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 Jf Friday, September 21, 1979 / Notices

DES. It appears, in fact, that if Ralgro is
substituted for DES, the same fat saving
(if any] would result. 'fbulls'were raised
as an alternative to treated steers, fat
content -wouldapparently be:decreased.
It is, in any case, not hinar-vhether Ith'e
indicators of-fat c6ntent in these 'studies
are significant in the real world. For
example, if'the fat on a steak is ;of the
type that would nornallybe trimmed by
the butcher, 'or-by the cook or consumer
prior to eating, then that fat wouldmet
have any adverseeffect on the
consumer. i(Presumably, where the
reports speak in terms -ofmarbling, the
fat in question would not-normally-be
trimmed before consumption.)
(b) Amount-of Beef and Lamhb That
Will Be Consumed. Another factor in
the computation of the potential
increase in fat intheliuman-diet-from
the withdrawal of approval'of the DES
NADA's is, of course, 'the amountdfbebI
and lamb that-a -uman -being-would
reasonablybe 'expected'to :onsume.
Nothing in the recordtells-ushov much
lamb a person may be expected to '
consume. The CAST Report (M-51 at'26)
cites a -1976 Department of Agriculture
economicxesearch service Teport as
calculatingthe average consumption by
Americans of beef as 2.3 pounds of
"carcass weight equivalent" per person
per week. Apparently,: the actual amount
of beef consumed would be smaller
since the "'carcass weight equivalent"
would include the nonedible portions-of
the animal's carcass.
Estimatesof the amount consumed
were also given by manufacturing
parties' witnesses seeking to compute a,
total risk to humans Irom the use 6f
DES. See, 'e.g., M.-63,at 261-62. They
estimated the .average intake -ofbeef,per
day variously at'140,g and.284 g for
purposes of calculation. Xf, as the
manufacturing parties seem to argue, the
withdrawal ,ofapprovalof the NADA's
for DES would decrease the availability
of beef to thepublic, -then-theamount'of
beef consumed .would decrease. If, .as
predicted by-the manufacturing parties.
beefjprices increase when -DES is no
longer available, that price increase
might lead to adecrease in beet
consumption (M-51 at 263. A decrease an
beef donsumption would, -of-course, tend
to carry with it-a .decrease in he
consumption-of beef fat. The magnitude
of this decrease.in:overall beef
consumption aid -itsimpaction total
consumption of fat cannot 'be
determined from the xecord. Nor does
the record show how this decrease infat
would 'compare to the increaseithatthe manufacturing parties project would
result from -discontinuance of the use of
-DES:"
-

-

(c) Amount.'ofFat in Alternatives o.
Beef andLamb. The record.contains
little information about the potential
substitutions likely to be made in the
diets ofAmericans if, in fact, the amount
of beef available is .decreased, or
consumption is lowered due to price
increases, as a result of the withdrawal
of the approval of the DES 'NADA's.
That substitutions would occur is
emphasized by anintervenor's exhibit
(PA-22), whichI is an attempt to predict
the economic impact of restricting feed
'additives in livestock.
In a simulation.dealing with the -banof
DES, 'theauthors of-PA-22 calculated
price effects.not-onlyin:beef, but also in
pork, broilers, and turkey. (The amount
of lamb produced in this-country is
apparently so small, relative to the
amounts of other meats, that it was .not
considered in thisanalysis.) The effect
on the prices-of these other meats
caused bya decrease in availabilityof
or rise in ,theprice.of beef-assumes that
the American-consumer will substitute
these other meat-products forbeef if-use
of-DES is no longerpermitted.'Thus, itis
important'to know what :the fat content
of these alternative meats is. This
information is not'inthe record. The
failure to take into account the amount
offal involved in 'the eating of
alternative -meat(orother)products
-wouldpresumably result in a faulty
computafion ofthe effect ofa 'banof
DES on fat in the diet
It is noteworthy that.one
manufacturing parties' exhibit states
that-a ban of DES, if it decreases the
amountof-beefconsumed, will lead to
consumption, in the alternative, of
cereal products :(M--bl at 6].
Presumably, this change -wouldresult in
less total fat intake in the average diet.
(iii) Conclusion:as to Claimed'Health
BenefitFrom DecreasedConsumption of
-Fat.TheAdministrativeLaw Judge
found, in essence, that the'
.
manufacturing partins had failed inttheir
burdenof showi'ng -benefits of DES. An
analysis ,ofthe 'claim'thatDES ,has a
health benefit inreduction df fafshows
that the Administrative Law Judges
conclusion -with-respectlo 4hat claim
was correct. The record simply'fails to
support the :contention that DES
provides-a health ,benefit by reducing
- dietary intake of fat.
' (dJHeathBeneit.FeedSavi g. The
manufacturing-partiescie as-a second
health benefit -ofDES the saving of food
- that resultsfrom 'he feed efficiency
associated with The drug (Manufacturing
Parties' xceptiofns at 177).,The '
manufacturing parties rely-on'the
testimony of Dr. Jukes that ;the feedsaving .value:of DES isestimated (he 'did
notsay-bywhom)at ,747billion
pounds

annually and as beingequivalent to 3
million,to 4 million acres of corn (M-.99
at 17-18). 'Dr. Jukes then stated that a
yield of 150to 175 bushels of cornper
acre per year would supply an
additional ration of 500 calories perday
per person to 80 percent -ofthe world's
hungry people (id.). (Dr. Jukes
apparently assumed that the saving In
animal feed grain would result in the
production of more human food grains.)
Dr. Jukes' argument is curious, since
presumably the amount ,offeed that DES
saves is presently available. Thus, if This
food is not being used at ths point to
supply the additional caloriesto BO
percent of the world's hungry people,
there is not much to be said for ;thb
argument that DES use should be
continued so hatthis excess food
capacity will be available.
The Administrative Law Judge noted
that any prospective grain saving from
DES would be of less importance
because there is presently no grain
shortage in the United States,'where the
grain savings would, ,of course, be .
generated. AA the manufacturing parties
. argued, the question properly Is
whether, if DES were no longer
available, there wpuld be a grain
shortage. In fact, the testimony cited by
Judge Davidson supports the proposition
that, at the time of cross-examination,
there was a surplus of,grainsfrr. -at
2014). Because the record does not
reveal whether any increase Ingrain
consumption associated with the
unavailability of DES would be greater
than anypreseit surplus of grain, It has
not been shown that a ban of DES, even
if it did increase grain consumption,
would lead to shorlage.
Evidence in the record suggests that
the unavailability of DES might not have
a very significant effect on the
fluctuating grain situation. A
Department of Agriculture Economic
Research Service report (PA-28] that is
undated 'but utilizes 19609 figures notes
that cattle finishing (the stage at which
DES is most often used] accounts for
only 16 percent of alfeed grain use lId.
at vi). (Thus, even if The unavailability of
DES increaied grain consumption in
feed'lots -to some extent, the effect on
the total grain supply would not
necessarily be great.)
This report's projection of the
different possibleeffects-of a DES ban
illustrates the difficulty involved in
making this type of estimate. The report,
which assumes the, bsence of
alternative growth promotants,
considers the effects of three possible
results of the-ban: '(1) feedingthe same
number of-cattle for the same lehgth-of
time (and thus producing less meat per
animal); (2) feeding the same number of

