[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Page 28933-28934]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2002D-0326]

International Cooperation on Harmonization of Technical 
Requirements for Approval of Veterinary Medicinal Products; Final 
Guidance for Industry on Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: General Approach to Testing; 

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; availability.


SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry ([numsign]149) entitled 
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: General Approach to Testing'' (VICH GL33). This guidance 
has been developed by the International Cooperation on Harmonization of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). This guidance outlines a recommended testing approach 
to assure human food safety following the consumption of food products 
derived from animals treated with veterinary drugs.

DATES:  Submit written or electronic comments at any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Communications Staff (HFV-12), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Comments should be identified with the 

full title of the guidance and the docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Louis T. Mulligan, Center for 
Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6984, e-mail: 


I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote the 
international harmonization of regulatory requirements. FDA has 
participated in efforts to enhance harmonization and has expressed its 
commitment to seek scientifically based harmonized technical procedures 
for the development of pharmaceutical products. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies in 
different countries.
    FDA has actively participated in the International Conference on 
Harmonization of Technical Requirements for Approval of Pharmaceuticals 
for Human Use for several years to develop harmonized technical 
requirements for the approval of human pharmaceutical and biological 
products among the European Union, Japan, and the United States. The 
VICH is a parallel initiative for veterinary medicinal products. The 
VICH is concerned with developing harmonized technical requirements for 
the approval of veterinary medicinal products in the European Union, 
Japan, and the United States, and includes input from both regulatory 
and industry representatives.
    The VICH Steering Committee is composed of member representatives 
from the European Commission, European Medicines Evaluation Agency; 
European Federation of Animal Health; Committee on Veterinary Medicinal 
Products; the FDA; the U.S. Department of Agriculture; the Animal 
Health Institute; the Japanese Veterinary Pharmaceutical Association; 
the Japanese Association of Veterinary Biologics; and the Japanese 
Ministry of Agriculture, Forestry and Fisheries.
    Four observers are eligible to participate in the VICH Steering 
Committee: One representative from the Government of Australia/New 
Zealand, one representative from the industry in Australia/New Zealand, 
one representative from the Government of Canada, and one 
representative from the industry of Canada. The VICH Secretariat, which 
coordinates the preparation of documentation, is provided by the 
International Federation for Animal Health (IFAH). An IFAH 
representative also participates in the VICH Steering Committee 

II. Guidance on General Testing

    In the Federal Register of September 4, 2002 (67 FR 56570), FDA 
published the notice of availability of the VICH draft guidance, giving 
interested persons until October 4, 2002, to submit comments. After 
consideration of comments received, the draft guidance was changed in 
response to the comments and submitted to the VICH Steering Committee. 
At a meeting held on October 10 and 11, 2002, the VICH Steering 
Committee endorsed the final guidance for industry, VICH GL33.
    Existing toxicological testing recommendations for veterinary drugs 
have evolved from the toxicological tests for human medicines, food 
additives, and pesticides. The following guidance was developed to 
include tests particularly relevant to the identification of a no-
observable adverse effect level (NOAEL) for veterinary drugs. The scope 
of this guidance is to identify the following tests: (1) Basic tests 
recommended for all new animal drugs used in food-producing animals in 
order to assess the safety of drug residues present in human food; (2)

[[Page 28934]]

additional tests recommended based on specific toxicological concerns 
associated with the structure, class, mode of action, etc., of the 
drug; and (3) special tests that might be useful in the evaluation of 
the relevance or the interpretation of data obtained in the basic or 
additional tests.

III. Significance of Guidance

    This document, developed under the VICH process, has been revised 
to conform to FDA's good guidance practices regulation (21 CFR 10.115). 
For example, the document has been designated ``guidance'' rather than 
``guideline.'' Because guidance documents are not binding, unless 
specifically supported by statute or regulation, mandatory words such 
as ``must,'' ``shall,'' and ``will'' in the original VICH documents 
have been substituted with ``should.''
    This guidance document represents the agency's current thinking to 
establish the safety of veterinary drug residues in human food in a 
variety of toxicological evaluations. This guidance does not create or 
confer any rights for or on any person and will not operate to bind FDA 
or the public. An alternative method may be used as long as it 
satisfies the requirements of applicable statutes and regulations.

IV. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written or electronic comments pertinent to this guidance. FDA will 
periodically review the comments in the docket and, where appropriate, 
will amend the guidance. The agency will notify the public of any such 
amendments through a notice in the Federal Register.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Copies of the guidance document entitled ``Studies to Evaluate the 
Safety of Residues of Veterinary Drugs in Human Food: General Approach 
to Testing'' (VICH GL33) may be obtained on the Internet from the CVM 
home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.

    Dated: May 13, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11254 Filed 5-18-04; 8:45 am]