ML23153A088

PR-002 - 59FR61293 - NRC Size Standards; Proposed Revision

ML23153A088
Person / Time
Issue date:	11/30/1994
From:	Taylor J NRC/EDO
To:
References
59FR61293, PR-002
Download: ML23153A088 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 11/30/1994 TITLE: PR-002 - 59FR61293 - NRC SIZE STANDARDS; PROPOSED REVISION CASE

REFERENCE:

PR-002 59FR61293 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR - 002 OPEN ITEM (Y/N) N RULE NAME: NRC SIZE STANDARDS; PROPOSED REVISION PROPOSED RULE FED REG CITE: 59FR61293 PROPOSED RULE PUBLICATION DATE: 11/30/94 NUMBER OF COMMENTS: 2 ORIGINAL DATE FOR COMMENTS: 12/3 0/94 EXTENSION DATE: I I FINAL RULE FED. REG. CITE: 60FR1 8344 FINAL RULE PUBLICATION DATE: 04 /11/ 95 NOTES ON: PROPOSED RULE SIGNED BY THE EDO. FINAL RULE (SIGNED BY EDO)

STATUS : BECOMES EFFECTIVE MAY 11, 1995. FILE LOCATED ON Pl .

• OF RULE :

HISTORY OF THE RULE PART AFFECTED: PR-002 RULE TITLE: NRC SIZE STANDARDS; PROPOSED REVISION PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: SRM DATE: I I SIGNED BY SECRETARY: 11/21/94 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: SRM DATE: I I SIGNED BY SECRETARY: 03/31/95 STAFF CONTACTS ON THE RULE CONTACTl: SARAH N. WIGGINTON MAIL STOP: T-6D-59 PHONE: 415-7164 CONTACT2: MAIL STOP: PHONE:

In the Matter of NRC SIZE STANDARDS; PROPOSED REVISION DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/28/94 11/21/94 FEDERAL REGISTER NOTICE - PROPOSED RULE 12/29/94 12/28/94 COMMENT OF ACNP/SNM (WILLIAM H. MCCARTNEY, M.D.) ( 1) 01/12/95 01/05/95 COMMENT OF RADIATION TECHNOLOGY, INC.

(DORIS C. BRYAN) ( 2)

- 04/07/95 03/31/95 FEDERAL REGISTER NOTICE - FINAL RULE

DOCKET NU BER DOC! 'f:T _D

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• 95 P -7 AiO :53 NUCLEAR REGULATORY COMMISSION GI 10 CFR Part 2 RIN 3150-AF24 NRC Size Standards; Revision AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending the NRC's size standards used to qualify an NRC licensee as a "small entity" under the Regulatory Flexibility Act. This action is necessary to establish a separate standard to be used to determine whether a licensee who is a manufacturer would qualify as a small entity, to adjust the receipts-based standard to account for the effects of inflation since 1985, and to eliminate the separate $1 million size standard for private practice physicians and apply the revised receipts-based size standard of

$5 million to this class of licensees.

~ \\ ffiS' EFFECTIVE DATE: (99 dayst-rc,}a date of publication in 'the Federal Register).

1

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FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rules Rveiew Section, Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, telephone (301) 415-7163.

SUPPLEMENTARY INFORMATION:

Background

In 1983, the NRC surveyed its materials licensees to create an economic profile sufficient to consider regulatory

- alternatives tailored to the size of the licensee. After analyzing the data and consulting with the Small Business Administration (SBA}, the NRC developed a proposed size standard that would be appropriate to use in determining which of its licensees would qualify as small entities for the purposes of compliance with the Regulatory Flexibility Act. The NRC published its proposed size standard for notice and comment in the Federal Register of May 21, 1985 (50 FR 20913). After considering the comments received, the NRC adopted its final size standards as noted in the Federal Register of December 9, 1985 (50 FR 50241). In the Federal Register of November 6, 1991 (56 FR 56671), the NRC restated the size standards to include the Regulatory Flexibility Act's definition of small governmental jurisdiction. To further improve clarity, the NRC changed the presentation of the size standards to conform to the listing of definitions of small entities in the Regulatory Flexibility Act.

