2015-01166. Environmental Protection Agency Acquisition Regulation (EPAAR); Environmental, Conservation, Occupational Safety, and Drug-Free Workplace

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule.

SUMMARY:

The Environmental Protection Agency (EPA) amends the EPA Acquisition Regulation (EPAAR) to address minor non-substantive changes in three clauses and two related prescriptions. The direct final rule updates “Protection of Human Subjects”, “Care of Laboratory Animals”, and “EPA Green Meetings and Conferences”. EPA does not anticipate any adverse comments.

DATES:

This rule is effective on March 30, 2015 without further notice, unless adverse comment is received February 26, 2015. If adverse comment is received, the EPA will publish a timely withdrawal of the rule in the Federal Register.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-HQ-OARM-2014-0515 by one of the following methods:

• www.regulations.gov: Follow the on-line instructions for submitting comments.
• Email: [e-mail].
• Fax: [phone].
• Mail: EPA-HQ-OARM-2014-0515, OEI Docket, Environmental Protection Agency, 2822T, 1200 Pennsylvania Ave. NW., Washington, DC 20460. Please include a total of three (3) copies.
• Hand Delivery: EPA Docket Center-Attention OEI Docket, EPA West, Room B102, 1301 Constitution Ave. NW., Washington, DC 20004. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No. EPA-HQ-OARM-2014-0515. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov,, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through http://www.regulations.gov your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​dockets.htm.

Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the Government Property-Contract Property Administration Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The 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 Public Reading Room is [phone] and the telephone number for the EPA Docket Center is [phone]. This Docket Facility is open from 8:30 a.m. to 4:30 p.m. Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT:

Holly Hubbell, Policy, Training, and Oversight Division, Acquisition Policy and Training Service Center (3802R), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-1091; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

General Information

1. Do not submit Classified Business Information (CBI) to EPA Web site ­http://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI, and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for Preparing Your Comments. When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).
• Follow directions—The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) Part or section number.
• Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

3. Make sure to submit your comments by the comment period deadline identified.

I. Background

The EPA is revising EPAAR 1552.223-70 Protection of Human Subjects and 1552.223-72 Care of Laboratory Animals to update the clauses with current references and legislative information. Except for administrative changes, the clauses were last updated in 1984 and 2000, respectively. Prescription 1523.303-72 for EPAAR 1552.223-72 clarifies the applicability of the clause of care and use. The revisions to prescription 1523.703-1 Acquisition of Environmentally Preferable Meeting and Conference Services updates the applicability of clause 1552.223-71 EPA Green Meetings and Conferences. The revision of EPAAR 1552.223-71 replaces the “14 questions” with more relevant questions which clarify the current requirements for environmentally preferred facilities.

II. Final Rule

This final rule makes the following changes:

1. Revise prescription EPAAR 1523.303-72 to clarify the applicability of the clause EPAAR 1552.223-72 Care of Laboratory Animals.

2. Revise prescription EPAAR 1523.703-1 to clarify the applicability of clause 1552.223-71 requiring information about the environmental preferability features and practices of lodging and non-lodging oriented meeting and conference facilities.

3. Revise EPAAR 1552.223-70 to update the legislative and guidance references and information.

4. Revise EPAAR 1552.223-71 by replacing the “14 questions” with more relevant questions that better clarify essential attributes for environmentally preferred facilities.

5. Revise EPAAR 1552.223-72 to update the legislative references and guidance information.

Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the EO 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b).

C. Regulatory Flexibility Act (RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq.

The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute; unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impact of today's final rule on small entities, “small entity” is defined as: (1) A small business that meets the definition of a small business found in the Small Business Act and codified at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; or (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of this rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, because the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the proposed rule on small entities” 5 U.S.C. 503 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. This action revises current EPAAR clauses and will not have a significant economic impact on substantial number of small entities. We continue to be interested in the potential impacts of the rule on small entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

This action contains no federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for State, local, and tribal governments or the private sector. The action imposes no enforceable duty on any State, local or tribal governments or the private sector. Therefore, this action is not subject to the requirements of Sections 202 or 205 of the UMRA. This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this action. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on this action from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks

Executive Order 13045, entitled “Protection of Children from Environmental Health and Safety Risks” (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be economically significant as defined under EO 12886, and (2) concerns an environmental health or safety risk that may have a proportionate effect on children. This rule is not subject to EO 13045 because it is not an economically significant rule as defined by EO 12866, and because it does not have a proportionate effect on children.

