General Training

c

Laws and Regulations

1)    General Training

a)      Required for all working with animals in research or teaching

b)      To start with, we will cover the laws and regulations.

c)      You can see we have a lot to cover, not necessarily in detail, but a lot.

2)      Laws, Regulations, Policies

i)        Animal Welfare Acts

ii)       Guide for the Care and Use of Laboratory Animals

iii)     Occupational Health and Safety in the Care and Use of Research Animals

iv)     FDA

v)      Private Funding

vi)     State

vii)   University

viii)  There are many regulatory agencies offering advice on the proper use of animals. Foremost, is the federal government. Next is the state and local governments. And, depending where our funding comes from, the funding agency itself may impose restrictions that we must adhere to. Lastly, in accordance with federal guidelines, each institution must have a "plan", then follow that plan, and lastly document it completely. This last document is referred to as the University's SOPs.

3)      Laws, Regulations, Policies

a)      To start off with, let's identify a few organizations associated with animal care.

b)      Terms

i)        AWA = Animal Welfare Act

ii)       USDA = U S Department of Agriculture

(1)   Is the department responsible for the enforcement of the AWA

iii)     APHIS = Animal and Plant Health Inspection Service

(1)   Regulate plants and animals coming into the U. S. and/or moved from state to state.

iv)     AC = Animal Care

(1)   Is the enforcement agency of USDA, under APHIS, that monitors and oversees the use of animals in biomedical research and teaching according to the AWA

v)      NIH = National Institute of Health

(1)   An agency of PHS that provides funding for research. It also provides guidance on animal use

vi)     OLAW = Office for Laboratory Animal Welfare

(1)   Agency under NIH that monitors animal use

4)      Laws, Regulations, Policies

a)      USDA

i)        Laboratory Animal Welfare Act 1966

(1)   Basically all it said was be humane to animals and not to steal them

(2)   Before 1966, there were only a couple of laws with little or no enforcement

ii)       Animal Welfare Act 1970

(1)   Minor amendment

iii)     Animal Welfare Act Amendment 1976

(1)   Minor amendment, added more detail and included the sea mammals.

iv)     Food Security Act 1985

(a)    The 1985 amendment was the major change in regulating animal use

(b)   Most of the requirements we abide by today was in this bill.

(c)    The law was very specific and the regulations that were written by USDA followed the law in a very specific manner.

(d)   AC (originally referred to as REAC) was established by the 1985 amendment and it enforces the act.

(e)    Applicable ‑ Facilities use live animals ‑ research, testing, education

(f)     Zoos, circuses, and breeding colonies that sell animals for research and teaching

(g)    The law is concerned with the use of animals in biomedical research, testing, or teaching.

(h)    Species covered are specifically listed

(i)      Dog, cat, rabbit, Guinea pig, hamster, non-human primate and other warm blooded mammals.

(ii)    It then excluded mice of the species Mus, and rats of the species Rattus, and birds.  It also excluded farm animals used for food or fiber and horses.

1.      These exclusions are constantly being argued in court and could at some point be included.

b)      NIH

i)        First in 1971

(1)   The first law was written in 1971 to regulate animals used by NIH

ii)       Health Research Extension Act 1985

(1)   In 1985, the second law was passed, along with the AWA amendment, involving animal use

iii)     Public Health Service Policy on Humane Care and Use of Laboratory Animals 1986

(1)   In 1986, another amendment was passed

(2)   Out of these last two were the "Principles" which described how we should select and care for the animals

(3)   The regulation covers all vertebrate animals funded by NIH any where in the world.

iv)     Enforcement – OLAR

v)      Applicable ‑ all PHS conducted or supported activities using animals at an institution

(1)   This requirement includes all animals used by an institution, not just the animals funded by NIH because the Assurance is for the institution, not specific animals.

5)      “Animal” Defined

i)        USDA’s and NIH's definition of animals differ slightly.

ii)       USDA

(a)    Any alive or dead dog, cat, nonhuman primate, Guinea pig, hamster, rabbit or any other warm blooded animal which is being used for research, teaching, testing, or experimentation, or exhibition or as a pet. 

(i)      Excludes birds, Mus, Rattus, and horses and farm animals used for food or fiber

(ii)    Note, USDA regulates alive or dead

iii)     NIH

(a)    Any live, vertebrate animal used or intended for use in research, training, experimentation, or biological testing or related purposes

(b)   Note, NIH covers only alive, vertebrates.

iv)     USDA + NIH - we combine the two for minimum standards - covers all vertebrates, including all dead or alive warm blooded mammals.

6)      USDA Regulations

a)      Part One – Definitions

i)        Includes what an "animal" is and a list of other words used in the regulation such as "study area", "wild life study", etc.

b)      Part Two ‑ Only subpart  AC@ for research facilities

i)        It is the regulatory part with Subparts A through Subpart I but only Subpart C pertains directly to the institution. This is where the IACUC and veterinary functions are defined, registration, record keeping, training, etc. are described

c)      Part Three ‑ Minimum standards for animal husbandry, care, treatment, and transportation

i)        Establishes minimum standards for the care of each covered species. Includes food, water, caging, sanitation, and handling requirements plus socialization and exercise for dogs and non-human primates. Violations result in a written reprimand, closure, and/or fines that can be into the millions of dollars plus possible jail time for certain people.