2

The Proposed Rule On November 30, 1994 (59 FR 61293), the NRC published a proposed rule to amend the NRC's size standards. The NRC proposed to establish a separate standard to be used to determine whether a licensee who is a manufacturer would qualify as a small entity and to adjust the receipts-based standard to account for the effects of inflation since 1985. In addition, the NRC proposed to eliminate the separate $1 million size standard for private practice physicians and apply the revised receipts-based size standard of $5 million to this class of licensees. By amending the size standards through rulemaking, the NRC indicated its intent to codify NRC's size standards in 10 CFR Part 2.

As discussed in the preamble to the proposed rule, these amendments were developed after several factors indicated that some adjustments to the NRC's size standards were desirable.

The NRC received a number of comments concerning its size standards and the failure of the NRC to promulgate a size standard that differentiates between manufacturing entities and service providers in response to the final rule implementing Public Law 101-508 (56 FR 31472; July 10, 1991, and subsequent years). These commenters indicated that applying a gross receipts standard to a manufacturing concern resulted in an adverse impact on a manufacturer. The SBA size standards for manufacturers are prescribed in terms of a maximum number of employees rather than in terms of gross receipts.

3

The NRC conducted a survey to update the economic profile of its :materials licensees. The purpose of this survey was to evaluate the continued efficacy of NRC's size standards and to obtain the information needed to determine the necessity and effect of a separate standard for manufacturers within the context of the nuclear industry.

The SBA adjusted its receipts-based size standard levels to mitigate the effects of inflation from 1984 to the present in a final rule published in the Federal Register of April 7, 1994 (59 FR 16513).

Public Comment The comment period on the proposed rule closed December 30, 1994. The NRC received two letters of public comment on this action.

One commenter objected to the inclusion of a size standard based on the number of employees for qualification of a manufacturing concern as a small entity in the NRC's regulatory programs and the assessment of reduced annual fees. The commenter stated that the total employee population of a manufacturer has little bearing on revenue potential and revenue has little bearing on the risk to public health and safety. The commenter believes that although employee population may be a consideration, it must be considered in conjunction with revenue produced and with the complexity of the operation in determining size standards. The commenter also asserts that because manufacturers are authorized to possess significant quantities of 4

multiple isotopes, both as sealed sources and loose material for use in the :manufacture and distribution of products, they present a much higher risk than entities that hold a license for possession and use of sealed sources. The commenter states that the loss of revenue from manufacturers categorized as small entities will have to be made up by small licensees who may have only one or two devices on site.

The NRC is retaining a separate standard based on the number of employees for :manufacturers in the final rule because this standard is required by the Small Business Act (15 u.s.c. 632 (a) (2)). This provision prohibits a Federal department or agency from prescribing a size standard for categorizing a business concern as a small business concern unless the standard provides for uetermining the size of a manufacturing concern based upon employment.

One commenter was pleased to see that the NRC raised the size standard for private practice physicians from $1 million to

$5 million. However, the commenter indicated that this action did not go far enough in addressing the assessment of user fees.

The commenter suggested that the NRC consider evaluating the gross receipts of departments within a medical facility that utilize NRC services and not the overall receipts of the facility. The commenter contends that if the NRC focused on the smaller entity within the license, many licensees would qualify for the small business exemptions and would pay fees based on the actual revenue generated under the license.

5

The NRC notes that the Small Business Act establishes criteria for a small business concern. To qualify as a small business concern, the concern must be independently owned and operated and not dominant in its field of operation (15 u.s.c.

632 (a) (1)). A department of a medical facility does not meet this criterion. The NRC has included language in the final rule to address this type of situation.

In response to each of the comments, the NRC further

- emphasizes that the purpose of this rule is to amend the size standards used by the NRC to qualify an NRC licensee as a "small entity" under the Regulatory Flexibility Act. The application of these standards in the fee schedule rulemaking, or any other rule:making proceeding, is beyond the scope of this rule.

The Final Rule The NRC is adopting a size standard of 500 or fewer employees for business concerns that are manufacturing entities.

