upon the Ohio standard) in the highest exposure group (2.70-27.80 mg/m
The Painesville cohort is small (482 employees). Excluded from the cohort were six employees who worked at other chromate plants after Painesville closed. However, exceptions were made for employees who subsequently worked at the company's North Carolina plant (number not provided) because exposure data were available from the North Carolina plant. Subsequent exposure to Cr(VI) by other terminated employees is unknown and not taken into account by the investigators. Therefore, the extent of the bias introduced is unknown.
The 10% lost to follow-up (47 employees) in a cohort of this size is striking. Four of the forty-seven had “substantial” follow-up that ended in 1997 just before the end date of the study. For the remaining 43, most were lost in the 1950s and 1960s (most is not defined). Since person-years are truncated at the time individuals are lost to follow up, the potential implication of lost person years could impact the width of the confidence intervals.
The authors used U.S. and Ohio mortality rates for the standards to compute the expectations for the SMRs, stating that the use of Ohio rates minimizes bias that could occur from regional differences in mortality. It is unclear why county rates were not used to address the differences in regional mortality.
c.
Baetjer reported the results of a case-control study based upon records of two Baltimore hospitals (Ex. 7-7). A history of working with chromates was determined from these hospital records and the proportion of lung cancer cases determined to have been exposed to chromates was compared with the proportion of controls exposed. Of the lung cancer cases, 3.4% had worked in a chromate manufacturing plant, while none of the controls had such a history recorded in the medical record. The results were statistically significant and Baetjer concluded that the data confirmed the conclusions reached by Machle and Gregorius that “the number of deaths due to cancer of the lung and bronchi is greater in the chromate-producing industry than would normally be expected” (Ex. 7-7, p. 516).
As a part of a larger study carried out by the U.S. Public Health Service, the morbidity and mortality of male workers in seven U.S. chromate manufacturing plants during the period 1940-1950 was reported (Exs. 7-1; 7-3). Nearly 29 times as many deaths from respiratory cancer (excluding larynx) were found among workers in the chromate industry when compared to mortality rates for the total U.S. for the period 1940-1948. The lung cancer risk was higher at the younger ages (a 40-fold risk at ages 15-45; a 30-fold risk at ages 45-54 and a 20-fold risk at ages 55-74). Analysis of respiratory cancer deaths (excluding larynx) by race showed an observed to expected ratio of 14.29 for white males and 80 for nonwhite males.
Taylor conducted a mortality study in a cohort of 1,212 chromate workers followed over a 24 year (1937-1960) period (Ex. 7-5). The workers were from three chromate plants that included approximately 70% of the total population of U.S. chromate workers in 1937. In addition, the plants had been in continuous operation for the study period (January 1, 1937 to December 31, 1960). The cohort was followed utilizing records of Old Age and Survivors Disability Insurance (OASDI). Results were reported both in terms of SMRs and conditional probabilities of survival to various ages comparing the mortality experience of chromate workers to the U.S. civilian male population. No measures of chromate exposure were reported although results are provided in terms of duration of employment. Taylor concluded that not only was there an excess in mortality from respiratory cancer, but from other causes as well, especially as duration of employment increased.
In a reanalysis of Taylor's data, Enterline excluded those workers born prior to 1989 and analyzed the data by follow-up period using U.S. rates (Ex. 7-4). The SMR for respiratory cancer for all time periods showed a nine-fold excess (O=69 deaths; E=7.3). Respiratory cancer deaths comprised 28% of all deaths. Two of the respiratory cancer deaths were malignant neoplasms of the maxillary sinuses, a number according to Enterline, “greatly in excess of that expected based on the experience of the U.S. male population.” Also slightly elevated were cancers of the digestive organs (O=16; E=10.4) and non-malignant respiratory disease (O=13; E=8.9).
Pastides
Personal air monitoring indicated that TWA Cr(VI) air concentrations were generally very low. Roughly half the samples were less than 1 μg/m
A study of four chromate producing facilities in New Jersey was reported by Rosenman (Ex. 35-104). A total of 3,408 individuals were identified from the four facilities over different time periods (plant A from 1951-1954; plant B from
Significantly elevated PMRs were seen for lung cancer among white males (170 deaths, PMR=1.95; 95% CI: 1.67-2.27) and black males (54 deaths, PMR=1.88; 95% CI: 1.41-2.45). PMRs were also significantly elevated (regardless of race) for those who worked 1-10, 11-20 and >20 years and consistently higher for white and black workers 11-20 years and >20 years since first hire. The results were less consistent for those with 10 or fewer years since first hire.
Bidstrup and Case reported the mortality experience of 723 workers at three chromate producing factories in Great Britain (Ex. 7-20). Lung cancer mortality was 3.6 times that expected (O=12; E=3.3) for England and Wales. Alderson
SMRs were computed for Eaglescliffe by duration of employment, which was defined, based upon plant process updates (those who only worked before the plant modification, those who worked both before and after the modifications, or those who worked only after the modifications were completed). Of the 179 deaths at the Eaglescliffe plant, 40 are in the pre-change group; 129 in the pre-/post-change and 10 in the post-change. A total of 36 lung cancer deaths occurred at the plant, in the pre-change group O= 7; E=2.3; SMR=303; in the pre-/post-change group O=27; E=13; SMR=2.03 and in the post-change group O=2; E=1.07; SMR=187.
In an attempt to address several potential confounders, regression analysis examined the contributions of various risk factors to lung cancer. Duration of employment, duration of follow-up and working before or after plant modification appear to be greater risk factors for lung cancer, while age at entry or estimated degree of chromate exposure had less influence.
Davies updated the work of Alderson,
Based upon the date of hire, the workers were assigned to one of three groups. The first, or “early” group, consists of workers hired prior to January 1945 who are considered long term workers, but do not comprise a cohort since those who left or died prior to 1950 are excluded. The second group, “pre-change” workers, were hired between January 1, 1945 to December 31, 1958 at Rutherglen or to December 31, 1960 at Eaglescliffe. Bolton employees starting from 1945 are also termed pre-change. The cohort of pre-change workers is considered incomplete since those leaving 1946-1949 could not be included and because of gaps in the later records. For those who started after 1953 and for all men staying 5+ years, this subcohort of pre-change workers is considered complete. The third group, “post-change” workers, started after the process changes at Eaglescliffe and Rutherglen became fully effective and are considered a “complete” cohort. A “control” group of workers from a nearby fertilizer facility, who never worked in or near the chromate plant, was assembled.
A total of 2,607 employees met the cohort entrance criteria. As of December 31, 1988, 1,477 were alive, 997 dead, 54 emigrated and 79 could not be traced (total lost to follow-up: 133). SMRs were calculated using the mortality rates for England and Wales and the mortality rates for Scotland. Causes of death were ascertained for all but three decedents and deaths were coded to the revision of the
There were 12 lung cancer deaths at Bolton, 117 at Rutherglen, 75 at Eaglescliffe and one among staff for a total of 205 lung cancer deaths. A statistically significant excess of lung cancer deaths (175 deaths) among early and pre-change workers is seen at Rutherglen and Eaglescliffe for both the adjusted and unadjusted SMRs. For Rutherglen, for the early period based upon 68 observed deaths, the adjusted SMR was 230 while the unadjusted SMR was 347 (for both SMRs p<0.001). For the 41 pre-change lung cancer deaths at Rutherglen, the adjusted SMR was 160 while the unadjusted SMR was 242 (for both SMRs p<0.001). At Eaglescliffe, there were 14 lung cancer deaths in the early period resulting in an adjusted SMR of 196 and an unadjusted SMR of 269 (for both SMRs p<0.05). For the pre-change period at Eaglescliffe, the adjusted SMR was 195 and the unadjusted was 267 (p<0.001 for both SMRs). At Bolton there is a non-significant excess among pre-change men. There are no apparent excesses in the post-change groups, the staff groups or in the non-exposed fertilizer group.
There is a highly significant overall excess of nasal cancers with two cases at Eaglescliffe and two cases at Rutherglen (O=4, Eadjusted=0.26; SMR=1538). All four men with nasal
Aw reported on two case-control studies conducted at the previously studies Eaglescliffe plant (Ex. 35-245). In 1960, the plant, converted from a “high-lime” to a ‘no-lime’ process, reducing the likelihood of calcium chromate formation. As of March 1996, 2,672 post-change workers had been employed, including 891 office personnel. Of the post-change plant personnel, 56% had been employed for more than one year. Eighteen lung cancer cases were identified among white male post-change workers (13 deceased; five alive). Duration of employment for the cases ranged from 1.5 to 25 years with a mean of 14.4. Sixteen of the lung cancer cases were smokers.
In the first case-control study reported, the 15 lung cancer cases identified up to September 1991 were matched to controls by age and hire date (five controls per case). Cases and controls were compared based upon their job categories within the plant. The results showed that cases were more likely to have worked in the kiln area than the controls. Five of the 15 cases had five or more years in the kiln area where Cr(VI) exposure occurred vs. six of the 75 controls. A second case-control study utilized the 18 lung cancer cases identified in post change workers up to March 1996. Five controls per case were matched by age (+/−5 years), gender and hire date. Both cases and controls had a minimum of one year of employment. A job exposure matrix was being constructed that would allow the investigators to “estimate exposure to hexavalent chromates for each worker in the study for all the jobs done since the start of employment at the site until 1980.” Starting in 1970 industrial hygiene sampling was performed to determine exposure for all jobs at the plant. Cr(VI) exposure levels for the period between 1960 and 1969 were being estimated based on the recall of employees regarding past working conditions relative to current conditions from a questionnaire. The author stated that preliminary analysis suggests that the maximum recorded or estimated level of exposure to Cr(VI) for the cases was higher than that of the controls. However, specific values for the estimated Cr(VI) exposures were not reported.
Korallus
Korallus
Process modifications at the two plants eliminated the high-lime process by January 1, 1958 at one location and January 1, 1964 at the second location. In addition, technical measures were introduced which led to reductions in the workplace air concentrations of chromate dusts. Cohort members were divided into pre- and post-change cohorts, with subcohorts in the pre-change group. SMRs were computed with the expected number of deaths derived from the regional mortality rates (where the plants are located). One plant had 695 workers (279 in the pre-change group and 416 in the post change group). The second plant had 722 workers (460 in the pre-change group and 262 in the post-change group). A total of 489 deaths were ascertained (225 and 264 deaths). Of the cohort members, 6.4% were lost to follow-up.
Lung cancer is defined as deaths coded 162 in the 9th revision of the
DeMarco
Exposure estimates were based upon the duration of cumulative exposure and upon a risk score (low, medium, high and not assessed) assigned to the department in which the worker was primarily employed. A committee assigned the scores, based upon knowledge of the production process or on industrial hygiene surveys taken in 1974, 1982 and 1984. The risk score is a surrogate for the workplace concentrations of Cr(VI) in the different plant departments. Since no substantial changes had been made since World War II, the assumption was made that exposures remained relatively stable. Lung cancer SMRs based upon type of exposure increased with level of exposure (Low: O=1; E=1.43; SMR=70; Medium: O=5; E=202; SMR=2.48; High: O=6; E=1.4; SMR=420; Not Assessed: O=2; E=1.6; SMR=126). Only the SMR for those classified as having worked in departments characterized as high exposure was statistically significant at the p<0.05 level.
A cohort study of workers at a chromium compounds manufacturing plant in Tokyo, Japan by Satoh
Results from the many studies of chromate production workers from different countries indicate a relationship between exposure to chromium and malignant respiratory disease. The epidemiologic studies done between 1948 and 1952 by Machle and Gregorius (Ex. 7-2), Mancuso and Hueper (Ex. 7-12) and Brinton,
It is worth noting that the magnitude of difference in the relative risks reported in a mortality study among workers in three chromate plants in the U.K. (Ex.7-20) were lower than the relative risks reported for chromate workers in the U.S. during the 1950s and 1960s. The observed difference could be the result of a variety of factors including different working conditions in the two countries, a shorter follow-up period in the British study, the larger lost-to-follow-up in the British study or the different statistical methods employed. While the earlier studies established that there was an excess risk for respiratory cancer from exposure to chromium, they were unable to specify either a specific chromium compound responsible or an exposure level associated with the risk. Later studies were able to use superior methodologies to estimate standardized lung cancer mortality ratios between chromate production cohorts and appropriate reference populations (Exs. 7-14; 7-22; 7-26; 7-99; 7-91). These studies generally found statistically increased lung cancer risk of around two-fold. The studies usually found trends with duration of employment, year of hire, or some production process change that tended to implicate chromium exposure as the causative agent.
The most recent studies were able to use industrial hygiene data to reconstruct historical Cr(VI) exposures and show statistically significant associations between cumulative airborne Cr(VI) and lung cancer mortality (Exs. 23; 31-22-11; Ex. 31-18-4). Gibb
The Davies, Korallus, and Luippold studies examine mortality patterns at chromate producing facilities where one production process modification involved conversion from a high-lime to a low-lime or a lime-free process (Exs. 7-99; 7-91; 31-18-4). In addition to process modification, technical improvements also were implemented that lowered Cr(VI) exposure. One of the plants in the Davies study retained the high-lime process and is not discussed. The lung cancer SMRs for one British plant and both of the German plants declined from early, to pre-change to post change time periods. In the remaining British plants, the lung cancer SMR is basically identical for the early and pre-change period, but does decline in the post-change time period. The lung cancer SMR in the Luippold cohort also declined over time as the amount of lime was reduced in the roasting process. Other modifications at the Painesville plant that reduced airborne Cr(VI) exposure, such as installation of covered conveyors and conversion from batch to continuous process occurred at the same time (Ex. 35-61). It is not clear whether reduced levels of the high-lime byproduct, calcium chromate, or the roasting/leaching end product, sodium dichromate that resulted from the various process changes is the reason for the decrease in lung cancer SMRs in these cohorts. However, it should be noted increased lung cancer risk was experienced by workers at the Baltimore plant (
Chromium compounds are used in the manufacture of pigments to produce a wide range of vivid colors. Lead and zinc chromates have historically been the predominant hexavalent chromium pigments, although others such as strontium and barium chromate have also been produced. These chromates vary considerably in their water solubility with lead and barium chromates being the most water insoluble. All of the above chromates are less water-soluble than the highly water-soluble sodium chromate and dichromate that usually serve as the starting material for chromium pigment production. The reaction of sodium chromate or dichromate with the appropriate zinc or lead compound to form the corresponding lead or zinc chromate takes place in solution. The chromate pigment is then precipitated, separated, dried, milled, and packaged. Worker exposures to chromate pigments are greatest during the milling and packaging stages.
There have been a number of cohort studies of chromate pigment production workers from the United States, the United Kingdom, France, Germany, the Netherlands, Norway and Japan. Most of the studies found significantly elevated lung cancers in workers exposed to Cr(VI) pigments over many years when compared against standardized reference populations. In general, the studies of chromate pigment workers lack the historical exposure data found in some of the chromate production cohorts. The consistently higher lung cancers across several worker cohorts exposed to the less water-soluble Cr(VI) compounds complements the lung cancer findings from the studies of workers producing highly water soluble chromates and adds to the further evidence that occupational exposure to Cr(VI) compounds should be regarded as carcinogenic. A summary of selected human epidemiologic studies in chromate production workers is presented in Table VI-2.
Langard and Vigander updated a cohort study of lung cancer incidence in 133 workers employed by a chromium pigment production company in Norway (Ex. 7-36). The cohort was originally studied by Langard and Norseth (Ex. 7-33). Twenty-four men had more than three years of exposure to chromate dust. From 1948, when the company was founded, until 1951, only lead chromate pigment was produced. From 1951 to 1956, both lead chromate and zinc chromate pigments were produced and from 1956 to the end of the study period in 1972 only zinc chromate was produced. Workers were exposed to chromates both as the pigment and its raw material, sodium dichromate.
The numbers of expected lung cancers in the workers were calculated using the age-adjusted incidence rates for lung cancer in the Norwegian male population for the period 1955-1976. Follow-up using the Norwegian Cancer Registry through December 1980, found the twelve cancers of which seven were lung cancers. Six of the seven lung cancers were observed in the subcohort of 24 workers who had been employed for more than three years before 1973. There was an increased lung cancer incidence in the subcohort based on an observed to expected ratio of 44 (O=6; E=0.135). Except for one case, all lung cancer cases were exposed to zinc chromates and only sporadically to other chromates. Five of the six cases were known to be smokers or ex-smokers. Although the authors did not report any formal statistical comparisons, the extremely high age-adjusted standardized incidence ratio suggests that the results would likely be statistically significant.
Davies reported on a cohort study of English chromate pigment workers at three factories that produced chromate pigments since the 1920s or earlier (Ex. 7-41). Two of the factories produced both zinc and lead chromate. Both products were made in the same sheds and all workers had mixed exposure to both substances. The only product at the third factory was lead chromate.
Cohort members are defined as males with a minimum of one year of employment first hired between 1933 and 1967 at plant A; 1948 and 1967 at plant B and 1946-1961 at plant C. The analysis excludes men who entered employment later than 1967 because of the short follow-up period. Three hundred and ninety-six (396) men from Factory A, 136 men from Factory B and 114 men from Factory C were followed to mid-1977. Ninety-four workers with 3-11 months employment during 1932-1945 at Factory A were also included. Expectations were based upon calendar time period-, gender- and age-specific national cancer death rates for England and Wales. The author adjusted the death rates for each factory for local differences, but the exact methods of adjustment were not explicit.
Exposure to chromates was assigned as high for those in the dry departments where pigments were ground, blended and packed; medium for those in the wet departments where precipitates were washed, pressed and stove dried and in maintenance or cleaning which required time in various departments; or low for those jobs which the author states involved “slight exposure to chromates such as most laboratory jobs, boiler stoking, painting and bricklaying” (Ex. 7-41, p. 159). The high and
For those entering employment from 1932 to 1954 at Factory A, there were 18 lung cancer deaths in the high/medium exposure group, with 8.2 deaths expected. The difference is significant at p<. 01. In the low exposure group, the number of observed and expected lung cancer deaths was equal (two deaths). There were no lung cancer deaths at Factory A for those hired between 1955-1960 and 1961-1967.
For those entering employment between 1948 and 1967 at Factory B, there were seven observed lung cancer deaths in the high/medium exposure group with 1.4 expected which is statistically significant at p<. 001. At Factory C (which manufactured only lead chromate), there was one death in the high/medium exposure group and one death in the low exposure group for those beginning employment between 1946 and 1967.
The author points out that:
There has been no excess lung cancer mortality amongst workers with chromate exposure rated as “low”, nor among those exposed only to lead chromate. High and medium exposure-rated workers who in the past had mixed exposure to both lead and zinc chromate have experienced a marked excess of lung cancer deaths, even if employed for as little as one year” (Ex. 7-41, p. 157).
Davies updated the lung cancer mortality at the three British chromate pigment production factories (Ex. 7-42). The follow-up was through December 31, 1981. The cohort was expanded to include all male workers completing one year of service by June 30, 1975 but excluded office workers.
Among workers at Factory A with high and medium exposure, mortality was statistically significantly elevated over the total follow-up period among entrants hired from 1932 to 1945 (O/E=2.22). A similar, but not statistically significant, excess was seen among entrants hired from 1946 to 1954 (O/E=2.23). The results for Factory B showed statistically significantly elevated lung cancer mortality among workers classified with medium exposures entering service during the period from 1948 to 1960 (O/E=3.73) and from 1961 to 1967 (O/E=5.62). There were no lung cancer deaths in the high exposure group in either time period. At Factory C, analysis by entry date (early entrant and the period 1946-1960) produced no meaningful results since the number of deaths was small. When the two periods are combined, the O/E was near unity. The author concluded that in light of the apparent absence of risk at Factory C, “it seems reasonable to suggest that the hazard affecting workers with mixed exposures at factories A and B * * * is attributable to zinc chromates” (Ex. 7-42, p. 166).
Davies also studied a subgroup of 57 chromate pigment workers, mostly employed between 1930 and 1945, who suffered clinical lead poisoning (Ex. 7-43). Followed through 1981, there was a statistically significantly elevated SMR for lung cancer based upon four cases (O=4; E=2.8; SMR=145).
Haguenoer studied 251 French zinc and lead chromate pigment workers employed for six months or more between January 1, 1958 and December 31, 1977 (Ex. 7-44). As of December 31, 1977, 50 subjects were identified as deceased. Cause of death was obtained for 30 of the 50 deaths (60%). Lung cancer mortality was significantly elevated based on 11 fatalities (SMR=461; 95% CI: 270-790). The mean time from first employment until detection of cancer was 17 years. The mean duration of employment among cases was 15 years.
The Haguenoer cohort was followed up in a study by Deschamps
Since individual work histories were not available, the authors made the assumption that the exposure level was the same for all workers during their employment at the plant. Duration of employment was used as a surrogate for exposure. Industrial hygiene measurements taken in 1981 provide some idea of the exposure levels at the plant. In the filtration department, Cr(VI) levels were between 2 and 3 μg/m
The expected number of deaths for the SMR analysis was computed from age-adjusted death rates in the northern region of France where the plant was located. There was a significant increase in lung cancer deaths based on 18 fatalities with five expected (SMR=360; 95% CI: 213-568). Using duration of employment as a surrogate for exposure, statistically significant SMRs were seen for the 10-15 years of exposure (O=6, SMR=720, 95% CI: 264-1568), 15-20 years (O=4, SMR=481, 95% CI: 131-1231), and 20+ years (O=6, SMR=377, 95% CI: 1.38-8.21) time intervals. There was a significantly elevated SMR for brain cancer based upon two deaths (SMR=844, 95% CI: 102-3049). There was a non-statistically significant increase for digestive tract cancer (O=9, SMR=130) consisting of three esophageal cancers, two stomach cancers and four colon cancers.
Equitable Environmental Health, Inc., on behalf of the Dry Color Manufacturers Association, undertook a historical prospective mortality study of workers involved in the production of lead chromate (Exs. 2-D-3; 2-D-1). The cohort was defined as male employees who had been exposed to lead chromate for a minimum of six months prior to December 1974 at one of three facilities in West Virginia, Kentucky or New Jersey. The New Jersey facility had a unit where zinc chromate was produced dating back to 1947 (Ex. 2-D-3). Most workers rotated through this unit and were exposed to both lead and zinc chromates. Two men were identified at the New Jersey facility with exposure solely to lead chromate; no one with exposure only to zinc chromate was identified.
Subsequent review of the data found that the Kentucky plant also produced zinc chromates from the late 1930s to early 1964. During the period 1961-1962, zinc chromates accounted for approximately 12% of chromate production at the plant. In addition, strontium chromate and barium chromate also were produced at the plant.
The cohort consisted of 574 male employees from all three plants (Ex. 2-D-1). Eighty-five deaths were identified with follow up through December 1979. Six death certificates were not obtained. SMRs were reported based on U.S. white male death rates. There were 53 deaths from the New Jersey plant including a statistically significant SMR for cancer of the trachea, bronchus and lung based upon nine deaths (E=3.9; SMR=231; 95% CI: 106-438). One lung cancer decedent worked solely in the
Sheffet
Positions at the plant were classified into three categories according to intensity of exposure: high (continuous exposure to chemical dust), moderate (occasional exposure to chemical dust or to dry or wet pigments) and low (infrequent exposure by janitors or office workers). Positions were also classified by type of chemical exposure: chromates, other inorganic substances, and organics. The authors' state that in almost all positions individuals “who were exposed to any chemicals were also exposed to hexavalent chromium in the form of airborne lead and zinc chromates (Ex. 7-48, p. 46).” The proportion of lead chromate to zinc chromate was approximately nine to one. Calculations, based upon air samples during later years, give an estimate for the study period of more than 2000 μg airborne chromium/m
Because of the large proportion of workers lost to follow-up (15% of white males and 20% of non-white males) and the large numbers of unknown cause of death (21% of white males and 12% of non-white males), the authors calculated three separate mortality ex-pectations based upon race-, gender-, age- and time-specific U.S. mortality ratios. The first expectation was calculated upon the assumption that those lost to follow-up were alive at the end of the study follow-up period. The second expectation was calculated on the assumption that those whose vital status was unknown were lost to follow-up as of their employment termination date. The third expectation was calculated excluding those of unknown vital status from the cohort. Deaths with unknown cause were distributed in the appropriate proportions among known causes of death which served as an adjustment to the observed deaths. The adjusted deaths were used in all of the analyses.
A statistically significant ratio for lung cancer deaths among white males (O/E=1.6) was observed when using the assumption that either the lost to follow-up were assumed lost as of their termination date or were excluded from the cohort (assumptions two and three above). The ratio for lung cancer deaths for non-white males results in an identical O/E of 1.6 for all three of the above scenarios, none of which was statistically significant.
In addition, the authors also conducted Proportionate Mortality Ratio (PMR) and Proportionate Cancer Mortality Ratio (PCMR) analyses. For white males, the lung cancer PMR was 200 and the lung cancer PCMR was 160 based upon 25.5 adjusted observed deaths (21 actual deaths). Both were statistically significantly elevated at the p<.05 level. For non-white males, the lung cancer PMR was 200 and the lung cancer PCMR was 150 based upon 11.2 adjusted observed deaths (10 actual deaths). The lung cancer PMR for non-white males was statistically significantly elevated at the p<.05 level. Statistically significantly elevated PMRs and PCMRs for stomach cancer in white males were reported (PMR=280; PCMR=230) based upon 6.1 adjusted observed deaths (five actual).
The Sheffet cohort was updated in a study by Hayes
The cohort included 1,181 white and 698 non-white males. Of the 453 deaths identified by the end of the follow-up period, 41 were lung cancers. For the entire study group, no statistically significant excess was observed for lung cancer (SMR=116) or for cancer at any other site. Analysis by duration of employment found a statistically significant trend (p=. 04) for lung cancer SMRs (67 for those employed < 1 year; 122 for those employed 1-9 years and 151 for those employed 10+ years).
Analysis of lung cancer deaths by duration of employment in chromate dust associated jobs found no elevation in risk for subjects who never worked in these jobs (SMR=92) or for subjects employed less than one year in these jobs (SMR=93). For those with cumulative employment of 1-9 and 10+ years in jobs with chromate dust exposure, the SMRs were 176 (nine deaths) and 194 (eight deaths) respectively.
Frentzel-Beyme studied the mortality experience of 1,396 men employed for more than six months in one of five factories producing lead and zinc chromate pigments located in Germany and the Netherlands (Ex. 7-45). The observed deaths from the five factories were compared with the expected deaths calculated on the basis of mortality figures for the region in which the plant was located. Additional analysis was conducted on relevant cohorts which included workers with a minimum of 10 years exposure, complete records for the entire staff, and exclusion of foreign nationals. Jobs were assigned into one of three exposure categories: high (drying and milling of the filtered pigment paste), medium (wet processes including precipitation of the pigment, filtering and maintenance, craftsmen and cleaning) and low or trivial exposure (storage, dispatch, laboratory personnel and supervisors).
There were 117 deaths in the entire cohort of which 19 were lung cancer deaths (E=9.3). The lung cancer SMRs in the relevant cohort analyses were elevated at every plant; however, in only one instance was the increased lung cancer SMR statistically significant, based upon three deaths (SMR=386, p<0.05). Analysis by type of exposure is not meaningful due to the small number of lung cancer death per plant per exposure classification.
Kano
In response to OSHA's August 2002 Request for Information, the Color Pigment Manufacturers Association suggested that OSHA consider reviewing the Davies (Ex. 7-43), Cooper [Equitable Environmental Health, Inc.] (Ex. 2-D-1) and Kano (Ex. 14-1-B) epidemiologic studies with respect to the health effects of lead chromate color pigments. The Equitable Environmental Health and the Kano
Chrome plating is the process of depositing chromium metal onto the surface of an item using a solution of chromic acid. The items to be plated are suspended in a diluted chromic acid bath. A fine chromic acid mist is produced when gaseous bubbles, released by the dissociation of water, rise to the surface of the plating bath and burst. There are two types of chromium electroplating. Decorative or “bright” involves depositing a thin (0.5-1 μm) layer of chromium over nickel or nickel-type coatings to provide protective, durable, non-tarnishable surface finishes. Decorative chrome plating is used for automobile and bicycle parts. Hard chromium plating produces a thicker (exceeding 5 μm) coating which makes it resistant and solid where friction is usually greater, such as in crusher propellers and in camshafts for ship engines. Limited air monitoring indicates that Cr(VI) levels are five to ten times higher during hard plating than decorative plating (Ex. 35-116).
There are fewer studies that have examined the lung cancer mortality of chrome platers than of soluble chromate production and chromate pigment production workers. The largest and best described cohort studies investigated chrome plating cohorts in the United Kingdom (Exs. 7-49; 7-57; 271; 35-62). They generally found elevated lung cancer mortality among the chrome platers, especially those engaged in chrome bath work, when compared to various reference populations. The studies of British chrome platers are summarized in Table VI-3.
Cohort studies of chrome platers in Italy, the United States, and Japan are also discussed in this subsection. Co-exposure to nickel, another suspected carcinogen, during plating operations can complicate evaluation of an association between Cr(VI) and an increased risk of lung cancer in chrome platers. Despite this, the International Agency for Research on Cancer concluded that the epidemiological studies provide sufficient evidence for carcinogenicity of Cr(VI) as encountered in the chromium plating industry; the same conclusion reached for chromate production and chromate pigment production (Exs. 18-1; 35-43). The findings implicate the highly water-soluble chromic acid as an occupational carcinogen. This adds to the weight of evidence that water-soluble (
Royle reported on a cohort mortality study of 1,238 chromium platers employed for a minimum of three consecutive months between February 20, 1969 and May 31, 1972 in 54 plating plants in West Riding, Yorkshire, England (Ex. 7-49). A control population was enumerated from other departments of the larger companies where chromium plating was only a portion of the companies' activities and from the former and current employees of two industrial companies in York where information on past workers was available. Controls were matched for gender, age (within two years) and date last known alive. In addition, 229 current workers were matched for smoking habits.
As of May 1974, there were 142 deaths among the platers (130 males and 12 females) and 104 deaths among the controls (96 males and 8 females). Among the male platers, there were 24 deaths from cancer of the lung and pleura compared to 13 deaths in the control group. The difference was not statistically significant. There were eight deaths from gastrointestinal cancer among male platers versus four deaths in the control group. The finding was not statistically significant.
The Royle cohort was updated by Sorahan and Harrington (Ex. 35-62). Chrome plating was the primary activity at all 54 plants, however 49 of the plants used nickel and 18 used cadmium. Also used, but in smaller quantities according to the authors, were zinc, tin, copper, silver, gold, brass or rhodium. Lead was not used at any of the plants. Four plants, including one of the largest, only used chromium. Thirty-six chrome platers reported asbestos exposure versus 93 comparison workers.
Industrial hygiene surveys were carried out at 42 plants during 1969-1970. Area air samples were done at breathing zone height. With the exception of two plants, the chromic acid air levels were less than 30 μg/m
The redefined cohort consisted of 1087 platers (920 men and 167 women) from 54 plants employed for a minimum of three months between February 1969 and May 31, 1972 who were alive on May 31, 1972. Mortality data were also available for a comparison group of 1,163 workers (989 men and 174 women) with no chromium exposure. Both groups were followed for vital status through 1997.
The lung cancer SMR for male platers was statistically significant (O=60; E=32.5; SMR=185; 95% CI: 141-238). The lung cancer SMR for the comparison group, while elevated, was not statistically significant (O=47; E=36.9; SMR=127; 95% CI: 94-169). The only statistically significant SMR in the comparison group was for cancer of the pleura (O=7; E=0.57; SMR=1235; 95% CI: 497-2545).
Internal regression analyses were conducted comparing the mortality rates of platers directly with those of the comparison workers. For these analyses, lung cancers mentioned anywhere on the death certificate were considered cases. The redefinition resulted in four additional lung cancer cases in the internal analyses. There was a statistically significant relative risk of 1.44 (p<0.05) for lung cancer mortality among chrome platers that was slightly reduced to 1.39 after adjustment for smoking habits and employment status. There was no clear trend between lung cancer mortality and duration of Cr(VI) exposure. However, any positive trend may have been obscured by the lack of information on worker employment post-1972 and the large variation in chromic acid levels among the different plants.
Sorahan reported the experience of a cohort of 2,689 nickel/chromium platers from the Midlands, U.K. employed for a minimum of six months between 1946 and 1975 and followed through December 1983 (Ex. 7-57). There was a statistically significant lung cancer SMR for males (O=63; E=40; SMR=158; p<0.001). The lung cancer SMR for women, while elevated (O=9; E=8.1; SMR=111), was not statistically significant. Other statistically significant cancer SMRs for males included: stomach (O=21; E=11.3; SMR=186; p<0.05); liver (O=4; E=0.6; SMR=667; p<0.01); and nasal cavities (O=2; E=0.2; SMR=1000; p<0.05). While there were several elevated SMRs for women, none were statistically significant. There were nine lung cancers and one nasal cancer among the women.
Analysis by type of first employment (i.e., chrome bath workers vs. other chrome work) resulted in a statistically significant SMR for lung cancer of 199 (O=46; E=23.1; p<0.001) for chrome bath workers and a SMR of 101 for other chrome work. The SMR for cancer of the stomach for male chrome bath workers was also statistically significantly elevated (O=13; E=6.3; SMR=206; p<0.05); for stomach cancer in males doing other chrome work, the SMR was 160 with 8 observed and 5 expected. Both of the nasal cancers in males and the one nasal cancer in women were chrome bath workers. The nasal cancer SMR for males was statistically significantly elevated (O=2; E=0.1; SMR=2000; p<0.05).
Regression analysis was used to examine evidence of association of several types of cancers and Cr(VI) exposure duration among the cohort. There was a significant positive association between lung cancer mortality and exposure duration as a chrome bath worker controlling for gender as well as year and age at the start of employment. There was no evidence of an association between other cancer types and duration of Cr(VI) exposure. There was no positive association between duration of exposure to nickel bath work and cancer of the lung. The two largest reported SMRs were for chrome bath workers 10-14 years (O=13; E=3.8; SMR=342; p<0.001) and 15-19 years (O=12; E=4.9; SMR=245; p<0.01) after starting employment. The positive associations between lung cancer mortality and duration of chrome bath work suggests Cr(VI) exposure may be responsible for the excess cancer risk.
Sorahan
There were 421 deaths among the men and 269 deaths among the women, including 52 lung cancers among the men and 17 among the women. SMRs were calculated for different categories of chrome work: period from first chrome work; year of starting chrome work, and cumulative duration of chrome work categories. Poisson regression modeling was employed to investigate lung cancer in relation to type of chrome work and cumulative duration of work.
A significantly elevated lung cancer SMR was seen for male workers with some period of chrome bath work (O=40; E=25.4; SMR=157; 95% CI: 113-214, p<0.01) that was not the case for male workers engaged in other chrome work away from the chromic acid bath (O=9; E=13.7; SMR=66; 95% CI: 30-125). Similar lung cancer mortality results were found for female chrome bath workers (O=15; E=8.6; SMR=175; 95% CI: 98-285; p<0.06). After adjusting for sex, age, calendar year, year starting chrome work, period from first chrome work, and employment status, regression modeling showed a statistically significant positive trend (p<0.05) between duration of chrome bath work and lung cancer mortality risk. The relative lung cancer risk for chrome bath workers with more than five years of Cr(VI) exposure (i.e., relative to the risk of those without any chrome bath work) was 4.25 (95% CI: 1.83-9.37).
Since the Sorahan cohort consists of nickel/chromium workers, the question arises of the potential confounding of nickel. In the earlier study, 144 of the 564 employees with some period of chrome bath work had either separate or simultaneous periods of nickel bath employment. According to the authors, there was no clear association between cancer deaths from stomach, liver, respiratory system, nose and larynx, and
Silverstein
White males who worked at the plant for less than 15 years had a lung cancer PMR of 1.65. Those with 15 or more years at the plant had a lung cancer PMR of 2.09 (p<0.001). For white males with less than 22.5 years between hire and death (latency) the lung cancer PMR was 1.78 (p<0.05) and for those with 22.5 or more years, the PMR was 2.11 (p<0.01).
A case-control analysis was conducted on the Silverstein cohort to examine the association of lung cancer risk with work experience. Controls were drawn from cardiovascular disease deaths (ICD 390-458, 8th revision). The 38 lung cancer deaths were matched to controls for race and gender. Odds ratios (ORs) were calculated by department depending upon the amount of time spent in the department (ever/never; more vs. less than one year; and more vs. less than five years). Three departments showed increasing odds ratios with duration of work; however, the only statistically significant result was for those who worked more than five years in department 5 (OR=9.17, p=0.04, Fisher's exact test). Department 5 was one of the major die-casting and plating areas of the plant prior to 1971.
Franchini
The cohort consisted of 178 males (116 from the hard chromium plating plants and 62 from the bright chromium plating plants) who had worked for at least one year between January 1, 1951 and December 31, 1981. In order to allow for a 10 year latency period, only those employed before January 1972 were included in further analysis. There were three observed lung cancer deaths among workers in the hard chrome plating plants, which was significantly greater than expected (O=3; E=0.6; p<0.05). There were no lung cancer deaths among decorative chrome platers.
Okubo and Tsuchiya conducted a study of plating firms with five or more employees in Tokyo (Exs. 7-51; 7-52). Five hundred and eighty nine firms were sent questionnaires to ascertain information regarding chromium plating experience. The response rate was 70.5%. Five thousand one hundred seventy platers (3,395 males and 1,775 females) met the cohort entrance criteria and were followed from April 1, 1970 to September 30, 1976. There were 186 deaths among the cohort; 230 people were lost to follow-up after retirement. The cohort was divided into two groups: chromium platers who worked six months or more and a control group with no exposure to chromium (clerical, unskilled workers). There were no deaths from lung cancer among the chromium platers.
The Okubo cohort was updated by Takahashi and Okubo (Ex. 265). The cohort was redefined to consist of 1,193 male platers employed for a minimum of six months between April 1970 and September 1976 in one of 415 Tokyo chrome plating plants and who were alive and over 35 years of age on September 30, 1976. The only statistically significant SMR was for lung cancer for all platers combined (O=16; E=8.9; SMR=179; 95% CI: 102-290). The lung cancer SMR for the chromium plater subcohort was 187 based upon eight deaths and 172 for the nonchromium plater subcohort, also based upon eight deaths. The cohort was followed through 1987. Itoh
Welding is a term used to describe the process for joining any materials by fusion. The fumes and gases associated with the welding process can cause a wide range of respiratory exposures which may lead to an increased risk of lung cancer. The major classes of metals most often welded include mild steel, stainless and high alloy steels and aluminum. The fumes from stainless steel, unlike fumes from mild steel, contain nickel and Cr(VI). There are several cohort and case-control studies as well as two meta analyses of welders potentially exposed to Cr(VI). In general, the studies found an excess number of lung cancer deaths among stainless steel welders. However, few of studies found clear trends with Cr(VI) exposure duration or cumulative Cr(VI). In most studies, the reported excess lung cancer mortality among stainless steel welders was no greater than mild steel welders, even though Cr(VI) exposure is much greater during stainless steel welding. This weak association between lung cancer and indices of exposure limits the evidence provided by these studies. Another limitation was the co-exposures to other potential lung carcinogens, such as nickel, asbestos, and cigarette smoke. Nevertheless, these studies add some further support to the much stronger link between Cr(VI) and lung cancer found in soluble chromate production workers, chromate pigment production workers, and chrome platers. The key studies are summarized in Table VI-4.
Sjogren
Polednak compiled a cohort of 1,340 white male welders who worked at the Oak Ridge nuclear facilities from 1943 to 1977 (Ex. 277). One thousand fifty-nine cohort members were followed through 1974. The cohort was divided into two groups. The first group included 536 welders at a facility where nickel-alloy pipes were welded; the second group included 523 welders of mild steel, stainless steel and aluminum materials. Smoking data were available for 33.6% of the total cohort. Expectations were calculated based upon U.S. mortality rates for white males. There were 17 lung cancer deaths in the total cohort (E=11.37; SMR=150; 95% CI: 87-240). Seven of the lung cancer deaths occurred in the group which routinely welded nickel-alloy materials (E=5.65; SMR=124; 95% CI: 50-255) versus 10 lung cancer deaths in the “other” welders (E=6.12; SMR=163; 95% CI: 78-300).
Becker
The International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) cosponsored a study on welders. IARC and WHO compiled a cohort of 11,092 male welders from 135 companies in nine European countries to investigate the relationship between the different types of exposure occurring in stainless steel, mild steel and shipyard welding and various cancer sites, especially lung cancer (Ex. 7-114). Cohort entrance criteria varied by country. The expected number of deaths was compiled using national mortality rates from the WHO mortality data bank.
Results indicated the lung cancer deaths were statistically significant in the total cohort (116 cases; E=86.81; SMR=134; 95% CI: 110-160). Cohort members were assigned to one of four subcohorts based upon type of welding activity. While the lung cancer SMRs were elevated for all of the subcohorts, the only statistically significant SMR was for the only mild steel welders (O=40; E=22.42; SMR=178; 95% CI: 127-243). Results for the other subgroups were: shipyard welders (O=36; E=28.62; SMR=126; 95% CI: 88-174); ever stainless steel welders (O=39; E=30.52; SMR=128; 95% CI: 91-175); and predominantly stainless steel welders (O=20; E=16.25; SMR=123; 95% CI: 75-190). When analyzed by subcohort and time since first exposure, the SMRs increased over time for every group except shipyard welders. For the predominantly stainless steel welder subcohort, the trend to increase with time was statistically significant (p <.05).
An analysis was conducted of lung cancer mortality in two stainless steel welder subgroups (predominantly and ever) with a minimum of five years of employment. Cumulative Cr(VI) was computed from start of exposure until 20 years prior to death. A lung cancer SMR of 170, based upon 14 cases, was observed in the stainless steel ever subgroup for those welders with >0.5 μg-years/m
In conjunction with the IARC/WHO welders study, Gerin
Cumulative dose estimates in mg/m
The IARC/WHO multicenter study is the sole attempt to undertake even a semi-quantified exposure analysis of stainless steel welders' potential exposure to nickel and Cr(VI) for <5 and ≥0.5 mg-years/m
Moulin compiled a cohort of 2,721 French male welders and an internal comparison group of 6,683 manual workers employed in 13 factories (including three shipyards) with a minimum of one year of employment from 1975 to 1988 (Ex. 7-92). Three
Hansen conducted a study of cancer incidence among 10,059 male welders, stainless steel grinders and other metal workers from 79 Danish companies (Ex. 9-129). Cohort entrance criteria included: Alive on April 1, 1968; born before January 1, 1965; and employed for at least 12 months between April 1, 1964 and December 31, 1984. Vital status follow-up found 9,114 subjects alive, 812 dead and 133 had emigrated. A questionnaire was sent to subjects and proxies for decedents/emigrants in an attempt to obtain information about lifetime occupational exposure, smoking and drinking habits. The overall response rate was 83%. The authors stated that no major differences in smoking habits were found between exposure groups with or without a significant excess of lung cancer.
The expected number of cancers was based on age-adjusted national cancer incidence rates from the Danish Cancer Registry. There were statistically significantly elevated Standardized Incidence Ratios (SIRs) for lung cancer in the welding (any kind) group (O=51; E=36.84; SIR=138; 95% CI: 103-181) and in the mild steel only welders (O=28; E=17.42; SIR=161; 95% CI: 107-233). The lung cancer SIR for mild steel ever welders was 132 (O=46; E=34.75; 95% CI: 97-176); for stainless steel ever welders 119 (O=23; E=19.39; 95% CI: 75-179) and for stainless steel only welders 238 (O=5; E=2.10; 95% CI: 77-555).
Laurtitsen reported the results of a nested case-control conducted in conjunction with the Hansen cancer incidence study discussed above (Exs. 291; 9-129). Cases were defined as the 94 lung cancer deaths. Controls were defined as anyone who was not a case, but excluded deaths from respiratory diseases other than lung cancer (either as an underlying or a contributing cause of death), deaths from “unknown malignancies” and decedents who were younger than the youngest case. There were 439 decedents eligible for use as controls.
The crude odds ratio (OR) for welding ever (yes/no) was 1.7 (95% CI: 1.0-2.8). The crude OR for mild steel welding only was 1.3 (95% CI: 0.8-2.3) and for stainless steel welding only the crude OR was 1.3 (95% CI: 0.3-4.3). When analyzed by number of years exposed, “ever” stainless steel welding showed no relationship with increasing number of years exposed. The highest odds ratio (2.9) was in the lowest category (1-5 years) based upon seven deaths; the lowest odds ratio was in the highest category (21+ years) based upon three deaths.
Kjuus
Hull
While the relative risk estimates in both cohort and case-control of stainless steel welders are elevated, none are statistically significant. However, when combined in two meta-analyses, a small but statistically significant increase in lung cancer risk was reported. Two meta-analyses of welders have been published. Moulin carried out a meta-analysis of epidemiologic studies of lung cancer risk among welders, taking into account the role of asbestos and smoking (Ex. 285). Studies published between 1954 and 1994 were reviewed. The inclusion criteria were clearly defined: only the most recent updates of cohort studies were used and only the mortality data from mortality/morbidity studies were included. Studies that did not provide the information required by the meta-analysis were excluded.
Five welding categories were defined (shipyard welding, non-shipyard welding, mild steel welding, stainless steel welding and all or unspecified welding). The studies were assigned to a welding category (or categories) based upon the descriptions provided in the paper's study design section. The combined relative risks (odds ratios, standardized mortality ratios, proportionate mortality ratios and standardized incidence ratios) were calculated separately for the population-based studies, case-control studies and
Three case-control studies (Exs. 243; 7-120; 7-72) and two cohort studies (Exs. 7-114; 277) were included in the stainless steel welding portion of the meta-analysis. The combined relative risk was 2.00 (O=87; 95% CI: 1.22-3.28) for the case-control studies and 1.23 (O=27; 95% CI: 0.82-1.85) for the cohort studies. When all five studies were combined, the relative risk was 1.50 (O=114; 95% CI: 1.10-2.05).
By contrast, the combined risk ratio for the case-control studies of mild steel welders was 1.56 (O=58; 95% CI: 0.82-2.99) (Exs. 7-120; 243). For the cohort studies, the risk ratio was 1.49 (O=79; 95% CI: 1.15-1.93) (Exs. 270; 7-114). For the four studies combined, the risk ratio was 1.50 (O=137; 95% CI: 1.18-191). The results for the stainless steel welders and the mild steel welders are basically the same.
The meta-analysis by Sjogren of exposure to stainless steel welding fumes and lung cancer included studies published between 1984 and 1993, which took smoking and potential asbestos exposure into account (Ex. 7-113). Five studies met the author's inclusion criteria and were included in the meta-analysis: two cohort studies, Moulin
Ferrochromium is produced by the electrothermal reduction of chromite ore with coke in the presence of iron in electric furnaces. Some of the chromite ore is oxidized into Cr(VI) during the process. However, most of the ore is reduced to chrome metal. The manufacture of ferroalloys results in a complex mixture of particles, fumes and chemicals including nickel, Cr(III) and Cr(VI). Polycyclic aromatic hydrocarbons (PAH) are released during the manufacturing process. The co-exposure to other potential lung carcinogens combined with the lack of a statistically significant elevation in lung cancer mortality among ferrochromium workers were limitations in the key studies. Nevertheless, the observed increase in the relative risks of lung cancer add some further support to the much stronger link between Cr(VI) and lung cancer found in soluble chromate production workers, chromate pigment production workers, and chrome platers. The key studies are summarized in Table VI-5.
Langard
Production of ferrosilicon at the plant began in 1928 and ferrochromium production began in 1932. Job characterizations were compiled by combining information from company personnel lists and occupational histories contained in medical records and supplemented with information obtained via interview with long-term employees. Ten occupational categories were defined. Workers were assigned to an occupational category based upon the longest time in a given category.
Industrial hygiene studies of the plant from 1975 indicated that both Cr(III) and Cr(VI) were present in the working environment. The ferrochromium furnance operators were exposed to measurements of 0.04-0.29 mg/m
Both observed and expected cases of cancer were obtained via the Norwegian Cancer Registry. The observation period for cancer incidence was January 1, 1953 to December 31, 1985. Seventeen incident lung cancers were reported in the 1990 study (E=19.4; SIR=88). A deficit of lung cancer incidence was observed in the ferrosilicon group (O=2; E=5.8; SIR=35). In the ferrochromium group there were a significant excess of lung cancer; 10 observed lung cancers with 6.5 expected (SIR=154).
Axelsson
The different working sites within the industry were classified into four groups with respect to exposure to Cr(VI) and Cr(III). Exposure was primarily to metallic and trivalent chromium with estimated levels ranging from 0-2.5 mg/m
Death certificates were obtained and coded to the revision of the
There were seven cases of cancers of the trachea, bronchus and lung and the pleura with 5.9 expected (SIR=119) for the period 1958-1975. Four of the seven cases in the lung cancer group were maintenance workers and two of the four cases were pleural mesotheliomas. In the arc furnace group, which was thought to have the highest potential exposure to both Cr(III) and Cr(VI), there were two cancers of the trachea, bronchus and lung and the pleura. One of the cases was a mesothelioma. Of the 380 deaths that occurred during the period 1951-1975, five were from cancer of the trachea, bronchus and lung and the pleura (E=7.2; SMR=70). For the “highly” exposed furnace workers, there was one death from cancer of the trachea, bronchus and lung and the pleura.
Moulin
Pokrovskaya and Shabynina conducted a cohort mortality study of male and female workers employed “some time” between 1955 and 1969 at a chromium ferroalloy production plant in the U.S.S.R (Ex. 7-61). Workers were exposed to both Cr(III) and Cr(VI) as well as to benzo [a] pyrene. Neither the number of workers nor the number of cancer deaths by site were provided. Death certificates were obtained and the deaths were compared with municipal mortality rates by gender and 10 year age groups. The investigators state that they were able to exclude those in the comparison group who had chromium exposures in other industries. The lung cancer SMR for male chromium ferroalloy workers was 440 in the 30-39 year old age group and 660 in the 50-59 year old age group (p=0.001). There were no lung cancer deaths in the 40-49 and the 60-69 year old age groups. The data suggest that these ferrochromium workers may have been had an excess risk of lung cancer.
The association between Cr(VI) exposure in ferrochromium workers and the incidence of respiratory tract cancer these studies is difficult to assess because of co-exposures to other potential carcinogens (
There are several other epidemiological studies that do not fit into the five industry sectors previously reviewed. These include worker cohorts in the aerospace industry, paint manufacture, and leather tanning operations, among others. The two cohorts of aircraft manufacturing workers are summarized in Table VI-6. All of the cohorts had some Cr(VI) exposure but, certain cohorts may have included a sizable number of workers with little or no exposure to Cr(VI). This creates an additional complexity in assessing whether the study findings support a Cr(VI) etiology for cancer of the respiratory system.
Alexander
In addition to cumulative chromate exposure, chromate exposure jobs were classified according to the species of chromate. According to the authors, in painting operations the exposure is to chromate pigments with moderate and low solubility such as zinc chromate, strontium chromate and lead chromate; in sanding and polishing operations the same chromate pigments exist as dust; while platers and tank tenders are exposed to chromium trioxide, which is highly soluble.
Approximately 26% of the cohort was lost to follow-up. The cohort was followed for a relatively short 8.9 years per cohort member. Cases were identified through the Cancer Surveillance System (CSS) at the Fred Hutchinson Cancer Research Center in Seattle, Washington. CSS records primary cancer diagnoses in 13 counties in western Washington. Expected numbers were calculated using race-, gender-, age- and calendar-specific rates from the Puget Sound reference population for 1974 through 1994. Fifteen lung cancer cases were identified with an overall standardized incidence ratio (SIR) of 80 (95% CI: 0.4-1.3). The SIRs for lung cancer by cumulative years of employment in the “high exposure” painting job category were based upon only three deaths in each of the cumulative years categories (<5 and ≥5); years of employment was inversely related to the risk of lung cancer. For those in the “low exposure” category, the SIRs were 130 for those who worked less than five years in that category (95% CI: 0.2-4.8) and 190 for those who worked five years or more (95% CI: 0.2-6.9). However, there were only two deaths in each category. The SIR for those who worked ≥5 years was 270 (95% CI: 0.5-7.8), but based only on three deaths.
Boice
Follow up of the cohort was through 1996. Expectations were calculated based on the general population of California for white workers, while general population rates for the U.S. were used for non-white workers. For the 3,634 cohort members who had potential for routine exposure to chromates, the lung cancer SMR (race and gender combined) was 102 based upon 87 deaths (95% CI: 0.82-1.26). There was a slight non-significant positive trend (p value>2.0) for lung cancer with duration of potential exposure. The SMR was 108 (95% CI: 0.75-1.57) for workers exposed to chromate for ≥5 years. Among the painters, there were 41 deaths from lung cancer yielding a SMR of 111 (95% CI: 0.80-1.51). For those who worked as a process operator or plater the SMR for lung cancer was 103 based upon 38 deaths (95% CI: 0.73-1.41).
OSHA believes the Alexander (Ex. 31-16-3) and the Boice
Dalager
Bertazzi
Morgan conducted a cohort study of 16,243 men employed after January 1, 1946 for at least one year in the manufacture of paint or varnish (Ex. 8-4). Analysis was also conducted for seven subcohorts, one of which was for work with pigments. Expectations were calculated based upon the mortality experience of U.S. white males. The SMR for cancer of the trachea, bronchus and lung was below unity based upon 150 deaths. For the pigment subcohort, the SMR for cancer of the trachea, bronchus and lung was 117 based upon 43 deaths. In a follow-up study of the subcohorts, case-control analyses were conducted for several causes of death including lung cancer (Ex. 286). The details of matching were not provided. The authors state that no significant excesses of lung cancer risk by job were found. No odds ratios were presented.
Pippard
In a different study of two U.S. tanneries, Stern
Blot
SMRs based on national and California rates were computed. Results in the paper are based on the California rates, since the overall results reportedly did not differ substantially from those using the national rates. SMRs were calculated for the entire cohort and for subsets defined by potential for gas generator plant exposure. No significant cancer excesses were observed and all but one cancer SMR was in deficit. There were eight lung cancer deaths in the gas generator workers (SMR=81; 95% CI: 0.35-1.60) and three lung cancer deaths among the Kettleman trainees (SMR=57; 95% CI: 0.12-1.67). There were no deaths from nasal cancer among either the gas generator workers or the Kettleman trainees. The risk of lung cancer did not increase with length of employment or time since hire.
Rafnsson and Johannesdottir conducted a study of 450 licensed masons (cement finishers) in Iceland born between 1905 and 1945, followed from 1951 through 1982 (Ex. 7-73). Stonecutters were excluded. Expectations were based on the male population of Iceland. The SMR for lung cancer was 314 and is statistically significant based upon nine deaths (E=2.87; 95% CI: 1.43-5.95). When a 20 year latency was factored into the analysis, the lung cancer SMR remained statistically significant (O=8; E=2.19; SMR=365; 95% CI: 1.58-7.20).
Svensson
Cornell and Landis studied the mortality experience of 851 men who worked in 26 U.S. nickel/chromium alloy foundries between 1968 and 1979 (Ex. 7-66). Standardized Proportionate Mortality Ratio (SPMR) analyses were done using both an internal comparison group (foundry workers not exposed to nickel/chromium) and the mortality experience of U.S. males. The SPMR for lung cancer was 105 (O=60; E=56.9). No nasal cancer deaths were observed.
Brinton
Hernberg
Most of the key animal cancer bioassays for chromium compounds were conducted before 1988. These studies have been critically reviewed by the IARC in the Monograph
In the experimental studies, Cr(VI) compounds were administered by various routes including inhalation, intratracheal instillation, intrabronchial implantation, and intrapleural injection, as well as intramuscular and subcutaneous injection. For assessing human health effects from occupational exposure, the most relevant route is inhalation. However, as a whole, there were very few inhalation studies. In addition to inhalation studies, OSHA is also relying on intrabronchial implantation and intratracheal instillation studies for hazard identification because these studies examine effects directly administered to the respiratory tract, the primary target organ of concern, and they give insight into the relative potency of different Cr(VI) compounds. In comparison to studies examining inhalation, intrabronchial implantation, and intratracheal instillation, studies using subcutaneous injection and intramuscular administration of Cr(VI) compounds were of lesser significance but were still considered for hazard identification.
In its evaluation, OSHA took into consideration the exposure regimen and experimental conditions under which the experiments were performed, including the exposure level and duration; route of administration; number, species, strain, gender, and age of the experimental animals; the inclusion of appropriate control groups; and consistency in test results. Some studies were not included if they did not contribute to the weight of evidence, lacked adequate documentation, were of poor quality, or were less relevant to occupational exposure conditions (
The summarized animal studies are organized by Cr(VI) compound in order of water solubility (
a.
In an analysis prepared by Exponent and submitted by the Chrome Coalition in response to OSHA's RFI, Exponent stated that “inhalation studies of Glaser
Steinhoff
In separate but similar studies, Levy
In the Hueper study, 26 rats (sex, age, and strain not specified) were given intrapleural implantation for 27 months (Ex. 10-4). Dosage was not specified. No significant increases in tumor incidence were observed in rats exposed to sodium dichromate or in the control group (0/26 vs. 0/34 in control).
In separate but similar studies, Levy
Similar to Levy
b.
Steinhoff
Snyder
In the analysis submitted to OSHA by the Chrome Coalition, Exponent stated that the “intratrachael instillation data of Steinhoff
Statistically significant increases in the incidence of bronchial carcinoma in rats exposed to calcium chromate through intrabronchial instillation were reported by Levy
Laskin
In the study by Hueper, strontium chromate was administered by intrapleural injection (doses unspecified) lasting 27 months (Ex. 10-4). Local tumors were observed in 17/28 treated rats vs. 0/34 for the untreated rats. Although the authors did not examine the statistical significance of tumors, the results clearly indicate a statistical significance.
c.
Basic potassium zinc chromate (slightly water soluble) was administered to mice, guinea pigs and rabbits via intratracheal instillation (Ex. 35-46). Sixty-two Strain A mice were given six injections of 0.03 ml of a 0.2% saline suspension of the zinc chromate at six week intervals and observed until death. A statistically significant increase in tumor incidence was observed in exposed animals when compared to controls (31/62 vs. 7/18). Statistically significant effects were not observed
Hueper found that intrapleural injection of slightly water soluble zinc yellow (doses were unspecified) resulted in statistically significant increases in local tumors in rats (sex, strain, and age of rat unspecified; dose was unspecified). The incidence of tumors in exposed rats was 22/33 vs. 0/34 in controls (Ex. 10-4).
Maltoni
Maltoni (Ex. 8-25), Maltoni (Ex. 5-2), and Maltoni
Carcinogenesis was observed after intramuscular injection in a study by Furst
In response to OSHA's RFI, the Color Pigments Manufacturers Association (CPMA) stated that the lack of carcinogenic response in two studies (Levy
d.
OSHA believes that the results from Adachi
Mechanistic information can provide insight into the biologically active form(s) of chromium, its interaction with critical molecular targets, and the resulting cellular responses that trigger neoplastic transformation. There has been considerable scientific study in recent years of Cr(VI)-initiated cellular and molecular events believed to impact development of respiratory carcinogenesis. Much of the research has been generated using
Recent experimental research has identified several biological steps critical to the mode of action by which Cr(VI) transforms normal lung cells into a neoplastic phenotype. These are: (a) Cellular uptake of Cr(VI) and its extracellular reduction, (b) intracellular Cr(VI) reduction to produce biologically active products, (c) damage to DNA, and (d) activation of signaling pathways in response to cellular stress. Each step will be described in detail below.
a.
Once deposited in the lower respiratory tract, solubility of Cr(VI) particulates becomes a major influence on disposition. Aqueous Cr(VI), such as sodium chromate and chromic acid, rapidly dissolves in the fluids lining the lung epithelia and can be taken up by lung cells via facilitated diffusion mediated by sulfate/phosphate anion transport channels (Ex. 35-148). This is because Cr(VI) exists in a tetrahedral configuration as a chromate oxyanion similar to the physiological anions, sulfate and phosphate (Ex. 35-231). Using cultured human epithelial cells, Liu
Aqueous insoluble Cr(VI) particulates do not readily dissolve into epithelial lining fluids of the bronchoalveolar region. This has led to claims that insoluble chromates, such as lead chromate pigments, are not bioavailable and, therefore, are unable to cause carcinogenesis (Ex. 31-15). However, several scientific studies indicate that insoluble Cr(VI) particulates can come in close contact with the bronchoalveolar epithelial cell surface, allowing enhanced uptake into cells. Wise
Reduction to the poorly permeable Cr(III) in the epithelial lining fluid limits cellular uptake of Cr(VI). Ascorbic acid and glutathione (GSH) are believed to be the key molecules responsible for the extracellular reduction. Cantin
De Flora, Jones, and others have interpreted the extracellular reduction data to mean that very high levels of Cr(VI) are required to “overwhelm” the reductive defense mechanism before target cell uptake can occur and, as
Wise
Singh
Finally, Cr(VI) deposited in the tracheobronchial and alveolar regions of the respiratory tract is cleared by the mucocilliary escalator (soluble and particulate Cr(VI)) and macrophage phagocytosis (particulate Cr(VI) only). In most instances, these clearance processes take hours to days to completely clear Cr(VI) from the lung, but it can take considerably longer for particulates deposited at certain sites. For example, Ishikawa
b.
After crossing the cell membrane, Cr(VI) compounds can be non-enzymatically converted to Cr(III) by several intracellular reducing factors (Ex. 35-184). The most plentiful electron donors in the cell are GSH, and other thiols, such as cysteine, and ascorbate. Connett and Wetterhahn showed that a Cr(VI)-thioester initially forms in the presence of GSH (Ex. 35-206). A two-phase reduction then occurs with rapid conversion to Cr(V) and glutathionyl radical followed by relatively slower reduction to Cr(III) that requires additional molecules of GSH. Depletion of cellular GSH and other thiols is believed to retard complete reduction of Cr(VI) to Cr(III), allowing buildup of intermediates Cr(V) and Cr(IV). The molecular kinetics of the Cr(VI) to Cr(III) reduction with ascorbate is less well understood but can also involve intermediate formation of Cr(V) and free radicals (Ex. 35-184).
Another important class of intracellular Cr(VI) reductions are catalyzed by flavoenzymes, such as GSH reductase, lipoyl dehydrogenase, and ferredoxin-NADP oxidoreductase. The most prominent among these is GSH reductase that uses NADPH as a cofactor in the presence of molecular oxygen (O
Although most intracellular reduction of Cr(VI) is believed to occur in the cytoplasm, Cr(VI) reduction can also occur in mitochondria and the endoplasmic reticulum. Cr(VI) reduction can occur in the mitochondria through the action of the electron transport complex (Ex. 35-230). The microsomal cytochrome P-450 system in the endoplasmic reticulum also enzymatically reduces Cr(VI) to Cr(V), producing ROS through reduction/oxidation cycling as described above (Ex. 35-171).
c.
Cr(VI) compounds are mutagenic in most bacterial and mammalian test systems (Ex. 35-118). In the bacterial
Genotoxicity has been reported from Cr(VI) administration to animals
Studies of chromosomal and DNA damage in workers exposed to Cr(VI) vary in their findings. Some studies reported higher levels of chromosomal aberrations, sister chromatid exchanges, or DNA strand breaks in peripheral lymphocytes of stainless steel welders (Exs. 35-265; 35-160) and electroplaters (Ex. 35-164). Other studies were not able to find excess damage in DNA from the blood lymphocytes of workers exposed to Cr(VI) (Exs. 35-185; 35-167). These reports are difficult to interpret since co-exposure to other genotoxic agents (
Because of the consistent positive response across multiple assays in a wide range of experimental systems from prokaryotic organisms (
There has been a great deal of research to identify the types of damage to DNA caused by Cr(VI), the reactive intermediates that are responsible for the damage, and the specific genetic lesions critical to carcinogenesis. It was shown that Cr(VI) was inactive in DNA binding assays with isolated nuclei or purified DNA (Ex. 35-47). However, Cr(III) was able to produce DNA protein cross-links, sister chromatid exchanges, and chromosomal aberrations in an acellular system. Zhitkovich
Another research group showed that plasmid DNA treated with Cr(III) produced intrastrand crosslinks and the production of these lesions correlated with DNA polymerase arrest (Ex. 35-126). The same intrastrand crosslinks and DNA polymerase arrest could also be induced by Cr(VI) in the presence of ascorbate as a reducing agent to form Cr(III) (Ex. 35-263). These results were confirmed in a cell system by treating human lung fibroblasts with soluble Cr(VI), isolating genomic DNA, and demonstrating dose-dependant guanine-specific arrest in a DNA polymerase assay (Ex. 35-188). Cr(V) may also form intrastrand crosslinks since Cr(V) interacts with DNA
DNA strand breaks and oxidative damage result from the one electron reduction/oxidation cycling of Cr(VI), Cr(V), and Cr(IV). Shi
Several researchers have been able to modulate Cr(VI)-induced DNA damage using cellular reductants such as ascorbate, GSH and the free radical scavenger tocopherol (vitamin E). This has provided insight into the relationships between DNA damage, reduced chromium forms and ROS. Sugiyama
Studies of the different types of DNA damage caused by Cr(VI) and the modulation of that damage inside the cell demonstrate that Cr(VI) itself is not biologically active. Cr(VI) must undergo intracellular reduction to Cr(V), Cr(IV), and Cr(III) before the damage to DNA can occur. The evidence suggests that Cr(III) can cause DNA-Cr-amino acid, DNA-Cr-DNA crosslinks and Cr-DNA monoadducts. Cr(V) and possibly Cr(IV) contribute to intrastrand crosslinks and perhaps other Cr-DNA binding. ROS generated during intracellular reduction of Cr(VI) lead to lesions such as chromosomal aberrations, DNA strand breaks, and oxidative DNA damage. The specific DNA lesions responsible for neoplastic transformation have yet to be firmly established so all forms of DNA damage should, at this time, be regarded as potential contributors to carcinogenicity.
d.
Blankenship
The p53 protein is a transcription factor known to be activated by DNA damage, lead to cell cycle arrest, and regulate genes responsible for either DNA repair or apoptosis. Therefore, it is likely that the p53 activation is a response to the Cr(VI)-induced DNA damage. Apoptosis (i.e., programmed cell death) is triggered once the Cr(VI)-induced DNA damage becomes too extensive to successfully repair. In this manner, apoptosis serves to prevent replication of genetically damaged cells. Several researchers have gone on to further elucidate the molecular pathways involved in Cr(VI)-induced apoptosis. ROS produced by intracellular Cr(VI) reduction/oxidation cycling have been implicated in the activation of p53 and apoptosis (Exs. 35-255; 35-122). Using specific inhibitors, Pritchard
Cr(VI) causes cell cycle arrest and reduces clonogenic potential (i.e., normal cell growth) at very low concentrations (
Pritchard
e.
OSHA preliminarily concludes that the study data summarized in the previous sections support the determination that Cr(VI) compounds should be regarded as carcinogenic to workers. The strongest evidence comes from the many cohort studies reporting excess lung cancer mortality in workers exposed to Cr(VI) during production of chromates and chromate pigments. Additional evidence comes from the less consistent elevations in lung cancer mortality found in workers exposed to Cr(VI) in other occupations, increased tumor incidence in experimental animals treated with Cr(VI), and cellular and molecular data on mode of action.
Studies of chromate production workers in several countries have consistently found significantly greater mortality from lung cancer than expected. In the earliest studies of chromate workers in whom Cr(VI) exposures were believed to be highest, the risk for respiratory cancer was between 15 and 29 times expectation (Exs. 7-2; 7-13; 7-1). Lung cancer risks of this magnitude cannot be explained by potential confounders and other biases.
Later studies that were able to reconstruct exposure histories in workers from production plants located in Baltimore, MD and Painesville, OH found significant trends between lung cancer mortality and both cumulative exposure to Cr(VI) and duration of employment (Exs. 31-22-11; 33-10). Workers were predominantly exposed to the highly water soluble sodium chromate and sodium dichromate at these plants, although probable exposure to other chromates also occurred. Gibb
Studies of workers in the chromate pigment production industry also consistently show significantly elevated lung cancer mortality. These include cohorts from Norway, Great Britain, U.S., and France. The workers were principally exposed to zinc and lead chromate pigments, but the levels of Cr(VI) exposure were not well characterized. Some studies presented data that suggested excess lung cancer was more strongly associated with zinc chromate, although workers were exposed to several chromium pigments (Exs. 7-41; 7-42).
Significantly elevated lung cancer mortality was found in two British chromium electroplating cohorts (Exs. 35-62; 271). The workers were exposed to Cr(VI) in the form of chromic acid mist as well as nickel, another potential lung carcinogen. The association between lung cancer and Cr(VI) in stainless steel welders and ferrochromium production workers are confounded by substantial exposures to other potential carcinogens and Cr(III). However, the generally elevated lung cancer mortality in these workers supports the stronger evidence from the soluble chromate and chromate pigment production cohorts.
