[Federal Register Volume 68, Number 70 (Friday, April 11, 2003)]
[Proposed Rules]
[Pages 17752-17755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8928]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 68, No. 70 / Friday, April 11, 2003 / 
Proposed Rules  

[[Page 17752]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 2

[Docket No. 97-033-1]


Animal Welfare; Medical Records

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the Animal Welfare Act regulations 
to require that research facilities, dealers, and exhibitors maintain 
medical records as part of their program of adequate veterinary care. 
We believe research facilities, dealers, and exhibitors should maintain 
medical records as a means of communication concerning the care being 
provided to animals and to ensure that animals receive adequate 
veterinary care. In addition, these records would provide a basis for 
the Animal and Plant Health Inspection Service to better assess the 
veterinary care programs of research facilities, dealers, and 
exhibitors.

DATES: We will consider all comments that we receive on or before June 
10, 2003.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 97-033-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 97-033-1. If you use e-mail, 
address your comment to [email protected]. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
97-033-1'' on the subject line.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Jerry DePoyster, Senior Veterinary 
Medical Officer, Animal Care, APHIS, 4700 River Road Unit 84, 
Riverdale, MD 20737-1231; (301) 734-7586.

SUPPLEMENTARY INFORMATION:

Background

    The Animal Welfare Act (the Act) (7 U.S.C. 2131 et seq.) authorizes 
the Secretary of Agriculture to promulgate standards and other 
requirements governing the humane handling, housing, care, treatment, 
and transportation of certain animals by dealers, research facilities, 
exhibitors, carriers, and intermediate handlers. The Secretary of 
Agriculture has delegated the responsibility of enforcing the Act to 
the Administrator of the Animal and Plant Health Inspection Service 
(APHIS). The regulations established under the Act are contained in 
title 9 of the Code of Federal Regulations (9 CFR), chapter I, 
subchapter A, parts 1, 2, and 3. Subparts C and D of 9 CFR part 2 
(Sec. Sec.  2.30 through 2.40, referred to below as the regulations) 
require, among other things, that each research facility, dealer, and 
exhibitor have an attending veterinarian and maintain a program of 
adequate veterinary care.
    Currently, Sec.  2.33(b), regarding research facilities, and Sec.  
2.40(b), regarding dealers and exhibitors, describe the elements that 
must be included in a program of adequate veterinary care. These 
elements include: (1) The availability of appropriate facilities, 
personnel, equipment, and services; (2) the use of appropriate methods 
to prevent, control, diagnose, and treat diseases and injuries and the 
availability of emergency, weekend, and holiday care; (3) daily 
observation of all animals for health assessment; (4) guidance to 
principal investigators and other personnel involved in the care and 
use of animals regarding handling, immobilization, anesthesia, 
analgesia, tranquilization, and euthanasia; and (5) adequate pre- and 
post-procedural care according to current established veterinary 
medical and nursing procedures. Sections 2.33(b)(3) and 2.40(b)(3) 
further provide that a mechanism of direct and frequent communication 
is required so that timely and accurate information on problems of 
animal health, behavior, and well-being is conveyed to the attending 
veterinarian.
    While maintenance of medical records is implied through our 
requirements for adequate veterinary care, the regulations do not 
specifically stipulate the maintenance of medical records as one of the 
elements in a program of adequate veterinary care. Medical records are 
an essential part of any program of adequate veterinary care. Adequate 
veterinary care can only be provided to animals if an accurate medical 
history is maintained on the animals to provide communication among all 
personnel involved in providing care. In addition, medical records 
provide a basis for APHIS inspectors to assess a veterinary care 
program and ensure that animals receive adequate veterinary care.
    Therefore, we propose to add new Sec. Sec.  2.33(b)(6) and 
2.40(b)(6) to the regulations to include the maintenance of legible 
medical records as an additional element of the program of adequate 
veterinary care required by the regulations. To ensure that medical 
records include, at a minimum, information such as the vaccination 
history, surgical history, and any known drug sensitivities of the 
animals, we would specify that each medical record must include: (1) 
The identity of the animal (with the exception that routine husbandry, 
such as vaccinations, preventive medical procedures, or treatments, 
performed on all animals in a group (or herd) may be kept on a single 
record); (2) the date, description of the problem, pertinent history, 
observations, examination findings, test results, and plan for 
treatment and care with a tentative diagnosis and a prognosis, when 
appropriate; (3) the type and chronology of treatment procedures 
performed, the context of