This standard is the most commonly used SBA employee standard and would be the standard applicable to the types of manufacturing industries that would hold an NRC license. Under this standard, approximately 48 percent of the licensees who indicated that they were manufacturers would qualify as small entities.

The NRC is adjusting its receipts-based size standard to accommodate inflation and to conform to the SBA final rule. The NRC is raising its receipts-based small business size standard from $3.5 million to $5 million. The NRC also is eliminating the separate $1 million size standard for private practice physicians 6

and applying the revised receipts-based size standard of $5 million to this class of licensees. This mirrors the revised SBA standard of $5 *illion for *edical practitioners. For greater clarity, the NRC has included a definition of the term receipts in the final rule.

The survey of :materials licensees indicated that 26 percent qualified as small entities under the NRC standards being replaced by this rule. Under the size standards adopted in this

- doc\ll1lent, 35 percent of these licensees would qualify as small entities, an increase of 9 percent. When NRC adopted its size standards in 1985, the NRC staff estimated that approximately 35 percent of the materials licen~ees would qualify as small entities.

The Small Business Credit and Business Opportunity Enhancement Act of 1992 (Pub. L. 102-366) amended the Small Business Act concerning the establishment of agency-specific small business size standards. The NRC size standards were developed so as to meet the criteria specified in Pub. L. 102-366. As required by Pub. L. 102-366, the NRC size standards were approved by the Administrator, SBA.

This final rule also codifies NRC's size standards in Part 2 of the Commission's regulations. Previously, NRC's size standards had been published in the notices section of the Federal Register.

Environmental Impact: Categorical Exclusion 7

The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c) (1).

Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final regulation.

Paperwork Reduction Act Statement This final rule does not contain a new or amended information collection requirement subject to the Paperwork

- Reduction Act of 1980 (44 u.s.c. 3501 et seq.). Existing requirements were approved by the Office of Managem~~t and Budget, approval number 3150-0136.

Regulatory Analysis A regulatory analysis has not been prepared for this final rule because the final rule is administrative in that it amends the criteria the NRC uses for determining which of its licensees qualify as small entities for the purposes of compliance with the Regulatory Flexibility Act. The amended size standards conform to SBA's re~*lsed standards and result in an increase in the number of NRC licensees that qualify as small entities.

Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 u.s.c. 605(b), the Commission certifies that this rule does not have a significant economic impact on a substantial number of small entities. The final rule is administrative in that it amends the criteria the NRC uses in determining which of its licensees qualify as small entities for the purposes of 8

compliance with the Regulatory Flexibility Act. The amended size standards conform to SBA's revised standards and result in an increase in the number of NRC licensees that would qualify as small entities.

Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this final rule and, therefore, that a backfit analysis is not required for this final rule because these amendments do not impose any provisions that.would impose backfits as defined in 10 CFR 50.109(a) (1).

List of Subjects in 10 CFR Part 2 Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Environmental protection, Nuclear materials, Nuclear power plants and reactors, Penalties, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal.

• For the reasons -set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 u.s.c. 552 and 553; the NRC is adopting the following amendment to 10 CFR Part 2.

PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND ISSUANCE OF ORDERS

1. The authority citation for Part 2 continues to read as follows:

AUTHORITY: Secs. 161, 181, 68 Stat. 948, 953, as amended (42 u.s.c. 2201, 2231); sec. 191, as amended, Pub. L.87-615, 76 9

Stat. 409 (42 u.s.c. 2241); sec. 20i, 88 Stat. 1242, as amended (42 u.s.c. 5841); 5 u.s.c. 552.

Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 105, 68 Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42 u.s.c. 2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f), Pub. L.97-425, 96 Stat. 2213, as amended (42 u.s.c.

10134(f)); sec. 102, Pub. L.91-190, 83 stat. 853, as amended (42 u.s.c. 4332); sec. 301, 88 Stat. 1248 (42 u.s.c. 5871). Sections 2.102, 2.103, 2.104, 2.105, 2.721 also issued under secs. 102, 103, 104, 105, 183, 189, 68 Stat. 936, 937, 938, 954, 955, as amended (42 u.s.c. 2132, 2133, 2134, 2135, 2233, 2239). Section 2.105 also issued under Pub. L.97-415, 96 stat. 2073 (42 u.s.c.