H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use

This action is not subject to Executive Order 13211 (66 FR 28335 May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995 (NTTAA)

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This action does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

Executive Order 12898 (59 FR 7629 (Feb. 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment in the general public.

K. Congressional Review Act

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. Section 804 exempts from section 801 the following types of rules (1) rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of Agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties.

List of Subjects

48 CFR Part 1523

• Environmental protection
• Acquisition of environmentally preferable meeting and conference services
• Care of laboratory animals
• Environmental, conservation, occupational safety, and drug-free workplace
• Government procurement

48 CFR Part 1552

• Environmental protection
• Care of laboratory animals
• EPA green meetings and conferences
• Protection of human subjects
• Government procurement

Dated: January 7, 2015.

John R. Bashista,

Director, Office of Acquisition Management.

For the reasons stated in the preamble, Chapter 15 of Title 48 Code of Federal Regulations, parts 1523 and 1552 are amended as set forth below:

PART 1523—ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE

1. The authority citation for part 1523 continues to read as follows:

Authority: Sec. 205(c), 63 Stat. 390, as amended, 40 U.S.C. 486(c).

2. Revise 1523.303-72 to read as follows:

1523.303-72

Use and care of laboratory animals.

Contracting officers shall insert the clause at 1552.223-72, Use and Care of Laboratory Animals, in all contracts involving the use of animals in testing, research or training.

3. Revise 1523.703-1 to read as follows:

1523.703-1

Acquisition of environmentally preferable meeting and conference facilities and services.

(a) Scope. This section establishes the policy and the procedures for acquiring environmentally preferable meeting and conference facilities and services. For purposes of this section, the term “contracting officer” refers to any EPA employee with purchasing authority. For purposes of this section, the terms “meeting and conference facilities” or “conference facilities” refer to any off-site commercial facility which is purchased for the use of an EPA conference or event, whether the purpose of the event is a meeting, conference, training session, or other official purpose.

(b) Conference facilities. EPA conducts government events at facilities owned and operated by private, third-party vendors. These facilities—

(1) May provide conference participants with lodging, food and beverage, and other on-site event support services.

(2) Demonstrate they are environmentally preferable by their responses to the 17 questions in 1552.223-71(c) highlighting environmental performance. These questions address, among other things, reducing greenhouse gas (GHG) emissions, the production and disposal of solid waste, the use of and exposure to toxic chemicals/materials, and the depletion of natural resources including water.

(c) Policy. Contracting officers shall purchase environmentally preferable meeting and conference facilities and services to the greatest extent practicable. Environmentally preferable is defined at FAR 2.101 and shall be considered in all purchases of meeting and conference facilities and services.

(d) Procedures for micropurchases. The contracting officer shall request that potential third party conference facility vendors respond to the 17 questions in 1552.223-71(c) or language substantially the same as these questions, in order to evaluate their environmental performance.

(e) Procedures for purchases of conference facilities exceeding the micropurchase threshold. The contracting officer shall request that potential third party conference facility vendors respond to the 17 questions in 1552.223-71(c) or language substantially the same as these questions, in order to evaluate their environmental performance. The contracting officer shall notify vendors that the basis for award will be best value with price and other factors considered. Environmental preferability, as determined by evaluating the information submitted in response to the questions and specifications at 1552.223-71(c) or information submitted in response to substantially similar questions and specifications, shall be considered among the other factors. The contracting officer shall determine the relative importance of price and other factors as appropriate to the acquisition, but in all cases shall consider environmental preferability as a significant factor.

(f) Contractor support for meetings and conferences. A contract, order, work assignment or purchasing agreement that includes contractor support for meeting and conference planning and logistics must include requirements to make use of environmentally preferable meeting and conference facilities and services. The contracting officer shall ensure language is included in the tasking document work statement that requires the contractor to use the provisions at 1552.223-71 or language approved by the contracting officer that is substantially the same as the provisions, when soliciting quotes or offers for meeting and conference services on behalf of the EPA.

