Proposed Rules. Final rule

Agency: Environmental Protection Agency (EPA)
Action: Final rule
Citation: FR Doc. 00-33288 · RIN 2070-AB78 · OPP-301098; FRL-6762-7 · 40 CFR 180

Summary

This regulation extends time-limited tolerances for the pesticides listed in Unit II of this document. These actions are in response to EPA's granting of emergency exemptions under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of these pesticides. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA.

Dates

This regulation is effective December 29, 2000. Objections and requests for hearings, identified by docket control number OPP-301098, must be received by EPA on or before February 27, 2001.

Supplementary Information

I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS Examples of Potentially Affected Entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically .You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,”“ Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. 2. In person . The Agency has established an official record for this action under docket control number OPP-301098. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805. II. Background and Statutory Findings EPA has previously issued a final rule for each chemical/commodity which were published in the Federal Register on the date listed in the summary for each chemical/commodity listed below. The initial issuance of these final rules announced that EPA, on its own initiative, under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) was establishing time-limited tolerances. EPA established the tolerances because section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Such tolerances can be established without providing notice or time for public comment. EPA received requests to extend the use of these chemicals for this year's growing season. After having reviewed these submissions, EPA concurs that emergency conditions exist. EPA assessed the potential risks presented by residues for each chemical/commodity. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rule originally published to support these uses. Based on that data and information considered, the Agency reaffirms that extension of these time-limited tolerances will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerances are extended until the date listed below. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on the date listed, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on the commodity after that date will not be unlawful, provided the residue is present as a result of an application or use of a pesticide at a time and in a manner that was lawful under FIFRA, the tolerance was in place at the time of the application, and the residue does not exceed the level that was authorized by the tolerance. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Tolerances for the use of the following pesticide chemicals on specific commodities are being extended: 1. 2,4-D . EPA has authorized under FIFRA section 18 the use of 2,4-D on wild rice for control of common water plantain in Minnesota. This regulation extends a time-limited tolerance for residues of the herbicide 2,4-dichlorophenoxyacetic acid in or on wild rice at 0.1 ppm for an additional 2-year period. This tolerance will expire and is revoked on December 31, 2002. A time-limited tolerance was originally published in the Federal Register on September 5, 1997 (62 FR 46900) (FRL-5738-9). 2. Paraquat . EPA has authorized under FIFRA section 18 the use of paraquat on artichokes for control of weeds in California. This regulation extends a time-limited tolerance for residues of the herbicide paraquat in or on artichokes at 0.05 ppm for an additional 2-year period. This tolerance will expire and is revoked on December 31, 2002. A time-limited tolerance was originally published in the Federal Register on November 22, 1999 (64 FR 63714) FRL-6392-9). 3. Lambda-cyhalothrin . EPA has authorized under FIFRA section 18 the use of lambda-cyhalothrin on barley for control of Russian wheat aphid in Wyoming, Montana, Idaho, and Colorado and sugarcane for the control of the sugarcane borer in Louisiana. This regulation extends time-limited tolerances for combined residues of the insecticide lambda-cyhalothrin and its epimer in or on barley, bran at 0.2 ppm; barley, grain at 0.05 ppm; barley, hay at 2.0 ppm; barley, straw at 2.0 ppm, and sugarcane at 0.03 ppm for an additional 2-year period. These tolerances will expire and are revoked on December 31, 2002. Time-limited tolerances were originally published in the Federal Register on January 29, 1999 (64 FR 4584-4590) (FRL-6056-2). 4. Bifenthrin . EPA has authorized under FIFRA section 18 the use of bifenthrin on citrus for control of Diaprepes root weevil in Florida. This regulation extends time-limited tolerances for residues of the insecticide bifenthrin in or on citrus, whole fruit; citrus, oil; and, citrus, dried pulp at 0.05, 0.3, and 0.3 ppm, respectively, for an additional 2-year period. These tolerances will expire and are revoked on December 31, 2002. Time-limited tolerances were originally published in the Federal Register on December 16, 1998 (63 FR 69200) (FRL-6048-1). 5. Difenoconazole . EPA has authorized under FIFRA section 18 the use of difenoconazole on sweet corn grown for seed for control of fungal pathogens in Florida. This regulation extends time-limited tolerances for residues of the fungicide difenoconazole in or on Corn, sweet (kernel + corn with husk removed); Corn, sweet, forage; and Corn, sweet, stover at 0.1 ppm for an additional 2-year period. These tolerances will expire and are revoked on 12/31/02. Time-limited tolerances were originally published in the Federal Register on September 1, 1999 (64 FR 47680) (FRL-6094-3). 