2239). Sections 2.200-2.206 also issued under secs. 161b, i, o, 182, 186, 234, 68 Stat. 948-951, 955, 83 Stat. 444, as amended (42 u.s.c. 2236, 2282); sec. 206, 88 Stat 1246 (42 u.s.c. 5846).

Sections 2.600-2.606 also issued under sec. 102, Pub. L.91-190, 83 Stat. 853, as amended (42 u.s.c. 4332). Sections 2.700a, 2.719 also issued under 5 u.s.c. 554. sections 2.754, 2.760, 2.770, 2.780 also issued under 5 u.s.c. 557. Section 2.764 and Table 1A of Appendix C also issued under secs. 135, 141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 2.790 also issued under sec. 103, 68 stat. 936, as amended (42 u.s.c. 2133) and 5 u.s.c. 552. Sections 2.800 and 2.808 also issued under 5 u.s.c. 553. Section 2.809 also issued under 5 u.s.c. 553 and sec. 29, Pub. L.85-256, 71 Stat. 579, as amended (42 u.s.c. 2039). Subpart K also issued under sec. 189, 68 Stat.

955 (42 u.s.c. 2239); sec. 134, Pub. L.97-425, 96 Stat. 2230 (42 u.s.c. 10154). Subpart L also issued under sec. 189, 68 Stat. 955 (42 u.s.c. 2239). Appendix A also issued under sec. 6, Pub. L.91-560, 84 stat. 1473 (42 u.s.c. 2135). Appendix B also issued under sec. 10, Pub. L.99-240, 99 Stat. 1842 (42 u.s.c.

?021b et seq.).

2. Section 2.810 is added to read as follows:

S 2.810 NRC Size standards.

The NRC shall use the size standards contained in this section to determine whether a licensee qualifies as a small entity in its regulatory programs.

(a) A small business is a for-profit concern and is a (1) Concern that provides a service or a concern not engaged in manufacturing with average gross receipts of $5 million or less over its last 3 completed fiscal years; or 10

(2) Manufacturing concern with an average number of 500 or fewer employees based upon employment during each pay period for the preceding 12 calendar months.

(b) A small organization is a not-for-profit organization which is independently owned and operated and has annual gross receipts of $5 million or less.

(c) A small governmental jurisdiction is a government of a city, county, town, township, village, school district, or

- special district with a population of less than 50,000.

(d) A small educational institution is one that is (1) Supported by a qualifying small governmental jurisdiction; or (2) Not state or publicly supported and has 500 or fewer employees.

(e) For the purposes of this section, the NRC shall use the Small Business Administration definition of receipts to include

"*** all revenues in whatever form received or accrued from whatever source *** " (13 CFR 402(b) (2)). A licensee who is a subsidiary of a large entity does not qualify as a small entity for purposes of this section.

Dated at Rockville, Maryland this 3/,,,./-day o f ~ ,

1995.

For the Nuclear Regulatory Commission.

for Operations.

11

This communication was sent via fax on 1/5/95.

n radiation I technology, inc.

January 5, 1995 DOC S1ED CS. RC

'95 JAN 12 Al O:11 Ms. Sarah N. Wigginton Acting Chief Rules Review and Directive Branch Division of Freedom oflnformation and Publications Services Office of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555 Re: RIN 3150-AF24 Amendment to NRC size standards under the Regulatory Flexibility Act

Dear Ms. Wigginton:

The purpose of this letter is to object to the inclusion of"a manufacturing concern with an average of 500 or fewer employees" in the size standard for qualification as a small entity in the NRC' s regulatory programs and assessment of reduced annual license fees. It is our opinion that several items should be reviewed when considering this amendment:

1. The total employee population of a manufacturer has little bearing on revenue potential, and revenue has little bearing on risk to public health and safety. While the employee population may be a consideration, we believe it must be considered in conjunction with revenue produced and complexity of the operation in determining "size standards."