A number of the epidemiological studies cited above were evaluated by the IARC in 1990 (Ex. 35-43). IARC found “sufficient evidence in humans for the carcinogenicity of chromium [VI] compounds as encountered in chromate production, chromate pigment production and chromate plating industries” (Ex. 35-43, p. 213). IARC gave Cr(VI) compounds their highest Group 1 classification for agents considered carcinogenic to humans. The EPA and ACGIH have designated Cr(VI) compounds as known and confirmed human carcinogens, respectively (Exs. 35-52; 35-207). NIOSH considers Cr(VI) compounds to be potential occupational carcinogens (Ex. 31-22-22, p. 8).
Experimental animals have generally been administered Cr(VI) compounds by routes other than inhalation. A number of studies in which Cr(VI) compounds were directly instilled in the respiratory tract of rodents produced a significant incidence of lung tumors (Exs. 11-2; 11-12; 11-7). The findings indicate different tumorigenic potencies among Cr(VI) compounds. The less water soluble calcium chromate, strontium chromates, and zinc chromates cause higher numbers of lung tumors at similar doses than the more water soluble sodium dichromate and chromic acid. Experimental research suggests that cellular uptake of the water-insoluble lead chromate is enhanced by the ability to achieve a high local concentration at the lung cell surface that does not occur during uptake of soluble chromates (Ex. 35-149). Because of the greater cancer potency in animal studies, ACGIH has recommended a lower occupational TLV for insoluble Cr(VI) compounds (10 μg/m
The few available inhalation studies are limited by abbreviated exposure durations, low exposure levels, or small number of animals per dose group. These studies report slightly elevated lung tumor incidence that are not statistically significant (Exs. 10-11; 35-26-1) or marginally significant (Exs. 10-8; 35-26). Cr(VI) administered to animals by intramuscular, subcutaneous, and other routes of administration have consistently produced a high incidence of tumors, usually near the site of administration.
Evidence from
The rate, as well as the magnitude of the Cr(VI) dose, that reaches the lung has been shown to influence carcinogenic outcome in experimental animals (Ex. 11-7). Less frequent, but higher dose levels of Cr(VI) instilled in the tracheas of rats caused greater tumor incidence than the same total amount of Cr(VI) instilled more frequently but at lower dose levels. This may result from a proliferation of neoplastic cells triggered by lung inflammation at the high Cr(VI) dose levels or from overwhelming any of a number of molecular pathways that serve to protect against Cr(VI)-induced respiratory
The following sections describe the evidence from the literature on nasal irritation, nasal ulcerations, nasal perforations, asthma, and bronchitis following inhalation exposure to water soluble Cr(VI) compounds. The evidence clearly demonstrates that workers can develop impairment to the respiratory system (nasal irritation, nasal ulceration, nasal perforation, and asthma) after work place exposure by inhalation exposure to Cr(VI) compounds below the current PEL.
It is very clear from the evidence that workers may develop nasal irritation, nasal septum ulcerations, and nasal septum perforations at occupational exposures level at or below the current PEL of 52 μg/m
Occupational exposure to Cr(VI) can lead to nasal septum ulcerations and nasal septum perforations. The nasal septum separates the nostrils and is composed of a thin strip of cartilage with an overlying mucous membrane known as the mucosa. The initial lesion after Cr(VI) exposure is characterized by localized inflammation or a reddening of the affected mucosa, which can later lead to atrophy. This may progress to an ulceration of the mucosa layer (Ex. 35-1; Ex. 7-3). If exposure is discontinued, the ulcer progression will stop and a scar may form. However, if exposure continues, the ulcer may break through the septum, resulting in a nasal septum perforation sometimes referred to chrome hole. Individuals with nasal perforations may experience a range of signs and symptoms, such as a whistling sound, bleeding, nasal discharge, and infection. Some individuals may experience no noticeable effects. It is currently not known precisely what level would trigger such nasal problems, but, as stated earlier, it is evident that workers are developing nasal problems at levels at or below the current PEL.
Several cohort and cross-sectional studies have described nasal lesions from airborne exposure to Cr(VI) at various electroplating and chrome production facilities. Most of these studies have been reviewed by the Center for Disease Control's Agency for Toxic Substances and Disease Registry (ATSDR) toxicological profile for chromium (Ex. 35-41). OSHA reviewed the studies summarized in the profile and conducted its own literature search to update and supplement the review. In its evaluation, OSHA took into consideration the exposure regimen and experimental conditions under which the studies were performed, including exposure levels, duration of exposure, number, and the inclusion of appropriate control groups. Studies were not included if they did not contribute to the weight of evidence either because of inadequate documentation or because of poor quality. This section only covers some of the key studies and reviews. OSHA has also identified two case reports demonstrating the development of nasal irritation and nasal septum perforations, and these case reports are summarized as well. One case report shows how a worker can develop the nasal perforations from direct contact (i.e., touching the inner surface of the nose with contaminated fingers).
Lindberg and Hedenstierna examined the respiratory symptoms and effects of 104 Swedish electroplaters (Ex. 9-126). Of the 104 electroplaters, 43 were exposed to chromic acid by inhalation. The remaining 61 were exposed to a mixture of chromic acid and nitric acid, hydrochloric acid, boric acid, nickel, and copper salts. The workers were evaluated for respiratory symptoms, changes in the nasal septum, and lung function. All workers were asked to fill out a detailed questionnaire on their history of respiratory symptoms and function. Physicians performed inspections of the nasal passages of each worker. Workers were given a pulmonary function test to assess lung function. For those 43 workers exposed exclusively to chromic acid, the median exposure time was 2.5 years, ranging from 0.2 to 23.6 years. The workers were divided into two groups, a low exposure group (19 workers exposed to eight-hour time weighted average levels below 2 μg/m
The investigators reported nasal ulcerations and perforations in a group of workers exposed at the highest peak exposure levels (ranging from 20 μg/m
The authors also reported that in the exposed workers, both forced vital capacity and forced expiratory volume in one second were reduced by 0.2 L, when compared to controls. The forced mid-expiratory flow diminished by 0.4 L/second from Monday morning to Thursday afternoon in workers exposed to chromic acid as Cr(VI) daily TWA average levels of 2 μg/m
Kuo
Cohen
Lucas and Kramkowsi conducted a Health Hazard Evaluation (HHE) on 11 chrome platers in an industrial electroplating facility (Ex. 3-84). The electroplaters worked for about 7.5 years on average. Physicians evaluated each worker for chrome hole scars, nasal septum ulceration, mucosa infection, nasal redness, perforated nasal septum, and wheezing. Seventeen air samples for Cr(VI) exposure were collected in the chrome area. Cr(VI) air concentrations ranged from 1 to 20 μg/m
Gomes evaluated 303 employees from 81 electroplating operations in Sao Paulo, Brazil (Ex. 9-31). Results showed that more than two-thirds of the workers had nasal septum ulcerations and perforations following exposure to chromic acid at levels greater than 100 μg/m
Lin et al. examined nasal septum perforations and ulcerations in 79 electroplating workers from seven different chromium electroplating factories in Taipei, Taiwan (Ex.35-13). Results showed six cases of nasal septum perforations, four having scar formations, and 38 cases of nasal septum ulcerations following inhalation exposure to chromic acid. Air sampling near the electroplating tanks had the highest range of chromic acid as Cr(VI) (mean of 28 μg/m
Bloomfield and Blum evaluated nasal tissue damage and nasal septum perforations in 23 workers employed at six chromium electroplating plants (Ex. 9-13). They found that daily exposure to chromic acid as Cr(VI) at levels of 52 μg/m
Kleinfeld and Rosso found seven cases out of nine of chrome electroplaters having nasal septum ulcerations (Ex. 9-41). Workers were exposed to chromic acid as Cr(VI) by inhalation at levels ranging from 93 μg/m
Royle, using questionnaire responses, reported a significant increase in the prevalence of nasal ulcerations among 997 British electroplaters exposed to chromic acid with an increasing prevalence the longer the worker was exposed to chromic acid (
Gibb
Gibb
Based on their hazard model, Gibb
The U.S. Public Health Service conducted a study of 897 chrome production workers in seven chromate-producing plants in the early 1950s (Ex. 7-3). The findings of this study were used in part as justification for the current OSHA PEL. Workers were exposed by inhalation to various water soluble chromates and bichromate compounds. The total mean exposure to the workers was a TWA of 68 μg/m
Case reports provide further evidence that airborne exposure to direct “hand to nose” contact of Cr(VI) compounds lead to the development of nasal irritation and nasal septum perforations.
For example, a 70-year-old man developed nasal irritation, incrustation, and perforation after continuous daily exposure by inhalation to chromium trioxide (doses were not specified, but most likely quite high given the nature of his duties). This individual inhaled chromium trioxide daily by placing his face directly over an electroplating vessel. He worked in this capacity from 1934 to 1982. His symptoms continued to worsen after he stopped working. By 1991, he developed large perforations of the nasal septum and stenosis (or constriction) of both nostrils by incrustation (Ex. 35-8).
Similarly, a 30-year-old female jigger (a worker who prepares the items prior to electroplating by attaching the items to be plated onto jigs or frames) developed nasal perforation in her septum following continuous exposure (doses in this case were not provided) to chromic acid mists. She worked adjacent to the automated Cr(VI) electroplating shop. She was also exposed to chromic acid from direct contact when she placed her contaminated fingers in her nose. Her hands became contaminated by handling wet components in the jigging and de-jigging processes (Ex. 35-24).
Evidence of nasal septum perforations has also been demonstrated in experimental animals. Adachi exposed 23 C57BL mice to chromic acid by inhalation at concentrations of 1.81 mg Cr(VI)/m
Adachi
Occupational asthma is considered “a disease characterized by variable airflow limitation and/or airway hyper responsiveness due to causes and conditions attributable to a particular occupational environment and not to stimuli encountered outside the workplace” (Ex. 35-15). Asthma is a serious illness that can damage the lungs and in some cases be life threatening. The common symptoms associated with asthma include heavy coughing while exercising or when resting after exercising, shortness of breath, wheezing sound, and tightness of chest. Many workers develop an asthmatic attack. An attack may be triggered by particles in the air (Ex. 35-3; Ex. 35-6). It is not clear what occupational exposure levels of Cr(VI) compounds would lead to the development of occupational asthma.
The strongest evidence of occupational asthma has been demonstrated in four case reports. OSHA chose to focus on these four case reports because the data from other occupational studies do not exclusively implicate Cr(VI), even though the studies generally show an increased prevalence of workers having difficulty breathing and other asthmatic-related symptoms following inhalation of multiple chemicals. The four case reports have the following in common: (1) The worker has a history of occupational exposure exclusively to Cr(VI); (2) a physician has confirmed a diagnosis that the worker has symptoms consistent with occupational asthma; and (3) the worker exhibits functional signs of air restriction (
DaReave reported the case of a 48-year-old cement floorer who developed asthma from inhaling airborne Cr(VI) (Ex. 35-7). This worker had been exposed to Cr(VI) as a result of performing cement flooring activities for more than 20 years. The worker complained of dyspnea, shortness of breath, and wheezing after work, especially after working in enclosed spaces. The Cr(VI) content in cement was about 12 ppm. A bronchial challenge test with potassium dichromate produced a 50% decrease in forced expiratory volume in one second. The occupational physician concluded that the worker's asthmatic condition triggered by exposure to Cr(VI) caused the worker to develop bronchial constriction.
LeRoyer reported a case of a 28-year-old roofer who developed asthma from breathing dust while sawing material made of corrugated fiber cement containing Cr(VI) for nine years (Ex. 35-12). This worker demonstrated
Novey
Shirakawa and Morimoto reported a case of a 50-year-old worker who developed asthma while working at a metal-electroplating plant (Ex. 35-21). Bronchial challenge by physicians produced positive results when using potassium bichromate, followed by a rapid recovery within 5 minutes, when given no exposures. The worker's forced expiratory volume in 1 second dropped by 37% after inhalation of potassium bichromate. The individual immediately began wheezing, coughing with dyspnea, and recovered without treatment within five minutes. The author believes that the worker developed his asthma from inhaling potassium bichromate.
In addition to the case reports confirming that Cr(VI) is responsible for the development of asthma using inhalation challenge tests, the following are several other case reports of Cr(VI) exposed workers having symptoms consistent with asthma where the symptoms were never confirmed by using inhalation challenge tests.
Lockman reported a case of a 41-year old woman, who was occupationally exposed to potassium dichromate during leather tanning (Ex. 35-14). The worker developed an occupational allergy to potassium dichromate. This allergy involved both contact dermatitis and asthma. The physicians considered other challenge tests using potassium dichromate as the test agent (
Williams reported a 23-year old textile worker who was occupationally exposed to chromic acid. He worked near two tanks of chromic acid solutions (Ex. 35-23). He inhaled fumes while frequently walking through the room with the tanks. He developed both contact dermatitis and asthma. He believes the tank was poorly ventilated and was the source of the fumes. He stopped working at the textile firm on the advice of his physician. After leaving, his symptoms improved greatly. No inhalation bronchial challenge testing was conducted to confirm that chromic acid was causing his asthmatic attacks. However, as noted above, chromic acid exposure has been shown to lead to occupational asthma, and thus, chromic acid was likely to be a causative agent in the development of asthma.
Park
In addition to nasal ulcerations, nasal septum perforations, and asthma, there is also limited evidence from reports in the literature of bronchitis associated with Cr(VI) exposure. It is not clear what occupational exposure levels of Cr(VI) compounds would lead to the development of bronchitis.
Royle found that 28% (104/288) of British electroplaters developed bronchitis upon inhalation exposure to chromic acid, as compared to 23% (90/299) controls (Ex. 7-50). The workers were considered to have bronchitis if they had symptoms of persistent coughing and phlegm production. In all but two cases of bronchitis, air samples revealed chromic acid at levels of 0.03 mg/m
Alderson
While the evidence for bronchitis is limited, evidence from experimental animals demonstrate that Cr(VI) compounds can cause lung irritation, inflammation in the lungs, and possibly lung fibrosis at various exposure levels. Glaser
Glaser
Overall, there is convincing evidence to indicate that Cr(VI) exposed workers can develop nasal irritation, nasal ulcerations, nasal perforations, and asthma. There is also some limited evidence that bronchitis may occur when exposed to Cr(VI) compounds at high levels. Most of the studies involved exposure to water-soluble Cr(VI) compounds. It is very clear that workers may develop nasal irritations, nasal ulcerations, and nasal perforations at levels below the current PEL of 52 μg/m
There are numerous studies in the literature showing nasal irritations, nasal perforations, and nasal ulcerations resulting from Cr(VI) inhalation exposure. It also appears that direct hand-to-nose contact (
There are numerous well documented case reports in the literature describing occupational asthma specifically triggered by Cr(VI) in sensitized workers. However, OSHA is not aware of any data from the literature to determine a Cr(VI) dose in the work place that leads to the asthmatic condition or to determine how many people may be affected by such Cr(VI) exposure.
The evidence that workers breathing Cr(VI) can develop respiratory disease that involve inflammation, such as asthma and bronchitis is supported by experimental animal studies. The 1985 and 1990 Glaser
Occupational exposure to Cr(VI) is a well-established cause of adverse health effects of the skin. The effects are the result of two distinct processes: (1) Irritant reactions, such as skin ulcers and irritant contact dermatitis, and (2) delayed hypersensitivity (allergic) reactions. Some evidence also indicates that exposure to Cr(VI) compounds may cause conjunctivitis.
The mildest skin reactions consist of erythema (redness), edema (swelling), papules (raised spots), vesicles (liquid spots), and scaling (Ex. 35-313, p. 295). The lesions are typically found on exposed areas of the skin, usually the hands and forearms (Exs. 9-9; 9-25). These features are common to both irritant and allergic contact dermatitis, and it is generally not possible to determine the etiology of the condition based on histopathologic findings (Ex. 35-314). Allergic contact dermatitis can be diagnosed by other methods, such as patch testing (Ex. 35-321, p. 226). Patch testing involves the application of a suspected allergen to the skin, diluted in petrolatum or some other vehicle. The patch is removed after 48 hours and the skin examined at the site of application to determine if a reaction has occurred.
Cr(VI) compounds can also have a corrosive, necrotizing effect on living tissue, forming ulcers, or “chrome holes” (Ex. 35-315). This effect is apparently due to the oxidizing properties of Cr(VI) compounds (Ex. 35-318, p. 623). Like dermatitis, chrome ulcers generally occur on exposed areas of the body, chiefly on the hands and forearms (Ex. 35-316). The lesions are initially painless, and are often ignored until the surface ulcerates with a crust which, if removed, leaves a crater two to five millimeters in diameter with a thickened, hardened border. The ulcers can penetrate deeply into tissue and become painful. Chrome ulcers may penetrate joints and cartilage (Ex. 35-317, p. 138). The lesions usually heal in several weeks if exposure to Cr(VI) ceases, leaving a flat, atrophic scar (Ex. 35-318, p.623). If exposure continues, chrome ulcers may persist for months (Ex. 7-3).
It is generally believed that chrome ulcers do not occur on intact skin (Exs. 35-317, p. 138; 35-315; 35-25). Rather, they develop readily at the site of small cuts, abrasions, insect bites, or other injuries (Exs. 35-315; 35-318, p. 138). In experimental work on guinea pigs, Samitz and Epstein found that lesions were never produced on undamaged skin (Ex. 35-315). The degree of trauma, as well as the frequency and concentration of Cr(VI) application, was found to influence the severity of chrome ulcers.
The development of chrome ulcers does not appear to be related to the sensitizing properties of Cr(VI). Edmundson provided patch tests to determine sensitivity to Cr(VI) in 56 workers who exhibited either chrome ulcers or scars (Ex. 9-23). A positive response to the patch test was found in only two of the workers examined.
Parkhurst first identified Cr(VI) as a cause of allergic contact dermatitis in 1925 (Ex. 9-55). Cr(VI) has since been confirmed as a potent allergen. Kligman (1966) used a maximization test (a skin test for screening possible contact allergens) to assess the skin sensitizing potential of Cr(VI) compounds (Ex. 35-
Adverse skin effects from Cr(VI) exposure have been known since at least 1827, when Cumin described ulcers in two dyers and a chromate production worker (Ex. 35-317, p. 138). Since then, skin conditions resulting from Cr(VI) exposure have been noted in a wide range of occupations. Work with cement is regarded as the most common cause of Cr(VI)-induced dermatitis (Exs. 35-313, p. 295; 35-319; 35-320). Other types of work where Cr(VI)-related skin effects have been reported include chromate production, chrome plating, leather tanning, welding, motor vehicle assembly, manufacture of televisions and appliances, servicing of railroad locomotives, aircraft production, and printing (Exs. 31-22-12; 7-50; 9-31; 9-100; 9-63; 9-28; 9-95; 9-54; 35-329; 9-97; 9-78; 9-9; 35-330). Some of the important studies on Cr(VI)-related dermal effects in workers are described below.
a.
Cement dermatitis can be caused by direct irritation of the skin, by sensitization to Cr(VI), or both (Ex. 35-317, p. 147). However, sensitization is considered to be of greater importance than irritation in causing cement dermatitis (Ex. 35-317, p. 147). Burrows (1983) combined the results of 16 separate studies to report that, on average, over 80% of cement dermatitis cases were found to be sensitized to Cr(VI) (Ex. 35-317, p. 148). Cement is alkaline, abrasive, and hydroscopic (water-absorbing), and it is likely that the irritant effect resulting from these properties interferes with the skin's defenses, permitting penetration and sensitization to take place more readily (Ex. 35-318, p. 624). Dry cement is considered relatively innocuous because it is not as alkaline as wet cement (Exs. 35-317, p. 147; 9-17). When water is mixed with cement the water liberates calcium hydroxide, causing a rise in pH (Ex. 35-317, p. 147).
Flyvholm
The relationship between Cr(VI) content in cement and the prevalence of Cr(VI)-induced allergic contact dermatitis is supported by the findings of Avnstorp (1989) in a study of Danish workers who had daily contact with wet cement during the manufacture of pre-fabricated concrete products (Ex. 9-131). Beginning in September of 1981, low concentrations of ferrous sulfate were added to all cement sold in Denmark to reduce Cr(VI) to trivalent chromium. Two hundred and twenty seven workers were examined in 1987 for Cr(VI)-related skin effects. The findings from these examinations were compared to the results from 190 workers in the same plants who were examined in 1981. The prevalence of hand eczema had declined from 11.7% to 4.4%, and the prevalence of Cr(VI) sensitization had declined from 10.5% to 2.6%. Both of these results were statistically significant. There was no significant change in the frequency of skin irritation.
b.
In the Baltimore, Maryland chromate production plant examined by Gibb
A number of factors make these results difficult to interpret. The reported findings are not specifically related to Cr(VI) exposure. They may have been the result of other workplace exposures, or non-workplace factors. The report also indicates the percentage of workers who were diagnosed with a condition during their tenure at the plant; however, no information is presented to indicate the expected incidence of these conditions in a population that is not exposed to Cr(VI).
Measurements of Cr(VI) air concentrations by job title were used to estimate worker exposures. Based on these estimates, the authors used a proportional hazards model to find a statistically significant correlation (p=0.004) between ulcerated skin and airborne Cr(VI) exposure. Statistically significant correlations between year of hire and findings of ulcerated skin and dermatitis were also reported. Exposures to Cr(VI) in the plant had generally dropped over time. Median exposure to Cr(VI) at the time of occurrence for most of the findings was said to be about 10 μg/m
Mean and median times on the job prior to initial diagnosis were also
Lee and Goh (1988) examined the skin condition of 37 workers who maintained chrome plating baths and compared these workers with a group of 37 control subjects who worked in the same factories but were not exposed to Cr(VI) (Ex. 35-316). Mean duration of employment as a chrome plater was 8.1 (SD±7.9) years. Fourteen (38%) of the chrome platers had some occupational skin condition; seven had chrome ulcers, six had contact dermatitis and one had both. A further 16 (43%) of the platers had scars suggestive of previous chrome ulcers. Among the control group, no members had ulcers or scars of ulcers, and three had dermatitis.
Where ulcers or dermatitis were noted, patch tests were administered to determine sensitization to Cr(VI) and nickel. Of the seven workers with chrome ulcers, one was allergic to Cr(VI). Of the six workers with dermatitis, two were allergic to Cr(VI) and one to nickel. The worker with ulceration and dermatitis was not sensitized to either Cr(VI) or nickel. Although limited by a relatively small study population, this report clearly indicates that Cr(VI)-exposed workers face an increased risk of adverse skin effects. The fact that the majority of workers with dermatitis were not sensitized to Cr(VI) indicates that irritant factors play an important role in the development of dermatitis in chrome plating operations.
Royle (1975) also investigated the occurrence of skin conditions among workers involved in chrome plating (Ex. 7-50). A questionnaire survey completed by 997 chrome platers revealed that 21.8% had experienced skin ulcers, and 24.6% had suffered from dermatitis. No information was presented to indicate the expected incidence in a comparable population that was not exposed to Cr(VI). Of the 54 plants involved in the study, 49 used nickel, another recognized cause of allergic contact dermatitis.
The author examined the relationship between the incidence of these conditions and length of exposure. The plater population was divided into three groups: those with less than one year of Cr(VI) exposure, those with one to five years of Cr(VI) exposure, and those with over five years of Cr(VI) exposure. A statistically significant trend was found between length of Cr(VI) exposure and incidence of skin ulcers. The incidence of dermatitis, on the other hand, bore no relationship to length of exposure.
In 1973, researchers from NIOSH reported on the results of a health hazard investigation of a chrome plating establishment (Ex. 3-5). In the plating area, airborne Cr(VI) concentrations ranged from less than 0.71 up to 9.12 μg/m
Gomes (1972) examined Cr(VI)-induced skin lesions among electroplaters in Sao Paulo, Brazil (Ex. 9-31). A clinical examination of 303 workers revealed 88 (28.8%) had skin lesions, while 175 (58.0%) had skin and mucus membrane lesions. A substantial number of employers (26.6%) also did not provide personal protective equipment to workers. The author attributed the high incidence of skin ulcers on the hands and arms to inadequate personal protective equipment, and lack of training for employees regarding hygiene practices.
Fleeger and Deng (1990) reported on an outbreak of skin ulcerations among workers in a facility where enamel paints containing chromium were applied to kitchen range parts (Ex. 9-97). A ground coat of paint was applied to the parts, which were then placed on hooks and transported through a curing oven. In some cases, small parts were places on hooks before paint application. Tiny holes in the oven coils apparently resulted in improper curing of the paint, leaving sharp edges and a Cr(VI)-containing residue on the hooks. Most of the workers who handled the hooks reportedly did not wear gloves, because the gloves were said to reduce dexterity and decrease productivity. As a result, cuts from the sharp edges allowed the Cr(VI) to penetrate the skin, leading to ulcerations (Ex. 9-97).
Cr(VI)-related dermatitis tends to become more severe and persistent with continuing exposure. Once established, the condition may persist even if occupational exposure ceases. Fregert followed up on cases of occupational contact dermatitis diagnosed over a 10-year period by a dermatology service in Sweden. Based on responses to questionnaires completed two to three years after treatment, only 7% of women and 10% of men with Cr(VI)-related allergic contact dermatitis were reported to be healed (Ex. 35-322). Burrows reviewed the condition of patients diagnosed with work-related dermatitis 10-13 years earlier. Only two of the 25 cases (8%) caused by exposure to cement had cleared (Ex. 35-323).
Hogan
Halbert
When the review was conducted, 62 (58%) patients were employed in the same occupation as when initially diagnosed. Fifty-five (89%) of these workers continued to suffer from dermatitis. Fifty-eight patients (48%) changed occupations after their initial diagnosis. Each of these individuals indicated that they had changed occupations because of their dermatitis. In spite of the change, dermatitis persisted in 40 members of this group (69%).
Lips
In a response to OSHA's RFI submitted on behalf of the Chrome Coalition, Exponent indicated that the findings of Fowler
The Fowler
The exposure scenario in the Fowler
OSHA believes that adverse dermal effects from exposure to Cr(VI), including irritant contact dermatitis, allergic contact dermatitis, and skin ulceration, have been firmly established. The available evidence is not sufficient to relate these effects to any given Cr(VI) air concentration. Rather, it appears that direct dermal contact with Cr(VI) is the most relevant factor in the development of dermatitis and ulcers. Based on the findings of Gibb
OSHA does not believe that the available evidence is sufficient to establish a threshold concentration of Cr(VI) below which dermal effects will not occur in the occupational environment. This preliminary finding is supported not only by the belief that the exposure scenario of Fowler
OSHA has examined the possibility of health effect outcomes associated with Cr(VI) exposure in addition to such effects as lung cancer, nasal ulcerations and perforations, occupational asthma, and irritant and allergic contact dermatitis. Unlike the Cr(VI)-induced toxicities cited above, the data on other health effects do not definitively establish Cr(VI)-related impairments of health from occupational exposure at or below the current OSHA PEL.
There is some positive evidence that workplace inhalation to Cr(VI) results in gastritis and gastrointestinal ulcers, especially at high exposures (generally over OSHA's current PEL) (Ex. 7-12). This is supported by ulcerations in the gastrointestinal tract of mice breathing high Cr(VI) concentration for long periods (Ex. 10-8). Other studies reported positive effects but significant information was not reported or the confounders made it difficult to draw positive conclusions (Ex. 3-84; Sassi 1956 as cited in Ex. 35-41). Other studies reported negative results (Exs. 7-14; 9-135).
Likewise, several studies reported increases in renal proteins in the urine of chromate production workers and chrome platers (Exs. 35-107; 5-45; 35-105; 5-57). The Cr(VI) air levels recorded in these workers were usually below the current OSHA PEL (Exs. 35-107; 5-45). Workers with the highest urinary chromium levels tended to also have the largest elevations in renal markers (Ex. 35-107). One study reported no relationship between chromium in urine and renal function parameters, no relationship with age or with duration of exposure, and no relationship between the presence of chromium skin ulcers and chromium levels in urine or renal function parameters (Ex. 5-57). In most studies, the elevations renal protein levels were restricted to only one or two proteins out of several examined per study, generally exhibited small increases (Ex. 35-105) and the effects appeared to be reversible (Ex. 5-45). It has been stated that low molecular weight proteinuria can occur from other reasons and cannot by itself be considered evidence of chronic renal disease (Ex. 35-195). Other studies reported no changes in renal markers (Exs. 7-27; 35-104) and animal inhalation studies did not report kidney damage (Exs. 9-135; 31-18-11; 10-11; 31-18-10; 10-10). Some studies with Cr(VI) administered by drinking water or gavage were positive for increases in renal markers, and some cell and tissue damage (Exs. 9-143; 11-10). However, it is not clear how to extrapolate such findings to workers exposed to Cr(VI) via inhalation. Well designed studies of effects in humans via ingestion were not found.
OSHA did not find information to clearly and sufficiently demonstrate that exposures to Cr(VI) result in significant impairment to the hepatic system. Two European studies, positive for an excess of deaths from cirrhosis of the liver and hepatobiliarity disorders, were not able to separate chromium exposures from exposures to the many other substances present in the workplace. The authors also could not rule out the role of alcohol use as a possible contributor to the disorder (Ex. 7-92; Sassi as cited in Ex. 35-41). Other studies did not report any hepatic abnormalities (Exs. 7-27; 10-11).
The reproductive studies showed mixed results. Some positive reproductive effects occurred in some welding studies. However, it is not clear that Cr(VI) is the causative agent in these studies (Exs. 35-109; 35-110; 35-108; 35-202; 35-203). Other positive studies were seriously lacking in information. Information was not given on exposures, the nature of the reproductive complications, or the women's tasks (Shmitova 1980, 1978 as cited in Ex. 35-41, p. 52). ATSDR states that because these studies were
The Occupational Safety and Health (OSH) Act and some landmark court cases have led OSHA to rely on quantitative risk assessment, where possible, to support the risk determinations required to set a permissible exposure limit (PEL) for a toxic substance in standards under the OSH Act. Section 6(b)(5) of the Act states that “The Secretary [of Labor], in promulgating standards dealing with toxic materials or harmful agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.” (29 U.S.C. 651
In a further interpretation of the risk requirements for OSHA standard setting, the United States Supreme Court, in the 1980 “benzene” decision, (
Although the Court in the Cotton Dust case, (
The determining factor in the decision to perform a quantitative risk assessment is the availability of suitable data for such an assessment. As reviewed in section VI.B. on Carcinogenic Effects, there are a substantial number of occupational cohort studies that reported excess lung cancer mortality in workers exposed to Cr(VI) in several industrial operations. Many of these found that workers exposed to higher levels of airborne Cr(VI) for a longer period of time had greater standardized mortality ratios (SMRs) for lung cancer. OSHA believes two recently studied occupational cohorts have the strongest data sets on which to quantify lung cancer risk from cumulative Cr(VI) exposure (i.e., air concentration x exposure duration). Using a linear relative risk model on these data to predict excess lifetime risk, OSHA preliminarily estimates that the lung cancer risk from a 45 year occupational exposure to Cr(VI) at an 8-hour TWA at the current PEL of 52 μg/m
In contrast to the more extensive occupational cohort data on Cr(VI) exposure-response, data from experimental animal studies are less suitable for quantitative risk assessment of lung cancer than human studies. Besides the obvious species difference, most of the animal studies administered Cr(VI) to the respiratory tract by less relevant routes, such as instillation or implantation. The few available inhalation studies in animals were limited by a combination of inadequate exposure levels, abbreviated durations, and small numbers of animals per dose group. Despite these limitations, the animal data do provide semi-quantitative information with regard to the relative carcinogenic potency of different Cr(VI) compounds. A more detailed discussion can be found in section VI.B.7.
The data that relate non-cancer health impairments, such as damage to the respiratory tract and skin, to Cr(VI) exposure are also not well suited for quantitative assessment. There are some data from cross-sectional studies and worker surveys that group the prevalence and severity of nasal damage by contemporary time-weighted average (TWA) Cr(VI) air measurements. However, there are no studies that track either incidence or characterize exposure over time. Nasal damage is also more likely influenced by shorter-term peak exposures that have not been as well characterized. While difficult to quantitate, the data indicate that the risk of damage to the nasal mucosa would be significantly reduced by lowering the current PEL, discussed further in section VIII on Significance of Risk.
There are even less suitable exposure-response data to assess risk for other Cr(VI)-induced impairments (
The more than 40 occupational cohort studies reviewed in Section VI.B on carcinogenic effects were evaluated to determine the adequacy of the exposure-response information for the quantitative assessment of lung cancer risk associated with Cr(VI) exposure. The key criteria were data that allowed for estimation of input variables, specifically levels of exposure and duration of exposure (
Additional criteria were applied to evaluate the strengths and weaknesses of the available epidemiological data sets. Studies needed to have well-defined cohorts with identifiable cases. Features such as cohort size and length of follow-up affect the ability of the studies to detect any possible effect of Cr(VI) exposure. Potential confounding of the responses due to other exposures was considered. Study evaluation also considered whether disease rates from an appropriate reference population were used to derive expected numbers of lung cancers. One of the most important factors in study evaluation was the ascertainment and use of exposure information (i.e., well-documented historical exposure data). Both level and duration of exposure are important in determining cumulative dose, and studies are often deficient with respect to the availability or use of such information. Evidence of exposure-response relationship was also important.
Two recently studied cohorts of chromate production workers were found to be the strongest data sets for quantitative assessment (Exs. 31-22-11; 33-10). Of the various studies, these two had the most extensive and best documented Cr(VI) exposures spanning three or four decades. Both cohort studies characterized observed and expected lung cancer mortality and reported a statistically significant positive association between lung cancer risk and cumulative Cr(VI) exposure. Four other cohorts had less satisfactory data for quantitative assessments of lung cancer risk (Exs. 7-11; 23; 7-14; 7-120; 31-16-3). While the lung cancer response in these cohorts was stratified across multiple exposure groups, there were limitations to these data that affected the certainty of the risk projections. The cohorts include chromate production workers, stainless steel welders, and aerospace manufacturing workers. Risk estimates from these lesser cohorts were used to examine the robustness of the more precise estimates from the Gibb and Luippold cohorts. The strengths and weaknesses of all six cohorts in terms of their use in exposure-response analysis are discussed in more detail below. Emphasis has been placed on the quantitative information available for each cohort.
Three other cohort studies that were used in the past to develop crude risk estimates from worker exposure to Cr(VI) are not being relied upon in the present assessment and therefore are not reviewed below (Exs. 7-37; 7-62; 7-95). In these cohorts, risk estimates were determined from background lung cancer rates and excess lung cancer mortality associated with a single, rather than multiple Cr(VI) exposure levels. There were also a number of other limitations to the study data that required the use of unsupported assumptions and raised uncertainties in the risks. The exposure-response data from the three studies and the resulting assessments are discussed in the 1995 report from the K.S. Crump Division (Ex. 13-5). OSHA believes the recent availability of several higher quality cohort studies cited above eliminates the need to rely on these more problematic cohorts to assess lung cancer risk from occupational Cr(VI) exposure.
The Gibb et al. study was one of the stronger studies for quantitative risk assessment, especially in terms of cohort size, historical exposure data, and evidence of exposure-response (Exs. 31-22-11; 33-11). Gibb et al. studied an updated cohort from the same Baltimore chromate production plant previously studied by Hayes et al. (see section VII.B.4). The cohort consisted of 2357 male workers (white and non-white) first employed between 1950 and 1974. Follow-up was through the end of 1992 for a total of 70,736 person-years and an average length of 30 years per member. Smoking status at the start of employment was available for 91% of the cohort members.
A significant advantage of the Gibb data was the sizable amount of personal and area sampling measurements from a variety of locations and job titles collected concurrently over the years during which the cohort members were exposed (from 1950 to 1985, when the plant closed). Using these concentration estimates as the basis, a job exposure matrix was constructed giving annual average exposures by job title. Based on the job exposure matrix and work histories for the cohort members, Gibb et al. computed the person-years of observation, the observed numbers of lung cancer deaths, and the expected numbers of lung cancer deaths categorized by cumulative Cr(VI) exposure and age of death. They found that cumulative Cr(VI) exposure was a significant predictor of lung cancer risk over the exposure range of 0 to 2.76 (mean±SD = 0.70±2.75) mg/m
The detailed reporting of the cumulative exposure, including mean values for four categories defined by the quartiles of cumulative exposure versus age, was another significant advantage. This level of documentation reduced some of the uncertainty associated with the estimation of cumulative exposure. Moreover, the cross-classification of cumulative exposure with age allowed the application of more elaborate models that consider the effect of age on lung cancer risk.
Since the publication of Gibb et al., the data file containing the demographic, exposure, and response data for the individual cohort members was made available (Ex. 295). These data have been used in a recent reanalysis (see subsection VII.C.1). The advantages of the study mentioned above are even greater now that the detailed cohort data can be accessed. Among other things, the exposure groups can be defined in alternative ways, the effect of considering different reference populations can be examined, and additional models can be applied in the dose-response analysis.
The other well-documented exposure-response data set comes from a second cohort of chromate production workers. Luippold
One aspect that the Luippold cohort had in common with the Gibb cohort was extensive and well-documented air monitoring of Cr(VI). Cr(VI) exposures for the Luippold cohort were based on 21 industrial hygiene surveys conducted at the plant between 1943 and 1971, yielding a total of more than 800 area samples (Ex. 35-61). A job exposure matrix was computed for 22 exposure areas for each month starting in 1940 and, coupled with detailed work histories available for the cohort members, cumulative exposures were calculated for each person-year of observation. The cumulative Cr(VI) exposures, which ranged from 0.003 to 23 (mean±SD = 1.58±2.50) mg Cr(VI)/m
Luippold
Mancuso (Ex. 7-11) studied the lung cancer incidence of an earlier cohort of 332 white male employees drawn from the same plant in Painesville, Ohio that was evaluated by the Luippold group. The Mancuso cohort was first employed at the facility between 1931 and 1937 and followed up through 1972, when the plant closed. Mancuso (Ex. 23) later extended the follow-up period through 1993, yielding a total of 12,881 person-years of observation for an average length of 38.8 years and a total of 66 lung cancer deaths. Since the Mancuso workers were first employed in the 1930s and the Luippold workers were first employed after 1940, the cohorts consisted of a completely different set of individuals.
A major limitation of the Mancuso study is the uncertainty of the exposure data. Mancuso relied exclusively on the air monitoring reported by Bourne and Yee (Ex. 7-98) conducted over a single short period of time during 1949. Bourne and Yee presented monitoring data as airborne insoluble chromium, airborne soluble chromium, and total airborne chromium by production department at the Painesville plant. The insoluble chromium was probably Cr(III) compounds with some slightly water-soluble and insoluble chromates. The soluble chromium was probably highly water-soluble Cr(VI). Mancuso (Exs. 7-11; 23) calculated cumulative exposures (mg/m
Mancuso presented observed lung cancer deaths and age-adjusted death rates stratified by age group and cumulative total, soluble and insoluble chromium exposure groups (Ex. 23). However, the study did not provide the expected numbers of lung cancers for the exposure groupings, making it more difficult to apply appropriate risk models to the data. Approaches that attempt to circumvent this limitation are discussed in subsection VII.E.1. Mancuso (Ex. 7-11; 23) reported cumulative exposure-related increases in age-adjusted lung cancer death rates for soluble, insoluble, or total chromium. Within a particular range of exposures to insoluble chromium, lung cancer death rates also tended to increase with increasing total cumulative chromium. However, the study did not report whether these tendencies were statistically significant, nor did it report the extent to which exposures to soluble and insoluble chromium were correlated. Thus, it is possible that the apparent relationship between insoluble chromium
Although a 1995 risk assessment based on data from the 1975 Mancuso study was prepared for OSHA under contract (Ex. 13-5), it has been superseded by an updated assessment from the more complete 1997 Mancuso data (Ex. 33-15). Specific limitations with respect to quantitative risk estimation from the Mancuso cohort are discussed in section VII.E.1 on supporting risk assessments.
Hayes
Hayes
Later on, Braver
Braver
Gerin
Unfortunately, the industrial hygiene data used to develop the Gerin exposure matrix included measurements in the 1970s from only 8 of the 135 companies that employed welders in the cohort. Individual work histories were also not available for about 25 percent of the stainless steel welders. In these cases, information was assumed based on the average distribution of welding practices within the company. The lack of specific Cr(VI) air measurements and work practice information for this cohort raises questions concerning the accuracy of the exposure estimates.
Gerin
Alexander
Industrial hygiene data collected between 1974 and 1994 were used to classify jobs in categories of “high” exposure, “moderate” exposure, or “low” exposure to Cr(VI). The use of respiratory protection was accounted for when setting up the job exposure matrix. These exposure categories were assigned summary TWA concentrations and combined with individual job history records to estimate cumulative exposures for each person-year of observation. As further discussed in section VII.E.4, it was not clear from the study whether exposures are expressed in units of Cr(VI) or chromate (CrO
Alexander
The epidemiologic database is quite extensive and contains several studies that have adequate data suitable for quantitative risk assessment. OSHA considers certain studies to be better suited for quantitative assessment than others. The Gibb and Luippold cohorts are considered the preferred sources for quantitative estimation because they have larger cohort sizes, extensive follow-up periods, fairly well documented historical Cr(VI) exposure levels, and because analysts have had access to the individual job histories and associated exposure matrices.
The Mancuso cohort and the Hayes cohort were derived from workers at the same plants as Luippold and Gibb, respectively, but have limitations associated with the reporting of quantitative information and exposure estimates that make them less suitable for a risk assessment. Similarly, the Gerin and Alexander cohorts are less suitable either because of the small size of the cohort, the shorter follow-up, or limitations with respect to exposure estimation. For example, the lung cancer status of the Alexander cohort had only been tracked for an average of nine years. This is in contrast to the Gibb, Luippold, and Mancuso cohorts that accumulated an average 30 or more years of observation. Long-term follow-up of cohort members is particularly important for determining the risk of lung cancer, which typically has an extended latency period of roughly twenty years. The Alexander cohort would need additional 20 years of
Despite the limitations, the lesser studies each provide independent estimates of risk, albeit with more uncertainty, that can be compared to the estimates derived from the preferred data sets. OSHA believes evaluating consistency in risk among several different worker cohorts adds to the overall quality of the assessment. In light of the extensive worker exposure-response data, there is little additional value in deriving quantitative risk estimates from tumor incidence results in rodents, especially considering the concerns with regard to route of exposure and study design.
The following sections, describing the quantitative estimates of risk, start with the preferred Gibb and Luippold cohorts. The risk estimates from the supporting studies and previous risk assessments are then discussed. A discussion of remaining issues and uncertainties follows the quantitative presentation.
Quantitative risk assessments have recently been performed on the exposure-response data from the Gibb cohort by three groups: Environ International (Exs. 33-15; 33-12) under contract with OSHA; the National Institute for Occupational Safety and Health (Ex. 33-13); and Exponent (Ex. 31-18-15-1) for the Chrome Coalition. All reported similar risks for Cr(VI) exposure over a working lifetime despite using somewhat different modeling approaches. The exposure-response data, risk models, statistical evaluation, and risk estimates reported by each group are discussed below.
In 2002, Environ International (Environ) prepared a quantitative analysis of the association between Cr(VI) exposure and lung cancer (Ex. 33-15). The Environ analysis relied on a summary of the person-years of observation and observed and expected lung cancer deaths broken down by age and cumulative exposure (Ex. 31-22-11, Table V). These data are presented in Table VII-1. The job exposure matrix was the basis for the calculation of individual cumulative exposure estimates for all 2357 members of the cohort. The cumulative exposure estimates were lagged 5 years (i.e., at any point in time after exposure began, an individual's cumulative exposure would equal the product of chromate concentration and duration of exposure, summed over all jobs held up to five years prior to that point in time). An exposure lag is commonly used in the dose-response analysis of lung cancer since there is a long latency period between first exposure and the development of disease. Gibb et al. found that models using five- and ten-year lags provided better fit to the mortality data than lags of zero, two and twenty years (Ex. 31-22-11). The cross-classification of cumulative exposure with age allowed Environ to evaluate models that considered the effect of age on lung cancer risk. A total of 71,994 person-years summed up from Table V of the Gibb et al. study was slightly greater than the reported 70,736 cited in their publication (Ex. 31-22-11, p. 119).
A set of “externally standardized” models was applied to the data in Table VII-1. These are externally standardized because they required estimates of expected lung cancer deaths from a standard reference population. The 2002 Environ analysis relied on expected lung cancer deaths from age-specific Maryland rates, as provided in Gibb
The set of models used was mathematically described as follows:
E1. N
E2. N
E3. N
Models E1 and E2 are relative risk models that differ with respect to the effect of age. In model E1, the background rates are adjusted for age whereas in E2 the dose coefficient is modified by the age. On the other hand, Model E3 is an additive risk model. In the case of additive risk models, the exposure-related estimate of risk is the same regardless of the age- and race-specific background rate of lung cancer. For relative risk models, a dose term is multiplied by the appropriate background rate of lung cancer to derive an exposure-related estimate of risk, so that excess risk is always relative to background.
Estimation of parameters (i.e., C
Goodness-of-fit for each model was evaluated by considering the deviance, a likelihood-based statistic for which larger p-values indicate better model fit. In addition, the fits of different models were compared using the Akaike Information Criterion (AIC) value, a statistic based on the model's maximized likelihood and the number of parameters used. For the quadratic model E1, addition of a dose-squared term did not significantly improve the fit of model to the data (i.e., C
A second set of “internally standardized” models, which did not require estimation of the expected number of lung cancers, was also fit to the data in Table VII-1 (Ex. 33-15). Model parameters were estimated by the maximum likelihood procedures described above. The test for goodness-of-fit indicated that these models did not fit the data well (p ≤ 0.01). The formulation and a more detailed description of these models can be found in the 2002 Environ report (Ex. 33-15).
Lifetable calculations were made of the number of extra lung cancers per 1000 workers exposed to Cr(VI), assuming a constant exposure from age 20 through a maximum of age 65. The lifetime probability of a lung cancer death was cumulated to age 100, resulting in a negligible loss of accuracy since the probability that a person will live longer than that is extremely small. Rates of lung cancer and other mortality for the lifetable calculations were based, respectively, on 1998 U.S. lung cancer and all-cause mortality rates for both sexes and all races.
The lifetable calculation of additional lifetime risk was completed for the maximum likelihood parameter estimates for each model. In addition, 95% confidence intervals for the additional lifetime risk were derived by a likelihood profile method. Details about the procedures used to estimate parameters, model fit, lifetable calculations, and confidence intervals are described in the 2002 Environ report (Ex. 33-15, p. 24-26).
Based on comparison of the models' AIC values, Environ indicated that the linear relative risk model (simplified E1/E2) was preferred over the E3 additive risk model. The relative risk model is also preferred over an additive risk model (fits being adequate in both cases) in the case of lung cancer because of its variable background rate with age. It may not be appropriate to assume, as an additive model does, that increased lung cancer risk at age 25, where background risk is relatively low, would be the same (for the same cumulative dose) as at age 50, where background rates are much higher.
The linear relative risk model predicted an excess lifetime risk of lung cancer associated with an occupational exposure of 45 years to 1 μg/m
Since the completion of the 2002 Environ analysis, individual data for the 2,357 men in the Gibb
In the 2002 analysis, Environ used the same four-group categorization of cumulative exposure reported by Gibb
The 2003 Environ analysis also derived expected cases using lung cancer rates from alternative reference populations. In addition to the State of Maryland lung cancer rates that were used by Gibb
The 2003 analysis used two externally standardized models, a quadratic relative risk model (model E1 from above, without the age factor) and a quadratic additive risk model (model E3 from above with the additional term C
All externally standardized models provided a good fit to the data (p≥0.40). The choice of exposure grouping had little effect on the parameter estimates of either model E1 or E4. However, the choice of reference rates had some effect, notably on the “background” parameter, C
The coefficient for cumulative dose in the model ranged from 2.87 to 3.48 per mg/m
For the internally standardized Cox proportional hazards models, C1 and C2, the other possible explanatory variables considered were cigarette smoking status, race, and calendar year of death. For both models, addition of a term for smoking status significantly improved the fit of the models to the data (p≤0.00001). The experience with non-linear model C1 indicated that race (p=0.15) and year of death (p=0.4) were not significant contributors when cumulative dose and smoking status were included in the model. Based on results for model C1, race and year of death were not considered by Environ in the linear model C2. The cumulative dose coefficient, β2, was 1.00 for model C1 and 2.68 for model C2. Model C2 provided a slightly better fit to the data than did model C1. A more complete description of the models and variables can be found in the 2003 Environ analysis (Ex. 33-12, p. 10).
Table VII-3 shows each model's predictions of excess lifetime lung cancer risk from various occupational exposures. The estimates are very consistent regardless of model, exposure grouping, or reference population. The model that appears to generate results least similar to the others is C1, which yielded one of the higher risk estimates at 52 μg/m
The estimates based on the individual data files were slightly greater than
NIOSH (Ex. 33-13) developed a risk assessment from the Gibb cohort. The NIOSH analysis, like the 2003 Environ assessment, used the cohort individual data files to compute cumulative Cr(VI) exposure. However, NIOSH also explored some other exposure-related assumptions. For example, they performed the dose-response analysis with lag times in addition to the 5-year lag used by Environ. NIOSH also analyzed dose-response using as many as 50 exposure categories, although their report presents data in five cumulative Cr(VI) exposure groupings.
NIOSH incorporated information on the cohort smoking behavior in their quantitative assessments. They estimated (packs/day)-years of cumulative smoking for each individual in the cohort, using information from a questionnaire that was administered at the time of each cohort member's date of hire. To estimate cumulative smoking, NIOSH assumed that the cohort members maintained the level of smoking reported in the questionnaire from the age of 18 through the end of follow-up. Individuals with unknown smoking status were assigned a value equal to the average smoking level among all individuals with known smoking levels (presumably including non-smokers). Individuals who were known to smoke but for whom the amount was unknown were assigned a smoking level equal to the average of all smokers.
NIOSH considered six different relative risk models, fit to the data by Poisson regression methods. They did not consider additive risk models. The six relative risk models were externally standardized using age- and race-specific U.S. lung cancer rates. Their background coefficients, C
NIOSH1a: N
NIOSH1b: N
NIOSH1c: N
NIOSH1d: N
NIOSH1e: N
NIOSH1f: N
NIOSH reported that the linear relative risk model 1e generally provided a superior fit to the exposure-response data when compared to the various log linear models, 1a-d. Allowing some non-linearity (
The dose coefficient (C
NIOSH reported a significantly higher dose-response coefficient for nonwhite workers than for white workers. That is, nonwhite workers in the Gibb cohort are estimated to have a higher excess risk of lung cancer than white workers, given equal cumulative exposure to Cr(VI). In contrast, no significant race difference was found in the Cox proportional hazards analysis reported by 2003 Environ.
In response to OSHA's Request For Information, Exponent (Ex. 31-18-15-1) prepared an analysis of lung cancer mortality from the Gibb cohort. Like 2003 Environ and NIOSH, the Exponent analysis relied on the individual worker data. Exponent performed their dose-response analyses based on three different sets of exposure categories using two reference populations and 70,808 person-years of follow-up. A total of four analyses were completed, using (1) Maryland reference rates and the four Gibb
The analysis using Maryland reference lung cancer rates and the Gibb
The two analyses that used Baltimore reference rates and either Exponent's six-category exposure grouping or the Gibb
The lowest excess lifetime risk for workers exposed to 1 μg/m
In addition, the Exponent six category cumulative exposure grouping may have led to an underestimate of the dose effect. The definition of Exponent's six exposure groups was not related to the distribution of cumulative exposure associated with individual person-years, but rather to the distribution of cumulative exposure among the workers at the end of their employment. This division does not result in either a uniform distribution of person-years or observed lung cancer cases among exposure categories. In fact, the six category exposure groupings of both person-years and observed lung cancers were very uneven, with a preponderance of both allocated to the lowest exposure group. This skewed distribution of person-years and observed cases puts most of the power for detecting significant differences from background cancer rates at low exposure levels, where these differences are expected to be small, and reduces the power to detect any significant differences from background at higher exposure concentrations.
Exponent conducted analyses to further explore the dose-response relationship in addition to the assessments described above (Ex. 31-18-1). Of particular interest was an examination of short-term workers' likely impact on the dose-response assessment and an SMR analysis based on peak exposure estimates. A substantial proportion of the Gibb cohort worked less than one year at the Baltimore plant. Inclusion of these workers in the exposure-response assessment could potentially bias the results, if, for example, these workers incurred unrecorded Cr(VI) exposures at other jobs. In brief, Exponent found that excluding these short-term workers would not likely impact the dose-response analysis.
Exponent reported that SMRs for workers with “peak” exposures less than 0.18 mg CrO
The validity of the “peak exposure” analysis also suffers from Exponent's problematic definition of exposure categories, which is similar to the six-part grouping used in the dose-response assessments. As with Exponent's cumulative exposure groups, the peak exposure grouping allocates most of the observed cancers and person-years to the lowest exposure groups, reducing the power to detect significant differences from background at more moderate exposure concentrations below 0.094 mg Cr(VI)/m
OSHA finds remarkable consistency among the risk estimates from the
Both Environ and NIOSH determined that linear relative risk models with respect to cumulative exposure generally provided a superior fit to the data when compared to other relative risk models. The Environ 2003 analysis further suggested that a linear additive risk model could adequately describe the observed dose-response data. The risk estimates for NIOSH and Environ's best-fitting models were statistically consistent (compare Tables VI-3 and VI-4).
The choice of reference population had little impact on the risk estimates. NIOSH used the entire U.S. population as the reference, but included adjustment terms for smoking, age and race in its models. The Environ 2003 analysis used both Maryland and Baltimore lung cancer rates, and included a generic background adjustment term. The adjustment was significant in the fitted model when Maryland rates were used for external standardization, but not when Baltimore rates were used. Since no adjustment in the model background term was required to better fit the exposure-response data using Baltimore City lung cancer rates, they may best represent the cohort's true background lung cancer incidence. OSHA considers the inclusion of such adjustment factors, whether specific to smoking, race, and age (as defined by NIOSH), or generic (as defined by Environ), to be appropriate and contribute to accurate risk estimation by helping to correct for confounding risk factors. The internally standardized Cox models, especially the linear Cox model, which also adjusted for smoking yielded risk estimates that were generally consistent with the externally standardized models.
Finally, the number of exposure categories used in the analysis had little impact on the risk estimates. When an appropriate adjustment to the background rates was included, the four exposure groups originally defined by Gibb
Having reviewed the analyses described in this section, OSHA finds that the best estimates of excess lung cancer risk to workers exposed to the current PEL (52 μg Cr(VI)/m
It is instructive to examine whether the excess lung cancer risk estimated from the mathematical modeling reasonably predicts the risk based on the mortality observed in the Gibb
The mean cumulative exposure for the Gibb cohort was 0.134 mg CrO
The model-predicted lung cancer risk is about half the risk calculated from the observed mortality in the Gibb
As discussed earlier, Luippold
Environ conducted a risk assessment based on the cumulative Cr(VI) exposure-lung cancer mortality data from Luippold
Linear relative and additive risk models fit the Luippold cohort data adequately (p≥0.25). The maximum likelihood estimates for the Cr(VI) exposure-related parameter, C
Crump
The Crump
The maximum likelihood estimate for the cumulative dose coefficient using the linear Cox regression model (i.e., model C2) was 0.66 (90% CI: 0.11 to 1.21), which was similar to the linear [Poisson regression] relative risk model. When the Cox analysis was restricted to the 197 workers with known smoking status and a smoking variable in the model, the dose coefficient for Cr(VI) was nearly identical to the estimate without controlling for smoking. This led the authors to conclude that “the available smoking data did not suggest that exposure to Cr(VI) was confounded with smoking in this cohort, or that failure to control for smoking had an appreciable effect upon the estimated carcinogenic potency of Cr(VI)” (Ex. 35-58, p.1156).
Crump
Given the similarity in results, OSHA believes it is reasonable to use the dose coefficients reported by Exponent based on their groupings of the individual cumulative exposure data to estimate excess lifetime risk from the Luippold cohort. Table VII-7 presents the excess risk for a working lifetime exposure to various TWA Cr(VI) levels as predicted by the relative and additive risk models using a lifetable analysis with 2000 U.S. rates for all causes and lung cancer mortality. The maximum likelihood estimates and 95 percent confidence limits from the Luippold cohort indicate that working lifetime exposures to the current Cr(VI) PEL would entail excess lifetime lung cancer risks around 100 per 1000 and that risks of 1.2 to 3.3 per 1000 would be expected from TWA exposures of 1 μg Cr(VI)/m
The excess lung cancer risk predicted from the mathematical modeling can be compared with the risk expected based on the actual mortality experience of the Luippold cohort. There were 303 observed deaths in the cohort of which 51 were from cancer of the lung (Ex. 33-10, Table 2). The expected number of lung cancer deaths from the age-, gender-, race-, and calendar year-adjusted reference population from Ohio was 21.2. Therefore, there were about 30 lung cancer deaths (51-21.2) presumably attributable to Cr(VI) exposure out of 303 total deaths, or 98 per 1000 workers (29.8/303 × 1000). If lung cancer were to continue to occur with the same proportionate mortality in this cohort (37 percent of the cohort was still living), their excess lifetime lung cancer risk would be about ten percent.
The mean cumulative exposure for the Luippold cohort was 1.58 mg Cr(VI)/
As previously explained, it is not surprising that the relative risk model may underpredict the excess risks calculated from study mortality data. The risk model predicts the probability of lung cancer risk in an individual or set of workers, all with the same cumulative Cr(VI) exposure. The excess lung cancer risk calculated from the observed mortality data were for a group of workers with a wide range of Cr(VI) exposures. Like the Gibb study, the lung cancer cases had a mean cumulative Cr(VI) that was twice that of the entire cohort. Therefore, their risk may be somewhat higher than predicted for the cohort as a whole. Since most of the Luippold cohort had died (i.e., 63 percent), the model-derived lung cancer risk based on the mean exposure of the entire Luippold cohort may better predict the mortality-derived excess risk estimate than was the case for the Gibb cohort, which had a lower percentage of deaths (i.e., 36 percent).
Crump
The lack of statistical significance for the subset of 103 workers in the Luippold cohort whose highest monthly TWA exposure was less than the OSHA PEL is readily explained by a further examination of the data. The highest monthly TWA exposures of those workers averaged 27 μg/m
Exponent suggested that the lack of a statistically significant increase in lung cancer mortality observed among workers whose reported average monthly TWA Cr(VI) was not above the PEL was evidence of an absence of increased risk at this level (Ex. 31-18-1). This assertion is not supported by the data. As explained above, the Crump
In addition to the preferred data sets analyzed above, there are four other cohorts with available data sets for estimation of additional lifetime risk of lung cancer. These are the Mancuso cohort, the Hayes cohort, the Gerin cohort, and the Alexander cohort. Environ (Ex. 33-15) recently did quantitative risk assessments on study data for all but the Hayes cohort. Several years earlier, the K.S. Crump Division (Ex. 13-5) did quantitative assessments on data from the Mancuso and Hayes cohort, under contract with OSHA. The U.S. EPA (Exs. 19-1; 35-52) developed quantitative risk assessments from the Mancuso cohort data for its Integrated Risk Information System (IRIS). The California EPA (Ex. 35-54), Public Citizen Health Research Group (Ex. 1), and the U.S. Air Force Armstrong Laboratory (AFAL) for the Department of Defense (Ex. 35-51) performed assessments from the Mancuso data using the 1984 U.S. EPA risk estimates as their starting point. The U.S. EPA also published a supporting risk assessment based on the Hayes cohort data (Ex. 7-102). Until the cohort studies of Gibb
The Mancuso and Hayes cohorts worked at the Painesville and Baltimore chromate production plants, respectively. Even though the entry date requirements, other cohort selection criteria, and the studied site facilities were different, the lung cancer risk estimated from the Hayes data set may not be completely independent from that estimated from the Gibb data set. A similar situation exists between the Mancuso and Luippold data sets. Unlike the Mancuso and Hayes cohorts, the Gerin and Alexander cohorts were not chromate production workers and lung cancer mortality did not show a statistically significant positive trend with cumulative Cr(VI) exposure. Environ performed quantitative assessments on these data sets to determine if the predicted lung cancer risks had statistical precision that was compatible with those estimated from the preferred Gibb and Luippold cohorts.
As described in subsection VII.B.3, the Mancuso cohort was initially defined in 1975 and updated in 1997. The cohort members were hired between 1931 and 1937 and worked at the same Painesville facility as the Luippold cohort workers. However,
In the first method, Environ used the recorded median age and year of entry into the cohort to estimate the calendar years that corresponded to the middle of the age categories for which expected numbers of lung cancers were needed. Data in the Mancuso study indicated that the median age at entry into the cohort was somewhere between 25 and 29 years and that the median year of entry into the cohort was in 1933 or 1934 (Ex. 23). Person-years of observation for the 40-44 age category would have been centered around 1948-49 (i.e., 15 years after 1933-34, where 15 is the difference between the age group under consideration and the median age at entry into the cohort, equal to 40-25 or 44-29). Similar calculations were made for the other age categories. Expected numbers were then derived from the U.S. lung cancer mortality rates for years as close to the target years as could be obtained.
The exposure-response data with the resulting expected number of lung cancer deaths are reported in Table 3 of the 2002 Environ report (Ex. 33-15, p. 39). The mean cumulative exposures to soluble Cr(VI) were assumed to be equal to the midpoints of the tabulated ranges. No lag was assumed for calculating the cumulative exposures. Environ applied three externally standardized models (see models E1-E3 in subsection VII.C.1) to these data. Unlike other data sets modeled by Environ, the age-related parameter k for the Mancuso data set was estimated to be different from 0, so that models E1 and E2 had different dose coefficients (Ex. 33-15, Table 6, p. 42). The quadratic term (i.e., C
Since the expected numbers of lung cancers for the Mancuso cohort could only be approximated, Environ also applied a set of internally-standardized models that did not require estimation of expected number of lung cancers to the exposure-response data (Ex. 33-15, p. 24-25). While both externally- and internally-standardized models provided adequate fit to the data (p≥0.13), the AIC procedure indicated that model E2, the linear relative risk model with an age-dependent exposure term, provided a superior fit over the other models. The next best fitting models, E1 and I2, presented other problems. Model E1 estimated risk predictions that were apparent outliers and the confidence intervals around risk predictions from model I2 were unusually wide (Ex. 33-15, Table 8, p. 43). Further explanation for the inherent instability of these models can be found in the 2002 Environ report (Ex. 33-15, p. 28-29).
The excess risk of lung cancer from a working lifetime exposure to Cr(VI) at the current OSHA PEL using the preferred model E2 is 293 per 1000 workers (95% CI: 188 to 403). The maximum likelihood estimate from working lifetime exposure to 1.0 μg/m
There are uncertainties associated with both the exposure estimates and the estimates of expected numbers of lung cancer deaths for the 1997 Mancuso data set. The estimates of exposure were derived from a single set of measurements obtained in 1949 (Ex. 7-98). Although little prior air monitoring was available, it is thought that the 1949 air levels probably understate the Cr(VI) concentrations in the plant during some of the 1930s and much of the 1940s when chromate production was high to support the war. The sampling methodology used by Bourne and Yee only measured soluble Cr(VI), but it is believed that the chromate production process employed at the Painesville plant in these early years yielded slightly soluble and insoluble Cr(VI) compounds that would not be fully accounted for in the sampling results (Ex. 35-61). This would imply that risks would be overestimated by use of concentration estimates that were biased low. However, it is possible that the 1949 measurements may not have underestimated the Cr(VI) air levels in the early 1930s prior to the high production years. Some older cohort members were also undoubtedly exposed to less Cr(VI) in the 1950s than measured in 1949 survey.
Another uncertainty in the risk assessment for the Mancuso cohort is associated with the post-hoc estimation of expected numbers of lung cancer deaths. The expected lung cancers were derived based on approximate summaries of the ages and assumed start times of the cohort members. Several assumptions were dictated by reliance on the published groupings of results (
There is also a potential healthy worker survivor effect in the Mancuso cohort. The cohort was identified as workers first hired in the 1930s based on employment records surveyed in the late 1940s (Ex. 2-16). The historical company files in this time period were believed to be sparse and more likely to only identify employees still working at the plant in the 1940s (Ex. 33-10). If there was a sizable number of unidentified short-term workers who were hired but left the plant in the 1930s or who may have died before 1940 prior to systematic death registration, then there may have been a selection bias (i.e., healthy worker survivor effect) toward longer-term, healthier individuals (Ex. 35-60). Since the mortality of these long-term “survivors” is often more strongly represented in the higher cumulative exposures, it can negatively confound the exposure-response and lead to an underestimation of risk, particularly to shorter-term workers (Ex. 35-63). This may be an issue with the Mancuso cohort, although the magnitude of the potential underestimation is unclear.
Several earlier quantitative risk assessments were done on cohort data presented in the 1975 Mancuso report (Ex. 7-11). These assessments did not have access to the 20 additional years of follow-up nor did they have age-grouped lung cancer mortality stratified by cumulative
The 1995 risk analysis by K.S. Crump Division, under contract with OSHA, estimated cumulative Cr(VI) exposures by multiplying cumulative total chromium exposure by an adjustment factor of 0.4 (Ex. 13-5). This factor is roughly the average contribution of soluble chromium to the total chromium exposure levels measured across departments in the Painesville plant by Bourne and Yee in 1949 (Ex. 7-98). The K.S. Crump Division used the lung cancer mortality data cross-classified by the eight exposure categories and three age groups reported in Table IX of the 1975 Mancuso report (Ex. 7-11). They estimated the expected number of lung cancer deaths in a manner similar to the Environ assessments in 2002. The median age at entry for the cohort was estimated to be 28.5 years from the 1975 Mancuso study with an estimated median start date of 1934. Average values for cumulative exposure in each group were estimated by the arithmetic mean of the endpoints defining the group.
An externally standardized linear relative risk model was used to fit the exposure-response data. A sensitivity analysis was used to examine the impact of different average cumulative exposure estimates to represent the highest exposure group (>3.0 mg-yr/m
Like Environ, the K.S. Crump Division explored another method of Poisson regression that internally controlled for age, and which consequently alleviated the need to estimate background rates from an external control population. The dose coefficients estimated for the internally standardized linear relative risk model were similar to those from the externally controlled model. However, sensitivity analysis indicated that the internally standardized model may lead to less stable risk estimates, in that relatively minor changes in average exposure assumptions led to bigger changes in the risk estimates.
The U.S. EPA also used exposure-response data presented in Table IX of the 1975 Mancuso report (Ex. 7-11) as the primary data source for calculating its unit risk estimate . The unit risk refers to an incremental lifetime cancer risk over background occurring in a hypothetical population in which all individuals are exposed continuously throughout life to a concentration of 1 μg Cr(VI)/m
The U.S. EPA assessment did not adjust the total cumulative chromium exposure estimates of Mancuso for the contribution of Cr(VI). While the EPA acknowledged that the resulting overestimation of dose would likely lead to an underestimation of risk, they judged that this would be potentially balanced by two factors that tend to overestimate the risk of lung cancer. One factor was the likelihood that the airborne Cr(VI) levels in the 1930s and 1940s were higher than measured by Bourne and Yee in 1949, as mentioned previously. EPA also suggested the possibility that the Mancuso cohort may have smoked more than the general population so that the expected numbers of lung cancer deaths associated with Cr(VI) exposure would be low and the relative risk overestimated for the cohort.
The 1984 U.S. EPA assessment employed an exposure-dependent multistage model of additive risk to fit the 1975 Mancuso cohort data that relied on average chromium exposure, rather than the cumulative workplace exposure (Ex. 19-1). In their review of the U.S. EPA assessment, the K.S. Crump Division pointed out potential flaws in the EPA conversion of cumulative workplace exposure to their “continuous exposure equivalent” that resulted in high average chromium exposure estimates and a correspondingly low unit risk (Ex. 13-5, p. 19-21). The U.S. EPA determined that the maximum likelihood estimate of additional lung cancer risk associated with continuous lifetime exposure to 1 μg/m
In 1985, the California Department of Health Services (CDHS) estimated a cancer potency factor for Cr(VI) in support of its Toxic Air Contaminants Program (Ex. 35-54, p. 210-215). They estimated the relative lung cancer risks and continuous total chromium exposure equivalents for the 1975 Mancuso data set using the same assumptions and procedures as the 1984 EPA assessment. An average relative risk and average total chromium exposure level, weighted by the person-years per age and exposure category, were calculated for all groups combined. The average total chromium exposure level was multiplied by one-seventh (0.142) as an assumed adjustment for the fraction of total chromium present as Cr(VI). A linear relative risk model was then used to calculate a “crude” approximation of the excess risk from continuous exposure to 1 μg/m
The Public Citizen Health Research Group (PCHRG) attempted to estimate the magnitude of lung cancer risks associated with occupational exposure to Cr(VI) from the 1984 U.S. EPA unit risk for continuous lifetime exposure (Ex. 1). They reported that the excess lung cancer risk from a working lifetime exposure to Cr(VI) at the OSHA PEL (52 μg/m
The U.S. Air Force Armstrong Laboratory (AFAL) estimated lung cancer risks to U.S. Navy workers from Cr(VI) exposures as a result of welding, abrasive blasting, spray painting, and other operations (Ex. 35-51). They used a cancer potency factor of 41 per mg Cr(VI)/kg-day derived from the 1984 EPA unit risk adjusted for an average breathing rate of 20 m
OSHA believes that the Environ quantitative risk assessment is the most credible analysis from the Mancuso cohort. It relied on the updated cohort mortality data and cumulative exposure estimates derived directly from air measurements of soluble chromium. The other assessments used older cohort mortality data with fewer years of follow-up and more problematic exposure estimates and calculations.