(g) Solicitation provision. The contracting officer shall insert provisions or language substantially the same as the provisions at 1552.223-71 EPA Green Meetings and Conferences, in solicitations for meeting and conference services. Contracting officers issuing an oral solicitation must also use these provisions, though they may be provided to the vendor orally or electronically. Contractors soliciting quotes or offers for meeting and conference services on behalf of EPA shall use the provisions, or language approved by the contracting officer that is substantially the same as the provisions.

PART 1552—SOLICITATION PROVISIONS AND CONTRACT CLAUSES

4. The authority citation for part 1552 continues to read as follows:

Authority: 5 U.S.C. 301; Sec. 205(c), 63 Stat. 390, as amended, 40 U.S.C. 486(c); and 41 U.S.C. 418b.

5. Revise 1552.223-70 to read as follows:

1552.223-70

Protection of human subjects.

As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects.

Protection of Human Subjects March 2015

(a) The contractor shall meet all EPA requirements for studies using human subjects prior to undertaking any work with human subjects in accordance with 40 CFR part 26 and EPA Order 1000.17 A1 Policy and Procedures on Protection of Human Research Subjects in EPA Conducted or Supported Research. Studies involving intentional exposure of human subjects who are children or pregnant or nursing women are prohibited. Requirements regarding observational studies involving children or pregnant women and fetuses are referenced in subparts C and D of 40 CFR part 26.

(b) The contractor's Institutional Review Board (IRB) approval must state that the contractor's study meets the EPA's regulations at 40 CFR part 26 and EPA Order 1000.17 A1. No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the contractor's IRB approval of the project and the EPA has also issued approval. Where human subjects are involved in the research, the contractor must provide evidence of subsequent IRB reviews, including amendments or minor protocol changes, as part of annual reports.

(c) The contractor shall bear full responsibility for the proper and safe performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the government for the acts of the contractor, its employees, sub-contractors, consultants, heirs, assignees, etc.

(d) If at any time during the performance of this contract, the contracting officer determines that the contractor is not in compliance with any of the requirements and/or standards stated in above, the contracting officer may immediately suspend, in whole or in part, work and further payments under this contract until the contractor corrects the noncompliance. The contracting officer may communicate the notice of suspension by telephone with confirmation in writing. If the contractor fails to complete corrective action within the period of time designated in the contracting officer's written notice of suspension, the contracting officer may terminate this contract in whole or in part.

(End of clause)

6. Revise 1552.223-71 to read as follows:

1552.223-71

EPA Green Meetings and Conferences.

As prescribed in 1523.703-1, insert the following provision, or language substantially the same as the provision, in solicitations for meetings and conference facilities.

EPA Green Meetings and Conferences March 2015

(a) The mission of the EPA is to protect human health and the environment. As such, all EPA meetings and conferences will be staged using as many environmentally preferable measures as possible. Environmentally preferable means products or services that have a lesser or reduced effect on the environment when compared with competing products or services that serve the same purpose.

(b) Potential meeting or conference facility providers for EPA shall provide information about the environmentally preferable features and practices identified by the checklist contained in paragraph (c) of this section, addressing sustainability for meeting and conference facilities including lodging and non-lodging oriented facilities.

(c) The following list of questions is provided to assist contracting officers in evaluating the environmental perferability of prospective meeting and conference facility providers. More information about EPA's Green Meetings initiative may be found on the Internet at http://www.epa.gov/​oppt/​greenmeetings/​.

(1) Does your facility track energy usage and/or GHG emissions through ENERGY STAR Portfolio Manager (http://www.energystar.gov/​benchmark) or some other calculator based on a recognized greenhouse gas tracking protocol? Y/N__

(2) If available for your building type, does your facility currently qualify for the Energy Star certification for superior energy performance? Y/N __, NA__

(3) Does your facility track water use through ENERGY STAR Portfolio Manager or another equivalent tracking tool and/or undertake best management practices to reduce water use in the facility (http://www.epa.gov/​watersense/​commercial)? Y/N__

(4) Do you use landscaping professionals who are either certified by a WaterSense recognized program or actively undertake the WaterSense “Water-Smart” landscaping design practices (http://www.epa.gov/​watersense/​outdoor)? Y/N__, NA__

(5) Based on the amount of renewable energy your buildings uses, does (or would) your facility qualify as a partner under EPA's Green Power Partnership program (http://www.epa.gov/​greenpower/​join/​purchase.htm)?