2. Manufacturers are authorized to possess significant quantities of multiple isotopes both as sealed sources and loose material, for use in the manufacture and distribution of products. Regardiess of population, they present a much higher risk than any sized entity holding a license for possession and use only of sealed sources.

3. Manufacturers currently pay annual fees from a few thousand to many thousands of dollars. The loss of this revenue from manufacturers categorized as "small entities" will by necessity, have to be made up by small licensees who may have only one or two devices on site.

MAR - 1 1995 Acknowledged by card ..............-,......;;;.

P.O. Box 27637

• Austin, Texas 78755 * (512) 346-7608

• Fax (512) 795-8718 8407 Skyline Avenue

• Odessa, Texas 79764 * (915) 550-9701

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Docum&nt Statistics

Ms. Sarah N. Wigginton January 5, 1995 Page Two We would like to reiterate that it is neither reasonable nor equitable in the business world to set size standards based solely upon the number of employees, without considering revenue or the complexity of authorized activities.

We appreciate your consideration of our comments.

Sincerely, Radiation Technology, Inc.

Doris C. Bryan Manager Licensing & Regulatory Affairs DCB:pz

American (202) 429-5120 Fax (202) 223-4579 The Society College of *94 OU: 29 P5 :13 of Nuclear Nuclear Medicine Physicians OFF !Cl U :Ff *1E - ~:{ y OG CtU. T,~ G t 1

• _, .. 'if'f OCKET NUMBER PR 2 December 28, 1994 Glc--1: f PROPOSED RULE-=-=~~-

( S 'f FT{ 61113)

John C. Hoyle Acting Secretary U.S . Nuclear Regulatory Commission 0

Washington, DC 20555 Attn: Docketing and Service Branch RE: Proposed Rule entitled "NRC Size Standards"; 59 Federal Register 61293, November 30, 1994.

Dear Secretary Hoyle:

The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) are pleased to see that NRC has raised the threshold for the small entity criteria for private practicing physicians to $5 million. 1 We feel however that this does not go far enough in addressing the assessment of user fees. We ask that NRC consider evaluating the gross receipts of departments within a medical facility that utilize the services of the NRC and not the overall receipts of the licensee. In virtually all cases, Nuclear Medicine departments make up a small portion of the total receipts of a hospital. In comparison the user fees charged to some medical facilities are a substantial part of that licensee's receipts for those activities. We urge the NRC to adopt the policy outlined below in order to accurately address the problem with the allocation of user fees.

The equation for determining the amount of fees allocated to each licensee under part 170 and 171 ,

fail to take into account the method of collection by the licensee in order to cover those fees.

Although the NRC has taken steps to alleviate the burden on small businesses by providing a cap on fees of not more than $1,800, this does not eliminate the burdensome fees on medical licensees whose institutions don't qualify for this exemption. The criteria on which the NRC currently bases its fee structure revolve around the revenue of the entire institution, rather than just that of the licensee. It is difficult to see the rationale behind the NRC using the revenues of an entire hospital or university

• in evaluating which licensees qualify for the small entity exemption. Basing a fee schedule on the non-nuclear medicine revenue of the hospital forces the hospital to allocate funds outside of the scope of the license in order to compensate for funds that are not raised through the activities of the licensee.

1 The American College of Nuclear Physicians and the Society of Nuclear Medicine represent over 15,000 nuclear medicine physicians, nuclear medicine pharmacists, nuclear medicine scientists, and nuclear medicine technologists involved in the delivery of essential health care.

MAR - 1 1995j Acknowledge bj -----

tl.S. NUC'Lf.: .. *.; ...: :..ATORY COMMISSION DOCiE! 1,/,; /i SERVICE SECTION OFFiCE OF TfiE SECRETARY OF THE COMMISSION Document Statistics

ACNP/SNM Comments to NRC December 28, 1994 Page2 ACNP/SNM would like the NRC to reconsider basing its fees on the smaller nuclear medicine department entity rather than relying on the licensee's annual receipts. By focusing on the smaller entity within the license, many licensees would qualify for the small business exemptions and would pay fees based on the actual revenue generated under the license. This would grant the larger entity the freedom to maintain the capabilities of its nuclear medicine department and continue to provide the best patient care available.