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

54839

cattle for longer periods; and (3) feeding
months), the proponents of DES use
expected if. as would be logical, beef
a larger number of cattle for the same
producers turn to other growth
have presented no cAreful analysis of
period (id. at v]. The report
promotants when DES is no longer
the economic results of that action. As
discussed above, the manufacturing
acknowledges that the actual result
available.
parties have the burden of proof on the
It is simply not possible from the
would probably be some combination of
risk/benefit issue, if that issue is
evidence in this record to determine
these options (id.). (Since this report
whether and to what extent the
appropriately a part of this proceeding
was apparently prepared without the
withdrawal of approval of the DES
at all.
benefit of data from the ban of DES in
(i) Does DES Providean Economic
NADA's will affect the availability of
the early 1970's, its projections are
Benefit? Without question. DES provides
feed grains. Even if there were a
necessarily more speculative than those
an economic benefit to the drug
decrease in the availability of feed
discussed below in the economic
companies that make and sell it.
grains, it is not possible to determine
benefits sectior)
whether and to what extent that
Presumably even if I were required to
The report projects that option (1)
make a risk/benefit analysis of DES, I
decrease would result in a decrease in
would result in a reduction in feed
could safely disregard that benefit. The
food that would otherwise be made
consumption of 2 percent (id. at vi) (feed
available to, and would provide a health discussion that follows thus considers
consumption would be reduced because
benefit to, human beings.
the evidence in the record that use of
untreated cattle consume less feed per
DES as an animal drug provides
(e) Economic Benefits. The nonparty
day than DES-treated cattle); option (2)
participants state their position that DES economic benefits to other segments of
would risult in a significant increase in
produces an economic benefit boldly: "If society.
feed consumption (no percentage is
To determine correctly whether the
DES really has no value, then as a
given) [id. at vii); option (3) would result
practical matter it simply won't be used" withdrawal of approval of the DES
feed
in a 2.1 percent increase in
(emphasis in original) (ntervenors'
NADA's will result in an economic cost
consumption (id.). The report then states
to society, I must know whether DES
Exceptions at 5). This argument has a
that option (2) (in which the ban of DES
improves the efficiency of cattle and
strong initial appeal. DES, without
results in an increase in feed
sheep production more than would the
question, enjoys wide use, presumably
consumption over consumption
alternatives to which DES users would
by people who believe it is in their
associated with DES treatment of cattle)
turn if DES were not available. To make
economic self-interest to use the drug..
would result in a $100 million saving to
my decisioi meaningful, however, I
Yet the FDA's experience with human
the economy because the increase in
must also know to what extent other
drugs counsels skepticism toward a
feed consumption would reduce the
growth promotants will be available to
claim that something is true because
costs of the feed grain program! (Id.)
0 most people believe it to be true. (Many
replace DES and whether (and to what
A manufacturing parties' documentsuch drugs have been widely used for
extent) such alternatives will be more
Council for Agricultural Science and
expensive than DES.
years, only to be found later, upon
Technology. HormonallyActive
The evidence in the record on the
objective test, to be worthless.)
Substances in Foods:A Safety
The record in this proceeding contains relative efficiency of DES and
Evaluation, Report No. 66 (March, 1977)
little support for the proposition that
alternatives is not sufficiently clear for
(CAST Report) (M-51 at 26)-notes that'
DES provides a significant economic
me to make any findings. A multitude of
in a
the ban of DES, assuming it results
studies in the record (almost all
benefit to society that would not be
decrease in efficiency of feed utilization
provided by available alternative
submitted by the intervenors) show that
in beef production, would be expected
growth promotants. More important, the
DES (1) increases the rate of weight gain
to have little effect on the release of
record provides no reliable basis for
of steers and (2) decreases the amount
grain for world trade. The report notes
determining how great the economic
of feed needed, and the amount of feed
that, as feed efficiency increases, the
lot time needed, for fattening. It was.
benefit of DES, if
any, is. Nor does the
price of beef decreases which, in turn,
-record make possible a decision as to
presumably. the demonstrated
encourages more consumption of beef
who receives any economic benefit
effectiveness of DES as a growth
and. thus, more production, followed by
promotant that justified its continued
associated with the use of DES as an
the use of more feed to produce that
approval after th6 1962 amendments to
animal drug.
beef. When efficiency decreases (as it
the drug laws required that drugs be
As I have discussed in section
would in the absence of DES and other
III(E)[1), I am not authorized by statute
shown to be effective as well as safe.
growth promotants), the price of beef
(There is no issue in this proceeding
to decide that an animal drug is "safe"
rises, consumption decreases,
because the economic value of that drug with respect to the evidence of DES's
prdduction of beef decreases and more
effectiveness except as that issue may
is more important to society than the
grain is available. On the other hand.
affect the issue of benefits and (if
risk of cancer it poses to consumers. If I
presumably any consumption decrease
were so authorized, I could not make a
benefits are relevant to safety]
will be associated with aturn by
responsible decision without substantial ultimately the issue of safety.) Thus.
consumers to other meats and to cereal
evidence that DES does provide an
when compared to the use of no growth
grains. This increased consumption of
promotant at all, the use of DES has
economic benefit, and without
cereal grains might itself have some
substantial evidence showing how great
been shown to result in an economic
effect on food grain availability. The
that benefit is and to whom it accrues.
benefit to cattle and sheep producers.
CAST Report does not discuss this
The proponents of DES use have done
The more difficult question is whether,
possibility, however.
and to what extent, DES presents a
a very poor job of providing information
to this record on this issue. No expert
The manufacturing parties do not
significant economic benefit compared
economist testified, though the task of
to the likely substitutes for it. The many
present evidenc&on the loss of grain,
substitute growth promotants mentioned
and on the effects of that loss, during the forecasting the economic effects of the
unavailability qf DES is complex.
in the record have been noted
1974 ban of DES. Perhaps more
previously in section I(E[1[)(2)[c(i).
Despite the fact that DES been removed
important, moreover, the manufacturing
Tests included in the record comparing
from the market previously (premixes
parties do not present evidence of the
for more than a year. implants for 9
substitutes to DES provide sometimes
amount of grain loss that could be

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

54890
I

I

conflicting evidence on this question.
Test conditions vary from actual
conditions of use. No expert testimony
was provided interpreting the results of
these, tests. For, these reasons, I cannot
make any findings on the'basis of them.
Because the FDA is proposing to
withdraw approval of the NADA's for
Synovex-S and Synovex-H, Idbnot.
consider those drugs to be substitutes
for DES. The tests comparing them to
DES are thus not discussed here. Test
results are reported for the following
other potential substitutes:
Ralgroimplant-In a test repcrted in
1975, a 15 mg DES implant Was
compared to a 36 mg Ralgro tresorcylic
acid lactone) implan (PS-20). The Ralgro implant produced a slightly lower
daily weight gain in a'test with steers
weighing from 309 to 352 kg, while
requiring less feed per kilogram of gain
than the 15 mg DES implant (id.). In a
second test involving steers weighing
192 kg, the Ralgro implant caused
slightly higher average daily gain than
the DES implantand required slightly
less food per kg of gain (id.).
In an unpublished report, a 36-mg
Ralgro implant was found to result in a
gain of about half the amount achieved
with a 36 mg DES implant [PA-25).
Essentially no improvement in cost of
gain over controls was obtained with
Ralgro (id.).
In astudy reported in 1973, a 36mg
Ralgro implant produced an average
dally gain in steer calves slightly, but"
not significantly, greater than 10 nag oral
DES and a 12 mg DES implant, with a
feed-to-gain ratio essentially equivalent
to that of the DES treatments '[PS-12.
Estradiol17-b-Estradiol 17-b, a
natural estrogen, has been tested
against various doses of DES under a
variety of 'onditions PS-12). In some of
these, the Estradiol 17-b has been shown
to be as good as or better than DES. In
others it was not as good.
Melengestrolacetate[AlGA)-Although neither DES noi MGA
influenced the growth of steers and
heifers during the hot summer months in
feed lots in Arizona, a 24 mg DES
implant increased the gains of steers
significantly more than did MGA
administered at the rate of 4 mng per
animal daily .(PS-44). On the other hand,
heifers treated with IMGA had
significanily greater daily gains than
control or DES treatedheifers.
Dienestroldiacetate--A study
reported in 1955 comlpared 10 mg DES
with 10 mg dienestrol and found that
dienestrol-fed steers gained "'slightly.
'less rapidly" than DES-fed steers,
though theirgains were significantly
greater than the gains of the control
animals (PS-19,.

I

I

Testosterone Propionate-10mg
in this record provides a basis for any.
implants of this androgen in lambs
findings on these questions.
(ii) How Greatis the Benefit? The
produced average daily gains only
calculations by the manufacturing
slightly less good than those produced
parties and pro-DES intervenors of the
by 3 and 6mg DES implants, but
actual economic effect of a ban of DES
required more food per-pound of gain
are, in each case, unsupported. In
than DES-implants (PS-34),
addition, these calculations appear to be
Reserpine-Thissubstance, when fed
based on the assumption that the
at 0.25 mg and 0.50 mg in lambs,
produced average daily gains lower than alternative to DES is the use of no
DES implants or DES fed orally, with the growth promotant at all. No other
evidence in the record provides a basis
higher amount oPreserpine producing
for a realistic calculation of the "real
the worst results (PS-34).The feed per
world" economic effects, if any, on
pound of gain was also increased over
society of the withdrawal of approval of
the DES treatments [id.).
the DES NADA's.
Raising bulls insteadofsteers-As
Dr. Jukes is cited by the
noted above in section 1II(E)(2)(c)(iiJ(a),
manufacturing parties as testifying that
Dr. DonaldR. Gill, a witness for the
the economic benefit to the American
intervenors, testified concqrning a
economy of DES is some $800 million to
suggestion that DES would be
,
$1 billion annually (Manufacturing
unnecessary if beef cattle were.raised as Parties' Exceptions at 180), The'
bulls rather than steers. Dr. Gill testified
testimony cited bases its computations
that the problem with this suggestion
'upon phrases attributed to Senator
was that bull feeding Woiidirequire
Kennedy and Representative Fountain,
putting calves of 6 to Z-mnths of age on
computing the cost respectively as $4 to
high grain rations. Apparently, unde'the $5per person per year and $3.8*5 per
present system such caves aid grazed
person per year (M-99 at 17). No
for from 6 months to a yearobefore being
evidence is presented that would
taken to the feed-lotsand fed for the last support the per capita estimates.
Dr. Preston, a manufacturing parties
2 to 3 months of their life (see Tr. at
witness, testified that "various estimates
2013). Thus, according to Dr. Gill.
indicate that $8-15 are returned for.
shifting to the production of bulls would
every dollar invested in the use of DES'
mean that grazing land presently used
in cattle and sheep production" (M-124
would cease to be usefuland more grain
at 4). Dr. Preston was very vague, on
would be consumed. Dr. Gill also noted
cross-examination, in explaining who
that the consumption of grain, in a
made the estimates and how they were
country where the government
arrived at (Tr. at 1620-21). He did say
purchases grain surpluses, can be good
that the savings was based upon feed
one year and bad the next. He stated
efficiency and the overhead, Interest,
.that on November2, 1977, the date of
"death loss" and other components of
cross-examination: "Iwas at a
cost saved by the decrease in the time In
conference with USDA people last
the feed lot necessary for DES-treated
week, and with our surpluses it's
cattle (id.).
becoming good again to use up grain"
Intervenors' witness Dr. Gill estimated
(Tr. at 2014]. Dr Gill further stated his
the value of the use of DES to feeders as
opinion 1hat the feeding of large groups
'$24 per head (PA-32 at 2). This figure
of mature bulls (50 or more in I pen]
was apparently calculated on the basis
presents'a very serious-management
of savings in feed and feeding lime
problem and will not work to the jbenefit
resultingfrom the use of DES (see Tr. at
of either producer or consumer (PA--32
2008-09). Dr. Gill could not cite the
at 2).
studies upon which he relied for the
'There is no reliable evidence in this
proposition that pasture-fed steers
record upon which to base conclusions
treated with DES improved their gain by
about either the availability of'
an average 22.46 percent. Although he
substitutes for DES or the relative cost
offered to try to find these studies and
of such substitutes.-Presumably, in the
produce them, theft were not available
absence of supply problems, market
for his cross-examination (Tr. at 2011)
forces would make substitutes more
and have not been identified for the
widely available if DES were banned.
record.
Economies of scale might bring prices of
An only slightly more helpful
these substitutes down from their
appraisal of the economic benefit of DES
present levels. Alternatively, the may be found in an inflation impact.
increased demand might drive prices up
statement for the withdrawal of
if supplies were constrained. New ,
approval of the DES NADA's submitted
products currently under development
by the Bureaus (G-115). The report Is
might also affect the economic
dated January 1976. It estimated the
consequences of a ban of DES. Nothing
total cost impact of removing DES from