The K.S. Crump Division (Ex. 13-5) and Gibb
The K.S. Crump Division applied the externally standardized linear relative risk approach to fit the exposure-response data (Ex. 13-5). The maximum likelihood estimate for the dose coefficient (
Gibb
Environ (Ex. 33-15) did a quantitative assessment of the observed and expected lung cancer deaths in stainless steel welders classified into four cumulative Cr(VI) exposure groups reported in Tables 2 and 3 of Gerin
The exposure-response data from the Gerin study was only presented for those stainless steel welders with at least five years employment. Workers were divided into “ever stainless steel welders” and “predominantly stainless steel welders” groups. The latter group were persons known to have had extended time welding stainless steel only or to have been employed by a company that predominantly worked stainless steel. As mentioned in section VII.B.5, the cumulative exposure estimates were not based on Cr(VI) air levels specifically measured in the cohort workers, and therefore are subject to greater uncertainty than exposure estimates from the chromate production cohort studies. Environ restricted their analysis to the “ever stainless steel welders” since that subcohort had the greater number of eligible subjects and person-years of follow-up, especially in the important lower cumulative exposure ranges. The person-years, observed numbers of lung cancers, and expected numbers of lung cancers were computed starting 20 years after the start of employment. Gerin
Environ used their externally standardized models, E1 to E3, to fit the data (Ex. 33-15). They assumed that the cumulative Cr(VI) exposure for the workers was at the midpoint of the reported range. A value of 2.5 mg/m
Environ chose the linear relative risk model, E2, as the best fitting model based on the AIC value. The projected excess risk of lung cancer from a working lifetime exposure to Cr(VI) at the current OSHA PEL using the preferred model E2 was 46 (95% CI: 0 to 130) cases per 1000 workers. The maximum likelihood estimates of excess risk from working lifetime exposure to 1.0 μg Cr(VI)/m
Environ (Ex. 33-15) did a quantitative assessment of the observed and expected lung cancer incidence in aerospace workers exposed to Cr(VI) classified into four cumulative chromate exposure groups, reported in Table 4 of Alexander
Alexander
The best estimate of excess risk of lung cancer from the Alexander cohort was 0 for all exposures to Cr(VI) based on the default dose coefficient. The upper 95 percent confidence bound on the risk was estimated to be 212 cases per 1000 workers from a working lifetime exposure to Cr(VI) at the current OSHA PEL. The upper 95 percent confidence bound on risk from working lifetime exposure to 1.0 mg Cr(VI)/m
If the cumulative exposures from Alexander
OSHA believes that the best estimates of excess lifetime lung cancer risks are derived from the Gibb and Luippold cohorts. These two cohorts have accumulated a substantial number of lung cancer deaths that were extensively examined in terms of cumulative Cr(VI) exposure. Cohort exposures were reconstructed from air measurements and job histories over three or four decades. The linear relative risk model adequately fitted the Gibb and Luippold data sets, as well as several other supporting data sets. Environ and NIOSH explored a variety of nonlinear dose-response forms, but none provided a statistically significant improvement over the linear relative risk model.
The maximum likelihood estimates from a linear relative risk model fitted to the Gibb data are three-to five-fold higher than estimates based on the Luippold data at equivalent cumulative Cr(VI) exposures and the confidence limits around the projected risks from the two data sets do not overlap. This indicates that the maximum likelihood estimates derived from one data set are unlikely to describe the lung cancer mortality observed in the other data set. Despite this statistical inconsistency between the risk estimates, the differences between them are not unreasonably great given that the cohorts worked in different chromate production facilities and the potential uncertainties involved in estimating cancer risk from the data (see section VII.G). Since the analyses based on these two cohorts are each of high quality and their projected risks are reasonably close (
OSHA's best estimates of excess lung cancer cases from a 45-year working lifetime exposure to Cr(VI) are presented in Table VII-8. This range of projected risks lie between the maximum likelihood estimates derived from the Gibb and Luippold data sets. As previously discussed, several acceptable assessments of the Gibb data set were performed, with similar results. The 2003 Environ model E1, applying the Baltimore City reference population and ten exposure categories based on a roughly equal number of person-years per group, was selected to represent the range of best risk estimates derived from the Gibb cohort, in part because this assessment employed an approach most consistent with the exposure grouping applied in the Luippold analysis (see Table VII-7). To characterize the statistical uncertainty of OSHA's risk estimates, Table VII-8 also presents the 95% confidence limits associated with the maximum likelihood risk estimates from the Gibb cohort and the Luippold cohort. The confidence interval on the risk estimates from the Luippold data set is smaller (i.e., just over a two-fold range) than those for the Gibb data set (i.e., about a 3.5-fold range) but the Gibb cohort is larger. Therefore, it appears reasonable to consider both analyses jointly in providing estimates of lung cancer risk.
OSHA finds that the most likely lifetime excess risk at the current PEL of 52 μg/m
The 95 percent confidence limits on estimates of risk for the four supporting cohort data sets are also presented in Table VII-8. As discussed previously, the exposure-response data from supporting cohorts are not as strong as those from the two featured cohorts. The cumulative Cr(VI) exposure reconstructions in these data sets were based on more limited air measurements and were frequently not linked to cohort workers on an individual basis. Some of the cohort data sets were weaker in terms of either number of workers, length of follow-up, documented mortality data, and possibility of co-exposures or a healthy worker survivor effect. These features may have introduced bias into the estimates of risk determined from the studies. However, observed lung cancers were grouped across multiple exposure groups in these more problematic cohorts that allowed quantitative assessments to be done and compared against the stronger Gibb and Luippold cohorts.
OSHA believes the supplemental assessments support the range of projected excess lung cancer risks from the Gibb and Luippold cohorts. This is illustrated by the 95 percent confidence intervals shown in Table VII-8. The confidence interval encompasses those risk estimates that are consistent with the cohort data to a certainty of 95 percent. The confidence intervals tend to be smaller for the larger data sets and better model fits. OSHA's range of best risk estimates for a given occupational Cr(VI) exposure overlap the 95 percent confidence bands for each of the four supporting cohorts. This indicates that the range of best estimates includes risks with a statistical precision that is compatible with all the exposure-response data sets, including the smaller Gerin and Alexander cohorts where the lung cancers did not show a clear positive trend with cumulative Cr(VI) exposure.
The 95 percent confidence intervals from the four supporting cohorts overlap those of either the Gibb or Luippold cohorts (or both). The confidence intervals for estimates of the Mancuso cohort overlap with those of the Gibb cohort but are higher than those of the Luippold cohort. The risks projected from the Mancuso data set are likely overestimated because they depend on air monitoring conducted near the end of the study period when exposures were likely lower and because the sampling method only captured highly soluble Cr(VI) compounds. The Mancuso cohort was also probably exposed to significant
While there is statistical consistency between the range of best risk estimates based on the primary studies and those estimated from the supporting data sets, the risk analysis does not account for potential bias introduced by the lack of exposure data, inadequate follow-up and other limitations in these weaker studies. Unfortunately, the magnitude and direction of this potential bias cannot be reasonably assessed and, thus, the impacts on the risk estimates are unclear.
It would be difficult to formally combine the data or the results (
The risk estimates presented in the previous sections include confidence limits that reflect statistical uncertainty. This statistical uncertainty concerns the limits of precision for statistical inference, given assumptions about the input parameters and risk models (
The uncertainty that may have the greatest impact on risk estimates relates to the assessment of worker exposure. Even for the Gibb cohort, whose exposures were estimated from roughly 70,000 air measurements over a 35-year period, the calculation of cumulative exposure is inherently uncertain. The methods used to measure airborne Cr(VI) did not characterize particle size that determines deposition in the respiratory tract (see section VI.A.). Workers differ from one another with respect to working habits and they may have worked in different areas in relation to where samples are taken. Inter-individual (and intra-facility) variability in cumulative exposure can only be characterized to a limited degree, even with extensive measurement. The impact of such variability is likely less for estimates of long-term average exposures when there were more extensive measurements in the Gibb and Luippold cohorts in the 1960s through 1980s, but could affect the reliability of estimates in the 1940s and 1950s when air monitoring was done less frequently. Exposure estimates that rely on annual average air concentrations are also less likely to reliably characterize the Cr(VI) exposure to workers who are employed for short periods of time. This may be particularly true for the Gibb cohort in which a sizable fraction of cohort members were employed for only a few months.
Like many retrospective cohort studies, the frequency and methods used to monitor Cr(VI) concentrations may also be a source of uncertainty in reconstructing past exposures to the Gibb and Luippold cohorts. Exposures to the Gibb cohort in the Baltimore plant from 1950 until 1961 were determined based on periodic collection of samples of airborne dust using high volume sampling pumps and impingers that were held in the breathing zone of the worker for relatively short periods of time (
In the 1960s, the Baltimore plant expanded its Cr(VI) air monitoring program beyond periodic high volume sampling to include extensive area monitoring in 27 exposure zones around the facility. Multiple short-term samples were collected (
The Exponent critique of the Gibb cohort suggested that the tape samplers used in the Baltimore plant from the mid-1960s to 1985 resulted in reduction of Cr(VI) to Cr(III) and that Braver
Some of the same uncertainties exist in reconstructing exposures from the Luippold cohort. Exposure monitoring from operations at the Painesville plant in the 1940s and early 1950s was sparse and consisted of industrial hygiene surveys conducted by various groups (Ex. 35-61). The United States Public Health Service (USPHS) conducted two industrial hygiene surveys (1943 and 1951), as did the Metropolitan Life Insurance Company (1945 and 1948). The Ohio Department of Health (ODH) conducted surveys in 1949 and 1950. The most detailed exposure information was available in annual surveys conducted by the Diamond Alkali Company (DAC) from 1955 to 1971. Exponent chose not to consider the ODH data in their analysis since the airborne Cr(VI) concentrations reported in these surveys were considerably lower than values measured at later dates by DAC. Excluding the ODH survey data in the exposure reconstruction process may have led to higher worker exposure estimates and lower predicted lung cancer risks.
There were uncertainties associated with the early Cr(VI) exposure estimates for the Painesville cohort. Like the monitoring in the Baltimore plant, Cr(VI) exposure levels were determined from periodic short-term, high volume sampling with impingers that may have underestimated exposures (Ex. 35-61). Since the Painesville plant employed a “high-lime” roasting process to produce soluble Cr(VI) from chromite ore, a significant amount of slightly soluble and insoluble Cr(VI) was formed. It was estimated that up to approximately 20 percent of the airborne Cr(VI) was in the less soluble form in some areas of the plant prior to 1950 (Ex. 35-61). The impingers were unlikely to have captured this less soluble Cr(VI) so some reported Cr(VI) air concentrations may have been slightly underestimated for this reason.
The annual air monitoring program at the Painesville plant was upgraded in 1966 in order to evaluate a full 24 hour period (Ex. 35-61). Unlike the continuous monitoring at the Baltimore plant, twelve area air samples from sites throughout the plant were collected for only 35 minutes every two hours using two in-series midget impingers containing water. The more frequent monitoring using the in-series impinger procedure may be an improvement over previous high-volume sampling and is believed to be less susceptible to Cr(VI) reduction than cellulose filters. While the impinger collection method at the Painesville plant may have reduced one source of potential exposure uncertainty, another source of potential uncertainty was introduced by failure to collect air samples for more than 40 percent of the work period. Also, personal monitoring of workers was not conducted at any time.
Another type of uncertainty is associated with extrapolation from one exposure pattern to another (
There are several examples in which an increasing relative risk of chronic disease has been observed to attenuate (
In order to evaluate the likelihood of an attenuated relative risk of lung cancer at high cumulative Cr(VI) exposures, Environ fit the Gibb and Luippold data sets to a power model of the form:
While the cumulative Cr(VI) exposure estimates determined from the Gibb and Luippold cohorts are much more extensive than usually available for a cancer cohort, they are still a primary source of uncertainty in the assessment of risk. As occurs in many retrospective cancer epidemiologic studies, it was difficult to reconstruct worker exposure in the 1950s from the limited air monitoring data available from the Painesville and Baltimore plants. It appears that the usual airborne Cr(VI) exposure levels in some chromate production and processing areas at these facilities dropped five to ten-fold from the late 1940s to the mid-1960s with little documentation in the intervening years. This required more indirect methods to complete the job-exposure matrices for these cohorts. The need to reconstruct cohort exposure in the absence of extensive air measurements combined with the different procedures used to collect air samples at the two plants could partially explain the slight but statistically different exposure-specific risks between the Gibb and Luippold cohorts. Finally, some uncertainty in risk is introduced when extrapolating cohort exposures to higher Cr(VI) levels for shorter periods to an equivalent cumulative exposure of lower intensity for a longer duration (
The models used to fit the observed data may also introduce uncertainty into the quantitative predictions of risk. Linear and non-linear risk models based on a Poisson distribution were applied to the exposure-response data sets. Both Environ (Ex. 33-12) and NIOSH (Ex. 33-13) evaluated nonlinear models among the suite of models fit to the Gibb
The linear relative risk model was used to estimate excess lung cancer risks at cumulative Cr(VI) exposures in the range of 0.01 to 2.3 mg/m
In their response to the OSHA Request For Information regarding occupational exposure to Cr(VI), the Chrome Coalition submitted comments, prepared by Exponent, suggesting that a threshold dose-response model is an appropriate approach to estimate lung cancer risk from Cr(VI) exposures (Ex. 31-18-1). Their arguments rely on: (1) The lack of a statistically significant increased lung cancer risk for workers exposed below a cumulative Cr(VI) exposure of 1.0 mg/m
The lack of a statistically significant result for a subset of the entire cohort should not be construed to imply a threshold. As pointed out in an earlier discussion (section VII.D) and by Crump
The Chrome Coalition characterized the work of De Flora
There are several problems with the threshold interpretation of De Flora
The Chrome Coalition has stated that the intratracheal instillation study in rats by Steinhoff
OSHA does not believe that the accelerated tumor development at the high Cr(VI) dose levels in the Steinhoff
OSHA believes that the existence of dose rate effects is supported by the available scientific evidence and may introduce uncertainty when projecting lung cancer risk based on workers exposed to higher Cr(VI) concentrations for shorter durations to workers exposed to the same cumulative exposure but at substantially lower Cr(VI) concentrations for substantially longer periods. However, the Steinhoff
OSHA solicits comment on the whether the linear relative risk model is the most appropriate approach on which to estimate risk associated with occupational exposure to Cr(VI). OSHA is particularly interested in whether there is convincing scientific evidence of a non-linear exposure-response relationship and, if so, whether there are sufficient data to develop a non-linear model that would provide more reliable risk estimates than the linear approach being used in the preliminary assessment.
A common confounder in estimating lung cancer risk to workers from exposure to a specific agent such as Cr(VI) is the impact of cigarette smoking. First, cigarette smoking is known to cause lung cancer. Ideally, lung cancer risk attributable to smoking among the Cr(VI)-exposed cohorts should be controlled or adjusted for in characterizing exposure-response. Secondly, cigarette smoking may interact with the agent (i.e., Cr(VI)) or its biological target (i.e., susceptible lung cells) in a manner that enhances or even reduces the risk of developing Cr(VI)-induced lung cancer from occupational exposures, yet is not accounted for in the risk model.
OSHA believes its risk estimates have adequately accounted for the potential confounding effects of cigarette smoking in the underlying exposure-lung cancer response data, particularly for the Gibb cohort. One of the key issues in this regard is whether or not the reference population utilized to derive the expected number of lung cancers appropriately reflects the smoking behavior of the cohort members. The risk analyses of the Gibb cohort by NIOSH and Environ indicate that cigarette smoking was properly controlled for in the exposure-response modeling. NIOSH applied a smoking-specific correction factor that included a cumulative smoking term for individual cohort members (Ex.33-13). Environ applied a generic correction factor and used lung cancer mortality rates from Baltimore City as a reference population that was most similar to the cohort members with respect to smoking behavior and other factors that might affect lung cancer rates (Ex. 33-12). Environ also used internally standardized models that did not require use of a reference population and included a smoking-specific (yes/no) variable. All these models predicted very similar estimates of risk over a wide range of Cr(VI) exposures. There was less information about smoking status for the Luippold cohort. However, regression modeling that controlled for smoking indicated that it was not a significant confounding factor when relating Cr(VI) exposure to the lung cancer mortality (Ex. 35-58).
Smoking has been shown to interact in a synergistic manner (i.e., combined effect of two agents are greater than the sum of either agent alone) with some lung carcinogens, most notably asbestos (Ex. 35-114). NIOSH reported a slightly negative but nonsignificant interaction between cumulative Cr(VI) exposure and smoking in a model that had separate linear terms for both variables (Ex. 33-13). This means that, at any age, the smoking and Cr(VI) contributions to the lung cancer risk appeared to be additive, rather than synergistic, given the limited smoking information in the Gibb cohort along with the cumulative smoking assumptions of the analysis. In their final linear relative risk model, NIOSH included smoking as a multiplicative term in the background rate in order to estimate lifetime lung cancer risks attributable to Cr(VI) independent of smoking. Although this linear relative risk model makes no explicit assumptions with regard to an interaction between smoking and Cr(VI) exposure, the model does assume a multiplicative relationship between the background rate of lung cancer in the reference population and Cr(VI) exposure. Therefore, to the extent that smoking is a predominant influence on the background lung cancer risk, the linear relative risk model implicitly assumes a multiplicative (
Although OSHA is not aware of any convincing evidence of a specific interaction between cigarette smoking and Cr(VI) exposure, prolonged cigarette smoking does have profound effects on lung structure and function that may indirectly influence lung cancer risk from Cr(VI) exposure . Cigarette smoke is known to cause chronic irritation and inflammation of the respiratory tract. This leads to decreases in airway diameter that could result in an increase in Cr(VI) particulate deposition. It also leads to increased mucous volume and decreased mucous flow, that could result in reduced Cr(VI) particulate clearance. Increased deposition and reduced clearance would mean greater residence time of Cr(VI) particulates in the respiratory tract and a potentially greater probability of developing bronchogenic cancer. Chronic cigarette
Differences in lung cancer incidence with race may also introduce uncertainty in risk estimates. Gibb
NIOSH suggested that exposure or smoking misclassification might plausibly account for the Cr(VI) exposure-related differences in lung cancer by race seen in the Gibb cohort (Ex. 33-13, p. 15). It is possible that such misclassification might have occurred as a result of systematic differences between whites and non-whites with respect to job-specific Cr(VI) exposures at the Baltimore plant, unrecorded exposure to Cr(VI) or other lung carcinogens when not working at the plant, or in smoking behavior. Unknown racial differences in biological processes critical to Cr(VI)-induced carcinogenesis could also plausibly account for an exposure-race interaction. However, OSHA is not aware of evidence that convincingly supports any of these possible explanations.
Another source of uncertainty that may impact the risk estimates is the healthy worker survivor effect. Studies have consistently shown that short-term employed workers have higher mortality rates than workers with long-term employment status. This is possibly due to a higher proportion of ill individuals and those with a less healthy lifestyle (Ex. 35-60). As a result, exposure-response analyses based on mortality of long-term healthy workers will tend underestimate the risk to short-term workers and vice versa, even when their cumulative exposure is similar. This might partially explain the higher risk estimates from the Gibb data set relative to the Luippold data set for the same cumulative exposures using similar risk models. The Gibb cohort contained a higher proportion of workers with short duration of employment, lower cumulative Cr(VI) exposure, and is arguably more prone to mortality. On the other hand, the Luippold cohort consisted of longer-term workers at higher cumulative exposures that may be more prone to negative confounding as a result of the survivor effect. The healthy worker survivor effect is thought to be less of a factor in diseases with a multifactorial causation and long onset, such as cancer.
An issue that needs to be addressed is whether the excess lung cancer risks derived from epidemiologic data for chromate production workers are representative of the risks for other Cr(VI)-exposed workers (
The primary operation at the plants in Painesville and Baltimore was the production of the water-soluble sodium dichromate from which other primarily water-soluble chromates such as sodium chromate, potassium dichromate, and chromic acid could be made (Exs. 7-14; 35-61). Therefore, it is likely that the Gibb and Luippold cohorts were principally exposed to water-soluble Cr(VI). The Painesville plant used a high-lime process known to form some less water-soluble Cr(VI) compounds (Ex. 35-61). Less water-soluble chromates is a designation that refers to all chromates not considered to be highly water soluble and readily captured by an aqueous impinger sampling device. These would include both slightly water-soluble chromates, such as calcium and strontium chromate and the more water-insoluble chromates, such as zinc and lead chromate. The 1953 USPHS survey confirmed that approximately 20 percent of the total Cr(VI) in the roasting residue at the Painesville plant consisted of the less water-soluble chromates (Ex. 2-14). The Painesville plant subsequently reduced and eliminated exposure to Cr(VI) roasting residue through improvements in the production process. The high-lime process was not used at the Baltimore plant and the 1953 USPHS survey detected minimal levels of less soluble Cr(VI) at this facility (Ex. 7-17). Proctor
As discussed in the preamble section VI.B on carcinogenic effects, both water-soluble and insoluble forms of Cr(VI) compounds are regarded as carcinogenic to the respiratory tract as a result of inhalation. This is not only supported by epidemiologic studies of the chromate production workers above, but also by studies of chromate pigment workers exposed primarily to the insoluble zinc and lead chromates (Exs. 7-36; 7-42; 7-49). The standardized lung cancer incidence and mortality ratios reported among these pigment workers were relatively high and clearly significant. Langard and Vigander found that the lung cancer incidence among a cohort of workers exposed primarily to zinc chromate, but also lead chromate, at a pigment production plant in
The slightly water-soluble Cr(VI) compounds, calcium and strontium chromate, led to significant increases in tumors when instilled in the respiratory tract of experimental animals (Exs. 11-7; 11-2). Levy
Other studies reported that insoluble Cr(VI) compounds are retained in the lung for longer periods and are considered a more persistent source of locally available Cr(VI) for uptake into lung cells than water-soluble Cr(VI) compounds. Bragt and Van Dura found that water-soluble sodium chromate is more rapidly absorbed and cleared from the lung than the highly insoluble lead chromate when intratracheally instilled in rats (Ex. 35-56). On day 50 after instillation, 13.8 percent of the initial lead chromate remained in the lungs as opposed to only 3.0 percent of the initial sodium chromate. Research at George Washington University Medical Center showed that treatment of embryo cells in culture with insoluble lead chromate particulates led to cell-enhanced dissolution and uptake of Cr(VI) resulting in DNA damage and neoplastic transformation (Exs. 35-104; 35-69; 35-132). Internalization, dissolution, and uptake of lead chromate and the resulting damage to DNA were later shown to also occur in normal human lung epithelial cells (Exs. 35-66; 35-327). Elias
Experts have evaluated the combined epidemiologic, animal, and mechanistic evidence and concluded that the less water-soluble chromates are likely more carcinogenic than highly water-soluble Cr(VI) compounds (Exs. 17-101; 17-5B). This is reflected in the lower recommended ACGIH TLVs for insoluble Cr(VI) compounds (i.e., 10 mg/m3) and certain slightly soluble Cr(VI) compounds (
OSHA seeks comment on whether its preliminary assessment of risk based on the exposure-response data from the two cohorts of chromate production workers is reasonably representative of the risks expected from equivalent exposures to different Cr(VI) compounds encountered in other industry sectors. Of particular interest is whether there is convincing evidence that the preliminary risk estimates from worker cohorts primarily engaged in the production of the highly water soluble sodium chromate and sodium dichromate would substantially overpredict the lung cancer risk for workers exposed at the same level and duration to airborne Cr(VI) during welding operations, chromic acid aerosol in electroplating operations, the less water soluble Cr(VI) particulates encountered during pigment production and painting operations, or Cr(VI) exposure in other important industry sectors and job categories.
OSHA contracted an independent organization known as Toxicology Excellence for Risk Assessment (TERA) to organize an external scientific peer review of the January 21, 2004 Draft Quantitative Risk Assessment (Exs. 36-1-1; 36-1-2). TERA selected three peer reviewers based on a high level of competence in occupational epidemiology and/or risk assessment. The reviewers were screened to ensure no apparent conflict of interest or involvement in the key studies that provided the basis for the OSHA assessment. OSHA did not participate in the selection process other than to examine reviewer credentials to confirm their qualifications. The three peer reviewers selected by TERA were Dr. David Gaylor, Dr. Allan Smith, and Dr. Irva Hertz-Picciotto. Curriculum Vitae of the three reviewers have been submitted to the docket (Ex. 36-1-3).
TERA provided the peer reviewers with a review package that consisted of the draft quantitative risk assessment, copies of the key studies, and a set of instructions and questions (Ex. 36-1-1). The reviewers were asked to comment on several aspects of the draft OSHA risk assessment including the suitability of the different data sets for exposure-response analysis, the choice of exposure metric and risk models, the appropriateness of the risk estimates, and the characterization of key issues and uncertainties. The peer reviewers filed written draft reports with TERA
The three peer reviewers agreed that the results from six occupational cohorts under review were adequately evaluated as to their suitability for exposure-response analysis and concurred that the Gibb and Luippold cohorts provided the strongest data sets for quantitative assessment. There was general agreement among the peer reviewers that the risk models and statistical methodologies used in the OSHA assessment were appropriately applied. Dr. Smith remarked that “there is no question in my mind that relative risk models are superior to others when conducting quantitative cancer risk assessments on epidemiological data” (Ex. 36-1-4-2) and commended OSHA for supporting a relatively straightforward [linear] model widely used in epidemiology (Ex. 36-1-4-2). At his suggestion, OSHA expanded on reasons for using a linear relative risk model to fit the epidemiological data. The selection of the linear relative risk model was not solely based on mathematical fit. Relative risk models inherently adjust for age-related increases in cancer incidence. The linear relative risk model has been extensively and successfully used to analyze other cancer mortality data sets and is an accepted approach in carcinogen risk assessment.
The peer reviewers were also in general agreement that cumulative exposure based on time-weighted average air concentrations by job title and employment history was a reasonable exposure metric to use. Dr. Hertz-Picciotto stated “the use of cumulative exposure constructed in this way is currently the standard, and the use of individual job histories is the best available method at this time (Ex. 36-1-4-4).” She pointed out that the underlying assumption that exposure patterns and dose rate differences at equivalent cumulative exposures do not influence cancer risk is an uncertainty in the assessment. This is more fully explained in section VII.G.1 on uncertainties with regard to worker exposure.
Dr. Smith raised another limitation to the cumulative exposure metric as it relates to relative risk. It has been shown, in some instances, that relative risk of chronic disease will not continue to rise at high cumulative exposure but will tend to stabilize or attenuate. In the case of a significant attenuation, the excess risk at high Cr(VI) exposures (
The peer reviewers showed less enthusiasm for the highest reported average monthly Cr(VI) air concentration as an appropriate exposure metric or for an exposure threshold below which there exists no lung cancer risk. Dr. Hertz-Picciotto remarked that “the newly published Crump
The peer reviewers found the range of excess lifetime risks of lung cancer presented by OSHA to be sound and reasonable. These preferred risk estimates were those bounded by the maximum likelihood estimates determined from the featured Gibb and Luippold data sets. Dr. Gaylor wrote “the confidence limits are tighter for the Luippold study, somewhat over a factor of two for the range from the lower to the upper 95% confidence limit, compared to a range of about 3.5 for the confidence limits in the Gibb study. However, the Gibb cohort is larger than the Luippold cohort. It appears reasonable to consider the two studies jointly to provide estimates of lung cancer risk” (Ex. 36-1-4-1). Dr. Gaylor went on to point out that the range of maximum likelihood between the featured data sets understates the [statistical] uncertainty in the risk estimates. He recommended that the uncertainty be expressed as the lower 95% confidence limit from the Luippold data set and the 95% upper confidence limit for the Gibb data set. OSHA agrees and has revised section VII.F to make clear that while the maximum likelihood range represents the most likely estimates of lung cancer risk, the 95% confidence bounds are the better representation of statistical uncertainty.
Dr. Gaylor suggested that the OSHA assessment make clear that the 45-year working lifetime exposure should be regarded as a worst case scenario and that the typical worker would be exposed to Cr(VI) for a shorter period of time. Dr. Smith also questioned the need to estimate risk from a 45-year working lifetime. He suggested that OSHA could probably make more confident estimates of risk for shorter exposure durations (
Dr. Hertz-Picciotto felt that OSHA may have overstated the consistency in lung cancer risk between the two primary studies and the four weaker supporting studies. She pointed out that two of the supporting cohorts overlapped the featured cohorts and were not truly independent data sets. She indicated that the weaker supporting studies had serious bias that rendered the discussion of overlap in confidence intervals to be relatively meaningless and, thus, prevented a definitive evaluation of consistency. OSHA agrees that the magnitude and direction of potential bias introduced by lack of exposure data, inadequate follow-up, and other limitations in the
Dr. Smith suggested that OSHA consider presenting risk estimates that can be readily calculated from the source data without use of a complex mathematical model. He contends that this would allow the reader to better understand how the risks relate to measures reported in the published studies. He provided some illustrations of simple and transparent risk estimations from the Gibb
OSHA does not agree with assertions by Dr. Smith that “there is no valid basis to conclude that more complex calculations [from mathematical models], such as found in the source material and draft [OSHA] document, have any greater validity than this estimate [directly calculated from the published cohort data]” and “there is no gain in validity in doing a full life table analysis but there is certainly a loss in transparency (Ex. 36-1-4-2).” OSHA believes excess risk estimated from standard, well-supported mathematical model constructs that incorporate the entire mortality data set is considerably more accurate, more robust, more stable and more statistically rigorous than a simple calculation from a single relative risk result determined from a small subset of the cohort data as applied by Dr. Smith. The life table analysis adjusts for both the increasing probability of developing lung cancer with advancing age and the competing risk of death from other causes. These age-related factors are not accounted for in a simple relative risk calculation and may lead to a less accurate risk estimate.
While the peer reviewers felt that most uncertainties in the risk assessment were adequately characterized, they suggested certain topics receive more attention. Dr. Hertz-Picciotto suggested that sensitivity analyses on plausible alternate exposure assumptions for workers in the Gibb and Luippold cohorts during the periods when there was very limited air monitoring data “would add concrete information on the magnitude of uncertainty in the risk estimates (Ex. 36-1-4-4).” Environ, while under contract with OSHA, had access to annual exposure estimates on individual workers in the Gibb cohort. They explored the feasibility of generating plausible alterative exposures using a forward and reverse replacement scheme for the air concentrations imputed during periods in the Gibb
Dr. Hertz-Picciotto recommended that OSHA address the potential impact on risk of the healthy worker survivor effect. The healthy worker survivor effect refers to a common observation that long-term workers have been found to have lower mortality than short-term workers. As a result, exposure-response analyses based on mortality of long-term healthy workers will tend to underestimate the risk to short-term workers and vice versa. This healthy worker effect may partially explain the higher risk estimates for the same cumulative exposures from the Gibb cohort, which included a higher proportion of workers with short exposure duration, relative to the Luippold cohort of longer-term workers. The healthy worker survivor effect may have also influenced risks estimated from the Mancuso cohort. OSHA agrees that the healthy worker survivor effect contributes to the uncertainty in the risk estimates and has included a discussion in section VII.G.3 on issues and uncertainties and in the section VII.E.1 on the Mancuso data set.
Dr. Smith thought that some important issues surrounding smoking needed to be better addressed in the preliminary risk assessment document. He agreed that OSHA adequately discussed the confounding due to smoking but suggested that it be made clear that the linear relative risk model, in the absence of any explicit interaction term between smoking and Cr(VI), implicitly assumes a synergy (i.e., lung cancer risk from smoking and Cr(VI) together is greater than the sum of the risks from either agent alone) between the two exposures. OSHA believes Dr. Smith has a valid point. Although the linear relative risk model makes no explicit assumptions with regard to an interaction between smoking and Cr(VI) exposure, the model does assume a multiplicative relationship between the background rate of lung cancer in the reference population and Cr(VI) exposure. Therefore, to the extent that smoking is a predominant influence on the background lung cancer risk, the linear relative risk model implicitly assumes a multiplicative (
Finally, the peer reviewers believed that OSHA adequately presented its position that workers in the Gibb and Luippold cohorts were primarily exposed to the less carcinogenic, highly water-soluble Cr(VI) compounds and that the lung cancer risks for workers exposed to equivalent levels of other Cr(VI) compounds will be of a similar magnitude and possibly greater in the case of certain less water-soluble Cr(VI). However, the peer reviewers stated that they lacked the expertise in toxicology and experimental carcinogenesis to critically evaluate its consistency with the existing scientific data. OSHA has made it clear in section VII.G.4 that the animal studies demonstrating higher carcinogenic potency for sparingly water-soluble Cr(VI), such as calcium chromate and strontium chromates, can not provide reliable quantitative estimates of human risk. This is because the studies employed an inadequate
OSHA believes that the best quantitative estimates of excess lifetime lung cancer risks are those derived from the data sets described by Gibb
OSHA does not believe that it is appropriate to employ a threshold dose-response approach to estimate cancer risk from a genotoxic carcinogen, such as Cr(VI). Federal Agencies, including OSHA, assume an exposure threshold for cancer risk assessments to genotoxic agents only when there is convincing evidence that such a threshold exists. In addition, OSHA does not consider absence of a statistically significant effect in an epidemiologic or animal study that lacks power to detect such effects to be convincing evidence of a threshold. OSHA also does not consider theoretical reduction capacities determined in vitro with preparations that do not fully represent physiological conditions within the respiratory tract to be convincing evidence of a threshold. Finally, as previously discussed, linear (and some non-linear) no-threshold risk models adequately fit the existing exposure-response data.
The Gibb and Luippold cohorts were predominantly exposed to water-soluble chromates, particularly sodium dichromate. The scientific evidence indicates that the water-soluble Cr(VI) compounds are generally less potent carcinogens than slightly-water soluble and water-insoluble Cr(VI) compounds. These less water-soluble Cr(VI) compounds are retained in the lung for longer periods, are more likely to concentrate at the lung cell surface, and are a more persistent source of locally available Cr(VI) for uptake into target cells than the highly water-soluble Cr(VI) compounds. Risks estimated from chromate production workers primarily exposed to water-soluble chromates in the Gibb and Luippold cohorts should adequately represent risks to workers exposed to other water-soluble Cr(VI) compounds. OSHA believes that workers exposed to equivalent levels of the potentially more carcinogenic, less water-soluble Cr(VI) compounds may even be at greater risk of lung cancer than predicted from the Gibb and Luippold cohorts.
As with any risk assessment, there is some degree of uncertainty in the projected risks that result from the data, assumptions, and methodology used in the analysis. The exposure estimates in the Gibb
OSHA s preliminary estimate of lung cancer risk from a 45 year occupational exposure to Cr(VI) at an 8-hour TWA at the current PEL of 52 μg/m
In promulgating health standards, OSHA uses the best available information to evaluate the risk associated with occupational exposures, to determine whether this risk is severe enough to warrant regulatory action, and to determine whether a new or revised rule will substantially reduce this risk. OSHA makes these findings, jointly referred to as the “significant risk determination”, based on the requirements of the OSH Act and the Supreme Court's interpretation of the Act in the “benzene” decision of 1980 (
set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard * * * for the period of his working life [6(b)(5)].
In the benzene decision, the Supreme Court's interpretation of Section 3(8)
By empowering the Secretary to promulgate standards that are “reasonably necessary or appropriate to provide safe or healthful employment and places of employment,” the Act implies that, before promulgating any standard, the Secretary must make a finding that the workplaces in question are not safe (IUD v. API 448 U.S. at 642).
The Agency has considerable latitude in defining significant risk and in determining the significance of any particular risk. The Court did not stipulate a means to distinguish significant from insignificant risks, but rather instructed OSHA to develop a reasonable approach to the significant risk determination. The Court stated that “it is the Agency's responsibility to determine in the first instance what it considers to be a “significant” risk”, and did not express “any opinion on the * * * difficult question of what factual determinations would warrant a conclusion that significant risks are present which make promulgation of a new standard reasonably necessary or appropriate” (448 U.S. at 659). The Court also stated that, while OSHA's significant risk determination should be supported by substantial evidence, the Agency “is not required to support the finding that a significant risk exists with anything approaching scientific certainty”. Furthermore, “A reviewing court [is] to give OSHA some leeway where its findings must be made on the frontiers of scientific knowledge [and] * * * the Agency is free to use conservative assumptions in interpreting the data with respect to carcinogens, risking error on the side of overprotection rather than underprotection”, so long as such assumptions are based in “a body of reputable scientific thought” (448 U.S. at 655, 656).
To make the significance of risk determination for a new or proposed standard, OSHA uses the best available scientific evidence to identify material health impairments associated with potentially hazardous occupational exposures, and, when possible, to provide a quantitative assessment of exposed workers' risk of these impairments. OSHA has reviewed extensive epidemiological and experimental research pertaining to adverse health effects of occupational Cr(VI) exposure, including lung cancer, and has established preliminary quantitative estimates of the excess lung cancer risk associated with currently allowable Cr(VI) exposure concentrations and the expected impact of the proposed PEL. OSHA has preliminarily determined that long-term exposure at the current PEL causes significant risk to workers' health, and that adoption of the proposed PEL will significantly reduce this risk.
As discussed in Section VI of this preamble, inhalation exposure to Cr(VI) causes a variety of adverse health effects, including lung cancer, nasal septum damage, and asthma. OSHA considers these conditions to be material impairments of health, as they are marked by significant discomfort and long-lasting adverse effects, can have adverse occupational and social consequences, and may in some cases have permanent or potentially life-threatening consequences. Based on this finding and on the scientific evidence linking Cr(VI) inhalation to each of these effects, OSHA concludes that exposure to Cr(VI) causes “material impairment of health or functional capacity” within the meaning of the OSH Act.
OSHA considers lung cancer, an irreversible and frequently fatal disease, to be a clear material impairment of health. OSHA's finding that inhaled Cr(VI) causes lung cancer is based on the best available epidemiological data, reflects substantial evidence from animal and mechanistic research, and is consistent with the conclusions of other government and public health organizations, including NIOSH, EPA, ACGIH, NTP, and IARC (Exs. 35-117; 35-52; 35-158; 17-9-D; 18-3, p. 213). The Agency's primary evidence comes from two epidemiological studies that show significantly increased incidence of lung cancer among workers in the chromate production industry (Exs. 25; 33-10). The high quality of the data collected in these studies and the analyses performed on them has been confirmed by OSHA and by independent peer review. Supporting evidence of Cr(VI) carcinogenicity comes from occupational cohort studies in chromate production, chromate pigment production, and chromium plating, and by cell culture research into the processes by which Cr(VI) disrupts normal gene expression and replication. Studies demonstrating uptake, metabolism, and genotoxicity of a variety of soluble and insoluble Cr(VI) compounds support the Agency's position that all Cr(VI) compounds should be regulated as occupational carcinogens (Exs. 35-148; 35-68; 35-67; 35-66; 12-5; 35-149; 35-134).
While OSHA has relied primarily on the association between Cr(VI) inhalation and lung cancer to demonstrate the necessity of the proposed standard, the Agency has also determined that several other material health impairments can result from exposure to airborne Cr(VI). As shown in several cross-sectional and cohort studies, inhalation of Cr(VI) can cause nasal passage atrophy, ulceration, and septum perforation (Exs. 35-1; 7-3; 9-126; 35-10; 9-18; 3-84; 7-50; 31-22-12). Septum ulcerations are often accompanied by swelling and bleeding, heal slowly, and in some cases may progress to a permanent perforation that can only be repaired surgically. Inhalation of Cr(VI) can also lead to occupational asthma, a potentially life-threatening condition in which workers become allergic to Cr(VI) compounds and experience symptoms such as coughing, wheezing, and difficulty in breathing upon exposure to small amounts of airborne Cr(VI). Several case reports have documented occupational asthma from Cr(VI) exposure, confirming Cr(VI) as the sensitizing agent by bronchial challenge (Exs. 35-7; 35-12; 35-16; 35-21).
When possible, epidemiological or experimental data and statistical methods are used to characterize the risk of disease that workers may experience under the current PEL, as well as the expected reduction of risk that would occur with implementation of the proposed PEL. The Agency finds that the available epidemiological data are sufficient to support quantitative risk assessment for lung cancer among Cr(VI)-exposed workers. Using the best available studies, OSHA has preliminarily identified a range of expected risk from regular occupational exposure at the current PEL (101-351 excess lung cancer deaths per 1000 workers) and at the proposed PEL of 1 μg/m
For preliminary estimates of lung cancer risk from Cr(VI) exposure, OSHA has relied upon data from two cohorts of chromate production workers. The Gibb cohort, which originates from a chromate production facility in Baltimore, Maryland, includes 2357 workers who began work between 1950 and 1974 and were followed up through 1992 (Ex. 25). The extensive exposure documentation available for this cohort, the high statistical power afforded by the large cohort size, and the availability of information on individual workers' race and smoking status provide a particularly strong basis for risk analysis. The Luippold cohort, from a facility in Painesville, Ohio, includes 482 workers who began work between 1940 and 1972, worked for at least one year at the plant, and were followed up through 1997 (Ex. 33-10). This cohort also provides a very strong basis for risk analysis, in that it has high-quality documentation of worker Cr(VI) exposure and mortality, a long period of followup, and a large proportion of relatively long-term employees (55% > 5 years).
Risk assessments were performed on the Gibb cohort data by Environ International Corporation (Ex. 33-12), under contract with OSHA; Park
Environ and Crump
The risk assessments performed on the Luippold cohort yield somewhat lower estimates of lung cancer risk than those performed on the Gibb cohort. This discrepancy is probably not due to statistical error in the risk estimates, as the confidence intervals for the estimates do not overlap. The risk estimates based on the Gibb and Luippold cohorts are nonetheless reasonably close. OSHA believes that both cohorts support reasonable estimates of lung cancer risk, and based on their results has selected a representative range of 101-351 per 1000 for 45 years' occupational exposure at the current PEL and 2.1-9.1 per 1000 for 45 years' occupational exposure at the proposed PEL for the significant risk determination. OSHA's confidence in these risk estimates is further strengthened by the results of the independent peer review to which the risk assessment and the primary supporting studies were submitted, which generally supported the Agency's approach and results.
Although nasal damage and asthma are well-established effects of occupational exposure to airborne Cr(VI), OSHA has preliminarily determined that there are no adequate studies to support a quantitative risk assessment for these effects. The Agency has nonetheless made careful use of the best available scientific information in its evaluation of noncancer health risks from occupational Cr(VI) exposure. In lieu of a quantitative analysis linking the risk of noncancer health effects with specific occupational exposure conditions, the Agency has considered information on the extent of these effects and occupational factors affecting risk, as discussed below.
Damage to the nasal mucosa and septum can occur from inhalation of airborne Cr(VI) or transfer of Cr(VI) on workers' hands to the interior of the nose. Epidemiological studies have found varying, but substantial, prevalence of nasal damage among workers exposed to high concentrations of airborne Cr(VI). In the cohort of 2357 chromate production workers studied by Gibb
Another important study, Lindberg and Hedenstierna's 1983 examination of nasal effects among Swedish chrome platers, characterizes the prevalence of nasal irritation, atrophy, ulceration, and perforation among workers exposed to various concentrations of Cr(VI) (Ex. 9-126). Workers' daily average exposure concentrations were measured as 8-hour averages using personal air samplers, and estimates of workers' peak exposures were derived from 6-hour average concentrations collected with stationary equipment near the chrome electroplating baths. Among 43 workers exposed almost exclusively to Cr(VI), septum ulceration and perforation were not observed among those exposed to peak exposures less than 20 μg/m
The Supreme Court's benzene decision of 1980 states that “before he can promulgate any permanent health or safety standard, the Secretary [of Labor] is required to make a threshold finding that a place of employment is unsafe—in the sense that significant risks are present and can be eliminated or lessened by a change in practices” (
It is the Agency's responsibility to determine in the first instance what it considers to be a “significant” risk. Some risks are plainly acceptable and others are plainly unacceptable. If, for example, the odds are one in a billion that a person will die from cancer by taking a drink of chlorinated water, the risk clearly could not be considered significant. On the other hand, if the odds are one in a thousand that regular inhalation of gasoline vapors that are 2 percent benzene will be fatal, a reasonable person might well consider the risk significant and take the appropriate steps to decrease or eliminate it. (
Table VIII-1 presents the estimated excess risk of lung cancer associated with various levels of Cr(VI) exposure allowed under the current rule, based on OSHA's risk assessment and assuming either 20 years' or 45 years' occupational exposure to Cr(VI) as indicated. The purpose of the OSH Act, as stated in Section 6(b), is to ensure “that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard * * * for the period of his working life.” 29 U.S.C. 655(b)(5). Taking a 45-year working life from age 20 to age 65, as OSHA has done in significant risk determinations for previous standards, the Agency preliminarily finds an excess lung cancer risk of approximately 100 to 350 per 1000 workers exposed at the current PEL of 52 μg/m
Workers exposed to lower concentrations of Cr(VI) and for shorter periods of time may also have significant excess cancer risk. OSHA's estimates of risk are therefore proportional to concentration for any given exposure duration; for example, workers exposed for 20 years to 10 μg/m
To further demonstrate significant risk, OSHA compares the risk from currently permissible Cr(VI) exposures to risks found across a broad variety of occupations. The Agency has used similar occupational risk comparisons in the significant risk determination for substance-specific standards promulgated since the benzene decision. This approach is supported by evidence in the legislative record that Congress intended the Agency to regulate unacceptably severe occupational hazards, and not “to establish a utopia free from any hazards”(116 Cong. Rec. 37614 (1970), Leg. Hist 480), or to address risks comparable to those that exist in virtually any occupation or workplace. It is also consistent with Section 6(g) of the OSH Act, which states: “In
Fatal injury rates for most U.S. industries and occupations may be obtained from data collected by the Bureau of Labor Statistics. Table VIII-2 shows average annual fatality rates per 1000 employees for several industries between 1992 and 2001, as well as projected fatalities per 1000 employees for periods of 20 and 45 years based on these annual rates (Ex. 35-305). While it is difficult to compare aggregate fatality rates meaningfully to the risks estimated in the quantitative risk assessment for Cr(VI), which target one specific hazard (inhalation exposure to Cr(VI)) and health outcome (lung cancer), these rates provide a useful frame of reference for considering risk from Cr(VI) inhalation. For example, OSHA's best estimate of excess lung cancer deaths per 1000 workers from regular occupational exposure to Cr(VI) in the range of 2.5-5 μg/m
Because there is little available information on the incidence of occupational cancer, risk from Cr(VI) exposure cannot be compared with overall risk from other workplace carcinogens. However, OSHA's previous risk assessments provide estimates of risk from exposure to certain carcinogens. These risk assessments, like the current assessment for Cr(VI), were based on animal or human data of reasonable or high quality and used the best information then available. Table VIII-3 shows the Agency's best estimates of cancer risk from 45 years' occupational exposure to several carcinogens, as published in the preambles to final rules promulgated since the benzene decision in 1980.
At 106-351 excess lung cancer deaths per 1000 workers, the estimated risk from lifetime occupational exposure to Cr(VI) at the current PEL is much higher than the estimated risk from permissible exposures to other workplace carcinogens for which OSHA has performed risk assessments (Table VIII-3, “Risk at Current PEL”). The Cr(VI) risk estimate is also higher than many risks the Agency has found to be significant in previous rules (Table VIII-3, “Risk at Prior PEL”). The estimated risk from lifetime occupational exposure to Cr(VI) at the proposed PEL is 2.2-9.1 excess lung cancer deaths per 1000 workers, a range comparable to the risks from other carcinogenic exposures remaining under recent rules (Table VIII-3, “Risk at Current PEL”).
Based on the results of the quantitative risk assessment, the Supreme Court's guidance on acceptable risk, comparison with rates of occupational fatality in various industries, and comparison with cancer risk estimates developed in previous rules, OSHA preliminarily finds that the risk of lung cancer posed to workers under currently permissible levels of occupational Cr(VI) exposure is significant. The proposed PEL of 1 μg/m
OSHA's Preliminary Economic and Initial Regulatory Flexibility Analysis (PEA) addresses issues related to the costs, benefits, technological and economic feasibility, and the economic impacts (including small business impacts) of the Agency's Occupational Exposure to Hexavalent Chromium rule. The full Preliminary Economic and Regulatory Flexibility Analysis has been placed in the docket as Ex. 35-391. The analysis also evaluates regulatory alternatives to the proposed rule. This rule is an economically significant rule under 3(f)(1) of Executive Order 12866 and has been reviewed by the Office of Information and Regulatory Affairs in the Office of Management and Budget, as required by executive order.
The purpose of this Preliminary Economic and Regulatory Flexibility Analysis is to:
• Identify the establishments and industries potentially affected by the proposed rule;
• Estimate current exposures and the technologically feasible methods of controlling these exposures;
• Estimate the benefits of the rule in terms of the reduction in lung cancer and dermatoses employers will achieve by coming into compliance with the standard;
• Evaluate the costs and economic impacts that establishments in the regulated community will incur to achieve compliance with the proposed standard;
• Assess the economic feasibility of the rule for affected industries; and
• Evaluate the principal regulatory alternatives to the proposed rule that OSHA has considered.
The Full Preliminary Economic Analysis contains the following chapters:
These chapters are summarized in sections B to G of this Preamble summary.
The proposed standard for occupational exposure to hexavalent chromium was developed by OSHA in response to evidence that occupational exposure to Cr(VI) poses a significant risk of lung cancer, nasal septum ulcerations and perforations and dermatoses. Exposure to Cr(VI) can also lead to asthma. To protect exposed workers from these effects, OSHA has set a Permissible Exposure Limit (PEL) of 1 μg/m
OSHA's proposed standards for occupational exposure to Cr(VI) are similar in format and content to other OSHA health standards promulgated under Section 6(b)(5) of the Act. In addition to setting PELS, the proposal requires employers to:
• Monitor the exposure of employees (except in shipyards and construction);
• Establish regulated areas when exposures may reasonably be expected to exceed the PEL (except in shipyards and constructions);
• Implement engineering and work practice controls to reduce employee exposures to Cr(VI);
• Provide respiratory protection to supplement engineering and work practice controls where they are not feasible, where such controls are insufficient to meet the PELS, or in emergencies;
• Provide other protective clothing and equipment as necessary for dermal protection;
• Make industrial hygiene facilities (hand washing stations) available in some situations;
• Provide medical surveillance when employees are exposed above the PEL in general industry (In the shipyard and construction sectors, medical exposure is only required for signs or symptoms of Cr(VI) related disease);
• Train workers about the hazards of Cr(VI) (including elements already required by OSHA's Hazard Communication Standard); and
• Keep records related to the standard.
The contents of the standards, and the reasons for proposing the separate standards for general industry, construction and shipyard employment, are more fully discussed the Summary and Explanation Section of this Preamble.
Chapter II of the full PEA describes the uses of Cr(VI) and the industries in which such uses occur. Employee exposures are defined in terms of “application groups,” i.e., groups of firms where employees are exposed to Cr(VI) when performing a particular function. This methodology is appropriate to exposure to Cr(VI) where a widely used chemical like chromium may lead to exposures in many kinds of firms in many industries, but the processes used, exposures generated, and controls needed to achieve compliance may be the same. For example, because a given type of welding produces Cr(VI) exposures that are essentially the same regardless of whether the welding occurs in a ship, on a construction site, as part of a manufacturing process, or as part of a repair process, it is appropriate to analyze such processes as a group. However, OSHA's analysis of costs and economic feasibility reflect the fact that baseline controls, ease of implementing ancillary provisions, and the economic situation of the employer may differ within different industries in an application group. One complication with the use of the application group concept is that some firms may have exposures in two or more different application groups. For example, a large transportation equipment company may engage in chromium electroplating, painting with paints that use chromium pigments, and welding of metal containing chromium.
The most common reasons to encounter occupational exposure to Cr(VI), in addition to the production and use of chromium metal and chromium metal alloys, are chromium electroplating; welding of metals containing chromium, such as stainless steel or other high chromium steels, or with chromium coatings; the production and use of Cr(VI) containing compounds, particularly Cr(VI) pigments, but also Cr(VI) catalysts, chromic acid, and the production of chromium-containing pesticides.
Some industries are seeing sharp declines in chromium use. However, many of the industries that are seeing a sharp decline have either a small number of employees or have low exposure levels (
In application groups where exposures are particularly significant, both in terms of workforce size and exposure levels—notably in electroplating and welding—OSHA anticipates very little decline in exposures to hexavalent chromium due to the low potential for substitution in the foreseeable future.
Table IX-1 shows the application groups analyzed in OSHA's PEA, as well as the principle industries in each application group, and for each provides the number of establishments affected, the number of employees working in those establishments, the number of entities (firms or governments) fitting SBA's small business criteria for the industry, and the number of employees in those firms. (The table shows data for both establishments, and entities-defined as firms or governments. An entity may own more than one establishment.) The table also shows the revenues of affected establishment and entities. (This table provides the latest available data at the time this analysis was produced. However, since the analysis was produced, there have been changes to some of the affected industries. OSHA will continue to incorporate more recent data as it becomes available.) As shown in the table, there are a total of 38,000 to 55,000 establishments, depending on the degree of overlap between application groups in some industries, affected by the proposed standard.
Various types of welding applications account for the greatest number of establishments and number of employees affected by the proposed standard.
Table IX-2 shows the current exposures to Cr(VI) by application group. The exposure data relied on by OSHA in developing the exposure profile and evaluating technological feasibility was compiled in a database of exposures taken from OSHA compliance officers, Site visits by OSHA contractors and the National Institute for Occupational Safety and Health (NIOSH), the U.S. Navy, published literature, and interested parties.
In all sectors OSHA has used the best available information to determine baseline exposures and technological feasibility. In a few sectors this information has been difficult to obtain and OSHA has had to rely on limited data in the industry or used analogous operations from similar processes. In these cases OSHA (or its contractor) discussed issues with industry experts and used their professional judgment to determine technological feasibility. The sectors that fall into the above categories are steel mills, welding in construction, woodworking and catalyst users.
Data obtained for steel mills included several sources such as NIOSH HHEs, IMIS exposure data and a site visit from IT Corporation, an OSHA contractor. OSHA's contractor could only obtain permission to conduct a site visit at a steel mill that used the teeming and primary rolling method versus continuous casting which is now used in approximately 95% of the steel mills. OSHA acknowledges this and uses exposures from analogous operations with additional information from industry experts. OSHA requests worker exposure information from steel mills using the continuous casting process. Exposure information was also limited for welding at construction sites. OSHA could use analogous operations from welding in maritime in open spaces. This could give a more detailed distribution for the baseline exposure profile. OSHA requests comments on the use of the Maritime data as an analogous operation for welding at construction sites.
In several sectors, such as woodworking and catalyst use, OSHA anticipates that airborne exposures will be low. In these cases exposure monitoring has been performed infrequently. OSHA then used professional judgment or has calculated exposure using total dust exposure to estimate employees' exposures to Cr(VI).
OSHA's analysis of technological feasibility analyzes employee exposures at the operation or task level to the extent that such data are available. There are a total of 380,000 workers exposed to Cr(VI), of which 84,000 are exposed above the proposed PEL of 1 microgram per cubic meter.
In Chapter II of OSHA's PEA, OSHA also assesses the technological feasibility of the proposed standard across a range of potential PELs in all affected industry sectors.
Many employers, and some entire application groups already have nearly all exposures below the proposed PEL. However, OSHA recognizes that some employers in some application groups may not be able to achieve the proposed PEL with engineering controls and work practices for all job categories and may need to use respirators.
In general, OSHA considered the following kinds of possible controls that could reduce employee exposures to Cr(VI): Local exhaust ventilation (LEV) which could include the maintenance or upgrade of the current LEV or installation of additional LEV; process enclosures that would isolate the worker
OSHA has determined that the primary controls most likely to be effective in reducing employee exposure to Cr(VI) are LEV, process enclosure and process modification, or substitution. In some cases, firms need not improve their local exhaust systems, but instead must spend more effort insuring that the exhaust system is working according to design specification throughout the process. In other cases, employers will need to upgrade or install new LEV. This includes installing duct work, a type of hood and/or a collection system. Examples of processes that would need to improve, maintain, or install LEV include hard chrome plating and welding processes that generate large volumes of fume such as shielded metal arc welding (SMAW) and gas metal arc welding (GMAW). (LEV is defined to include portable LEV systems such as fume extraction guns (FEG).) Other sectors where new or better maintained LEV may be needed are: painting and abrasive blasting, chromate production, the production of pigments, catalyst, dyes and plastic colorants.
OSHA estimates that process enclosures will be needed for difficult to control operations such as dusty operations. These enclosures would isolate the employees from high exposure processes and reduce the need for respirators. For example, the packaging of chromic acid in small bags is totally enclosed and therefore, employees only need to enter the room during product upset or planned changes. This technology could also be applied to other packaging operations involving similar sized bags in other industries such as pigment manufacturing, catalyst production and plastic colorants. Process modifications can also be effective in reducing exposures in some industries. For example, employers can significantly reduce employee exposure through the use of automation in catalyst production, the use of fume suppressants in electroplating and significant reduction of welding fume emission, by up to 80 percent, is attainable using the pulsed arc GMAW welding process as compared to the conventional short arc GMAW process.
OSHA recognizes that there are certain instances where the supplemental use of respirators may be needed because engineering and work practices are not sufficient to reduce airborne exposures below the proposed PEL. For example, this is the case for hard chrome electroplating in some circumstances. There are many factors that are involved in the generation of Cr(VI) including the size of the part and the thickness of the coating needed. In some worst case conditions, respirators will be needed to supplement engineering controls. Welding also includes many factors that contribute to Cr(VI) exposures; these include type of welding, the base metal, the consumable, as well as the environment in which the welding is being conducted. As a result, engineering controls and work practices may not be sufficient in the most severe conditions and therefore the supplemental use of respirators will be needed. Table IX-3 shows OSHA's estimate of respirator use by industry for each of the proposed PELs.
Table IX-3 identifies sectors where respirators will be needed for some workers. Even at a PEL of 1 μg/m
PELs lower than 1 μg/m
For a complete analysis of technical feasibility please see the Preliminary Economic Analysis, Chapter III, where feasibility is reviewed for each industry/process by job category.
The costs employers are expected to incur to comply with the proposed standard are $223 million per year. In addition, OSHA estimates that employers will incur $67 million per year to comply with the personal protective equipment and hygiene requirements already present in existing generic standards. The proposed requirements to provide protective clothing and equipment and hygiene
All costs are measured in 2003 dollars. Any one-time costs are annualized over a ten year period, and all costs are annualized at a discount rate of 7 percent. (A sensitivity analysis using a discount rate of 3 percent is presented in the discussion of net benefits.) The derivation of these costs is presented in Chapter III of the full PEA. Table IX-4 provides the annualized costs by provision and by industry. Engineering control costs represent 45 percent of the costs of the new provisions of the proposed standard, and respiratory protection costs represent 19 percent of the costs of the new provisions of the proposed standard.
Costs for the new provisions for General Industry are $179 million per year, costs for constructions $35 million per year, and costs for the shipyard sector and $9 million per year. (In developing the costs for construction, OSHA assumed that all work by construction firms would be covered by the construction standard. However, in practice some work by construction firms takes the form of maintenance operations that would be covered by the
OSHA also presents the distribution of compliance costs according at the time they are imposed in Table IX-5. Because firms will have the choice of whether to finance expenditures in order to spread out, for example, startup costs over several years, OSHA considers it unlikely that a firm would be impacted in an amount equal to the entire startup cost in the year that the initial requirements are imposed. On the other hand, capital markets are not perfectly liquid and particular firms may face additional lending constraints, therefore OSHA believes that identifying startup costs and the time distribution of imposed costs, in addition to the annualized costs, is relevant when exploring the question of economic feasibility and the overall impact of this rulemaking.
To determine whether the proposed rule's projected costs of compliance would raise issues of economic feasibility for employers in affected industries, i.e., would adversely alter the competitive structure of the industry,
OSHA developed quantitative estimates of the economic impact of the proposed rule on the affected establishments. In this analysis, compliance costs are compared with industry revenues and profits.
To assess the potential economic impacts of the proposed standard, OSHA compared the anticipated costs of achieving compliance against revenues and profits of entities affected by the rule. OSHA compared the baseline financial data (from Table IX-1) with total annualized costs of compliance by computing compliance costs as a percentage of revenues. This impact assessment is presented in Table IX-6. This table is considered a screening analysis because it measures costs as a percentage of pre-tax profits and revenues but does not predict impacts on pre-tax profits and sales.
This screening analysis is used to determine whether the compliance costs potentially associated with the standard would lead to significant impacts on establishments in the affected industries. The actual impact of the standard on the viability of establishments in a given industry will depend on the price elasticity of demand for the services sold by establishments in that industry.
Price elasticity refers to the relationship between the price charged for a service and the demand for that service; that is, the more elastic the relationship, the less able an establishment is to pass the costs of compliance through to its customers in the form of a price increase and the more it will have to absorb the costs of compliance from its profits. When demand is inelastic, establishments can recover most of the costs of compliance simply by raising the prices they charge for that service; under this scenario, profit rates are largely unchanged and the industry remains viable. On the other hand, when demand is elastic, establishments cannot recover all the costs simply by passing the cost increase through in the form of a price increase; instead, they must absorb some of the increase from their profits. Commonly, this will mean both reductions in the quantity of goods and services produced and in profits. In general, “when an industry is subject to a higher cost, it does not simply swallow it, it raises its price and reduces its output, and in this way shifts a part of the cost to its consumers and a part to its suppliers,” in the words of the court in
Specifically if demand is completely inelastic (i.e., price elasticity is 0), then the impact of compliance costs that amount to 1 percent of revenues would be a 1 percent increase in the price of the product or service, with no decline in demand or in profits. Such a situation is rare but might be approximately correct in situations in which there are few, if any, substitutes for the product or service offered by the affected sector or if the products or services of the affected sector account for only a small portion of the income of its consumers. If the demand is perfectly elastic (i.e., the price elasticity is infinitely large), then no increase in price is possible, and before-tax profits would be reduced by an amount equal to the costs of compliance (minus any savings resulting from improved worker health) if the industry attempted to keep producing the same amount of goods and services as previously. Under this scenario, if the costs of compliance represent a large percentage of the sector's profits, some establishments might be forced to close. This scenario is highly unlikely to occur, however, because it can only arise when there are other goods and services that are, in the eye of the consumer, perfect substitutes for the goods and services the affected establishments produce or provide.
A common intermediate case would be a price elasticity of one. In this situation, if the costs of compliance amount to 1 percent of revenues, then production would decline by 1 percent and prices would rise by 1 percent. In this case, the industry revenues would stay the same, with somewhat lower production but similar profit rates. Consumers would, however, get less of the product or the service for their expenditures, and producers would collect lower total profits; this, as the court described in
Table IX-6 provides costs as percentage of revenues and profits for all affected establishments. OSHA believes that this is the best way to examine its statutory responsibility to determine whether the standard affects the viability of an industry as a whole. There is only one industry where costs exceed one percent of revenues (chromium catalyst production), and none in which costs exceed 1.5 percent of revenues. In only four industries (electroplating, construction welding, chromium catalyst production and chromium catalyst service) do compliance costs exceed 10 percent of profits.
In the case of construction, such cost changes are unlikely to significantly alter the demand for construction welding services which are essential for many projects and not subject to foreign competition. Independent electroplating shops have also been subject to annual changes larger in magnitude than the
Table IX-7 shows costs as percentage of profits and revenues for firms classified as small by the Small Business Administration and Table IX-8 shows costs as a percentage of revenues and profits for establishments with less than 20 employees. These Tables show greater potential impacts, especially for small electroplating establishments. Based on these results, OSHA has prepared an Initial Regulatory Flexibility Analysis to examine the impacts on small businesses and how they can be alleviated.
OSHA estimated the benefits associated with alternative PELs for Cr(VI) by applying the dose-response relationship developed in the risk assessment to current exposure levels. OSHA determined current exposure levels by first developing an exposure profile for industries with Cr(VI) exposures using OSHA inspection and site visit data, and then applying this profile to the current worker population. The industry by industry exposure profile was given in Table IX-2 above.
By applying the dose-response relationship to estimates of current exposure levels across industries, it is possible to project the number of lung cancers expected to occur in the worker population given current exposures (the “baseline”), and the number of these cases that would be avoided under alternative, lower PELs. OSHA assumed that exposures below the limit of detection (LOD) are equivalent to no exposure to Cr(VI), thus assigning no baseline or avoided lung cancers (and hence, no benefits) to these exposures. For exposures above the current PEL and for purposes of determining the benefit of reducing the PEL, OSHA assumed exposure at exactly the PEL. Consequently, the benefits computed below are attributable only to a change in the PEL. No benefits are assigned to the effect of a new standard increasing compliance with the current PEL. OSHA estimates that between 2,247 and 8,708 lung cancers attributable to Cr(VI) exposure will occur during the working lifetime of the current worker population. Table IX-9 shows the number of avoided lung cancers by PEL. At the proposed PEL of 1 μg/m
Note that the Agency based these estimates on a worker that is employed in a Cr(VI) exposed occupation for his entire working life, from age 20 to 65. The calculation also does not allow workers to enter or exit Cr(VI) jobs, or switch to other exposure groups during their working lives. While the assumptions of 45 years of exposure and no mobility among exposure groups may seem restrictive, these assumptions actually are likely to yield somewhat conservative estimates of the number of avoided cancers, given the nature of the risk assessment model. For example, consider the case of job covered by five workers, each working nine years rather than one worker for 45 years. The former situation will likely yield a slightly higher rate of lung cancers, since more workers are exposed to the carcinogen (albeit for a shorter period of time) and that the average age of the workers exposed is likely to decrease. This is due to: (1) The linearity of the estimated dose-response relationship, and (2) once an individual accumulates a dose, the increase in relative risk persists for the remainder of his lifetime. For example, a worker exposed from age 20 to 30 will have a constant increased relative risk for about 50 or so years (from age 30 on, assuming no lag between exposure and increased risk and death at age 80), whereas a person exposed from age 40 to 50 will have only about 30 years of increased risk (again assuming no lag and death at age 80). The persistence of the increased relative risk for a lifetime follows directly from the risk assessment, and is typical of life table analysis. OSHA intends to investigate the implications of alternative exposure scenarios in the
For informational purposes only, OSHA has estimated the monetary value of the benefits associated with the draft proposed rule. These estimates are informational because OSHA cannot use benefit-cost analysis as a basis for determining the PEL for a health standard. In order to estimate monetary values for the benefits associated with the proposed rule, OSHA reviewed the approaches taken by other regulatory agencies for similar regulatory actions. OSHA found that occupational illnesses are analogous to the types of illnesses targeted by EPA regulations and has thus used them in this analysis.
OSHA is adopting EPA's approach, applying a value of $6.8 million to each premature fatality avoided. The $6.8 million value represents individuals' willingness-to-pay (WTP) to reduce the risk of premature death.
Nonfatal cases of lung cancer can be valued using a cost of illness (COI) approach, using data on associated medical costs. The EPA Cost of Illness Handbook (Ex.35-333) reports that the medical costs for a nonfatal case of lung cancer are, on average, $136,460. Updating the EPA figure to 2003 dollars yields the value of $160,030 Including values for lost productivity, the total COI which is applied to the OSHA estimate of nonfatal cases of lung cancer is $188,502.
An important limitation of the COI approach is that it does not measure individuals' WTP to avoid the risk of contracting nonfatal cancers or illnesses. As an alternative approach, nonfatal cancer benefits may be estimated by adjusting the value of lives saved estimates. In its Stage 2 Disinfection and Disinfection Byproducts water rule, EPA used studies on the WTP to avoid nonfatal lymphoma and chronic bronchitis as a basis for valuing nonfatal cancers. In sum, EPA valued nonfatal cancers at 58.3% of the value of a fatal cancer. Using WTP information would yield a higher estimate of the benefits associated with the reduction in nonfatal lung cancers, as the nonfatal cancers would be valued at $4 million rather than $188,502 per case. These values represent the upper bound values for nonfatal cases of lung cancer avoided.
Using these assumptions, and latency periods of 10, 20 and 35 years and possible increases in the value of life over time, OSHA estimated the total annual benefits of the standard at various PELS in Table IX-10, considering both the benefits from preventing fatal and non-fatal cases of lung cancer.
Occupational exposure to Cr(VI) has also been linked to a multitude of other health effects, including irritated and perforated nasal septum, skin ulceration, asthma, and dermatitis. Current data on Cr(VI) exposure and health effects are insufficient to quantify the precise extent to which many of these ailments occur. However, it is possible to provide an upperbound estimate of the number of cases of dermatitis that occur annually and an upper estimate of the number that will be prevented by a standard. This estimate is an upperbound because it uses data on incidence of dermatitis among cement workers, where dermatitis is more common than it would be for other exposures to Cr(VI). It is important to note that if OSHA were able to quantify all Cr(VI)-related health effects, the quantified benefits would be somewhat higher than the benefits presented in this analysis.
