[Federal Register Volume 64, Number 180 (Friday, September 17, 1999)]
[Notices]
[Pages 50519-50520]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-24208]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2975]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
VICH GL6 Draft Guidance on ``Environmental Impact Assessments (EIA's) 
for Veterinary Medicinal Products (VMP's)-Phase I;'' Availability; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of the following VICH GL6 draft guidance for 
industry entitled ``Environmental Impact Assessments (EIA's) for 
Veterinary Medicinal Products (VMP's)-Phase I.'' This draft guidance 
document has been developed by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). It is intended to assist in developing 
harmonized guidance for conducting environmental assessments for VMP's 
in the European Union, Japan, and the United States.

DATES:  Submit written comments by October 18, 1999. FDA must receive 
comments before the deadline in order to ensure their consideration at 
the next meeting, but the agency will accept general comments after the 
deadline at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be identified with the full title 
of the draft guidance document and the docket number found in the 
heading of this document.
    Copies of this Federal Register notice and the draft guidance 
document entitled ``Environmental Impact Assessments (EIA's) for 
Veterinary Medicinal Products (VMP's)-Phase I'' may be obtained from 
the Center for Veterinary Medicine (CVM) home page at ``http://
www.fda.gov/cvm/fda/TOCs/guideline.html''. Persons without Internet 
access may submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests.

FOR FURTHER INFORMATION CONTACT:
    Regarding VICH: Sharon R. Thompson, Center for Veterinary Medicine 
(HFV-3), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-594-1798, e-mail: ``sthompso@cvm.fda.gov'', or
    Robert C. Livingston, Center for Veterinary Medicine (HFV-145), 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 
301-594-5903, e-mail: ``rlivings@cvm.fda.gov''.
    Regarding the guidance document: Charles E. Eirkson, Center for 
Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6958, e-mail: 
``ceirkson@cvm.fda.gov''.

SUPPLEMENTARY INFORMATION: 

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities, industry associations, and individual sponsors 
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 requirements for the development of pharmaceutical products. 
One of the goals of harmonization is to identify and reduce the 
differences in technical requirements for drug development among 
regulatory agencies in different countries.
    FDA has actively participated in the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH) 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 VMP's. The 
VICH is concerned with developing harmonized technical requirements for 
the approval of VMP's in the European Union, Japan, and the United 
States, and includes input from both regulatory and industry 
representatives.
    The VICH meetings are held under the auspices of the Office 
International des Epizooties. The VICH Steering Committee is composed 
of member representatives from the European Commission; the European 
Medicines Evaluation Agency; the European Federation of Animal Health; 
the Japanese Veterinary Pharmaceutical Association; the Japanese 
Ministry of Agriculture, Forestry, and Fisheries; the Committee on 
Veterinary Medicinal Products; the U.S. FDA; the U.S. Department of 
Agriculture; the Animal Health Institute; and the Japanese Association 
of Veterinary Biologics.
    Two observers are eligible to participate in the VICH Steering 
Committee: One representative from the Government of Australia/New 
Zealand, and one representative from the industry in Australia/New 
Zealand. The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by the Confederation Mondiale de L'Industrie 
de la Sante Animale (COMISA). A COMISA representative participates in 
the VICH Steering Committee meetings.

II. Guidance on Assessing Environmental Impacts of VMP's Other Than 
Veterinary Biological Products

    At a meeting held on October 20 through 22, l998, the VICH Steering 
Committee agreed that the draft guidance entitled ``Environmental 
Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)-
Phase I'' should be made available for public comment.
    This draft guidance document presents guidance on how to assess the 
environmental impact of VMP's other than veterinary biological 
products. This draft guidance document is intended to be consistent 
with the laws of the European Union, Japan, and the United States. In 
an effort to harmonize the different requirements in each of these 
areas for assessing the environmental impact of VMP's, this draft 
guidance document adopts the terminology ``Phase I EIA's'' and ``Phase 
II EIA's.''
    In the United States, the environmental impact of VMP's is 
determined under the requirements established by the National 
Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.) and its 
implementing regulations (40 CFR part 1500 and part 25 (21 CFR part 
25)). Under NEPA, an environmental assessment (EA) is conducted to 
determine whether a VMP may have a significant environmental impact. A 
particular VMP may be categorically excluded from the requirement of an

[[Page 50520]]