Federal Register / Vol. 44, No. 185 / Friday. September 21. 1979
the market at $65 million during the
time of his testimony, September 13.
first year (id. at 5). The bases for this
1977, that cycle was coming to a turning
evaluation are open to question.
point after years of over-supply and
It is estimafed that feed lot producers
three years of liquidation (PA-29 at 4).
of cattle will experience increased costs
He argued that lower production costs
of $156 million (id.). Of this,
eventually mean lower meat costs but
approximately $4 million will be
admitted that "this is at times hard to
incurred by the producers of DESsee due to the daily and cyclical market
implanted cattle as costs for changing to
fluctuations" (id,). Mr.
Algeo's testimony
alternative estrogenic growth
was withdrawn on the day on which he
.promotants (id.). The report stated that
was to have been cross-examined (Tr. at
in 1974, 65 percent of fed steers received
210), and I do not rely upon that
implants, of which 3.9 million of 10.9
testimony.)
million (approximately 36 percent) were
An article by Mann and Paulsen.
using DES implants (id. at 4). The
entitled "Economic Impact of Restricting
remainder were, it states using Synovex
Feed-Additives in Livestock and Poultry
and Raigro implants (id.). The
Production" FA-221, apparently
assumption that those producers using
published in Amer. .Ar. Econ. in
DES implants would change over to the
February 197, was submitted by
alternative estrogenic implants is based
intervenors. This article, using
upon experience with the previous FDA
simulation techniques, attempted to
ban of DES implants.
predict the rise in wholesale prices that
One hundred fifty-tuzo million dollars
would be the result of bans of
in increased costs is allotted to the
antibiotics and DES. This simulation
producers who use oral DES and
takes into account the effect on prices of
represents the cost of increasing feed to
alternative meats should beef
provide the same amount of growth in
production be cut by the unavailability
untreated steers as would occcur with
of DES. In a simulation dealing only
DES (id. at 4-5j. The report states that 25 with the unavailability of DES. the
percent of the steers slaughtered in 1974
authors calculated that meat prices for
were receiving oral DES (id. at 3).
beeEl pork, broilers, and turkey would
The assumption that producers
rise substantially and remain high for
feeding oral DES would switch to
the five year period for which
nonmedicated feed is also based upon
calculations were made.
experience with the previous ban of DES
The authors also performed a
(id. at 4). The report notes, however, that
simulation, however, that takes into
the failure of producers to switch from
oral DES to non-DES implants during the account the likelihood of technology
developing replacements for DES and
previous ban may be attributed to a
antibiotics. (The simulation assumed
shortage of supply of the non-DES
that it would take a year for
implants id. at 5). The allocation of
replacement therapy to be available.
cost--$152 million for the 25 percent of
though it acknowledged the present
the steers that use DES orally and $4
availability of Synovex and Ralgro.) In
million for the approximately 22 percent
this assessment, the authors conclude
of steers that use DES implants (36
that by the fourth year prices will
percent of 65 percent--suggests that it
actually fall below the first year
would make economic sense for those
baseline in each meat category after the
using DES in feed simply to change over
ban of both antibiotics and DES (PA-22
to non-DES implants. The report notes
at 51). This reduction in prices was
that in the opinion of a consulting
predicted to result from the stimulation
animal scientist it would be no problem
to supply provided by the increased
for a feed lot producer to make such a
prices during the ban, which would, as
switch (id.j.
the cycle reached the point of slight
The remainder of the dstimated $659
over-supply, reduce prices.
million cost is allocated to an increase
Neither the authors of this report nor
in the retail cost of meat by 2.2t per
any other expert economist trained to
pound. This increased cost of M3a
forecast the likely effect of such actions
million is based upon an estimated
decrease in the availability of meat. This as the withdrawal of approval of the
DES NADA's was presented as a
estimate in turn is based, again, on no
witness at the hearing. No attempt was
change-over from DES in feed to nonmade by any witness to analyze the real
DES implants. It also assumes that meat
world economic effects of the lack of
producers do not, as they in fact do,
availability of DES-and the availability
decrease herd sizes when prices go
down and increase herd sizes when they of alternatives to it.
Moreover, the CAST Report contains
rise (cf. M-Sl at 26).
a statement that would seem to
(A witness for the intervenors, fohan
contradict the manufacturing parties'
W. Algeo, in fact testified concerning
position:
the "cattle cycle." He stated that at the

1 Notices

M491

A ban of DES at present would probably
have little effect on the beef-cattle industry
as long as substitutes, which have similar
effects, remain available (Cothern. 1974, i975,
1975a). Meanwhile. a ban on DES would
permit the export of fed beef from the United
States to countries such as Canada that now
forbid its import because they ban DES and
we do not.
(M-51 at 29.) The report also cites
calculations of the estimated changes in
wholesale prices of meats following
withdrawal of approval of the DES
NADA's with no substitutes being
available. Because however there are
substitutes, this information is of
questionable relevance.
The CAST Report in considering the
possible effect of the removal of DES
from the market "without replacement"
on the availability of grains for export to
developing countries, concludes that the
"quantitative effects [of the ban of DES]
would probably be too small to detect
among the numerous-other factors that
influence prices of beef cattle and feed
grains" (id. at 6).
This record simply lacks information
sufficient to allowme to make any
determination about the extent of the
economic costs, if any, of the
withdrawal of approv-al of the DES
NADA's.

(iii) Costs of Use of DES. The
Administrative Law Judge noted that a
consideration of the possible economic
benefits of DES must include
consideration of the economic costs of
such use (LD. at 21). He cited the
economic costs of "bulling" (id.). The
term "bulling" or "riding" refers to
steers mounting one another I.D. at 21,
n. 15). Although bulling occurs in
feedlots without DES-implanted or fed
cattle, the incidence of this activity
increases where DES implants are used
(Tr. at 2067). The only witness testifying
on this subject. Dr. Flack gave his
opinion that DES feeding, as opposed to
implantation, does not lead to increased
bulling (Tr. at 2068).
The steers apparently can harm or kill
one another during bulling. The record
does not state the extent to which this
activity increases, or the extent of harm
to the cattle, when DES is administered.
Nor does it provide information
sufficient to be a basis for any
conclusion about the economic costs
associated with bulling.
The Administrative Law Judge also
included in the economic costs of the
use of DES a greater incidence of liver
abscesses associated with that use.
There is little information in the record
about how much greater this incidence
is in actual practice. The intervenors' Dr.
Flack testified that livers of cattle are
valued at approximately $2.50 per head

54892

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

(Tr. at 2061). I cannot, however, on this
record fairly estimate the cost to DES
users and the economy resulting from
the loss of livers abscessed because of
use of DES.
One cost (or reduction in benefit)
associated with DES-use that was not
discussed by the Administrative Law
Judge necessarily follows from the
manufacturing parties' argument that
DES-treated beef pioduces less marbling
and, thus, a lower Department of
Agriculture grade, than untreated beef.
It is common knowledge that higher
grade beef is more expensive than lower
grade beef. If there is a significant
difference, then meat producers pay a
cost (or reduction in benefit) in lost
profits resulting from use of DES.
(iv) Conclusion As to Economic
Benefits. Again, the Administrative Law
Judge's conclusion that the
manufacturing parties have failed to
show the economic benefit of DES is
justified. Neither the manufacturing
parties nor the intervenors provided
information on-the basis of which I can
determine (1) the difference, if any,
between the economic benefits of using
DES and the economic benefits of using
other growth promotants (or even what
growth promotants are available), (2)
the likely cost or savings from any
changes in consumer selection of foods
that might result from action with
respect to DES, or (3) the costs that
might be saved-by the withdrawal of
approval of the DES NADA's.
There is some credible evidence that
the withdrawal of approval of the DES
NADA's would cause little economic
harm to the public and to the beef-cattle
industry beyond the cost of transition
from the use of DES to other products
(cf. M-51 at 26). The transition cost itself
may be lessened because of the way in
which events have proceeded. The
Administrative Law Judge's decision has
put the industry, including the
manufacturers of alternatives to DES, on
notice that withdrawal of approval of the DES NADA's is likely. Presumably,
the manufacturers of alternatives have
been readying themselves to increase
production when the withdrawal
becomes final.
If there were no alternative growth.
promotants for beef and sheep, DES
would provide some economic benefit,
unquantifiable on this record, to society.
In light of the availability of alternatives
to DES, however, the manufacturing
parties have not shown that the
withdrawal of the DES NADA's would
result in the loss to society of significant
economic benefits,
Manufacturing parties argue that they
have no "special burden to prove a point
that the Bureaus have already