Using National Institute for Occupational Safety and Health (NIOSH) data, Ruttenberg and Associates (Ex. XXXX) estimate that the incidence of dermatitis among concrete workers is between 0.2 and 1 percent. Applying the 0.2 percent-1 percent incidence rate indicates that there are presently 418-2,089 cases of dermatitis occurring annually. This approach represents an overestimate for cases of dermatitis in other application groups, since some dermatitis among cement workers is caused by other known factors, such as the high alkalinity of cement. If the measures in this draft proposed standard are 50 percent effective in preventing dermatitis, then there would be an estimated 209-1,045 cases of Cr(VI) dermatitis avoided annually.
To assign values to the cases of avoided dermatitis OSHA applied the COI approach. Ruttenberg and Associates computed that, on average, the medical costs associated with a case of dermatitis are $119 (in 2003 dollars) and the indirect and lost productivity costs are $1,239. These estimates were based on an analysis of BLS data on lost time associated with cases of dermatitis, updated to current dollars. Based on the Ruttenberg values, OSHA estimates that a Cr(VI) standard will yield $0.3 million to $1.4 million in annual benefits due to reduced incidence of dermatitis. (These benefits associated with dermatitis are not included in the net benefits analysis, as these benefits largely result from full compliance with existing requirements for PPE and hygiene areas.)
Occupational exposure to Cr(VI) can lead to nasal septum ulcerations and nasal septum perforations. As for cases of dermatitis, the data were insufficient to conduct a formal quantitative risk assessment to relate exposures and incidence. However, previous studies provide a basis for developing an approximate estimate of the number of nasal perforations expected under the current PEL as well as PELs of 0.25 μg/m
OSHA estimates that 5,387 nasal perforations/ulcerations occur annually
Finally, for informational purposes, OSHA examined the net benefits of the standard, based on the benefits and costs presented above, and the costs per case of cancer avoided as shown in Table IX-11.
In addition to examining alternative PELs, OSHA also examined alternatives to other provisions of the standard. These alternatives are discussed in the Initial Regulatory Flexibility Analysis in the next section.
As noted above, the OSH Act requires OSHA to set standards based on eliminating risk to the extent feasible. Eliminating risk to the extent feasible does not necessarily have anything to do with the results of a benefit cost analysis. Thus, these analyses of net benefits cannot be used as the basis for a decision concerning the choice of a PEL for a Cr(VI) standard.
Incremental costs and benefits are those that are associated with increasing stringency of the standard. Comparison of incremental benefits and costs provides and indication of the relative efficiency of the various PELs. OSHA cannot use this information in selecting a PEL, but it has conducted these calculations for informational purposes. Incremental costs, benefits, net benefits and cost per cancer avoided are presented in Table IX-12. Note that dermal benefits are excluded since they do not vary with the PEL and hence, do not affect the calculations.
Several well-conducted scientific investigations have found increased lung cancer mortality among workers breathing Cr(VI) dusts and mists in the workplace. The high rate of lung cancer mortality has been documented in workers from several countries across multiple industries that use a broad spectrum of Cr(VI) compounds. Many of the studies found that the rate of lung cancer was greatest among workers in jobs where Cr(VI) exposure was highest and in workers employed in those jobs for the longest periods of time. These exposure-related trends implicate Cr(VI) as a likely causative agent and suggest that other known lung carcinogens to which the workers may be exposed, such as cigarette smoke, are unlikely to account for the increased lung cancers observed in the studies. The International Agency for Research on Cancer, the U.S. Environmental Protection Agency, and the American Conference of Governmental Industrial Hygienists have evaluated the human, animal, and other experimental evidence and concluded that Cr(VI) compounds are “known” or “confirmed” human carcinogens.
Two independent epidemiologic studies of workers from chromate production plants in Baltimore, Maryland (Gibb
Exposure to airborne Cr(VI) can cause other adverse effects to the respiratory tract and the skin. Occupational surveys and medical examinations have found nasal septum ulcerations and perforations (i.e. “chrome holes”) among chromium production workers and chrome electroplaters exposed repeatedly to relatively high levels of Cr(VI) (
A full discussion of the health effects and risk assessment that support the reasons why this action is being considered are given in Section VI of the Preamble, Health Effects, and Section VII, Quantitative Risk Assessment.
The objective of the proposed rule is to reduce the numbers of fatalities and illnesses occurring among employees exposed to Cr(VI) in general industry, construction, and shipyard sectors. This objective will be achieved by requiring employers to install engineering controls where appropriate and to provide employees with the equipment, respirators, training, medical surveillance, and other protective measures to perform their jobs safely.
The legal basis for the rule is the responsibility given the U.S. Department of Labor through the Occupational Safety and Health Act of 1970 (OSH Act). The OSH Act authorizes the Secretary of Labor to promulgate occupational safety and health standards as necessary “to assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources.” 29 U.S.C. 651(b). The legal authority can also be cited as 29 U.S.C. 655(b).
In addition to the statutory basis for a possible standard, the legal basis for the action also involves litigation on the need for and timetable for a Cr(VI) standard. See the Preamble Section III, for a fuller discussion.
Table IX-1 above provides an overview of the number of small entities affected by the standard, by sector. Additional detail is provided in the Full Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis (Ex. 35-391).
Table IX-13 shows the costs of the proposed standard for entities classified as small businesses by the SBA.
Table IX-14 shows the unit costs these estimates are based on. (For a full discussion of the engineering control costs, and of the basis for the unit costs, see Chapter 3 of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis).
OSHA's SBREFA panel for this rule suggested that OSHA address a number of possible overlapping or conflicting rules: EPA's Maximum Achievable Control Technology (MACT) standard for chromium electroplaters; EPA's standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for Chromium Copper Arsenate (CCA) applicators; and state use of OSHA PELs for setting fenceline air quality standards. The Panel was also concerned that, in some cases other OSHA standards might overlap and be sufficient to assure that a new proposed standard would not be needed, or that some of the proposed standard's provisions might not be needed.
OSHA has discussed EPA's MACT standard with EPA. The standards are not duplicative or conflicting. The rules are not duplicative because they have different goals—environmental protection and protection against occupation exposure. It is quite possible, as many electroplaters are now doing, to achieve environmental protection goals without achieving occupational protection goals. The regulations are not conflicting because there exist controls that can achieve both goals without interfering with one another. However, it is possible that meeting the proposed OSHA standard would cause someone to incur additional costs for the MACT standard. If an employer has to make major changes to install LEV, this could result in significant expenses to meet EPA requirements not accounted for in OSHA's cost analysis. OSHA believes that chromium electroplaters can generally meet a PEL of 1 μg/m
OSHA examined the potential problem of overlapping jurisdiction for CCA applicators, and found that there would indeed be overlapping jurisdiction. For this proposed rule, OSHA had excluded CCA applicators from the scope of the coverage of the proposed rule. OSHA has been unable to find a case where a state, as a matter of law, bases fenceline standards on OSHA PELs. OSHA notes that the OSHA PEL is designed to addresses the risks associated with life long occupational exposure only. OSHA welcomes comment on this issue.
OSHA has also examined other OSHA standards, and where standards are overlapping, referred to them by reference in the proposed standard. Existing OSHA standards that may duplicate the proposed provisions in some respect include the standards addressing respiratory protection (29 CFR 1910.134); hazard communication (29 CFR 1910.1200); access to medical and exposure records (29 CFR 1910.1020); general requirements for personal protective equipment in general industry (29 CFR 1910.132), construction (29 CFR 1926.95), and shipyards (29 CFR 1915.152); and sanitation in general industry (29 CFR 1910.141), construction (29 CFR 1926.51), and shipyards (29 CFR 1915.97).
This section discusses various alternatives to the proposed standard that OSHA is considering, with an emphasis on the those suggested by the SBREFA Panel as potentially alleviating impacts on small firms. (A discussion on the costs of some if these alternatives to OSHA's proposed regulatory requirements for the hexavalent chromium standard can be found in
OSHA considered the Panel recommendation that sectors where there is little or no known exposure to Cr(VI) be excluded from the scope of the standard. OSHA has preliminarily decided against this option. The costs for such sectors are relatively small—probably even smaller than OSHA has estimated because OSHA did not assume that any industry would use objective data to demonstrate that initial assessment was not needed. However, it is possible that changes in technology and production processes could change the exposure of employees in what are currently low exposure industries. If this happens, OSHA would need to issue a new standard to address the situation. As a result, OSHA is reluctant to exempt industries from the scope of the standard.
As stated above, the proposed standard does not cover cement work in construction. OSHA's preliminary assessment of the data indicates that the primary exposure to cement workers is dermal contact that can lead to irritant or contact allergic dermatitis. Current information indicates that the exposures in wet cement work in construction are well below 0.25 μg/
OSHA's analysis suggests that there are 2,093 to 10,463 cases of dermatitis among cement workers annually. Using a cost of illness (COI) approach, avoiding 95 percent of these dermatoses would be valued at $2.5 to $12.6 million annually, and avoiding 50 percent of these dermatoses would be valued $1.3 million to $6.6 million annually.
The costs of including wet cement would depend on what requirements were applied to wet cement workers. OSHA estimates that adding wet cement to the scope of the standard would have costs of $33 million per year. The cost of addressing the problem through existing standards could range from $80 to $300 million per year. OSHA considered the SBREFA Panel recommendation that sectors where there is little or no known exposure to Cr(VI) be excluded from the scope of the standard. OSHA has preliminarily decided against this option. The costs for such sectors are relatively small—probably even smaller than OSHA has estimated because OSHA did not assume that any industry would use objective data to demonstrate that initial assessment was not needed. Beyond the initial exposure assessment (required only in general industry), very little would be required in workplaces where Cr(VI) exposures are below the PEL and no hazard is present from skin or eye
The SBREFA Panel also suggested alternatives to a uniform PEL across all industries and exposures. The Panel recommended that OSHA consider alternative approaches to industries that are intermittent users of Cr(VI). OSHA has preliminarily adopted the concept of permitting employers with intermittent exposures to meet the requirements of the standard using respirators rather than engineering controls. This approach has been used in other standards and does not require workers to routinely wear respirators.
The SBREFA Panel also recommended considering Separate Engineering Control Airborne Limits (SECALs). OSHA has preliminarily not adopted this approach because OSHA does not believe it would serve workers or small businesses well. If an approach which requires a significant number of workers to wear respirators on a regular basis were to be adopted, that approach would result in many workers wearing respirators with the associated risks, and in setting a lower PEL in accord with the QRA's estimate that there is significant risk at PELS lower than one.
The SBREFA Panel also suggested that OSHA consider different PELs for different Cr(VI) compounds leading to exposure to Cr(VI). This issue is fully discussed in the QRA. Here, it will only be noted that this would suggest lower PELs than OSHA is setting in at least some industries, and thus potentially increase impacts on small businesses.
This approach reduces the specification oriented aspects of the standard in these sectors, but may make it difficult for employers to determine how to comply with the standard. OSHA is considering a more specification oriented approach, similar to that used in the asbestos in construction standard, and in “control banding” approaches used abroad. Such an approach would require OSHA to specify what controls would need to be used in various circumstances, and employers using such controls would be considered to be in compliance with the standard. OSHA does not have the information at this time to develop or cost such an approach. OSHA welcomes comments on how it might develop such an approach.
Table IX-15 lists all of the SBREFA Panel recommendations and notes OSHA responses to these recommendations.
The proposed standard for chromium (VI) contains collections of information (paperwork) that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA95), 44 U.S.C. 3501 et seq, and its regulation at 5 CFR Part 1320. PRA 95 defines collection of information to mean, “the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public of facts or opinions by or for an agency regardless of form or format” [44 U.S.C. § 3502(3)(A)].
The title, description of the need for and proposed use of the information, summary of the collections of information, description of respondents, and frequency of response of the information collection are described below with an estimate of the annual cost and reporting burden has required by § 1320.5(a) (1)(iv) and § 1320.8(d)(2). The reporting burden includes the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information.
OSHA invites comments on whether each proposed collection of information:
(1) Ensures that the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Estimates the projected burden accurately, including the validity of the methodology and assumptions used;
(3) Enhances the quality, utility, and clarity of the information to be collected; and
(4) Minimizes 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,
Paragraph (d)(5) of this section requires the employer to notify employees of their exposure monitoring results within 15 working days after the receipt for the exposure monitoring performed in this section (§ 1910.1026(d)(2) Initial Exposure Monitoring, § 1910.1026(d)(3) Periodic Monitoring, and § 1910.1026 (d)(4) Additional Monitoring).
Employers may notify each affected employee individually in writing of the results or by posting the exposure-monitoring results in an appropriate location that is accessible to all affected employees. If the exposure monitoring results indicate that employee exposure is above the PEL, the employer must include in the written notification the corrective action being taken to reduce employee exposure to or below the PEL.
Paragraph (g)(2) in the general industry section, and paragraph (e)(2) in the shipyards and construction sections require the employer to institute a respiratory protection program in accordance with 29 CFR 1910.134. The Respiratory Protection Standard's (§ 1910.134) information collection requirements require employers to: Develop a written respirator program; conduct employee medical evaluations and provide follow-up medical evaluations to determine the employee's ability to use a respirator; provide the physician or other licensed health care professional with information about the employee's respirator and the conditions under which the employee will use the respirator; and administer fit-tests for employees who will use negative or positive-pressure, tight-fitting facepieces.
Paragraph (h)(3)(iii) in the general industry section and (f)(3)(iii) in the shipyards and construction sections require the employer to inform any person who launders or cleans protective clothing or equipment contaminated with chromium (VI) of the potentially harmful effects of exposure to chromium (VI) and that the clothing and equipment should be laundered or cleaned in a manner that minimizes skin or eye contact with chromium (VI) and effectively prevents the release of airborne chromium (VI) in excess of the PEL.
Paragraphs (k)(4) in the general industry section and (h)(4) in the shipyards and construction sections require the employer to provide the examining PLHCP with a copy of the standard. In addition, for each employee receiving a medical examination, the employer must provide the following information:
1. A description of the affected employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to chromium (VI);
2. The employee's former, current and anticipated levels of occupational exposure to chromium;
3. A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used that equipment; and,
4. Information from records of employment-related medical examinations previously provided to the affected employee currently within the control of the employer.
Paragraphs (k)(5) in the general industry section, and (h)(5) in shipyards and construction sections require the employer to obtain a written medical opinion from the PLHCP, within 30 days for each medical examination performed on each employee. The employer must provide the employee with a copy the PLHCPs written medical opinion within two weeks of receipt. This written opinion must contain the following information:
1. The PLHCP's opinion as to whether the employee has any detected medical condition(s) that would place the employee at increased risk of material impairment to health from further exposure to chromium (VI);
2. Any recommended limitations upon the employee's exposure to chromium (VI) or upon the use of personal protective equipment such as respirators;
3. A statement that the PLHCP has explained to the employee the results of the medical examination, including any medical conditions related to chromium (VI) exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment.
Paragraph (l)(4) of the general industry section, and (i)(3) of the shipyards and construction sections require that the employer provide
1. The health hazards associated with chromium (VI) exposure;
2. The location, manner of use, and release of chromium (VI) in the workplace and the specific nature of operations that could result in exposure to chromium (VI), especially above the PEL;
3. The engineering controls and work practices associated with the employee's job assignment;
4. The purpose, proper selection, fitting, proper use, and limitations of respirators and protective clothing;
5. Emergency procedures;
6. Measures employees can take to protect themselves from exposure to chromium (VI), including modification of personal hygiene and habits such as smoking;
7. The purpose and a description of the medical surveillance program required by paragraph (k) of the general industry section and paragraph (h) of shipyards and construction sections;
8. The contents of the standard; and
9. The employee s rights of access to records under 29 CFR 1910.1020(g).
Paragraph (m)(1) of the general industry section requires that employers maintain an accurate record of all employee exposure-monitoring records required in paragraph (d) of this section. The record must include at least the following information:
1. The date of measurement for each sample taken;
2. The operation involving exposure to chromium (VI) that is being monitored;
3. Sampling and analytical methods used and evidence of their accuracy;
4. Number, duration, and the results of samples taken;
5. Type of personal protective equipment, such as respirators worn; and,
6. The name, social security number, and job classification of all employees represented by the monitoring, indicating which employees were actually monitored.
Employers must maintain and make available employee exposure monitoring records in accordance with 29 CFR 1910.1020.
Paragraph (m)(2) of the general industry section requires employers who rely on historical monitoring data to maintain a record of historical data. The record must include information that reflects the following conditions:
1. The data were collected using methods that meet the accuracy requirements of paragraph (d)(6) of the general industry section;
2. The processes and work practices that were in use when the historical monitoring data were obtained are essentially the same as those to be used during the job for which initial monitoring will not be performed;
3. The characteristics of the chromium (IV) containing material being handled when the historical monitoring data were obtained are the same as those on the job for which initial monitoring will not be performed;
4. Environmental conditions prevailing when the historical monitoring data were obtained are the same as those on the job for which initial monitoring will not be performed; and
5. Other data relevant to the operations, materials, processing, or employee exposures covered by the exception.
This record must be maintained and must be made available in accordance with 29 CFR 1910.1020.
Paragraph (m)(3) of the general industry section requires employers who rely on objective data to satisfy initial monitoring requirements to establish and maintain an accurate record of the objective data relied upon. The record must include at least the following information:
1. The chromium (VI)-containing material in question;
2. The source of the objective data;
3. The testing protocol and results of testing, or analysis of the material for the release of chromium (VI);
4. A description of the operation exempted from initial monitoring and how the data support the exemption; and
5. Other data relevant to the operations, materials, processing or employee exposures covered by the exemption.
Employers must maintain this record for the duration of the employer's reliance upon such objective data and must make such records available in accordance with 29 CFR 1910.1020.
Paragraph (m)(4) of the general industry section, and paragraph (j)(1) of the shipyard and construction sections, require employers to establish and maintain an accurate record for each employee covered by medical surveillance under paragraph (k) of the general industry section, or paragraph (h) of the shipyard and construction sections. This record must include the following information about the employee:
1. Name and social security number;
2. A copy of the PLHCP's written opinions as required by paragraph (k)(5) of the general industry section, or paragraph (h)(5) for the shipyard and construction sections;
3. A copy of the information provided to the PLHCP as required by paragraph (k)(4) of the general industry section, or (h)(4) in the shipyards and construction sections; Employers must ensure that medical records are maintained and made available in accordance with 29 CFR 1910.1020.
Paragraph (m)(5) of the general industry section and paragraph (j)(2) of the shipyards and construction sections require employers to prepare a record at the completion of training that indicates the identity of the individuals trained and the date the training was completed. This record must be maintained for three years after the completion of training. The employer must provide to the Assistant Secretary or the Director, upon request, all materials relating to employee information and training.
The Agency has submitted a copy of the information collection request to OMB for its review and approval. Interested persons may submit comments regarding the burden
Copies of the referenced information collection request are available for inspection and copying in the OSHA Docket Office and will be provided to persons who request copies by telephoning Todd Owen at (202) 693-1941. For electronic copies of the chromium (VI) information collection request, contact the OSHA Web page on the Internet at
The Agency reviewed the proposed Cr(VI) standard according to the most recent Executive Order on Federalism (Executive Order 13132, 64 FR 43225, August 10, 1999). This Executive Order requires that federal agencies, to the extent possible, refrain from limiting state policy options, consult with states before taking actions that restrict their policy options, and take such actions only when clear constitutional authority exists and the problem is of national scope. The Executive Order allows federal agencies to preempt state law only with the expressed consent of Congress; in such cases, federal agencies must limit preemption of state law to the extent possible. Under section 18 of the Occupational Safety and Health Act (the “Act” or “OSH Act”), Congress expressly provides that OSHA preempt state occupational safety and health standards to the extent that the Agency promulgates a federal standard under section 6 of the Act. Accordingly, under section 18 of the Act OSHA preempts state promulgation and enforcement of requirements dealing with occupational safety and health issues covered by OSHA standards unless the state has an OSHA-approved occupational safety and health plan (i.e., is a state-plan state) [
As explained in section VIII of this preamble, employees face a significant risk from exposure to Cr(VI) in the workplace. These employees are exposed to Cr(VI) in general industry, construction, and shipyards. Accordingly, the proposal would establish requirements for employers in every state to protect their employees from the risks of exposure to Cr(VI). However, section 18(c)(2) of the Act permits state-plan states to develop their own requirements to deal with any special workplace problems or conditions, provided these requirements are at least as effective as the final requirements that result from this proposal.
The 26 states and territories with their own OSHA-approved occupational safety and health plans must adopt comparable provisions within six months after the Agency publishes the final hexavalent chromium standard. These states and territories are: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, Washington, and Wyoming. Connecticut, New Jersey and New York have OSHA-approved State Plans that apply to state and local government employees only. Until a state-plan state promulgates its own comparable provisions, Federal OSHA will provide the state with interim enforcement assistance, as appropriate.
The Agency reviewed the proposed Cr(VI) standard according to the Unfunded Mandates Reform Act of 1995 (UMRA)(2 U.S.C. 1501
Executive Order 13045 requires that Federal agencies submitting covered regulatory actions to OMB's Office of Information and Regulatory Affairs (OIRA) for review pursuant to Executive Order 12866 must provide OIRA with (1) an evaluation of the environmental health or safety effects that the planned regulation may have on children, and (2) an explanation of why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency. Executive Order 13045 defines “covered regulatory actions” as rules that may (1) be economically significant under Executive Order 12866 (i.e., a rulemaking that has an annual effect on the economy of $100 million or more, or would adversely effect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities), and (2) concern an environmental health risk or safety risk that an agency has reason to believe may disproportionately affect children. In this context, the term “environmental health risks and safety risks” means risks to health or safety that are attributable to products or substances that children are likely to come in contact with or ingest (
The Agency reviewed the proposed Cr(VI) standard according to the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321
As a result of this review, OSHA has made a preliminary determination that the proposed Cr(VI) standard will have no impact on air, water, or soil quality; plant or animal life; the use of land or aspects of the external environment. Therefore, OSHA concludes that the proposed Cr(VI) standard would have no significant environmental impacts.
OSHA encourages members of the public to participate in this rulemaking by submitting comments on the proposal, and by providing oral testimony and documentary evidence at the informal public hearing that the Agency will convene after the comment period ends. The Agency invites interested persons having knowledge of, or experience with, occupational exposure to Cr(VI) to participate in this process, and welcomes any pertinent data and cost information that will provide it with the best available evidence on which to develop the final regulatory requirements. This section describes the procedures the public must use to submit their comments to the docket in a timely manner, and to schedule an opportunity to deliver oral testimony and provide documentary evidence at informal public hearings on the proposal. Comments, notices of intention to appear, hearing testimony, and documentary evidence will be available for inspection and copying at the OSHA Docket Office. You also should read the sections above titled
Although the presiding officer at such hearings is an ALJ, and questioning by interested persons is allowed on crucial issues, the proceeding is informal and legislative in purpose. Therefore, the hearing provides interested persons with an opportunity to make effective and expeditious oral presentations in the absence of procedural restraints or rigid procedures that could impede or protract the rulemaking process. The hearing is an informal administrative proceeding, rather than adjudicative one in which the technical rules of evidence would apply; its primary purpose is to gather and clarify information. The regulations that govern public hearings, and the pre-hearing guidelines issued for this hearing, will ensure participants fairness and due process, and also will facilitate the development of a clear, accurate, and complete record. Accordingly, application of these rules and guidelines will be such that questions of relevance, procedure, and participation generally will favor development of the record. Conduct of the hearing will conform to the provisions of 29 CFR part 1911, “Rules of Procedure for Promulgating, Modifying, or Revoking Occupational Safety and Health Standards.”
Although the ALJs who preside over these hearings make no decision or recommendation on the merits of OSHA's proposal, they do have the responsibility and authority to ensure that the hearing progresses at a reasonable pace and in an orderly manner. To ensure that interested persons receive a full and fair informal hearing as specified by 29 CFR part 1911, the ALJ has the authority and power to: Regulate the course of the proceedings; dispose of procedural requests, objections, and comparable matters; confine the presentations to matters pertinent to the issues raised; use appropriate means to regulate the conduct of the parties who are present at the hearing; question witnesses, and permit others to question witnesses; and limit the time for such questioning.
At the close of the hearing, the ALJ will establish a post-hearing comment period for parties who participated in the hearing. During the first part of this period, the participants may submit additional data and information to OSHA, while during the second part of this period, they may submit briefs, arguments, and summations.
OSHA believes that, based on currently available information, the proposed requirements set forth in this notice are necessary and appropriate to provide adequate protection to employees exposed to Cr(VI). OSHA has considered responses to the RFI as well as numerous reference works, journal articles, and other data obtained by the Agency in the development of this proposed standard.
The language of the standards and the order of the various provisions are generally consistent with drafting in other recent OSHA health standards, such as the methylene chloride, formaldehyde, and cadmium standards. OSHA believes that a similar style should be followed from standard to standard when possible in order to facilitate uniformity of interpretation of similar provisions. This approach is also consistent with Section 6(b)(5) of the OSH Act, which states that health standards shall consider “experience gained under this and other health and safety laws.”
OSHA is proposing to issue separate standards addressing hexavalent chromium exposure in general industry, construction, and shipyards. The standard for shipyards would also apply to marine terminals and longshoring. The standards are intended to provide equivalent protection for all workers, while accounting for the different work activities, anticipated exposures, and other conditions in these sectors. The proposed standards for construction and shipyards are very similar to each other, but differ in some respects from the proposed standard for general industry. This summary and explanation will describe the proposed standard for general industry and will note differences between it and the proposed standards for construction and shipyards.
Based on the record developed to date, OSHA believes that certain activities in construction and shipyards are different enough to warrant requirements that are somewhat modified from those proposed for general industry. This preliminary determination is consistent with the recommendation of the Maritime Advisory Committee on Occupational Safety and Health (MACOSH), which has recommended that a separate standard be developed for maritime. The proposed standards do not cover the agricultural sector. OSHA is not aware of significant exposures to Cr(VI) in agriculture. The Agency is interested in any evidence indicating that significant exposures to Cr(VI) occur in sectors not covered under the proposed standards. Accordingly, the subject has been raised in the “Issues” section of this proposal.
The proposed standard applies to occupational exposures to hexavalent chromium (also referred to as chromium (VI) or Cr(VI)), that is, any chromium species with a valence of positive six, regardless of form or compound. Examples of Cr(VI) compounds include chromium oxide (CrO
Some stakeholders have argued that specific Cr(VI) compounds should be excluded from this rulemaking and addressed in a separate standard. Notably, after OSHA was initially petitioned to issue a Cr(VI) standard, the Color Pigments Manufacturers Association (CPMA) submitted a cross-petition calling for a separate standard for lead chromate pigments (Ex. 2). CPMA argued that differences in the bioavailability and toxicity of lead chromate when compared to other Cr(VI) compounds warranted a separate standard (Ex. 2, p. 5). CPMA stated:
Simply put, there are no studies which show a link between lead chromate pigments in a finished form and cancer caused by exposure to Chromium VI. To the contrary, studies of lead chromate workers in the manufacture of lead chromate pigments alone do not show any increased risk of cancer (Ex. 2, p. 5).
In its response to the RFI, the Boeing Company also expressed the view that OSHA should consider the bioavailability of different Cr(VI) compounds (Ex. 31-16, p. 8). Boeing indicated that exposures to strontium chromate and zinc chromate used in aerospace manufacturing are not equivalent to Cr(VI) exposures in other industries. The findings of two epidemiological studies of Cr(VI)-exposed aerospace workers were said to support this conclusion.
OSHA has proposed a rule that covers all Cr(VI) compounds because the Agency believes the evidence supports this approach. As discussed in Section VI.A of this preamble, absorption of Cr(VI) from the lung into the bloodstream is greatly dependent on the solubility of the Cr(VI) compound. Insoluble chromates are poorly absorbed and as a result remain in the lungs for a longer period of time (Ex. 35-87). While in the lungs, insoluble Cr(VI) particulates can come into contact with the epithelial cell surface, resulting in uptake into cells (Exs. 35-68; 35-67). Cellular uptake leads to DNA damage, apoptosis, and neoplastic transformation (Ex. 35-119). Less water-soluble chromates (
Experimental studies involving Syrian hamster embryo cells support the belief that cytotoxicity and neoplastic transformation occur when exposures involve lead chromate pigments (Ex. 12-5). Evidence indicates that even chromates that are encapsulated in a paint matrix may be released in the lungs (Ex. 31-15, p. 2). OSHA therefore sees no reason to exempt these
OSHA believes this view is consistent with the epidemiological studies involving chromate pigment production workers and aerospace workers. While co-exposures to other Cr(VI) compounds do not allow for specific findings related to lead chromate exposure, OSHA has found that epidemiological studies of workers in the chromate pigment production industry have consistently shown excess risks for lung cancer (see Section VI.B.2 of this preamble). The studies of aerospace workers did not find an increased risk of lung cancer. However, this is not convincing evidence that aerospace workers are not at risk from Cr(VI) exposure. The small cohort size, lack of smoking data, relatively young age of the population, and number of members lost to follow-up in the study reported by Alexander
The proposed standard applies to occupational exposure in which Cr(VI), in any quantity, is present in an occupationally related context. Exposure of employees to the ambient environment, which may contain small concentrations of Cr(VI) unrelated to the job, is not subject to this standard.
The proposed standard for construction does not cover exposure to Cr(VI) in portland cement. Cement ingredients (clay, gypsum, and chalk), chrome steel grinders used to crush ingredients, refractory bricks lining the cement kiln, and ash may serve as sources of chromium that may be converted to Cr(VI) during kiln heating, leaving trace amounts of Cr(VI) in the finished product (Ex. 35-317, p. 148).
The amount of Cr(VI) in American cement is generally less than 20 μg/g (Ex. 9-57). While the Cr(VI) in cement may represent a dermal hazard, the evidence obtained by OSHA thus far indicates that the Cr(VI) concentration is generally so low that the proposed PEL could not be reached without exceeding OSHA's current PEL for Particulates Not Otherwise Regulated (PNOR). The PEL for PNOR (15 μg/m
OSHA has proposed to cover exposures to Cr(VI) in portland cement in general industry. The Agency's preliminary exposure profile indicates that some employees in general industry are exposed to airborne Cr(VI) levels associated with a significant risk of lung cancer as a result of work with portland cement. OSHA's preliminary findings show that nearly 2500 workers in general industry are exposed to Cr(VI) levels between 0.25 μg/m
This proposal does not cover exposures to Cr(VI) that occur in the application of pesticides. Some Cr(VI)-containing chemicals, such as chromated copper arsenate (CCA) and acid copper chromate (ACC), are used for wood treatment and are regulated by EPA as pesticides. Section 4(b)(1) of the OSH Act precludes OSHA from regulating working conditions of employees where other Federal agencies exercise statutory authority to prescribe or enforce standards or regulations affecting occupational safety or health. Therefore, OSHA proposes to specifically exclude those exposures regulated by EPA from coverage under the standard.
The manufacture of pesticides containing Cr(VI) is not considered pesticide application, and is covered under this proposed standard. The use of wood treated with pesticides containing Cr(VI) is also covered. In this respect, the proposed Cr(VI) standard differs from OSHA's Inorganic Arsenic standard (29 CFR 1910.1018). The Inorganic Arsenic standard explicitly exempts the use of wood treated with arsenic. When the Inorganic Arsenic standard was issued in 1978, OSHA found that the evidence in the record indicated “the arsenic in the preserved wood is bound tightly to the wood sugars, exhibits substantial chemical differences from other pentavalent arsenicals after reaction, and appears not to leach out in substantial amounts” (43 FR 19584, 19613 (5/5/78)). Based on the record in that rulemaking, OSHA did not consider it appropriate to regulate the use of preserved wood. The record in this rulemaking indicates that work with wood treated with pesticides containing Cr(VI) can involve significant Cr(VI) exposures. OSHA's exposure profile for woodworking indicates that over 30% of current employee Cr(VI) exposures exceed the proposed PEL. OSHA therefore believes it appropriate to include these activities under the scope of the proposed standard.
“Action level” is defined as an airborne concentration of Cr(VI) of 0.5 micrograms per cubic meter of air (0.5 μg/m
Because of the variable nature of employee exposures to airborne concentrations of Cr(VI), maintaining exposures below the action level provides reasonable assurance that employees will not be exposed to Cr(VI) at levels above the PEL on days when no exposure measurements are made. Even when all measurements on a given day may fall below the PEL (but are above the action level), there is some chance that on another day, when exposures are not measured, the employee's actual exposure may exceed
The action level is also intended to encourage employers to lower exposure levels in order to avoid the costs associated with the exposure monitoring and medical surveillance provisions. Some employers would be able to reduce exposures below the action level in all work areas, and other employers in some work areas. As exposures are lowered, the risk of adverse health effects among workers decreases.
OSHA s preliminary risk assessment indicates that significant risk remains at the proposed PEL of 1.0 μg/m
As discussed under the requirements for exposure monitoring, OSHA has not proposed an action level for construction and shipyards. This definition is therefore not included in the proposed standards for construction and shipyards.
“Chromium (VI) [hexavalent chromium or Cr(VI)]” means chromium with a valence of positive six, in any form or chemical compound in which it occurs. This term includes Cr(VI) in all states of matter, in any solution or other mixture, even if encapsulated by another or several other substances. The term also includes Cr(VI) when created by an industrial process, such as when welding of stainless steel generates Cr(VI) fume.
For regulatory purposes, OSHA is treating Cr(VI) generically, instead of addressing specific compounds individually. This is based on OSHA's preliminary determination that the toxicological effect on the human body is similar from Cr(VI) in any of the substances covered under the scope of this standard, regardless of the form or compound in which it occurs. As discussed in Section VI of this preamble, some variation in potency may result due to differences in the solubility of compounds. Other factors, such as encapsulation, may have some effect on the bioavailability of Cr(VI). However, OSHA believes that these factors do not result in differences that merit separate provisions for different Cr(VI) compounds. OSHA considers it appropriate to apply the requirements of the proposed standard uniformly to all Cr(VI) compounds.
“Emergency” means any occurrence that results, or is likely to result, in an uncontrolled release of Cr(VI), such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment. Every spill or leak is not necessarily an emergency. The exposure to Cr(VI) must be unexpected and significant.
If an incidental release of Cr(VI) may be safely cleaned up by employees at the time of release, it is not considered to be an emergency situation for the purposes of this section. The particular circumstances of the release itself, such as the quantity involved, confined space considerations, and the adequacy of ventilation will have an impact on employee safety. In addition, factors such as the knowledge of employees in the immediate work area, the personal protective equipment available, pre-established standard operating procedures for responding to releases, and engineering controls that employees can activate to assist them in controlling and stopping the release are all factors that must be considered in determining whether a release is incidental or an emergency. Those instances that constitute an emergency trigger certain requirements in this proposed standard (
“Employee exposure” means exposure to airborne Cr(VI) that would occur if the employee were not using a respirator. This definition is included to clarify the fact that employee exposure is measured outside any respiratory protection worn. It is consistent with OSHA's previous use of the term in other standards.
“Physician or other licensed health care professional (PLHCP)” refers to an individual who is legally permitted to provide some or all of the health care services required by this section. This definition is included because the proposed standard requires that all medical examinations and procedures be performed by or under the supervision of a PLHCP.
Any professional may perform the medical examinations and procedures provided under the standard when they are licensed by state law to do so. The Agency recognizes that this means that the personnel qualified to provide the required medical examinations and procedures may vary from state to state, depending on state licensing laws. This provision grants the employer the flexibility to retain the services of a variety of qualified licensed health care professionals, provided that these individuals are licensed to perform the specified service. OSHA believes that this flexibility will reduce cost and compliance burdens for employers and increase convenience for employees. The approach taken in this proposed standard is consistent with the approach OSHA has taken in other recent standards, such as those for methylene chloride (29 CFR 1910.1052), bloodborne pathogens (29 CFR 1910.1030), and respiratory protection (29 CFR 1910.134).
“Regulated area” means an area, demarcated by the employer, where an employee's exposure to airborne concentrations of Cr(VI) exceeds, or can reasonably be expected to exceed the PEL. This definition is consistent with the use of the term in other standards, including those for cadmium (29 CFR 1910.1027), butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052).
OSHA has not proposed a requirement for regulated areas in construction and shipyards. This definition is therefore not included in the proposed standards for construction and shipyards.
The definitions for “Assistant Secretary”, “Director”, “High-efficiency particulate air [HEPA] filter”, and “This section” are consistent with OSHA's previous use of these terms found in other health standards.
OSHA proposes to set an 8-hour time-weighted average (TWA) exposure limit of 1 microgram of Cr(VI) per cubic meter of air (1 μg/m
OSHA proposes a new PEL of 1 μg/m
OSHA considers the level of risk remaining at the proposed PEL to be significant. However, as discussed in Section IX of this preamble, the proposed PEL is set at the lowest level that the Agency believes to be feasible in all affected industry sectors. As guided by the 1988 Asbestos decision, OSHA is proposing additional requirements to further reduce the remaining risk. OSHA anticipates that the ancillary provisions in the proposed standard will further reduce the risk beyond the reduction that would be achieved by the proposed PEL alone.
OSHA believes that it is appropriate to establish a single PEL that applies to all Cr(VI) compounds. OSHA's preferred estimates of risk supporting the proposed PEL are derived from worker cohorts that were predominantly exposed to soluble sodium chromate. The evidence reviewed by OSHA indicates that similar doses of less soluble chromates result in higher numbers of lung tumors when compared to more soluble compounds such as sodium chromate (see Section VI of this preamble). Thus, any variation in toxicological effect due to solubility is expected to result in a higher level of risk than is indicated by OSHA's preliminary risk estimates. OSHA consequently believes that the Agency's findings regarding significance of risk are valid regardless of the solubility of the Cr(VI) compound. However, the available evidence is not sufficient to make quantitative estimates of risk for each individual Cr(VI) compound. OSHA is therefore proposing a single PEL for all Cr(VI) compounds. The Agency seeks comment on whether different PELs for different Cr(VI) compounds should be set and how such determinations should be made, and has included this topic in the “Issues” section of the preamble.
The proposed general industry standard imposes monitoring requirements pursuant to Section 6(b)(7) of the OSH Act (29 U.S.C. 655) which mandates that any standard promulgated under section 6(b) shall, where appropriate, “provide for monitoring or measuring of employee exposure at such locations and intervals, and in such manner as may be necessary for the protection of employees.”
The purpose of requiring assessment of employee exposures to Cr(VI) include: determination of the extent and degree of exposure at the worksite; identification and prevention of employee overexposure; identification of the sources of exposure to Cr(VI); collection of exposure data so that the employer can select the proper control methods to be used; and evaluation of the effectiveness of those selected methods. Assessment enables employers to meet their legal obligation to ensure that their employees are not exposed to Cr(VI) in excess of the permissible exposure level and to notify employees of their exposure levels, as required by section 8(c)(3) of the Act. In addition, the availability of exposure data enables the PLHCP performing medical examinations to be informed of the extent of occupational exposures.
Paragraph (d)(1) contains proposed general requirements for exposure monitoring. Monitoring to determine employee exposures must represent the employee's time-weighted average exposure to airborne Cr(VI) over an eight-hour workday. Samples must be taken within the employee's breathing zone (i.e., “personal breathing zone samples” or “personal samples”), and must represent the employee's exposure without regard to the use of respiratory protection.
Employers must accurately characterize the exposure of each employee to Cr(VI). In some cases, this will entail monitoring all exposed employees. In other cases, monitoring of “representative” employees is sufficient. Representative exposure sampling is permitted when a number of employees perform essentially the same job under the same conditions. For such situations, it may be sufficient to monitor a fraction of these employees in order to obtain data that are “representative” of the remaining employees. Representative personal sampling for employees engaged in similar work with Cr(VI) exposure of similar duration and magnitude can be achieved by monitoring the employee(s) reasonably expected to have the highest Cr(VI) exposures. For example, this may involve monitoring the Cr(VI) exposure of the employee closest to an exposure source. This exposure result may then be attributed to the remaining employees in the group.
Exposure monitoring should include, at a minimum, one full-shift sample taken for each job function in each job classification, in each work area, for each shift. These samples must consist of at least one sample characteristic of the entire shift or consecutive representative samples taken over the length of the shift. Where employees are not performing the same job under the same conditions, representative sampling will not adequately characterize actual exposures, and individual monitoring is necessary.
OSHA proposes that employers who have workplaces covered by the general industry standard determine if any of their employees are exposed to Cr(VI) at or above the action level. Further obligations under the standard would be based on the results of this assessment. These may include obligations for periodic monitoring, establishment of regulated areas, implementation of control measures, and provision of medical surveillance.
Initial monitoring need not be conducted under two circumstances. First, where the employer has previously monitored for Cr(VI) in the past 12 months and the data were obtained during work operations conducted under workplace conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions used and prevailing in the employer's current operations, and where that monitoring satisfies all other requirements of this section, including the accuracy and confidence requirements, the employer may rely on such earlier monitoring results to satisfy the initial monitoring requirements of this section. This provision is designed to make it clear that OSHA does not intend to require employers who have recently performed appropriate employee monitoring to conduct “initial” monitoring. OSHA anticipates that this provision will reduce the compliance burden on employers, since monitoring for tasks that involve essentially the same exposures would
Second, where the employer has objective data demonstrating that a particular product or material containing Cr(VI) or a specific process, operation, or activity involving Cr(VI) cannot release dust, fumes, or mist in concentrations at or above the action level under any expected conditions of use, the employer may rely upon such data to satisfy initial monitoring requirements. The data must reflect workplace conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions in the employers' current operations.
Objective data demonstrate that the work operation or the product may not reasonably be foreseen to release Cr(VI) in airborne concentrations at or above the action level under the expected conditions of use that will cause the greatest possible release, or in any plausible accident. The objective data may include monitoring data, or mathematical modeling or calculations based on the chemical and physical properties of a material. For example, data collected by a trade association from its members that meet the definition of objective data may be used. When using the term “objective data”, OSHA is referring to employers' reliance on manufacturers' worst case studies, laboratory studies, and other research that demonstrates, usually by means of exposure data, that meaningful exposures cannot occur. OSHA has allowed employers to use objective data in other standards such as those for formaldehyde (29 CFR 1910.1048) and asbestos (29 CFR 1910.1001) in lieu of initial monitoring and hence, from most of the provisions of these standards.
Paragraph (d)(3) contains requirements for periodic monitoring. The requirement for continued monitoring depends on the results of initial monitoring. If the initial monitoring indicates that employee exposures are below the action level, no further monitoring would be required unless changes in the workplace result in new or additional exposures. If the initial determination reveals employee exposures to be at or above the action level but below the PEL, the employer must perform periodic monitoring at least every six months. If the initial monitoring reveals employee exposures to be above the PEL, the employer must repeat monitoring at least every three months.
The proposed rule also includes provisions to adjust the frequency of periodic monitoring based on monitoring results. If periodic monitoring results indicate that employee exposures have fallen below the action level, and those results are confirmed by consecutive measurements taken at least seven days later, the employer may discontinue monitoring for those employees whose exposures are represented by such monitoring. Similarly, if periodic monitoring measurements indicate that exposures are below the PEL but above the action level, and those results are confirmed by consecutive measurements taken at least seven days later, the employer may reduce the frequency of the monitoring to at least every six months.
OSHA recognizes that exposures in the workplace may fluctuate. Periodic monitoring provides the employer with assurance that employees are not experiencing higher exposures that may require the use of additional control measures. In addition, periodic monitoring reminds employees and employers of the continued need to protect against the hazards associated with exposure to Cr(VI).
Because of the fluctuation in exposures, OSHA believes that when initial monitoring results exceed the action level but are below the PEL, employers should continue to monitor employees to ensure that exposures remain below the PEL. Likewise, when initial monitoring results exceed the PEL, periodic monitoring allows the employer to maintain an accurate profile of employee exposures. If the employer installs or upgrades controls, periodic monitoring will demonstrate whether or not controls are working properly. Selection of appropriate respiratory protection also depends on adequate knowledge of employee exposures.
In general, the more frequently periodic monitoring is performed, the more accurate the employee exposure profile. Selecting an appropriate interval between measurements is a matter of judgment. OSHA believes that the proposed frequency of six months for subsequent periodic monitoring for exposures above the action level but below the PEL, and three months for exposures above the PEL, provides intervals that are both practical for employers and protective for employees. This belief is supported by OSHA's experience with comparable monitoring intervals in other standards, including those for cadmium (29 CFR 1910.1027), methylenedianiline (29 CFR 1910.1050), methylene chloride (29 CFR 1910.1052), and formaldehyde (29 CFR 1910.1048). The proposed requirement for periodic monitoring is also consistent with OSHA's Standards Improvement Project (SIPs) proposal for monitoring frequency (67 FR 66494, 66504 (8/31/02)).
OSHA recognizes that monitoring can be a time-consuming, expensive endeavor and therefore offers employers the incentive of discontinuing monitoring for employees whose sampling results indicate exposures are below the action level. The Agency does not believe that periodic monitoring is generally necessary when monitoring results show that exposures are below the action level because there is a low probability that the results of future samples would exceed the PEL. The Agency intends for this provision to encourage employers to control their employees' exposures to Cr(VI) below the action level, thus maximizing the protection of employees' health.
Under paragraph (d)(4), employers are to perform additional monitoring when there is a change in production process, raw materials, equipment, personnel, work practices, or control methods, that may result in new or additional exposures to Cr(VI). In addition, there may be other situations which can result in new or additional exposures to Cr(VI) which are unique to an employer's work situation. In order to cover those special situations, OSHA requires the employer to perform additional monitoring whenever the employer has any reason to believe that a change has occurred which may result in new or additional exposures. This additional monitoring is necessary to ensure that monitoring results accurately represent existing exposure conditions. This is necessary so that the employer can take appropriate action to protect exposed employees, such as instituting additional engineering controls or providing appropriate respiratory protection.
Under paragraph (d)(5) of the general industry standard, employers are to notify each affected employee of their monitoring results within 15 working days after the receipt of the results. The employer shall either notify each affected employee in writing or post the monitoring results in an appropriate location accessible to all affected employees. In addition, whenever the PEL has been exceeded, the written notification must contain a description of the corrective action(s) being taken by the employer to reduce the employee's exposure to or below the PEL. The requirement to inform employees of the
The proposal would require that all affected employees be notified of the monitoring results. When using the term “affected employees” in this context, OSHA is not referring only to the employee(s) actually subject to personal monitoring. Affected employees include all employees represented by the employee(s) sampled.
Individual notification in writing or posting would be acceptable under the proposed rule. This is consistent with other OSHA standards such as those for methylenedianiline (29 CFR 1910.1050), butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052). In addition, the SIPs proposal (67 FR 66494, 66508 (10/31/02)) allows for employer choice of notification method. The Cr(VI) proposal is also consistent with SIPs in that SIPs specifies 15 working days after the receipt of monitoring results as the appropriate time to notify employees in general industry (67 FR 66494, 66508 (10/31/03)).
Under paragraph (d)(6), the employer would be required to use monitoring and analytical methods that can measure airborne levels of Cr(VI) to within an accuracy of plus or minus 25% (+/-25%) and can produce accurate measurements to within a statistical confidence level of 95% percent for airborne concentrations at or above the action level. Many laboratories presently have methods to measure Cr(VI) at the proposed action level with at least the required degree of accuracy. One example of an acceptable method of monitoring and analysis is OSHA method ID215. Rather than specifying a particular method that must be used, OSHA proposes to take a performance approach and instead allows the employer to use any method as long as the chosen method meets the accuracy specifications.
Paragraph (d)(7) requires the employer to provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to Cr(VI). When observation of monitoring requires entry into an area where the use of protective clothing or equipment is required, the employer must provide the observer with that protective clothing or equipment, and assure that the observer uses such clothing or equipment and complies with all other applicable safety and health procedures.
The requirement for employers to provide employees or their representatives the opportunity to observe monitoring is consistent with the OSH Act. Section 8(c)(3) of the OSH Act mandates that regulations developed under Section 6 provide employees or their representatives with the opportunity to observe monitoring or measurements. Also, Section 6(b)(7) of the OSH Act states that where appropriate, OSHA standards are to prescribe suitable protective equipment to be used in dealing with hazards. The provision for observation of monitoring and protection of the observers is also consistent with OSHA's other substance-specific health standards such as those for cadmium (29 CFR 1910.1027) and methylene chloride (29 CFR 1910.1052).
The proposed construction and shipyard standards for Cr(VI) do not include provisions for exposure monitoring. OSHA recognizes that in these sectors in many instances the results of exposure monitoring required under this proposed standard would not be available until after operations involving Cr(VI) exposure have been completed. For example, a welding task may be finished in a single day. If air monitoring is performed, the task would be completed before the employer is informed of the monitoring results. Therefore, the employer would not be in a position to make use of the monitoring results to determine appropriate control measures for that task. In other cases, the workplace conditions in construction and shipyard worksites may vary to such a great extent that it may be difficult to accurately characterize employee exposure from one day to the next. For example, a stainless steel welder may work outdoors on a windy day one day and in an enclosed environment the next day. Personal monitoring for Cr(VI) exposure on a given day may not accurately reflect these changing conditions. OSHA has therefore proposed a performance-oriented requirement for construction and shipyard employers. Rather than include specific requirements for exposure monitoring for these employers, OSHA proposes to allow construction and shipyard employers the flexibility to assess Cr(VI) exposures in any manner they choose. Thus, construction and shipyard employers could use historical data, objective data, or employee monitoring to determine employee exposures. Because the obligation to comply with the PEL would remain, whatever method the employer chooses would have to be sufficient to ensure that no employee is exposed to an airborne concentration of Cr(VI) in excess of the PEL.
In some cases, the employer may choose not to perform any monitoring. For example, certain tasks (
Similarly, an employer may not find it necessary to perform exposure monitoring where exposures are well below the PEL. For example, there are several construction application groups (
This approach is consistent with OSHA's standard for air contaminants (29 CFR 1910.1000), which establishes PELs for over 400 substances, but does not include specific requirements for exposure monitoring. The Agency seeks comment as to whether this performance-oriented approach to exposure monitoring is appropriate in construction and shipyard workplaces, and has included this topic in the “Issues” section of this preamble.
Under paragraph (e), general industry employers must establish regulated areas wherever an employee's exposure to airborne concentrations of Cr(VI) is, or can reasonably be expected to be, in excess of the PEL. Regulated areas are to be demarcated from the rest of the workplace in a manner that adequately establishes and alerts employees to the boundaries of these areas, and would be required to include the warning signs specified in paragraph (l)(2) of the proposed standard. Access to regulated areas is limited to persons authorized by the employer and required by work
The purpose of a regulated area is to ensure that the employer makes employees aware of the presence of Cr(VI) at levels above the PEL, and to limit Cr(VI) exposure to as few employees as possible. The establishment of a regulated area is an effective means of limiting the risk of exposure to substances known to have carcinogenic effects. Because of the potentially serious results of exposure and the need for persons entering the area to be properly protected, the number of persons given access to the area should be limited to those employees needed to perform the job. Limiting access to regulated areas also has the benefit of reducing the employer's obligation to implement provisions of this proposal to as few employees as possible.
In keeping with the performance orientation of this proposed standard, OSHA has not specified how employers are to demarcate regulated areas. The demarcation should effectively warn employees not to enter the area unless they are authorized, and then only if they are using the proper personal protective equipment. The demarcation must include display of warning signs at all approaches to the regulated areas, consistent with the requirements of paragraph (l)(2) of this proposed standard. In many cases these warning signs alone will be sufficient to identify the boundaries of the regulated area.
Access to the regulated area is restricted to “authorized persons”. For the purposes of this proposed standard, these are persons required by their job duties to be present in the area, as authorized by the employer. In addition, persons exercising the right to observe monitoring procedures are also allowed to enter regulated areas. Employees in some workplaces may designate a union representative to observe monitoring; this person would be allowed to enter the regulated area. Persons authorized under the OSH Act, such as OSHA compliance officers, are also allowed access to regulated areas.
OSHA has not included a requirement for regulated areas in construction and shipyard workplaces, due to the expected difficulties in establishing regulated areas in construction and shipyard workplaces. For example, several small entity representatives (SERs) from the construction and shipyard industries who participated in the SBREFA review noted that in their work settings regulated areas would be particularly problematic and might require that the entire worksite be designated as a regulated area. They also noted that due to the changing nature of the work site (namely construction sites) the demarcation of the regulated area would have to be changed each day as the work progressed (
The proposed standard requires employers to institute effective engineering and work practice controls as the primary means to reduce and maintain employee exposures to Cr(VI) to levels that are at or below the PEL, unless the employer can demonstrate that such controls are not feasible, or if employees are not exposed above the PEL for 30 or more days per year. Employers would be required to institute engineering controls and work practices to reduce exposure to the lowest feasible level even if these measures alone would not reduce the concentration of airborne Cr(VI) to or below the PEL. The employer would then be required to supplement these controls with respirators to ensure that employees are not exposed to Cr(VI) above the PEL.
Primary reliance on engineering controls and work practices is consistent with good industrial hygiene practice and with OSHA's traditional adherence to a hierarchy of preferred controls. Engineering controls are reliable, provide consistent levels of protection to a large number of workers, can be monitored continually and inexpensively, allow for predictable performance levels, and can efficiently remove toxic substances from the workplace. Once removed, the toxic substance no longer poses a threat to employees. The effectiveness of engineering controls does not generally depend to any substantial degree on human behavior, and the operation of equipment is not as vulnerable to human error as is personal protective equipment. For these reasons, engineering controls are preferred by OSHA.
Engineering controls can be grouped into three main categories: (1) Substitution; (2) isolation; and (3) ventilation, both general and localized. Quite often a combination of these controls can be applied to an industrial hygiene control problem to achieve satisfactory air quality. It may not be necessary to apply all these measures to any specific potential hazard.
Substitution can be an ideal control measure. One of the best ways to prevent workers from being exposed to a toxic substance is to stop using it entirely. Although substitution is not always possible, replacement of a toxic material with a less hazardous alternative should always be considered.
In those cases where substitution of a less toxic material is not possible, substituting one type of process for another process may provide effective control of an air contaminant. For example, process changes from batch operations to continuous operations will usually reduce exposures. This is true primarily because the frequency and duration of workers' potential contact with process materials is reduced in continuous operations. Similarly, automation of a process can further reduce the potential hazard.
In addition to substitution, isolation should be considered as an option for controlling employee exposures to Cr(VI). Isolation can involve containment of the source of a hazard, thereby separating it from most workers. Workers can be isolated from Cr(VI) by working in a clean room or booth, or by placing some other type of barrier between the source of exposure and the employee. Employees can also be protected by being placed at a greater distance from the source of Cr(VI) emissions.
Frequently, isolation enhances the benefits of other control methods. For example, Cr(VI) compounds may be used in the formulation of certain paints. If the mixing operation is conducted in a small, enclosed room the airborne Cr(VI) potentially generated by the operation could be confined to a small area. By ensuring containment, local exhaust ventilation is more effective.
Ventilation is a method of controlling airborne concentrations of a contaminant by supplying or exhausting air. A local exhaust system is used to remove an air contaminant by capturing the contaminant at or near its source before it spreads throughout the workplace. General ventilation (dilution ventilation), on the other hand, allows the contaminant to spread throughout the work area but dilutes it by circulating large quantities of air into and out of the area. A local exhaust system is generally preferred to dilution ventilation because it provides a cleaner and healthier work environment.
Work practices controls involve adjustments in the way a task is performed. In many cases, work practice controls complement engineering controls in providing worker protection. For example, periodic inspection and maintenance of process equipment and control equipment such as ventilation systems is an important work practice control. Frequently, equipment which is in disrepair or near failure will not perform normally. Regular inspections can detect abnormal conditions so that timely maintenance can then be performed. If equipment is routinely inspected, maintained, and repaired or replaced before failure is likely, there is less chance that hazardous exposures will occur.
Workers must know the proper way to perform their job tasks in order to minimize their exposure to Cr(VI) and to maximize the effectiveness of control measures. For example, if an exhaust hood is designed to provide local ventilation and a worker performs a task that generates a contaminant away from the exhaust hood, the control measure will be of no use. Workers can be informed of proper operating procedures through information and training. Good supervision provides further support for ensuring that proper work practices are carried out by workers. By persuading a worker to follow proper procedures, such as positioning the exhaust hood in the correct location to capture the contaminant, a supervisor can do much to minimize unnecessary exposure.
Employees' exposures can also be controlled by scheduling operations with the highest exposures at a time when the fewest employees are present. For example, routine clean-up operations that involve Cr(VI) releases might be performed at night or at times when the usual production staff is not present.
OSHA has traditionally relied less on respiratory protection in the hierarchy of controls because the use and efficacy of respirators depends to a great extent on human behavior. Often work is strenuous, and the increased breathing resistance of the respirator reduces its acceptability to employees. Respirators can limit an employee's vision and ability to communicate. In some difficult and dangerous jobs, effective vision or communication is vital to a safe, efficient operation. Voice communication when using a respirator can be difficult and fatiguing. In any event, movement of the jaw in speaking can cause a temporary breaking of the face-to-facepiece seal, thereby reducing the efficiency of the respirator and decreasing the employee's protection. Skin irritation can result from wearing a respirator in hot, humid conditions. Such irritation can cause considerable distress to workers and may disrupt work schedules. To be used effectively, respirators must be individually selected; fitted and periodically refitted; conscientiously and properly worn; regularly maintained, including filter changes; and replaced as necessary. In some workplaces, these preconditions for effective respirator use can be difficult to achieve. It is more difficult to assure that each employee is wearing a respirator correctly than to ascertain that engineering controls are operational. Thus, OSHA has concluded that reliance upon respirators should be minimized when engineering and work practice controls are found to be effective.
OSHA has proposed an exception to the general requirement for primary reliance on engineering and work practice controls for those employers who do not have employee exposures above the PEL for 30 or more days per year (12 consecutive months) from a particular process or task. Thus, if an employee is exposed to Cr(VI) on only 29 days during any 12 consecutive months from a particular process or task, even if the exposure is above the PEL on all of these days, the employer would not be required by this proposed standard to implement engineering and work practice controls to control exposures to the PEL. The burden would be on the employer to show that exposures do not exceed the PEL on 30 or more days per year. OSHA believes this provision would provide needed flexibility to employers, while still protecting workers.
Under the proposed exception, the employer's obligation to implement engineering and work practice controls to comply with the PEL would not be triggered until an employee in a process or task is exposed above the PEL on 30 or more working days during a year. Where the exposure is for fewer than 30 working days, the employer could use any combination of controls to prevent employees from being exposed above the PEL, including respirators alone. The employer may use this exception if he or she has a reasonable basis for believing that employees in a process or task will not be exposed above the PEL for 30 or more days per year (12 consecutive months). OSHA intends for this exception to be process- or task-based,
OSHA has proposed this exception because the Agency realizes that in some industries (
In proposing this exception, OSHA intends to provide relief exclusively to employers whose employees are exposed to Cr(VI) only for short periods (in terms of days and weeks) and otherwise are not exposed to Cr(VI) above the PEL. Where the employee has other exposures above the PEL, the employer would be obligated to achieve the PEL by means of engineering and work practice controls. The Agency believes the proposed 30-working-day exclusion would make the standard more flexible in workplaces where exposure days are extremely limited.
In order for this exception to apply, the proposed standard states that the employer must have a “reasonable basis for believing that no employees in a
In order to take advantage of the proposed exception, the employer would have the burden to demonstrate that his or her employees in a process or task will not be exposed above the PEL for more than 30 days per year. The burden of proof is placed on the employer because the employer has access to needed information about employee exposure levels and processes and tasks at the worksite. Where existing information is inadequate, the employer is also in the best position to develop the necessary information. The obligation to demonstrate that a reasonable basis exists for believing that employees in a process or task will not be exposed above the PEL for more than 30 days per year is the same for general industry, construction, and shipyard employers.
Paragraph (f)(2) of the proposed rule (paragraph (d)(2) of the construction and shipyard proposals) would prohibit the employer from using employee rotation as a means of compliance with the PEL. Worker rotation reduces the exposures to individual employees, but increases the number of employees exposed. Since OSHA has made a preliminary determination that Cr(VI) is carcinogenic, the Agency considers it inappropriate to place more workers at risk. Since no threshold has been established for the carcinogenic effects of Cr(VI), it is prudent to limit the number of workers exposed at any concentration. This provision does not, however, prohibit worker rotation when it is conducted for reasons other than compliance with the PEL. For example, an employer may rotate workers in order to provide cross-training on different tasks, or to allow workers to alternate physically demanding tasks with less strenuous activities. OSHA does not intend for this provision to be interpreted as a general prohibition on employee rotation where workers are exposed to Cr(VI). This proposed provision is consistent with other OSHA standards such as those for butadiene (29 CFR 1910.1051), methylene chloride (29 CFR 1910.1052), and cadmium (29 CFR 1910.1027).
When engineering controls and work practices cannot reduce employee exposure to Cr(VI) to within the PEL, OSHA proposes that the employer must protect employees' health through the use of respirators. Specifically, respirators would be required as supplementary protection to reduce employee exposure during the installation and implementation of engineering and work practice controls; during work operations where engineering and work practice controls are not feasible; when all feasible engineering and work practice controls have been implemented, but are not sufficient to reduce exposure to or below the PEL; during work operations where employees are exposed above the PEL for fewer than 30 days per year, and the employer has elected not to implement engineering and work practice controls to achieve the PEL; and during emergencies.
These limitations on the required use of respirators are generally consistent with other OSHA health standards, such as those for butadiene (29 CFR 1910.1051) and methylene chloride (29 CFR 1910.1052). They reflect the Agency's determination, discussed in the section on methods of compliance, that respirators are inherently less reliable than engineering and work practice controls. OSHA has therefore proposed to allow reliance on respirators only in certain designated situations.
In those circumstances where engineering and work practice controls cannot be used to achieve the PEL (
OSHA anticipates that engineering and work practice controls will be in place by the effective dates specified in paragraph (n) of this proposal (paragraph (k) for construction and shipyards). The Agency realizes that in some cases employers may commence operations that involve employee Cr(VI) exposures after that date, may install new or modified equipment, or make other workplace changes that result in new or additional exposures to Cr(VI). In these cases, a reasonable amount of time may be needed before appropriate engineering controls can be installed and proper work practices implemented. When employee exposures exceed the PEL in these situations, employers are expected to provide respiratory protection to protect workers.
Respiratory protection is also required during work operations where engineering and work practice controls are not feasible. OSHA anticipates that there will be very few situations where no engineering and work practice controls are feasible to limit employee exposure to Cr(VI). In other cases, some engineering and work practice controls may be feasible, but these controls may not be capable of lowering employee exposures to or below the PEL. For example, tasks such as stainless steel welding or abrasive blasting may present certain difficulties when performed in confined spaces. In these cases, the employer would be required to provide respiratory protection. In any event, the employer must always install engineering controls and implement work practice controls when such controls are feasible to reduce exposures, even if these controls cannot reduce exposures below the PEL.
The requirement to provide respiratory protection when feasible engineering controls are not sufficient to reduce exposures to within the PEL would also apply in instances where effective engineering controls have been installed and are being maintained or repaired. In these situations, controls may not be effective while maintenance or repair is underway. Where exposures exceed the PEL, the employer would be required to provide respirators.
As discussed earlier with regard to methods of compliance, OSHA is proposing an exemption from the general requirement for use of engineering and work practice controls where employee exposures do not exceed the PEL on 30 or more days per year. Where this exception applies, the employer would then be required to provide respiratory protection to achieve the PEL. OSHA also believes that emergencies are situations where respirators must be used to protect employees. Since an emergency, by definition, involves or is likely to involve an uncontrolled release of Cr(VI), it is important to protect
Whenever respirators are used to comply with the requirements of the standard, OSHA proposes that the employer implement a comprehensive respiratory protection program in accordance with the Agency's Respiratory Protection standard (29 CFR 1910.134). The respiratory protection program is designed to ensure that respirators are properly used in the workplace, and are effective in protecting workers. The program must include procedures for selecting respirators for use in the workplace; medical evaluation of employees required to use respirators; fit testing procedures for tight-fitting respirators; procedures for proper use of respirators in routine and reasonably foreseeable emergency situations; procedures and schedules for maintaining respirators; procedures to ensure adequate quality, quantity, and flow of breathing air for atmosphere-supplying respirators; training of employees in the proper use of respirators; and procedures for evaluating the effectiveness of the program. In addition, this provision will serve as a reminder to employers covered by the Cr(VI) rule that they must also comply with the Respiratory Protection standard when respirators are provided to employees.
OSHA has proposed to revise the Respiratory Protection standard to include assigned protection factors (68 FR 34036 (6/6/03)). The proposed revision includes a table which indicates the level of respiratory protection that a given respirator or class of respirators is expected to provide, and will apply to employers whose employees use respirators for protection against Cr(VI) when it becomes a final rule (68 FR 34036, 34115 (6/6/03)).
The proposed standard would require that the employer provide protective clothing and equipment at no cost to employees where a hazard is present or is likely to be present from skin or eye contact with Cr(VI). The employer would also be required to ensure that employees use the clothing and equipment provided. The intent of this provision is to prevent the adverse health effects associated with dermal exposure to Cr(VI) (described in Section VI.D of this preamble) and the potential for inhalation of Cr(VI) that may be deposited on employees' street clothing. The proposed requirements for protective clothing and equipment are similar to those in other OSHA health standards such as those for cadmium (29 CFR 1910.1027) and methylenedianiline (29 CFR 1910.1050), and are based upon widely accepted principles and conventional practices of industrial hygiene. The proposed requirements are also consistent with Section 6(b)(7) of the OSH Act which states that, where appropriate, standards shall prescribe suitable protective equipment to be used in connection with hazards.
OSHA has proposed a standard that will cover payment for personal protective equipment in all workplaces (64 FR 15401 (3/31/99)). The Agency is incorporating the record of that rulemaking into the Cr(VI) rulemaking and will give due consideration to all relevant comments.
Criteria for determining when a hazard is present or is likely to be present from skin or eye contact with Cr(VI) are not specified. When evaluating the potential for hazardous eye or skin contact with Cr(VI), OSHA anticipates that the employer will assess the workplace in a manner consistent with the current requirements of the Agency's standards for use of personal protective equipment in general industry (29 CFR 1910.132) and shipyards (29 CFR 1915.152). These standards require the employer to assess the workplace to determine if hazards (including hazards associated with eye and skin contact with chemicals) are present, or are likely to be present.
As described in the non-mandatory appendices providing guidance on hazard assessment for these standards (29 CFR 1910 Subpart I Appendix B; 29 CFR 1915 Subpart I Appendix A), the employer should “exercise common sense and appropriate expertise” in assessing hazards. The recommended approach involves a walk-through survey to identify sources of hazards to workers. Review of injury/accident data is also recommended. Information obtained during this process provides a basis for the evaluation of potential hazards.
Based on the results of this assessment, the employer must determine what clothing and equipment is necessary to protect employees from Cr(VI) hazards. The proposed requirement is performance-oriented, and is designed to allow the employer flexibility in selecting the clothing and equipment most suitable for his or her particular workplace. The type of protective clothing and equipment needed to protect employees from Cr(VI) hazards will depend on the potential for exposure and the conditions of use in the workplace. Examples of protective clothing and equipment include, but are not limited to gloves, aprons, coveralls, foot coverings, and goggles. Ordinary street clothing and work uniforms or other accessories that do not serve to protect workers from Cr(VI) hazards are not considered protective clothing and equipment under this proposed standard.
The employer must exercise reasonable judgment in selecting the appropriate clothing and equipment to protect employees from Cr(VI) hazards. This provision is consistent with OSHA's current standards for provision of personal protective equipment (
OSHA has not proposed a threshold concentration of Cr(VI) for determining when a substance would be covered under the rule. In some OSHA standards an exemption from certain requirements based on percentage composition has been included. For example, the standard for formaldehyde requires that the employer prevent eye and skin contact with liquids containing one percent or more formaldehyde (29 CFR 1910.1048(h)(1)(i)). Contact with liquids containing less than one percent formaldehyde is exempt from this provision. Such exemptions have been included so that coverage would not be extended to trivial exposures that were not associated with adverse health effects.
A similar exemption has not been included in this proposed standard because adverse health effects have been shown to occur as a result of dermal contact to relatively low concentrations of Cr(VI). For example, exposures to portland cement have been associated with allergic contact dermatitis, even though Cr(VI) concentrations in the cement were reported to be below 10 μg/
Paragraph (h)(2) (paragraph (f)(2) of the proposals for construction and shipyards) contains proposed requirements for removal and storage of protective clothing and equipment. The employer must ensure that all protective clothing and equipment contaminated with Cr(VI) is removed at the completion of the work shift or at the completion of tasks involving Cr(VI) exposure. Where employees must change their clothes (i.e., take off their street clothes), removal of protective clothing and equipment must occur in change rooms provided in accordance with paragraph (i) of this section (paragraph (g) of the construction and shipyard proposals). This provision is intended to reduce Cr(VI) contamination of the workplace, and limit Cr(VI) exposures outside the workplace. Wearing contaminated clothing outside the work area could lengthen the duration of exposure, and could carry Cr(VI) from regulated areas to other areas of the workplace. In addition, contamination of personal clothing could result in Cr(VI) being carried to employees' cars and homes, increasing the worker's exposure as well as exposing other individuals to Cr(VI) hazards.