[[Page 17753]]

the problem to which the treatment procedures pertain, and the 
identification of the medication used, the date given, dosage, route of 
administration, frequency, and duration of treatment; (4) the names of 
all vaccines administered and the dates of vaccination; and (5) the 
dates and results of all screening, routine, or other required or 
recommended tests.
    Amending the regulations to specifically include requirements for 
maintaining medical records would necessitate changes to the provisions 
of the regulations regarding recordkeeping requirements for research 
facilities, dealers, and exhibitors. Section 2.35 pertains to the 
recordkeeping requirements for research facilities, and paragraph (f) 
of that section stipulates that records and reports must be maintained 
for at least 3 years. We would amend the recordkeeping requirements for 
research facilities in Sec.  2.35(f) to require that medical records be 
kept for 1 year after the disposition of the animals and that one copy 
of those records be provided to subsequent owners of the animals or to 
any person to whom the animals are consigned. The retention period for 
all other records and reports would continue to be 3 years.
    We would amend Sec.  2.75, regarding recordkeeping by dealers and 
exhibitors, by adding a new paragraph (b)(4) requiring that one copy of 
the medical records be provided to subsequent owners of the animals or 
to any other person to whom the animals are consigned. Because Sec.  
2.80 currently contains a requirement that dealers and exhibitors, 
among others, retain records for 1 year after the disposition of the 
animals, we would not need to provide a specific retention period for 
medical records.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be not significant for the purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.
    This proposed rule would amend the Animal Welfare Act regulations 
to require that research facilities, dealers, and exhibitors maintain 
medical records as part of their program of adequate veterinary care. 
Currently, the maintenance of medical records is not specifically 
listed as one of the elements of a program of adequate veterinary care. 
However, we believe that requiring research facilities, dealers, and 
exhibitors to maintain medical records would help ensure that animals 
receive adequate veterinary care. In addition, these records would 
provide a basis for APHIS to better assess the veterinary care programs 
of research facilities, dealers, and exhibitors.
    In fiscal year 2000, there were 8,773 facilities of all sizes 
licensed or registered under the Act, including 4,612 dealers; 2,508 
exhibitors; and 1,265 research facilities. Most research facilities are 
large relative to other regulated entities, and the average number of 
animals per research facility in fiscal year 2000 was 1,027.\1\ This 
rule would affect those facilities that provide veterinary care.
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    \1\ See APHIS'' Animal Welfare Enforcement Report for Fiscal 
Year 2000, available on the Internet at http://www.aphis.usda.gov/ac/publications.html. The average of 1,027 animals per research 
facility is based on 1,265 total facilities (1,231 active facilities 
and 34 inactive facilities).
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    In 1997, there were 10,045 U.S. farms in North American Industry 
Classification System (NAICS) category 11299 (All Other Animal 
Production, which includes dog and cat breeders/dealers), and the 
average annual sales per farm for that year was $105,624, well below 
the U.S. Small Business Administration's (SBA) small entity threshold 
of $750,000. In addition, in 1997, there were 4,607 U.S. firms in NAICS 
541710 (Research and Development in the Physical, Engineering, and Life 
Sciences, which includes research facilities) that operated for the 
full year, and 99 percent of those firms had fewer than 500 employees, 
which is the SBA's small entity threshold for firms in NAICS 541710. In 
1997, there were 498 firms in NAICS 711190 (Other Performing Arts 
Companies, which includes circus exhibitors) that operated for the full 
year, and 99 percent of those firms had less than $5 million in sales 
that year, which is the SBA's small entity threshold for firms in NAICS 
711190.
    APHIS does not anticipate a great increase in burden to regulated 
entities. Almost all research facilities and more than 75 percent of 
other regulated facilities already comply with these proposed minimum 
standards for medical records. However, there may be a few entities 
that would need to improve the recordkeeping already in place, thus 
increasing their burden at least temporarily. We anticipate that the 
costs associated with any increase in burden would be minimal and would 
be limited primarily to the salary costs for the employee or employees 
responsible for assembling the documentation necessary to establish a 
medical record that contains the information described in this proposed 
rule.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. It is not intended to have retroactive effect. 
This rule would not preempt any State or local laws, regulations, or 
policies, unless they present an irreconcilable conflict with this 
rule. The Act does not provide administrative procedures which must be 
exhausted prior to a judicial challenge to the provisions of this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. 97-033-1. 
Please send a copy of your comments to: (1) Docket No. 97-033-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance 
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue 
SW., Washington, DC 20250. A comment to OMB is best assured of having 
its full effect if OMB receives it within 30 days of publication of 
this proposed rule.
    This proposed rule would amend the Animal Welfare Act regulations 
by requiring research facilities, dealers, and exhibitors to maintain 
medical records as part of their program of adequate veterinary care. 
We would require medical records to include: (1) The identity of the 
animal (with the exception that routine husbandry, such as 
vaccinations, preventive medical procedures, or treatments, performed 
on all animals in a group (or herd) may be

