[Federal Register: September 17, 1999 (Volume 64, Number 180)]
[Notices]
[Page 50519-50520]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se99-76]

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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VICH GL6 Draft Guidance on ``Environmental Impact Assessments (EIA's)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availability for comment of the following VICH GL6 draft guidance for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Veterinary Medicinal Products (VMP's)-Phase I.'' This draft guidance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of the draft guidance document and the docket number found in the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    Copies of this Federal Register notice and the draft guidance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access may submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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 (EIC<INF>aquatic</INF>) of a VMP released from
aquaculture facilities is less than 1 microgram/liter (<greek-m>g/L).
Similarly, question 17 relates to whether the predicted environmental
concentration in soil (PEC<INF>soil</INF>) for VMP's used in
terrestrial species is less than 100 <greek-m>g/kilogram (kg). Based
upon information reviewed to support the guidance,
EIC<INF>aquatic</INF> at or above 1 <greek-m>g/L, or PEC<INF>soil</INF>
at or above 100 <greek-m>g/kg, could result in an environmental
exposure concentration that could potentially have significant impact
on the environment. Thus, an EIC<INF>aquatic</INF> equal to or greater
than 1 <greek-m>g/L or a PEC<INF>soil</INF> equal to or greater than
100 <greek-m>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
<greek-m>g/L EIC<INF>aquatic</INF> or the 100 <greek-m>g/kg
PEC<INF>soil</INF> 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