Contaminated protective clothing and equipment must be removed at the end of the work shift or at the completion of tasks involving Cr(VI) exposure, whichever comes first. This language is intended to convey that protective clothing contaminated with Cr(VI) must generally not be worn when tasks involving Cr(VI) exposure have been completed for the day. For example, if employees perform work tasks involving Cr(VI) exposure for the first two hours of a work shift, and then perform tasks that do not involve Cr(VI) exposure, they must remove their protective clothing after the exposure period to avoid the possibility of increasing the duration of exposure and contamination of the work area from Cr(VI) residues on the protective clothing. If, however, employees are performing tasks involving Cr(VI) exposure intermittently throughout the day, or if employees are exposed to other contaminants where their protective clothing and equipment is needed, this provision does not prevent them from wearing the clothing and equipment until the completion of their shift.
To limit exposures outside the workplace, OSHA proposes that the employer ensure that Cr(VI)-contaminated protective clothing and equipment be removed from the workplace only by those employees whose job it is to launder, clean, maintain, or dispose of such clothing or equipment. Furthermore, the proposed standard would require that clothing and equipment that is to be laundered, cleaned, maintained, or disposed of be placed in closed, impermeable containers. This provision is intended to assure that contamination of the change room is minimized and that employees who later handle these items are protected. Those cleaning the Cr(VI)-contaminated clothing and equipment will be further protected by the requirement that warning labels be placed on containers to inform them of the potential hazards of exposure to Cr(VI).
The proposed standard requires that the employer clean, launder, repair and replace protective clothing as needed to ensure that the effectiveness of the clothing and equipment is maintained. This provision is necessary to ensure that clothing and equipment continue to serve their intended purpose of protecting workers. This would also prevent unnecessary exposures outside the workplace from employees taking contaminated clothing and equipment home for cleaning.
In keeping with the performance-orientation of the proposed rule, OSHA does not specify how often clothing and equipment should be cleaned, repaired or replaced. The Agency believes that appropriate time intervals may vary widely based on the types of clothing and equipment used, Cr(VI) exposures, and other circumstances in the workplace. The obligation of the employer, as always, is to keep the clothing and equipment in the condition necessary to perform its protective functions.
Removal of Cr(VI) from protective clothing and equipment by blowing, shaking, or any other means which disperses Cr(VI) in the air would be prohibited. Such actions would result in unnecessary exposure to airborne Cr(VI) as well as possible dermal contact.
The proposal would require that the employer inform any person who launders or cleans protective clothing or equipment contaminated with Cr(VI) of the potentially harmful effects of exposure to Cr(VI), and the need to launder or clean contaminated clothing and equipment in a manner that effectively prevents skin or eye contact with Cr(VI) or the release of airborne Cr(VI) in excess of the PEL. This provision is intended to ensure that persons who clean or launder Cr(VI)-contaminated items are aware of the associated hazards, and can then take appropriate protective measures.
The proposed standard would require employers to provide protective clothing and equipment at no cost to employees. The Agency believes that the employer is generally in the best position to select and obtain the proper type of protective clothing and equipment. OSHA also believes that by providing and owning protective clothing and equipment, the employer will be in a better position to maintain control over the inventory of protective clothing and equipment, conduct periodic inspections, and, when necessary, repair or replace it to maintain its effectiveness. The protective clothing and equipment at issue is designed and intended for work use. As discussed above, employees must remove contaminated clothing and equipment at the end of the work shift or the completion of tasks involving Cr(VI) exposure, whichever comes first. Employees may not remove contaminated clothing and equipment from the worksite, except for the employees whose job it is to launder, clean, maintain, or dispose of such clothing or equipment. The employer is responsible for cleaning or disposing of the protective clothing and equipment and retains complete control over it. The Agency is seeking comment on the proposed provision, and has included this topic in the “Issues” section of this preamble.
The proposed standard would require employers to provide hygiene facilities and to assure employee compliance with basic hygiene practices that serve to minimize exposure to Cr(VI). The proposal includes requirements for change rooms and washing facilities, ensuring that Cr(VI) exposure in eating and drinking areas is minimized, and a prohibition on certain practices that may contribute to Cr(VI) exposure. OSHA believes that strict compliance with these provisions would substantially reduce employee exposure to Cr(VI).
Several of these provisions are presently required under other OSHA standards. For example, OSHA's current standard addressing sanitation in general industry (29 CFR 1910.141) requires that whenever employees are required by a particular standard to wear protective clothing because of the possibility of contamination with toxic materials, change rooms equipped with storage facilities for street clothes and separate storage facilities for protective clothing shall be provided. The sanitation standard also includes
In workplaces where employees must change their clothes to use protective clothing and equipment, OSHA believes it is essential to have change rooms with separate storage facilities for street and work clothing to prevent contamination of employees' street clothes. This provision will minimize employee exposure to Cr(VI) after the work shift ends, because it reduces the duration of time they may be exposed to contaminated work clothes. Potential exposure resulting from contamination of the homes or cars of employees is also avoided. Change rooms also provide employees with privacy while changing their clothes. OSHA intends the proposed requirement for change rooms to apply to all covered workplaces where employees must change their clothes (i.e., take off their street clothes) to use protective clothing and equipment. In those situations where removal of street clothes would not be necessary (
Paragraph (i)(3) (paragraph (g)(3) of the proposals for construction and shipyards) contains proposed requirements for washing facilities. The employer is to provide readily accessible washing facilities capable of removing Cr(VI) from the skin and is to ensure that affected employees use these facilities when necessary. Also, the employer is to ensure that employees who have skin contact with Cr(VI) wash their hands and faces at the end of the work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet.
Washing reduces exposure by diminishing the period of time that Cr(VI) is in contact with the skin. Although engineering and work practice controls and protective clothing and equipment are designed to prevent hazardous skin and eye contact from occurring, OSHA realizes that in some circumstances these exposures will occur. For example, a worker who wears gloves to protect against hand contact with Cr(VI) may inadvertently touch his face with the contaminated glove during the course of the day. The intent of this provision is to have employees wash in order to mitigate the adverse effects when skin and eye contact does occur. At a minimum, employees are to wash their hands and faces at the end of the shift because washing is needed to remove any residual Cr(VI) contamination. Likewise, washing prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics or using the toilet also protects against further Cr(VI) exposure.
OSHA has made a preliminary determination that washing facilities would be sufficient to allow employees to remove significant levels of Cr(VI) contamination that may occur under the proposed standard. A requirement for provision and use of showers has not been included in the proposal. Some other health standards, such as the standards for cadmium (29 CFR 1910.1027) and lead (29 CFR 1910.1025), have included requirements for showers. OSHA requests information and comment as to whether provisions for showers should be included in a final Cr(VI) standard, and has included this topic in the “Issues” section of this preamble.
To minimize the possibility of food contamination and to reduce the likelihood of additional exposure to Cr(VI) through inhalation or ingestion, OSHA believes it is imperative that employees have a clean place to eat. Where the employer chooses to allow employees to eat at the facility, the proposal would require the employer to ensure that eating and drinking areas and surfaces are maintained as free as practicable of Cr(VI). Employers would also be required to assure that employees do not enter eating or drinking areas wearing protective clothing, unless properly cleaned beforehand. This is to further minimize the possibility of contamination and reduce the likelihood of additional Cr(VI) exposure from contaminated food or beverages. Employers are given discretion to choose any method for removing surface Cr(VI) from clothing and equipment that does not disperse the dust into the air or onto the employee's body. For example, if a worker is wearing coveralls for protection against Cr(VI) exposure, thorough HEPA vacuuming of the coveralls could be performed prior to entry into a lunchroom.
The employer is not required to provide eating and drinking facilities to employees. Employees may consume food or beverages off the worksite. However, where the employer chooses to allow employees to consume food or beverages at a worksite where Cr(VI) is present, OSHA intends to ensure that employees are protected from Cr(VI) exposures in these areas.
Proposed paragraph (i)(5) (paragraph (g)(5) in the construction and shipyard proposals) specifies certain activities that would be prohibited. These activities would include eating, drinking, smoking, chewing tobacco or gum, or applying cosmetics in regulated areas, or in areas where skin or eye contact occurs. Products associated with these activities, such as food and beverages, could not be carried or stored in these areas. This provision is intended to protect employees from additional sources of exposure to Cr(VI). Because the construction and shipyard proposals do not include requirements for regulated areas, reference to regulated areas is omitted in the proposed regulatory text for these standards.
The proposed standard includes housekeeping provisions that would require the employer to maintain surfaces as free as practicable of Cr(VI), promptly clean Cr(VI) spills and leaks, use appropriate cleaning methods, and properly dispose of Cr(VI)-contaminated waste. These provisions are exceptionally important because they minimize additional sources of exposure that engineering controls generally are not designed to address. Good housekeeping is a cost effective way to control employee exposures by removing accumulated Cr(VI) that can become entrained by physical disturbances or air currents and carried into an employee's breathing zone, thereby increasing employee exposure. Contact with contaminated surfaces may also result in dermal exposure to Cr(VI). The proposed provisions are consistent with housekeeping requirements in other OSHA standards, such as those for cadmium (29 CFR 1910.1027) and lead (29 CFR 1910.1025).
Cr(VI) deposited on ledges, equipment, floors, and other surfaces should be removed as soon as practicable, to prevent it from becoming airborne and to minimize the likelihood that skin contact will occur. When Cr(VI) is released into the workplace as a result of a leak or spill, the proposal would require the employer to promptly clean up the spill. Measures for clean-up of liquids should provide for the rapid containment of the leak or spill to minimize potential exposures. Clean-up procedures for dusts must not disperse the dust into the workplace air. These work practices aid in minimizing the number of employees exposed, as well as the extent of any potential Cr(VI) exposure.
The proposed standard would require that, where possible, surfaces contaminated with Cr(VI) be cleaned by vacuuming or other methods that minimize the likelihood of Cr(VI) exposure. OSHA believes vacuuming to be the most reliable method of cleaning surfaces on which dust accumulates, but equally effective methods may be used. Shoveling, dry or wet sweeping, and brushing would be permitted only if the employer shows that vacuuming or other methods that are usually as efficient as vacuuming are not effective under the particular circumstances found in the workplace. The proposal would also require that vacuum cleaners be equipped with HEPA filters to prevent the dispersal of Cr(VI) into the workplace. The use of compressed air for cleaning would only be allowed when used in conjunction with a ventilation system designed to capture the dust cloud created by the compressed air. This provision is also intended to prevent the dispersal of Cr(VI) into the workplace.
Cleaning equipment is to be handled in a manner that minimizes the reentry of Cr(VI) into the workplace. For example, cleaning and maintenance of HEPA-filtered vacuum equipment should be done carefully to avoid exposures to Cr(VI). Filters need to be changed and the contents of bags disposed of properly to avoid unnecessary Cr(VI) exposures.
The proposal would also require that items contaminated with Cr(VI) and consigned for disposal be collected and disposed of in sealed impermeable bags or other closed impermeable containers. These containers would include warning labels to inform individuals who handle these items of the potential hazards. By alerting employers and employees who are involved in disposal to the potential hazards of Cr(VI) exposure, they will be better able to implement protective measures.
No housekeeping provision has been included in the proposals covering construction or shipyards. OSHA has made a preliminary determination that a specific housekeeping provision is not appropriate because of the difficulties of performing housekeeping related to Cr(VI) exposure in the construction and shipyard environments. For example, in shipyard and particularly in construction work environments the generally dusty nature of outdoor work settings is likely to make it difficult to distinguish Cr(VI)—contaminated dusts from other dirt and dusts commonly found at the work site. The same control measures that apply to general industry are likely to be more difficult to implement and burdensome in these environments.
This preliminary determination differs from OSHA's determination in the standards for lead in construction (29 CFR 1926.62) and cadmium in construction (29 CFR 1926.1127), where the Agency included housekeeping provisions. In these rulemakings, OSHA did not find housekeeping provisions to present the difficulties anticipated with Cr(VI). The Agency believes that Cr(VI)-contaminated dusts will not generally be as easily identified as lead- or cadmium-contaminated dusts. Welding, in particular, could result in deposition of minute quantities of Cr(VI) that would be difficult for a construction or shipyard employer to identify. OSHA seeks comment on this preliminary finding, and has included this topic in the “Issues” section of this preamble.
Construction and shipyard employers would still need to comply with the general housekeeping requirements found at 29 CFR 1926.25 (for construction) or 29 CFR 1915.91 (for shipyards). These standards include general provisions for keeping workplaces clear of debris, but do not contain the more specific requirements found in the proposed Cr(VI) standard for general industry (such as those addressing cleaning methods) that are designed to limit Cr(VI) contamination of the workplace.
OSHA proposes to require that each employer covered by this rule make medical surveillance available at no cost, and at a reasonable time and place, for all employees who are experiencing signs or symptoms of the adverse health effects associated with Cr(VI) exposure, or who are exposed in an emergency. In addition, general industry employers would be required to provide medical surveillance for all employees exposed to Cr(VI) at or above the PEL for 30 or more days a year. The required medical surveillance must be performed by or under the supervision of a physician or other licensed health care professional.
The purpose of medical surveillance for Cr(VI) is, where reasonably possible, to determine if an individual can be exposed to the Cr(VI) present in his or her workplace without experiencing adverse health effects; to identify Cr(VI)-related adverse health effects so that appropriate intervention measures can be taken; and to determine the employee's fitness to use personal protective equipment such as respirators. The proposal is consistent with Section 6(b)(7) of the OSH Act which requires that, where appropriate, medical surveillance programs be included in OSHA health standards to aid in determining whether the health of workers is adversely affected by exposure to toxic substances. Other OSHA health standards have also included medical surveillance requirements.
The proposed standard is intended to encourage participation by requiring that medical examinations be provided by the employer without cost to employees (also required by section 6(b)(7) of the Act), and at a reasonable time and place. If participation requires travel away from the worksite, the employer would be required to bear the cost. Employees would have to be paid for time spent taking medical examinations, including travel time. OSHA is proposing that medical surveillance be provided to employees in general industry exposed at or above the PEL for 30 or more days a year in order to focus on those workers at greatest risk. Employees exposed below the PEL, or exposed for only a few days in a year, will be at lower risk of developing Cr(VI)-related disease. OSHA believes that these cutoffs, based both on exposure level and on the number of days an employee is exposed to Cr(VI), are a reasonable and administratively convenient basis for providing medical surveillance benefits to Cr(VI)-exposed workers. In past health standards, OSHA has used 30 days above the action level for triggering medical surveillance. Because of the large reduction in the PEL down to 1 μg/m
OSHA has not included exposure above the PEL for 30 or more days per year as a trigger for medical surveillance in the construction or shipyard Cr(VI) proposals. As discussed earlier, OSHA has not proposed to require exposure monitoring for construction or shipyard employment because of the difficulties in conducting such monitoring in these work settings. While OSHA assumes that some monitoring will be conducted in order for employers to know when or if they are above the PEL, OSHA also assumes that certain employers will not conduct exposure monitoring and may choose to presume that certain work processes or practices are above the PEL or rely on historical or objective data to show exposure levels. However, if medical surveillance for individual
Some employees may exhibit signs and symptoms of the adverse health effects associated with Cr(VI) exposure even when not exposed above the PEL for 30 or more days per year. These employees could be especially sensitive, may have been unknowingly exposed, or may have been exposed to greater amounts than the exposure assessment suggests. OSHA has therefore proposed that employees who experience signs or symptoms of the adverse health effects associated with Cr(VI) exposure be subject to medical surveillance. Signs and symptoms that may warrant surveillance include dermatitis, chrome holes, and nasal septum ulcers or perforations. Thus, the proposal would protect all employees exposed to Cr(VI) in unusual circumstances even if they fall outside the criteria for routine medical surveillance.
Appropriate surveillance would be required to be made available for employees exposed in an emergency regardless of the airborne concentrations of Cr(VI) normally found in the workplace. Emergency situations involve uncontrolled releases of Cr(VI), and the significant exposures that occur in these situations justify a requirement for medical surveillance. The proposed requirement for medical examinations after exposure in an emergency is consistent with the provisions of several other OSHA health standards, including the standards for methylenedianiline (29 CFR 1910.1050), butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052).
OSHA has made a preliminary determination not to include eye or skin contact as a basis for medical surveillance. OSHA believes that compliance with the proposed provisions for protective work clothing and equipment, hygiene areas and practices, and other protective measures will minimize the potential for adverse eye and skin effects. When such health effects occur, OSHA believes that trained employees will be able to detect these conditions, report them to their employer, and obtain medical assistance. In such situations, affected employees would be provided medical surveillance on the basis that they are experiencing signs or symptoms of Cr(VI)-related health effects.
OSHA has proposed that the medical examinations provided under the rule be performed by or under the supervision of a physician or other licensed health care professional (PLHCP). The Agency considers it appropriate to allow any professional to perform medical examinations and procedures provided under the standard when they are licensed by state law to do so. This provision provides flexibility to the employer, and would reduce cost and compliance burdens. The proposed requirement is consistent with the approach of other recent OSHA standards, such as those for methylene chloride (29 CFR 1910.1052), bloodborne pathogens (29 CFR 1910.1030), and respiratory protection (29 CFR 1910.134).
The proposed standard also specifies how frequently medical examinations are to be offered to those employees covered by the medical surveillance program. Employers would be required to provide all covered employees with medical examinations whenever an employee shows signs or symptoms of Cr(VI) exposure; within 30 days after an emergency resulting in an uncontrolled release of Cr(VI); and within 30 days after a PLHCP's written medical opinion recommends an additional examination. In addition, employers in general industry would be required to provide covered employees with examinations within 30 days after initial assignment unless the employee has received a medical examination provided in accordance with the standard within the past 12 months; annually; and at the termination of employment, unless an examination has been given less than six months prior to the date of termination.
Signs or symptoms may indicate that adverse health effects attributable to Cr(VI) exposure are occurring. In such situations OSHA believes it would be appropriate to evaluate the employee's condition to determine if exposure to Cr(VI) is the cause of the condition, and to determine if protective measures are necessary. Emergency situations may involve high or unknown exposures, and OSHA believes that a medical examination is necessary to evaluate the possible adverse effects of these exposures.
In addition to medical evaluations after exposures in an emergency or when signs or symptoms occur, OSHA is proposing that additional examinations be offered following a PLHCP's recommendation that additional exams are necessary. A PLHCP may recommend additional evaluations in order to follow developments in a worker's condition, or to allow for specialized evaluation. For example, if nasal ulceration is identified in a Cr(VI)-exposed worker, a PLHCP may recommend follow-up examinations to ensure that treatment and workplace interventions are successful in addressing the condition, or a worker who exhibits dermatitis may be referred to a dermatologist for testing to determine if they are sensitized to Cr(VI).
The proposed requirement for general industry that a medical examination be offered at the time of initial assignment is intended to achieve the objective of determining if an individual will be able to work in the job involving Cr(VI) exposure without adverse effects. It also serves the useful function of establishing a health baseline for future reference. Where an examination that complies with the requirements of the standard has been provided in the past 12 months, that previous examination would serve these purposes, and an additional examination would not be needed.
OSHA believes that the provision of medical surveillance on an annual basis in general industry is an appropriate frequency for screening employees for Cr(VI)-related diseases. The main goal of periodic medical surveillance for workers is to detect adverse health effects at an early and potentially reversible stage. The proposed requirement for annual examinations is consistent with other OSHA health standards, including those for cadmium (29 CFR 1910.1027), formaldehyde (29 CFR 1910.1048), and methylene chloride (29 CFR 1910.1052). Based on the Agency's experience, OSHA believes that annual surveillance would strike a reasonable balance between the need to diagnose health effects at an early stage, and the limited number of cases likely to be identified through surveillance. The proposed requirement for general industry that the employer offer a medical examination at the termination of employment is intended to assure that no employee terminates employment while carrying an active, but undiagnosed, disease.
The examination to be provided by the PLHCP is to consist of a medical and work history; a physical examination of the skin and respiratory tract; and any additional tests considered appropriate by the PLHCP. Special emphasis is placed on the portions of the medical and work history focusing on Cr(VI) exposure, health effects associated with Cr(VI) exposure, and smoking. The physical exam focuses on organs and systems known to be susceptible to Cr(VI) toxicity. The information obtained will allow the PLHCP to assess
The proposal does not indicate specific tests that must be included in the medical examination. OSHA does not believe that any particular tests are generally applicable to all employees covered by the medical surveillance requirements, and the Agency proposes to give the examining PLHCP the flexibility to determine any appropriate tests to be selected for a given employee. For example, tests for dermal sensitization exist, but they are not recommended as a screening tool because they are capable of sensitizing persons who had not been affected previously. These tests should be considered by the PLHCP if a medical history indicating probable sensitization exists or if the employee experiences signs or symptoms indicative of sensitization. Radiological examinations and pulmonary function tests may also be useful in evaluating possible effects of Cr(VI). OSHA believes that the PLHCP is in the best position to decide which medical tests are necessary for each individual examined. Where specific tests are deemed appropriate by the PLHCP, the proposed standard would require that they be provided.
OSHA is aware that certain methods are available for evaluating Cr(VI) exposures based on analysis of chromium in urine or blood. However, the Agency is not aware of evidence indicating that these methods adequately characterize Cr(VI) exposures in most occupational environments. OSHA has also found no medical justification for routine urine or blood analysis for the detection of Cr(VI)-related health effects. Therefore, no requirement for such analysis is proposed.
The proposed standard would require the employer to ensure the PLHCP has a copy of the standard, and to provide the following information: a description of the affected employee's former and current duties as they relate to Cr(VI) exposure; the employee's former, current, and anticipated exposure level; a description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used that equipment; and information from records of employment-related medical examinations previously provided to the affected employee, currently within the control of the employer. Making this information available to the PLHCP will aid in the evaluation of the employee's health in relation to assigned duties and fitness to use personal protective equipment, when necessary.
The results of exposure monitoring are part of the information that would be supplied to the PLHCP responsible for medical surveillance. These results contribute valuable information to assist the PLHCP in determining if an employee is likely to be at risk of harmful effects from Cr(VI) exposure. A well-documented exposure history would also assist the PLHCP in determining if a condition (
The proposed rule would require employers to obtain from the examining PLHCP a written opinion containing the results of the medical examination with regard to Cr(VI) exposure, the PLHCP's opinion as to whether the employee would be placed at increased risk of material health impairment as a result of exposure to Cr(VI), and any recommended limitations on the employee's exposure or use of personal protective equipment. The PLHCP would also need to state in the written opinion that these findings were explained to the employee. The purpose of requiring the PLHCP to supply a written opinion to the employer is to provide the employer with a medical basis to aid in the determination of placement of employees and to assess the employee's ability to use protective clothing and equipment. The employer must obtain the written opinion within 30 days of the examination; OSHA believes this will provide the PLHCP sufficient time to receive and consider the results of any tests included in the examination, and allow the employer to take any necessary protective measures in a timely manner. The proposed requirement that the opinion be in written form is intended to ensure that employers and employees have the benefit of this information.
The PLHCP would not be allowed to include findings or diagnoses which are unrelated to Cr(VI) exposure in the written opinion provided to the employer. OSHA has proposed this provision to reassure employees participating in medical surveillance that they will not be penalized or embarrassed by the employer's obtaining information about them not directly pertinent to Cr(VI) exposure. The employee would be informed directly by the PLHCP of all results of his or her medical examination, including conditions of non-occupational origin. The employer would also be required to provide a copy of the PLHCP's written opinion to the employee within two weeks after receiving it, to ensure that the employee has been informed of the result of the examination in a timely manner.
In some OSHA health standards, a provision for medical removal protection (MRP) has been included. MRP typically requires that the employer temporarily remove an employee from exposure when such an action is recommended in a written medical opinion. During the time of removal, the employer is required to maintain the total normal earnings, as well as all other employee rights and benefits. However, MRP is not intended to serve as a worker's compensation system. The primary reason MRP has been included in these previous standards has been to encourage employee participation in medical surveillance. By protecting employees who are removed on a temporary basis from economic loss, this potential disincentive to participating in medical surveillance is alleviated.
The proposed rule does not include a provision for MRP, because OSHA has made a preliminary determination that MRP is not reasonably necessary or appropriate for Cr(VI)-related health effects. The Agency believes that Cr(VI)-related health effects generally fall into one of two categories: Either they are chronic conditions that temporary removal from exposure will not remedy (
The proposed standard includes requirements intended to ensure that the dangers of Cr(VI) exposure are communicated to employees by means of signs, labels, and employee information and training. These proposed requirements would parallel the existing requirements of OSHA's Hazard Communication standard (29 CFR 1910.1200). The hazard communication requirements of the proposed rule are designed to be substantively as consistent as possible with the Hazard Communication standard, while including additional specific requirements needed to protect employees exposed to Cr(VI).
The proposed standard would require that all approaches to regulated areas be
The signs are intended to serve as a warning to employees who otherwise may not be aware that they are entering a regulated area, and to remind employees of the hazards of Cr(VI) so that they take necessary protective steps before entering the area. These signs are intended to supplement the training that employees receive regarding the hazards of Cr(VI), since even trained employees need to be reminded of the locations of regulated areas and of the precautions necessary before entering these dangerous areas.
In some instances, regulated areas are permanent, because the employer is unable to reduce Cr(VI) exposures in that area below the PEL with engineering controls. In those cases, the signs serve to warn employees not to enter the area unless they are authorized and are wearing respirators. In other cases, such as emergency situations and maintenance operations, regulated areas may be established temporarily. The use of warning signs is particularly important in these situations to make employees who are regularly scheduled to work at these sites aware of the hazards. Access is limited to authorized personnel to ensure that those entering the area are adequately trained and equipped, and to limit exposure to only those whose presence is absolutely necessary.
The proposed standard specifies the wording of the warning signs for regulated areas in order to ensure that the proper warning is given to employees. OSHA believes that the use of the word “Danger” is appropriate, based on the evidence of the toxicity and carcinogenicity of Cr(VI). “Danger” is used to attract the attention of workers in order to alert them to the fact that they are entering an area where the PEL may be exceeded and to emphasize the importance of the message that follows. The use of the word “Danger” is also consistent with other OSHA health standards dealing with carcinogens such as cadmium (29 CFR 1910.1027), methylenedianiline (29 CFR 1910.1050), asbestos (29 CFR 1910.1001), and benzene (29 CFR 1910.1028).
The proposed standard would also require that the sign indicate that respirators are required in the area. Regulated areas are areas demarcated by the employer where the employee's exposure to airborne concentrations of chromium (VI) exceeds, or can reasonably be expected to exceed the PEL (definition of a regulated area). The employer has made the determination that such areas are regulated on the basis of his/her own exposure assessments of the employees in the area. Since the employer has determined that such areas are not able to be reduced below the PEL, respirators are required as a means of control to protect the employees in those areas. The sign also serves as a means to warn other employees not in the regulated area not to enter, or if those other employees enter the area, they need to protect themselves in situations where excessive exposures can occur.
The proposal would require that warning labels be affixed to all bags or containers of contaminated clothing and equipment that are to be removed from the workplace for laundering, cleaning, or maintenance. Containers of waste, scrap, debris, and any other materials contaminated with Cr(VI) that are consigned for disposal would also need to be labeled. The labels must state: Danger; Contains Chromium (VI); Cancer Hazard; Can Damage Skin, Eyes, Nasal Passages, and Lungs. The purpose of this requirement is to ensure that all affected employees, not only those of a particular employer, are apprised of the hazardous nature of Cr(VI) exposure. These proposed requirements are consistent with the mandate of Section (6)(b)(7) of the OSH Act, which requires that OSHA health standards prescribe the use of labels or other appropriate forms of warning to apprise employees of the hazards to which they are exposed. Because the construction and shipyard proposals do not include disposal requirements, no provision is included in the construction and shipyard proposals for placing warning labels on containers of waste, scrap, debris, and other materials contaminated with Cr(VI).
Information and training is essential to inform employees of the hazards to which they are exposed and to provide employees with the necessary understanding of the degree to which they themselves can minimize potential health hazards. As part of an overall hazard communication program, training serves to explain and reinforce the information presented on labels and in material safety data sheets. These written forms of communication will be successful and relevant only when employees understand the information presented and are aware of the actions to be taken to avoid or minimize exposures, thereby reducing the possibility of experiencing adverse health effects.
OSHA proposes that employers provide training for all employees who are exposed to airborne Cr(VI) or who have skin or eye contact with Cr(VI), ensure that employees participate in the training, and maintain a record of the training provided. Training would be provided to all employees exposed to Cr(VI), and would not be limited to only those exposed above the PEL or action level. This proposed requirement is consistent with the Hazard Communication standard (29 CFR 1910.1200), which requires training for all employees exposed to hazardous chemicals and defines this to include potential (
The employer is to provide initial training prior to or at the time of initial assignment to a job involving potential exposure to Cr(VI). An employer who is able to demonstrate that a new employee has received training within the last 12 months is allowed to use that training for purposes of initial training required by the standard, provided the previous training has addressed the elements specified in the training provisions of the proposal, and the employee is able to demonstrate knowledge of those elements. In cases where understanding of some elements is lacking or inadequate, the employer would be required to provide training only in those elements. This allowance for prior training is intended to ensure that employees receive sufficient training, without requiring unnecessary repetition of that training.
The training requirements in this standard are performance-oriented. The proposed standard lists the subjects that must be addressed in training, but not the specific ways that this is to be accomplished. Hands-on training, videotapes, slide presentations, classroom instruction, informal discussions during safety meetings, written materials, or any combination of these methods may be appropriate. Such performance-oriented requirements are intended to encourage employers to tailor training to the needs of their workplaces, thereby resulting in the most effective training program in each specific workplace.
OSHA believes that the employer is in the best position to determine how the training can most effectively be accomplished. The Agency has therefore laid out the objectives to be met to ensure that employees are made aware of the hazards associated with Cr(VI) in their workplace and how they can help to protect themselves. The specifics regarding how this is to be achieved are left up to the employer.
In order for the training to be effective, the employer must ensure that it is provided in a manner that the employee is able to understand. Employees have varying educational levels, literacy, and language skills, and the training must be presented in a language and at a level of understanding that accounts for these differences in order to meet the proposed requirement that individuals being trained understand the specified elements. This may mean, for example, providing materials, instruction, or assistance in Spanish rather than English if the workers being trained are Spanish-speaking and do not understand English. The employer would not be required to provide training in the employee's preferred language if the employee understood both languages; as long as the employee is able to understand the language used, the intent of the proposed standard would be met.
In order to ensure that employees comprehend the material presented during training, it is critical that trainees have the opportunity to ask questions and receive answers if they do not fully understand the material that is presented to them. When videotape presentations or computer-based programs are used, this requirement may be met by having a qualified trainer available to address questions after the presentation, or providing a telephone hotline so that trainees will have direct access to a qualified trainer.
Under the proposal, the employer would be required to ensure that each employee can demonstrate knowledge of the specified elements. This could be determined through methods such as discussion of the required training subjects, written tests, or oral quizzes.
The frequency of training under the proposed standard would be determined by the needs of the workplace. Individuals would need to be trained sufficiently to understand the specified elements. Additional training is needed periodically to refresh and reinforce the memories of individuals who have previously been trained, and to ensure that these individuals are informed of new developments in the workplace that may result in new or additional exposures to Cr(VI). For example, training after new control measures are implemented would generally be necessary in order to ensure that employees are able to properly use the new controls that are introduced. Employees would likely be unfamiliar with new work practices undertaken, with the operation of new engineering controls, or the use of new personal protective equipment; training would rectify this lack of understanding. Additional training would ensure that employees are able to actively participate in protecting themselves under the conditions found in the workplace, even if those conditions change.
The proposed standard for general industry would require employers to maintain exposure monitoring, medical surveillance, and training records. Because the proposed construction and shipyard standards do not include requirements for exposure monitoring, no provision for retention of exposure monitoring records is included in the proposed regulatory texts for construction and shipyards. However, the record retention requirements of OSHA's standard on access to medical and exposure records (29 CFR 1910.1020) apply to any exposure records that construction and shipyard employers produce.
The recordkeeping requirements are proposed in accordance with section 8(c) of the OSH Act, which authorizes OSHA to require employers to keep and make available records as necessary or appropriate for the enforcement of the Act or for developing information regarding the causes and prevention of occupational injuries and illnesses. The proposed recordkeeping provisions are also consistent with the OSHA's standard addressing access to employee exposure and medical records (29 CFR 1910.1020).
The proposal would require that records be kept of environmental monitoring results that identify the monitored employee and accurately reflect the employee's exposure. The employer would be required to keep records for each exposure measurement taken. Specifically, records must include the following information: The date of measurement for each sample taken; the operation involving exposure to Cr(VI) that was monitored; sampling and analytical methods used and evidence of their accuracy; the number, duration, and results of samples taken; the type of personal protective equipment used; and the name, social security number, and job classification of all employees represented by the monitoring, indicating which employees were actually monitored.
Most of OSHA's substance-specific standards require that exposure monitoring and medical surveillance records include the employee's social security number. OSHA has included this requirement in the past because social security numbers are particularly useful in identifying employees, since each number is unique to an individual for a lifetime and does not change when an employee changes employers. When employees have identical or similar names, identifying employees solely by name makes it difficult to determine to which employee a particular record pertains. However, based on privacy concerns, OSHA is examining alternatives to requiring social security numbers for employee identification. In its Standards Improvement Project proposal, the Agency requested public comment on the necessity, usefulness, and effectiveness of social security numbers as a means of identifying employee records, and any privacy concerns or issues raised by this requirement, as well as the availability of other effective methods of identifying employees for OSHA recordkeeping purposes (67 FR 66493 (19/31/02)). OSHA intends for the requirements of the Cr(VI) standard to conform with any final determination made through the Standards Improvement Project.
The proposal would allow the employer to rely on Cr(VI) monitoring results obtained in the past 12 months when the data were obtained during operations conducted under workplace conditions closely resembling the employer's current operations. Where historical monitoring data are used, the proposal would require that records of these data be maintained. The records of historical data must demonstrate that exposures on a particular job will be below the action level by showing that the work being performed, Cr(VI)-containing material being handled, and environmental conditions at the time the historical data were obtained are the same as those on the job for which monitoring was not performed. The records must also demonstrate that the data were obtained using a method sufficiently accurate to be allowed under the standard. Other data relevant to operations, materials, processing, or employee exposures must also be included in records.
A provision allowing the use of objective data in place of initial monitoring is included in this proposed standard. Objective data are information demonstrating that a particular product or material cannot release Cr(VI) in
Compliance with the requirement to maintain a record of objective data protects the employer at later dates from the contention that initial monitoring was not conducted in an appropriate manner. The record would also be available to employees so that they can examine the determination made by the employer. The employer would be required to maintain the record for the duration of the employer's reliance upon the objective data.
In addition to records relating to employee exposures to Cr(VI), the proposal would require the employer to establish and maintain an accurate medical surveillance record for each employee subject to the medical surveillance requirements of the standard. OSHA believes that medical records, like exposure records, are necessary and appropriate both to the enforcement of the standard and to the development of information regarding the causes and prevention of occupational illnesses. Good medical records, including the record of the examination at termination of employment itself, can be useful to the Agency and others in enumerating illnesses and deaths attributable to Cr(VI), in evaluating compliance programs, and in assessing the accuracy of the Agency's risk estimates. Furthermore, medical records are necessary for the proper evaluation of the employee's health.
The medical surveillance records would be required to include the following information: The name, social security number, and job classification of the employee; a copy of the PLHCP's written opinions; and a copy of the information provided to the PLHCP. This information includes the employee's duties as they relate to Cr(VI) exposure, Cr(VI) exposure levels, and descriptions of personal protective equipment used by the employee.
The employer would be required under the proposal to maintain records of employees' Cr(VI)-related training. At the completion of training, the employer would be required to prepare a record that indicates the identity of the individuals trained and the date the training was completed. The record would need to be maintained for three years after the completion of training. In addition, the employer would need to provide materials relating to employee information and training to OSHA or NIOSH, if requested.
OSHA believes that a three year retention period for training records is reasonable. Since OSHA is not proposing specific intervals for periodic retraining, but is making retraining contingent upon the need to maintain employee understanding of safe use and handling of Cr(VI) and workplace changes which result in significant increases in employee exposures to Cr(VI), it is appropriate to have records of training to allow employers to determine when and how employees have been trained. The proposed requirement to provide training materials upon request is necessary to allow for evaluation of training programs, and is consistent with the other OSHA standards such as those for bloodborne pathogens (29 CFR 1910.1030) methylene chloride (29 CFR 1910.1052), butadiene (29 CFR 1910.1051), and methylenedianiline (29 CFR 1910.1050).
All medical and exposure records developed under the Cr(VI) rule would be made available to employees and their designated representatives in accordance with OSHA's standard on access to records (29 CFR 1910.1020). The medical and exposure records standard requires that exposure records be kept for at least 30 years and that medical records be kept for the duration of employment plus thirty years. It is necessary to keep these records for extended periods because of the long latency period commonly associated with cancer. Cancer often cannot be detected until 20 or more years after first exposure. The extended record retention period is therefore needed because diagnosis of disease in employees is assisted by, and in some cases can only be made by, having present and past exposure data as well as the results of present and past medical examinations.
OSHA proposes that the final Cr(VI) rule become effective 60 days after its publication in the
Additional time would be allowed for the employer to establish change rooms and to implement engineering controls. Change rooms would be required no later than one year after the effective date of the standard, and engineering controls would need to be in place within two years after the effective date. This is to allow affected employers sufficient time to design and construct change rooms (where necessary), and to design, obtain, and install the necessary control equipment. OSHA solicits comment on the adequacy of these proposed start-up dates. In particular, the Agency is aware that in some cases employers may be required to reevaluate modified ventilation systems for compliance with regulations governing discharges of Cr(VI) to the environment. OSHA would like to ensure that employers are provided sufficient time to complete this process, and has included this topic in the “Issues” section of this preamble.
This document was prepared under the direction of John L. Henshaw, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210.
The Agency issues the proposed sections under the following authorities: Sections 4, 6(b), 8(c), and 8(g) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); section 107 of the Contract Work Hours and Safety Standards Act (the Construction Safety Act) (40 U.S.C. 333); section 41, the Longshore and Harbor Worker's Compensation Act (33 U.S.C. 941); Secretary of Labor's Order No. 5-2002 (67 FR 65008); and 29 CFR Part 1911.
Cancer, Chemicals, Hazardous substances, Health, Occupational safety and health, Reporting and recordkeeping requirements.
Chapter XVII of Title 29 of the Code of Federal Regulation is proposed to be amended as follows:
1. The authority citation for Subpart Z of Part 1910 is revised to read as follows:
Secs. 4, 6, 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657: Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), or 5-2002 (67 FR 65008), as applicable; and 29 CFR part 1911.
All of subpart Z issued under section 6(b) of the Occupational Safety and Health Act, —except those substances that have exposure limits listed in Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000. The latter were issued under Sec. 6(a) (29 U.S.C. 655(a)).
Section 1910.1000, Tables Z-1, Z-2 and Z-3 also issued under 5 U.S.C. 553, Section 1910.1000 Tables Z-1, Z-2, and Z-3 not issued under 29 CFR part 1911 except for the arsenic (organic compounds), benzene, and cotton dust listings.
Section 1910.1001 also issued under Sec. 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704) and 5 U.S.C. 553.
Section 1910.1002 also issued under 5 U.S.C. 553 but not under 29 U.S.C. 655 or 29 CFR part 1911.
Sections 1910.1018, 1910.1029 and 1910.1200 also issued under 29 U.S.C. 653.
Section 1910.1030 also issued under Pub. L. 106-430, 114 Stat. 1901.
2. In § 1910.1000, Table Z-2, the entry for Chromic acid and chromates 1.0 mg/10 m
3. A new § 1910.1026 is added to read as follows:
(a)
(b)
(c)
(d)
(2)
(ii) Where the employer has monitored for chromium (VI) in the past 12 months, and the data were obtained during work operations conducted under workplace conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions used and prevailing in the employer's current operations, and where that monitoring satisfies all other requirements of this section, including the accuracy and confidence levels of paragraph (d)(6) of this section, the employer may rely on such earlier monitoring results to satisfy the requirements for initial monitoring.
(iii) Where the employer has objective data demonstrating that a material containing chromium (VI) or a specific process, operation, or activity involving chromium (VI) cannot release dust, fumes, or mist of chromium (VI) in concentrations at or above the action level under any expected conditions of use, the employer may rely upon such data to satisfy initial monitoring requirements. The data must reflect workplace conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions in the employer's current operations.
(3)
(ii) If initial monitoring or periodic monitoring reveals employee exposures to be at or above the action level, the employer shall perform periodic monitoring at least every six months.
(iii) If initial monitoring reveals employee exposures to be at or above the PEL, the employer shall perform periodic monitoring at least every three months.
(iv) If periodic monitoring indicates that employee exposures are below the action level, and the result is confirmed by the result of another monitoring taken at least seven days later, the employer may discontinue the monitoring for those employees whose exposures are represented by such monitoring.
(4)
(5)
(ii) Whenever monitoring results indicate that employee exposure is above the PEL, the employer shall describe in the written notification the corrective action being taken to reduce employee exposure to or below the PEL.
(6)
(7)
(ii) When observation of monitoring requires entry into an area where the use of protective clothing or equipment is required, the employer shall provide the observer with clothing and equipment and shall assure that the observer uses such clothing and equipment and complies with all other applicable safety and health procedures.
(e)
(2)
(3)
(i) Persons authorized by the employer and required by work duties to be present in the regulated area;
(ii) Any person entering such an area as a designated representative of employees for the purpose of exercising the right to observe monitoring procedures under paragraph (d) of this section; or
(iii) Any person authorized by the Occupational Safety and Health Act or regulations issued under it to be in a regulated area.
(f)
(ii) Where the employer has a reasonable basis for believing that no employee in a process or task will be exposed above the PEL for 30 or more days per year (12 consecutive months), the requirement to implement engineering and work practice controls to achieve the PEL does not apply to that process or task.
(2)
(g)
(i) Periods necessary to install or implement feasible engineering and work practice controls;
(ii) Work operations, such as maintenance and repair activities, for which engineering and work practice controls are not feasible;
(iii) Work operations for which an employer has implemented all feasible engineering and work practice controls and such controls are not sufficient to reduce exposures to or below the PEL;
(iv) Work operations where employees are exposed above the PEL for fewer than 30 days per year, and the employer has elected not to implement engineering and work practice controls to achieve the PEL; or
(v) Emergencies.
(2)
(h)
(2)
(ii) The employer shall ensure that no employee removes chromium (VI)-contaminated protective clothing or equipment from the workplace, except for those employees whose job it is to launder, clean, maintain, or dispose of such clothing or equipment.
(iii) When contaminated protective clothing or equipment is removed for laundering, cleaning, maintenance, or disposal, the employer shall ensure that it is stored and transported in sealed, impermeable bags or other closed, impermeable containers.
(iv) Bags or containers of contaminated protective clothing or equipment that are removed from change rooms for laundering, cleaning, maintenance, or disposal shall be labeled in accordance with paragraph (l) of this section.
(3)
(ii) The employer shall prohibit the removal of chromium (VI) from protective clothing and equipment by blowing, shaking, or any other means that disperses chromium (VI) into the air or onto an employee's body.
(iii) The employer shall inform any person who launders or cleans protective clothing or equipment contaminated with chromium (VI) of the potentially harmful effects of exposure to chromium (VI) and that the clothing and equipment should be laundered or cleaned in a manner that minimizes skin or eye contact with chromium (VI) and effectively prevents the release of airborne chromium (VI) in excess of the PEL.
(i)
(2)
(3)
(ii) The employer shall ensure that employees who have skin contact with chromium (VI) wash their hands and faces at the end of the work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet.
(4)
(ii) The employer shall ensure that employees do not enter eating and drinking areas with protective work clothing or equipment unless surface chromium (VI) has been removed from the clothing and equipment by methods that do not disperse chromium (VI) into the air or onto an employee's body.
(5)
(j)
(i) All surfaces are maintained as free as practicable of accumulations of chromium (VI).
(ii) All spills and releases of chromium (VI) containing material are cleaned up promptly.
(2)
(ii) Shoveling, sweeping, and brushing may be used only where HEPA-filtered vacuuming or other methods that minimize the likelihood of exposure to chromium (VI) have been tried and found not to be effective.
(iii) The employer shall not allow compressed air to be used to remove chromium (VI) from any surface unless the compressed air is used in conjunction with a ventilation system designed to capture the dust cloud created by the compressed air.
(iv) The employer shall ensure that cleaning equipment is handled in a manner that minimizes the reentry of chromium (VI) into the workplace.
(3)
(i) Waste, scrap, debris, and any other materials contaminated with chromium (VI) and consigned for disposal are collected and disposed of in sealed, impermeable bags or other closed, impermeable containers.
(ii) Bags or containers of waste, scrap, debris, and any other materials contaminated with chromium (VI) that are consigned for disposal are labeled in accordance with paragraph (l) of this section.
(k)
(A) Who are or may be occupationally exposed to chromium (VI) above the PEL for 30 or more days a year;
(B) Experiencing signs or symptoms of the adverse health effects associated with chromium (VI) exposure; or
(C) Exposed in an emergency.
(ii) The employer shall assure that all medical examinations and procedures required by this section are performed by or under the supervision of a PLHCP.
(2)
(i) Within 30 days after initial assignment, unless the employee has received a chromium (VI) related medical examination, provided in accordance with this standard, within the last twelve months;
(ii) Annually;
(iii) Within 30 days after a PLHCP's written medical opinion recommends an additional examination;
(iv) Whenever an employee shows signs or symptoms of the adverse health effects associated with chromium (VI) exposure;
(v) Within 30 days after exposure during an emergency which results in an uncontrolled release of chromium (VI); or
(vi) At the termination of employment, unless the last examination that satisfied the requirements of paragraph (k) of this section was less than six months prior to the date of termination.
(3)
(i) A medical and work history, with emphasis on: past, present, and anticipated future exposure to chromium (VI); any history of respiratory system dysfunction; any
(ii) A physical examination of the skin and respiratory tract; and
(iii) Any additional tests deemed appropriate by the examining PLHCP.
(4)
(i) A description of the affected employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to chromium (VI);
(ii) The employee's former, current, and anticipated levels of occupational exposure to chromium (VI);
(iii) A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used that equipment; and
(iv) Information from records of employment-related medical examinations previously provided to the affected employee, currently within the control of the employer.
(5)
(A) The PLHCP's opinion as to whether the employee has any detected medical condition(s) that would place the employee at increased risk of material impairment to health from further exposure to chromium (VI);
(B) Any recommended limitations upon the employee's exposure to chromium (VI) or upon the use of personal protective equipment such as respirators;
(C) A statement that the PLHCP has explained to the employee the results of the medical examination, including any medical conditions related to chromium (VI) exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment.
(ii) The PLHCP shall not reveal to the employer specific findings or diagnoses unrelated to occupational exposure to chromium (VI).
(iii) The employer shall provide a copy of the PLHCP's written medical opinion to the examined employee within two weeks after receiving it.
(l)
(1)
(2)
(ii) Warning signs required by paragraph (l)(2)(i) of this section shall include at least the following information:
(3)
(4)
(ii) The employer shall provide initial training prior to or at the time of initial assignment to a job involving potential exposure to chromium (VI). An employer who is able to demonstrate that a new employee has received training within the last 12 months that addresses the elements specified in paragraph (l)(4)(iii) of this section is not required to repeat such training provided that the employee can demonstrate knowledge of those elements.
(iii) The employer shall provide training that is understandable to the employee and shall ensure that each employee can demonstrate knowledge of at least the following:
(A) The health hazards associated with chromium (VI) exposure;
(B) The location, manner of use, and release of chromium (VI) in the workplace and the specific nature of operations that could result in exposure to chromium (VI), especially exposure above the PEL;
(C) The engineering controls and work practices associated with the employee's job assignment;
(D) The purpose, proper selection, fitting, proper use, and limitations of respirators and protective clothing;
(E) Emergency procedures;
(F) Measures employees can take to protect themselves from exposure to chromium (VI), including modification of personal hygiene and habits such as smoking;
(G) The purpose and a description of the medical surveillance program required by paragraph (k) of this section;
(H) The contents of this section; and
(I) The employee's rights of access to records under 29 CFR 1910.1020(g).
(iv) The employer shall provide additional training when:
(A) Training is necessary to ensure that each employee maintains an understanding of the safe use and handling of chromium (VI) in the workplace.
(B) Workplace changes (such as modification of equipment, tasks, or procedures) result in an increase in employee exposures to chromium (VI), and those exposures exceed or can reasonably be expected to exceed the action level or result in a hazard from skin or eye contact with chromium (VI).
(v) The employer shall make a copy of this section and its appendices readily available without cost to all affected employees.
(m)
(ii) This record shall include at least the following information:
(A) The date of measurement for each sample taken;
(B) The operation involving exposure to chromium (VI) that is being monitored;
(C) Sampling and analytical methods used and evidence of their accuracy;
(D) Number, duration, and the results of samples taken;
(E) Type of personal protective equipment, such as respirators worn; and
(F) Name, social security number, and job classification of all employees represented by the monitoring, indicating which employees were actually monitored.
(iii) The employer shall ensure that exposure records are maintained and made available in accordance with 29 CFR 1910.1020.
(2)
(ii) The record shall include information that reflects the following conditions:
(A) The data were collected using methods that meet the accuracy requirements of paragraph (d)(6) of this section;
(B) The processes and work practices that were in use when the historical monitoring data were obtained are essentially the same as those to be used during the job for which initial monitoring will not be performed;
(C) The characteristics of the chromium (VI) containing material being handled when the historical monitoring data were obtained are the same as those on the job for which initial monitoring will not be performed;
(D) Environmental conditions prevailing when the historical monitoring data were obtained are the same as those on the job for which initial monitoring will not be performed; and
(E) Other data relevant to the operations, materials, processing, or employee exposures covered by the exception.
(iii) The employer shall ensure that historical exposure records are maintained and made available in accordance with 29 CFR 1910.1020.
(3)
(ii) This record shall include at least the following information:
(A) The chromium (VI)-containing material in question;
(B) The source of the objective data;
(C) The testing protocol and results of testing, or analysis of the material for the release of chromium (VI);
(D) A description of the operation exempted from initial monitoring and how the data support the exemption; and
(E) Other data relevant to the operations, materials, processing or employee exposures covered by the exemption.
(iii) The employer shall maintain this record for the duration of the employer's reliance upon such objective data and shall make such records available in accordance with 29 CFR 1910.1020.
(4)
(ii) The record shall include the following information about the employee:
(A) Name and social security number;
(B) A copy of the PLHCP's written opinions;
(C) A copy of the information provided to the PLHCP as required by paragraph (k)(4) of this section.
(iii) The employer shall ensure that medical records are maintained and made available in accordance with 29 CFR 1910.1020.
(5)
(ii) The employer shall provide to the Assistant Secretary or the Director, upon request, all materials relating to employee information and training.
(n)
(2)
(i) Change rooms required by paragraph (i) of this section shall be provided no later than one year after the effective date.
(ii) Engineering controls required by paragraph (f) of this section shall be implemented no later than two years after the effective date.
4. The authority citation for 29 CFR part 1915 is revised to read as follows:
Sec. 41, Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941); secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017) or 5-2002 (67 FR 65008), as applicable.
Sections 1915.120, 1915.152 and 1915.1026 also issued under 29 CFR part 1911.
5. In § 1915.1000, Table Z, the entry for “Chromic acid and chromates (as CrO(3)) 0.1” is removed and the following entry added in its place:
6. A new § 1915.1026 is added, to read as follows:
(a)
(b)
(c)
(d)
(ii) Where the employer has a reasonable basis for believing that no employee in a process or task will be exposed above the PEL for 30 or more days per year (12 consecutive months), the requirement to implement engineering and work practice controls to achieve the PEL does not apply to that process or task.
(2)
(e)
(i) Periods necessary to install or implement feasible engineering and work practice controls;
(ii) Work operations, such as maintenance and repair activities, for which engineering and work practice controls are not feasible;
(iii) Work operations for which an employer has implemented all feasible engineering and work practice controls and such controls are not sufficient to reduce exposures to or below the PEL;
(iv) Work operations where employees are exposed above the PEL for fewer than 30 days per year, and the employer has elected not to implement engineering and work practice controls to achieve the PEL; or
(v) Emergencies.
(2)
(f)
(2)
(ii) The employer shall ensure that no employee removes chromium (VI)-contaminated protective clothing or equipment from the workplace, except for those employees whose job it is to launder, clean, maintain, or dispose of such clothing or equipment.
(iii) When contaminated protective clothing or equipment is removed for laundering, cleaning, maintenance, or disposal, the employer shall ensure that it is stored and transported in sealed, impermeable bags or other closed, impermeable containers.
(iv) Bags or containers of contaminated protective clothing or equipment that are removed from change rooms for laundering, cleaning, maintenance, or disposal shall be labeled in accordance with paragraph (i) of this section.
(3)
(ii) The employer shall prohibit the removal of chromium (VI) from protective clothing and equipment by blowing, shaking, or any other means that disperses chromium (VI) into the air or onto an employee's body.
(iii) The employer shall inform any person who launders or cleans protective clothing or equipment contaminated with chromium (VI) of the potentially harmful effects of exposure to chromium (VI) and that the clothing and equipment should be laundered or cleaned in a manner that minimizes skin or eye contact with chromium (VI) and effectively prevents the release of airborne chromium (VI) in excess of the PEL.
(g)
(2)
(3)
(ii) The employer shall ensure that employees who have skin contact with chromium (VI) wash their hands and faces at the end of the work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet.
(4)
(ii) The employer shall ensure that employees do not enter eating and drinking areas with protective work clothing or equipment unless surface chromium (VI) has been removed from the clothing and equipment by methods that do not disperse chromium (VI) into the air or onto an employee's body.
(5)
(h)
(A) Experiencing signs or symptoms of the adverse health effects associated with chromium (VI) exposure; or
(B) Exposed in an emergency.
(ii) The employer shall assure that all medical examinations and procedures required by this section are performed by or under the supervision of a PLHCP.
(2)
(i) Whenever an employee shows signs or symptoms of the adverse health effects associated with chromium (VI) exposure;
(ii) Within 30 days after exposure during an emergency which results in an uncontrolled release of chromium (VI); or
(iii) Within 30 days after a PLHCP's written medical opinion recommends an additional examination.
(3)
(i) A medical and work history, with emphasis on: Past, present, and anticipated future exposure to chromium (VI); any history of respiratory system dysfunction; any history of asthma, dermatitis, skin ulceration, or nasal septum perforation; and smoking status and history;
(ii) A physical examination of the skin and respiratory tract; and
(iii) Any additional tests deemed appropriate by the examining PLHCP.
(4)
(i) A description of the affected employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to chromium (VI);
(ii) The employee's former, current, and anticipated levels of occupational exposure to chromium (VI);
(iii) A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used that equipment; and
(iv) Information from records of employment-related medical examinations previously provided to the affected employee, currently within the control of the employer.
(5)
(A) The PLHCP's opinion as to whether the employee has any detected medical condition(s) that would place the employee at increased risk of material impairment to health from further exposure to chromium (VI);
(B) Any recommended limitations upon the employee's exposure to chromium (VI) or upon the use of personal protective equipment such as respirators;
(C) A statement that the PLHCP has explained to the employee the results of the medical examination, including any medical conditions related to chromium (VI) exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment.
(ii) The PLHCP shall not reveal to the employer specific findings or diagnoses unrelated to occupational exposure to chromium (VI).
(iii) The employer shall provide a copy of the PLHCP's written medical opinion to the examined employee within two weeks after receiving it.
(i)
(1)
(2)
(3)
(ii) The employer shall provide initial training prior to or at the time of initial assignment to a job involving potential exposure to chromium (VI). An employer who is able to demonstrate that a new employee has received training within the last 12 months that addresses the elements specified in paragraph (l)(4)(iii) of this section is not required to repeat such training provided that the employee can demonstrate knowledge of those elements.
(iii) The employer shall provide training that is understandable to the employee and shall ensure that each employee can demonstrate knowledge of at least the following:
(A) The health hazards associated with chromium (VI) exposure;
(B) The location, manner of use, and release of chromium (VI) in the workplace and the specific nature of operations that could result in exposure to chromium (VI), especially exposure above the PEL;
(C) The engineering controls and work practices associated with the employee's job assignment;
(D) The purpose, proper selection, fitting, proper use, and limitations of respirators and protective clothing;
(E) Emergency procedures;
(F) Measures employees can take to protect themselves from exposure to chromium (VI), including modification of personal hygiene and habits such as smoking;
(G) The purpose and a description of the medical surveillance program required by paragraph (h) of this section;
(H) The contents of this section; and
(I) The employee's rights of access to records under 29 CFR 1910.1020(g).
(iv) The employer shall provide additional training when:
(A) Training is necessary to ensure that each employee maintains an understanding of the safe use and handling of chromium (VI) in the workplace.
(B) Workplace changes (such as modification of equipment, tasks, or procedures) result in an increase in employee exposures to chromium (VI), and those exposures exceed or can reasonably be expected to exceed the PEL or result in a hazard from skin or eye contact with chromium (VI).
(v) The employer shall make a copy of this section and its appendices readily available without cost to all affected employees.
(j)
(ii) The record shall include the following information about the employee:
(A) Name and social security number;
(B) A copy of the PLHCP's written opinions;
(C) A copy of the information provided to the PLHCP as required by paragraph (h)(4) of this section.
(iii) The employer shall ensure that medical records are maintained and made available in accordance with §1910.1020.
(2)
(ii) The employer shall provide to the Assistant Secretary or the Director, upon request, all materials relating to employee information and training.
(k)
(2)
(i) Change rooms required by paragraph (g) of this section shall be provided no later than one year after the effective date.
(ii) Engineering controls required by paragraph (d) of this section shall be implemented no later than two years after the effective date.
7. The authority citation for 29 CFR Part 1917 is revised to read as follows:
Sec. 41, Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941); secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 6-96 (62 FR 111), or 5-2002 (67 FR 65008), as applicable; 29 CFR part 1911.
Section 1917.28 also issued under 5 U.S.C. 553.
8. New paragraphs (a)(2)(xiii)(E) and (b) are added to § 1917.1, to read as follows:
(a) * * *
(2) * * *
(xiii) * * *
(E) Hexavalent chromium § 1910.1026 (See § 1915.1026)
(b) Section 1915.1026 applies to any occupational exposures to hexavalent chromium in workplaces covered by this part.
9. The authority citation for 29 CFR Part 1918 is revised to read as follows:
Secs. 4, 6, 8, Occupational Safety and Health Act of 1970, 29 U.S.C. 653, 655, 657; Walsh-Healey Act, 41 U.S.C. 35
10. New paragraphs (b)(9)(v) and (c) are added to § 1918.1 to read as follows:
(b) * * *
(9) * * *
(v) Hexavalent chromium § 1910.1026 (See § 1915.1026)
(c) Section 1915.1026 applies to any occupational exposures to hexavalent chromium in workplaces covered by this part.
11. The authority citation for subpart D of 29 CFR Part 1926 is revised to read as follows:
Sec. 107, Contract Work Hours and Safety Standards Act (40 U.S.C. 333); secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 6-96 (62 FR 111), or 5-2002 (67 FR 65008), as applicable; and 29 CFR part 1911.
12. In Appendix A to § 1926.55, the entry for “Chromic acid and chromates (as CrO
13. The authority citation for subpart Z of 29 CFR Part 1926 is revised to read as follows:
Sec. 107, Contract Work Hours and Safety Standards Act (40 U.S.C. 333); secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), or 5-2002 (67 FR 65008), as applicable; and 29 CFR part 1911.
Section 1926.1102 not issued under 29 U.S.C. 655 or 29 CFR part 1911; also issued under 5 U.S.C. 553.
14. A new § 1926.1126 is added to subpart Z of 29 CFR Part 1926 to read as follows:
(a)
(b)
(c)
(d)
(ii) Where the employer has a reasonable basis for believing that no employee in a process or task will be exposed above the PEL for 30 or more days per year (12 consecutive months), the requirement to implement engineering and work practice controls to achieve the PEL does not apply to that process or task.
(2)
(e)
(i) Periods necessary to install or implement feasible engineering and work practice controls;
(ii) Work operations, such as maintenance and repair activities, for which engineering and work practice controls are not feasible;
(iii) Work operations for which an employer has implemented all feasible engineering and work practice controls and such controls are not sufficient to reduce exposures to or below the PEL;
(iv) Work operations where employees are exposed above the PEL for fewer than 30 days per year, and the employer has elected not to implement engineering and work practice controls to achieve the PEL; or
(v) Emergencies.
(2)
(f)
(2)
(ii) The employer shall ensure that no employee removes chromium (VI)-contaminated protective clothing or equipment from the workplace, except for those employees whose job it is to launder, clean, maintain, or dispose of such clothing or equipment.
(iii) When contaminated protective clothing or equipment is removed for laundering, cleaning, maintenance, or disposal, the employer shall ensure that it is stored and transported in sealed, impermeable bags or other closed, impermeable containers.
(iv) Bags or containers of contaminated protective clothing or equipment that are removed from change rooms for laundering, cleaning, maintenance, or disposal shall be labeled in accordance with paragraph (i) of this section.
(3)
(ii) The employer shall prohibit the removal of chromium (VI) from protective clothing and equipment by blowing, shaking, or any other means that disperses chromium (VI) into the air or onto an employee's body.
(iii) The employer shall inform any person who launders or cleans protective clothing or equipment contaminated with chromium (VI) of the potentially harmful effects of exposure to chromium (VI) and that the clothing and equipment should be laundered or cleaned in a manner that minimizes skin or eye contact with chromium (VI) and effectively prevents the release of airborne chromium (VI) in excess of the PEL.
(g)
(2)
(3)
(ii) The employer shall ensure that employees who have skin contact with chromium (VI) wash their hands and faces at the end of the work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet.
(4)
(ii) The employer shall ensure that employees do not enter eating and drinking areas with protective work clothing or equipment unless surface chromium (VI) has been removed from the clothing and equipment by methods that do not disperse chromium (VI) into the air or onto an employee's body.
(5)
(h)
(A) Experiencing signs or symptoms of the adverse health effects associated with chromium (VI) exposure; or
(B) Exposed in an emergency.
(ii) The employer shall assure that all medical examinations and procedures required by this section are performed by or under the supervision of a PLHCP.
(2)
(i) Whenever an employee shows signs or symptoms of the adverse health effects associated with chromium (VI) exposure;
(ii) Within 30 days after exposure during an emergency which results in an uncontrolled release of chromium (VI); or
(iii) Within 30 days after a PLHCP's written medical opinion recommends an additional examination.
(3)
(i) A medical and work history, with emphasis on: Past, present, and anticipated future exposure to chromium (VI); any history of respiratory system dysfunction; any history of asthma, dermatitis, skin ulceration, or nasal septum perforation; and smoking status and history;
(ii) A physical examination of the skin and respiratory tract; and
(iii) Any additional tests deemed appropriate by the examining PLHCP.
(4)
(i) A description of the affected employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to chromium (VI);
(ii) The employee's former, current, and anticipated levels of occupational exposure to chromium (VI);
(iii) A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used that equipment; and
(iv) Information from records of employment-related medical examinations previously provided to the affected employee, currently within the control of the employer.
(5)
(A) The PLHCP's opinion as to whether the employee has any detected medical condition(s) that would place the employee at increased risk of material impairment to health from further exposure to chromium (VI);
(B) Any recommended limitations upon the employee's exposure to chromium (VI) or upon the use of personal protective equipment such as respirators;
(C) A statement that the PLHCP has explained to the employee the results of the medical examination, including any medical conditions related to chromium (VI) exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment.
(ii) The PLHCP shall not reveal to the employer specific findings or diagnoses unrelated to occupational exposure to chromium (VI).
(iii) The employer shall provide a copy of the PLHCP's written medical opinion to the examined employee within two weeks after receiving it.
(i)
(2)
(3)
(ii) The employer shall provide initial training prior to or at the time of initial assignment to a job involving potential exposure to chromium (VI). An employer who is able to demonstrate that a new employee has received training within the last 12 months that addresses the elements specified in paragraph (l)(4)(iii) of this section is not required to repeat such training provided that the employee can demonstrate knowledge of those elements.
(iii) The employer shall provide training that is understandable to the employee and shall ensure that each employee can demonstrate knowledge of at least the following:
(A) The health hazards associated with chromium (VI) exposure;
(B) The location, manner of use, and release of chromium (VI) in the workplace and the specific nature of operations that could result in exposure to chromium (VI), especially exposure above the PEL;
(C) The engineering controls and work practices associated with the employee's job assignment;
(D) The purpose, proper selection, fitting, proper use, and limitations of respirators and protective clothing;
(E) Emergency procedures;
(F) Measures employees can take to protect themselves from exposure to chromium (VI), including modification of personal hygiene and habits such as smoking;
(G) The purpose and a description of the medical surveillance program required by paragraph (h) of this section;
(H) The contents of this section; and
(I) The employee's rights of access to records under 29 CFR 1910.1020(g).
(iv) The employer shall provide additional training when:
(A) Training is necessary to ensure that each employee maintains an understanding of the safe use and handling of chromium (VI) in the workplace.
(B) Workplace changes (such as modification of equipment, tasks, or procedures) result in an increase in employee exposures to chromium (VI), and those exposures exceed or can reasonably be expected to exceed the PEL or result in a hazard from skin or eye contact with chromium (VI).
(v) The employer shall make a copy of this section and its appendices readily available without cost to all affected employees.
(j)
(ii) The record shall include the following information about the employee:
(A) Name and social security number;
(B) A copy of the PLHCP's written opinions;
(C) A copy of the information provided to the PLHCP as required by paragraph (h)(4) of this section.
(iii) The employer shall ensure that medical records are maintained and made available in accordance with §1910.1020.
(2)
(ii) The employer shall provide to the Assistant Secretary or the Director, upon request, all materials relating to employee information and training.
(k)
(2)
(i) Change rooms required by paragraph (g) of this section shall be provided no later than one year after the effective date.
(ii) Engineering controls required by paragraph (d) of this section shall be implemented no later than two years after the effective date.
Office of the Assistant Secretary for Housing—Federal Housing. Commissioner, HUD.
Notice of final order.
This notice sets forth a final order of the Department of Housing and Urban Development (HUD or Department) which provides that certain loan-level mortgage data elements submitted to HUD by the Federal National Mortgage Association (Fannie Mae) and the Federal Home Loan Mortgage Corporation (Freddie Mac) (collectively, the government-sponsored enterprises, or GSEs) are classified as non-proprietary and shall be made available to the public. After careful review of the previous proprietary orders, the Department is making a number of changes to the proprietary classification of certain GSE single-family and multifamily mortgage data elements. The list of data elements that HUD is making available to the public is described in the following sections. In addition, the Department is setting forth in the Appendix to this final order the loan-level data elements that the Department has determined to classify as proprietary and non-proprietary. The final order implements the Department's prior determination that the unpaid principal balance (UPB) of mortgages in the single-family Census Tract File shall be released, subject to a top-code expressed as a ratio to the current conforming loan limit for one-family properties. In releasing these data, the Department will use the top-coding convention already employed for the years 1993 through 1995. The Department will release the reclassified data elements beginning in 2005, via the Department's public use database covering the GSEs' 2004 mortgage purchases, and in all future public use databases. Finally, the Department is making four technical changes with respect to the disclosure of data elements previously determined by HUD to be non-proprietary. This final order supersedes the final order of October 17, 1996 (1996 Order).
The Final Order set forth in this notice is effective on October 4, 2004.
Sandra Fostek, Director, Office of Government Sponsored Enterprises Oversight, Office of Housing, Room 3150, telephone (202)708-2224. For questions on data or methodology, contact John L. Gardner, Director, Financial Institutions Regulation Division, Office of Policy Development and Research, Room 8212, telephone (202) 708-1464. For legal questions, contact Paul S. Ceja, Deputy Assistant General Counsel for Government Sponsored Enterprises/RESPA, and Ronnie Shorenstein, Senior GSE/RESPA Division Attorney, Office of the General Counsel, Room 9262, telephone (202) 708-3137. The address for all of these persons is Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410. Persons with hearing and speech impairments may access the phone numbers through TTY by calling the Federal Information Relay Service at (800) 877-8399.
Pursuant to sections 1323 and 1326 of the Federal Housing Enterprises Financial Safety and Soundness Act (FHEFSSA), codified at 12 U.S.C. 4543 and 4546, the Department has determined that certain loan-level mortgage data elements, as detailed in the attached Appendix and contained in the annual loan-level data files that will be submitted by Fannie Mae and Freddie Mac to the Department in accordance with sections 309(m) and (n) of the Federal National Mortgage Association Charter Act (Fannie Mae Charter Act), codified at 12 U.S.C. 1723a(m) and 1723a(n), and sections 307(e) and (f) of the Federal Home Loan Mortgage Corporation Act (Freddie Mac Act), codified at 12 U.S.C. 1456(e) and 1456(f), respectively, shall be treated as non-proprietary information. The Appendix further identifies data elements that lose their proprietary character when categorized in ranges, adjusted, or recoded in other ways. The data so identified in the Appendix shall be made available for public disclosure under sections 1323 and 1326 of FHEFSSA and HUD's regulations at 24 CFR part 81, subpart F.