[[Page 17754]]

kept on a single record); (2) the date, description of the problem, 
pertinent history, observations, examination findings, test results, 
and plan for treatment and care with a tentative diagnosis and a 
prognosis, when appropriate; (3) the type and chronology of treatment 
procedures performed, the context of the problem to which the treatment 
procedures pertain, and the identification of the medication used, the 
date given, dosage, route of administration, frequency, and duration of 
treatment; (4) the names of all vaccines administered and the dates of 
vaccination; and (5) the dates and results of all screening, routine, 
or other required or recommended tests.
    In addition, we would amend the regulations regarding recordkeeping 
requirements for research facilities, dealers, and exhibitors. 
Specifically, we would amend the recordkeeping requirements for 
research facilities in Sec.  2.35(f) to require that medical records be 
kept for 1 year after the disposition of the animals and that one copy 
of those records be provided to subsequent owners of the animals or to 
any person to whom the animals are consigned. We would amend Sec.  
2.75, regarding recordkeeping by dealers and exhibitors, by adding a 
new paragraph (b)(4) requiring that one copy of the medical records be 
provided to subsequent owners of the animals or to any other person to 
whom the animals are consigned.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.083 hours per response.
    Respondents: Research facilities, dealers, and exhibitors.
    Estimated annual number of respondents: 8,000.
    Estimated annual number of responses per respondent: 691,975.
    Estimated annual number of responses: 5,535,800.
    Estimated total annual burden on respondents: 459,605 hours. (Due 
to averaging, the total annual burden hours may not equal the product 
of the annual number of responses multiplied by the reporting burden 
per response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
734-7477.

Government Paperwork Elimination Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires Government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this proposed rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects in 9 CFR Part 2

    Animal welfare, Pets, Reporting and recordkeeping requirements, 
Research.

    Accordingly, we propose to amend 9 CFR part 2 as follows:

PART 2--REGULATIONS

    1. The authority citation for part 2 would continue to read as 
follows:

    Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.

    2. In Sec.  2.33, paragraph (b) would be amended as follows:
    a. In paragraph (b)(4), by removing the word ``and'' immediately 
after the semicolon.
    b. In paragraph (b)(5), by removing the period and adding the word 
``; and'' in its place.
    c. By adding new paragraph (b)(6) to read as set forth below.