Both of these policy changes would have a drastic impact on the evaluation of small entities. We feel that it is critical for NRC to look at these changes, not simply in the context of fee setting and collection, but rather at the global impact that small entity status would have on medical licensees.

We contend that almost every nuclear medicine department would meet the small entity threshold of

$5 million now established for physicians in private practice. For this reason NRC should consider nuclear medicine departments that are part of a larger licensee under the same criteria as a physician in private practice. Location alone should not be the sole determining factor in the evaluation of small entity status. NRC also indicates that it has raised the percentage covered under small entity status from 25% to 35%. This still leaves 65% of the medical facilities under NRC jurisdiction facing large user fees. The result is continually increasing fees allocated for over two- thirds of NRC's medical licensees.

Thank you for considering our suggestions. If you have any questions feel free to contact Mr. David Nichols, Regulatory Affairs Coordinator at (202) 429-5120.

w~,:--~- 1Y\.c.c..~a Cl:~*~~

Sincerely, WilliamH. McCartney, M.D. -- -

President President American College of Nuclear Physicians Society of Nuclear Medicine

Copy to SECY-Original sent to the DOCKET NUMBER Office of the Federal Register PROPOSED RULE PR 2 fo~ublication

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• 94 v 28 P12 :oo "94 Nov 28 NUCLEAR REGULATORY COMMISSION OF:1 ,. -

10 CFR Part o~,_-!

RIN 3150-AF24 NRC Size Standards; Proposed Revision AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing to amend the NRC's size standards used to qualify an NRC licensee as a "small entity" under the Regulatory Flexibility Act. The amendments would: (i) establish a separate standard to be used to determine whether a licensee who is a manufacturer would qualify as a small entity; and (ii) adjust the receipts-based standard to account for the effects of inflation since 1985.

It-/ '30 {t:fL/

DATE: Comment period expires (30 days from date of publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.

1

ADDRESSES: Mail written comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555. ATTN: Docketing and Service Branch.

Deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 am and 4:15 pm Federal workdays.

Copies of any comments received may be examined at the NRC Public Document Room at 2120 L Street, NW. (lower level),

Washington, DC.

FOR FURTHER INFORMATION CONTACT: Sarah N. Wigginton, Acting Chief, Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, telephone (301) 415-7158.

SUPPLEMENTARY INFORMATION:

In 1983, the NRC surveyed its materials licensees to create an economic profile sufficient to consider regulatory alternatives tailored to the size of the licensee. After analyzing the data and consulting with the Small Business Administration (SBA), the NRC developed a proposed size standard that would pe appropriate to use in determining which of its licensees would qualify as small entities for the purposes of compliance with the Regulatory Flexibility Act. The NRC published its proposed size standard for notice and comment in the Federal Register of May 21, 1985 (50 FR 20913). After considering the comments received, the NRC adopted its final size standards as noted in the Federal Register of December 9, 1985 2

(50 FR 50241). In the Federal Register of November 6, 1991 (56 FR 56671), the NRC restated the size standards to include the Regulatory Flexibility Act's definition of small governmental jurisdiction. To further improve clarity, the NRC changed the presentation of the size standards to conform to the listing of definitions of small entities in the Regulatory Flexibility Act.

The size standards developed by the NRC were used in the NRC's final rule implementing Public Law 101-508 to provide for a reduced annual fee for those NRC licensees who qualified as small entities under these standards (56 FR 31472; July 10, 1991 and subsequent years). In response to these rules, the NRC has received a number of comments concerning its size standards and the failure of the NRC to promulgate a size standard that differentiates between manufacturing entities and service providers. These commenters indicated that applying a gross receipts standard to a manufacturing concern resulted in an adverse impact on a manufacturer. The gross receipts of a service provider reflect the value added by the service provider, which is essentially the value of the service itself. However, the gross receipts of a manufacturer that are equal to those of a service provider reflect a smaller percentage of the value added by the manufacturer. *A manufacturer's gross receipts include the costs of the raw materials or components that, when added to the cost of manufacture, quickly send a manufacturer's gross receipts into fairly sizeable sums. The SBA size standards for 3

manufacturers are prescribed in terms of a maximum number of employees rather than in terms of gross receipts.