EA, or it may require an EA or an environmental impact statement (EIS), 
or it may require both.
    Using the terminology of the draft guidance document, a Phase I EIA 
is equivalent under NEPA to either a categorical exclusion or an EA 
that addresses only environmental exposures (40 CFR 1508.4 and 1508.9). 
A Phase II EIA represents an EA with more extensive data than would be 
necessary under the U.S. equivalent of a Phase I EIA. A Phase II EIA 
may lead to a finding of no significant impact or preparation of an EIS 
under NEPA.
    Questions 2, 3, and 4 of the VICH guidance, which respectively 
address natural substances, nonfood animals, and minor species, 
directly parallel existing categorical exclusions under NEPA. (See 
Sec. 25.33(c), (d)(1), and (d)(4).) These classes of actions have been 
determined not to have significant environmental impacts. Similarly, 
question 5, which concerns VMP's used to treat a small number of 
animals, generally parallels categorical exclusions in 
Sec. 25.33(d)(2), (d)(3), (d)(4), and (d)(5). These questions provide 
guidance for defining when a categorical exclusion may be appropriate 
for U.S. environmental reviews.
    Even when a VMP might ordinarily be categorically excluded under 
NEPA, there may be extraordinary circumstances that require the 
submission of an EA. Questions 11 through 13 and 17 provide guidance on 
when such extraordinary circumstances exist. Specifically, questions 11 
through 13 relate to whether the environmental introduction 
concentration (EICaquatic) of a VMP released from 
aquaculture facilities is less than 1 microgram/liter (g/L). 
Similarly, question 17 relates to whether the predicted environmental 
concentration in soil (PECsoil) for VMP's used in 
terrestrial species is less than 100 g/kilogram (kg). Based 
upon information reviewed to support the guidance, 
EICaquatic at or above 1 g/L, or PECsoil 
at or above 100 g/kg, could result in an environmental 
exposure concentration that could potentially have significant impact 
on the environment. Thus, an EICaquatic equal to or greater 
than 1 g/L or a PECsoil equal to or greater than 
100 g/kg represents a level of exposure that constitutes 
extraordinary circumstances that require the submission of an EA or an 
EIS (see Sec. 25.21(a)).
    Additionally, for questions 11 through 13 and 17, FDA is concerned 
that if the VMP is not expected to degrade or may bioconcentrate, then 
the aggregate level of exposure from repeated uses could exceed the 1 
g/L EICaquatic or the 100 g/kg 
PECsoil guidance. FDA is seeking comment on how to address 
the degradability and bioconcentration of a VMP when applying these 
guidance.
     There are no categorical exclusions which parallel questions 6 
through 17. Consequently, an EA to address the issues identified in 
these questions will be required under NEPA for U.S. environmental 
review. The EA must provide data demonstrating that any conditions of 
the question (e.g., the VMP is extensively metabolized in the treated 
animal) or any proposed mitigations (e.g., waste disposal by 
incineration or sewage treatment) will result in no significant 
environmental impacts from the VMP.
    FDA specifically requests comment on questions 8 and 14 and the 
text following these questions because FDA is concerned that the text 
might create the mistaken impression that any time incineration is used 
to dispose of a waste matrix, there will be no significant impact on 
the environment under NEPA. For any mitigation, including incineration, 
the sponsor needs to provide data in the EA that demonstrates that the 
mitigating measures do in fact ensure that the VMP has no significant 
impact on the environment.
    CVM will provide more detailed guidance, including guidance on 
formatting for EA's submitted to the United States, guidance on other 
extraordinary circumstances, and guidance on other NEPA-related 
environmental issues, such as impacts on natural and historical 
resources.
    Comments about this draft guidance document will be considered by 
FDA and the VICH Ecotoxicity Working Group. Ultimately, FDA intends to 
adopt and publish the VICH Steering Committee's final guidance.
     This document, developed under the VICH process, has been revised 
to conform to FDA's good guidance practice regulations (62 FR 8961, 
February 27, l997) . For example, the document has been designated 
``guidance'' rather than ``guideline.'' Since guidance documents are 
not binding, mandatory words such as ``must'' and ``shall,'' and 
``will'' in the original VICH document have been substituted with 
``should.'' Additionally, the term(s) ``veterinary medicinal products'' 
and ``veterinary pharmaceuticals products'' may require revision to be 
consistent with product terms used in other VICH guidance documents.
     This draft guidance document represents a portion of FDA's current 
thinking on the conduct of ecological risk assessment for veterinary 
medicinal products proposed for marketing in the European Union, Japan, 
and the United States. The document does not create or confer any 
rights for or on any person and will not operate to bind FDA or the 
public. Alternate approaches may be used if they satisfy the 
requirements of applicable statutes, regulations, or both.

III. Comments

    General comments on agency guidance documents are welcome at any 
time. However, in order to ensure consideration at the next meeting, 
interested persons should submit written comments on or before October 
18, 1999, to the Dockets Management Branch (address above) regarding 
this draft guidance document. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments should 
be identified with the docket number found in brackets in the heading 
of this document. A copy of the document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 10, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-24208 Filed 9-16-99; 8:45 am]
BILLING CODE 4160-01-F