the human body, safety problems with
conceded" in the inflation impact
statement (Manufacturing Parties'
DES itself must also be attributed to
Exceptions at 180). I do not agree that
DES conjugates (section III{(C).
the Bureaus have conceded that the
Risk-benefit analysis is not
appropriate in determining the safety of
withdrawal.of the DES NADA's will
have the total economic impact stated in an animal drug that poses a risk to
the inflation impact statement. That
humans (section III(E)(1)). Such an
analysis has been attempted here
statement itself staes that-one of the
pivotal assumptions upon which it
nevertheless (section IlI(E)(2)). The
proponents of the use of DES have the
relies, that producers using DES in feed
will not switch to non-DES implants,
burden of showing that the benefits of
may not be valid (G-115 at 5). In
DES outweigh its risks (id.). They have
addition, that statement was a
not, in this record, provided an adequate
basis for determining either the risks of
projection based on the economic
situation in the beef cattle industry in
DES or the benefits, if any, that it
1976. As the Bureaus argue (Bureau's
provides to society (id.).
Brief at 144), conditions have changed
Withdrawal of approval of the DES
NADA's is thus required on the basis of
since the issuance ofthat document. It
the so-called "safety clause" of 21 U.S,C,
would thus be unrealistic for me to rely
upon the inflation impact statement as a 360b(e)(1)(B) (as well as on the basis of
the Delaney Clause discussed In section
projection of the economic costs of
II of the Decision),
withdrawing approval of the DES
NADA's.
IV. Liver Discard as an Alternative
Even accepting the manufacturing
Condition of Use
parties' position on this issue, I could
The manufacturing parties note
not find that a saving of $659 million in
(Manufacturing Parties' Exceoptlons at
the first year after withdrawal
186) that the Court of Appeals in -loss
(projected by the impact statement)
Clark stated that "the FDA might
outweighs the risk of cancer associated
restrict such consumption [of any DES
with the continued use of DES. Even the
residue] by a ban on sale of liver, the
manufacturing parties' Dr. Jukes stated
only food material in which any
his agreement with the proposition that
residues have been detected" (footnote
no saving in meat prices can justify a
omitted), 495 F. 2d at 994. As discussed
real risk of cancer in the food
above (section III(B)(1)) with respect to
Americans eat (Tr. at 2183-84). Some
the manufacturing parties' contention
would argue that this amount of money,
that the NADA's for DES as a feed
if put, for example, into cancer research,
additive should be judged as If they
would result in a saving of more lives
than would the ban 6f DES (see, e.g., M- provided for 14-day withdrawal periods,
the statute is clear that I must consider
99 at 17). There is, however, no showing
the conditions of use that were
that there is any relationship between
originally approved. Thus, a change In
the alleged savings of costs because of
the use of DES and the funding of cancer conditions of use to require liver discard
research. In fact, there is clearly no such would be proper only if the
manufacturing parties had sought to
relationship.
amend their NADA's.
(F) Summary of Safety Clause Issue
In seeking such an amendment, the
applicants would have the burden of
Evidence in the record from radioshowing their product to be safe in the
tracer studies and the Department of
first instance. In a withdrawal ,
Agriculture residue monitoring program
proceeding, an applicant's interest in the
provides independent bases for the
conclusion that approved uses the DES
status quo outweighs the public Interest
to the extent that the Bureaus seeking
result in residues of DES and/or its
withdrawal have the initial burden,
conjugates in edible tissues of treated
discussed above, of coming forward
animals (see section III(B)). Animal and
with evidence warranting that
human cancer data demonstrate that
DES is a carcinogen, and that there is no withdrawal. When an applicant seeks
approval for a change in the NADA, that
identifiable no-effect level for its
carcinogenicity (section III(D)(1) and,
burden on the Bureaus no longer exists.
I have, however, considered the
(2)). Evidence in the record raises but
fails to resolve serious questios about
question whether approval of the DES
the potential teratogenicity and
NADA's would still have to be
mutagenicity of DES, and there is no
withdrawn if they required as they now
demonstrated no-effect level for DES for do not, the discard of all livers.
these adverse effects (section III(D)3)).
The Hess &Clark Court's
understanding that livers were the only
Because the conjugates of molecules
food material in which DES residues had
often retain the characteristics of the
unconjugated molecule, and because
been detected is not correct. DES
conjugates of DES hydrolyze to DES in
residues have been reported by the

Federal Register / Vol. 44, No. 185 / Friday. September 21, 1979 / Notices
Department of Agriculture only in livers
(G-58 at 2). That Department, however,
only analyzes livers (G-94 at 3). As
noted in section III(B](2) of this
Decision, DES residues were found in
edible tissues other than liver, e.g.,
kidneys and tongues, in radio-tracer
studies (see --2; G-5; G-76 at 5; cE G791 of both feeding and implantation of
DES.
The manufacturing parties, however,
focus on the question of-whether DES
residues have been found in muscle
tissues. As discussed above in section

II1[B)(2), radioactivity that may be
attributable to DES residues has been
found in the muscle tissue of steers 10
days after dosing with radiolabeled DES
(G-2 at 1190, Table 4) and 120 days after
implantation with radiolabeled DES (GI at 4; G-5 at 535, Table 2). The
manufacturing parties' criticisms of
these results, which are at very low
levels, are discussed above (see section

II(jB)(Z)).

Act, 21 U.S.C. 601 et seq. (Intervenors'
Exceptions at 2). It is unclear what point
they seek-t make. If they are arguing
that USDA will automatically remove
from the market tissues with DES
residues. I reject that argument. As
discussed above (section 1(A)). there is
no analytical method available by which
USDA could assure that meat does not
contain DES residues at levels not
shown to be safe. If they are arguing
that no method can ever detect DES
residues in edible tissues, see 21 U.S.C.
360b(d](1](H).because any tissue that
contains a residue is not edible, I reject
that argument as absurd.)
V. Need for an Environmental Impact
Statement
The National Environmental Policy
Act, 42 U.S.C. 432"(c), requires the
preparation of an environmental impact
statement for "major Federal actions
significantly affecting the quality of the
human environment, * *.. The
Bureaus, in an 'environmental impact
analysis report and assessment," issued
in October of 1976 (prior to issuance of
the notice of hearing), found that the ban
of DES would not constitute an action
"significantly affecting the quality of the
human environment" (G-116). The
Bureaus thus concluded that no detaied
environmental impact statement need be
prepared. The basis for theBureaus'
conclusion was the finding that meat
producers will simply turn to available
alternative growth promotants if DES is
no longer availabl. The report refers
specifically to estradiol beazoate plus
testosterone propionate (Synovex-H),
estradiol benzoate plus progesterone
(Synovex-S). zeranol (Ragro).
melengestrol acetate (MGA]. and
monensin (Rumensin).
It is appropriate, under the statute, for
an agency to determine that its proposed
action does not create the kind of
significant environmental impact that
would justify a full environmental
impact statement That decision must be
based upon a careful consideration of
the question, including consideration of
courses of action that are alternatives to
the action proposed. TrinityEpiscopaI

More important than these findings is '
the fact that in the muscle of animals
tested at less than approved withdrawal
times, DES residues were observed in
amounts significantly less than those
found in the animals' livers. In light of
that fact, I conclude that evidence that
DES has been detected after use of DES
animal drugs under their approved
conditions of use in cattle's livers (and
other organsl is an indication that DES
exists, in smaller (perhaps undetectable)
amounts, in muscle tissue. See also M63 at 261. citing Goldhammer. G. S.,
Government Operations-Part 1 (1971) at
70 for the proposition that the
concentration of DES in liver is ten
times that in beef muscle.
I find that the record supports the
conclusion that use bf DES results in
DES residues in edible tissues other
than liver. It follows from this finding
that it has been shown that use of the
DES animal drugs, even with the
restriction that the livers of DES-treated
animals (Or that any combination of the
edible tissues of such animals) be
discarded, has not been shown to be
safe. Therefore, even if the DES NADA's
contained the liver-discard condition of
School CorA v. Romney 523 F.2d 88, 9zuse, approval would be withdrawn
93 (2 Cir. 1975]. The Bureaus' statement
pursuant to the "safety clause" of 21
is quite detailed, has a bibliography
U.S.C. 360(e)(1J(B).
listing 21 articles and books, and does
My analysis of the Delaney Clause
issue would also not change. The
consider the alternatives to the
approved orproposed analytical
withdrawal of approval of the DES
methods would be no more acceptable if NADA's.
the NADA's provided for liver discard.
The most important finding of the
report is, of course, that users of DES
On that basis, withdrawal would still be
will predictably turn to alternative
required by the statute.
growth promofants. The report bases
(The intervenors assert that liver
this conclusion on experience during the
tissues containing substantial quantities
of DES are not -edible tissues" within
period when approval of the DES
the meaning of the Wholesome Meat
NADA's was withdrawn previously

54893

before being reinstated by court order.
The report notes that the alternative
drugs to which it refers are approved by
the FDA for use. No one disputed, at the
hearing, the Bureaus' assertion that
alternatives are available.
Intervenors" witnesses did. however.
raise questions about reliance upon the
availability of two alternative growth
promotants. First, an intervenors*
witness noted that the FDA'is seeking to
withdraw approval of the Synovex
products (PA-33 at 5). The problem
posed by the proposed withdrawal of
approval of the Synovex products is
discussed above in the benefits section.
The agency was not proposing to
withdraw approval of these drugs at the
time the Bureaus decision that an
environmental impact statement was
unnecessary was made. Because
alternative growth promotants such as
Ralgro are still available, I conclude that
the proposed action with respect to
Synovex does not invalidate the
decision that the withdrawal of
approval of the DES NADA's will not
significantly affect the quality of the
hunkan environment
Another interveners" witness argues
that the fact that monensin can be used
either concurrently with DES therapy or
by itself means that monensin is not
properly a replacement for DES (PA-31
at 61. The Bureaus do not contest the
assertion that monensin is additive to
DES treatment and that. for that reason,
monensin should not be considered a
substitute for DES for those now using
the two drugs concurrently. As a
practical matter, on the other hand.
cattle feeders who are content to use
only one growth promotant may well
begin to use monensin when DES is
banned.
The preparation of the environmental
impact analysis report by the Bureaus
before the hearing commenced was the
correct procedure, see Calvert Cliffs'
CoordinatingCommittee v. Atomic
Energy Commission,449 F2d 1109,
1117-18 (D.C. Cir. 1971). The

manufacturing parties argue that they
were denied a fair hearing on the
environmental impact issues because
the Bureaus did not present a witness to
stand cross-examination on the
environmental impact analysis. The
courts have not gone so far as to require
that the authors of the analysis be
presented for cross-examination. Rather,
the requirement is that the analysis (or
statement) be available so that the
parties are -given the opportunity to
cross-examine * * * witnesses in light
of the statement." Greene County
PlanningBoardv.
FPC,455 F2d 41z. 42z.
(2d Cir. 1972).