The NRC recently completed a survey to update the economic profile of its materials licensees. The purpose of this survey was to evaluate the continued efficacy of NRC's current size standards and to obtain the information that is necessary to determine the necessity and effect of a separate standard for manufacturers within the context of the nuclear industry.

Of the licensees who responded to the survey request, approximately 20 percent (1131 of 5704) indicated that manufacturing was a primary line of their business. This indicates that a number of licensees would benefit from the establishment of a separate standard for businesses engaged in manufacturing.

Therefore, the NRC is proposing to adopt a size standard for business concerns that are manufacturing entities. The NRC proposes to use a standard of 500 or fewer employees. This standard is the most commonly used SBA employee standard and would be the standard applicable to the types of industries that would hold an NRC license. Under this standard, approximately 48 percent of the licensees who indicated that they were manufacturers would qualify as small entities.

On September 2, 1993 (58 FR 46573), SBA published a proposed rule in the Federal Register that would have streamlined its size standards by reducing the number of its fixed size standard levels from 30 to 9. As part of this proposed rule, the SBA 4

proposed to adjust most of its receipts-based size standard levels to mitigate the effects of inflation from 1984 to the present. In a final rule published in the Federal Register of April 7, 1994 (59 FR 16513), the SBA adopted only that portion of its proposed rule that increased its receipts-based size standards as a result of inflation.

The NRC is proposing to adjust its receipts-based size standard to accommodate inflation and to conform to the SBA final rule. The NRC proposes to raise its receipts-based small business size standard from $3.5 million to $5 million. After analyzing the data received in response to the survey and the revised SBA size standards, the NRC also is proposing to eliminate the separate $1 million size standard for private practice physicians and apply the revised receipts-based size standard of $5 million to this class of licensees. This would mirror the revised SBA standard of $5 million for medical practitioners. The survey of materials licensees indicates that 26 percent qualify as small entities under current NRC standards.

If the NRC adopts the proposed revisions to its size standards presented in this document, 35 percent of these licensees would qualify as small entities, an increase of 9 percent. When NRC adopted its size standards in 1985, the NRC staff estimated that approximately 35 percent of the materials licensees would qualify as small entities.

The Small Business Credit and Business Opportunity Enhancement Act of 1992 (Pub. L. 102-366) amended the Small 5

Business Act concerning the establishment of agency specific small business size standards. The proposed NRC size sta~dards have been developed so as to meet the criteria specified in Pub.

L. 102-366. The NRC has submitted these proposed size standards for the review and approval of the Administrator, SBA.

This proposed rule also would codify NRC's size standards in Part 2 of the Commission's regulations. Previously, NRC's size standards had been published in the notices section of the Federal Register.

Environmental Impact: Categorical Exclusion The NRC has determined that this proposed rule is the type of action described in categorical exclusion 10 CFR 51.22(c) (1).

Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.

Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1980 (44 u.s.c. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget, approval number 3150-0136.

Regulatory Analysis A regulatory analysis has not been prepared for this proposed rule because the proposed rule is administrative in that it would amend the criteria the NRC uses for determining which of its licensees would qualify as small entities for the purposes of 6

compliance with the Regulatory Flexibility Act. The amended size standards would conform to SBA's revised standards and result in an increase in the number of NRC licensees that would qualify as small entities.

Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 u.s.c. 605(b), the Commission certifies that this rule, if adopted, will not have a significant economic impact on a substantial number of small entities. The proposed rule is administrative in that it would amend the criteria the NRC uses in determining which of its licensees would qualify as small entities for the purposes of compliance with the Regulatory Flexibility Act. The amended size standards would conform to SBA's revised standards and result in an increase in the number of NRC licensees that would qualify as small entities.

Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this proposed rule and, therefore, that a backfit analysis is not required for this proposed rule because these amendments do not impose any provisions which would impose backfits as defined in 10 CFR 50.109(a) (1).

