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

Filing 33

DECLARATION of Jennifer A. Sorenson in Support re: 19 MOTION for Summary Judgment.. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (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, # 17 Exhibit Q, # 18 Exhibit R, # 19 Exhibit S, # 20 Exhibit T, # 21 Exhibit U, # 22 Exhibit V, # 23 Exhibit W, # 24 Exhibit X, # 25 Exhibit Y, # 26 Exhibit Z, # 27 Exhibit AA, # 28 Exhibit BB, # 29 Exhibit CC, # 30 Exhibit DD)(Sorenson, Jennifer)

EXHIBIT D
TO DECLARATION OF
JENNIFER A. SORENSON
Antibiotic and Sulfonamide Drugs in the Feed of Animals,
38 Fed. Reg. 9811 (1973)

90_1

RULES AND REGULATIONS
force was nearly equally divided on
several major points. Ia spite of the
various opinions expressed within the
task force on various points of considorders issuing such certifcates represent the eration, its members umanlmously agreed
tat
area rate levels for the areas involved
ta the report All members concurred
son shall promulsuch time- as the Com
that reliable and appropriate research is
just and. reasonable rates in
gate applicable
needed to provide data pertinent to the
sald areaconclusions of the task force. The minor(E) Fffective upon the issuance of this ity reports have been evaluated In proper
order, paragraphs (c) and (d) of § 2-,
perspective and it is concluded that they
part 2-General Policy and Interpreta- do not provide an adequate basis on
the Code of which to alter the findings of the ta
tions, chapter I of title 13 of
Federal Regulations are amended to force.
strike therefrout all references to the
2. It was stated that many of the
Rocky Mountain area or anypart thereof, antibacterial drugs have been in wideand tables Z and 3 are hereby modL- spread use of approximately 20 years and
zowemer. in billions.of animals as well as in countfled. accordingly. ProVW4de,
That nothing in this amendment of less studies serving to document their
§2.56 (c) and (d) shall operate to safety and effectivene:s. Present data and
amend § 154.93 of the, Commisson's experience with. antibacterial drugs in
Regulations under the Natural Gas Act. animal feeds fall to satisfy the specific
(F) The amendments provided for questions raised by the task force reherein shall be effective as of the date of lating to the health of man and other
issuance of this order.
, (G) The proceedings In docket Nos. animals. In addition to the task force's
findings, the void of information has
R-389 and R-389A shall remain open for previously been elucidated by the Nasuch other orders as the Commssionmay tional Academy of Sciences-National Ref Ind appropriate.
search Council. Committee on Veterinary
(E The Secretary of the Comission Drug Emcacy and more recently by the
shal causeprompt publication of this low-level antibacterial drug review
order to be made in the FEDERAL completed by the Bureau of Veterinary
REGISTE.
Medicine. Whenever significant questions
are rdised about a potential or theoretical
By the Commission.
hazard, sound scientific data must be
provided to resolve the Issues.
. KEn=ETH F. PLuMB,
[SEAL]
3. Restricting the therapeutic uses of
Secretar.
the antibacterial drugs in feeds to a
[FR Doc.73-7625 Eiled r-19-73;8:45 am]
prescription basis was questioned regarding its practicality and feasibility. The
Title 21--Food and Drugs
task force recommended and the Food
proposed that
CHAPTER I-FOOD AND DRUG ADMINIS- and Drug Administration
TRATION, DEPARTMENT OF HEALTH, an antibacterial drug in animal feeds be
restricted to prescription status only if
EDUCATION, AND WELFARE
the drug fails to satisfy the criteria dealSUBCHAPTER C-DRUGS
ing with human and animal safety and
PART 135-NEW ANIMAL DRUGS
drug efficacy. Conversely an antibacterial
and
Subpart B--Statements of Policy and drug which is confirmed to be cafe subInterpretation Regarding Animal Drugs effective for its intended purpose at
therapeutic levels will not become suband Medicated Feeds
ject to the prescription requirement.
A2-=iorcO ma SUimoxsA m DRUGS n Acknowledging that very potent drugs
T- u Ftsn or A1mnAs
are involved, when data indicate hazards
Some 380 responses were received to at low and internediate use levels, then
the proper course of action appears to be
the proposal published in the FmRAL
-REGISTER of February 1, 1972 (37,F& more stringent regulation of the prod24), regarding the use of antibiotic ucts' use. Assuming that a drug is useful
and sulfonamide drugs in animal feeds. for specific clncal disease(s), it Is apViews were received from individuals, propriate to reserve the drug for highlivestock and poultry producers, pro- level, short-term use following specific
'ducer associations, State, Federal, and diagnosis of a disease. Restricting the
university personnel, and drug and feed drug to use under prescription requiremanufacturers. Of those responses ex- ments would insure the continued anvailpressing support for the proposed re- ability of a useful product while at the
striction, five- offered grounds for the same time limiting the improper use of
position taken, and of those opppsed. 7 a product which has exhibited a safety
offered grounds; many views expressed hazard or has failed to show efficacy at
were related to an interpretation of the subtherapeutic levels.
4. It was stated that administration
data reviewed by the task force on the
use of antibiotics in animal feeds. A re- of drugs to large numbers of individual
view of the comments submitted re- animals by injection or oral dosage form
flected certain issues. These issues of' Is not practical and would result in an
concern, along with the responses of the increase in the cost of production- AcCommissioner of Food and Drugs to cordingly, consumer costs could be expected to increase for a smaller supply
them, are as follows:
1. It was stated that there existed con- of lower quality meat, milk and egg.
siderable difference of opinion within the Implementation of the report of the task
task force membership and that the task force would not necessarily preclude the