54894'
Ill

II

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

The manufacturing parties argue that
the economic and public health effects
of the ban of DES, discussed above,
demonstrate that the ban would be a
major federal action significantly
affecting the quality of the human
environment (Manufacturing Parties'
Exceptions at 184). The manufacturing
parties do not'explain how loss of the
claimed economic benefits of DES
would constitute an effect on the quality
of the human environment. The Bureaus'
analysis did consider the effect that the
ban would have on the availability of
feed (G-116 at 11). The analysis did not
consider the effect of the ban on human
intake of fat.
An increase in fat intake is not an
environmental effect to be considered in
an environmental assessment. See
CalorieControl Council,Inc. v. DHEW,
No. 77-0776, slip op. at 5-6 (D. D.C.
September 9, 1977). remandedon other
grounds (D.C. Cir. September 22,1978)
(health effects of saccharin ban not
cognizable under environmental law): cf.
Breckinridgev. Rumsfeld, 537 F. 2d 864,
866 (6th Cir. 1976); NationalAss'n of
Gov't Employees v. Rumsfeld, 413 F.
Supp. 1224, 1229 (D.D.C. 1976). In any
case, the fat question is unusual enough
that it is hot logical that it would have
been raised in the initial analysis. In
fact, in light of the evidence in this
record, I consider this Issue as bordering
on the frivolous. I conclude that the full
discussion 'of the issue in this opinion
satisfies the statute's intent that allenvironmental issues be considered
tefore action of this type is taken.
The manufacturing parties point out
that although the Administrative Law
Judge found that the withdrawal of DES
from the market would not significantly
affect the quality of the humaff
environmenmt, he did not discus§ this
issue specifically in his opinion. [The
manufacturing parties themselves
devote only two and a half of the 217
pages of their exceptions to this issue.) I
have, however, considered carefully the
possibility that the withdrawal of
approval of the DES NADA~s will affect
the human environment. This
discussion, together with the applicable
segments of the risk/befiefit analysis;
constitutes my decision on this issue.
I conclude that withdrawal of
approval of the DES NADA's will not
significantly affect the quality of the
human environmeht because DES will
be replaced by alternative growth
promotants. Therefore, the Bureaus'
decision not to fil& a complete
environmental impact statement for the
withdrawal of approval of the DES
NADA's was correct.

I

VI. Exceptions to Evidentiary Rulings

I

and Dr. Jensen's report of those data Is
hearsay.
Both the manufacturing parties'and
I find, however, that this testimony
the Bureaus have filed exceptions to
should have been admitted for what It Is
certain- evidentiary rulings by the
worth, and I therefore reverse the
Administrative Law Judge in the course.
Administrative Law Judge's ruling on
of the hearing. In the interest of
removing any possible cause for remand this issue.
Direct testimony of Dr.Kliman (Mof this hearing from a reviewing court
110). The manufacturing parties except
due to evidentiary'rulings, I have
to the exclusion from evidence of panes
considered those evidentiary
19 through 29 of Dr. Kltman's testimony.
submissions by the manufacturing
The Bureaus had sought the exclusion
parties that were excluded from the
on the grounds that this testimony,
record, whether or not I have concluded
which dealt specifically with the
that those exclusion were proper.
testimony of Bureaus' witnesses, Wag
I have relied upon certain Bureaus'
argumentative and, in some Instances,
evidence that the manufacturing parties
irrelevant and without factmal basis. The
argue should-be excluded. I have,
statements made in this part of Dr.
however, reviewed the record carefully
Kiliman's testimony would more
to determine whether reversal of any
appropriately have been made in a brief.
evidentiary ruling with respect to such
I find, however, that there Is sufficient
evidence would change my decisions on
basis for this testimony to support Its
the issued presented by this hearing.
admission into evidence and I reverse
Thus, the following discussion
the Administrative Law Judge's ruling
considers, in each instance in which I
with respect to the pages in question. I
uphold the refusal to exclude Bureaus'
have discussed Dr. Kilman's testimony,
evidence, whether excluding that
where relevant, above.
evidence would alter my conclusions in
Directtestimony of Dr. Tennent (Many respect. As will be apparent, even if 132). The manufacturing parties except
all evidence that the manufacturing
to the striking of the last sentence on
parties seek to exclude were in fact
page 7 of Dr. Tennent's testimony. The
excluded from th administrative record, motion to strike this testimony was
my debision of the issues presented
originally denied but was then, after
would not change.
cross-examination of Dr. Tennent,
(A) ManufacturingPartes'
granted (Tr. at 1283). The testimony was
Exceptions. The manufacturing parties
stricken as hypothetical and not
have specifically-excepted to certain
relevant to the proceeding. The
exclusions of their evidence
statement'stricken deals with a
(Manufacturing Parties' Exemptions,
calculation for which Dr. Tennent
Appendix C). I will, as did the
admitted he did not have data (Tr. at
manufacturing parties in their
1282) and which was not directly related
exceptions, review those rulings under
to the issues at hand. Although It Is not
the name of the witness, or the number
clear why there was a need to strike this
of the exhibit, in.question.
testimony, I do not find thilt striking to
Direct testimony ofDr.Booth (M-40]. be error.
The manufacturing parties except to the
The manufacturing parties also except
striking of a sentence from page 8 of'Dr.
to the striking of a statement by Dr.
Booth's testimony. That sentepce was
Tennent concerning a procedure
stricken neither in the October 20, 1977,
followed by Dr. Williams in attempting
order to which they refer nor during
to identify radioactivity found in a
cross-examination. Although the
radioisotope experiment. The first of the
sentence-referred to appears on its face
two sentences stricken states that Dr.
to be unobjectionable (and I have V
Williams made a certain assumption.
therefore, considered it); the
The Bureaus moved to strike this
manufacturing parties' failure to state in
statement because Dr. Tennent had not
whai context the decision to strike was
shown a basis for concluding that the
made makes reversal of that decision
assumption had been made. The striking
inappropriate.
I
of that sentence appears to have been
appropriate. However, the next
Directtestimony of Dr.Jensen (M669). The manufacturing parties except
sentence, which states: "This procedure
was counterproductive so far as
to the exclusion of a statement by Dr.
Jensen concerning a'study dealing with
purification is concerned," is simply a
estrogen receptors. A written report of
statement of expert opinion on a
the study was apparently prepared but
relevant subject and should not have
not yet published and was not submitted been stricken. I therefore reverse the
to the record. The data upon which Dr.
Administrative Law Judge's ruling with
respect to the latter sentence. I do not,
Jensen based his statements were not
however, consider Dr. Tennent's
available for analysis by the Bureaus,

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

testimony to be a basis for discounting
the results Dr. Williams reported.
Direct testimony of Dr. C. IL Weaver
(M-139). The manufacturing parties
object to the striking after crossexamination (Tr. at 1520-21) of a
statement by Dr. Weaver about the
"apparent experimental design" of the
Gass study. Dr. Weaver admitted on
cross-examination that he based his
testimony on a statement by Dr.
Tennent, who was in turn reporting a
statement by Dr. Gass (Tr. at 1518). It
was within the Administrative Law
Judge's discretion to find this double
hearsay to be unworthy of admission
into evidence in this proceeding, and his
ruling is upheld with respect to those
statements. The Administrative Law
Judge also struck from the record a
statement by Dr. Weaver about the.
usual procedure in a controlled
- experiment. This testimony is relevant
only if Dr, Weaver's hearsay testimony
about the experimental design of the
Gass study remains in the rqcord. Thus,
the striking of this testimony was also
appropriate..
The manufacturing parties object to
the striking of two paragraphs (at pages
19 and 20 of M-139) that seek to
incorporate the views of a Professor
Mantel. I believe that a fairly liberal
policy with respect to the receipt of
hearsay is appropriate in a proceeding
such as this one. One legitimate function
of that rule, however, is to force the
parties to present witnesses that they
regard as important for crossexamination. If the manufacturing
parties wished to rely upon the views of
Professor Mantel, they had an obligation
to present him as a witness for crossexamination. This testimony was
properly stricken as hearsay.
ExhibitsM-141 and M-142. The
manufacturing parties object to the
exclusion from evidence of affidavits of
Drs. Nathan Mantel and David Salsburg.
Because neither of these individuals was
made available for'cross-examiation,
the striking of their affidavits was
entirely justified. (Although the
manufacturing parties argue that this
ruling by the Administrative Law Judge
is inconsistent with other rulings that
permitted witnesses to refer to
statements of other experts, they
provide no examples of such "other

rulings.")
Exhibit M-148a. This exhibit.purports
to list reported residue findings for
animal drugs other than DES. The
striking of this exhibit is consistent with
the agency's, and the Administrative
Law Judge's, established position that
an administrative hearing on one
product is not a proper forum for an
argument that that product is being

treated differently than other products.
This position has been recently upheld
by the United States Court of Appeals
for the District of Columbia Circuit,
EdisonPharmaceutical Inc. v. FDA,
Co.,
No. 77-1636, slip op. at 23 (D.C. Cir.