List of Subjects in 10 CFR Part 2 Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Environmental protection, Nuclear materials, Nuclear power plants and reactors, Penalties, 7

Sex discrimination, Source material, Special nuclear* material, Waste treatment and disposal.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 u.s.c. 553, the NRC is proposing to adopt the following amendments to 10 CFR Part 2.

PART 2 v RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND ISSUANCE OF *oRDERS

1. The authority citation for Part 2 continues to read as follows:

AUTHORITY: Secs. 161, 181, 68 Stat. 948, 953, as amended (42 U.S.C. 2201, 2231); sec. 191, as amended, Pub. L.87-615, 76 Stat. 409 (42 u.s.c. 2241); sec. 201, 88 Stat. 1242, as amended (42 u.s.c. 5841); 5 u.s.c. 552.

Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 105, 68 Stat. 930, 932, .933, 935, 936, 937, 938, as amended (42 u.s.c. 2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f), Pub. L.97-425, 96 Stat. 2213, as amended (42 u.s.c.

10134(f)); sec. 102, Pub. L.91-190, 83 Stat. 853, as amended (42 u.s.c. 4332); sec. 301, 88 Stat. 1248 (42 u.s.c. 5871). Sections 2.102, 2.103, 2.104, 2.105, 2.721 also issued under secs. 102, 103, 104, 105, 183, 189, 68 Stat. 936, 937, 938, 954, 955, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2233, 2239). Section 2.105 also issued under Pub. L.97-415, 96 Stat. 2073 (42 u.s.c.

2239). Sections 2.200-2.206 also issued under secs. 161b, i, o, 182, 186, 234, 68 Stat. 948-951, 955, 83 Stat. 444, as amended (42 U.S.C. 2236, 2282); sec. 206, 88 Stat 1246 (42 u.s.c. 5846).

Sections 2.600-2.606 also issued under sec. 102, Pub. L.91-190, 83 Stat. 853, as amended (42 u.s.c. 4332). Sections 2.700a, 2.719 also issued under 5 u.s.c. 554. Sections 2.754, 2.760, 2.770, 2.780 also issued under 5 u.s.c. 557. Section 2.764 and Table lA of Appendix C also issued under secs. 135, 141, Pub. L.97-425, 96 stat. 2232, 2241 (42 u.s.c. 10155, 10161). Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended (42 U.S.C. 2133) and 5 U.S.C. 552. Sections 2.800 and 2.808 also issued under 5 U.S.C. 553. Section 2.809 also issued under 5 u.s.c. 553 and sec. 29, Pub. L.85-256, 71 Stat. 579, as amended (42 u.s.c. 2039). Subpart K also issued under sec. 189, 68 Stat.

955 (42 u.s.c. 2239); sec. 134, Pub. L.97-425, 96 Stat. 2230 (42 u.s.c. 10154), Subpart L also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239). Appendix A also issued under sec. 6, 8

Pub. L.91-560, 84 Stat. 1473 (42 u.s.c. 2135). Appendix B also issued under sec. 10, Pub. L.99-240, 99 Stat. 1842 (42 u.s.c.

2021b et seq.).

2. Section 2.810 is added to read as follows:

S 2.810 NRC Size standards.

The NRC shall use the size standards contained in this section to determine whether a licensee qualifies as a small entity in its regulatory programs.

(a) A small business is a for-profit concern and is a (1) Concern that provides a service or a concern not primarily engaged in manufacturing with average gross receipts of

$5 million or less over its last 3 completed fiscal years; or (2) A manufacturing concern with an average number of 500 or fewer employees based upon employment during each pay period for the preceding 12 calendar months.

(b) A small organization is a not-for-profit organization which is independently owned and operated and has annual receipts of $5 million or less.

(c) Small governmental jurisdictions are governments of cities, counties, towns, townships, villages, school districts, or special districts with a population of less than 50,000.

(d) A small educational institution is one that is (1) Supported by a qualifying small governmental jurisdiction; or 9

(2) One that is not state or publicly supported and has 500 employees or less.

Dated at Rockville, Maryland this,<./~ day o f , 7 ~

1994.

For the Nuclear Regulatory Commission.

M. T or, ive irector for Operations.

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