This final order concerns whether loan-level data elements are proprietary. It is not applicable to aggregated information on activities that has been or will be submitted by the GSEs in their Annual Housing Activities Reports (AHARs) and Mortgage Reports. It is not applicable to aggregations of information above the loan-level that the Department may produce for various reasons, including fulfilling its responsibilities to inform the public about the GSEs' activities.
A detailed discussion of HUD's determinations in this Final Order is set forth in Section D below.
The Federal Housing Enterprises Financial Safety and Soundness Act of 1992, enacted as Title XIII of the Housing and Community Development Act of 1992, (FHEFSSA) (Pub. L. 102-550, approved October 28, 1992), codified generally at 12 U.S.C. 4501-4561, requires the Secretary of Housing and Urban Development to establish and monitor the performance of Fannie Mae and Freddie Mac in meeting annual goals for purchases of mortgages on housing for low- and moderate-income families; housing located in central cities, rural areas, and other underserved areas; and special affordable housing (
Section 1323 of FHEFSSA, codified at 12 U.S.C. 4543, provides that the Secretary shall make available to the public the data submitted by the GSEs in the data reports required under section 309(m) of the Fannie Mae Charter Act and section 307(e) of the Freddie Mac Act, except data that the Secretary determines, by regulation or order pursuant to section 1326, codified at 12 U.S.C. 4546, are proprietary. Section 1323(b)(2) of FHEFSSA, codified at 12 U.S.C. 4543(b)(2), specifically provides that the Secretary may not restrict access to data consisting of income, census tract location, race, and gender of mortgagors of single-family properties.
In addition, section 1326 of FHEFSSA provides that the Secretary may, by regulation or order, provide that certain information shall be treated as proprietary information and not subject to disclosure under section 1323 of FHEFSSA, section 309(n)(3) of the Fannie Mae Charter Act or section 307(f)(3) of the Freddie Mac Act. Section 1326 of FHEFSSA also states that the Secretary shall not provide public access to, or disclose to the public, any information required to be submitted by a GSE under section 309(n) of the Fannie Mae Charter Act or section 307(f) of the Freddie Mac Act that the Secretary determines is proprietary. Pending the issuance of a final decision on the matter, such
The legislative history of FHEFSSA provides that “ * * * every effort should be made to provide public disclosure of the information required to be collected and/or reported to the regulator consistent with the exemption for proprietary data * * *” S. Rep. 102-282, 102d Cong., 2d Sess. 40 (1992). In addition, the legislative history indicates that Congress intended that the GSE public use database help fill the “information vacuum” on GSE mortgage activities and complement the database established under the Home Mortgage Disclosure Act (HMDA) (
On October 13, 1993, the Department published in the
On June 7, 1994, the Department published in the
As part of its 1995 proposed and final rules to establish regulations governing the GSEs, the Department developed regulations governing the use of the public use database to make available to the public loan-level data on the GSEs' single-family and multifamily mortgage purchases.
In the Department's December 1, 1995 final GSE rule (1995 Final Rule) (60 FR 61846, 61897-8) which implemented the Secretary's GSE regulatory authorities, HUD required, for 1996 and future years, each GSE to provide data and other information on mortgages purchased in two forms—Annual Housing Activities Reports (AHARs) that discuss each GSE's performance under the housing goals, and quarterly Mortgage Reports that include aggregate data on mortgage purchases and, in the second and fourth quarter reports, loan-level computerized data files that provide details on each mortgage purchased by each GSE. The data required in the loan-level data files include, for each mortgage purchased by the GSEs: the borrower(s) annual income, race, and gender; census tract location; other geographic identifiers; loan-to-value (LTV) ratio; number of units; owner-occupancy status; and other details about the mortgage, the property, and the borrower(s). The information required for the Mortgage Reports includes aggregate data concerning: the amount of mortgage purchases that qualify towards each housing goal, classified by number of units and dollar volume; borrower(s) income and race; location of property; and various other categories. (
In addition, the Department's regulation at 24 CFR 81.74, set forth in the 1995 Final Rule, established six factors for the Secretary to consider and procedures to be followed when the Secretary determines whether or not to accord proprietary treatment to mortgage data or AHAR information.
Section 81.75, which was set forth in the 1995 Final Rule provided, in part, that:
Section 81.75 further provided that the Secretary “may, from time-to-time, by regulation or order, issue a list entitled ‘GSE Mortgage Data and AHAR Information: Proprietary Information/Public-Use Data’ providing that certain information shall be treated as proprietary information” and expressly authorized the Secretary to “modify the list by regulation or order.”
The Department set forth in Appendix F to the 1995 Final Rule a final order identifying the list of data elements that HUD had determined under section 1326 of FHEFSSA to be proprietary (and, thus, not available to the public) and those data elements that it had determined to be non-proprietary and available to the public. (See 60 FR 62001-62005.) The 1995 Final Rule stated that Appendix F contained the most current listing of data and information determined by HUD to be proprietary and that it superseded the 1994 Temporary Order.
The 1995 Final Rule also identified in Appendix F the structure of the public use database, including that GSE single-family data would be released to the public in three separate files: a Census Tract File that identified the census tract location of the mortgaged property, a National File A (with mortgage-level data on owner-occupied one-unit properties but without census tract identifiers), and a National File B (with unit-level data on all single-family properties also without census tract identifiers). The GSE multifamily data are disclosed in two files, the Census Tract File, which identifies the census tract location of the mortgaged property and the National file, which does not identify the location of mortgaged properties but contains mortgage level data and unit class level data on all multifamily properties.
In 1996, based upon a review of the 1995 order and comments provided by the GSEs, HUD determined that the issuance of a new order was needed. Therefore, on October 17, 1996, the Department issued a new order (see 61 FR 54322) (1996 Order) releasing some new data and reconfiguring files to protect proprietary information. In the 1996 Order, the Department's changes included the following: For the single-family files: (1) Add an indicator for served or underserved areas to the Census Tract File; (2) in certain cases recode area median family income and borrower(s) annual income to protect proprietary information in the Census Tract File; (3) specify properties included in National File A and the presentation of unit-level information in National File B; (4) recode the borrower income ratio for rental units in National File B to provide the public with affordability information; (5) provide information on whether mortgages were originated in the same or a previous year, consistent with HMDA, in National File B; and (6) revise the reporting of the occupancy code in National File B. For the multifamily files, release the type of seller institution in the Census Tract File, and release data on the affordability of units in the National File.
Subsequently, as part of its GSE housing goals proposed rule of March 9, 2000 (65 FR 12660) (the 2000 Proposed Rule), the Department included several additional changes to its classifications of certain GSE mortgage data. As part of
(1) A code distinguishing loans on properties in metropolitan areas from loans on properties in non-metropolitan areas in the two single-family National Files;
(2) A code distinguishing home purchase, refinance, second, and rehabilitation loans in the single-family Census Tract File and National File A;
(3) An identifier for federally guaranteed loans (with type of guarantee) in the single-family Census Tract File;
(4) Identification of the borrower's and co-borrower's race/national origin in the two single-family National Files; and
(5) A code distinguishing owner-occupied from investor properties in the single-family Census Tract File and National File A.
In addition, HUD proposed two changes to the GSE multifamily files that would allow the release to the public of:
(1) A code in the National File that would distinguish loans originated in the year of purchase by the GSE from loans originated in prior years; and
(2) A code in the National File identifying the type of seller institution.
HUD also proposed four technical recoding and definitional changes concerning: (1) the borrower(s) annual income in the single-family database; (2) the Purpose of Loan in the Census Tract File; (3) the Purpose of Loan in the multifamily database; and (4) the Occupancy Code in the single-family database. (
In the final GSE rule that HUD published on October 31, 2000 (65 FR 65044) (the 2000 Final Rule), HUD decided not to make a final determination with regard to which GSE data elements would be designated as proprietary or non-proprietary. Instead, the Department decided, after referencing its authority under section 1326 of FHEFSSA and § 81.75 of its regulations, that it would issue an order setting forth its determinations regarding the proprietary or non-proprietary status of the subject data elements following publication of the 2000 Final Rule. The Department stated that its decision would be issued in accordance with its regulations at §§ 81.72 to 81.74. (See 65 FR 65801-65802.)
In 2003, the Department prepared and submitted to the Office of Management and Budget (OMB) a draft final order in which it stated determinations with respect to each of the changes that it had proposed in the 2000 Proposed Rule (the Draft Final Order). The Department also included in the Draft Final Order items that were not discussed in the 2000 proposed rulemaking, including:
(1) The designation as non-proprietary in National Files A and B of the borrower's and co-borrower's gender (information which previously was made available in the National files only as a combined borrower/co-borrower data element); and
(2) Increasing the top-coding of the unpaid principal balance (UPB) of mortgage loans at the time of acquisition by a GSE to reflect increases in the conforming loan limit.
In May 2003, the GSEs requested a copy of the Department's submission to OMB and, in response, the Department provided Fannie Mae and Freddie Mac with a copy of the list of proprietary and non-proprietary determinations from its Draft Final Order (the 2003 List). The 2003 List reflected the Department's initial views about the proprietary and non-proprietary status of each of the data elements that had been included in the 2000 Proposed Rule, as well as items (1) and (2) above.
In May 2003 HUD representatives met separately with Fannie Mae and Freddie Mac staff to discuss the proposed treatment of the data elements in the 2003 List. The Department informed the GSEs that they could each submit written comments reflecting the views that they had expressed at the May 2003 meetings. On June 24, 2003, the GSEs submitted written comments. The Department has reviewed and considered these comments.
As described further below, the Department has concluded that the GSE data elements that were identified in the 2000 Proposed Rule and 2003 administrative proceedings, when released in certain files and with certain modifications as described below, may be treated as non-proprietary and may be released to the public via the public use database.
In making its determinations, the Department considered the public comments submitted on the 2000 Proposed Rule and the GSEs' comments (described below) on the 2003 List. HUD received comments on the 2000 Proposed Rule from both GSEs and from trade organizations, advocacy groups, researchers, and lenders. The Department discussed the comments in the 2000 Final Rule (see 65 FR 65044, 65081-65082) and incorporates that discussion herein. The Department is further discussing, in this final order, Freddie Mac's comments on the 2003 List.
Freddie Mac asserted that a portion of its June 24, 2003, comment letter is confidential and proprietary. In this final order, the Department discusses only those Freddie Mac comments that were not designated as proprietary. Fannie Mae asserted that the entire contents of its June 24, 2003, comment letter are confidential and proprietary.
Although the Department fully considered all the comments raised by the GSEs in their June 24, 2003 letters, due to the confidentiality concerns raised by the GSEs regarding those letters, only those portions of Freddie Mac's comments that it has not designated as confidential and proprietary are discussed herein. Because Fannie Mae requested confidential treatment of all issues raised in its comments, the Department has considered, but is not discussing, these comments in this final order.
Prior to publication of this final order, the Department sent to the GSEs a copy of this final order, together with separate determination letters in which the Department responded to the comments that each GSE contended are confidential and proprietary.
In its comments on the 2003 List, Freddie Mac asserted that the Department's administrative process for changing the treatment of the items of proprietary data in the 2003 List was inadequate. Freddie Mac agreed that the Department could modify its designations of proprietary and non-proprietary data in the public use database by regulation or order, but stated that neither the process for a regulation nor for an order had been followed. Freddie Mac did not elaborate further on the process it considered proper for issuing an order.
The Department has considered Freddie Mac's comments relating to the administrative process it used in making the determinations set forth in this final order and has determined that it followed the appropriate administrative process under section 1326 of FHEFSSA, HUD's regulations at 24 CFR 81.74 and 81.75, and the Administrative Procedure Act. The Department has provided various opportunities to the GSEs to have their views considered during both the 2000 and 2003 administrative proceedings, and the GSEs did, in fact, avail themselves of each of these opportunities by submitting written comments and meeting with HUD representatives. Moreover, the Department has fully considered the GSEs' oral and written comments. Accordingly, the Department
HUD's determinations, including a specific discussion of each change to the 1996 Order, are set forth below in Section D.
The Department is issuing this final order setting forth its determinations of proprietary and non-proprietary status with respect to the data element changes HUD proposed in its 2000 Proposed Rule, and the two additional items proposed by the Department in the 2003 List. The following section sets forth HUD's determinations and how those determinations change the 1996 Order.
In making its determinations, HUD has considered all of the the public and non-public comments regarding its proposed changes to the public use database, and acted pursuant to its regulations at 24 CFR 81.71-81.75. Further, in making its determination, the Department specifically employed the six factors listed for making proprietary determinations of mortgage data or AHAR information set forth in 24 CFR 81.74(b), including a consideration of any effect that disclosure of GSE data may have on the GSEs' financial or competitive positions. In this final order, the Department is making the following changes to the treatment of the following single-family loan level data elements:
In the 2000 Proposed Rule, HUD proposed to add an identifier to National Files A and B that would identify only whether a mortgaged property is located in a metropolitan area or is located in a non-metropolitan area, or that the information is missing, without revealing the specific Metropolitan Statistical Areas (MSAs) of the property by disclosing the MSA code. MSA Codes for specific MSAs will continue to be available only in the Census Tract File.
HUD has determined that its proposal should be implemented and that data identifying whether a property is in a metropolitan or non-metropolitan area should not be accorded proprietary treatment in the National Files. The incremental amount of information made available to the public through the release of metropolitan/non-metropolitan data is necessary in order to accurately characterize GSE purchases, to fully understand the ability of the GSEs to lead the mortgage market, and to help to fill the “information vacuum” related to the GSEs” mortgage purchase activities as noted by Congress when it enacted FHEFSSA in 1992.
In addition, separately identifying data on metropolitan and non-metropolitan activities of the GSEs is of critical importance in order to accurately compare the GSEs to the primary mortgage market. By allowing analysis of the GSEs' purchases of mortgages on properties in metropolitan areas, as opposed to non-metropolitan areas, HUD's release of this data would allow comparisons with market data, reported in accordance with HMDA, which contain information on newly originated mortgages in metropolitan areas at the census tract level. National File B also separates the GSEs' mortgage purchases into prior-year and current-year originations. The market analysis, comparing GSE purchases with HMDA-reported originations in the primary market, will allow HUD and others to accurately evaluate GSE leadership capabilities relative to the conventional conforming mortgage market, one of the statutory factors that Congress mandated that HUD consider in setting the housing goals.
In the 2000 Proposed Rule, HUD proposed to add Purpose of Loan to the Census Tract File and National File A by releasing data on whether a mortgage was for home purchase, refinance, or was a second mortgage. HUD further proposed to add a previously unreleased indicator for rehabilitation loans to the coded values of Purpose of Loan, and to redefine code “9” as “information not applicable/not available.”
HUD has determined not to accord proprietary treatment to Purpose of Loan data if Purpose of Loan data are released in the Census Tract File and National File A in two categories, either “home purchase” or “all other”, the latter of which would include refinance, second, and rehabilitation mortgages combined into one element. For National File B, the public use database would retain the existing level of detail, although an additional element would be provided to indicate whether a loan is a code 4, which indicates rehabilitation loans. The public use database will redefine code 9 from “Not Applicable” to “Not Applicable/Not Available.”
By making these changes, the Census Tract File and National File A of the public use database will clearly identify home purchase mortgages, which are central to the GSEs' missions and important to the formulation of regulatory policy toward the GSEs while addressing any concerns relating to the public release of this information. Meanwhile, National File B of the public use database will continue to report greater detail on loan purpose, including information on second mortgages and rehabilitation loans.
The need to distinguish home purchase loans in the Census Tract File has been conveyed to HUD by researchers who have attempted to use the GSE public use database in conjunction with HMDA data (which separately identifies home purchase and refinance loans). These researchers indicate that the usefulness of the Census Tract File is severely limited because it does not separately identify home purchase loans.
The level of down payment is a major factor in determining access to homeownership for lower-income families. With respect to National File A, separately identifying the distribution of home purchase loans across LTVs would allow users of the public use database to perform analyses of the GSEs' contributions to homeownership opportunities for those lower-income families that find it most difficult to raise cash. Such identification would permit the public to consider whether the GSEs are purchasing sufficient low down payment loans to serve the needs of lower-income borrowers. Currently, questions such as these cannot be answered using the GSE public use database. Including Purpose of Loan in National File A will enable HUD and others to analyze the GSEs' contributions to expanding homeownership opportunities.
Federal Guarantee is already disclosed in National Files A and B. HUD proposed to add it to the Census Tract File. This data element identifies whether the loan is a Federal Housing Administration (FHA) loan or Veterans Administration (VA) loan, a Rural Housing Service (RHS) guaranteed rural housing loan, a home equity conversion mortgage (HECM), a Title I-FHA loan, or a loan without any federal guarantee. Federal Guarantee (FHA, VA, RHS) is disclosed in the HMDA database.
HUD has determined that proprietary restrictions will not be violated if the Census Tract File reports the Federal Guarantee in one of three categories—“FHA/VA,” “other federal guarantee,” or “no federal guarantee.” HUD has
HUD previously determined in the 1996 Order that the Federal Guarantee data element specifying whether a loan is an FHA or a VA loan, an RHS-guaranteed rural housing loan, a HECM, a Title I FHA loan, or a loan without any federal guarantee, is not proprietary when released in the National Files A and B, as specified in that Order. On the other hand, HUD also determined, with regard to the Census Tract File, that this element is proprietary. However, since HMDA does make available to the public information on whether current year loans are conventional, FHA, VA, or RHS, the Department believes that a revocation of its prior proprietary determination with regard to the Census Tract File is warranted.
The public benefit of being able to distinguish FHA/VA, Other Federal Guarantee and No Federal Guarantee loans by geographical location is substantial. As noted earlier, HMDA reports such information for most loans originated in the primary market in metropolitan areas and for most loans sold to the GSEs. This addition to the Census Tract File will make the data in that file consistent with the primary market data reported by HMDA. By including the Federal Guarantee information in the Census Tract File, HUD will enable users of the GSE public use database to analyze the GSEs' mortgage purchases with more precision.
Section 1323(b)(2) of FHEFSSA, codified at 12 U.S.C. 4543(b)(2), provides that the Secretary shall not restrict access to certain data elements listed in the GSEs' respective Charter Acts; these data elements include the race of mortgagors. The race/national origin of the borrower and co-borrower are already made public in the Census Tract File. This data element also includes designations for why information is not available. The race/national origin of the borrower and co-borrower are also made public in National Files A and B as a combined data element which presents data on the race/national origin of the borrower and co-borrower, including whether they are of a different race/national origin from each other. There is no designation for why information is missing in National Files A and B.
In the 2000 Proposed Rule, HUD proposed to change the presentation in National Files A and B to provide a separate race/national origin data element for the borrower and co-borrower, and to detail reasons for missing race data currently provided only in the Census Tract File (specifically whether information was not provided by the applicant in a mail or telephone application, the field is not applicable, or the information is not available). HUD has determined that its proposal should be implemented and that data identifying “race/national origin,” as described herein, should not be accorded proprietary treatment in National Files A and B.
HUD previously determined in the 1995 Final Rule, and reaffirmed in the 1996 Order, that the race/national origin data element is non-proprietary when released for the borrower and co-borrower in the Census Tract File, and that combined race/national origin data for both the borrower and co-borrower are non-proprietary in the form in which these have been released in the National Files A and B. Thus, the Department has not previously made available to the public, via the public use database, separate data on race/national origin for the borrower and the co-borrower in National Files A and B. However, since HMDA does make available to the public separate data on the race/national origin of the borrower and the co-borrower, as does the Census Tract File, the Department believes that a revocation of its prior proprietary determination is warranted.
Section 1323(b)(2) of FHEFSSA, codified at 12 U.S.C. 4543(b)(2), provides that the Secretary shall not restrict access to certain data elements listed in the GSEs' respective Charter Acts. These data elements include the gender of single-family mortgagors. The gender of the borrower and co-borrower are already present in the Census Tract File, and as a combined data element in National Files A and B. There is no designation for why information is missing in National Files A and B.
HUD is now changing the presentation in National Files A and B to provide borrower and co-borrower information separately. In addition, HUD will include in National Files A and B additional information on the reasons why data are missing,
The disclosure, on a disaggregated basis in the National Files, of separate gender information for borrowers and co-borrowers, would not affect the financial or competitive position of either GSE. As noted above, the two National Files already report gender information on an aggregated basis (combining the primary borrower and co-borrower information). The Department would be providing separate gender information for the borrower and the co-borrower in the form in which gender information is already provided in the Census Tract File.
HUD previously determined in the 1996 Order that gender qualifies for proprietary treatment when released in the form of separate borrower and co-borrower gender data elements in the two National Files. As a result, the Department has not previously made this information available to the public via the public use database. Information on the gender of the borrower and co-borrower for GSE-purchased loans is readily available from the Census Tract File (for all single-family loans) and from HMDA (for most home purchase and refinance loans sold to the GSEs).
The Department's release of separate information on borrower and co-borrower race/national origin (as discussed in the preceding section) will have the effect of revealing, in National Files A and B, information on whether the number of borrowers is one or at least two. Given this information with the existing combined borrower/co-borrower gender data element, the level of gender information in National Files A and B will become substantively equivalent to the level of gender information provided if the borrower and co-borrower information are provided separately. (In some cases there are three or more borrowers; information on the total number of borrowers for a loan will continue to be excluded from the GSE public use database.) To make this as clear as possible for users of the public use database, HUD will code borrower and co-borrower information separately as is done with HMDA data.
For these reasons, HUD has determined that it is appropriate to release this augmented disclosure of information on gender in the National Files.
The Department uses “top-coding” in the public use database to present the maximum unpaid principal balance of a mortgage at the time of acquisition by a GSE as a number less than the conforming loan limit. In this way, users of the public use database can gain information on the unpaid principal balance of GSE mortgage purchases without being able to discern whether a unit is a one-unit or a two-to-four unit property. The top-code for a single-family mortgage is calculated by applying a fixed ratio to the conforming loan limit.
The first year for which HUD collected proprietary data on UPB was 1993, when the conforming loan limit for one-unit properties (except in Alaska and Hawaii) was $203,150. For that year, HUD top-coded UPB at $200,000, or 98.45 percent of the conforming loan limit.
Under the 1994 Temporary Order, UPB was designated as proprietary and not released. Under Appendix F of the 1995 Rule, data on UPB were allowed to be released as either less than or greater than $200,000 in the single-family Census Tract File, but not in National File A or B. The 1996 Order did not change the treatment of this data element.
After the 1996 Order was published, HUD released UPB data, top-coded at $200,000 for the years 1993 through 1995. For subsequent years, HUD has continued to apply a $200,000 top-code, even as the conforming loan limit has risen. For 2004, with a conforming loan limit of $333,700, a $200,000 top-code means that information on the distribution of UPB that HUD has asserted to be relevant for public purposes and non-proprietary is being masked.
Accordingly, HUD will henceforth adjust annually the top-code UPB for all single-family properties by applying the fixed ratio (200/207) to the then-current single-family conforming loan limit. Therefore, consistent with the top-coding convention already employed for 1993 through 1995, HUD is ordering the top-coding convention for each year to be 98.4 percent of the conforming loan limit, rounded to the nearest $500. This will result in a top-code for the year 2004, in which the conforming loan limit is $333,700, of $328,500.
HUD has determined that there is no adverse consequence from annually re-specifying the top-code of UPB, as it only restores the level of disclosure established in the Final Order that is set forth in Appendix F to the 1995 Final Rule and in the 1996 Order. HUD previously determined in those Orders that the Acquisition UPB data element qualifies for proprietary treatment, but may be released to the public after applying top-coding to this data. In those Orders, the Department indicated that the purpose of top-coding was to mask two-to four-unit properties by combining them with one-unit properties within approximately 1.5 percentage points below the conforming loan limit. Over time, the top-code set in 1996 has decreased to 59.93 percent of the conforming loan limit in 2004, as the conforming loan limit has risen.
Because the Department has already determined that the Acquisition UPB data element can be released to the public when a top-code is applied, and since the effect of the current modification is limited to adjusting the top-code to reflect annual changes in the conforming loan limit, the Department believes this clarification of HUD's prior proprietary determination is warranted.
Occupancy Code (identifying whether the unit is owner-occupied, a rental unit in an owner-occupied property, a unit in an investment property, or information not available) is already provided in National File B of the public use database. In the 2000 Proposed Rule, HUD proposed to add this data element to the Census Tract File and to National File A (identifying whether the property is owner-occupied, is an investment property, or that the information is not available). The Census Tract File currently does not distinguish mortgages on owner-occupied properties from mortgages on investor-owned properties. Separately identifying mortgages on owner-occupied and investor-owned properties in the Census Tract File of the public use database would make the Census Tract File comparable with HMDA, which distinguishes between mortgages on owner-occupied and non-owner-occupied properties. This change would permit comparison of the GSEs' purchases of mortgages on owner-occupied properties with HMDA-reported mortgages on owner-occupied properties originated in the conventional conforming primary market. (In the public use database second homes are included in the “owner-occupied” category while in HMDA they are included in the “non-owner-occupied” category.)
HUD has determined that its proposal should be implemented and that occupancy code information in the Census Tract File should not be accorded proprietary treatment. HUD previously determined in the 1996 Order that the Occupancy Code data element is not proprietary in National File B when recoded to mask whether the property is the second home, but that the data element is accorded proprietary treatment in the Census Tract File and National File A. However, since HMDA does make available to the public the occupancy code data element, and for the other reasons set forth in this final order, the Department believes that a revocation of its prior proprietary determination with respect to the Census Tract File is warranted. (HUD has further determined that because National File A contains only mortgage data on owner-occupied one-unit properties, release of information on investor-owned properties is not applicable to this File.)
Under HMDA, lenders report information for most loans originated in the primary market in metropolitan areas and for most loans sold to the GSEs. This addition to the single-family Census Tract File would make the data in that file consistent with the primary market data reported by HMDA, thus allowing for comparisons of the characteristics of loans on owner-occupied properties that are originated in the primary market and loans that are bought by the GSEs. This would provide a better understanding of the role of the GSEs in purchasing mortgages in the owner-occupied portions of the metropolitan housing markets. In addition, single-family rental properties provide an important source of financing for low-income housing, particularly in inner cities, but more needs to be known about the GSEs' activities in this important market. For these reasons, the public benefit of being able to distinguish, by geographical location, between mortgages on owner-occupied and investor-owned properties is substantial.
Under the 2000 Proposed Rule, HUD proposed to add the following data elements to the GSE public use database for multifamily properties:
Date of Mortgage Note was proposed by HUD in the 2000 Proposed Rule to be released in the multifamily National File only, showing whether the mortgage was originated in the same year as acquired by the GSE, or in a prior year, or whether this information is missing.
HUD has determined that its proposal should be implemented and that data on the Date of Mortgage Note in the
HUD previously determined in the 1996 Final Order that the Date of Mortgage Note data element qualifies for proprietary treatment in both the Census Tract File and the National File. As a result, the Department has not previously made this information available to the public via the public use database. However, since HMDA does make available to the public the Date of Mortgage Note data element, the Department believes that a revocation of its prior proprietary determination is warranted. This will permit public analyses of GSE purchases of multifamily loans originated in prior years and also facilitate comparisons between data in the GSE public use database and HMDA data.
Type of Seller Institution (showing whether the loan seller is a mortgage company, Savings Association Insurance Fund (SAIF)-insured depository institution, Bank Insurance Fund (BIF)-insured depository institution, National Credit Union Administration (NCUA)-insured credit union, or some other type of institution) is already provided to users in the Census Tract File of the public use database. In the 2000 Proposed Rule, HUD proposed to release this information in the National File as well.
HUD has determined that data on the Type of Seller Institution in the National File should not be accorded proprietary treatment and that its proposal should be implemented with one change: SAIF-insured depository institution and BIF-insured depository institution will be recoded as a combined data element in the National File.
HUD previously determined in the 1996 Order that the Type of Seller Institution data element is not proprietary when released in the Census Tract File and is proprietary when released in the National File. As a result, the Department has not previously made this information available to the public via the public use database. However, since HMDA does make available to the public the Type of Seller Institution data element, the Department believes that a revocation of its prior proprietary determination is warranted. This will facilitate comparisons between data contained in the GSE and HMDA databases and will also facilitate analyses by members of the public of affordability, property and size characteristics, as well as other key characteristics by type of seller at the national level.
In the 2000 Proposed Rule, HUD proposed the following additional changes, of a minor technical or definitional nature, to the public use database:
HUD proposed to change the “not available” code for borrower(s) annual income from “999999” to “9999999.” No objection was raised to this change. Accordingly, it will be implemented.
HUD proposed to add code “4” for rehabilitation loans as a code under Purpose of Loan in the single-family GSE public use database, and to change code “9” from “not applicable” to “not applicable/not available.” No objection was raised to this change. Accordingly, it will be implemented.
HUD proposed to change code “9” under Purpose of Loan in the multifamily GSE public use database from “not applicable” to “not applicable/not available.” No objection was raised to this change. Accordingly, it will be implemented.
In the preamble to the 2000 Proposed Rule, HUD proposed that Occupancy Code be disclosed in National File A. In seeming contradiction to this proposal, HUD's matrix in Appendix E to the 2000 Proposed Rule indicated that this data element would continue not to be disclosed. The issue is, however, substantively immaterial given that National File A is limited to mortgages on owner-occupied one-unit properties, all of which would have an Occupancy Code of “1” under the proposal. In order to economize on space in the data file, and since the code is unnecessary, HUD will continue to omit this data element from National File A.
An appendix is attached to this Final Order that summarizes the structure of the single-family and multifamily GSE public use database files incorporating the changes that will be implemented based on HUD's determinations in this Final Order. For GSE single-family mortgage data, changes are reflected in data fields 4, 15, 18, 22, 27, 41, 42, 43, 44, and 47. For GSE multifamily mortgage data, changes are reflected in data fields 19, 21, and 33.
The Department is complying fully with the requirements of FHEFSSA and will not restrict access to the data submitted by the GSEs to HUD under sections 309(m) and (n) of the Fannie Mae Charter Act and sections 307(e) and (f) of the Freddie Mac Act, other than as described in this final order and the attached Appendix. Also, the Department has considered the assertions of the GSEs and other commenters that certain data should be treated as proprietary and has concluded that revising the 1996 Order is necessary to release GSE information that is reported to HUD to the public, to complement the HMDA database, and to fill the “information vacuum” on GSE mortgage purchase activities, while at the same time protecting the GSEs' proprietary information, in accordance with FHEFSSA and its legislative history.
Pursuant to sections 1323 and 1326 of FHEFSSA, codified at 12 U.S.C. 4543 and 4546, and HUD's regulations at 24 CFR part 81, the Department has determined that certain loan-level mortgage data elements, as detailed in the attached Appendix and contained in the annual loan-level data files submitted by Fannie Mae and Freddie Mac to the Department in accordance with sections 309(m) and (n) of the Fannie Mae Charter Act (12 U.S.C. 1723a(m) and 1723a(n)) and sections 307(e) and (f) of the Freddie Mac Act (12 U.S.C. 1456(e) and 1456(f)), shall not be accorded proprietary treatment and shall be made available for public use via the public use database established by section 1323 of FHEFSSA. The Appendix further identifies those data elements for which HUD has made these determinations.
Finally, this final order provides that the Department also will revise the top-coding convention on the unpaid principal balance (UPB) of mortgages in the single-family Census Tract File beginning with the year 2004 and consistent with the top-coding convention already employed for the years 1993 through 1995.
The Department will release the reclassified data elements, as set forth in this Final Order, beginning in 2005, through the Department's public use database covering the GSEs' 2004 mortgage purchases, and in all future public use databases.
The Department also has determined to make the technical changes to its implementation of the public use database, as originally described in the 2000 Proposed Rule and as described in
This final order supersedes the final order of October 17, 1996 (61 FR 54322) and shall be effective until such time as the Department determines that it is necessary and/or appropriate to withdraw or modify it.
Federal Aviation Administration, DOT.
Final rule.
The Federal Aviation Administration (FAA) is adopting procedures for administratively assessing civil penalties for violations of the laws and regulations the agency enforces. These procedures pertain to initiating and adjudicating a civil penalty against an individual acting as a pilot, flight engineer, mechanic, or repairman. These procedures are needed because the National Transportation Safety Board now reviews these civil penalty actions and the FAA's existing rules for civil penalty actions are not sufficiently flexible to adequately address the procedural differences that review in a different forum entails. This final rule also makes other minor modifications to the FAA's procedures for assessing civil penalties against persons other than individuals acting as pilots, flight engineers, mechanics, or repairmen.
Effective Date: This rule is effective on November 3, 2004.
Joyce Redos, Attorney, Enforcement Division (AGC-300), Federal Aviation Administration, 800 Independence Ave., SW., Washington, DC 20591; telephone (202) 267-3137.
You can get an electronic copy of this action using the Internet by:
(1) Searching the Department of Transportation's electronic Docket Management System (DMS) Web page at
(2) Visiting the Office of Rulemaking's Web page at
(3) Accessing the Government Printing Office's Web page at
You can also get a copy of this action if you submit 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 docket number, notice number, or amendment number of this rulemaking.
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
The Small Business 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. If you are a small entity and you have a question regarding this document, you may contact a local FAA official or the person listed under
The FAA has authority to assess civil penalties for certain violations of the FAA's governing statute and regulations or orders issued under that statute as well as other statutes, regulations, or orders the agency enforces. This authority formerly covered all civil penalty actions involving a civil penalty of $50,000 or less.
In 49 U.S.C. 46301(d)(5), Congress transferred the authority to review the FAA's administrative civil penalty actions against individuals acting as pilots, flight engineers, mechanics, or repairmen to the National Transportation Safety Board (NTSB). Proceedings against individuals acting as pilots, flight engineers, mechanics and repairmen, therefore, are adjudicated under the NTSB's Rules of Practice in Air Safety Proceedings, located in 49 CFR part 821.
This rulemaking adopts procedures under a new section of the FAA's regulations, 14 CFR 13.18, for initiating civil penalty actions adjudicated by the NTSB. It amends existing 14 CFR 13.16 to exclude actions covered under new § 13.18. It adds a new section, 14 CFR 13.14, that lists those provisions that, if violated, may result in a civil penalty being sought or assessed administratively. Section 13.14(c) also states that the amounts of civil penalties are periodically adjusted for inflation under the formula set by Congress in 28 U.S.C. 2461 note. We implemented this formula in 14 CFR part 13, subpart H. This regulation also makes other clarifying changes to part 13.
Although the FAA published the notice of proposed rulemaking (NPRM) almost 10 years ago, the final rule adopts procedural rules and publishes informational regulations. Therefore, another opportunity for notice and comment is not warranted.
Three commenters responded to the NPRM, which the FAA issued on July 29, 1994 (59 FR 40192, Aug. 5, 1994). The first commenter questioned two aspects of the NPRM. Those aspects related to (1) which forum has jurisdiction of security screening cases involving pilots and (2) why the penalty for disrupting a flight crewmember's duties is less than the penalty for tampering with a smoke alarm device. The first comment is moot because Congress transferred responsibility for aviation security to the Department of Homeland Security. The second comment is beyond the scope of the NPRM because Congress set the penalty amounts in question, not the agency. In any event, in 49 U.S.C. 46318, Congress set a maximum penalty of $25,000 for certain violations involving interference with a crewmember.
The second commenter raised a number of concerns about the fairness of the proposed rule and the FAA's authority to assess civil penalties. All but one of this commenter's concerns were unresponsive to, or otherwise beyond the scope of, the rulemaking. The remaining comment was “[t]he way the system looks now, the first a person hears of a problem is when the government sends him/her a notice specifying a violation of the FARs with the amount they owe the gov[ernmen]t. That just is [not] fair and is not right.” The commenter seemingly misunderstood the intent of the notice of proposed assessment. Contrary to the comment, the notice of proposed assessment does not constitute a finding of a violation. Nor does the notice impose a civil penalty. The notice of proposed assessment gives an alleged
The third commenter raised the issue of stale complaint, arguing that the NTSB's 6-month stale complaint rule for certificate actions should apply to civil penalty actions against pilots, flight engineers, mechanics and repairmen. This comment is moot because the NTSB has adopted a rule extending its 6-month stale complaint rule to civil penalty actions against pilots, flight engineers, mechanics and repairmen. 59 FR 59050, 59051-59052 (Nov. 24, 1994).
In the NPRM, the FAA proposed an interpretation of the phrase “a person acting in the capacity of a pilot, flight engineer, mechanic or repairman.” When Congress recodified the FAA's statute, it changed this phrase to “an individual acting as a pilot, flight engineer, mechanic or repairman”. Congress intended no substantive change. The only comment directed at the definition outlined in the NPRM was the objection that the proposed definition would allow the FAA decisionmaker to review security screening violations involving pilots. As stated above, that objection is moot due to the transfer of aviation security functions to the Department of Homeland Security.
The FAA interprets the phrase “an individual acting as a pilot, flight engineer, mechanic, or repairman” to refer to an individual who has engaged in conduct that involves the exercise of the privileges and duties of these certificates, regardless of whether that individual holds a valid pilot, flight engineer, mechanic, or repairman certificate.
In adopting this interpretation, the FAA considered whether an individual must hold a relevant certificate to obtain NTSB review under 49 U.S.C. 46301(d)(5). The FAA concluded that holding one of these certificates is not determinative because the phrase “acting as” describes the alleged violator in terms of the activities he or she performs, not the alleged violator's legal status. Therefore, it is the nature of the activity involved in the violation that determines whether the case falls within the scope of 49 U.S.C. 46301(d)(5).
Furthermore, if the Congress had intended to limit NTSB review of civil penalty actions to those against certificate holders, it would have drafted section 46301(d)(5)(A) differently. For example, section 46301(a)(5) distinguishes between civil penalty liability of an “individual” and of an “airman serving as an airman.” The Congress’ failure to use more specific language is evidence of its intent that “individual acting as a pilot, flight engineer, mechanic, or repairman” be given a noticeably broader construction than “holder.”
The term “acting” may include the failure to act. For example, acting as a pilot, flight engineer, mechanic, or repairman includes failing to surrender a pilot, flight engineer, mechanic, or repairman certificate when it has been revoked, as required by 14 CFR 61.19(f), 63.15(c), or 65.15(c). As this example shows, the privileges and duties under the FAA's regulations extend beyond actually flying an aircraft or performing maintenance on an aircraft. Therefore, the NTSB also reviews these cases.
In the NPRM, the FAA proposed that “* * * any civil penalty action for violations by a person acting in the capacity of a flight instructor would be heard under the NTSB procedures.” (59 FR 40193.) Even though the FAA specifically welcomed comments on the interpretation of “person acting in the capacity of a pilot * * *,” the FAA received no comments on the flight instructor aspect of the interpretation. On further review, the statement in the NPRM would be, in some instances, inconsistent with the proposition that “* * * [i]t is the nature of the activity that triggers the applicability of” NTSB review. For example, a flight instructor usually is not exercising the privileges of a pilot certificate when the flight instructor gives ground training or executes or maintains pilot records. (
An inspection authorization differs from a flight instructor certificate in that it is more like a rating on a mechanic certificate than a separate certificate. Both the NTSB and its predecessor, the Civil Aeronautics Board, have recognized the inspection authorization as a rating on the mechanic certificate.
The mere fact that an individual holds a pilot, flight engineer, mechanic, or repairman certificate is not sufficient to vest jurisdiction in the NTSB to review a case. If an alleged violator is not exercising the privileges associated with one of these certificates in connection with the alleged violation, then the case will be reviewed by the FAA decisionmaker under section 46301(d)(7) even though the alleged violator happens to hold one or more of these certificates. For example, the FAA decisionmaker would review a case involving a passenger who interferes with a cabin or flight crewmember even if the passenger holds a pilot certificate because the passenger's conduct did not involve the exercise of the privileges of the passenger's pilot certificate.
New 14 CFR 13.18 implements the statutory requirements for initiating cases that the NTSB reviews. Section 46301(d)(5)(A) of the FAA's statute provides that the Administrator may issue an order imposing a civil penalty against an individual acting as a pilot, flight engineer, mechanic, or repairman only after (1) advising the individual of the charges or any reason relied on by the FAA for the proposed action, and (2) providing the individual with an opportunity to answer the charges. Once the Administrator has issued an order, section 46301(d)(5)(B) authorizes the individual against whom it was issued to appeal the order to the NTSB. In addition, section 46301(d)(5)(D) provides that filing an appeal to the NTSB stays the Administrator's order. These procedural requirements are substantially similar to the procedural requirements set forth in 49 U.S.C. 44709(c) through (e) of the FAA's statute for non-emergency certificate actions.
In preparing the final rule, we have reorganized the subsections of new § 13.18 to reflect as closely as possible the actual step-by-step processing of a civil penalty action.
New 14 CFR 13.18(a)(1) states the statutory authority for administratively assessing a civil penalty against an individual acting as a pilot, flight engineer, mechanic, or repairman. Under 49 U.S.C. 46301(d)(5)(B), the
The FAA did not receive any comments on proposed § 13.18 (b) and (d), which contained definitions and delegations of authority, respectively. With some minor changes to paragraph (d) to improve clarity, including separating the delegations into numbered subparagraphs, these sections are adopted as § 13.18(b) and (c), respectively.
Under new § 13.18(d), the FAA initiates a civil penalty action against an individual acting as a pilot, flight engineer, mechanic, or repairman by issuing a notice of proposed assessment. The notice contains a statement of the charges and the amount of the proposed civil penalty. The notice also sets forth the procedures for responding to the notice. Subsections 13.18(d)(1)-(4) state the specific options for responding to the notice. The options are (1) submitting the amount of proposed civil penalty, (2) answering the charges in writing, (3) submitting a written request for an informal conference with an agency attorney and submitting relevant information or documents, or (4) requesting that an order be issued in accordance with the notice of proposed assessment so that the individual charged may appeal to the NTSB. The notice of proposed assessment and the opportunity to respond using informal procedures satisfy the statutory requirement in section 46301(d)(5)(A) of the FAA's statute to advise alleged violators of the charges and give them an opportunity to answer.
After the informal response procedures outlined above are completed, the FAA considers all information the alleged violator has supplied. If the parties have not agreed to resolve the case, the FAA will issue an order of assessment under new § 13.18(f). Before issuing the order of assessment, the FAA considers all the information available in the record at that point. The individual charged may then appeal the order of assessment to the NTSB, as provided in 14 CFR 13.18(g). These procedures satisfy the requirements of 49 U.S.C. 46301(d)(5)(B). As stated previously, once the individual charged has filed a notice of appeal with the NTSB, the case is subject to the NTSB's Rules of Practice in Air Safety Proceedings, located in 49 CFR part 821.
Under new § 13.18(e), the FAA may also issue an order of assessment if the individual charged does not respond to the notice of proposed assessment within 15 days. Furthermore, if the individual does not file a notice of appeal with the NTSB within the time provided by the NTSB's rules of practice, the order of assessment becomes final.
Under 14 CFR 13.18(g), the alleged violator may file an appeal from an order of assessment with the NTSB. A timely appeal to the NTSB stays the effectiveness of the order of assessment until the NTSB issues a final decision in the matter, as required by 49 U.S.C. 46301(d)(5)(D).
Section 13.18(h) states the provision for judicial review of a final decision of the NTSB provided for in 49 U.S.C. 46301(d)(6). Appeal is to a United States court of appeals for the circuit in which the individual charged resides or has his or her principal place of business or to the United States Court of Appeals for the District of Columbia Circuit. Section 13.18(h) also specifies, based on 49 U.S.C. 46110(d), that the Administrator's order of assessment is not a final order for the purpose of judicial review unless it has first been appealed to the NTSB.
Section 46301(i)(1) of the FAA's statute authorizes the Secretary of Transportation to compromise the amount of a civil penalty. The Secretary has delegated this authority to the Administrator in 49 CFR 1.47. New § 13.18(i)(1) provides agency attorneys with the authority to compromise civil penalty assessment actions initiated under 49 U.S.C. 46301(d)(5) against an individual acting as a pilot, flight engineer, mechanic, or repairman with no finding of a violation. New § 13.18(i)(2) authorizes agency attorneys to compromise the amount of a civil penalty proposed or assessed in an order with a finding of a violation as well.
Existing § 13.16(l)(1), on which § 13.18(i) is modeled, does not specifically require the alleged violator either to pay the civil penalty or sign a promissory note before a compromise order is issued. As stated in the NPRM, the FAA has experienced problems with this approach. In some cases, when the FAA did not receive payment before it issued the compromise order, the alleged violator has subsequently failed to pay the civil penalty. Also, if the person has not signed a promissory note agreeing to the amount of the penalty and a payment schedule, a risk exists that the person will dispute whether the amount in the compromise order is the amount the parties agreed on, complicating collection procedures. Debt collection procedures often are time-consuming and costly, and may not result in recovery of the full amount of the debt.
To avoid these problems, the FAA proposed in the NPRM that it will not issue a compromise order under new § 13.18(i) unless the alleged violator has prepaid the civil penalty or has signed a promissory note providing for installment payments. The FAA did not receive any comments on this issue. We are therefore adopting these changes as proposed. The FAA also amends current § 13.16(l) to incorporate these changes; it is redesignated as § 13.16(n).
Under 14 CFR 13.18(j), the individual charged must pay the civil penalty assessed in an order of assessment within 30 days, unless the individual has filed a timely notice of appeal with the NTSB. In cases that have been appealed, § 13.18(j) further requires the individual charged to pay the civil penalty within 30 days after a final order of the Board or the Court of Appeals affirms the order of assessment in whole or in part.
The NPRM included a provision, now located in new § 13.18(k), for collection of civil penalties. That proposed subsection was copied nearly verbatim from current 14 CFR 13.16(j). The provision was not discussed in the preamble to the NPRM. In reviewing the FAA's actual debt collection procedures, however, it appears that § 13.16(j), and therefore proposed § 13.18(i), do not reflect all methods the FAA may use to collect a delinquent debt. Following the enactment of the Debt Collection Act of 1996, the FAA generally transfers delinquent debts to the Department of the Treasury for collection. In addition, we have deleted reference to failure to pay within 60 days. The timeframe for payment after which a debt becomes delinquent is subject to change. In addition, an order of assessment, like an order assessing civil penalty, states when the debt imposed by the order may become delinquent and, if a delinquency notice is issued, it states what actions to recover the debt may be taken and
The preamble to the NPRM proposed amending certain sections of the Rules of Practice in FAA Civil Penalty Actions. The FAA did not receive any comments on the proposed amendments. The FAA therefore adopts these amendments as proposed in the NPRM.
The FAA did not receive any comments on the proposed revision of the heading for 14 CFR 13.15. We are therefore adopting it as proposed.
Since the NPRM was issued, Congress has recodified the Federal transportation law, increased the amounts of civil penalties available for certain violations, provided a requirement for agencies to periodically adjust for inflation the amount of the minimum and maximum civil penalties for statutes the agencies enforce, and added provisions to the FAA's statute that include new authority to seek or administratively assess civil penalties. The FAA's Office of the Chief Counsel has also undergone certain organizational changes, including the creation of a new Deputy Chief Counsel for Operations position. We are conforming §§ 13.15, 13.16, and 13.18 to these changes. As discussed elsewhere, we are also adopting a new § 13.14, which among other things, lists in one place the statutory provisions for which the FAA has authority to seek or administratively assess civil penalties.
Existing § 13.16(a) contains an obsolete list of the statutory provisions authorizing the FAA to assess civil penalties. In the NPRM, the FAA proposed to update the list to provide more information. Proposed § 13.16(a)(1) would have set forth a new list of the statutory provisions authorizing the FAA to assess civil penalties. Proposed § 13.16(a)(2) would have set forth the maximum amount of civil penalties that could be assessed. Because of recent changes in the FAA's governing statute and our adoption of regulations governing the periodic adjustment for inflation of civil monetary penalties, in compliance with 28 U.S.C. 2461 note, we have concluded that proposed § 13.16(a)(2) would be redundant. Accordingly, we are deleting proposed § 13.16(a)(2) from the final rule. Because we are adopting a new 14 CFR 13.14, discussed below, we are revising the remainder of § 13.16(a) to state that the FAA uses the procedures in § 13.16 when it assess a civil penalty against a person other than an individual acting as a pilot, flight engineer, mechanic or repairman for a violation cited in 49 U.S.C. 46301(d)(2) or 47531. We are adding a new paragraph (b) indicating when the United States district courts have exclusive jurisdiction. We are adding a new § 13.16(c) for violations of 49 U.S.C. chapter 51, the Federal hazardous materials transportation law. We are revising current § 13.16(d) to delete references to the statutes the FAA enforces and redesignating it as § 13.16(f). We are also redesignating the remaining paragraphs of current § 13.16 to accommodate the addition of new §§ 13.16(b) and 13.16(c). These actions are simply informational or editorial in nature. The agency has, therefore, determined that prior notice and opportunity for comment is unnecessary under section 553 of the Administrative Procedure Act.
Under 49 U.S.C. 46110, exclusive jurisdiction for judicial review of final orders of the Administrator issued under the FAA's statute is in the United States courts of appeals. Current § 13.16(k) incorporates that statutory review provision.
Current § 13.16(k) makes no distinction between cases involving the FAA's governing statute and the Federal hazardous materials transportation law, 49 U.S.C. chapter 51, for purposes of judicial review. The Federal hazardous materials transportation law itself, however, is silent on the issue of judicial review. That statute's silence on the issue of judicial review results in judicial review in an appropriate United States district court under 5 U.S.C. 701
The FAA published a final rule on December 28, 1995 (60 FR 67254), revising the authority citations for its regulations in Chapter I of Title 14 of the Code of Federal Regulations (14 CFR parts 1-199), including the authority citation for part 13. In adopting the revised authority citations, the FAA stated:
In July 1994, the Federal Aviation Act of 1958 and numerous other pieces of legislation affecting transportation in general were recodified. The statutory material became “positive law” and was recodified at 49 U.S.C. 1101
The Federal Aviation Administration is amending the authority citations for its regulations in Chapter I of 14 CFR to reflect the recodification of its statutory authority. No substantive change was intended to any statutory authority by the recodification, and no substantive change is introduced to any regulation by this change.
Because of the editorial nature of this change, it has been determined that prior notice is unnecessary under the Administrative Procedure Act. * * *
The NPRM had proposed amending part 13 with respect to delegations of authority to reflect the reorganization of the former Regulations and Enforcement Division into two separate divisions. The proposed amendments are no longer necessary as the FAA published a final rule reflecting organizational changes and delegations of authority in various parts of the FAA's regulations on September 4, 1997 (62 FR 46864).
On March 3, 2004, however, the FAA published Notice 1100.290. Notice 1100.290 announces the realignment of functions and responsibilities within the Office of the Chief Counsel. Among other things, the new organizational structure created the position of Deputy Chief Counsel for Operations. Based on Notice 1100.290, we are revising §§ 13.15(b), (c)(1), (c)(3), 13.16(e)(1-4), and 13.18(d)(1-3) to replace references to the Deputy Chief Counsel with references to the Deputy Chief Counsel for Operations.
In preparing the final rule, we concluded that it would be helpful to list in one place those provisions of the statutes the FAA enforces, and rules, regulations, or orders issued under those statutes, for which civil penalties may be sought or administratively assessed. We also concluded that it would be helpful to include a statement indicating that the maximum amounts of civil penalties are subject to periodic adjustment for inflation under the formula established by Congress. Therefore, we are adopting a new section, 14 CFR 13.14. We have concluded that notice and comment are unnecessary because this new section does no more than list the applicable statutory provisions and states that Congress has established a formula for periodically adjusting the maximum amounts of civil penalties. That formula is implemented in 14 CFR part 13, subpart H.
Proposed changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 directs that each Federal agency may 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. 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 requires agencies to consider international standards and, where appropriate, that they be the basis for U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $120.7 million or more annually, adjusted for inflation.
The FAA believes that the procedural changes adopted in this rule conform the existing procedural rules to amendments made in the FAA's statute, and clarify existing rules where necessary. The changes do not, in economic terms, alter the basic processes by which civil penalties are assessed within the agency. For this reason, a full Regulatory Evaluation is not warranted. This regulatory evaluation examines the potential costs and benefits of the amendments to part 13.
The potential benefits of this rule include clarifying the rule and explaining in detail how portions of the Administrator's administrative civil penalty assessment authority are implemented. These changes will provide potentially affected aviation parties (
The potential costs of the rule are zero because it consists only of procedural and clarifying changes to part 13. The procedural changes do no more than explain how the requirements of the Administrator's administrative civil penalty assessment authority under the FAA's statute and other statutes are implemented. The changes do not impose new economic requirements on potentially affected parties. The clarifying changes will enhance the public's comprehension of the civil penalty assessment process.
The rule represents procedural and clarifying changes only. These changes do not impose any costs on either U.S. or foreign operators. Therefore, a competitive trade disadvantage will not be incurred by U.S. operators abroad or foreign operators in the United States.
Under the Regulatory Flexibility Act of 1980, the FAA certifies that the rule will not have a significant economic impact, positive or negative, on a substantial number of small entities because the rule addresses procedures for initiating civil penalty actions against persons who have violated the statutes the FAA enforces, or rules, regulations, or orders issued under those statutes. Such changes do not impose any cost burdens or result in any cost savings.
The Unfunded Mandates Reform Act of 1995 (the Act) 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 an expenditure of $100 million or more (adjusted annually for inflation) in any 1 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.” The FAA currently uses an inflation-adjusted value of $120.7 million in lieu of $100 million.
This final rule does not contain such a mandate. The requirements of Title II do not apply.
This amendment 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. The respondents affected by the new procedures are private persons, not state governments. Therefore, under Executive Order 12612, preparation of a federalism assessment is not warranted.
This rule does not contain any information collection requests requiring approval of the Office of Management and Budget pursuant to the Paperwork Reduction Act of 1980 (Pub. L. 96-511). There are no requirements for information collection associated with this rule.
For the reasons discussed in the preamble, and based on the findings of the Regulatory Flexibility Determination and the International Trade Analysis, the FAA has determined that this regulation is not economically significant under Executive Order 12866. Although there has been significant public interest in the FAA's rules of practice in civil penalty assessment actions in the past, the FAA has determined that this regulation is a nonsignificant regulatory action under the Executive Order. This regulation is considered nonsignificant under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979). In addition, the FAA certifies that this regulation will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. In view of the minimal economic impact of this final rule, a full regulatory evaluation is unnecessary.
Administrative practice and procedure, Air transportation, Hazardous materials transportation, Investigations, Law enforcement, Penalties.
18 U.S.C. 6002; 28 U.S.C. 2461 (note); 49 U.S.C. 106(g), 5121-5124, 40113-40114, 44103-44106, 44702-44703, 44709-44710, 44713, 46101-46110, 46301-46316, 46318, 46501-46502, 46504-46507, 47106, 47111, 47122, 47306, 47531-47532; 49 CFR 1.47.
(a) Any person who violates chapter 401 (except sections 40103(a) and (d), 40105, 40116, and 40117), chapter 441 (except section 44109), section 44502(b) or (c), chapter 447 (except section 44717 and 44719-44723), chapter 451, 46301(b), 46302-46303, 46318, 46319, 47528-47530 of Title 49 of the United States Code, or any rule, regulation, or order issued thereunder, is subject to a civil penalty.
(b) Any person who violates any of the following statutory provisions, or any rule, regulation, or order issued thereunder, is subject to a civil penalty of not more than the amount specified in 49 U.S.C. chapter 463 for each violation:
(1) Chapter 401 (except sections 40103(a) and (d), 40105, 40116, and 40117);
(2) Chapter 441 (except section 44109);
(3) Section 44502(b) or (c);
(4) Chapter 447 (except sections 44717 and 44719-44723);
(5) Chapter 451;
(6) Sections 46301(b), 46302, 46303, 46318, or 46319; or
(7) Sections 47528 through 47530.
(c) Any person who knowingly commits an act in violation of 49 U.S.C. chapter 51 or a regulation prescribed or order issued under that chapter, is subject to a civil penalty under 49 U.S.C. 5123.
(d) The minimum and maximum amounts of civil penalties for violations of the statutory provisions specified in paragraphs (a) and (b) of this section, or rules, regulations, or orders issued thereunder, are periodically adjusted for inflation in accordance with the formula established in 28 U.S.C. 2461 note and implemented in 14 CFR part 13, subpart H.
(a) The FAA uses the procedures in this section when it seeks a civil penalty other than by the administrative assessment procedures in §§ 13.16 or 13.18.
(b) The authority of the Administrator, under 49 U.S.C. chapter 463, to seek a civil penalty for a violation cited in § 13.14(a), and the ability to refer cases to the United States Attorney General, or the delegate of the Attorney General, for prosecution of civil penalty actions sought by the Administrator is delegated to the Chief Counsel; the Deputy Chief Counsel for Operations; the Assistant Chief Counsel for Enforcement; the Assistant Chief Counsel, Europe, Africa, and Middle East Area Office; the Regional Counsel; the Aeronautical Center Counsel; and the Technical Center Counsel. This delegation applies to cases involving:
(1) An amount in controversy in excess of:
(i) $50,000, if the violation was committed by any person before December 12, 2003;
(ii) $400,000, if the violation was committed by a person other than an individual or small business concern on or after December 12, 2003;
(iii) $50,000, if the violation was committed by an individual or small business concern on or after December 12, 2003; or
(2) An in rem action, seizure of aircraft subject to lien, suit for injunctive relief, or for collection of an assessed civil penalty.
(c) The Administrator may compromise any civil penalty proposed under this section, before referral to the United States Attorney General, or the delegate of the Attorney General, for prosecution.
(1) The Administrator, through the Chief Counsel; the Deputy Chief Counsel for Operations; the Assistant Chief Counsel for Enforcement; the Assistant Chief Counsel, Europe, Africa, and Middle East Area Office; the Regional Counsel; the Aeronautical Center Counsel; or the Technical Center Counsel sends a civil penalty letter to the person charged with a violation cited in § 13.14(a). The civil penalty letter contains a statement of the charges, the applicable law, rule, regulation, or order, the amount of civil penalty that the Administrator will accept in full settlement of the action or an offer to compromise the civil penalty.
(3) If the person charged with the violation offers to compromise for a specific amount, that person must send to the agency attorney a certified check or money order for that amount, payable to the Federal Aviation Administration. The Chief Counsel; the Deputy Chief Counsel for Operations; the Assistant Chief Counsel for Enforcement; the Assistant Chief Counsel, Europe, Africa, and Middle East Area Office; the Regional Counsel; Aeronautical Center Counsel; or the Technical Center Counsel may accept the certified check or money order or may refuse and return the certified check or money order.
(5) If the parties cannot agree to compromise the civil penalty action or the offer to compromise is rejected and the certified check or money order submitted in compromise is returned, the Administrator may refer the civil penalty action to the United States Attorney General, or the delegate of the
(a) The FAA uses these procedures when it assesses a civil penalty against a person other than an individual acting as a pilot, flight engineer, mechanic, or repairman for a violation cited in 49 U.S.C. 46301(d)(2) or 47531.
(b)
(1) The amount in controversy is more than $50,000 for a violation committed by any person before December 12, 2003;
(2) The amount in controversy is more than $400,000 for a violation committed by a person other than an individual or small business concern on or after December 12, 2003;
(3) The amount in controversy is more than $50,000 for a violation committed by an individual or a small business concern on or after December 12, 2003;
(4) The action is in rem or another action in rem based on the same violation has been brought;
(5) The action involves an aircraft subject to a lien that has been seized by the Government; or
(6) Another action has been brought for an injunction based on the same violation.
(c)
(1) The nature, circumstances, extent, and gravity of the violation;
(2) With respect to the violator, the degree of culpability, any history of prior violations, the ability to pay, and any effect on the ability to continue to do business; and
(3) Such other matters as justice may require.
(e)
(2) The authority of the Administrator under 49 U.S.C. 5123, 49 CFR 1.47(k), 49 U.S.C. 46301(d), and 49 U.S.C. 46305 to refer cases to the Attorney General of the United States, or the delegate of the Attorney General, for collection of civil penalties is delegated to the Deputy Chief Counsel for Operations; the Assistant Chief Counsel for Enforcement; Assistant Chief Counsel, Europe, Africa, and Middle East Area Office; the Regional Counsel; the Aeronautical Center Counsel; and the Technical Center Counsel.
(3) The authority of the Administrator under 49 U.S.C. 46301(f) to compromise the amount of a civil penalty imposed is delegated to the Deputy Chief Counsel for Operations; the Assistant Chief Counsel for Enforcement; Assistant Chief Counsel, Europe, Africa, and Middle East Area Office; the Regional Counsel; the Aeronautical Center Counsel; and the Technical Center Counsel.
(4) The authority of the Administrator under 49 U.S.C. 5123(e) and (f) and 49 CFR 1.47(k) to compromise the amount of a civil penalty imposed is delegated to the Deputy Chief Counsel for Operations; the Assistant Chief Counsel for Enforcement; Assistant Chief Counsel, Europe, Africa, and Middle East Area Office; the Regional Counsel; the Aeronautical Center Counsel; and the Technical Center Counsel.
(f)
(l)
(m)
(2)
(n)
(1) An agency attorney may compromise any civil penalty action where a person charged with a violation agrees to pay a civil penalty and the FAA agrees not to make a finding of violation. Under such agreement, a
(i) The person has paid a civil penalty or has signed a promissory note providing for installment payments.
(a)
(2)
(i) The amount in controversy is more than $50,000.
(ii) The action involves an aircraft subject to a lien that has been seized by the Government; or
(iii) Another action has been brought for an injunction based on the same violation.
(b)
(1)
(2)
(3)
(4)
(5)
(c)
(2) The authority of the Administrator to refer cases to the Attorney General of the United States, or the delegate of the Attorney General, for collection of civil penalties is delegated to the Chief Counsel; the Deputy Chief Counsel for Operations; the Assistant Chief Counsel for Enforcement; Assistant Chief Counsel, Europe, Africa, and Middle East Area Office; the Regional Counsel; the Aeronautical Center Counsel; and the Technical Center Counsel.
(3) The authority of the Administrator to compromise the amount of a civil penalty under 49 U.S.C. 46301(f) is delegated to the Chief Counsel; the Deputy Chief Counsel for Operations; the Assistant Chief Counsel for Enforcement; Assistant Chief Counsel, Europe, Africa, and Middle East Area Office; the Regional Counsel; the Aeronautical Center Counsel; and the Technical Center Counsel.
(d)
(1) Submit the amount of the proposed civil penalty or an agreed-on amount, in which case either an order of assessment or a compromise order will be issued in that amount.
(2) Answer the charges in writing.
(3) Submit a written request for an informal conference to discuss the matter with an agency attorney and submit relevant information or documents.
(4) Request that an order be issued in accordance with the notice of proposed assessment so that the individual charged may appeal to the National Transportation Safety Board.
(e)
(f)
(g)
(h)
(i)
(1) An agency attorney may compromise any civil penalty action where an individual charged with a violation agrees to pay a civil penalty and the FAA agrees to make no finding of violation. Under such agreement, a compromise order is issued following the payment of the agreed-on amount or the signing of a promissory note. The compromise order states the following:
(i) The individual has paid a civil penalty or has signed a promissory note providing for installment payments;
(ii) The FAA makes no finding of violation; and
(iii) The compromise order will not be used as evidence of a prior violation in any subsequent civil penalty proceeding or certificate action proceeding.
(2) An agency attorney may compromise the amount of any civil penalty proposed or assessed in an order.
(j)
(i) Sending a certified check or money order, payable to the Federal Aviation Administration, to the FAA office identified in the order of assessment, or
(ii) Making an electronic funds transfer according to the directions specified in the order of assessment.
(2) The civil penalty must be paid within 30 days after service of the order of assessment, unless an appeal is filed with the National Transportation Safety Board. The civil penalty must be paid within 30 days after a final order of the
(k)
(a) This subpart applies to all civil penalty actions initiated under § 13.16 of this part in which a hearing has been requested.
(b)
(1) Whether each finding of fact is supported by a preponderance of reliable, probative, and substantial evidence;
(3) Whether the administrative law judge committed any prejudicial errors that support the appeal.
(j)
Federal Communications Commission.
Final rule.
In this document, the Commission adopts final rules that resolve several issues important to the rapid conversion of the nation's broadcast television system from analog to digital television. The Order adopts a multi-step channel election and repacking process through which broadcast licensees and permittees (“licensees”) will select their ultimate DTV channel inside the core. The Order also adopts deadlines for replication and maximization; provides for flash cut transition for satellite stations; eliminates simulcasting requirements; mandates broadcaster use of PSIP; clarifies rules concerning closed captioning and v-chip functionalities; amends interference protection rules; and permits limited use of distributed transmission systems.
Effective November 3, 2004 except for § 73.1201 which contains information collection requirements that are not effective until approved by the Office of Management and Budget. The FCC will publish a document in the
Evan Baranoff,
This is a summary of the Federal Communications Commission's Report and Order FCC 04-192, adopted on August 4, 2004 and released on September 7, 2004. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Qualex International, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at: www.fcc.gov. Alternative formats are available to persons with disabilities by contacting Brian Millin at (202) 418-7426 or TTY (202) 418-7365 or at
This document contains modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. OMB, the general public, and other Federal agencies will be invited to comment on the modified information collection requirements contained in this proceeding.
1. With this
2. In this
3. We adopt the following replication and maximization protection deadlines:
• July 1, 2005—Use-it-or-lose-it deadline for DTV licensees affiliated with the top-four networks (
• July 1, 2006—Use-it-or-lose-it deadline for all other commercial DTV licensees as well as noncommercial DTV licensees. Those licensees that receive a tentative DTV channel designation in the channel election process on their current digital channel must construct full, authorized DTV facilities. Those licensees that receive a tentative DTV channel designation on a channel that is not their current DTV channel must serve at least 80 percent of the number of viewers served by the 1997 facility on which their replication coverage was based.
4. In evaluating service areas we will consider the population served within the geographic area reached by a station's service area as defined under § 73.622(d) of the Commission's rules less any portions of that area that receive interference from other stations. Stations failing to meet the replication/maximization requirements on their allotted DTV channels by our deadlines will lose interference protection to the unserved portions of their current DTV service areas, as well as to the equivalent unserved portion of their NTSC Grade B contours for stations using those channels for DTV service after the transition occurs. Those
5. In this
6. Finally, we sought comment in the NPRM on how we should interpret certain portions of section 309(j)(14) of the Communications Act, which requires the Commission to reclaim the 6 MHz each broadcaster uses for transmission of analog television service by December 31, 2006, unless an extension is granted pursuant to the criteria established in section 309(j)(14)(B). Commenters made a number of suggestions regarding the interpretation of various aspects of section 309(j)(14)(B). We are continuing to review these comments and to consider the issues raised in the NPRM regarding section 309(j)(14) and plan to address these issues in the near future.
7. In January 2001, we released the
8. In the
The reduced build-out requirements adopted in the
9. By permitting stations to elect a more graduated approach to providing DTV service, we allowed stations to focus their energies initially on providing digital service to their core communities, with the expectation that they would increase operating hours and expand their coverage area as the transition progresses.
10. On January 27, 2003, we began this Second Periodic Review of the Commission's Rules and Policies Affecting the Conversion to Digital Television. Among other things, we sought comment on new channel election, replication, and maximization deadlines for broadcast television service. We also sought comment on a number of other issues concerning the protection that must be provided to incumbent analog and digital broadcasters in channels 52-69 (698-806 MHz, also referred to as the “700 MHz band”) during the transition. The Second DTV Periodic NPRM raised a number of other issues, including: (1) Whether the Commission should retain, revise, or remove the requirement that licensees simulcast a certain percentage of their analog channel programming on their DTV channel; (2) whether the Commission needs to take steps to assist noncommercial television stations in the transition; (3) whether labeling requirements for TV-related consumer equipment would assist the transition and protect consumers; (4) whether and how the Commission should license multiple lower-powered transmitters, similar to cellular telephone systems, called distributed transmission systems; (5) whether broadcasters should be required to include Program System and Information Protocol (“PSIP”) information within their digital signals to ensure the availability of certain functions; (6) whether the Commission should adopt digital V-chip and closed captioning requirements; and (7) what station identification requirements should apply to digital stations. In the Second DTV Periodic NPRM, we also invited commenters to update the records in the DTV Public Interest Form NPRM (MM Docket No. 00-168), Children's DTV Public Interest NPRM (MM Docket No. 00-167), and the public interest NOI (MM Docket No. 99-360), and directed that such comments be filed in those proceedings. We will address any comments on public interest issues filed in response to the Second DTV Periodic NPRM when we finalize the public interest proceedings in the near future.
11. The transition to digital television is a massive and complex undertaking, affecting virtually every segment of the television industry and every American who watches television. The spectrum that will be recovered at the end of the transition will bring tremendous benefits to consumers and the United States economy. Twenty-four megahertz of spectrum currently used for television broadcast channels 63, 64, 68, and 69 will be returned and used for first responders and other critically important public safety needs. The remaining 84 MHz in the 700 MHz band (currently television broadcast channels 59-62 and 65-66) have been or will be auctioned for use by new wireless services. The Commission has been continuously involved in the migration to digital television by, among other things, adopting a standard for digital broadcasting, creating a DTV Table of Allotments, awarding DTV licenses, establishing operating rules for the new service, and overseeing the physical build-out of digital broadcast stations.