54895

I I

The manufacturing parties' desire to
have the last word (and perhaps to
delay the completion of the hearing.
since acceptance of surrebuttal
testimony would have led to further
cross-examination) is understandable.
Administrative hearings have to end
March 21,1979).
sometime, however, and the conclusion
In any case, as discussed in section
of this hearing prior to the submission of
III(BX(3) of this Decision, the evidence
the manufacturing parties' purported
with respect to the regulatory treatment
surrebuttal evidence was appropriate.
of the residues of other drugs is
ExhibitAf-209. As discussed below,
irrelevant to the evidence with respect
the Administrative Law Judge allowed
to DES because the residue findings are
the Bureaus to submit into evidence an
not comparable. With respect to other
interim report (G-192) of the "Chicago
drugs, residues should be detectable by
study", discussed above (see section
the approved methods at any level
m(D)(2][b) above]. In their opposition to
above a computed "safe" or "virtually
admission of this document, the
safe" ("no residue") dosage. Since no
"safe" or "virtually safe" dosage for
manufacturing parties submitted a
statement by Dr. Herbst, who had been
DES can be ascertained, there is no
a witness for the Bureaus. Dr. Herbst, in
evidence of the number of residues
this statement, gave his opinion that the
existing in edible meat products above
report was not evidence of
that dosage level for DES. Certainly the
carcinogeniciiy of DES in humans. The
Department of Agriculture findings,
exhibit (G-192) was nevertheless
which at best provide evidence of the
admitted and, on March 20,1978, (ten
number of residues above 0.5 ppb DES,
days before final briefs were due]. the
are not comparable to the residue
manufacturing parties moved Dr.
figures for other drugs.
Herbst's statement into evidence
Surrebuttaltestimony of Dr.
Jensen
(Record No. 373]. On March 24, the
[M-203) and referencedpopers [A-204Administrative Law Judge denied the
208). Briefs to the Administrative Law
motion for admission of Dr. Herbst's
Judge were due to be filed on March 30,
statement.
1978. On March 3,1978, the
Exhibit G-192 was an update of a
manufacturing parties presented the
study about which all parties had had
purported surrebuttal testimony of Dr.
Jensen together with a number of papers an opportunity to comment. Neither the
Bureaus nor the manufacturing parties
that.had not yet been made part of the
were given an opportunity to present
administrative record. The
testimony concerning the update.
Administrative Law Judge reviewed this
Accepting testimony from either side on
new evidence and concluded correctly
this report would have required another
that it was not proper surrebuttal. The
round of cross-examination.
arguments made by Dr. Jensen, in almost
The Administrative Law Judge noted
all instances, would more appropriately
that, by the terms of Dr. Herbst's
have been made in the final brief of the
statement, Dr. Herbst and the other
parties. In fact. Dr. Jensen's testimony
researchers working on the "Chicago
has been included in the manufacturing
study" had completed an analysis of the
parties' brief (Manufacturing Parties'
study. They were not, however, willing
Exceptions, Appendix B).
to submit that analysis to the
The Administrative Law Judge's
administrative record before the
decision to exclude this evidence on the publication of the analysis in April. The
ground that it was not proper surrebuttal failure to admit, at that late date in the
was correct. Surrebuttal is justified only -proceeding. the partial. conclusory
by a showing of the necessity to respond evaluation of the study that was
to unanticipated issues raised during
proffered is not error. The
rebuttal. It is clearly not appropriate for
manufacturing parties were free to
the manufacturing parties to seek to
comment upon the information
introduce as surrebuttal new evidence
presented by the report and have done
that could have been produced earlier in so in their briefs. (As noted above, I
the hearing and would have been
have considered Dr. Herbst's statement
subjected to the scrutiny of the
in any case.)
witnesses for all parties. Since there
The manufacturing parties also
was no showing that exhibits M-204-208 objected to the admission into evidence
were not available earlier in the
of certain testimony and exhibits
proceeding (or that the issues to which
presented by the Bureaus.
they are relevant were not raised earlier
Direct testimony ofDr.Bixier (C-1).
in the proceeding), the Administrative
One sentence from this testimony is
Law Judge's decision with respect to
objected to because it uses the phrase
these documents was clearly justified.
"the livestock producer may think he is

54896

Federal, Register / Vol. 44, No. 185

feeding his animals a withdrawal
(nonmedicated) feed" -IG-1l at 2). The
manufacturing parties argue that this
testimony "purports to probe the mental,
processes of 'the livestock producer.',
(Manufacturing Parties' Exceptions.
Appendix C at 13]. Since the rest of this
statement explains Dr. Bixler's view of
the likelihood of unintentional DES drug
carryover, this testimony is properly
admissible. I have not. however, relied
upon Dr. Bixler's testimony in this
Decision.
Cross-examinationof Dr.
Bix.er. The
manufactiing parties object to a ,
statement made by Dr. Bixier on crossexamination in which he testified that it
was possible that animals implanted
with DES might also be inadvertently
fed feed containing DES. The
Administrative Law Judge correctly
denied a motion to strike'this statement;
he thought the question on crossexamination was unnecessary and that"
the answer was obvious. He noted that
counsel for the mnufachring parties-,
had, in his objection to the question,
pointed out that anything was possible.
Dr. Bixler also stated that "farmers
have admitted that theyhave fed-DES
feed in conjunction with implanting" (TY.
at 571). This statement is hereby
stricken as hearsay.
Exhibit G-47.The manufacturing
parties move to strike this document,
entitled -Survey of Compounds Which
Have Been Tested for Carcinogenic
Activity." This is a government
publication briefly summarizing test.
results with respect to the carcinogenic
activity of various substances. An administrative law judge is not-bound
by the Federal Rules of Evidence. though
Judge Davidson sought to apply them.to
the extent reasonable in this proceedingThe Administrative Law Judge
concluded that G47 was admissible,
even though hearsay, either because it
wa a public record or report or because
its admission otherwise served the
purposes of justice; see Rule 803. Fed. R.
%I
Evid.
- The admission of this exhibit might
conceivably have been improper ifit
had been intended to show the results of
a particular study about which there
was an active dispute and if that study
had not been produced. Here. however.
that was not the case. lhe studies
specifically relied upon by the Bureaus
were produced. This exhibit was
proffered merely to demonstrate that
DES is carcinogenic.The Administrative
Law Judge's decision not to strike this
document was proper. There is sufficient
evidence in the record showing DES to
be a carcinogen in animalsso thaL if G47 had been excluded from evidence, my'
findings would not change on any issue.

1

Friday, September 21, 1979 / Notices

The manufacturing parties also object
Direct testimony ofDr. Mghrran(Cto three answers by Dr. Kokoski to
54). The manufacturing parties object to
questions on redirect examination (Tr.
the entire direct testimony of Dr.
at 10,4&-49). In this testimonyDr.
Highman. Dr. Highman reported on
Kokoski stated that Exhibit G-24 refers
incomplete results of the NCTR DES
to drugs in general, though its primary
animal study. The manufacturing parties
also submitted testimony with respect to thrust deals with carcinogenic drugs.
The manufacturing parties then moved
incomplete reports Of fhe results of this
to strike this redirect examination as not
study (see section 111(13(2)[a) of this
having been covered on crossDecision). The question of how to deal
examination. The Administrative Law
with ongoing studies in an
Judge denied the inotion to strike on the
administrative hearing is a difficult one.
ground that whether or not the witness
I have concluded that it is not
was correct in his appraisal of the
appropriate to rely, inan administrative
exhibit was immaterial, because the
hearing, upon Incqmplete repbrts of
exhibit was in evidence fand could thus
results of a study of this type. Although
be evaluated on its own merits). He
the technical question of whether this
stated, "1 do not know what you are
testimony is admissible is perhaps a
fussing about" (Tr. at 1049). ] concur in
close one, in light of the fact that I have
the Administrative Law Judge's
assigned no weight to this evidence [see
comment upon the frivolousness of this
s6ction 1l[1D)f2)[a) of this Decision), I
motion. Itis unclear whether the
I
hold that this testimony should be
'AdministratiVe Law Judge ruled upon
excluded,.
the issue of whether the testimony in
Direct testimony of Dr. Kokoski[Gquestion was proper redirect
57). The manufacturing parties seek to
examination. As I can find nothing in
strike certain testimony of Dr. Kokoski
the cross-examination of Dr. Kokoskt
setting out what he and the Bureau oT"
that deals with the subject of his
Foods' Division of Toxicology consider
redirect, I must reverse the
necessary to show the safety of a
Administrative Law Judge's denial or
substance. The manufacturing parties'
'this motion.
'objection to this testimony is that it
Directtestimony of Dr.Leiy fG-58)
represents the views not.of the
The manufacturing parties ask that this
individual witness but of the division of
entire testimofiy be stricken because Dr.
the Bureau. Since. however. Dr. Rokoskd Levy did not have personal knowledge
stated that this testimony on these.
of the factual data upon which he based
subjects was in fact a statement of the
his statistical calculations Idiscussed
criteria he would use in evalu~ting the
above in section 1[B)(3) of this
safety ofla substance Fr. at I18-19), it
Decision). Dr. Levy's testimony can ba
is apparent that this testimony is
accepted, at the very least. us
properly admissible. I zonclude that the
demonstrating the fact that a relatively
exclusion of his testimony on this
small number of detected residues
subject would not have led me to a
represent a larger number ofresidues
different decision with respect to The
among all animals treated. '[The
safety of DES.
manufacturing parties do not object to
Cross-ex-aminaLFnn of Dr.Xokos I
this treatneit of the testimony. Tr. at
The manufacturlng parties refer to a
738.)
response to a question asked Dr.
Dr. Levy testified that the figures he
Kokoski on cross-examination in which
utilized in this testimony were
Dr. Kokoski slated his opinion that the
government figures provided by the
"law does-not provide for establishing a
United States Department of
safe tolerance for an agent which is
Agriculture. The manufacturing parties
shown to induce canver"
fTx.at 1045].
provided no basis for suspicion that
The manufacturing parties moved to
these figures are not correct. In an
strike this sentence, apparently on the
administrative hearing of this type.
grpunds. urged at the time of crossstruct adherence to the evidentiary rules
examination, that Dr. Kokosld is not
of courtrooms is neither required nor
qualified to give an opinion on a legal
efficient. If there were any reason to
question. I ail to see why any time is
believe that USDA had in fact not found
wasted by either unaking this objection
the residues reported byDr. Levy or if
or appealing the ruling-denying it. It
the difference of a few residue
would seem an obvious mitter that Dr.
detections more or less would make a
Kokoski's opinion on a legal matter will.
difference in my ultimate decision, there
would be more reason to require
be given no weight. Because The legal.
opinion was not within Dr. Kokoski's
technical proof that the figures to which
expertise, hmvwever the Administrative
Dr. Levy testified were correct. Because
Law Judge's ruling on this issue is
neither of these reasons, mor any other
reason of which I am aware, requires
reversed..-

