Selected USDA Regulatory Requirements the Differ from the PHS Policy

1 The PHS Policy requires that Assured institutions comply with the regulations (9 CFR, Subchapter A) issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act, as applicable. The endnotes below are specific USDA regulatory requirements that differ from or are in addition to the PHS Policy. This list is not intended to be all inclusive. For additional information please refer to 9 CFR Subchapter A - Animal Welfare.

2 Part 2 Subpart C - Research Facilities
- 2.31(b)(2) - "The Committee shall be composed of a Chairman and at least two additional members; ... at least one shall not be affiliated in any way with the facility...such person will provide representation for general community interests in the proper care and treatment of animals." [PHS policy requires 5 members]

32.32(c)(4) - "...No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act." [USDA requirement additional to PHS Policy]

42.31(d)(5) - "...shall conduct continuing reviews of activities..not less than annually." [PHS Policy requires a complete new review every 3 years utilizing all the criteria for initial review]

52.31(d)(1)(x) - "...no animal will be used in more than one major operative procedure from which it is allowed to recover unless ... (it is) justified for scientific reasons ... (or is) required as routine veterinary procedure ... or other special circumstances as determined by the Administrator on an individual basis." [this last point is an additional USDA justification for multiple survival surgeries]

62.36 - "...each reporting facility shall submit an annual report to the APHIS, AC sector supervisor for the State where the facility is located on or before December 1 of each calendar year." [The USDA annual report has a list of requirements which differ from PHS annual report]

72.31(c)(3) - "...The reports shall be reviewed and signed by a majority of committee members..." [USDA requirement additional]

82.36(b)(3) - "...exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the IACUC. A summary of all such exceptions must be attached to the facility's annual report." [Refers to the USDA annual report]

92.31(c)(3) - "...Any failure to adhere to the plan and schedule that results in a significant deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC, through the institutional official, to APHIS and any Federal agency funding that activity." [PHS Policy requires prompt reporting to OLAW of serious or continuing noncompliance with the PHS Policy or serious deviations from the provisions of the Guide]

10[In addition to PHS requirements for IACUC review/application for funding, USDA regulations require]:

2.31(d)(1)(ii) - "The principal investigator (PI) consider alternatives to procedures that cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources...used to determine that alternatives were not available."

2.31(d)(1)(iii) - "The PI has provided written assurance that the activities do not unnecessarily duplicate previous experiments."

2.31(d)(1)(iv) - "Procedures that may cause more than momentary or slight pain or distress to the animals will:

2.31(d)(1)(x) - "No animal will be used in more than one major operative procedure from which it is allowed to recover, unless justified for scientific reasons by the principal investigator, in writing..."

112.33(a)(1) - "In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall include a written program of veterinary care and regulatory scheduled visits to the research facility." [USDA requirement additional]

122.32(c) - "Humane methods of animal maintenance and experimentation, including the basic needs of each species, proper handling and care for the various species of animals used by the facility, proper pre-procedural and post-procedural care of animals, and aseptic surgical methods and procedures.

132.32(c) - additional specifications include:

142.31(d)(iv)(C) - "Procedures that may cause more than momentary or slight pain or distress to the animals will...not include the use of paralytics without anesthesia."

15Part 3 Subpart A 3.6(c)(1) - "Each dog housed in a primary enclosure must be provided with a minimum amount of floor space, calculated as follows:
(length of dog in inches + 6)2/144 = required floor space in square feet

- Part 3 Subpart D 3.80 (b) "Primary enclosures [for nonhuman primates] must meet the minimum space requirements provided in this subpart."

- In situtations where the USDA regulations and the Guide differ with respect to space requirements, the larger of the two must be followed.

16Part 3 Subpart A 3.8 - "...research facilities must develop, document, and follow an appropriate plan to provide dogs with the opportunity for exercise. In addition the plan must be approved by the attending veterinarian. The plan must provide written standard procedures..."

17Part 3 Subpart D 3.81 - "...research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates."

Go To OER web posting: 2000/04/07