sales made under contracts dcated after Octo-

ber 1, 1968, are set forth In table No. 1A and;
subject to the additional requirements, restrictions, and authoriztions provided in the

use of antibacterial drugs In animal feed.
It is expected that effective products
would continue to be avaltable and the
drug industry Is actively develping effective and safe new antibacterial drugs.
The economic Impact, If any, is difficult
to quantitate. It appears that the impTementation of the report would have a
favorable long-term. ecolomic.effect.
5. It was stated by several persons that
the proposed time limits should be altered. These Included Individuals requesting that restrictlon be immediately
placed into effect, and those who stated
that no time limits should be Included.
The Commissioner has concluded that
there is slfficient proof of the safety and
effectiveness of the drugs Involved to
justify continued approval conditioned
upon the Immediate undertakingof acdl-

tional tests to confirm safety and effec-

tiveness. This procedureis comparable to
that set out In §§ 130.47 and 121.400 (21
CFR 130.47 and 121.4000). Unless testing
is undertaken, however, there is no acceptable basis for continued marketing.
a. ?Many comments were addressed to
the question of the Immediacy and
seriousness of the human and animal

health hazards. These comments ranged

from personal opinions to lengthy Interpretations of some of the published liter-

ature pertaining to potential health
hazards. That the task force completely.

thoroughly, and objectively reviewed
these subjects is evidenced by the documentation reviewed by the task force.
In addition, the task force Included recognized experts on transferable drug resistance. No additional evidence or data
were submItted which would Justify a
conclusion other than that arrived at
by the task force regarding the question
of health hazard.
7. One comment stated that It would
appear to be iogical to restrict; the subtherapeutic use of antibiotics in animal
feeds and to continue to allow the reservolr of resistant bacteria, and bacteria
which can transfer the resistance factor,
to be maintained by therapeutic we of
those same antibiotics in animals. It was
stated that if there Is a public health
hazrd from administration of lowlevels,
then the same hazard would exist from
administration of therapeutic Ievels
Antibacterial drugs used for therapeutic
treatment of clinical disease produce a
selection pressure which is high, of short
duration, and has a igh degree of unfversal bacterial susceptibility. The converse Is true of subtherpeutic levels.
The logical conclusion foIIows that the
greatest potential hazard existas with the
lon,-term use of an antibacterial dru at;
subtherapaut!c levels.
8. There was comment that a quantitative guarantee for all low-level antibiotlcs should not be required in the
ebsence of analytical methods of adequate sensitivity to guarantee their presence in the indicated amounts in feed.
Further, It was commented that the
variability of analytical results are a
potential source of serious Problems for
industry nnd regulatory officias. The
Commissioner reco=niz-- that the current application of available analytical