Sec.  2.33  Attending veterinarian and adequate veterinary care.

* * * * *
    (b) * * *
    (6) The maintenance of medical records is a required component of 
adequate veterinary care. They serve as a basis for reviewing the 
medical history and planning veterinary care and provide a mechanism of 
communication for matters of animal health, behavior, and well-being. 
Medical records document the animal's illness, veterinary care, and 
treatment and serve as a basis for review, study, and evaluation of 
veterinary care rendered by the facility. Medical records must be 
legible and include at least the following information:
    (i) The identity of the individual animal; Provided, however, That 
routine husbandry, such as vaccinations, preventive medical procedures, 
or treatments, performed on all animals in a group (or herd) may be 
kept on a single record;
    (ii) The date, description of the problem, pertinent history, 
observations, examination findings, test results, and plan for 
treatment and care with a tentative diagnosis and a prognosis, when 
appropriate;
    (iii) The type and chronology of treatment procedures performed, 
the context of the problem to which the treatment procedures pertain, 
and the identification of the medication used, the date given, dosage, 
route of administration, frequency, and duration of treatment;
    (iv) The names of all vaccines administered and the dates of 
vaccination; and
    (v) The dates and results of all screening, routine, or other 
required or recommended tests.
    3. In Sec.  2.35, paragraph (f), the first sentence would be 
removed and two new sentences would be added in its place to read as 
follows:


Sec.  2.35  Recordkeeping requirements.

* * * * *
    (f) The medical records required under Sec.  2.33(b)(6) shall be 
kept for at least 1 year after the disposition of the animal, and a 
copy shall be given to the subsequent owner of the animal or to any 
person to whom the animal is consigned. All other records and reports 
shall be maintained for at least 3 years. * * *
    4. In Sec.  2.40, paragraph (b) would be amended as follows:
    a. In paragraph (b)(4), by removing the word ``and'' immediately 
after the semicolon.
    b. In paragraph (b)(5), by removing the period and adding the word 
``; and'' in its place.
    c. By adding new paragraph (b)(6) to read as set forth below.


Sec.  2.40  Attending veterinarian and adequate veterinary care 
(dealers and exhibitors).

* * * * *
    (b) * * *
    (6) The maintenance of medical records is a required component of

[[Page 17755]]

adequate veterinary care. They serve as a basis for reviewing the 
medical history and planning veterinary care and provide a mechanism of 
communication for matters of animal health, behavior, and well-being. 
Medical records document the animal's illness, veterinary care, and 
treatment and serve as a basis for review, study, and evaluation of 
veterinary care rendered by the facility. Medical records must be 
legible and include at least the following information:
    (i) The identity of the individual animal; Provided, however, That 
routine husbandry, such as vaccinations, preventive medical procedures, 
or treatments, performed on all animals in a group (or herd), may be 
kept on a single record;
    (ii) The date, description of the problem, pertinent history, 
observations, examination findings, test results, and plan for 
treatment and care with a tentative diagnosis and a prognosis, when 
appropriate;
    (iii) The type and chronology of treatment procedures performed, 
the context of the problem to which the treatment procedures pertain, 
and the identification of the medication used, the date given, dosage, 
route of administration, frequency, and duration of treatment;
    (iv) The names of all vaccines administered and the dates of 
vaccination; and
    (v) The dates and results of all screening, routine, or other 
required or recommended tests.
    5. In Sec.  2.75, a new paragraph (b)(4) would be added to read as 
follows:


Sec.  2.75  Records: Dealers and exhibitors.

* * * * *
    (b) * * *
    (4) One copy of the medical records containing the information 
required by Sec.  2.40(b)(6) shall be provided to the subsequent owner 
of the animal or to any person to whom the animal is consigned.

    Done in Washington, DC, this 7th day of April 2003.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-8928 Filed 4-10-03; 8:45 am]
BILLING CODE 3410-34-P