­Y/N__

(6) Do you restrict idling of motor vehicles in front of your facility, at the loading dock and elsewhere at your facility? Y/N__

(7) Does your facility have a default practice of not changing bedding and towels unless requested by guests?

Y/N__, NA__

(8) Does your facility participate in EPA's WasteWise (http://www.epa.gov/​epawaste/​conserve/​smm/​wastewise/​) and/or Food Recovery Challenge ­(http://www.epa.gov/​foodrecoverychallenge/​) programs? Y/N__

(9) Do you divert from landfill at least 50% of the total solid waste generated at your facility? Y/N__

(10) Will your facility be able to divert from the landfill at least 75% of the total solid waste expected to be generated during this conference/event? Y/N__

(11) Do you divert from landfill at least 50% of the food waste generated at your facility (through donation, use as animal feed, recycling, anaerobic digestion, or composting)? Y/N__

(12) Will your facility be able to divert from landfill at least 75% of the food waste expected to be generated during this conference/event (through donation, use as animal feed, recycling, anaerobic digestion, or composting)?

Y/N__

(13) Does your facility provide recycling containers for visitors, guests and staff (paper and beverage at minimum)? Y/N__

(14) With respect to any food and beverage prepared and/or served at your facility, does at least 50% of it on average meet sustainability attributes such as: Local, organic, fair trade, fair labor, antibiotic-free, etc.? Y/N__

(15) Will your facility be able to ensure that at least 75% of the food and beverage expected to be served during this conference/event meets sustainability attributes such as: Local, organic, fair trade, fair labor, antibiotic-free, etc.? Y/N__

(16) Does your facility use Design for the Environment (DfE) cleaning products (http://www.epa.gov/​dfe/​), or similar products meeting other recognized standards for being `environmentally preferable' (http://www.epa.gov/​epp/​) or more sustainable? Y/N__

(17) Is your facility prepared to document or demonstrate all of the claims you have made above? Y/N__

(d) The contractor shall include any additional “Green Meeting” information in their proposal which is believed is pertinent to better assist us in considering environmental preferability in selecting our meeting venue.

7. Revise 1552.223-72 to read as follows:

1552.223-72

Use and care of laboratory animals.

As prescribed in 1523.303-72, insert the following clause in all contracts involving the use of animals in testing, research or training:

Use and Care of Laboratory Animals March 2015

(a) Use of laboratory animals. (1) Before undertaking performance of any contract involving the use of laboratory animals, the contractor shall register with the Secretary of Agriculture of the United States in accordance with the Secretary of Agriculture of the United States in accordance with the Animal Welfare Act of 1966, as amended (AWA), codified at 7 U.S.C. 2131 et seq. and promulgated at 9 CFR parts 1-4. The contractor shall furnish evidence of such registration to the contracting officer.

(2) The contractor shall acquire animals used in research and development programs from a dealer licensed by the Secretary of Agriculture, or from exempted sources in accordance with 9 CFR 2.25-2.28. Animals shall not be acquired from any random source Class B dealer.

(3) The contractor may request registration of his/her facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which his/her research facility is located. The location of the appropriate APHIS Regional Office as well as information concerning this program may be obtained at http://www.aphis.usda.gov/​contact_​us/​.

(b) Care of laboratory animals. (1) In the care of any live animals used or intended for use in the performance of this contract, the contractor shall adhere to:

(i) The standards and practices incorporated in the Guide for Care and Use of Laboratory Animals, prepared by the Institute of Laboratory Animal Research of the National Research Council of the National Academies (ILAR/NRC),

(ii) The Animal Welfare Regulations found in 9 CFR parts 1-4, and

(iii) The National Institutes of Health (NIH) Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals.

(2) In case of conflict between standards, the higher standard shall be used.

(3) The contractor's reports on portions of the contract in which animals were used shall contain a certificate stating that the animals were cared for in accordance with the principles enunciated in the Guide for Care and Use of Laboratory Animals, prepared by the ILAR/NRC, and/or in the Animal Welfare Regulations found in 9 CFR parts 1-4.

(End of clause)