Federal Register / Vol. 44, No. 185 / Friday, September 21, 1979 / Notices
dismissal of Dr. Levy's testim6ny, I have

relied upon it and hold that the denial of
the motion to strike this testimony was
appropriate.
I have considered whether exclusion
of Dr. Levy's testimony would require
reversal of any of my findings in this
proceeding. FDA Establishment
Investigation Reports hive been
submitted to the record (as G-89) that
show FDA investigations of USDA DES
residue findings (see also G-139, G-140).
Thus, there would be evidence of such
findings-upon which I would base the
conclusion that USDA findings show
that DES use results in DES residues in
edible tissues-even were Dr. Levy's
testimony excluded.
Direct testimony of Dr.Rodricks (G72). The manufacturing parties move to
strike Dr. Rodricks' statement that,
because the USDA monitoring program
was utilizing a method with a lowest
level of measurement above the level
that would be considered adequate for
DES, it must be concluded that a far
higher residue occurrence rate would be'
observed if a method with a lower level
of measurement were utilized by the
monitoring program (G-72 at 6). The
manufacturing parties argue that this
conclusion is speculative and without
factual basis in the record. However, Dr.
Rodricks was an expert witness, and the
conclusion is appropriately based upon
his expertise. (Indeed, the conclusion he
voiced is self-evident to one with basic
scientific knowledge about the
occurrence of residues.]
The manufacturing parties also object
to the admission into evidence of a
number of statements by Dr. Rodricks
(id. at 7-10) that they consider to be
"argumentative, hearsay, and to a large
extent not based upon evidence of
record." I have reviewed the statements
objected to and find the manufacturing
parties' objections to them to be
unfounded.
Direct testimony of Dr.Saffiotti (C80). The manufacturing parties move to
strike the first seven pages of Dr.
Saffiotti's eight page written direct
testimony on the grounds that it set out
procedures for determining whether
chemical carcinogens are safe and that
Dr. Safflotti was unable to relate DES to
chemical carcinogens. The
manufacturing parties' argument is that
DES is simply another estrogen and thus
not a chemical carcinogen. As discussed
in some detail above (section re(D)(1)), I
find that DES is not simply another
estrogen and may have some properties
of chemical carcinogens. Thus, Dr.
Saffiotti's testimony is relevant to DES,
and the refusal to strike this testimony
was justified. (The first one and one
quarter pages of the testimony contains,

-

at any rate, a description of Dr.
Saffiotti's qualifications and would not,
even if the manufacturing parties' theory
had validity, be stricken.)
The manufacturing parties also object
to a statement by Dr. Saffiotti that: "It is
clear that DES Is a cancer-causing agent
in animals and in humans," and to a
subsequent statement that a publication
containing summaries of experimental
and epidemiological data supports that
statement (G-80 at 7). The
manufacturing parties argue that they
were unable to cross-excamine Dr.
Saffiotti fairly on his conclusion that
DES is a cancer-causing agent because
they had not been provided with copies
of all of the reports summarized in the
publication referred to. However, Dr.
Saffioti's expertise in this area is clear
(G-80 at 1-2; G-0a; G-80b), and he is
qualified to give the opinion, based upon
literature upon which he reasonably
relies in forming opinions of this type,
that DES is a carcinogen (cf. Rule 703,
Fed. R. Evid.; McCormick on Evidence
[2d Ed. 1972) at 3a). Thus, his conclusion
on that point would be admissible
whether or not he had stated that data
supporting his testimony were
summarized anywhere.
The statement that such summaries
exist seems to be straightforward and
need not be stricken. A study in the
record showing DES to be a carcinogen,
such as the Gass study, is, of course,
given more weight than the statement of
an expert, unsupported by submitted
evidence, that DES is a cancer-causing
agent. The latter statement is, however,
relevant evidence and should be
considered as such (id.). I note that there
is ample evidence of the carcinogenicity
of DES in the record so that, if Dr.
Saffiotti's testimony were excluded, no
finding I have made In this proceeding
would change.
Exhibits G-139 and G-140. These
exhibits contained reports from the
Department of Agriculture to the FDA
about recent findings of DES residues. It
was established on the record that these
memoranda were prepared and
transmitted in the normal course of
government business (Tr. at 1183-84). As
such, these documents are properly
admissible in a Food and Drug
Administration administrative hearing.
Even if they did not. as they appear to
do, come within a recognized exception
to the Federal Rules of Evidence
hearsay rule, Rule 803(8)(B), Fed. R.
Evid., it would be necessary for the
orderly conduct of Food and Drug
Administration administrative hearings
to admit this type of evidence unless a
reasonable basis for believing that the
evidence was not correct had been

54897

proffered. No such basis was proffered
here. I note that these documents were
only cumulative of other evidence of
USDA residue findings and that
exclusion of them would not, therefore,
change my finding on any issue.
Direct testimony of Dr.Shimkin (C90). The manufacturing parties object to
the testimony by Dr. Shimkin to the
effect that it is not possible to conclude
that any level of DES residues can be
shown to be safe for human
consumption. Though the manufacturing
parties argue that this is a legal
conclusion. I do not share that
characterization. The statement
objected to is an appropriate conclusion
for an expert witness. Even under the
Federal Rules of Evidence, an expert
witness may give his opinion on the
ultimate issue to be decided by the
factfinder. Rule 704, Fed. R. Evid. This
testimony is not, however, an essential
basis for any finding that I have made.
Direct testimony ofMs. Weissinger
(G-95). The manufacturing parties object
to testimony by Ms. Weissinger about a
study of the breakdown of DES
conjugates in humans. This study was
an outgrowth of work she had done on
the subject in animals (see G-95, Tr. at
827-28). Ms. Weissinger was not a party
to the actual performance of the tests in
humans. The manufacturing parties
object to her testimony about the study
on that ground. However, the record is
replete with testimony by persons
shown to have expertise about studies
that they did not perform (see, for
example, my discussion of the
conflicting expert interpretations of the
Gass study in section 111(D](2](a)). Ms.
Weissinger has significant expertise in
the performance and evaluation of this
general type of study (G-95 at 1-2; C-95a), and there is thus no valid objection
to her testimony concerning this study, a
report of which is part of the record (G97). Because the study itself was part of
the record of this proceeding, I find that
I would reach the same conclusions
about the significance of this study even
were Ms. Weissinger's testimony
excluded.
Submissionof Dr. Willams (C-102].
The manufacturing parties object to Dr.
Williams' statement that "[tihere
appears to be no reasonable doubt that
DES conjugate(s) are present in liver 120
days after implantation of 4 -C-DES"(C102.: Comments on the Vineland
Laboratories Submission at 1]. The
manufacturing parties' objection to this
statement as being beyond the expertise
of the witness, speculation and without
proper foundation, is totally without
merit. Dr. Williams has been shown to
be an expert in this area (0-99 at 1; C-

54898

Federal Register

I

99a; G-99b). A second sentence in the
same paragraph, in.which Dr. Williams
gives his opinion as to whether a
conjugate constitutes a residue of DES,
is less clearly within Dr. Williams' area
of expertise. The questionis simply one
of semantics. Whether or not conjugates
found in animal tissues as the result of
the use of DES are characterized as
"residues" is of no significance in this
hearing. Although I have not relied upon
Dr. Williams' testimony on this issue, I
conclude that the Administrative Law
Judge's refusal to strike it was proper.
The manifacturing parties object to a
statement by Dr. Williams that an
estrogen conjugate is known to give rise
to high circulating plasma levels of free
estrogen in humans after oral
administration. Dr. Williams cited a
private communication from another
scientist for this proposition fG-102
Comments on the Vineland Laboratories
Submission at 2). The manufacturing
parties were not given an opportunity to
examine the data for a report of the
study) about which Dr. Williams
testified, and Dr. Williams" statement is
hearsay. I have concluded, however,
that this statement like that of Dr.
Jensen in M-69, discussed at the
beginning of this section. should have
been admitted for what it was worth. I
have, however, not relied upon this
statemenL
The manufacturing parties also object
to a further statement by Dr. Williams
that he feels that "it is most probable
that conjugated DES occurring in animal
tissues will give rise to free DES after
ingestion by humans" (dj. Contrary to
the manufacturing parties' assertion, this
statement is not beyond the expertise.of
the witness, does not constitute hearsay,
and is an appropriate expression of an
expert's opinion. (Dr. Williams cited
bases for this opinion oth~r than the
hearsay statement discussed above fid.).
In any case, that information would be a
permissible basis for the formation of
his opinion, rule 703, Fed. R. Evid.J Even
were Dr. Williams" testimony excluded,
other evidence in the record [see section
III(C) of this Decision)'would support
the conclusion, discussedabove, that I
have drawn on this issue."
Exhibit G-137. The manufacturing
parties object to the admission of this
summary of the results of FDA
investigations of DES residues.
Apparently the manufacturing parties at
one time thought this document-was
admissible, as they submitted it
themselves (M-27). Nevertheless, there
does not appear to be a clear
explanation in the record of how this
document was prepared. Nor is there
any clear showing that this is a