(1)   Penalties

(a)    $2500 per violation

(b)   Stop all research and teaching involving animals

(c)    Stop all federal funds to University

7)      Public Health Service

a)      More a policy than a regulation

i)        Ensures PHS grantees and contractors care for and use animals humanely

ii)       Oversight by OLAW

iii)     Compliance with AWA and the “Guide”

iv)     Assurance

v)      They encourage AAALAC accreditation and use them to inspect for them

vi)     Penalty ‑ Revocation of Assurance and loss of PHS support for entire institution (Millions)

vii)   Intended to ensure that PHS grantees and contractors care for and use animals humanely. OLAW has oversight responsibilities. Normally do not inspect unless suspected of noncompliance.

viii)  OLAW oversees all animal use in research. Primarily states policy and requires institutions to abide by all laws. The institution has to annually make a statement that they are meeting all federal standards. If not meeting all federal standards, all PHS money will be stopped that is coming to the institution and the Institutional Official may be sent to jail for falsifying government documents and inhumane care.
 

Quiz time!!!    What is the most used species in research?

8)      Good Laboratory Practice

a)      Involves two agencies

i)        Environmental Protection Agency

ii)       Food and Drug Administration

b)      Requirements

i)        SOPs

ii)       Specialized room requirements

iii)     Extensive record keeping

(1)   Especially on environment in animal room

c)      GLP is used when working with substances, chemicals, drugs, cosmetics, etc. and the product is "tested" for safety. When it is done, a very strict Standard Operating Procedure (SOP) has to be written, followed, and documented. There are special requirements for the housing and care of animals, especially environmental care.

9)      Institutional Animal Care and Use Committee

a)      Membership

i)        Appointed by Institutional Official

ii)       Number

(1)   3 minimum required by AWA

(2)   5 minimum required by PHS

iii)     Scientist, Laboratory Animal specialized Veterinarian, Non‑affiliated, Non‑scientist

iv)     The IACUC is made up of 3 (AWA) or 5 (PHS) members minimum with the Chairperson being a scientist experienced with animals used in research and teaching, a veterinarian trained in laboratory animal medicine, and a person totally non-affiliated with the institution (not even a spouse). PHS requires a non-scientist and another person on the committee. The members are appointed by the Institutional Official.

b)      Function

i)        Reviews all protocols

ii)       Reviews all animal facilities

iii)     Review total animal use program

iv)     Reviews concerns about animal use

v)      Suspends activities no longer to be in compliance

vi)     In summary, the IACUC is responsible for the animal use program and reports to the Institutional Official semiannually or more often as required. They review all animal facilities, animal policies, and protocols.

The most used species in research is (if you really want to know, click here)!

10)  Protocol Process

a)      Researcher writes draft

i)        May consult with veterinarian

b)      Researcher schedules meeting with veterinarian

i)        Discuss entire protocol primarily concentrating on animal use

c)      Researcher submits protocol to the IACUC (Sponsored Research)

d)      Protocol reviewed and approved

i)        Other options other than approval are

(1)   Approved with modifications and clarifications.  Generally need to meet with veterinarian

(2)   Tabled because too many unanswered questions and procedures need major modification

e)      With Protocol approved, you can order animals through Veterinary Services and get started

i)        Note: Only order animals through animal facility.  Any other process and the animals will not be allow in the facility

(1)   Besides an approved protocol for the species, there has to be space and equipment available and an acceptable health status that is compatible with currently housed animals.

f)        For more information on protocol process, got to the Sponsored Research web site.

11)  Other Regulatory Agencies

a)      AAALAC

i)        Association for Assessment and the Accreditation of Laboratory Animal Care, Inc. is a private organization that is used by most institutions as a consultant. Originally organized by veterinarians to standardize the care of research animals.

ii)       Their primary regulatory compliance guide is the ILAR Guide for the Care and Use of Laboratory Animals

(1)   AAALAC uses what ever laws or regulations that are applicable to the species and research. i.e. For wildlife, it would include the NSF's wildlife guide.

iii)     NIH accepts AAALAC inspections instead of doing them

iv)     They will do an initial inspection, follow-up as necessary and every three years.  A report has to be sent annually.

b)      Private

i)        AHA, American Cancer, drug companies, etc

ii)       Private funding may require anything they wish. To get the funding, we have to do what they require. General, it is just abide by all regulations.

c)      Florida

d)      Florida Atlantic University

i)        FAU will have IACUC policies and Veterinary Services has SOPs.

12)  In Summary

a)      Most of the regulations that you will be involved with have been briefly touched upon. The approach was to make you aware that regulations do exist concerned with the use of animals in biomedical research and teaching. We will return to some of the regulatory requirements in the next parts in detail, however, if there are any questions at this time, let us know. It is strongly suggested that you get a copy of the AWA and PHS Policy manuals and review them in detail.  The “Guide” is the best quick and easy to read regulation we have.

You have now completed the Laws and Regulations portion of General Training

Now you need to go to Ethics next