6. Fenbuconazole . EPA has authorized under FIFRA section 18 the use of fenbuconazole on blueberries for control of mummy berry disease in Georgia. This regulation extends a time-limited tolerance for combined residues of the fungicide fenbuconazole alpha-2-(4-chlorophenyl)-ethyl-alpha-phenyl-3-(1 H -1,2,4-triazole)-1-propanenitrile and its metabolites cis-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1 H -1,2,4-triazole-1-ylmethyl)-2-3 H -furanone and trans-5-(4-chlorophenyl)dihydro-3-phenyl-3-(1 H -1,2,4-triazole-1-ylmethyl-2-3H-furanone expressed as fenbuconazole in or on blueberries at 1.0 ppm for an additional 2-year period. This tolerance will expire and is revoked on December 31, 2002. A time-limited tolerance was originally published in the Federal Register on June 10, 1998 (63 FR 31633) (FRL-5791-5). 7. Sulfentrazone . EPA has authorized under FIFRA section 18 the use of sulfentrazone on cowpea and lima bean for control of hophornbeam copperleaf in Tennessee and on sunflower for control of weeds in North Dakota. This regulation extends a time-limited tolerance for residues of the herbicide sulfentrazone, N -[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H -1,2,4-triazol-1-y-l]phenyl] methanesulfonamide in or on bean, succulent seed without pod (lima beans and cowpeas) and sunflower at 0.1 ppm for an additional 2-year period. These tolerances will expire and are revoked on December 31, 2002. A time-limited tolerance was originally published in the Federal Register on September 21, 1999 (64 FR 51060) (FRL-6097-8). 8. Imazamox . EPA has authorized under FIFRA section 18 the use of imazamox on canola for control of wild mustard in Minnesota and North Dakota. This regulation extends a time-limited tolerance for residues of the herbicide imazamox, 2-4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1 H -imidazol-2-yl-5-methoxymethyl-3-pyridine-carboxylic acid, applied as the free acid or ammonium salt in or on canola at 0.05 ppm for an additional 17-month period. This tolerance will expire and is revoked on December 31, 2003. A time-limited tolerance was originally published in the Federal Register on July 14, 1999 (64 FR 37855) (FRL-6086-5). III. Objections and Hearing Requests Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301098 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 27, 2001. 1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865. 2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.” EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit III.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301098, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). IV. Regulatory Assessment Requirements This final rule establishes time-limited tolerances under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established under FFDCA section 408(l)(6) in response to an exemption under FIFRA section 18, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). V. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 22, 2000. James Jones, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346(a) and 371. § 180.142 [Amended] 2. In § 180.142, in the table to paragraph (b), amend the entry for “Wild rice” by revising the expiration date “12/31/00” to read “12/31/02”. § 180.205 [Amended] 3. In § 180.205, in the table to paragraph (b), amend the entry for “Artichokes” by revising the expiration date “12/31/00” to read “12/31/02”. § 180.438 [Amended] 4. In § 180.438, in the table to paragraph (b) amend the entries for “Barley, bran”; “Barley, grain”; “Barley, hay”; “Barley straw”; and “Sugarcane” by revising the expiration date “12/31/00” to read “12/31/02”. § 180.442 [Amended] 5. In § 180.442, in the table to pararaph (b) amend the entries for “Citrus, whole fruit”; “Citrus oil”; and “Citrus, dried pulp” by revising the expiration dates “12/31/00” to read “12/31/02”. 6. In § 180.475, revise the table in paragraph (b) to read as follows: § 180.475 Difenoconazole; tolerances for residues. (b) * * * Commodity Parts per million Expiration/Revocation date Corn, sweet (kernel + corn with husk removed) 0.1 12/31/02 Corn, sweet, forage 0.1 12/31/02 Corn, sweet, stover 0.1 12/31/02 § 180.480 [Amended] 7. In § 180.480, in the table to paragraph (b) amend the entry for “Blueberries” by revising the expiration date “12/31/00” to read “12/31/02”. § 180.498 [Amended] 8. In § 180.498, in the table to paragraph (b) amend the entries for “Bean, succulent seed without pod (lima beans and cowpeas)” and “Sunflower” by revising the expiration date “12/30/00” to read “12/31/02”. § 180.508 [Amended] 9. In § 180.508, in the table to paragraph (b) amend the entry for “Canola” by revising the expiration date “7/15/01” to read “12/31/03”. FR Doc. 00-33292 Filed 12-27-00; 1:00 pm BILLING CODE 6560-50-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Care Financing Administration Centers for Disease Control and Prevention 42 CFR Part 493 [HCFA-2024-FC2] RIN 0938-AI94 Medicare, Medicaid, and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements Under CLIA AGENCY: Centers for Disease Control and Prevention (CDC) and Health Care Financing Administration (HCFA), HHS. ACTION: Final rule with comment period. SUMMARY: This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department to revise quality control requirements and establish the qualification requirements necessary for individuals with doctoral degrees to serve as directors of laboratories performing high complexity testing. These effective date extensions do not reduce the current requirements for quality test performance. DATES: Effective Date: December 29, 2000. Comment Date: We will consider comments if we receive them at the appropriate address, as provided below, no later than 5 p.m. on February 27, 2001. ADDRESSES: Mail written comments (one original and three copies) to the following addresses: Health Care Financing Administration, Department of Health and Human Services, Attention: HCFA-2024-FC2, P.O. Box 8018, Baltimore, MD 21244-8018; and Centers for Disease Control and Prevention, Department of Health and Human Services, Attention: HCFA-2024-FC2, 4770 Buford Hwy., N.E., MS F11, Atlanta, Georgia 30341-3724. To ensure that mailed comments are received in time for us to consider them, please allow for possible delays in delivering them. If you prefer, you may deliver your written comments (one original and three copies) to one of the following addresses: Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, or Room C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-8018. Comments mailed to the above addresses may be delayed and received too late for us to consider them. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. In commenting, please refer to file code HCFA-2024-FC2. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 443-G of the Department's office at 200 Independence Avenue, SW., Washington, DC, on Monday through Friday of each week from 8:30 to 5 p.m. (phone: (202) 690-7890). For information on ordering copies of the Federal Register containing this document and on electronic access, see the beginning of SUPPLEMENTARY INFORMATION . FOR FURTHER INFORMATION CONTACT: Rhonda S. Whalen (CDC), (770) 488-8155, Cecelia Hinkel (HCFA), (410) 786-3531. SUPPLEMENTARY INFORMATION: Availability of Copies, and Electronic Access Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-7800 (or toll free at 1-888-293-6498) or by faxing to (202) 512-2250. The cost for each copy is $8.00. As an alternative, you can view and photocopy the Federal Register document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the Federal Register . This Federal Register document is also available from the Federal Register online database through GPO Access, a service of the U.S. Government Printing Office. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is http://www.access.gpo.gov/su_docs/, by using local WAIS client software, or by telnet to swais.access.gpo.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512-1661; type swais, then log in as guest (no password required). I. Background On February 28, 1992, we published in the Federal Register (57 FR 7002) final regulations with an opportunity for public comment. These regulations set forth the requirements for laboratories that are subject to CLIA. These regulations established uniform requirements for all laboratories regardless of location, size, or type of testing performed. In developing the regulations, we included requirements that would ensure the quality of laboratory services and be in the best interest of the public health. We recognized that a rule of this scope required time for laboratories to understand and implement the new requirements. Therefore, certain requirements were phased-in and given prospective effective dates. We also planned to address the comments we received on the February 28, 1992 rule and make modifications, if necessary, in the subsequent final rule. On December 6, 1994, May 12, 1997, and October 14, 1998, we published in the Federal Register (59 FR 62606, 62 FR 25855, and 63 FR 55031, respectively) final rules with opportunity for comment. These rules extended the phase-in of the quality control requirements applicable to moderate and high complexity tests and the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These changes were made due to the resource constraints that had prevented the Department of Health and Human Services from establishing a review process for manufacturers' test system quality control instructions for CLIA compliance and the inability of many laboratory directors to complete certification requirements within the time period originally specified. II. Revisions to the Regulations The date extensions provided by the October 14, 1998 rule have proven to be inadequate for the reasons set forth below. In addition, based on our evaluation of comments submitted in response to the May 12, 1997 rule, advice from the Clinical Laboratory Improvement Advisory Committee (CLIAC) concerning the quality control requirements appropriate to ensure quality testing, and the qualification requirements for laboratory directors, we have found it necessary to make the following revisions to our regulations: • We are extending from December 31, 2000, to December 31, 2002, the current phase-in quality control requirements for moderate and high complexity tests. The phase-in quality control requirements for unmodified, moderate complexity tests cleared by the Food and Drug Administration (FDA) (through 510(k) or premarket approval processes, unrelated to CLIA) are less stringent than the requirements applicable to high complexity and other moderate complexity tests. • We are extending from December 31, 2000, to December 31, 2002, the date for laboratories to meet certain CLIA quality control requirements by following manufacturers' FDA CLIA-cleared test system instructions. • We are extending from December 31, 2000, to December 31, 2002, the date by which individuals with doctoral degrees must obtain board certification to qualify as directors of laboratories that perform high complexity tests. These revisions are discussed in more detail below. A. Quality Control Requirements 42 CFR 493.1202 contains the quality control requirements applicable to moderate and high complexity tests and allows a laboratory that performs tests of moderate complexity, using test systems cleared by the FDA through the section 510(k) or premarket approval processes, until December 31, 2000, to comply with the quality control provisions of part 493, subpart K, by meeting less stringent quality control requirements, as long as the laboratory has not modified the instrument, kit, or test system's procedure. Section 493.1203, effective