FEDERAL REGISTER, VOL 38, NO. 76-F-RIDAY, APRIL 20, 1973

No. 76.-Pt. I-4

HeinOnline -- 38 Fed. Reg. 9811 1973

9812

RULES AND REGULATIONS

procedures to animal feeds containing
low levels of antibiotics does not provide
a desirable level of precision. However, it
is well known that thfIs level of antibacterial drug is capable of selecting for
transferable drug resistance determinants. The user should know the level of
drug present in the feed that he purchases. The FDA concurs with this conclusion of the task force. In addition, it
is recommended that improved analytical procedures be developed. Since this
requirement will not be placed into effect
until full implementation of the task
force report, adequate time will be available for the development of improved
methodology.
9. At least one food animal producer
offered his own personal experience using
subtherapeutic levels of antibacterial
drugs In feed. He stated that his animals
experienced a number of health problems when rations containing no antibacterial drugs were given. The purpose
of the proposed studies is to evaluate the
hazard as related to human and animal
health as well as the effectiveness of
antibacterial drugs for their intended
use when considering benefit versus risk.
Therefore, effectiveness for the intended
purpose will be a major criterion for the
continued use of any antibacterial drug
intended for-use in animal feeds.
The deliberations and actions of the
FDA concerning the use of antibacterial
drugs in animal feeds are only a part,
and perhaps a small part, of the total
picture of antibacterial use as it relates
to public health. It is logical to assume
that the direct use of antibacterial drugs
in man has the potential-for exerting
considerably more impact on the health
of man than the impact of antibacterial
drug use in food animals. There has been
a dramatic increase in the total use of
antibacterial drugs in recent years. In
1960, the annual production of antibiotics in the United States was 4.16 million pounds of which 2.96 million pounds
was used for, therapeutic purposes in
human and veterinary medicine and 1.20
million pounds in animal-feed additives.
Production had doubled by 1965. By 1970,
the human and veterinary medical pharmaceutical use was 9.6 million pounds,
a threefold increase over 1960, and the
feed additive usage was 7.3 million
pounds, a sixfold increase over 1960.
Since the continued effectiveness of
antibacterial drugs depends in large
measure on the extent to which they are
reserved for appropriate use on susceptible organisms, and since the indiscriminate or inappropriate use of antibacterials is detrimental to the public health,
It is in the national interest to determine
with precision how antibiotics are being
employed and what steps should be taken
by the FDA and medical professions to
promote the informed and most appropriate use of these agents. The FDA is
presently increasing activities in the assessment of the use of these drugs Inman and at the same time the IbA will
continue to address the questions before
It concerning use of antibacterial drugs
in animal feeds.

The task force on the use of antibiotics in aiimal feeds concluded that
the long-term use of subtherapeuto
amounts of antibiotics in animal feeds
may give rise to a potential (although
not fully documented) human and animal health hazard. The task force
pointed out, however, and other recognized experts who have been consulted
generally agree, that a significant increase in the reservoir of salmonella
organisms in food animals constitutes
an increased risk to human health. A
feed-use drug used on a continuing basis
which significantly increases the numbers of salmonella organisma in the animal would logically affect the numbers
of salmonella organisms on the animalderived food products. Therefore, the
Commissioner concludes that a significant increase in the salmonella organisms in animals would constitute an
increased hazard to human health.
There is less agreement on the hazard
to human health presented by other animal-source bacteria (e.g., coliforms). It
is generally agreed that there are great
difficulties involved in documenting the
absence of risk or absolute safety from
the potential hazard posed by the colonization and possible R-factor transfer in
the human gastointestinal tract. An
effort to assess this potential hazard will
require many large-scale studies which
will address this hazard as a concept. The
possibility of proving the absolute lack
of hazard under actual conditions of use
is questionable. The probability of the
use of an antibacterial drug in animal
feed enhancing the pathogenicity of bacteria by linkage of toxin production to
R-factor also will be difficult to determine. Nevertheless, the task force has
raised these questions and the Commissioner concludes that these theoretical
hazards exist, and require further study
if nontherapeutic use of these drugs in
feed is to be continued.
The commercial animal and poultry
production practices used in this country
today, including the use of medication in
feed administered to the entire herd or
flock, have riade it possible to effectively
concentrate large numbers of animals into small areas without serious losses in
production efficiency. From such concentration and intensified production, benefits accrue in terms of efficient land usage,
labor savings, and more efficient conversion of animal feed to animal protein,
thereby making a major contribution to
the abundance of food from animals. The
Commissioner acknowledges the benefit
from such drugs, when properly used,
for increased rate of gain, improved feed
efficiency, and animal disease control.
Immediate and total withdrawal of these
drugs from animal feeds could seriously
disrupt the quality and quantity of an
important portion of our total human
diet.
Becduse of the geographical proximity
of the United States and Canada and the
international commerce in animal drugs,
animal feed, and food between the two
countries, It is essential that policies and