12. In 1997, the Commission set dates for construction and operation of broadcasters' allotted digital broadcast facilities. Pursuant to the construction schedule set forth in § 73.624(d) of the Commission's rules, affiliates of the top four networks in the top ten television markets were required to complete construction of their digital facilities by May 1, 1999; top four network affiliates in markets 11-30 by November 1, 1999; all remaining commercial television stations by May 1, 2002; and all noncommercial television stations by May 1, 2003.
13. As of July 28, 2004, 1,658 television stations in all markets (representing approximately 96 percent of all stations) have been granted a DTV construction permit (“CP”) or license. A total of 1,423 stations are now broadcasting a digital signal, 634 with licensed facilities or program test authority and 789 operating pursuant to special temporary authority (“STA”) or experimental DTV authority.
14. In the top 30 television markets, all 119 network-affiliated television stations are on the air in digital, 110 with licensed DTV facilities or program test authority and nine with STAs. In markets 1-10, of the 40 network affiliates due to be on the air by May 1, 1999, all are providing digital service, 38 with licensed DTV facilities and two with STAs. Two stations that were licensed and on the air prior to September 11, 2001, went off the air due to the attack on the World Trade Center. WABC-DT and WNBC-DT are now back and operating at STA facilities, thereby completing the list of stations once on the air that have returned to operations In markets 11-30, all 79 network affiliate stations required to be on the air by November 1, 1999 are providing digital service. Seventy-two have constructed their licensed DTV facilities and seven are on the air with STAs.
15. Approximately 1,230 commercial television stations were due to commence digital broadcasts by May 1, 2002. As of July 28, 2004, 1,018 of these stations (83 percent) are broadcasting a digital signal. In addition, approximately 373 noncommercial educational television stations were required to commence digital operations by May 1, 2003. As of July 28, 2004, 286 (77 percent) of these stations are broadcasting a digital signal.
16. In the NPRM, we asked several questions about the types and availability of DTV equipment on the market. We invited commenters to provide us with up-to-date information about the pace of DTV receiver sales and the price of such units as well as trends in consumer demand for digital equipment.
17. The Consumer Electronics Association (“CEA”) reports that manufacturers offer more than 400 models of HDTV monitors and integrated sets, which is three times the number from 2000. It reports an 11 percent drop in HDTV monitor prices from March 2002 to March 2003, with a larger drop expected over the duration of 2003. The consumer electronics industry invested $15 billion in DTV products from 1998 through 2003. In addition, CEA reports that DTV products represented more than 10 percent of all television sales in 2002. In the first quarter of 2003, according to CEA, 766,000 DTV product units were sold, which was up 86 percent over the first quarter unit sales of 2002. CEA projected that manufacturers would sell 3.8 million DTV sets and displays in 2003.
18. According to the CEA's website, 4.1 million DTV products were sold in 2003 for about $6.1 billion, a 44 percent increase in dollar sales and a 56 percent increase in unit sales from 2002. More
19. Since the First DTV Periodic Report and Order, we have taken a number of important steps to encourage the consumer adoption of digital television. On August 8, 2002, the Commission adopted the DTV Tuner Order requiring that all TV receivers manufactured or shipped in the U.S. with screen sizes 13 inches and above be capable of receiving DTV signals over the air no later than July 1, 2007. This requirement will be phased in beginning with the largest sets in 2004 to minimize the cost impact on consumers. Receivers with screen sizes 36 inches and above—50 percent of a responsible party's units must include DTV tuners effective July 1, 2004; 100 percent of such units must include DTV tuners effective July 1, 2005. Receivers with screen sizes 25 to 35 inches—50 percent of a responsible party's units must include DTV tuners effective July 1, 2005; 100 percent of such units must include DTV tuners effective July 1, 2006. Receivers with screen sizes 13 to 24 inches—100 percent of all such units must include DTV tuners effective July 1, 2007. TV Interface Devices, VCRs, and DVD players/recorders, etc. that receive broadcast television signals—100 percent of all such units must include DTV tuners effective July 1, 2007 The DTV tuner requirement was designed to facilitate the transition to digital television by promoting the availability of reception equipment, as well as to protect consumers by ensuring that their television sets go on working in the digital world just as they do today.
20. In addition to the Order mandating DTV tuners, in October 2003, the Commission released a Second Report and Order and Second Further Notice of Proposed Rulemaking regarding Commercial Availability of Navigation Devices and Compatibility Between Cable Systems and Consumer Electronics Equipment. This Plug and Play Order was another step forward in the transition to digital television. Under the specifications developed by the cable and consumer electronics industries and adopted in the Plug and Play Order, consumers will be able to plug their cable directly into their digital TV set without the need of a set-top box. The new rules will ease the transition to digital TV by promoting competition, convenience, and simplicity for consumers.
21. In addition, we adopted a redistribution control system, also known as the “broadcast flag,” for digital broadcast television. The goal of the Broadcast Flag Order is to prevent the mass indiscriminate redistribution of digital broadcast television in order to foster the transition to digital TV and forestall potential harm to the viability of free, over-the-air broadcasting in the digital age. We found that the current lack of digital broadcast content protection could be a key impediment to the DTV transition's progress. Specifically, we found that the absence of such content protection could lead to reduced availability of high value content on broadcast television and thereby harm the viability of free over-the-air television and slow the DTV transition. Given our progress on this front, we expect that such programming will not be unreasonably withheld from over-the-air television.
22. In the DTV Sixth Memorandum Opinion and Order, we determined that, after the transition, DTV service would be limited to a “core spectrum” consisting of current television channels 2 through 51 (54-698 MHz). Although some licensees received DTV transition channels out of the core, and a few have both their NTSC and DTV channels outside the core, there will be sufficient spectrum to accommodate all DTV stations at the end of the transition. At this stage in the transition it is important for licensees with two in-core channels to indicate which one of their channels they prefer to use for digital broadcasting after the transition. In addition, we will require licensees with one in-core channel to make a decision about their in-core channel, and will require licensees involved in negotiated channel election arrangements with other licensees to inform us of these arrangements. This step is critical in determining what channels will be available for stations with two out-of-core channels and in clearing the out-of-core spectrum.
23. In the First DTV Periodic Report and Order, we established December 31, 2003, as the channel election deadline for commercial stations. Largely due to reports of difficulties some stations were facing in meeting our construction deadlines, we later decided that this date might be too early for some stations and suspended the channel election deadline, announcing that we would use this second periodic review to re-establish the date. We also stated in the First DTV Periodic Report and Order that we would resolve in a future DTV periodic review whether and when licensees with one or both of their channels out of the core will have the opportunity to make a channel election as well as the details and procedures for the election process. We stated that
24. In this
25. We initially established December 31, 2003, as the channel election deadline for commercial stations, but suspended the date pending a date to be established in this Order. We now agree with the commenters, such as CEA and KM Companies, which state that the industry has had enough time to evaluate DTV operations. Circumstances are significantly different from the time we suspended the channel election deadline. At the time, less than 400 of the 1,688 full-power stations with
26. We therefore conclude that stations are likely to understand the performance characteristics of the DTV transmission standard and to know which channel they prefer to operate on after the transition, and reject the option that the channel election deadline be tied to replication requirements or DTV tuner penetration rates. As discussed more fully below in section IV.J.2., infra, we are adopting the ATSC A/65B (“PSIP”) standard and mandating its use by DTV stations. As part of PSIP, a broadcaster's “major channel number” is its NTSC channel number. This major channel number is the station's channel identity during and after the transition. Therefore, a station's channel election decision will have no effect on the assignment of its NTSC channel number as its “major channel number” in PSIP. Consequently, channel election decisions need not be based on considering stations' historic “branding” to consumers, but instead may be based more on the operating characteristics of a particular frequency and the service populations the stations would project for each channel.
27. We find that the multi-step approach offered by MSTV has merit, and we adopt its proposal with modifications. We agree with many of the goals set forth by MSTV. First, the channel election process should provide the best possible DTV service to the public. Second, the plan should move the DTV transition along without undue delay. Third, we seek to create an orderly channel election process that produces as much clarity and transparency as possible. Fourth, licensees should be afforded the best opportunity for informed choice when making their channel election decisions. Fifth, we seek to provide every eligible station with a channel for operation after the end of the transition. Sixth, we seek to recognize industry expectations by protecting existing service and respecting investments already made, to the extent feasible. Finally, the channel election process should take into account overall spectrum efficiency, even as we seek to ensure to the extent possible that the final channel allotments accommodate replicated and maximized service areas for those stations certifying their intent to serve such areas.
28. To enable us to complete the reallocations necessary to accommodate all stations with a channel in the core, we need to know each in-core licensee's channel preference as soon as possible. Therefore, we adopt December 2004, as the starting date for channel elections, by which time commercial and noncommercial broadcast licensees with an in-core channel must state their channel preference. As of this date, commercial and noncommercial broadcasters will have had ample time after their applicable digital construction deadlines to make their channel decisions. A December 2004, channel election deadline for in-core licensees will also provide out-of-core licensees time to plan for their move into the core. We recognize that this date is earlier than the election date proposed in the Second DTV Periodic NPRM. Given, however, our adoption of a multi-step channel election process as proposed by MSTV and other necessary election procedures, this deadline is necessary to arrive at a final election for all stations in a timely manner. The choice of this election deadline strikes an appropriate balance between the need for stations to have a sufficient amount of time in which to gain experience in DTV operation and allowing stations that will have to move—particularly from out-of-core to in-core—to plan for the DTV channel conversion.
29. We adopt a multi-step channel election plan based in considerable part on the MSTV proposal, but which also incorporates certain modifications and refinements. Specifically, we adopt a seven-step channel election and repacking process as follows: (1) Step 1 addresses any preliminary matters to the channel election and repacking process, which includes requiring all licensees to certify their intent to replicate their allotted facilities or maximize their already-authorized facilities; (2) Step 2 is the first round of elections in which in-core licensees (
30. Database clean up. We agree with MSTV that it is important for our database to provide a consistent starting point. To that end, we ask that licensees review the accuracy of their database technical information and contact staff as quickly as possible with any submitted corrections. Any proposed corrections to database information must be consistent with station authorizations, as reflected in the Commission's records. So that we may consider any proposed corrections to our database, licensees should contact staff by October 1, 2004, with any concerns. We note that it may not be possible to process and consider any proposed corrections to database information offered after this date. Database errors that are discovered after this date may be corrected at the discretion of Commission staff. To ensure that licensees timely review their database information, we will require them to certify that they have reviewed their database information on file with the Commission and that it is accurate to the best of their knowledge. Licensees will make this certification using the Pre-Election Certification Form, which must be filed by November 2004. The Pre-Election Certification Form will also include licensees' certifications of their intent to replicate or maximize. While MSTV proposes a one-year period devoted to “database clean up,” we do not believe such an extended period is necessary. Moreover, we do not believe that there is a need for a formal process to invite licensees to submit information to “clean up the database” because we expect that licensees have informed us of any discrepancies as they arose. We note that MSTV has notified its members about the need to make sure their database information is accurate, and invited them to contact the Commission and MSTV concerning questions about database inaccuracies or discrepancies. MSTV also asked its
31. Filing freeze. On August 3, 2004, the Media Bureau imposed a freeze on the filing of certain TV and DTV requests for allotment or service area changes to facilitate the channel election and repacking process. Included in the freeze are: (i) Petitions for rulemaking to change DTV channels within the DTV Table of Allotments, (ii) petitions for rulemaking to establish a new DTV channel allotment, (iii) petitions for rulemaking to swap in-core DTV and NTSC channels; Notwithstanding the freeze, negotiated channel election arrangements may be sought during the election process. (iv) applications to change DTV channel allotments among two or more licensees; (v) petitions for rulemaking by licensees/permittees to change NTSC channels or communities of license; (vi) applications to maximize DTV or analog TV facilities; and (vii) certain Class A station applications. Notwithstanding this freeze, licensees are not prevented from filing modification applications that would resolve international coordination issues. We do this to alleviate a burden on those licensees who are actively working to resolve their international coordination issues, or when a broadcast station seeks a new tower site due to the events of September 11, 2001. In addition, the Media Bureau will consider requests for waiver of the freeze on a case-by-case basis. Such a filing freeze is necessary to provide a stable baseline for developing a final DTV Table of Allotments. The freeze is discussed more fully in section IV.A.2., infra.
32. Table of station assignment and service information. As a preliminary matter to the channel election process, the Media Bureau will issue a table of station assignment and service information (“table of station information”) for use by TV station licensees and other interested parties so they may determine and evaluate the DTV service populations to be used by the Commission to process stations' channel elections and create the new DTV table of allotments. In developing the table of station information, the Commission will generally use the DTV and NTSC station locations and facilities authorized by license or construction permit (CP). Where station records include both a construction permit and license, we will use the construction permit given that the changes permitted in the construction permit reflect the station's facilities for the future, as of October 1, 2004, a month before TV station licensees will be asked to file their Pre-Election Certification Forms. The Pre-Election Certification Form will require all broadcast licensees and permittees to certify to (1) the accuracy of their database information on file with the Commission, which will be reflected by the table; and (2) their intent to replicate or maximize pursuant to their existing authority, as will be defined by the table. We will issue this table of station information prior to the filing of the Pre-Election Certification Forms. (We note that the Media Bureau imposed a freeze on the filing of certain TV and DTV requests for allotment or service area changes in anticipation of generating this table of station information.) The data provided in the table of station information will be based on the technical information on file in the Commission database. Licensees should review the table of station information before making their pre-election certifications. We will update the table of station information to reflect service areas based on certifications to build to replication or maximization facilities and any other changes to station facilities prior to the first round election date.
33. Station service evaluations based on currently authorized operations. As noted above, we will use current authorized station operations to determine and evaluate the DTV service populations in processing channel elections and creating the new DTV table of allotments. We believe that basing station service evaluations on current authorized station operations will more accurately reflect the current viewer access to station services than the parameters specified for the initial DTV Table of Allotments in 1997, and will at the same time preserve the service areas of those stations that constructed and are operating in accordance with the DTV buildout schedules. Consistent with MSTV ex parte submissions and discussions, we will define new interference as interference beyond that caused by NTSC and DTV operations, as described by the table of station information, in evaluating new interference to post-transition TV operations.
34. On this basis, stations that operate, or plan to operate as authorized by a CP, in accordance with the facilities specified in the initial DTV Table of Allotments will have the same service as that contemplated in the DTV Second MO&O, less any changes in interference received from new stations or from stations that changed their operations. Stations that have departed from their initial DTV allotment facilities (including location and/or channel changes) or maximized (or in a few cases reduced) their operations through such modifications and new stations, will have service as authorized in those changes or new authorizations, again less interference from other stations. Stations granted a DTV channel change are generally authorized facilities that they requested if such operations do not cause new interference to other stations that exceed the
35. Border coordination. We agree with commenters that it is important to resolve international coordination issues as quickly as possible. To that end, we have reduced the number of coordination conflicts from several hundred to fewer than 50. We cannot, however, delay the implementation of our channel election and repacking process pending resolution of every outstanding case of Canadian or Mexican coordination. Parties with pending applications that are being delayed due to coordination issues are advised that while we will make every effort in negotiating on their behalf, we can provide no assurance that such issues will be resolved favorably. In nearly all of the remaining cases, the licensee can build a checklist facility.
36. We are aware of some stations with a DTV channel outside of the core and an analog channel inside the core for which, according to the stations, the analog channel is not available for digital transmission because of international coordination issues with Canada. These stations should indicate this fact on their channel election form and attach a brief explanation of why their in-core channel is not available for digital use under the U.S.—Canada Letter of Understanding, which governs modifications of the initial DTV table of allotments within 400 km of the U.S./Canadian border. Stations with an out-of-core DTV channel and an in-core analog channel that is not available for digital transmission because of international coordination issues will be treated like stations with two out-of-core channels.
Certifications for replication and maximization. We adopt a requirement, that stations that intend to fully replicate or maximize certify this commitment to the Commission by November 2004, subject to sanctions if the station fails to meet its commitment. In the Pre-Election Certification Form, licensees will certify their intent to build-out their allotted “replication” facilities or already-authorized “maximization” facilities. Licensees are reminded that false certifications may result in fines and loss of license. Moreover, where stations do not build-out to their certified facilities, we will limit their station's interference protection to the service population within the noise-limited contour predicted from the station's operating facilities, as of the certification date. (In other words, a licensee's failure to replicate or maximize to the extent it certified will result in the loss of interference protection to those service areas not replicated or maximized.) Licensees will be required to replicate and maximize by the replication/maximization deadline (
37. Such certifications must be filed with the Commission in advance of the channel election date so that all licensees will be able to consider the commitments of other licensees in their channel elections. To provide sufficient time for this information to be useful, we will require that such certifications be filed in November 2004. Stations that do not submit certification forms by this date will be presumed not to intend to replicate or maximize, and such decision will be taken into account in determining final channel assignments. More specifically, in establishing the authorized facilities and service area for a station not certifying to fully replicate or maximize, we will provide for the station to serve the same geographic area served by its existing DTV facilities, operating as of the certification date. Certifications must be filed electronically and will be made accessible to the public.
38. Election Forms. All broadcast licensees participating in the channel election process are required to file a pre-election certification form and a channel election form. Stations that do not timely submit a pre-election certification form will be presumed both (i) to agree that their database technical information on file with the Commission is accurate and complete, and (ii) not to intend to replicate or maximize, and such decision will be taken into account in determining final channel assignments. Stations that do not timely submit a channel election form will be assigned a post-transition DTV channel by the Commission prior to the end of the channel election process. Appendices E and F to this Report and Order illustrate the forms to be used in the channel election and repacking process. We have developed the following six forms: (1) Pre-Election Certification Form; (2) First Round Election Form; (3) First Round Conflict Decision Form; (4) Second Round Election Form; (5) Second Round Conflict Decision Form; and (6) Third Round Election Form. These forms, which are adopted by this Report and Order, must be filed electronically and will be made accessible to the public on the Commission's database.
39. We set December 2004 as the date for the first round of channel elections. Although we proposed in the NPRM an election date of May 1, 2005, we believe that the broadcasters making first round elections are able to make an informed statement of their final channel preference at this time. Moreover, given that we will be adopting a multi-step and multi-round approach that will occur over the course of several months, we find that we must begin the process as soon as possible in order to effectuate a timely transition.
40. In this first round, licensees with in-core channels (
41. Negotiated Channel Election Arrangements. As an alternative to the channel election process, licensees may negotiate channel election arrangements with other stations. Such negotiated arrangements are subject to Commission approval, including particular consideration of the effect on the channel election rights of, and interference impact on, any licensee not a party to the negotiated channel election agreement. “Channel swapping” is an existing practice with beneficial results for the marketplace and consumers, and these channel election arrangements are similar in nature to them. We do not anticipate that channel election arrangements are likely to have anti-competitive effects. We will, however, review them for such effects. All licensees involved in a negotiated channel election arrangement must file a channel election form. Licensees will be asked to indicate their negotiated channel elections on their channel election forms. To select the channel they would use for digital operations after the transition if the negotiated channel election arrangement is approved, as well as the channel they would elect if the negotiated arrangement is not approved. Stations involved in the negotiated channel election arrangement must satisfy our DTV interference rules with regard to their relationship to other stations not involved in the negotiated arrangement. Evidence of a signed negotiated channel election arrangement and technical engineering information demonstrating compliance with § 73.623(g) of the Commission's rules must be submitted to the Commission to enable us to consider negotiated channel election arrangement requests. In order to demonstrate the validity of their negotiated channel election arrangements, licensees will be required to provide the name(s) and call sign(s) of the other licensees involved in the arrangement. Licensees may, upon request, be required to provide a copy of the negotiated channel election agreement and/or engineering information to the Commission. The Commission may contact proponents of these arrangements, as may be necessary. We will review all agreements to assure compliance with the public interest and will not approve agreements proposing the acceptance of significant levels of interference or loss of service.
42. Election of DTV in-core channel. We conclude that if a two in-core licensee elects its DTV channel, then its NTSC channel will be released. By “release,” we mean that the licensee relinquishes its post-transition rights to this channel and that the channel now becomes available for future selection by another licensee. The DTV channel will be “locked in.” By “locked in,” we mean that the channel assignment is confirmed. However, the amount of interference the station is subjected to may increase to some extent in the Final Table in an effort to provide all licensees with an in-core DTV channel that replicates their analog service, to the extent the station has certified intent to so replicate. In other words, even though channels may be “locked in,” licensees may be required at the end of the allotment process to accept interference resulting from establishment of DTV stations at full replication facilities to accommodate all stations with a channel in the DTV core spectrum. This system of “locking in” channels can be viewed as making an informal tentative channel designation to that licensee. While informal tentative channel designations in themselves cannot confer legal rights to licensees, they do come with a heavy presumption that these informal designations will be the channel assignments proposed in the new DTV Table of Allotments. (
43. Election of NTSC in-core channel. If a two in-core licensee elects its NTSC channel, then Commission staff will determine whether and to what extent DTV operations on this channel would cause new interference to the service populations of other DTV stations. For purposes of this analysis, DTV service populations will be those resulting from the allotted “replication” facilities or authorized “maximization” facilities, as certified. This interference conflict analysis will take place in Step 3, when we intend to resolve, to the extent possible, the interference conflicts
44. We do not expect there to be widespread difficulties in fitting replicated DTV service into paired NTSC channels, as paired DTV channels were initially designed to be the best approximation of the NTSC Grade B contours. However, the interference relationships between DTV to DTV and NTSC to DTV operations are such that a DTV station would have a 1 dB greater interference impact on another co-channel DTV station than a NTSC station and an 8 dB greater impact on adjacent channel DTV station than an NTSC station, assuming the same coverage and locations for all stations. Thus, it is likely that in some cases DTV operation on an associated NTSC channel could result in new interference. In such cases, it may be possible to resolve the new interference by reducing the DTV station's operating facilities. We would allow stations to make such adjustments to address such conflicts. For those stations electing their NTSC channel for their eventual in-core DTV channel, we will attempt to accommodate the broadcasters' authorized maximized facilities into the NTSC “destination” channels. As discussed in section IV.B.,
45. Elections by one in-core licensees. Licensees with only one in-core channel (including singletons Singletons' or “single-channel licensees” refers to those licensees that do not have a second or “paired” channel to convert to DTV. In 1998, in the “Service Reconsideration Order,” the Commission decided to afford new NTSC permittees, whose applications were not granted on or before April 3, 1997, and who were therefore not eligible for an initial DTV paired license, the choice to immediately construct either an analog or a digital station on the channel they were granted. Pursuant to this policy, the Commission specified that these new NTSC permittees, which we now sometimes refer to as “singletons” or “single-channel licensees,” would not be awarded a second channel to convert to DTV, but could, instead, convert on their single 6 MHz channel. It was further decided that if they choose initially to build an analog station, they may request Commission authorization to convert to DTV at any point during the transition, up to the end of that period), including those with low VHF channels (2-6), must elect to either (1) keep their in-core channel or (2) release their in-core channel in favor of being treated like a licensee with two out-of-core channels. MSTV proposed that we assume that such stations would decide to remain on their in-core channels; however, we find that it is more efficient to determine which in-core channels are unacceptable to these stations so that those channels can become available for future elections and to ensure that those stations are given an opportunity to identify a workable channel.
46. We expect that in most cases stations with only one in-core channel, where the channel is a DTV channel, will choose to remain on that channel. In such cases, that channel will be “locked-in,” as defined above. If the one in-core licensee chooses not to elect its in-core DTV channel, then that channel will be released, and the licensee will be treated as a two out-of-core licensee. In being treated like a two out-of-core licensee, the licensee will be required to file a new election form in the second round of elections. Licensees with only one in-core channel (including singletons), where the in-core channel is the NTSC channel, must elect to either (1) keep their in-core NTSC channel or (2) release their in-core NTSC channel in favor of being treated like a two out-of-core licensee. If a one in-core licensee elects its NTSC, then Commission staff will determine (in Step 3's “interference conflict analysis”) whether and to what extent this NTSC channel would cause new interference to the service populations of DTV stations. In light of their status, in-core NTSC channels of one in-core licensees will be afforded a high priority in permitting their conversion to a DTV channel.
47. Later opportunity to change elections of low VHF channels and channels subject to international coordination. Licensees electing, and receiving a tentative channel designation for, a low VHF channel or a channel subject to a pending international coordination issue will be permitted to seek an alternate tentative channel designation in the third round of elections. See discussion in section IV.A.1.f., infra.
48. No first round election for two out-of-core licensees. Licensees with two out-of-core channels will not make an election in the first round. Requiring two out-of-core licensees to elect at this time would be premature and unnecessarily limit the channel choices available to these licensees. We disagree with MSTV that it would be beneficial for two out-of-core licensees to make elections in the first round a month after the two in-core licensees have elected. We note, for example, that under MSTV's plan two out-of-core licensees would not know at this time whether a two in-core licensee selecting its NTSC channel in the first round would ultimately obtain that election. This situation would not be resolved until Step 3, through interference conflict analysis MSTV would have two out-of-core licensees protect both channels of two-in-core licensees electing their NTSC channel, effectively denying two out-of-core licensees' the ability to select certain otherwise available channels. Accordingly, as will be discussed below, two out-of-core licensees will make their elections in the second round, at which point two in-core and one in-core licensees may already have a channel “locked in” (as defined above) and have released an in-core channel, making that in-core channel available for future selection.
49. The interference conflict analysis contemplated in our Step 3, which we expect to complete by February 2005, will determine whether and to what extent an elected in-core NTSC channel would cause interference to an existing or proposed in-core DTV channel. Using objective computer analysis, we will identify and communicate interference conflicts arising from the first round. We agree with MSTV that knowing what channels are available for selection in the second round is important in order to provide second round electors with an informed choice among all channels remaining after completion of the first round. Accordingly, through the interference conflict analysis process, we will set tentative channel designations for in-core licensees with channels that have been elected in the first round and “locked in.”
50. Specifically, through our first round interference conflict analysis, Commission staff will determine whether and to what extent an elected in-core NTSC channel causes an interference conflict to: (1) An in-core DTV channel that was elected in the first round; (2) an in-core DTV channel of any licensee that elected its NTSC channel in the first round that still may need to revert to its DTV channel; or (3) another elected in-core NTSC channel in the first round. We note that the nature of the interference conflict differs with respect to an elected NTSC channel of a one-in-core station, which enjoys a special status, as opposed to an elected NTSC channel of a two-in-core station, which has the option to change its election to its currently assigned DTV channel.
51. Upon completion of our first round interference conflict analysis, the Media Bureau will issue a letter to each licensee determined to cause an interference conflict(s). Licensees with interference conflicts will have 60 days from the date of this conflict notification letter in which to file their First Round Conflict Decision Forms, indicating how they intend to resolve their interference conflict. These First Round Conflict Decision Forms, which we expect to be filed in April 2005, will provide licensees with the opportunity to decide whether to maintain their in-core NTSC election, change their election to their in-core DTV channel, or, if a one-in-core licensee, elect to participate in the second round. Two in-core licensees may not release both in-core channels to participate in the second round of elections, except for the case of two in-core low VHF channels. We note that two in-core licensees already have the advantage of having an in-core DTV channel. Licensees can maintain their in-core NTSC election if they resolve their interference conflict by (1) agreeing to accept interference and reduce facilities; In choosing this option, licensees would have to agree to accept interference or reduce facilities, as necessary. Licensees must certify that they will resolve their interference conflict(s), and will be required to demonstrate such by submitting technical engineering data. and/or (2) negotiating an agreement (
52. Licensees currently allotted an out-of-core DTV channel will be afforded the opportunity for full replication facilities on an in-core DTV channel, unless they choose to accept less. The licensee may agree to accept interference as long as it is still able to serve all of its community of license. If the conflict is thus resolved, the licensee's currently assigned in-core DTV channel is released. After receipt of the First Round Conflict Decision Forms, we will announce any additional channel elections that have been “locked in” as tentative channel designations. Based on this information, second round electors will be able to determine which channels will be available for selection in the second round of elections.
53. An interference conflict exists when it is determined that more than tolerable new interference exists (
54. The interference conflict analysis performed in the first round is illustrated through the following examples. In the case of a two-in-core licensee whose election of its in-core NTSC channel causes an interference conflict which prevents granting the in-core NTSC channel with the certified coverage, the licensee will file a conflict decision form indicating whether it will accept its in-core NTSC channel with interference and reduced facilities or if it will revert to its DTV channel. The channel selected at this time would be “locked in” and the other channel
55. In our second round of elections, which we expect to occur July 2005, licensees with two out-of-core channels and those now treated like them, This category includes those first round electors that indicated in their conflict decision forms that they wanted to be treated as two out-of-core licensees, rather than accept their in-core NTSC channel with interference and reduced facilities. Also included in this category are licensees that do not have an in-core channel (
56. Two out-of-core licensees. In their Second Round Election Form, two out-of-core licensees may submit one channel election preference (two out-of-core licensees may negotiate channel election arrangements with other licensees) or may request that the Commission determine a “best available” channel (
57. We recognize that there may be a sizable number of election preferences filed in the second round and that licensees may list conflicting channel preferences. Second round electors may also be asked to accept a channel with interference and reduced facilities because of an interference conflict with a protected channel. In anticipation of these issues, our second round interference conflict analysis, which we expect to complete by September 2005, offers a process of identifying and resolving such interference conflicts. We will evaluate election preferences for interference conflicts (as defined above), and “lock in” second round election preferences as tentative channel designations, to the extent possible. We will accommodate the election preference of each licensee to the extent possible, but cannot guarantee that licensees will receive their selected channel. The Second Round Conflict Form will provide second round electors with the opportunity to decide whether the interference and reduced facilities to which they would have to agree to obtain their channel preference would be acceptable to maintain their election preference. Second round electors unwilling to accept its election preference with interference and reduced facilities or that otherwise cannot resolve their interference conflict may participate in the third round of elections. We believe that in many cases of conflicting second round channel preferences, licensees will be able to reach settlement agreements, thereby avoiding the necessity of having the Commission resolve their conflict after the third round of elections.
58. Upon completion of our second round interference conflict analysis, the Media Bureau will notify each licensee that is determined to cause an interference conflict(s). Licensees will have 60 days from the date of this conflict notification letter in which to file their Second Round Conflict Decision Forms, indicating how they intend to resolve their interference conflict. These Second Round Conflict Decision Forms, which we expect to be filed in November 2005, will provide licensees with the opportunity to decide whether to maintain their second round channel elections or instead participate in the third round. Licensees have several options available to them. Licensees can maintain their second round channel election if they resolve their interference conflict by (1) agreeing to accept interference and reduce facilities; Licensees must certify that they will resolve their interference conflict(s), and will be required to demonstrate such by submitting technical data. and/or (2) negotiating an agreement (
59. We will hold a third round of elections, expected to occur in January 2006, to find channels for licensees that were not “locked in” at tentative channel designations in the previous two rounds. This third round provides a subsequent round for two out-of-core licensees whose election preferences could not be accommodated in their initial round of elections. We agree with MSTV that these licensees, as well as any other licensees that remain unplaced at this time, should be afforded the opportunity to make one additional channel election preference. These licensees will file a Third Round Election Form Election preferences made in this round must protect all “locked in” channels. Participants in the Third Round may elect from available channels and may file negotiated channel election arrangements. If a licensee is not able to specify a preferred channel on which it can operate satisfactorily without conflicting with a protected channel, it may ask the Commission to specify a channel for its use at full replication facilities. In such cases, the Commission will select a channel that minimizes new interference among all affected stations.
60. In this third round, we will also permit licensees with a low VHF channel or a channel subject to international coordination issues to seek an alternate tentative channel designation. Although the data are incomplete at this time, we are persuaded that low VHF licensees should be afforded an additional opportunity to find a channel that may better serve the public. For this reason, we will also permit two in-core low VHF licensees to release both of their channels after the first round so that they may be treated as two out-of-core licensee and participate in the second round of elections. MSTV proposed an additional election round for licensees who found their prior election unacceptable and contemplated that licensees which had to choose between two low VHF channels would be among those possibly dissatisfied licensees. Specifically, to the extent a preferred channel is available in this final election round, we will allow such licensees to elect a different channel for their final DTV operations, notwithstanding that they have an elected and “locked in” channel. These licensees may also request that the Commission determine a “best available” channel for them at full replication facilities. We note that it may not be possible to accommodate these preferences. Moreover, it is possible that the low VHF channel may be the best available channel for the licensee. No other licensees with an elected (and “locked in”) channel will be permitted to participate in this third and final round of elections.
61. Conflicts among third round preferences. In deciding among third round election preferences, we will determine on a case-by-case basis what channel best replicates a station's service area while minimizing new interference to other stations. If, for example, the channel elected conflicts with a DTV channel tentatively designated for post-transition use by another station, the Commission will resolve the conflict by determining the best available channel for the licensee, as described herein. This analysis includes considerations of service to the public “ including service to local communities Considering licensees” ability to reach and provide coverage to local communities is consistent with the Commission's statutory obligation to ensure that broadcasters are responsive to the needs and interests of local communities. “ and overall spectrum efficiency. We will also consider in our analysis those factors enumerated by MSTV: (1) Whether the station was an early adopter of DTV technology (
62. After completion of our channel election and repacking process, expected by August 2006, we will issue a Notice of Proposed Rule Making to propose a New DTV Table of Allotments. In creating the new DTV allotments proposals, we will provide all eligible stations with channels for DTV operations after the transition. In developing the new allotments, we will attempt to accommodate the preferences of broadcasters to the extent possible. To clarify as requested by Cox Broadcasting, the process will account for interference agreements among stations under § 73.623(g) of the Commission's rules and will generally preserve the protection afforded by those agreements. Our proposed Table will be based on the tentative channel designations established through our channel election process, as well as on our evaluation of overall spectrum efficiency and providing the best service to the public, including service to local communities. In the NPRM, we will seek comment on our proposed new DTV Table of Allotments.
63. Only Commission licensees and permittees will participate in the channel election process. Applicants for new stations and petitioners for new allotments will not make elections. We note that there are remaining applications that have been pending since before 1997 to obtain approximately 50 new NTSC stations. These applications will be dismissed if found to be inconsistent with the current protection requirements. In developing the post-transition DTV table, we will generally protect those NTSC allotments with pending new station applications that have “cut-off” status (do not face an additional opportunity for filing of mutually exclusive applications). This is consistent with the protection that must be afforded by DTV applications pursuant to § 73.623(h)(2) of the rules. An exception to this protection is that we will not protect the existing channel allotment where the applications are associated with a rule making petition that requests another channel (but may protect the new channel proposed in the rule making petition in accordance with the discussion that follows). For mutually-exclusive groups of applications where there is a settlement, or the tentative selectee is known, we will consider the facilities proposed by the prevailing applicant in the settlement group or the tentative selectee. We will continue to process these protected applications to grant of an NTSC construction permit and note that these will be new single-channel stations, allowed to choose between NTSC and DTV operation during the transition, but required to become DTV
64. Pursuant to opportunities the Commission provided, some of the pre-1997 NTSC applicants have continued to pursue a new station authorization by filing rule making petitions requesting a different NTSC channel or a DTV channel. In addition, some petitions have been filed seeking DTV channel allotments for new stations. These pending NTSC and DTV rule making proposals will be dismissed if found to be inconsistent with the current protection requirements. Each rule making request, including those associated with applications and those seeking new DTV allotments, falls into one of three groups: (1) Pending petitions for rulemaking; (2) outstanding rule makings (Notice of Proposed Rule Making issued); or (3) completed rule makings that now have pending applications for a construction permit. We will attempt to protect allotments and proposed allotments in the second and third groups where we have already adopted a Notice of Proposed Rule Making or a Report and Order to establish a channel allotment. Protection of these rule making proceedings is consistent with the requirements placed on DTV applications by § 73.623(h)(2) of the rules. However, we advise these petitioners that there may be a few cases where we must modify, restrict or eliminate their requested allotment in order to accommodate all eligible broadcasters with a post-transition DTV allotment. Remaining rule making petitions will be evaluated at the conclusion of the channel election and repacking process and may be accommodated with a post-transition DTV allotment or dismissed when we issue the NPRM proposing the new DTV Table of Allotments.
65. A stable database is not only crucial to the channel election process, but is vital to the completion of the technically difficult task of developing a new DTV Table of Allotments. To make the channel election process and the creation of the new DTV Table of Allotments as manageable as possible, the Media Bureau has temporarily suspended certain procedures for altering DTV and analog TV service areas and channels until after the new DTV Table of Allotments is complete. We will continue to process rulemakings in which a Notice of Proposed Rule Making has been issued prior to the adoption of this Order. Additionally, the Media Bureau staff is directed to dismiss all pending petitions to change the NTSC Table of Allotments in which a Notice of Proposed Rule Making has not been issued prior to the adoption of this Order. We note that the Media Bureau staff previously dismissed or denied a number of petitions for new or changed NTSC allotments on various grounds, thereby declining to issue a Notice of Proposed Rule Making for these petitions. Several petitioners have sought reconsideration or review of these actions. In view of our decision to dismiss all pending petitions for new NTSC allotments which have not been subject to the notice process, all pending petitions for reconsideration or review of NTSC allotment requests that have not advanced to the notice stage are hereby dismissed. Pursuant to the freeze, the Media Bureau we will not accept for filing, until further notice, the following:
• Petitions for rulemaking to change DTV channels within the DTV Table of Allotments.
• Petitions for rulemaking for new DTV allotment proceedings.
• Petitions for rulemaking to swap in-core DTV and NTSC channels. In the NPRM, we sought comment on whether we should allow stations to use an application process to make these swaps. We proposed to require that parties meet the spacing requirements for amending the analog Table of Allotments pursuant to 47 CFR 73.610 and to allow parties to use Longley-Rice analysis to demonstrate that an analog TV station protects DTV stations and for amending the DTV Table of Allotments pursuant to 47 CFR 73.623. We invited comment on these proposals and on how the Commission should address any loss of analog service or cable carriage or other public interest issues that may arise in connection with analog/DTV channel swap proposals.
• Applications to change DTV channel allotments among two or more licensees. 47 CFR 73.622(c)(1), 73.623. Stations hoping to participate in negotiated channel election arrangements, discussed supra, must notify the Commission in the channel election form. If these arrangements are approved, the participants will be notified.
• Petitions for rulemaking by licensees/permittees to change NTSC channels or communities of license.
• Television modification applications that would increase a station's DTV service area in channels 2-51 in one or more directions beyond the combined area resulting from the station's parameters as defined in the following: (1) The DTV Table of Allotments; (2) Commission authorizations (license and/or construction permit); and (3) applications on file with the Commission prior to release of this Order; and television modification applications that would increase a station's analog service area in channels 2-51 in one or more directions beyond the combined area resulting from the station's parameters as defined in the following: (1) Commission authorizations (license and/or construction permit) and (2) applications on file with the Commission prior to release of this Order. We froze maximization applications for channels 52-59 on June 18, 2002. Public Notice, 17 FCC Rcd 11290 (2002). We froze maximization applications for channels 60-69 on January 24, 2003. Public Notice, 18 FCC Rcd 627 (2003). We will continue to process applications on file as of the date this Order is adopted. The Media Bureau may consider, on a case by case basis and consistent with the public interest, amendments to those applications to, for example, resolve interference with other stations or pending applications or resolve mutual exclusivity with other pending applications.
• Class A station displacement applications and applications for coverage changes that would serve any area that is not already served by that Class A station's authorized facilities. As an exception to this freeze, on-air Class A stations demonstrating that they
66. Notwithstanding the freeze, licensees will not be prevented from filing modification applications when the application would help resolve international coordination issues or when a broadcast station seeks a new tower site due to the events of September 11, 2001. In addition, the Media Bureau will consider, on a case-by-case basis, requests for waiver of the freeze when the modification application is necessary or otherwise in the public interest for technical or other reasons, such as when zoning restrictions preclude tower construction at a particular site or when unforeseen events, such as extreme weather events or other extraordinary circumstances, require relocation to a new tower site.
67. There are approximately 43 stations with DTV applications awaiting international coordination. As of August 4, 2004, there are 32 pending DTV applications/rule making proposals requiring Canadian approval and 11 pending DTV applications/rule making proposals requiring Mexican approval. (These numbers do not reflect those applications which have failed the coordination process or which require further action by the applicant.) We recognize that certain issues may remain to be completed in connection with the Canadian approval process for these stations. We will still require, however, broadcasters to make timely channel elections. As noted above, broadcasters with an out-of-core DTV channel and an in-core analog channel that is not available for digital use under the LOU should indicate this fact on their channel election form. Like any one in-core licensee, these licensees may release their in-core channel and participate in the second round of elections; however, we will also afford licensees a later opportunity in the third round to elect another channel in the event their elected channel remains subject to, or was in the interim adversely affected by, international coordination. Those broadcasters remaining on their DTV allotments that do not have applications to maximize should not have unusual difficulties in the approval process. With respect to post-transition DTV replication of stations' current analog service, we must coordinate DTV use of NTSC channels in border areas. We will conduct this coordination in the course of the new allotment rulemaking. We will resolve any remaining international coordination issues as part of the process of developing new DTV allotments.
68. In the creation of the DTV Table of Allotments, each DTV channel allotment was chosen to allow DTV service thereon to best match the Grade B service contour of the NTSC station with which it was paired. We took this approach to ensure that broadcasters have the ability to reach the audiences that they have been serving with the NTSC analog transmission system and that viewers continue to have access to the stations that they are accustomed to receiving over the air. Although we have declined to make full signal replication mandatory, we continue to believe that most DTV broadcasters eventually will replicate their NTSC coverage with DTV service. As an incentive to replicate, we stated that DTV licensees must either be on the air replicating their April 1997 NTSC Grade B service area as of the replication deadline or lose interference protection to the unreplicated portion of this service area outside the noise-limited signal contour. We stated that other full or low-power stations would then have the opportunity to expand their service areas to serve the viewers made available as a result of a DTV station's failure to fully replicate. We also stated in the First DTV Periodic MO&O that we would treat stations seeking to maximize their service areas in a similar manner. First DTV Periodic MO&O, 16 FCC Rcd at 20606, paras. 29-30. By maximizing, stations make power and antenna height increases above the values allotted in the DTV Table, and site changes that extend the service area of DTV facilities beyond the NTSC replication facilities. Class A Order, 15 FCC Rcd at 6377, para. 52. Congress has recognized the importance of preserving the right of DTV stations to maximize and has established specific measures to protect coverage areas defined in maximization applications. In the Community Broadcasters Protection Act of 1999, Congress protected applications for maximization against new Class A stations. To be entitled to protection by low power television stations applying for primary Class A status, DTV stations were required to have filed an application for maximization or a notice of intent to seek maximization by December 31, 1999, and to have filed a bona fide application for maximization by May 1, 2000. We have emphasized DTV service maximization in the digital transition as a means by which stations may increase their DTV signal coverage and provide DTV service competitively within their respective markets. Sixth Report and Order, 12 FCC Rcd at 14605, para. 30. The Media Bureau froze maximization applications in the 698-746 MHz band (channels 52-59 or the “Lower 700 MHz band”) to assist participants in Auction No. 44 to determine the areas potentially available in the band for the provision of service by auction winners before the channels are cleared. Public Notice, 17 FCC Rcd 11,290 (2002). The Media Bureau later froze maximization applications in the 746-806 MHz spectrum band (channels 60-69 or the “Upper 700MHz band”) to protect Guard Band and Public Safety entities from shifts or expansion in existing broadcast service, and to facilitate the eventual clearing of this spectrum and the auction of the commercial portions of the spectrum.
69. In the First DTV Periodic MO&O, our goal in temporarily deferring the replication protection deadline established in the First DTV Periodic Report and Order was to permit stations to elect a more gradual build-out of their DTV facilities, and thereby increase the number of stations capable of commencing digital service to at least their core communities by the May 2002 and May 2003 construction deadlines. We also gave DTV licensees seeking to maximize facilities, including analog UHF licensees, the same flexibility to implement graduated construction plans as analog VHF licensees.
70. We stated in the First DTV Periodic MO&O that we would establish in this second DTV periodic review a date by which broadcasters must either replicate their NTSC coverage or lose DTV service protection to the unreplicated areas, and by which broadcasters with authorizations for maximized digital facilities must either provide service to the associated coverage area or lose DTV service protection to the uncovered portions of those areas. For DTV channels within the core spectrum, we proposed in the NPRM to set new replication and maximization protection dates: July 1, 2005, for affiliates of the top-four networks (
71. We take seriously our mandate to speed the transition and to ensure that the spectrum is used efficiently. At the same time, we have attempted to accomplish these objectives without imposing undue cost and delay on broadcasters. After careful consideration of the comments, we will adopt the following use-it-or-lose-it replication and maximization deadlines:
• July 1, 2005—Use-it-or-lose-it deadline for DTV licensees affiliated with the top-four networks (
• July 1, 2006—Use-it-or-lose-it deadline for all other commercial DTV licensees as well as noncommercial DTV licensees. Those licensees that receive a tentative DTV channel designation in the channel election process on their current digital channel must construct full, authorized DTV facilities. Those licensees that receive a tentative DTV channel designation on a channel that is not their current DTV channel must serve at least 80 percent of the number of viewers served by the 1997 facility on which their replication coverage was based.
72. We adopt these deadlines for the following reasons. First, we believe that the time has come to ensure that consumers have access to a full range of digital programming services from their local broadcast stations. We note that, even according to MSTV's own study, approximately 40 percent of stations operating pursuant to STAs are reaching less than 70 percent of their analog population with a digital signal. The unserved households are more likely to be in outlying or rural areas, since the minimum STA coverage requirement is that a station's DTV signal covers its actual community of license. Those consumers, like all consumers, reasonably expect that when they buy a digital television set they will be able to receive the same broadcast stations in digital that they receive in analog.
73. Second, our temporary deferral of the replication and maximization deadlines in 2001 recognized that, given the existing marketplace conditions, some broadcasters, particularly those in smaller markets, needed to take a more graduated build-out approach. In particular, we recognized the existing reality of modest DTV receiver penetration, which affected the financial decisions of broadcasters and those who fund them. The outlook for DTV receivers has changed dramatically since 2001. In August 2002, the Commission adopted a DTV tuner mandate. Beginning on July 1, 2004, television receivers shipped in the U.S. must include digital broadcast tuners on a phased-in basis; by July 2007, all television receivers 13 inches and above must include a digital broadcast tuner. In addition, in September 2003, the Commission adopted rules to permit the manufacture of cable-ready “plug-and-play” sets for one-way digital programming. By Commission mandate, each of these sets will also include an over-the-air digital tuner. Between these mandates and the overall increasing pace of the DTV transition, we expect that the penetration of digital televisions with off-air reception capability will dramatically increase in the coming years. Indeed, in testimony before Congress in June 2004, the Consumer Electronics Association (“CEA”) forecast that more than 85 million American homes will have DTV tuners by 2010. This emerging reality should alleviate the concerns of commenters stating that they do not wish to provide service in advance of widespread DTV set penetration. Therefore, we do not believe it is appropriate to further postpone replication and maximization deadlines.
74. Third, we do not believe a replication/maximization deadline will impose an undue burden on broadcasters. Approximately 45 percent of broadcasters currently on the air have built licensed facilities and are operating at full power. Many of these full-power stations are located in smaller markets and/or are non-commercial. Not only did they incur higher build-out costs than a station building today, but they have been incurring higher power costs to operate at full power. It would be inequitable to permit broadcasters operating at lower power—who have already accrued significant benefits from the Commission's STA policy—to continue to require the full-power broadcasters continue to shoulder a heavier load throughout the transition.
75. Fourth, we do not believe that the build-out deadlines will result in undue “stranded investment.” As an initial matter, we are not requiring stations to replicate or maximize. The “use-it-or-lose-it” deadline simply means that after a reasonable build-out period has passed, if a station fails to provide a signal to serve certain viewers, another entity should have the opportunity to do so. After a reasonable build-out period, we believe that the objectives of providing service to the public and spectrum efficiency militate against further protection of the unserved areas. In addition, we have made a significant accommodation for those broadcasters moving to a new DTV channel at the end of the transition: The top-four network affiliates in the top 100 markets need only provide service to the same number of viewers as their replicated service area in order to preserve their right to maximize/replicate on their ultimate DTV channel; the remaining stations need only serve 80 percent of the number of viewers in their replicated service area to preserve their right to maximize/replicate on their ultimate DTV channel. If, as MSTV asserts, a significant amount of power (and hence, expense) is needed to “push” a UHF television signal out the last few miles beyond the station's “line of sight” or “radio horizon,” this should help address the concern. Moreover, we have made a special accommodation, described below, for many of the broadcasters for whom there would certainly be stranded investment—those with a DTV allotment outside of the core. We also note, according to Harris Corporation, that much of the investment in building out will not be stranded even if a station ultimately moves to another channel because some of the equipment can be re-used. Depending on the station's power level and whether it ultimately moves to an in-core VHF or UHF channel, the “stranded” investment caused by an intermediate power increase on the existing DTV channel could range from $345,000 for a higher power station (out of a total investment of $1,355,000 to $1,975,000) to $505,000 for a lower
76. Fifth, as with other aspects of the transition such as the initial construction deadlines, we recognize the particular needs of smaller market and non-commercial broadcasters by setting earlier deadlines for the larger market, commercial broadcasters expected to lead the transition. In addition, we are adopting a waiver process for stations that truly cannot afford to build out to these minimum requirements, or that cannot build out for other reasons beyond their control.
77. Stations on any channel that have received construction permits with construction deadlines that extend beyond these replication/maximization interference protection dates must meet their replication/maximization requirements at the expiration date specified by their construction permit. In the First DTV Periodic MO&O, the Commission established a process whereby certain commercial stations and all noncommercial educational stations operating pursuant to a DTV STA would receive automatic DTV CP extensions until a future “use or lose” date. 16 FCC Rcd at 20608, para. 36. In the Second DTV Periodic NPRM, we sought comment on new replication and maximization protection dates and on the disposition of construction permits or applications for replication or maximization pending at the time of the deadline. In conjunction with the replication and maximization protection dates adopted herein, we clarify that we will also apply the DTV CP extension policy to all stations operating with a licensed DTV facility. Therefore, all properly authorized operating DTV stations with authorized CPs to make changes to their licensed facilities, including the network affiliate stations in the top 30 markets, will have their CPs extended until the replication/maximization interference protection deadlines established in this order. We believe this change is appropriate in order to provide consistency in the treatment of stations with outstanding CPs that have already received a DTV license and those with an outstanding CP operating pursuant to a DTV STA. They must build facilities that meet the minimum requirements by that date or lose interference protection.
78. A station that fails to meet the above replication/maximization requirements will lose interference protection to the unused portion of the associated area as of the applicable interference protection deadline, as described more fully in section IV.D., infra. As a practical matter, nearly every station that has fully replicated its analog coverage will have maximized its DTV coverage by reaching at least some small areas beyond the analog Grade B contour. Where a station has maximized its DTV coverage by a coverage shift that leaves some of its replication coverage area unserved, then the station's protection will shift to its maximized coverage area and it will lose interference protection to the unserved replication area. In addition, a station failing to meet the above deadlines will lose the ability to “carry over” its interference protection to its unserved DTV service area on its post-transition channel (
79. By contrast, a station that meets its applicable build-out requirements will retain interference protection to its authorized service area on its DTV channel if it remains on that channel, as well as the ability to “carry over” its interference protection for its authorized DTV service area if it moves to a different DTV channel post-transition. This decision modifies our decisions in the Class A Order and Class A Recon. Class A Order, 15 FCC Rcd at 6379-80, para. 58; Class A Recon., 16 FCC Rcd 8269-70, para. 67. In the Class A Order, in the context of relative interference protection priorities of Class A and DTV stations, we stated that “[t]o preserve their ability to maximize * * * within the core, we will require stations * * * to * * * maximize their DTV service area on their * * * DTV channel. These stations must have filed a notice of intent to maximize and must file an application to maximize within the deadlines mandated by the CBPA. [W]e will allow these stations to carry over to their in-core [NTSC] channel the maximized digital service area achieved on the [DTV] channel, to the extent that the [NTSC] channel facilities for maintaining the maximized service area provide required interference protection to other DTV stations.” Class A Order, 15 FCC Rcd at 6379-80, para. 58. Under today's decision, stations need only meet our replication/maximization build-out deadlines to preserve their ability to maximize on their ultimate DTV channel. Similarly, stations electing to forfeit their current DTV channel and “flash-cut” to digital on their analog channel under the options described below for stations with out-of-core DTV allotments and satellite stations, will be entitled to interference protection as if they met the applicable replication/maximization build-out deadlines. However, a station moving to a different DTV channel at the end of the transition will lose interference protection during the transition to any unserved areas on its current DTV channel as of the applicable deadlines, notwithstanding the fact that it meets the minimum build-out requirements. For example, assume a broadcaster subject to the July 1, 2006 deadline will be changing DTV channels at the end of the transition and meets the 80 percent build-out requirement by serving 90 percent of its replicated service population by July 1, 2006. Assume further that it was authorized to build maximized facilities, serving 120 percent of its replicated service population. At the end of the transition, it will be entitled to “carry over” its full maximization service area, to the extent possible under our rules. However, during the transition, the station will lose interference protection on its existing DTV channel for those areas within its maximized service area that are unserved as of the deadline (
80. For those stations that are unable to provide the required service by our replication/maximization protection deadlines because of severe financial
81. KM Companies requests that we specifically address the treatment of single channel broadcasters with respect to the interference protection deadline. As discussed elsewhere, single channel broadcasters will participate in the channel election process. Analysis of their channel elections will be based on their authorized facilities (construction permit for stations that have both a license and a construction permit). Whether their single-channel authority is analog or digital, a broadcaster that has not constructed or is not operating the appropriate facilities on which its election analysis is based will lose protection of the unserved area as of the applicable interference protection deadline (except in cases where the DTV allotment coverage is based on a construction permit that expires after the deadline, in which case they will keep their protection as long as the construction permit remains valid).
82. The Second DTV Periodic NPRM asked if we should establish earlier replication and/or maximization interference protection deadline(s) for out-of-core broadcasters (
83. The Commission permits broadcasters with NTSC stations in the Upper 700 MHz (60-69) or the Lower 700 MHz (52-59) to enter into voluntary band clearing arrangements consistent with the Commission's existing band-clearing rules and Section 6 of the Auction Reform Act of 2002. Auction Reform Act of 2002, Pubic Law 107-195, 116 Stat. 715 (“Auction Reform Act”) section 6(a), 47 U.S.C. 337 note. Section 6 of the Auction Reform Act restricts the Commission from waiving certain broadcast interference standards and the minimum spacing requirements for certain proposals to relocate Channel 52-69 analog operations to a Channel 2-51 DTV allotment, if such waiver “will result in any degradation in or loss of service, or an increased level of interference to any television household except as the Commission's rules would otherwise expressly permit, exclusive of any waivers previously granted.” Id. These restrictions do not, however, apply to proposals to move Channel 63, 64, 68, or 69 analog operations to in-core DTV allotments “in order to make such frequencies available for public safety purposes.” Id., Section 6(b). In furtherance of the significant public interest in rapid band clearing, and in recognition of the fact that all out-of-core DTV facilities will have to move at the end of the transition, we will permit stations with an in-core NTSC channel paired with an out-of-core DTV channel, as well as stations with two out-of-core channels, to surrender their out-of-core DTV channels and operate in analog on their analog channels. We will also permit single-channel DTV stations out of the core, upon Commission approval, to elect not to construct DTV facilities and instead to give up their assigned DTV channel in the 700 MHz band in return for a DTV channel inside the core. We will assign these broadcasters an in-core DTV channel when we generate a revised DTV Table of Allotments Stations have up to their initial channel election deadline to inform the Commission that they will use this option. We delegate the authority to grant these requests to the Media Bureau. Upon approval from the Commission, these stations will then surrender their out-of-core digital channel and be treated as single channel stations, allowed to “flash cut” to digital on their in-core channel no later than the end of the transition in the stations' markets. These stations will retain their ability to replicate and/or maximize on their NTSC allotment as if they met the applicable replication/maximization build-out requirement. The station will then be responsible for meeting any DTV service obligations (
84. This presumption, however, is neither conclusive nor dispositive. We will also consider whether special circumstances raised by the resulting loss of digital broadcast service would be sufficient to rebut the presumption. We find that the surrender of DTV channels of these out-of-core stations will generally not create a loss of particular programming to viewers during the transition because, as presented in Paxson's comments, the stations will continue analog operations until switching to DTV by the end of the transition Also, for requests that do not meet the presumption, we would consider all the relevant public interest factors regarding opportunities for provision of wireless and public safety services, acceleration of the DTV transition, and the loss of broadcast service in deciding whether or not to approve the request.
85. Stations that have been denied an extension of the construction requirements and admonished because they failed to demonstrate that they are meeting the necessary criteria for an extension and have not come into compliance are not eligible to surrender their out-of-core DTV channel. On April 16, 2003, the Commission released an Order establishing remedial measures to be followed when a television station fails to meet its DTV construction deadline and fails to adequately justify an extension of its DTV construction deadline. Under the three-step graduated sanction process we will first deny the request for an unqualified extension and admonish the station for its failure to comply with its DTV
86. In the Second DTV Periodic NPRM we sought comment on whether the public interest would be served by allowing television satellite stations to turn in their digital authorization and “flash-cut” to DTV transmission at the end of the transition period. TV satellite stations are full power terrestrial broadcast stations authorized under part 73 of the Commission's rules to retransmit all or part of the programming of a parent station that is typically commonly owned. Eligible satellite stations were assigned a paired DTV channel in the current DTV Table of Allotments. The Commission first authorized TV satellite operations in small or sparsely populated areas, which were deemed to have economic bases insufficient to support stand-alone, full-service operations. The Commission later authorized satellite stations in larger markets when the applicant demonstrated that the proposed satellite could not operate as a stand-alone, full-service station. The Commission has also allowed a full-service station to convert to satellite operation upon a showing that the community no longer has a sufficient economic base to support a full-service operation.
87. On October 16, 2003, the Commission deferred the digital construction deadlines for 30 satellite stations that had requested a third extension of time to construct. The Commission noted that the issue of whether to permit satellites to turn in their digital authorization and “flash cut” to DTV transmission at the end of the transition period is under consideration in this proceeding.
88. To ensure that the channel election process described herein proceeds smoothly and that the channels being surrendered by satellite licensees are included, we will require all satellite stations to participate in the channel election process. We will permit satellite stations to surrender one of their paired channels (the one not elected on their channel-election form for use after the transition) and flash cut from analog to digital transmission by the end of the transition period. Satellite stations that choose to flash cut must make the flash cut decision and notify the Commission by their initial channel election deadline. Satellite stations choosing the flash cut option will be required to surrender one of their two broadcast channels. Except as provided below (for stations with out-of-core analog and in-core DTV channels), satellite stations that choose not to flash cut and instead choose to retain both an analog and a digital channel during the transition period must comply with the applicable digital construction deadlines, including any extension granted by the Commission. As noted above, a satellite station that surrenders one of its channels under the “flash-cut” option will be treated as if it met the applicable replication/maximization build-out requirements.
89. Satellite stations with an analog channel outside the core and that are electing their current in-core DTV channels for post-transition DTV service will not be required to surrender a channel at this time. To do so would require these stations to give up their DTV channels unnecessarily or to build DTV facilities now, unlike other satellite stations which, under the flash cut policy announced herein, may elect to wait to build their digital facilities until closer to the end of the transition period. In this instance, we believe the benefits of this approach outweigh our interest in rapid clearing of the out-of-core television spectrum. Satellite stations with an out-of-core analog channel and an in-core digital channel may retain their out-of-core channel for continued analog service until the end of the transition or until they decide to build and transmit only in digital, whichever is earlier.
90. Stations electing to return their DTV channel to the Commission will retain interference protection to the areas defined in existing DTV replication or maximization applications on file with the Commission until the end of the transition when the station must commence digital transmissions. This interference protection will apply to the digital service area of the channel on which the station flash cuts to digital to the extent that the station replicates and maximizes at the time of the flash cut and to the extent consistent with our DTV interference protection rules. To ensure that satellite stations that have already constructed digital facilities or that do so before the end of the transition are not disadvantaged, we will also permit these stations to retain replication and maximization interference protection for their digital stations until the end of the transition in their market. Similarly, to provide satellite stations that have constructed digital facilities additional flexibility during the transition while maintaining an basic level of service to the public, we will also permit satellite stations that choose to construct separate digital facilities to operate only during prime time hours (at a minimum) until the end of the transition.
91. We believe that this approach will best ensure that satellite stations complete the conversion to digital format and continue to provide broadcast programming to viewers in their communities. We agree with LeSEA, Media General, and MSTV/NAB that many satellite stations may not be financially capable of operating both an analog and a digital facility concurrently. As these commenters point out, satellite stations provide programming to communities that cannot support operation of these stations on a full-service basis. Indeed, Media General and LeSEA state that their satellite stations continually operate at a loss and that, absent some relief from the requirement of constructing and operating dual facilities during the transition, they may be forced to turn in their satellite licenses and cease all operations. Unlike full-service stations, satellite stations have chosen to forego or relinquish full-service status and instead retransmit the programming of a parent station because full-service operation of the satellite facility is not economically viable. We believe that the unique status of and circumstances faced by satellite stations warrant special treatment of these stations during the transition.
92. We do not believe that granting this special relief to satellite stations will unduly hinder the overall transition to digital television. Some of the affected viewers may have access to other digital signals. According to a study of its satellite stations. Moreover, the alternative to the flash-cut option we are adopting today, that of requiring
93. In the NPRM, we asked for comment on how the Commission should dispose of a station's construction permit or application for replication or maximization facilities if the station fails to construct and operate facilities that fully replicate its NTSC service or provide signal coverage over an authorized maximized service area by the interference protection deadlines established in this proceeding. We stated that our inclination was to restrict any station that has failed to fully replicate or construct its authorized maximization facilities by the applicable deadline from filing an application to expand coverage for a certain period of time in order to allow other existing or new stations, including Class A eligible LPTV stations on out-of-core channels, to apply to use this spectrum.
94. We will dismiss any applications and cancel any construction permits for facilities in excess of those in actual operation by a station as of the applicable interference protection date. We will require broadcasters to file applications for licenses to cover their actual facilities served as of the interference protection deadline. We have given broadcasters ample opportunities over the past years to expand their service areas, and advance warning that if they elect not to provide their viewers with DTV the Commission may ensure the area is served in other ways. Therefore, we will permit existing DTV stations seeking to expand their coverage area and Class A eligible stations on out-of-core channels to apply for unused spectrum within the core. LPTV stations may also apply for secondary operation on unused spectrum. We will describe the procedures for filling in those unserved areas in a future public notice or as part of the periodic review process. Broadcasters failing to meet our replication or maximization deadlines will be permitted to reapply for authorization to provide service to those areas, but their applications will be subject to conflicting applications. This will allow other existing stations, including Class A eligible LPTV stations on out-of-core channels, the opportunity to apply to use this spectrum. The process for resolving conflicting applications will be announced in another public notice or proceeding.
95. Approximately 65 commercial and noncommercial television licensees have not yet been granted an initial DTV CP. Almost all of these licensees have filed an application for a digital CP, but grant of these applications has been delayed for a variety of reasons, including delays in international coordination with Canada and Mexico and unresolved interference issues. To date, these applicants have not been required to construct DTV facilities pending action on their outstanding DTV applications. To ensure that all licensees that have been allotted digital spectrum begin to provide digital service, we proposed in the Second DTV Periodic NPRM to require that all television licensees that have filed an application for a digital CP with the Commission that has not yet been granted commence digital service pursuant to special temporary authority (“STA”) within one year from adoption of the Report and Order in this proceeding.
96. It is crucial at this stage of the transition that all licensees with DTV CP applications that have not yet been granted begin to construct digital facilities. We will therefore adopt a proposal similar to that advanced in the NPRM. Rather than requiring licensees with pending DTV CP applications to construct at least the minimum initial facilities required to serve their communities of license within a year from the adoption of this Report and Order, as we proposed, we will instead require such licensees, within the same time frame, to construct and operate “checklist” facilities that conform with the parameters of the DTV Table of Allotments and other key processing requirements. “Checklist” facilities have power and antenna height equal to or less than those specified in the DTV Table of Allotments and are located within a specified minimum distance from the reference coordinates specified in the DTV Table of Allotments. Because these facilities comply with the interference requirements specified in the rules, no further consideration of interference is required. In addition, because the DTV Table has been coordinated with Canada and Mexico, “checklist” facilities generally do not require further international coordination. This approach best advances our goal of ensuring continued progress in the transition by requiring that all licensees begin to provide DTV service. “Checklist” applications are routinely processed by the Commission staff within three days of filing, and most do not require international coordination. Thus, this procedure is the most expeditious means of awarding DTV construction permits to those licensees who do not yet have them.
97. Many licensees with pending DTV CP applications are facing delays beyond their control. Some are awaiting international coordination of pending applications or resolution of interference issues. Other licensees have applied for new DTV allotments either to replace an initial out-of-core allotment with one in the core or to otherwise improve their potential DTV service. Although the Commission will continue to work with applicants to resolve outstanding issues and to process pending applications for digital facilities as expeditiously as possible, we nonetheless agree with those commenters who argue that it is critical at this stage in the transition that all licensees begin working toward construction of DTV facilities.
98. We will allow licensees with pending DTV CP applications that file checklist applications to continue to pursue their non-checklist applications now on file. Thus, while these applicants will receive a construction permit for a checklist facility and will be required to construct such facilities within one year from adoption of the Report and Order in this proceeding, we will permit these applicants to continue to attempt to resolve the issues delaying approval of their non-checklist application currently on file with the Commission. If the non-checklist application is approved before construction of the checklist facility is complete, the permittee may request that the Commission substitute the non-checklist CP for the checklist CP. The Commission will consider requests for waiver of the one year construction deadline, on a case-by-case basis, using the criteria for extension of DTV construction deadlines. Grounds for an extension must relate to the checklist facility, not the pending non-checklist application.
99. In the First DTV Periodic MO&O, we allowed stations to commence digital operations by constructing and operating facilities that at least provide the required level of digital signal strength to their communities of license. We predicted that the “requirement that
100. We conclude that we will not impose an intermediate signal level requirement. With the community of license signal strength increases set for 2004 and 2005, we expect that more of broadcasters' service areas will be covered as these dates approach. Increasing power is one way of increasing the signal strength within an area, such as the community of license. A 7 dB increase in a station's power will result in a 7 dB increase in signal strength. A power increase will also increase the station's service area. Increasing antenna height is another way to increase a station's signal strength and service area. Nonetheless, we will closely monitor reports from consumers and other parties regarding broadcasters operating at insufficiently low power levels and will act on these reports should a pattern of abuse of our signal level requirements become evident. We may also, on our own initiative, conduct signal strength tests to ensure that broadcasters are operating at power levels that are consistent with the Commission's requirements.
101. The Second DTV Periodic NPRM sought comment on an issue raised in the Public Safety Spectrum Report and Order. The NPRM explained that §§ 90.545(c) and 27.60(b) of the Commission's rules describe alternative methods for a wireless applicant or licensee in the 700 MHz band to move closer to an analog TV or DTV antenna while still complying with the interference protection requirements in the rules. Pursuant to one of these alternatives, the applicant or licensee may submit an engineering study that considers the “actual,” rather than “hypothetical,” parameters of the analog TV or DTV station and that demonstrates that the station's actual coverage area is smaller than its hypothetical operating parameters—because the station is operating, for example, with lower power than that presumed in the hypothetical parameters or because intervening terrain or other factors reduce the station's coverage area—thereby permitting land mobile stations and these broadcast facilities to be more closely spaced. Reference to the Grade B contour of a “hypothetical” station permits an applicant or licensee to determine if there is any need to submit additional engineering studies or if there is not even a hypothetical station within the relevant area. If there is a hypothetical station, then the applicant or licensee must demonstrate how it would protect the actual (including authorized or applied for) parameters. The Public Safety Order allowed applicants to submit engineering studies showing how they propose to meet the appropriate desired to undesired (“D/U”) signal strength ratio at the existing TV station's “authorized or applied for” Grade B service contour or equivalent contour for DTV stations instead of providing the protection built into the distance spacing table, which is based on a standard TV station's hypothetical Grade B contour. In the Second DTV Periodic NPRM, we tentatively concluded that §§ 90.545(c)(1)(ii) and 27.60(b)(1)(iii) of our rules should be amended to make clear that the interference protection specified in those provisions should be afforded to authorized and/or applied for NTSC and DTV facilities, including the facilities specified on the broadcast station's license or construction permit or both when a station has both a license and a construction permit. We sought comment on this tentative conclusion, as well as alternatives.