beginning December 31, 2000, establishes a mechanism for laboratories using commercial, unmodified tests to fulfill certain quality control requirements by following manufacturers' test system instructions that have been reviewed and determined by the FDA to meet applicable CLIA quality control requirements. Implementation of this review process, however, depended upon the availability of sufficient additional resources necessary to meet the projected workload. These resources were not available due to financial and other constraints of the program. Following the publication of some of the previous extensions, we received comments that the current quality control requirements are not appropriate for some test methodologies, and that a comprehensive quality control regulation should be developed to address current quality control needs. A final rule addressing quality control issues raised by these commenters is close to completion; however, it will not be published by December 31, 2000. Commenters also raised issues that stressed the need to ensure that the quality control requirements are practical and flexible enough to accommodate different testing sites and test systems that range from current methodologies to new and emerging technologies, in order to not impede access. We must also, as the commenters suggest, base the requirements on technical considerations as well as their impact on patient care. To assist us in determining the types of quality control requirements necessary to monitor laboratory test performance, we also considered advice provided by the CLIAC, as well as information obtained from a public meeting held in September 1996 for manufacturers and others to make presentations on quality control. Due to the complexity of the issues that must be addressed, we are extending the December 31, 2000 sunset date for quality control standards in § 493.1202 to December 31, 2002, and extending the effective date for § 493.1203 from December 31, 2000 to December 31, 2002, to allow laboratories to continue to meet current regulations until we make further determinations regarding quality control issues. We are extending the effective date for these sections to ensure that we have sufficient time to develop final rules concerning quality control that address new technology, including point-of-care testing, molecular methods and advances in testing in the specialties and subspecialties. Subsequent to the publication of the final regulations and prior to the actual implementation of the revised requirements, we must develop new surveyor guidelines, design new survey forms, reprogram the CLIA data system, conduct surveyor training, and inform and educate the laboratory community, State programs with CLIA-exempt laboratories and HCFA-approved accreditation organizations. Time must be allocated for HCFA-approved State licensure programs and HCFA-approved accreditation organizations to review their requirements and determine whether they must make changes to maintain their overall equivalency with the CLIA requirements. State programs with CLIA-exempt laboratories may need to make changes to their State laws and implementing regulations. Accreditation organizations may also need time to revise policies and requirements and have them approved by their organizations for adoption. An implementation period will provide States and accreditation organizations the time needed to make changes to their program requirements and for their subsequent review by CDC and HCFA. Failure to provide sufficient time for education and implementation could cause confusion and interfere with laboratories' continued compliance with CLIA requirements and jeopardize the continued equivalency of State programs with CLIA-exempt laboratories and accreditation organizations. B. Laboratory Director Qualifications Section 493.1443(b)(3) provides that a director of a laboratory performing high complexity testing, who has an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution, must be certified by a board recognized by the Department as of December 31, 2000. The phase-in was designed to allow the Department adequate time to review requests for approval of certification programs and to ensure that a laboratory director with a doctoral degree had sufficient time to successfully complete the requirements for board certification. As stated previously in the preamble to the December 1994 final rule, a number of comments to the February 1992 final rule suggested that board certification not be a mandatory requirement for currently employed individuals. In addition, CLIAC suggested the development of alternative provisions to qualify currently employed individuals with a doctoral degree on the basis of laboratory training or experience, in lieu of requiring board certification. We are extending the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing to December 31, 2002. This extension will allow time for review of the qualifications required for laboratory director to determine whether modifications should be made for inclusion in the final rule being developed. In summary, we are extending the phase-in period in § 493.1443(b)(3) from December 31, 2000, to December 31, 2002. III. Waiver of Proposed Rulemaking and Delayed Effective Date We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on proposed rules. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed and the terms and substance of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. The revisions in this final rule are essential, because if the dates for quality control requirements are not extended, many laboratories performing moderate complexity testing will be faced unnecessarily with meeting more stringent and burdensome quality control requirements at a time when we are actively working to revise these same quality control requirements. While this activity is nearly complete, the issues we are addressing are many and complex, particularly in light of changing technologies. Since we will be revising the quality control requirements in the reasonably near future, to impose more stringent requirements now is unreasonable, unnecessary, and confusing. With respect to the personnel standards addressed in this rule, if the date is not extended, those individuals currently qualified as laboratory directors under the phase-in requirements based on their doctoral degree and laboratory training and work experience would no longer qualify to serve as directors of laboratories performing high complexity testing. Since we are contemplating revisions that would allow individuals with a doctoral degree to qualify under alternative provisions that would recognize their laboratory training and experience, we would not want to disenfranchise these currently employed directors at this time. Extending the dates governing laboratory director qualifications will provide the opportunity for individuals with a doctoral degree who have laboratory training and experience, but do not have board certification to continue to qualify as laboratory directors of high complexity testing while we consider appropriate revisions to the CLIA regulations. Accordingly, we believe that it is impracticable, unnecessary, and not in the public interest to engage in proposed rulemaking and believe there is good cause for not doing so and are therefore issuing this final rule with a 60-day comment period. To do otherwise would create confusion among laboratories in understanding the requirements they must meet with respect to quality control and laboratory director qualifications. It could also impose unnecessary burdens on laboratories and hardships on persons affected by these requirements. Because current regulations will expire on December 31, 2000, additional urgency has been placed on the implementation of this rule. We, therefore, believe there is good cause to waive a delay in the effective date of this rule. To do otherwise would create unnecessary confusion among laboratories in understanding the requirements they must meet with respect to quality control and laboratory director qualifications. It could also impose unnecessary burdens on laboratories and hardships on individuals affected by these requirements. IV. Regulatory Impact Statement Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 through 612), we prepare a regulatory flexibility analysis unless we certify that a rule will not have a significant economic impact on a substantial number of small entities. For purposes of the RFA, all laboratories are considered to be small entities. Individuals and States are not included in the definition of a small entity. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. That analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 50 beds. Extending the phase-in periods will continue the quality control and personnel requirements in effect prior to December 31, 2000, allow adequate time for addressing all concerns with respect to revising quality control requirements, and not change costs, savings, burden, or opportunities to manufacturers, laboratories, individuals performing tests, or patients undergoing the tests. For these reasons, we have determined, and the Secretary certifies, that this regulation does not result in a significant impact on a substantial number of small entities and does not have a significant effect on the operations of a substantial number of small rural hospitals. Therefore, we are not preparing analyses for either the RFA or section 1102(b) of the Act. The Unfunded Mandates Reform Act of 1995 also requires (in section 202) that agencies prepare an assessment of anticipated costs and benefits for any rule that may result in annual expenditures by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million. The final rule has no consequential effect on State, local, or tribal governments. We believe the private sector costs of this rule fall below these thresholds, as well. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. V. Response to Comments Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, if we proceed with a subsequent document, we will respond to the major comments in the preamble to that document. List of Subjects in 42 CFR Part 493 Grant programs-health, Health facilities, Laboratories, Medicaid, Medicare, Reporting and recordkeeping requirements. 42 CFR chapter IV, part 493 is amended as set forth below: PART 493—LABORATORY REQUIREMENTS 1. The authority citation for part 493 continues to read as follows: Authority: Sec. 353 of the Public Health Service Act, secs. 1102, 1861(e), and the sentence following sections 1861(s)(11) through 1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), and the sentence following 1395x(s)(11) through 1395x(s)(16)). § 493.1202 [Amended] 2. In § 493.1202, in the section heading, remove “December 31, 2000” and add in its place “December 31, 2002”. § 493.1203 [Amended] 3. In § 493.1203, in the section heading, remove “December 31, 2000” and add in its place “December 31, 2002”. § 493.1443 [Amended] 4. Section 493.1443 is amended as set forth below: a. In § 493.1443(b)(3)(ii) introductory text, remove “December 31, 2000,” and add in its place “December 31, 2002,”. b. In § 493.1443(b)(3)(ii)(C), remove “December 31, 2000,” and add in its place “December 31, 2002,”. (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: November 20, 2000. Jeffrey P. Koplan, Director, Centers for Disease Control and Prevention. Dated: November 28, 2000. Michael M. Hash, Acting Administrator, Health Care Financing Administration. Dated: December 18, 2000. Donna E. Shalala, Secretary. [FR Doc. 00-33288 Filed 12-26-00; 1:13 pm]