Vol. 44. No. 185

1 Friday,

September 21, 1979

/

Notices

document prepared in the normal course reason I do not believe that a
substantial delay of the effective dale of
of government business. though its.
format would suggest that it is. If the
my decision is appropriate. Certalinly no
document summarized only
such delay would be proper without a
establishment inspection reports that
clear showing that an early effective
were submitted to the record, it might be date would cause economic disruption
admissible as a shorthand-summary of
in the meat production industry.
those documents. However, some of the
It is also true, however, that in a
establishnent-inspeclion reports noted
complex set of activities such as the
in the summarj'were nolprovided to the manufacture, shipment, and use of
record. It appears hat this document
animal drugs involving many economic
should have been stricken from
Wits in different parts of the country, it
evidence and I reverse the
is not feasible to terminate operations
Administrative Law Judge's decision not with a widely used drug immediately.
to strike this document. Ibave
Moreover, although for several years
disregarded the document in reaching
there have been clearsignals that the
my decision.
continued'approval of DES was in
Exhibit C-192. This exhibit is the
-jeopardy (particularly, the
interim report of the Chicago study
Administrative LawJudge's decision in
discussed above. The manufacturing
September4 1978). nevertheless there are
parties' basic objection to this document legitimate reliance interests on the part
is that it was submitted after the hearing of animal producers who. during the
was, in effect, completed and that the
period while DES wag approved, have
manufacturing parties were not
administered it to animals that they will
provided a chance to present testimony
be bringing to slaughter in coming
analyzing the document. The Bureaus
months. Those reliance interests deserve
were not. however, given an opportunity some equitable consideration.
to present testimony analyzing this
I have concluded, therefore, that rhis
document either. The manufacturing
decision will become effective in 14
parties treat this document as if it were
days (on July -13,1979) with respect to
testimony as to which rebuttal evidence
the manufacture of DES animal drugs
would be proper. The document,
and the shipment of DES animal drigs
however, constitutes only data from
by anyone (including manufacturers,
which all parties can draw whatever
wholesalers, jobbers, and other
conclusions appear to be appropriate.
Since this document was not available middlemen or persons acting as
middlemen). That effective date is
prior to the hearing itself, its admission
intended to allow a fair and reasonable
after it became availablawas proper.
period (but no more than a fair and
Because I have based no conclusions on
reasonable period) to bring the
this document-see, e.g., discussion of
production and shipment of these
human carcinogenicity data insecion
products to an end. Petitions for stay of
1I(D)}(2(b)-the manufacturing parties
this effective dale may be submitted
are noL in any case, prejudiced by its
pursuant to 21 CFR 12.139,10.35: and
admission. ,
(B)Bureaus'Excepthns

The .ureaus exceptonlyto the
exclusion from'evidence of certain
statements thatlheyxegard as the
opinions of experts on ultimate issues.
Although I have not relied on any such
statements, Iregard the exclusion of
expert testimony on the ground that it
involves an opinion on the ultimate
issue as inappropriate. The common law
rile against such testimony was
designed to protect fact-finding juries.
Certainly here neither the
Administrative Law Judge nor Iam
likely to be unduly swayed by any
expert's opinion on an ultimate-issue.
The common law rule hs,in any-case,
been changed for federal courts. Rule
704, Fed. R. Evid.
VII. Effective Date
The risk associated with continued
use of the DES animal drags is. though
unquantifiable. signifinanL For lhat .

arguments contained it such petitions
will be considered expeditiously.
Submission of such petitions will not,
however, automatically stay this
effective date.
I am also delaying the effective date
of this action 21 days (until July 20,1970)
with respect to the administration of
DES animal drugs to animals (in any
form whether as an additive to feed or
as an implant) and the manufacture,
shipment, and use of feed containing
DES. This effective date is intended to
allow a fair and reasonable period (but
not more than a fair and reasonable
period) to bring these.activities to an
end. A somewhat longer period is
allowed for bringing these activities to
an end than is being allowed to
terminate the manufacture and shipment
of DES drugs. The reason for this
difference is that the activities relating
to the use of DES in feed or in animals
involve many more economic units,
some of which are small and may not

Federal Register

I

learn of this decision immediately. I .
have set this second effective date in the
expectation that a petition or petitions
for stay of this action will be received
by the FDA prior to the end of the 21
day period. See 21 CFR 12.139; 10.35.
Receipt of such petitions will
automatically stay the effect of this
decision with respect to the activities
and persons covered by this paragraph
for another period of 14 days (August 3,
1979). If petitions are received within 21
days, either they will be ruled upon
before the end of the additional 14 day
period or that period will be extended
pending a ruling on the request for stay.
I recognize that 21 days is a relatively
short time within which to prepare the
necessary papers. I also believe,
however, that it is sufficient time; and I
am concerned about the risk to the
public from any continued use of DES
animal drugs.
This Decision will not be effective
with respect to edible products of
animals treated with DES animal drugs
when the treatment of the animals was
before the effective date for use of the
drug. Any added treatment of such
animals with DES after the effective
date (including the continuation of
feeding with DES-treated feed begun
before the effective date) will, however,
make the meat from the treated unimals
adulterated within the meaning of the
Federal Food, Drug, and Cosmetic Act;
see discussion below. Implants inserted
before the effective date will not be
effected by this Decision even if they
continue to operate after the effective
date; no new or additional implants may
be inserted, however, after the effective
date.
I will first describe the legal
consequences that will flow from my
decision to withdraw approval of these
NADA's on the dates that this decision
becomes effective. I will then discuss
the options that may be available to the
agency if it finds that any further stay is
appropriate. Finally, I will outline the
data that must be submitted to support
any petition for a further stay of this
action.
The animal drugs themselves will,
upon withdrawal of approval of the
NADA's that cover them, be deemed,
pursuant to 21 U.S.C. 360b(a), to be
"unsafe" within the meaning of 21 U.S.C.
351(a)(5). Thus, pursuant to the latter
section, these drugs will be
"adulterated".
The withdrawal of approval of the
NADA's will also mean that, pursuant to
21 U.S.C. 360b(a), DES will be deemed
unsafe within the meaning of 21 U.S.C.
342(a](2)(D). Pursuant to the latter
section, any food containing DES will be
deemed adulterated. Thus, animal feed

Vol. 44, No. 185 / Friday, September 21, 1979 / Notices
containing DES and the edible products
of animals treated with DES will be
adulterated food within the meaning of
the Federal Food. Drug, and Cosmetic
Act.
The following acts with respect to
adulterated drugs and adulterated foods
(and thus with respect to DES, animal
feed containing DES, and edible
products of animals that have been
treated with DES) are violations of
federal law:

1. The act of. or causing the act oL the
introduction or delivery for Introduction Into
interstate commerce of such drugs or foods.
21. U.S.C. 331(a).
2. The act of, or causing the act of, receipt
in interstate commerce of such drugs or foods
or the delivery or proffered delivery of such
drugs or foods, 21 U.S.C. 331(c).
3. The act of. or causing the act of,
manufacture of such drugs or foods within
the District of Columbia or any other federal
territory, 21 U.S.C. 331(g).
4. The manufacture or doing of any other
act with respect to a product if that act is
done while the product is held for sale after
shipment in interstate commerce and results
in the adulteration of the product. 21 U.S.C.
331(k).
I interpret the latter provision as
prohibiting the manufacture of DES, the
mixing of DES with feed. and the
treating of animals intended for food

with DES when either the DES, its
components, the feed, or the animals
involved have crossed a state line.
If the FDA finds that a further stay of
the effective date of this action is
appropriate, several options suggest
themselves. The decision might be
stayed until judicial review of it has
been completed. I do not regard that
possibility as likely. The risk of use of
DES is significant, and I believe that my
decision is correct and will be upheld.
The agency could allow all existing
stocks of DES to be used up.
Alternatively, the agency could allow all
existing stocks held by cattle producers
and feed lots to be used up, but refuse to
stay this decision as to stocks of DES
that are now held by manufacturers or
middlemen. Another alternative would
be to stay the decision with respect to
feed with which DES has already been
mixed, but to deny a stay as to unused
DES implants and DES drugs not yet
mixed with feed.
I do not believe that I can make a
decision adopting any of the alternatives

listed without knowledge of how much
DES is not available on the market, in
what forms, and in whose hands that
DES is. Cf. EnvironmentalDefense
Fund,Inc. v. EnvironmentalProtection
Agency, 510 F.2d 1292,1306 (D.C. Cir.
1975).
Petitions for stay of the effective date
of my decision should be submitted in

54899

the format prescribed by 21 CFR 10.35.
They should identify the type of stay
requested. The agency has no intention
of allowing existing stocks of DES to be
used up if it is apparent that
manufacturers, cattle producers, or
others have been stockpiling unusually
large quantities of DES against just such
a decision. The following information
should be submitted in support of any,
petition:
1.The amount of existing stocks of DES
held by manufacturing parties;
2. The amount of existing stocks of DES
held by cattle producers and feed lots;
3. The amount of existing stocks of DES
held by middlemen, carrers, and other

persons.

4. The time that it is estimated would be

required to use up any presently existing

stocks of DES (a) held by manufacturing
parties, and (b] held by others.
5. A comparison of the amount of DES
produced from January 1 through June 30,
1979., with the amount produced during the
comparable period in 1976,1977 and 1978.
6. A statement of the amount of DES
produced between June 29,1974. and July 13,
1979 (the effective date of this decision with
respect to manufacture ofDES animal drugs).
7. An explanation of the petitioner's
reasons for believing that a stay would cause
economic disruption in the cattle producing
industries, accompanied by factual data
supporting that explanation.
8. An explanation of the legal basis upon
which the petitioner relies in requesting the
type of stay requested.
9. Any other reason that the petitioner
believes justifies a total or partial stay of this
decision.

The petition for stay should be
accompanied by sworn statements by
the responsible individuals within the
firms in question (manufacturing parties,
middlemen, and the larger cattle
producers and feed lots) as to the
existing stocks of DES. The agency will
entertain requests that information
regarded as trade secret be kept
confidential. See 21 CFR 10.20(i)
514.11(g)(2). The FDA will discount
statements that are not sworn. Due to its
concern about the possibility of
stockpiling, I am announcing now that
the FDA will presume that the failure to
submit information about the existence
of stocks in any major component of the
stream of commerce for DES means that
large stocks are held by that component.
I should note with respect to the
question of the effective date that I
reject the argument that, because it has
taken the FDA several years to issue a
final decision with respect to the DES
animal drugs, that decision can be
delayed yet a longer time. The delay in
the issuance of this decision reflects the
importance of the decision and the fact
that administrative hearings on
complicated issues simply take a long