102. As proposed, we will amend §§ 90.545(c)(1)(ii) and 27.60(b)(1)(iii) to make clear that the interference protection specified in those provisions will be afforded to authorized and/or applied for NTSC and DTV facilities, including the facilities specified on the broadcast station's license or construction permit or both when a station has both a license and a construction permit. In the TV and DTV broadcasting services, applicants file separately for a construction permit and a license to operate a facility when construction is completed. Licensees may also file applications for construction permits to modify their stations' facilities. When applications are granted, the facilities are authorized by a construction permit or license. While some public safety and other entities in the 700 MHz band assert that protecting authorized and/or applied for NTSC and DTV facilities is unnecessary, this protection is necessary to permit broadcasters to increase their service to reach their replication and maximization levels without risk of interference from new services. Permitting stations to achieve replication and maximization coverage serves the transition to DTV by increasing the population with access to digital signals. In addition, as discussed in section IV.B., supra, replication on out-of-core DTV channels is necessary to preserve broadcasters' opportunity to carry over their DTV service areas to their eventual in-core channels. As asserted by Sinclair, protecting less than the full replicated or maximized facilities could create loss of service to wireless or public safety providers when DTV stations increase to replicated or maximized facilities. Our existing band-clearing policies and newly introduced “flash cut” policy discussed in section IV.B.2, supra, should alleviate some of the 700 MHz entities' concerns by more rapidly freeing up additional spectrum in channels 52-69. New operations in the 700 MHz band will essentially need to provide the interference protection specified in §§ 90.545(c)(1)(ii) and 27.60(b)(1)(iii) for authorized or applied for but un-built facilities only until the July 1, 2005, and July 1, 2006, replication/maximization interference protection dates. In limited circumstances we will grant interference protection beyond the replication/maximization dates for stations granted construction extension waivers. As discussed above, if a broadcaster is not serving its fully authorized replication or maximization facilities on the
103. As we stated in the
104. In the Lower 700 MHz Band Report and Order, we dismissed pending petitions for new NTSC channel allotments in the band comprising channels 52-59, stating that adding new analog TV allotments or stations at this stage of the transition would be inconsistent with the DTV transition process. With respect to pending applications for construction permits for new analog TV stations in this band, we provided a 45-day opportunity (referred to herein as the “March 8, 2002 filing window”) for applicants to request a change in their applications to either (1) provide analog or digital service in the core television spectrum,
105. In the Second DTV Periodic NPRM we indicated that digital service in the Lower 700 MHz band could be proposed after the auction of channels in that band by a station with an existing DTV allotment on a channel outside the 52-58 band seeking to move to a channel inside this band or by a DTV station inside this band seeking to move to another channel inside the band. As we indicated in section IV. A. 2, supra, we have determined herein that, in order to facilitate the channel election process, we will no longer accept, as of the date of adoption of this Report and Order, applications for DTV channel changes and swaps. Thus, there will be no new analog or DTV entrants in the 698-740 MHz band other than those acquired through auction.
106. A few requests for DTV channels in the 52-58 band were filed during the July 15, 2000, and March 8, 2002, filing windows. The Commission has completed processing all but one of these petitions for rulemaking. While these parties may continue to pursue construction of their proposed facilities within the 52-58 band, we will permit these parties, upon Commission approval, to elect not to construct these facilities and instead to give up their assigned DTV channel in the 52-58 band in return for a DTV channel inside the core. We will assign these broadcasters an in-core DTV channel when we generate a revised DTV Table of Allotments.
107. In the Second DTV Periodic NPRM, we sought comment on the interference protection that should be afforded by wireless entities and other new service providers to future analog TV and DTV facilities on channel 51 that are authorized or requested after the auction of the spectrum comprising channel 52. Channel 51 will remain allocated to broadcast use as part of the core television spectrum (channels 2-51), and is available for use by existing and new analog TV and DTV stations. However, as we stated in the Second DTV Periodic NPRM, because channel 51 is adjacent to channel 52 we are concerned about possible interference between new wireless and other licensees on channel 52 and operations on channel 51. In the Lower 700 MHz Report and Order, we declined to adopt a guard band or other specialized mechanism to protect DTV operations on channel 51, and stated that we would instead rely on interference protection criteria to ensure that new licensees adequately protect core channel TV and DTV operations. We noted that the adjacent channel protection for TV and DTV stations on channels 52-69 is no different from the protection for those stations in the core spectrum; only the duration of that protection differs. Because DTV stations on channels 52-69 will eventually relocate to the core TV spectrum, the broadcast interference protection standards on channels 52-69 will no longer apply after the transition. By contrast, the need for protection of broadcast operations on core TV channel 51 will continue indefinitely. In light of our concern about possible adjacent channel interference, we sought comment on whether we should provide the same level of adjacent channel protection to future analog and digital broadcast facilities on channel 51 as is currently provided by wireless or other operators to incumbent analog and digital stations on this channel and, if so, how we can accomplish such protection without unduly restricting use of the channel 52 spectrum.
108. We will accord the same level of adjacent channel protection to both incumbent and future analog and digital broadcast facilities on channel 51. Thus, wireless and other operators on channel 52 must provide the interference protection prescribed in the Lower 700 MHz Report and Order to all broadcasters on channel 51, including any that may commence operation after the auction of the adjacent channels in the 52-58 band. We agree with MSTV/NAB that stations on channel 51 should receive the same level of protection as other stations on in-core channels, including protection from wireless and other new service providers. We disagree with Flarion that any interference protection the Commission adopts for channel 51 should be reciprocal. Channel 51 is part of the core channels reserved for broadcast use, and we do not believe use of channel 51 for broadcast purposes should be restricted in order to protect operations on channel 52, even if those operations predate the commencement of operations on channel 51. We also decline to adopt Flarion's proposal that the Commission reduce or eliminate the required desired/undesired signal strength ratio for “distantly adjacent” wireless channels. This proposal to revisit the wireless to TV and DTV protection criteria established in the 700 MHz proceedings is beyond the scope of this proceeding. The Commission's rules do permit wireless and other operators in the 52-58 band to negotiate agreements with broadcasters and other operators to accept any interference that may be caused by operations on distantly adjacent frequencies. Licensees proposing new operations in the 700 MHz bands on a frequency “distantly adjacent” to an existing
109. In the
110. In the Second DTV Periodic NPRM, the Commission sought comment on whether we should retain, revise, or remove the simulcasting requirement in 47 CFR 73.624(f), how to define simulcasting, and whether the existing dates for implementation of the simulcasting requirements are appropriate. We asked in the Second DTV Periodic NPRM whether the ultimate requirement of 100 percent simulcasting other than at the very end of the transition creates a disincentive for broadcasters to innovate. We also asked whether a requirement to simulcast is necessary or whether broadcasters have a market-based incentive to simulcast and are currently simulcasting 100 percent of their analog programming on their digital channel. In addition, we sought comment on whether something less than a 100 percent simulcasting requirement would be sufficient to protect analog viewers while allowing for innovation on the DTV channels.
111. In an Order adopted April 28, 2003, the Media Bureau granted noncommercial educational television stations a six-month waiver of the DTV simulcasting requirements, until November 1, 2003. The Bureau noted that, in light of the burden faced by NCE stations in complying with both the construction and simulcasting requirements at once, and in light of our pending re-evaluation of our simulcasting requirements, good cause existed to grant NCE stations a six-month waiver of the simulcasting requirements in § 73.624(f) of the Commission's rules. We also stated that we would consider requests for waiver extensions from NCE stations on their individual merits if the Commission had not yet acted on the simulcasting issues raised in the Second DTV Periodic NPRM by November 1, 2003. The Media Bureau has granted several additional requests for waiver of the DTV simulcasting requirements to give stations additional time to acquire and install the facilities necessary to meet the simulcasting requirement or to permit stations to experiment with innovative uses of the digital channel.
112. We believe that, at this point in the transition, mandating a requirement that the programming aired on the analog channel be simulcast on the digital channel is not necessary to advance transition progress. Simulcasting has been the general practice of broadcasters as the transition has progressed. Thus, broadcasters are not now treating their digital channel as a separate, unique program stream. We also agree with HDNet, Belo, and Disney/ABC that the availability of high-quality innovative digital content is critical to the advancement of the transition. There is evidence in the record that the simulcasting rule may impede the distribution of high definition programming to broadcasters. We are concerned that broadcasters not be impeded in developing, obtaining, or airing high definition and other innovative programming that could spur consumer demand for DTV.
113. Accordingly, we will eliminate, for the time being, the requirement that broadcasters air on their digital channel the programming aired on their analog channel. We expect broadcasters to use this increased flexibility to provide innovative, value-added programming to consumers; if this expectation proves misplaced, we will take appropriate action. However, as we continue to monitor the progress of the transition in future DTV periodic reviews, we will continue to consider whether re-imposition of a simulcasting requirement is advisable. Our concern is to ensure that, as the end of the transition nears, significant numbers of viewers will not be denied access to desirable programming aired only on analog channels. We believe that eliminating rather than reducing the simulcasting requirement is appropriate at this point in the transition. There is no evidence of the need for any simulcasting requirement at this time. While we recognize that, as NCTA argues, viewers could lose access to programs at the end of the transition if programs available on analog channels are not available on digital channels, we believe we can address this concern if the need arises closer to the end of the transition. Because we are eliminating the simulcasting requirement, we do not address herein the issue of how to define simulcasting in the context of the digital transition.
114. Minimum hours of operation of digital stations. In the DTV Fifth Report and Order, we required DTV licensees and permittees to transmit at least one DTV signal at any time the licensee or permittee transmits an analog signal. In the First DTV Periodic MO&O, the Commission revised this requirement to allow stations subject to the May 1, 2002, or May 1, 2003, digital construction deadlines to operate initially at a reduced schedule by providing, at a minimum, a digital signal during prime time hours, consistent with their simulcasting obligations. The top-four network affiliates in the top 30 television markets are required to operate their DTV stations whenever their analog stations are operating. The reduced digital operating schedule tied to the simulcasting requirements applies only to commercial stations in the top 30 markets not affiliated with a top-four network, commercial stations in markets below the top 30, and noncommercial stations. The minimum operating hours for these digital stations effectively increases as the simulcasting obligations are phased in. For example, beginning April 1, 2003, DTV stations that were required to be on the air by May 1, 2002, are required to provide a simulcast digital signal at least 50 percent of the time they transmit an analog signal and, under the requirements of § 73.624(b)(1) of the Commission's rules, are also required to air a digital video program signal during prime time. Along with the simulcasting requirements, the minimum hours requirements step up to a 75 percent requirement in April 2004, and a 100 percent requirement in April 2005. Stations that were subject to the earlier DTV construction deadlines (May 1, 1999 for top-four network affiliates in the top 10 television markets and November 1, 1999 for all remaining top-four network affiliates in the top 30 television markets) are subject to our original rule requiring that they operate their DTV station at any time that the analog station is operating.
115. We proposed in the Second DTV Periodic NPRM that, if we eliminate or reduce the simulcasting requirements in § 73.624(f), we amend § 73.624(b)(1) of our rules in order to retain the same phased-in minimum DTV operating hours for smaller and smaller-market stations that were tied to the simulcasting requirements. A number of commenters argue that the Commission should postpone the date by which smaller-market stations have to expand
116. As we proposed in the NPRM, we will retain the same minimum DTV operating hours for smaller and smaller-market stations as were in effect under the simulcasting requirements. Thus, DTV stations subject to the May 1, 2002, or May 1, 2003, construction deadlines will continue to be subject to the requirement, effective April 1, 2004, that they air a digital signal for an amount of time equivalent to 75 percent of the amount of time they provide an analog signal. Effective April 1, 2003 and until the requirement increased on April 1, 2004, these stations were required to air a digital signal for 50 percent of the time they provided an analog signal The digital signal must be aired during prime time hours. The minimum digital operation requirement will increase to 100 percent on April 1, 2005 (requiring the airing of a digital signal for an amount of time equivalent to at least 100 percent of the amount of time the station airs an analog signal). We herein amend § 73.624 of our rules to retain the minimum operating hours requirements while deleting the simulcasting requirements.
117. We disagree with Paxson that the minimum operating hours requirement should be delayed pending the Commission's decision in the must-carry proceeding. As we indicated in denying Paxson's earlier request for a one-year waiver of the April 1, 2003 operating hours requirement, we do not believe that the increase in the hours of digital programming offered to viewers needs to await finalization of the Commission's separate proceeding regarding mandatory carriage of analog and digital signals during the transition.
118. We also disagree with the other commenters who support a delay in the increase in the minimum operating hours of DTV stations. Increasing the operating hours of digital stations subject to the May 1, 2002, and May 1, 2003, digital construction deadlines will help further the transition by helping to drive DTV set penetration and encouraging content producers and advertisers to invest in DTV. These stations have been on notice since the November 2001 adoption of the phased-in simulcasting requirement in the First DTV Periodic MO&O that their DTV operating hours must be stepped-up on April 1, 2004, and April 1, 2005. Postponing the required, gradual increase in the digital operating hours of these stations would be inconsistent with the ultimate goal of this proceeding of moving to an all digital television service.
119. Finally, MSTV/NAB suggests that the Commission permit DTV stations coming on the air later than the April 1, 2003, and April 1, 2004, minimum operating hour deadlines (
120. Noncommercial television broadcasters were scheduled to complete construction of their digital stations and commence digital service by May 1, 2003. Of the 373 noncommercial television stations, 84 were on the air either on time or ahead of this construction deadline and approximately 214 requested extensions of the deadline. The Commission has granted all of these extension requests. Other NCE stations have construction permits that have not yet expired or have filed construction permit applications with the Commission that have been processed and are awaiting additional information or international coordination, or are mutually exclusive. We invited comment in the Second DTV Periodic NPRM on what steps, if any, the Commission should take to assist noncommercial stations in the transition to DTV. In particular, we sought comment on whether the financial hardship standard for grant of an extension of time to construct a digital television station should be applied differently to noncommercial licensees.
121. As we have acknowledged before, noncommercial stations face unique financial difficulties in constructing digital facilities. According to Public Television, 24 percent of the public television stations seeking an extension of the May 1, 2003, construction deadline cited funding difficulties as a motivating reason for the extension request. For those stations facing funding shortfalls we have and will continue to consider the unique funding needs of noncommercial educational broadcasters in assessing a station's request for an extension of time to construct a DTV facility. As the unique circumstances of noncommercial stations are being considered under our current extension criteria, we do not believe it is necessary at this time to revise those criteria for noncommercial stations or to change the way we are applying the current criteria to this group.
122. According to Public Television, NCE stations cite non-financial impediments to construction more frequently than financial impediments as the cause for delay in completing their DTV facilities. However, there is no evidence that noncommercial licensees face unique non-financial obstacles to completing construction. Thus, we also do not believe it is necessary at this time to revise our criteria for evaluating non-financial grounds for an extension for noncommercial licensees to assist this group to complete the digital transition. We will continue to monitor the progress of noncommercial educational television stations in their conversion to digital transmissions, however, and will continue to assess whether further steps are needed to assist these stations in accomplishing the conversion.
123. In the DTV Tuner Order, we revised our rules to specify that the August 7, 2001, version of the ATSC] DTV standard A/53B should be used in place of the September 16, 1995, version originally adopted. We revised § 73.682(d) of the rules to specify ATSC Doc. A/53B (ATSC Digital Television Standard, 7 Aug. 01), except for § 5.1.2 (“Compression format constraints”) of Annex A (“Video Systems Characteristics”) and the phrase “see Table 3” in Section 5.1.1 Table 2 and Section 5.1.2 Table 4). We also acknowledged the likelihood that there will be further improvements made to the DTV standard over time, and stated our intention to consider incorporation
124. We find that it is desirable and appropriate to update our DTV rules to recognize Amendment 1 (May 23, 2002) to ATSC DTV Standard A/53B (August 7, 2001). We decline to mandate that broadcasters use the AFD when the active video portion picture does not completely fill the coded picture. The revisions in the new version of the ATSC DTV Standard were developed through careful consideration and deliberation within the technical committees of ATSC and thus reflect a consensus agreement based on the input of parties from various segments of the industry. While broadcasters will have the option to use AFD, if a station includes AFD data it must follow the ATSC DTV standard. As more consumers acquire widescreen aspect ratio sets, the problem of “postage stamp video” will become more prevalent if not addressed by broadcasters. Broadcasters should have every incentive to make their programming attractive to viewers and to avoid disenfranchising those viewers as they begin to adopt DTV.
125. We will update our DTV rules to recognize Amendment 2, as released by the ATSC on May 19, 2003. Updating the rules to reflect improvements in the standard will benefit both the public and broadcasters by allowing broadcasters to make technical improvements in their service that will enhance the quality of DTV services they provide. Accordingly, we are revising § 73.682(d) of the rules to specify ATSC Doc A/53B (ATSC Digital Television Standard, 7 Aug 01), Revision B with Amendment 1 and Amendment 2. We also continue to encourage further improvements to the DTV standards. Although it will be necessary to conduct additional rule making activity to incorporate such changes in the rules, we nonetheless will endeavor to pursue such rule making as quickly as possible, either through our periodic review of the DTV transition or through separate proceedings as may be appropriate.
126. The ATSC also adopted Amendment 2 to A/53B, which revises the transport section of the ATSC Digital Television Standard, Annex C, to update normative references to avoid conflicts, and to establish a common methodology for carriage of private data in the ATSC Transport Stream. The amendment defines the ATSC Private Information Descriptor for the carriage of private descriptor-based data, and it also clarifies rules for use of the MPEG-2 Registration Descriptor mechanism for management of private data in the digital multiplex. To be consistent with the current version of the ATSC A/52 Digital Audio Compression Standard, Amendment 2 revises the way audio language is signaled in the ATSC system and specifies the use of ISO-639 language encoding to identify written and spoken languages. Amendment 2 also specifies some requirements that had been implemented in transmission and receiving equipment but not properly specified in A/53B. These included the requirement that each service with an audio component must include at least one “complete main” audio service and the requirement that the video Elementary Stream component be identified with MPEG-2 stream-type value 2. Upon final approval of the ATSC membership, ATSC suggests that the Commission incorporate Amendment 2 to A/53B into its rules.
127. In the DTV Tuner Order, we stated that we would seek comment on whether the Commission should adopt the ATSC Program System and Information Protocol (“PSIP”) standard into our rules as part of the DTV periodic review process. We stated that in the interim we will continue to support and encourage the voluntary use of the PSIP specification by broadcasters and cable operators and its inclusion in consumer electronics equipment. Section 73.682(d) of our rules includes a reference to the ATSC PSIP Standard as a document that licensees may consult for guidance PSIP is data that is transmitted along with a station's DTV signal that tells DTV receivers information about the station and what is being broadcast. PSIP provides a method for DTV receivers to identify a DTV station and to determine how a receiver can tune to it. PSIP identifies both the DTV channel and the associated NTSC channel and enables DTV receivers to associate the two channels, thereby making it easy for viewers to tune to the DTV station even if they do not know the channel number. Linkages between analog and DTV channels are managed through the DTV “Transport Stream Identifier” and analog “Transmission Signal ID” (Both, “TSID”). The Association for Maximum Service Television (“MSTV”) has undertaken the task of maintaining a list of TSIDs. In addition to identifying the channel number, PSIP tells the receiver whether multiple program channels are being broadcast and, if so, how to find them. It also identifies whether the programs are closed captioned, and conveys available v-chip information, among other things. As will be discussed in sections J. 3 and K., infra, PSIP enables the proper functioning of v-chip and closed captioning. The Commission has recognized the utility that the ATSC PSIP Standard offers for both broadcasters and consumers. The channel mapping protocols contained in the PSIP identification stream could help resolve issues associated with digital channel positioning. In the NPRM, we sought comment on whether to require the use of PSIP and which aspects of PSIP should be adopted into our rules. We also sought comment on, among other things, whether and how broadcasters include PSIP information with their digital broadcast signals and also how consumer electronics equipment manufacturers build equipment to search for information in DTV signals.
128. We conclude that adoption of ATSC A/65B (PSIP) into our broadcast transmission standards will serve the public interest. As pointed out by commenters, during the development of PSIP, the ATSC carefully considered which elements of PSIP should be mandatory and which should be optional. Further, based its experience with the deployment of over 180 PSIP systems, Harris states that it is not aware of any difficulties that are experienced by either the broadcaster or the viewing consumer if the ATSC A/65B PSIP standard is properly implemented. We find the cost to broadcasters of implementing PSIP will be minor in comparison to the overall costs of converting to DTV and will provide many options to expand on the investments they have made to convert to DTV. Harris reports that based on its experience as a manufacturer of broadcast station PSIP equipment, it currently would cost a DTV broadcast station $29,900 for full implementation of PSIP, including all Program and System tables. Harris Comments at 9. We therefore require that broadcasters fully implement PSIP to the extent that ATSC A/65B requires. According to A/65, the PSIP mandatory tables are: Master Guide Table (MGT); Terrestrial Virtual Channel Table (TVCT); Event Information Tables (EIT-0 to EIT-3); System Time Table (STT); Rating Region Table (RRT). According to A/65, the RRT is not mandatory for the U.S. region (0x01). Transmission of the RRT is not necessary where the content
129. Major/Minor Channel Numbers. In the NPRM, we noted that the ATSC PSIP standard attaches the assignment of “major channel number” values to a broadcaster's current NTSC RF channel number regardless of the actual RF channel used for DTV transmission, and sought comment on whether there was any need to modify this standard. For example, a broadcaster who operates an NTSC service on channel 4 and a DTV service on channel 27 would use the major channel 4. The PSIP “minor channel number” is used to identify programs and other services, which are a part of the DTV service. For example, channel 4.1 may be an HDTV program service and it may be multiplexed with an SDTV service, which is channel 4.2. According to ATSC, this allows a viewer to easily “surf” from, for example, 4.0 (NTSC) to 4.1 (HDTV) to 4.2 (SDTV). ATSC, MSTV/NAB, and others state that the major/minor channel number scheme established in ATSC A/65B will be useful. ATSC states that the PSIP Standard defines specific requirements for use of “major channel numbers” to provide viewers with a uniform methodology to access DTV services and to avoid conflict with duplicative numbers in a market. The major channel number also allows broadcasters to maintain their local brand identification. We see no reason to modify this standard. During the development of PSIP, ATSC recognized that in some situations broadcasters would need to deviate from the rule that the major channel number is the same as the broadcaster's NTSC channel number and created certain exceptions. Exceptions are, for example: (1) If a broadcaster without an NTSC broadcast license applies and receives a license for a digital broadcast channel, the major channel number should be the same as the DTV RF channel; (2) if a broadcaster owns or controls broadcast licenses for two or more different RF channels having overlapping service areas, a common major channel number for all services on all channels may be used; (3) if a broadcaster includes in its DTV service programming originating from a different licensed broadcaster, the major channel number of the original broadcast may be used as long as it is coordinated to avoid conflicts; and, (4) for a translated signal, the major/minor channel numbers shall remain the same as the original broadcast station unless the major channel conflicts with a broadcaster operating in the service area of the translator. In that case, the translator changes the major number to a non-conflicting number. We agree with ATSC and MSTV/NAB that these exceptions should provide broadcasters with the necessary flexibility to address most circumstances. To the extent broadcasters have a unique situation that is not provided for in PSIP, the Commission may grant exceptions on a case-by-case basis. The correct TSIDs must be used to ensure that receivers link the analog and digital channels properly. Accordingly, broadcasters are required to transmit the TSIDs assigned for their stations in their digital transmission. During the transition period while both analog and digital signals are broadcast, stations are required to transmit the NTSC TSID in line 21, field 2 in order for the receiver to locate the programs referenced in PSIP.
130. In the NPRM we asked if the Commission needs to do more to ensure that v-chip functionality is available in the digital world. While the Commission's rules require that digital television receivers have the capability to enable viewers to block the display of programs with a common rating, the technical standards to achieve this goal are not specified. We expressed concern that the lack of a specific requirement may lead to confusion among broadcasters and manufacturers with regard to where to place program rating information, resulting in the failure of the blocking functionality that the v-chip provides. Accordingly, we sought comment on whether the Commission should adopt the provisions of the ATSC A/65A standard that requires all digital television broadcasters to place v-chip rating information in the PSIP. We also asked whether it was necessary to require equipment manufacturers to develop equipment that accesses program rating information in the PSIP. Finally, we requested comment on a Petition for Rulemaking filed by CEA which sought to incorporate industry standard EIA/CEA—766 into the Commission's rules to facilitate v-chip functionality in digital receivers.
131. As an initial matter, we reiterate that this Order adopts the ATSC A/65 PSIP standard in its entirety. This Order also requires that broadcasters transmit all mandatory tables and descriptors of PSIP with their digital programming. Accordingly, the Event Information Tables (“EITs”) defined within PSIP will contain any available Content Advisory Descriptors (“CADs”) for broadcast programming. The PSIP requirements do not mandate broadcaster use of v-chip but rather require that broadcasters that choose to provide v-chip blocking information do so by following the PSIP protocols. For terrestrial broadcast, if parental advisory information is to be provided, the Content Advisory Descriptor is required in the EIT, which is an element of the PSIP Standard. This uniform transmission practice will ensure that various receiver manufacturers can more readily design products which will search for and react to program rating information on a consistent basis. Sharp Electronic Corporation states that numerous consumer electronics companies are currently designing and/or selling digital televisions that utilize the content advisory data as defined in the PSIP. While we believe that this is indeed the case, we are nonetheless adopting rules to require digital television receivers to look for the content advisory descriptors in the EITs. 47 U.S.C 330(c) instructs the Commission to oversee “the adoption of standards by industry for blocking technology,” and to ensure that blocking capability continues to be available to consumers as technology advances.
132. The PSIP carries the Rating Region Table (“RRT”), which describes the content advisory rating system being used. Without the information in the RRT, the program rating icons (
133. As requested by CEA, we are adopting by reference CEA-766 CEA-766 specifies the exact syntax to be used to define the U.S. and Canadian RRTs in accordance with A/65, as well as exact syntax to be used for the CADs that convey the rating information. U.S. and Canadian Rating Region Tables (RRT). We note that the adoption of the standard will not preclude manufacturers from incorporating additional blocking standards or techniques into receivers. Therefore, additional blocking techniques that are dependent only on inputs such as the date, time of day, or television channel, may be incorporated into television receivers as manufacturers see fit.
134. Additionally, we are adopting our proposal to apply v-chip rules to digital television receivers with displays in the 16:9 aspect ratio that are 7.8 inches or greater in height. Furthermore, we are requiring that v-chip technology be included in all digital television receivers with integrated 4:3 displays measuring at least 13 inches diagonally. Similar to our requirements for closed caption capabilities in digital television receivers, the rules will also be applicable to DTV tuners which are sold without an associated display device.
135. Finally, we are inclined to provide a transition period for manufacturers to begin producing compliant digital television receivers. We understand that the design cycle of a television receiver model is generally about 18 months. The Commission has previously taken into consideration receiver design cycles in proceedings that required the introduction of new television technology. We also understand that many manufacturers are currently relying on CEA 766 to comply with the Commission's v-chip requirements as applied to digital receivers. Our existing requirement that digital television receivers react in a similar manner as analog televisions when programmed to block specific rating categories ensures that digital receivers will continue to respond to v-chip information during the phase-in period. Therefore, we believe it is reasonable to provide an 18 month transition period. After the transition period, all digital television receivers will be required to provide v-chip functions following the regulations that we adopt in this proceeding.
136. We also requested comment on issues concerning the implications of PSIP on the operation of TV translator facilities. We requested comment on how the proper PSIP information is to be provided on TV translator rebroadcasts and who will be responsible for ensuring that that information is provided. We also requested comment regarding the costs of providing PSIP information on TV translators as well as any other concerns that translator operators might have in implementing PSIP on their DTV operations. We further note that a similar issue arises with cable service when a broadcast DTV signal or its associated analog signal is carried on a cable system on a channel that is different from its broadcast signal. PSIP in the context of cable carriage is a topic in a pending proceeding. We received comments from CEA, ATSC, Public Television, and Harris in response to our questions. In August 2003, the Commission initiated a proceeding to examine issues related to the authorization of digital translators and boosters. Because the record will be more specifically tailored to LPTV, translators, and boosters, we will address the implications of PSIP on those facilities in connection with the Digital LPTV proceeding.
137. The Television Decoder Circuitry Act of 1990 requires generally that television receivers contain circuitry that is able to decode and display closed captioning. The Act also directs the Commission to take such action that it determines appropriate to ensure that closed captioning service continues to be available to consumers as new technology is developed. In accordance with the Act, in July, 2000, the Commission adopted regulations with regard to the functioning of digital television receivers and closed captioning services. The DTV Closed Captioning Order incorporated Section 9 of the EIA/CEA standard EIA-708-B with minor modifications into the Commission's rules. This industry standard provides guidelines for caption providers as well as encoder and decoder manufacturers to implement closed captioning services with digital television technology. The DTV Closed Captioning Order also amended § 79.1 of the Commission's regulations to require an increasing amount of digital programming to be captioned in a format that can be recovered and displayed by decoders meeting the EIA-708-B standard.
138. As part of Second DTV Periodic NPRM, the Commission sought comment on whether there was additional action that it should take to ensure the accessibility and functioning of closed captioning service for digital television. Several commenters asserted that some issues need to be clarified in order for closed captioning services to be consistently and effectively delivered. For example, NCAM contends that in some cases broadcasters may not be delivering true DTV caption data intended for digital television receivers. Instead, those broadcasters are delivering NTSC type data, intended for use when digital programming is down-converted for display on analog receivers. NCAM states that, without DTV captioning data, digital receivers may not be able to function in the manner in which the Commission intended. In fact, some of these receivers may not display any captions at all.
139. We note that the EIA-708 standard provides comprehensive instructions for the encoding, delivery, and display of closed caption information for digital television systems. The standard provides for a larger set of captioning characters than the analog captioning standard, EIA-608. However, EIA-708 also supports
140. In the DTV Closed Captioning Order, the Commission observed that viewers will be able to watch digital programming on existing analog displays by using a DTV converter. With regard to the broadcasters' responsibility to deliver closed caption data, the DTV Closed Captioning Order states that, “[I]n order for programming distributors to count captioned digital television programming toward their closed captioning requirements in 47 CFR Section 79.1, they must also transmit captions than can be decoded by the decoder in that analog set.” Therefore, while all captions supplied with new digital programming should conform to the standards for “native” EIA-708 style captions as detailed in the standard, analog captions must also be provided if a broadcaster wishes to count the programming towards its quarterly captioning requirements.
141. In the Second DTV Periodic NPRM we noted that at the time the DTV Closed Captioning Order was adopted the Commission had not made broadcasters' adherence to the ATSC A/65 (PSIP) standard a requirement. We stated that the standard requires the caption service descriptor to be in the EITs and makes optional the presence of the caption service descriptor in the Program Mapping Table (PMT). EIA-708 standard requires the caption service descriptor to be in the PMT and, when present, in the EITs. We questioned whether a requirement for all digital television broadcasters to place the caption service descriptor in the EITs alone would eliminate situations in which digital television receivers that search for closed captioning information in the EITs are not able to find any captioning information although it is present in the PMT according to EIA-708. We believe that our decision to adopt the PSIP standard in its entirety along with the previous adoption of the EIA-708 results in the caption service descriptor being present in both EITs and in the PMTs. This proposal to require the caption service descriptor to be present in both places will ensure that legacy digital receivers that have been designed according to EIA-708 alone could continue to find the caption service descriptor in the PMT and would not be rendered obsolete.
142. The
143. In the first DTV periodic review proceeding, we sought comment on whether we should require digital television equipment that cannot receive over-the-air digital broadcast signals to carry a label informing consumers of this limitation on the receivers' functionality. In the DTV Tuner Order, we observed that the reluctance of the public to buy digital receivers is the problem with reaching the 2007 target date for completing the transition. We required that all TV receivers with screen sizes greater than 13 inches manufactured in the U.S. after July 1, 2007 be capable of receiving DTV signals over-the-air. As DTV tuners reach the market, consumers will only buy them if they understand what they are and that the future utility of analog-only televisions is limited. We decided not to require in that proceeding that television receivers that cannot receive over-the-air digital broadcast signals carry a label informing consumers of this limitation but we resolved to monitor the marketplace and take steps as necessary to protect consumers' interests.
144. Accurate communication of the impending change from analog to digital transmission is a highly material disclosure for consumers contemplating the purchase of a television. Retailers sell analog-only televisions for over $500 without prominent disclosure that they will not receive television signals without additional equipment after the analog spectrum is returned. We believe, as retailers and manufacturers agree, that communicating product attributes and features spur sales. We agree with Thompson that it is important to use the same nomenclature and definitions industry-wide. CEA has developed uniform nomenclature that appears in its Consumer Guide to HDTV, but the labeling recommended has not been adopted by manufacturers and retailers on a widespread basis. For example, Best Buy offers “HD-Ready” televisions, which is not a term defined in CEA's consumer guide. Best Buy's website defines it as “Fully capable of high-definition display when connected to an optional HDTV source. Conventional analog TV reception is provided via a built-in NTSC tuner.” The prices for such “HD-Ready” televisions range from $999.99 (Samsung) to $1999.99 (Toshiba). Recent ex parte filings indicate that the relevant industries, manufacturers and some retailers, are working on improved sales materials and clear, standard terminology and an increasing amount of information available for consumers who research on the Internet or in industry publications. However, much of the mass advertising and point of sale information remains confusing, inconsistent, and lacks explanation of the eventual limitations on analog-only equipment. For example, a sign or cling label displayed at point of sale could say: “Analog only—Not digital; will need separate converter box for over-air reception.” We have been reluctant to
145. Under our current rules, television stations are required to make station identification announcements at the beginning and end of each time of operation as well as hourly. 47 CFR 73.1201(a). Section 73.1705 (“Time of Operation”) of the FCC's rules specifies whether commercial and noncommercial TV and radio stations may be licensed for unlimited time operation, share time operation, and/or specified hours operation (such as daytime-only). 47 CFR 73.1705. Official station identification may be made visually or aurally, and must consist of the station's call letters immediately followed by the community or communities specified in the station's license as the station's location. 47 CFR 73.1201(b). Digital television stations have been assigned the same call letters as their associated analog TV stations, except that the digital station is identified with the suffix “DT.” Either or both the name of the licensee and the station's channel number may be inserted between the call letters and the station location, but no other insertion is permissible. Television satellite stations must include in their station identification announcements the number of the channel on which each station is operating. 47 CFR 73.1201(c)(3)(i).
146. We will adopt our proposal and require digital television stations to follow the same rules for station identification as analog television stations. Thus, digital stations will be required to make station identification announcements, either visually or aurally, at the beginning and end of each time of operation as well as hourly. As with analog stations, we will require that the identification consist of the station's call letters followed by the community or communities specified in the station's license as the station's location. Stations may insert between the call letters and the station's community of license the station's frequency, channel number, name of the licensee, and/or the name of the network, at their discretion. We will not adopt the proposal of WDLP to permit stations to omit the station's call letters in their identification. Each station's call letters are unique; thus, call letters serve as the clearest means of distinguishing among stations. As stations transition to digital format and provide multicast programming, thereby increasing the number of program streams potentially available to the public, clear identification of the station providing the programming viewers are watching becomes increasingly important, both for viewers and for stations themselves.
147. If a station chooses to include its channel number in its station identification, we will require that the station use the major (analog) channel number. As discussed above, we have decided to adopt the ATSC A/65B standard into our rules. One of the most important benefits of PSIP is that it defines specific requirements for use of “major” channel numbers to provide viewers with a uniform methodology to access DTV services and avoid conflict with duplicative numbers in a market. PSIP will allow viewers to see a broadcaster's major channel number regardless of the broadcaster's allocated digital broadcast channel. Thus, PSIP allows broadcasters to keep their existing channel number in the digital world, thereby assisting viewers who have come to identify these numbers with particular broadcasters and preserving the investment broadcasters have made in marketing these numbers. We believe that it is consistent with our adoption of the PSIP standard into our rules to require stations electing to identify themselves by channel number to use their major channel number, which is defined in the PSIP standard as the broadcaster's current NTSC RF (analog) channel number. Thus, a broadcaster who operates an NTSC service on channel “26” and a DTV service on channel “27” would use the major channel “26” in station identification announcements. We will permit stations that choose to multicast to include additional information in their station announcements identifying each program stream. Thus, a station with major channel number 26 might have channel 26.0 (NTSC program stream), channel 26.1 (HDTV) and 26.2 (SDTV). Stations may also provide information in the station announcement identifying the network affiliation of the program service (
148. For stations simulcasting their analog programming on the digital channel, we will permit station identification announcements to be made simultaneously for both stations as long as the identification includes both call signs (
149. In the Second DTV Periodic NPRM we sought comment on whether we should provide for DTV stations using distributed transmission technologies. A DTV distributed transmission system would employ multiple synchronized transmitters spread around a station's service area. Each transmitter would broadcast the station's DTV signal on the same channel, relying on the performance of “adaptive equalizer” circuitry in DTV receivers to cancel or combine the multiple signals plus any reflected signals to produce a single signal. Such distributed transmitters could be considered to be similar to analog TV booster stations, a secondary, low power service used to “fill in” holes in the parent station's coverage area, but DTV technology has the potential to enable this type of operation in a much more efficient manner. The Commission's Spectrum Policy Task Force has recommended that digital television broadcasters be permitted to operate single frequency low power distributed transmission systems within their present service areas. For analog TV boosters, in contrast, significant self-interference will occur unless there is substantial terrain blocking the arrival of multiple signals into the same area (for example, one signal from the primary analog station directly and one signal from a booster station).
150. In addition to the fundamental question of whether to allow distributed transmission technology, we sought comment on many related issues, such as whether such facilities should have primary or secondary regulatory status, whether we should limit the location of or area served by distributed transmitters, how interference to and from such transmitters should be calculated, and what power, antenna height, or other technical standards or limits should be imposed.
151. We agree with the generally supportive comments that the technology has potential benefits to the public and the reported testing to date is encouraging. Thus, in principle, we approve of the use of DTS technology. As suggested by MSTV/NAB, we will soon open a separate “fast track” proceeding to propose rules for DTS operation and to develop an adequate record on several technical and policy issues related to its use. In that proceeding, we will address the regulatory status of DTS facilities, limitations on where DTS facilities can provide service, and how DTS facilities are treated from the standpoint of interference they would be predicted to cause to other broadcast stations and interference they would receive from other stations. In addition, we will consider policy issues such as how to avoid situations where stations could fail to serve significant populations within their nominal coverage area and how stations employing DTS facilities should be evaluated with respect to meeting replication and maximization deadlines.
152. While that DTS proceeding is conducted, we will allow stations to request DTS operation on a case-by-case basis based on conservative parameters. Specifically, interim DTS operations will not be allowed if they would provide predicted service beyond a station's currently authorized area (including its replication area as well as any maximization area resulting from facilities granted by a construction permit or license). An interim DTS proposal will only be approved if it is designed to serve essentially all of its replication coverage area. An acceptable application during this interim period must show that all viewers within the station's replicated service area who are predicted to be served by their current analog transmitter would likewise be predicted to receive the minimum signal strength from at least one DTT transmitter. A station's desire to explore DTS operation will not be acceptable grounds for it requesting an extension of the replication and maximization interference protection deadline. Beyond these decisions, our staff will determine on a case-by-case basis the adequacy of other aspects of proposed operation (including permissible power, antenna height, and the acceptability of interference showings). We note that the record in this proceeding does not reflect current successful and practical operation of DTS technology. We will authorize additional experimentation and development work through our Special Temporary Authority (STA) process. Operation under such authority will be allowed to continue while we conduct the rule making proceeding. Depending upon the outcome of that proceeding, we may then convert the STAs to regular authorizations.
153. Accessibility Information. Accessible formats of this Report and Order (computer diskettes, large print, audio recording and Braille) are available to persons with disabilities by contacting Brian Millin, of the Consumer & Governmental Affairs Bureau, at (202) 418-7426, TTY (202) 418-7365, or at
154. Paperwork Reduction Act of 1995 Analysis. This Report and Order contains new or modified information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. The Commission is requesting OMB approval under the emergency processing provisions of the 1995 Act (5 CFR 1320.13) of the information collection requirements and forms contained in this Report and Order. OMB, the general public, and other Federal agencies are invited to comment on the new or modified information collection(s) contained in this proceeding.
155. Written comments by the public on the proposed information collection(s) are due 60 days from date of publication of this Report and Order in the
156. Regulatory Flexibility Act. As required by the Regulatory Flexibility Act, the Commission has prepared a Final Regulatory Flexibility Analysis (“FRFA”) relating to this Report and Order.
157. As required by the Regulatory Flexibility Act of 1980, as amended (“RFA”), an Initial Regulatory Flexibility Analysis (“IRFA”) was incorporated in the Notice of Proposed Rule Making (“NPRM”). The Commission sought written public comment on the proposals in the NPRM, including comment on the IRFA. One comment was received on the IRFA and is discussed below. This Final Regulatory Flexibility Analysis (“FRFA”) conforms to the RFA.
158. Need for and Objectives of the Report and Order. The policies and rules set forth herein are required to ensure a smooth transition of the nation's television system from analog to digital format. In the Commission's DTV proceeding (MM Docket No. 87-268), the Commission stated its intention to hold periodic reviews of the progress of the digital conversion and to make any adjustments necessary to our rules and policies to “ensure that the introduction of digital television and the recovery of spectrum at the end of the transition fully serves the public interest.” In this second periodic review, we revisit, as we indicated we would, several issues addressed in the first periodic review, and address a number of additional issues that we consider essential to resolve in order to ensure continued progress on the digital transition. The objective of this second periodic review is to make adjustments to our rules and policies to facilitate the introduction of digital television and the recovery of spectrum at the end of the transition.
159. Foremost among the steps taken in this item, the Report and Order establishes the timing and procedures necessary to establish a new Table of DTV Allotments that will determine the post-transition channels for all digital stations. Specifically, the item commences a three-round channel election process in the fall of 2004. Licensees are encouraged to ensure accuracy of database technical information on-file with the Commission before October 1, 2004. The Commission will issue a Table of
160. To facilitate the election process, the Media Bureau has implemented a freeze on certain requests for allotment and service area changes by TV and DTV stations. Notwithstanding the freeze, stations with international coordination issues or other problems beyond their control may amend applications as necessary.
161. In addition, the Order finds that firm but fair replication and maximization dates are necessary to increase DTV service to the public and also to advance the clearing of spectrum in the Lower and Upper 700 MHz bands (comprising television channels 52-69). The Order establishes two replication and maximization deadlines. The first deadline is July 1, 2005 and it applies to the top four affiliates in the top 100 markets. If they will remain on their digital channel assignments after the transition, they must fully replicate and maximize by this date. If they will move to another channel post-transition, they must be serving by July 1, 2005 100% of the number of viewers served by the 1997 facility on which their replication was based. The second deadline, July 1, 2006, applies to all other stations. If they will remain on their current digital channel after the transition, they must fully replicate and maximize by this date. If they will move to another channel post-transition, they must be serving by July 2006 at least 80% of the number of viewers served by the 1997 facility on which their replication was based. Failure to replicate or maximize by these deadlines will result in loss of interference protection to the unserved areas. If they have met these deadlines, the item would allow stations that are going to move to a different channel after the transition to carry-over their authorized maximized area to their new channels.
162. The Order does not adopt an intermediate signal requirement, but retains the 7 dB increase required by December 31, 2004, for commercial stations and December 31, 2005, for noncommercial stations.
163. To provide additional flexibility and fairness for many of the stations that are currently out-of-core, the Order allows such stations to return out-of-core digital channels before the transition and “flash cut” to digital on their in-core channels without losing replication or maximization protection on their eventual in-core channel assignments.
164. In addition to resolving the channel election, replication and maximization issues, the item encourages creative and value-added programming on digital channels by removing the requirement that licensees simulcast their analog video programming on their digital channel, while retaining the requirements for minimum hours of operation. This “simulcast requirement” could be reinstituted near the end of the transition if warranted.
165. In addition, the Report and Order permits satellite stations to “flash-cut” from analog to digital at the end of the transition; clarifies the interference protection parameters of broadcast stations on channels 51-69; and requires stations to use Program and System Information Protocol (“PSIP”), which will facilitate digital operations and features, including channel numbering, v-chip, and closed captioning, and will establish technical requirements that will permit the TV ratings system to be modified in the future.
166. Finally, the Report and Order approves in principle the use of distributed transmission technologies for digital television service. Digital Transmission Systems (“DTS”) would employ multiple synchronized transmitters spread around a station's service area, enabling broadcasters to fill gaps in service coverage. The item states the Commission will open a separate “fast track” proceeding to propose rules for DTS operation and to address related technical and policy issues. In the interim, the Order allows stations to request authorization for DTS operation on a case-by-case basis based on conservative parameters.
167. The Report and Order defers action on whether to require point-of-sale labels describing TV equipment capabilities (such as, high definition, digital monitor only, or analog) and on the issue of how the Commission should interpret the Section of the Communications Act that sets December 31, 2006, as the deadline for return of analog spectrum and establishes criteria for extensions of that deadline. The Order states that the Commission plans to address these issues in the near future.
168. Summary of Significant Issues Raised by Public Comments in Response to the IRFA. The American Cable Association (“ACA”) filed a comment in response to the IRFA in this proceeding. ACA states that the Commission's DTV transition regulations must accommodate the unique circumstances and higher cost structures of smaller cable systems. In particular, ACA asks that the Commission address the following issues: (1) The disproportionate cost of the DTV transition for smaller cable systems due to headend and set-top box costs; (2) the disproportionate burden of dual must-carry for smaller cable systems due to more limited channel capacity; (3) the unwillingness of some broadcasters to deliver an adequate quality DTV signal to outlying areas of their markets; and (4) the “continuing abuse” of retransmission consent of a handful of media conglomerates, which is constraining channel capacity, raising costs, and hampering small systems' ability to develop solutions to DTV carriage. ACA urges the Commission to consider alternatives to its rules that would minimize any significant economic impact on small entities, including exemption from coverage of the rule or parts thereof for small entities.
169. The issues raised by ACA regarding the impact of the transition on smaller cable systems are more pertinent to the Commission's pending must-carry proceeding than to this DTV periodic review. The rules and policies addressed herein apply primarily to broadcasters and equipment manufacturers, and relate only
170. Although we decline to address the issues raised by ACA in this proceeding, we do adopt herein a number of policies that take into consideration the legitimate needs and interests of small businesses. For example, the item provides for a later replication and maximization interference protection deadline of July 1, 2006 for smaller stations (not affiliated with a top-four network) and those in smaller markets. Affiliates of the top-four networks (
171. The Report and Order also permits certain stations with an in-core NTSC channel paired with an out-of-core DTV channel, as well as stations with two out-of-core channels, to surrender their out-of-core DTV channel before the end of the transition and operate in analog on their in-core channel. The item also permits single-channel DTV stations out of the core, upon Commission approval, to elect not to construct DTV facilities and instead give up their out-of-core DTV channel in return for a DTV channel inside the core. Upon approval from the Commission, these stations will “flash-cut” to digital operations on their in-core channel no later than the end of the transition in the station's market. This “flash-cut” policy will assist stations with an out-of-core DTV channel that are concerned about the cost of constructing DTV facilities outside the core that cannot be operated after the transition. In addition, the Report and Order permits satellite stations to surrender one of their paired channels and flash cut from analog to digital transmissions by the end of the transition period. This flash-cut option should provide significant financial relief for satellite stations, many of which are small and all of which serve communities unable to support a full-service station.
172. Description and Estimate of the Number of Small Entities to Which the Proposed Rules Will Apply. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the proposed rules. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small government entity.” 5 U.S.C. 601(3) (incorporating by reference the definition of “small business concern” in 15 U.S.C. 632. Pursuant to the RFA, the statutory definition of a small business applies, “unless an agency, after consultation with the Office of Advocacy of the SBA and after opportunity for public comment, establishes one or more definitions of such the term which are appropriate to the activities of the agency and publishes such definition(s) in the
173. Television Broadcasting. The Small Business Administration defines a television broadcasting station that has no more than $12 million in annual receipts as a small business. Business concerns included in this industry are those “primarily engaged in broadcasting images together with sound.” NAICS Code 515120. This category description continues, “These establishments operate television broadcasting studios and facilities for the programming and transmission of programs to the public. These establishments also produce or transmit visual programming to affiliated broadcast television stations, which in turn broadcast the programs to the public on a predetermined schedule. Programming may originate in their own studios, from an affiliated network, or from external sources.” Separate census categories pertain to businesses primarily engaged in producing programming. See Motion Picture and Video Production, NAICS code 512110; Motion Picture and Video Distribution, NAICS Code 512120; Teleproduction and Other Post-Production Services, NAICS Code 512191; and Other Motion Picture and Video Industries, NAICS Code 512199. According to Commission staff review of the BIA Publications, Inc. Master Access Television Analyzer Database as of May 16, 2003, about 814 of the 1,220 commercial television stations in the United States have revenues of $12 million or less. We note, however, that, in assessing whether a business concern qualifies as small under the above definition, business (control) affiliations “Concerns are affiliates of each other when one concern controls or has the power to control the other or a third party or parties controls or has to power to control both.” 13 CFR 121.103(a)(1). Must be included. Our estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. There are also 2,127 low power television stations (LPTV). Given the nature of this service, we will presume that all LPTV licensees qualify as small entities under the SBA definition.
174. In addition, an element of the definition of “small business” is that the entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific television station is dominant in its field of operation. Accordingly, the estimate of small businesses to which rules may apply do not exclude any television station from the definition of a small business on this basis and are therefore over-inclusive to that extent. Also as noted, an additional element of the definition of “small business” is that the entity must be independently owned and operated. We note that it is difficult at times to assess these criteria in the context of media entities and our estimates of small businesses to which
175. Cable and Other Program Distribution. The SBA has developed a small business size standard for cable and other program distribution services, which includes all such companies generating $12.5 million or less in revenue annually. This category includes, among others, cable operators, direct broadcast satellite (“DBS”) services, home satellite dish (“HSD”) services, multipoint distribution services (“MDS”), multichannel multipoint distribution service (“MMDS”), Instructional Television Fixed Service (“ITFS”), local multipoint distribution service (“LMDS”), satellite master antenna television (“SMATV”) systems, and open video systems (“OVS”). According to the Census Bureau data, there are 1,311 total cable and other pay television service firms that operate throughout the year of which 1,180 have less than $10 million in revenue. Economics and Statistics Administration, Bureau of Census, U.S. Department of Commerce, 1997 Economic Census, Subject Series—Establishment and Firm Size, Information Sector 51, Table 4 at 50 (2000). The amount of $10 million was used to estimate the number of small business firms because the relevant Census categories stopped at $9,999,999 and began at $10,000,000. No category for $12.5 million existed. Thus, the number is as accurate as it is possible to calculate with the available information. We address below each service individually to provide a more precise estimate of small entities.
176. Cable Operators. The Commission has developed our own definition of a small cable system operator for the purposes of rate regulation. Under the Commission's rules, a “small cable company” is one serving fewer than 400,000 subscribers nationwide. 47 CFR 76.901(e). The Commission developed this definition based on its determinations that a small cable system operator is one with annual revenues of $100 million or less. Sixth Report and Order and Eleventh Order on Reconsideration, 10 FCC Rcd. 7393 (1995). We last estimated that there were 1,439 cable operators that qualified as small cable companies. Since then, some of those companies may have grown to serve over 400,000 subscribers, and others may have been involved in transactions that caused them to be combined with other cable operators. Consequently, we estimate that there are fewer than 1,439 small entity cable system operators that may be affected by the decisions and rules in this Report and Order.
177. The Communications Act, as amended, also contains a size standard for a small cable system operator, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” The Commission has determined that there are 68,500,000 subscribers in the United States. Therefore, an operator serving fewer than 685,000 subscribers shall be deemed a small operator if its annual revenues, when combined with the total annual revenues of all of its affiliates, do not exceed $250 million in the aggregate. Based on available data, we find that the number of cable operators serving 685,000 subscribers or less totals approximately 1,450. Although it seems certain that some of these cable system operators are affiliated with entities whose gross annual revenues exceed $250,000,000, we are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act.
178. Direct Broadcast Satellite (“DBS”) Service. Because DBS provides subscription services, DBS falls within the SBA-recognized definition of Cable and Other Program Distribution Services. This definition provides that a small entity is one with $12.5 million or less in annual receipts. There are four licensees of DBS services under part 100 of the Commission's rules. Three of those licensees are currently operational. Two of the licensees that are operational have annual revenues that may be in excess of the threshold for a small business. The Commission, however, does not collect annual revenue data for DBS and, therefore, is unable to ascertain the number of small DBS licensees that could be impacted by these proposed rules. DBS service requires a great investment of capital for operation, and we acknowledge, despite the absence of specific data on this point, that there are entrants in this field that may not yet have generated $12.5 million in annual receipts, and therefore may be categorized as a small business, if independently owned and operated.
179. Home Satellite Dish (“HSD”) Service. Because HSD provides subscription services, HSD falls within the SBA-recognized definition of Cable and Other Program Distribution Services. This definition provides that a small entity is one with $12.5 million or less in annual receipts. The market for HSD service is difficult to quantify. Indeed, the service itself bears little resemblance to other MVPDs. HSD owners have access to more than 500 channels of programming placed on C-band satellites by programmers for receipt and distribution by MVPDs, of which 150 channels are scrambled and approximately 350 are unscrambled. HSD owners can watch unscrambled channels without paying a subscription fee. To receive scrambled channels, however, an HSD owner must purchase an integrated receiver-decoder from an equipment dealer and pay a subscription fee to an HSD programming package. Thus, HSD users include: (1) Viewers who subscribe to a packaged programming service, which affords them access to most of the same programming provided to subscribers of other MVPDs; (2) viewers who receive only non-subscription programming; and (3) viewers who receive satellite programming services illegally without subscribing. Because scrambled packages of programming are most specifically intended for retail consumers, these are the services most relevant to this discussion.
180. Multipoint Distribution Service (“MDS”), Multichannel Multipoint Distribution Service (“MMDS”) Instructional Television Fixed Service (“ITFS”) and Local Multipoint Distribution Service (“LMDS”). MMDS systems, often referred to as “wireless cable,” transmit video programming to subscribers using the microwave frequencies of the MDS and ITFS. LMDS is a fixed broadband point-to-multipoint microwave service that provides for two-way video telecommunications.
181. In connection with the 1996 MDS auction, the Commission defined small businesses as entities that had annual average gross revenues of less than $40 million in the previous three calendar years. This definition of a small entity in the context of MDS auctions has been approved by the A. The MDS auctions resulted in 67 successful bidders obtaining licensing opportunities for 493 Basic Trading Areas (“BTAs”). Of the 67 auction winners, 61 met the definition of a small business. MDS also includes licensees of stations authorized prior to the auction. As noted, the SBA has developed a definition of small entities for pay television services, which includes all such companies generating $12.5 million or less in annual receipts. This definition includes multipoint distribution services, and thus applies to MDS licensees and wireless cable operators that did not participate in the MDS auction. Information available to us indicates that there are approximately 850 of these licensees and operators that do not generate
182. The SBA definition of small entities for Cable and Other Program Distribution Services, which includes such companies generating $12.5 million in annual receipts, seems reasonably applicable to ITFS. There are presently 2,032 ITFS licensees. All but 100 of these licenses are held by educational institutions. Educational institutions are included in the definition of a small business. SBREFA also applies to nonprofit organizations and governmental organizations such as cities, counties, towns, townships, villages, school districts, or special districts, with populations of less than 50,000. 5 U.S.C. 601(5). However, we do not collect annual revenue data for ITFS licensees, and are not able to ascertain how many of the 100 non-educational licensees would be categorized as small under the SBA definition. Thus, we tentatively conclude that at least 1,932 licensees are small businesses.
183. Additionally, the auction of the 1,030 LMDS licenses began on February 18, 1998, and closed on March 25, 1998. The Commission defined “small entity” for LMDS licenses as an entity that has average gross revenues of less than $40 million in the three previous calendar years. An additional classification for “very small business” was added and is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding calendar years. These regulations defining “small entity” in the context of LMDS auctions have been approved by the SBA. There were 93 winning bidders that qualified as small entities in the LMDS auctions. A total of 93 small and very small business bidders won approximately 277 A Block licenses and 387 B Block licenses. On March 27, 1999, the Commission re-auctioned 161 licenses; there were 40 winning bidders. Based on this information, we conclude that the number of small LMDS licenses will include the 93 winning bidders in the first auction and the 40 winning bidders in the re-auction, for a total of 133 small entity LMDS providers as defined by the SBA and the Commission's auction rules.
184. In sum, there are approximately a total of 2,000 MDS/MMDS/LMDS stations currently licensed. Of the approximate total of 2,000 stations, we estimate that there are 1,595 MDS/MMDS/LMDS providers that are small businesses as deemed by the SBA and the Commission's auction rules.
185. Satellite Master Antenna Television (“SMATV”) Systems. The SBA definition of small entities for Cable and Other Program Distribution Services includes SMATV services and, thus, small entities are defined as all such companies generating $12.5 million or less in annual receipts. Currently, there are approximately 250 SMATV operators providing service to approximately 1.2 million residential subscribers. The best available estimates indicate that the largest SMATV operators serve between 15,000 and 55,000 subscribers each. Most SMATV operators serve approximately 3,000-4,000 customers. Because these operators are not rate regulated, they are not required to file financial data with the Commission. Furthermore, we are not aware of any privately published financial information regarding these operators. Based on the estimated number of operators and the estimated number of units served by the largest ten SMATVs, we believe that a substantial number of SMATV operators qualify as small entities.
186. Open Video Systems (“OVS”). Because OVS operators provide subscription services, OVS falls within the SBA-recognized definition of Cable and Other Program Distribution Services. This definition provides that a small entity is one with $ 12.5 million or less in annual receipts. The Commission has certified 25 OVS operators with some now providing service. Affiliates of Residential Communications Network, Inc. (“RCN”) received approval to operate OVS systems in New York City, Boston, Washington, DC, and other areas. RCN has sufficient revenues to assure us that they do not qualify as small business entities. Little financial information is available for the other entities authorized to provide OVS that are not yet operational. Given that other entities have been authorized to provide OVS service but have not yet begun to generate revenues, we conclude that at least some of the OVS operators qualify as small entities.
187. Electronics Equipment Manufacturers. Rules adopted in this proceeding could affect manufacturers of DTV receiving equipment and other types of consumer electronics equipment. The SBA has developed definitions of small entity for manufacturers of audio and video equipment as well as radio and television broadcasting and wireless communications equipment. These categories both include all such companies employing 750 or fewer employees. The Commission has not developed a definition of small entities applicable to manufacturers of electronic equipment used by consumers, as compared to industrial use by television licensees and related businesses. Therefore, we will utilize the SBA definitions applicable to manufacturers of audio and visual equipment and radio and television broadcasting and wireless communications equipment, since these are the two closest NAICS Codes applicable to the consumer electronics equipment manufacturing industry. However, these NAICS categories are broad and specific figures are not available as to how many of these establishments manufacture consumer equipment. According to the SBA's regulations, an audio and visual equipment manufacturer must have 750 or fewer employees in order to qualify as a small business concern. Census Bureau data indicates that there are 554 U.S. establishments that manufacture audio and visual equipment, and that 542 of these establishments have fewer than 500 employees and would be classified as small entities. Economics and Statistics Administration, Bureau of Census, U.S. Department of Commerce, 1997 Economic Census, Industry Series—Manufacturing, Audio and Video Equipment Manufacturing, Table 4 at 9 (1999). The amount of 500 employees was used to estimate the number of small business firms because the relevant Census categories stopped at 499 employees and began at 500 employees. No category for 750 employees existed. Thus, the number is as accurate as it is possible to calculate with the available information. The remaining 12 establishments have 500 or more employees; however, we are unable to determine how many of those have fewer than 750 employees and therefore, also qualify as small entities under the SBA definition. Under the SBA's regulations, a radio and television broadcasting and wireless communications equipment manufacturer must also have 750 or fewer employees in order to qualify as a small business concern. Census Bureau data indicates that there 1,215 U.S. establishments that manufacture radio and television broadcasting and wireless communications equipment, and that 1,150 of these establishments have fewer than 500 employees and would be classified as small entities. Economics and Statistics Administration, Bureau of Census, U.S. Department of Commerce, 1997 Economic Census, Industry Series—Manufacturing, Radio and Television
188. Electronic Computer Manufacturers. The Commission has not developed a definition of small entities applicable to computer manufacturers. Therefore, we will utilize the SBA definition of electronic computers manufacturing. According to SBA regulations, a computer manufacturer must have 1,000 or fewer employees in order to qualify as a small entity. Census Bureau data indicates that there are 563 firms that manufacture electronic computers and of those, 544 have fewer than 1,000 employees and qualify as small entities. The remaining 19 firms have 1,000 or more employees. We conclude that there are approximately 544 small computer manufacturers.
189. Description of Projected Reporting, Recordkeeping and other Compliance Requirements. The Report and Order requires all full power commercial and noncommercial television broadcast licensees and permittees to file a pre-election certification form by November 2004. In addition, full power licensees and permittees choosing to participate in the channel election process will file channel election forms in one or more of the three election rounds, and may file conflict decision forms based on the outcome of their election. The purpose of these filings is to permit stations to inform the Commission of their preference for a final DTV channel. Without these election forms, stations could not inform the Commission of their preferred channel for post-transition DTV operation. The decision as to which channel to elect for post-transition operation may be a difficult and time-consuming one for some broadcasters. However, channel election and the development of a new DTV Table of Allotments are steps integral to the digital transition. Factors that could make the channel election decision time consuming are not likely to be related to whether the entity is small or large. Licensees may elect not to participate in the channel election process and not file these forms and instead have the FCC assign them a post-transition channel at the end of the election process.
190. Steps Taken to Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.
191. In a number of instances, while adopting a given rule for larger entities, the Report and Order considers and adopts alternative requirements for small or smaller market entities to assist these entities in completing the digital conversion. For example, the Report and Order adopts the following interference protection deadlines for DTV channels within the core spectrum: July 1, 2005, for affiliates of the top-four networks (
192. While the Commission considered applying the same deadline and replication and maximization requirements to all stations, it concluded that a later deadline and reduced requirement for smaller and smaller market stations is warranted. In addition, to assist stations facing severe financial constraints or obstacles beyond a station's control that are specific to the DTV transition process, the item permits these stations to apply for a six-month waiver of the interference protection deadline.
193. In some instances, a rule was adopted applicable to large and small entities in the same way conferring the same benefits upon both. In furtherance of the significant public interest in rapid band-clearing and to address the potential for stranded investment in facilities outside of core channels, the Report and Order permits certain stations with an in-core NTSC channel paired with an out-of-core DTV channel, stations with two out-of-core channels, and single-channel DTV stations out-of-the-core, to surrender their out-of-core DTV channel before the end of the transition and operate in analog on their in-core channel. Upon approval from the Commission, these stations will “flash-cut” to digital operations on their in-core channel no later than the end of the transition in the station's market. This “flash-cut” policy will assist both smaller and larger stations with an out-of-core DTV channel that are concerned about the cost of constructing DTV facilities outside the core that cannot be operated after the transition. These entities will be permitted to surrender early their out-of-core channel and operate only in analog on their in-core channel until they flash-cut to digital-only operation on that channel no later than the end of the transition. The Commission considered not permitting these stations to flash-cut, but finally concluded that permitting this flash-cut option would best advance the transition and the clearing of the out-of-core spectrum.
194. In addition, the Report and Order permits satellite stations to surrender one of their paired channels and flash
195. The Report and Order also adopts another waiver that will most likely benefit smaller stations as opposed to larger stations. The Report and Order requires television licensees that have not yet been granted an initial DTV CP to construct, within a year from the adoption date of this Report and Order, a “checklist” facility that conforms with the parameters of the DTV Table of Allotments and other key processing requirements. The Commission will consider requests for waiver of the one year construction deadline, on a case-by-case basis, using the criteria for extension of DTV construction deadlines. Grounds for an extension must relate to the checklist facility, not the pending non-checklist application. This waiver procedure permits stations facing financial hardship as well as other obstacles to construction of digital facilities to make a showing why waiver of the construction deadline would serve the public interest. The waiver is available to all stations regardless of size or income, but it likely to benefit smaller stations more as these stations are more likely to encounter financial hardships in constructing DTV checklist facilities.
196. The Report and Order declines to postpone the existing phased-in minimum operating hours for smaller and smaller-market digital television stations. However, these phased-in dates permit these stations to step up gradually the number of hours of digital programming they offer. In contrast, top-four network affiliates in the top 30 television markets are required to operate their DTV station at any time that the analog station is operating.
197. Federal Rules Which Duplicate, Overlap, or Conflict with the Commission's Proposals. None.
198. Report to Congress. The Commission will send a copy of the Report and Order, including this FRFA, in a report to be sent to Congress pursuant to the Congressional Review Act. In addition, the Commission will send a copy of the Report and Order, including this FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the Report and Order and FRFA (or summaries thereof) will also be published in the
199.
200.
201.
202.
Communications equipment, Computer technology, Incorporation by reference, Labeling, Radio, Reporting and recordkeeping requirements, Security measures, Telephone, Wiretapping and electronic surveillance.
Communications common carriers, Radio.
Civil defense, Communications equipment, Defense communications, Education, Equal employment opportunity, Foreign relations, Incorporation by reference, Mexico, Political candidates, Radio, Reporting and recordkeeping requirements, Television.
Administrative practice and procedure, Business and industry, Civil defense, Common carriers, Communications equipment, Emergency medical services, Individuals with disabilities, Radio, Reporting and recordkeeping requirements.
47 U.S.C. 154, 302, 303, 304, 307, 336, and 544A.
(b) * * *
(13) CEA-766-A: “U.S. and Canadian Region Rating Tables (RRT) and Content Advisory Descriptors for Transport of Content Advisory Information using ATSC A/65-A Program and System Information Protocol (PSIP),” April 2001, IBR approved for § 15.120.
(c) * * *
(2) Digital television program rating information shall be transmitted in digital television signals in accordance with § 73.682(d) of this chapter.
(d) * * *
(2) Digital television receivers shall react in a similar manner as analog televisions when programmed to block specific rating categories. Effective March 15, 2006, digital television receivers will receive program rating descriptors transmitted pursuant to industry standard EIA/CEA-766-A “U.S. and Canadian Region Rating Tables (RRT) and Content Advisory Descriptors for Transport of Content Advisory Information using ATSC A/65-A Program and System Information Protocol (PSIP),” 2001 (incorporated by reference,
47 U.S.C. 154, 301, 302, 303, 307, 309, 332, 336, and 337 unless otherwise noted.
(b) * * *
(1) * * *
(iii) Submit an engineering study justifying the proposed separations based on the parameters of the land mobile station and the parameters, including authorized and/or applied for facilities, of the TV/DTV station(s) it is trying to protect; or,
47 U.S.C. 154, 303, 334 and 336.
(b) DTV broadcast station permittees or licensees must transmit at least one over-the-air video program signal at no direct charge to viewers on the DTV channel. Until such time as a DTV station permittee or licensee ceases analog transmissions and returns that spectrum to the Commission, and except as provided in paragraph (b)(1) of this section, at any time that a DTV broadcast station permittee or licensee transmits a video program signal on its analog television channel, it must also transmit at least one over-the-air video program signal on the DTV channel. The DTV service that is provided pursuant to this paragraph must be at least comparable in resolution to the analog television station programming transmitted to viewers on the analog channel.
(1) DTV broadcast station permittees and licensees required to construct and operate a DTV station by May 1, 2002, or May 1, 2003, pursuant to paragraph (d) of this section must, at a minimum, beginning on the date on which the DTV station is required to be constructed, provide a digital video program signal, of the quality described in paragraph (b) of this section, during prime time hours as defined in § 79.3(a)(6) of this chapter. These licensees and permittees must also comply with the minimum operating hours requirements in paragraph (f) of this section.
(f)(1) Commencing on April 1, 2003, DTV television licensees and permittees required to construct and operate a DTV station by May 1, 2002, or May 1, 2003, must transmit at least one over-the-air video program signal at no direct charge to viewers on their DTV channel at least 50 percent of the time they are transmitting a video program signal on their analog channel.
(2) Commencing on April 1, 2004, DTV licensees and permittees described in paragraph (f)(1) of this section must transmit a video program signal as described in paragraph (f)(1) of this section on the DTV channel at least 75 percent of the time they are transmitting a video program signal on the analog channel.
(3) Commencing on April 1, 2005, DTV licensees and permittees described in paragraph (f)(1) of this section must transmit a video program signal as described in paragraph (f)(1) of this section on the DTV channel at least 100 percent of the time they are transmitting a video program signal on the analog channel.
(4) The minimum operating hours requirements imposed in paragraphs (f) (1) through (3) of this section will terminate when the analog channel terminates operation and a 6 MHz channel is returned by the DTV licensee or permittee to the Commission.
(d) Digital broadcast television transmission standard. Effective February 1, 2005, transmission of digital broadcast television (DTV) signals shall comply with the standards for such transmissions set forth in ATSC A/52: “ATSC Standard Digital Audio Compression (AC-3)” (incorporated by reference,
(b)
(c)
(b) * * *
(2) ATSC A/53B: “ATSC Digital Television Standard,” dated August 7, 2001, Revision B, with Amendment 1 dated May 23, 2002 and Amendment 2
(3) ATSC A/65B: “ATSC Program and System Information Protocol for Terrestrial Broadcast and Cable,” (Revision B) March 18, 2003, and IBR approved for § 73.682, IBR approved for §§ 73.9000-73.9001.
Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 303(g), 303(r), 332(c)(7).
(c) * * *
(1) * * *
(ii) Submit an engineering study justifying the proposed separations based on the parameters of the land mobile station and the parameters, including authorized and/or applied for facilities, of the TV/DTV station(s) it is trying to protect; or,
[
58249-58250 in the
2004, is being reprinted with White House corrections.]