Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 44

DECLARATION of Amy A. Barcelo in Support re: 40 MOTION for Summary Judgment.. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P Part 1 of 5, # 17 Exhibit P Part 2 of 5, # 18 Exhibit P Part 3 of 5, # 19 Exhibit P Part 4 of 5, # 20 Exhibit P Part 5 of 5)(Barcelo, Amy)

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Federal Register / Vol. 44, No. 185 / Friday, September 21, 1979 / Notices

time. The case of DES itself
demonstrates the results of attempts by
the ageicy to utilize procedural shortcuts. (As-discussed in section I of this
Decision, the previous withdrawal of
approval of these NADA's was
overturned on judicial review.) Thus, in
the absence of a clear showing that, in
accordance with the dates announced
a,bove, the implementation of this
decision will seriously disrupt the meat
production industry, the FDA intends to
make this decision effective on these
dates.
VIII. Conclusion
My conclusions with respect to the
various issues in this hearing, together
with citations to the record'in support of
my conclusions, have been stated as part of my discussion of those issues.
The following is a summary of those
conclusions:
1. Neither the mouse uterine/paper
chromatography method, which is the
currently approved method, nor any
other analytical method has been shown
to be acceptable to be approved dr to
remain approved for purposes of the socalled-"DES exception" to the "Delaney
Clause," 21 U.S.C. 360b(d)(1)(H).
2. DES is a carcinogen when ingested
by animals. Evidence in the record
suggests that DES is a carcinogen when
ingested by human beings. There is no
known no-effect level for the
carcinogenic properties of DES.
3. Because I have revoked apprdval of
the analytical method for detecting DES
residues and have not substituted for it
any other approved method, DES cannot
qualify for the "DES exception" to the,
*
."Delaney Clause." The Delaney Clause,
therefore, applies ' to DES and, because
DES has been found to inducqe cancer in
animals, requires withdrawal of
approval of all'DES NADA's 21 U.S.C.
360b(3)(1](B); (d)(1)(H).
4. DES has adverse biological effects
other than carcinogenesis, specifically
teratogenic and mutagenic effects,
which raise serious questions about its
safety. On thb record in this proceeding,
those questions have not been resolved.
No safe tolerance levels can be
established for these effects.
5,The record demonstrates that use of
DES animal drugs pursuant to their
approved conditions of use (and, with
respect to DES used in animal feed, use
with a 14-day withdrawal period) results
in residueg of DES in the edible tissues
of treated animals after slaughter.
Although it is impossible to tell at what
level these residues appear, residues
will result at levels that must be
regarded as significant from a public
health standpoint. There has been no

showing that any level of DES residue in
edible tissues of treated animals is safe.
6. The Bureaus have provided new
evidence that, together with evidence
previously available, shows that the
DES animal drugs are not shown to be
safe for use under the conditions of use
upon the basis of which the DES
NADA's were approved. Approval of
those NADA's must, therefore, be
withdrawn pursuant to 2 U.S.C.
360b(e)(1)(B).
7. FDA is not authorized, under the
Food, Drug and Cosmetic Act, in
considering the question whether a new
animal drug has been shown to be safe
for use, to weigh the "socio-economic"
benefits that that drug provides against
a health risk to the ultimate human
consumers of treated animals. Even
were I to attempt to weigh the benefits
of DES against its risks, this record
would not provide sufficient information
to compute the risk associated with DES
or to determine whether, and to what
extent, use of DES provides any health
benefit or ev-en any economic benefit to
society.
8. This record provides no evidence
upon the basis of which I can conclude
that there are apy conditions of use of
the DES animal drugs under which use
of those drugs would be shown to be
safe. The discard of all livers (or any
other organs] of these animals would
not constitute a condition of use that has
been shown to be safe.
9. Because alternatives to DES are
available, I conclude that the
withdrawal of approval of these NADAs
will not significantly affect the quality of
the human environment.
I Dated: June 29,1979.
Donald Kennedy,
CommissionerofFoodandDrugs.
iFR Doc.

79-29114.Filed 9-20-79, 8:45 am l
BILNG CODE 4110-03-M

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