requirements on products such as these
be uniform. An agreement has been
reached which will allow for similar actions, based on similar timetables to be
Initiated by the Food and Drug Administration and the agency's counterpart in
Canada, the Health Protection Branch.
The two nations have also agreed to form
a joint United States-Canada committee
to review major questions which may
arise in the course of evaluating study
proposals submitted by drug sponsors.
The Commissioner has reviewed the information and conclusions In the report
of the task force, the comments. submitted in response to the proposal, the
deliberations of a committee subsequently
appointed by the National Academy of
Sciences-National Research Council under the chairmanship of Maxwell Finland, M.D., to consider the same matter,
conferences with Canadian Health officlals, and other data and information
available to him, in determining whether
new evidence or tests, evaluated together
with the evidence available when the new
animal drug applications for these drugs
were approved, shows that any or all of
them are not shown to be safe for use
under the conditions of use upon the
basis of which the applications were approved, and thus should be withdrawn
from use pursuant to section 512(e) (1)
(B) of the act. The concept of "safety" as
used in the act does not require complete certainty of the absolute harmlessness of a drug, but rather the reasonable
certainty in the minds of competent
scientists that It Is not harmful, when
balanced against the benefits to be obtained from the drug. Using these criteria, the Commissioner concludes, upon
the basis of all of the evidence currently
available, that these drugs have been
shown to be safe tnder the conditions of
use, within the meaning of that term as
used In section 512 of the act, and thus
that there is presently no basis for withdrawing any of these drugs solely on
safety grounds under section 512(e) of
the act.
The Commissioner recognizes that the
task force report recommended withdrawal of the drugs by certain specifio
target dates. Those target dates arg not
adopted in the final regulation for two
reasons. First, establishment of the testing requirements to be imposed with
respect to these drugs has been far more
complex than the task force realized, and
therefore has taken far longer than Initially contemplated. Second, in the absence of a finding of a lack of proof of
safety, or failure to submit required reports, there is no legal basis for a decision
arbitrarily to withdraw these drugs from
the market. If the task force had found
a lack of proof of safety of these drugs,
withdrawal of approval would have been
required immediately rather than permitting continued manufacture, absent
a finding of a compelling medical justification for these products.
The Commissioner recognizes that
difficult questions exist with respect to
the benefit-risk analysis necessary in
determining whether the safety evidence

FEDERAL REGISTER, VOL 38, NO. 76-FRIDAY, APRIL 20, 1973

HeinOnline -- 38 Fed. Reg. 9812 1973

RULES AND REGULATIONS
is sufficient to approve or insufficient to
justify continued approval of the safety
of any drug. Questions about potential
and theoretical hazard, of the nature
raised with respect to the use of antibacterials in animal feed for growth pro-

motion purposes, continually arise and

obviously deserve serious consideration.
Where these questions indicate a serious
health hazard, withdrawal should immediately be ordered. Where, as here,
only a potential or theoretical hazard Is
raised, which does not show that the
drug is nQt shown to be safe, it is the
opinion of the Commissioner that the
proper way to proceed is to require the
submission of appropriate records and
reports pursuant to section 512(1) of the
determination
act, to facilitate a
whether thereis a ground for withdrawing approval of the drug in question
under section 512(e) of the act. Failure
to submit such required records and reports is itself a violation of the act, justifying withdrawal of approval of the drug
for the manufacturer or distributor
involved.
It would be chaotic, and is clearly not
feasible, to withdraw approval of allfood
or drug substances merely because new
questions have arisen, new testing is, considered scientifically appropriate, or new
studies raise issues that require further
exploration. That is the situation involved here. The Commissioner has
therefore concluded that, while there is
insufficient evidence or questions to justify a finding that these drugs -have not
been shown to be safe, there is sufficient
question to invoke the authority under
section 512(1) fully to investigate these
issues in order to obtain more definitive
data to resolve them. The Commissioner
has chosen the following course of
action.
1. The antibacterial drugs commonly
used in animal feed and which are recognized to cause transferable drug resistance and are commonly used to treat
human and animal diseases include the
streptomycin, dihydrotetracyclines,
streptomycin, the sulfonamides, and
penicillin The use of these drugs in
feeds may also affect the reservoir of salmonella organisms in food animals. An
assessment of the effect of subtherapeutic levels of these drugs in feed on the
salmonella reservoir can be completed
in a relatively short time. Therefore,
continued marketing of products containing any of these named drugs will be
dependent on completion of salmonella
reservoir studies by no later than 1 year
following the effective date of this order.
A determination that the drug promotes
a significant increase in the salmonella
reservoir will be considered sufficient
grounds for proceeding to withdrawal
approval of that drug.
2. The approval for the use of antibiotic. and sulfonamide drugs in animal
feeds at subtherapeutic levels will be
withdrawn, unless by no later than 2
years following the Ulate of this order
there has been submitted conclusive evidence demonstrating that no human or
animal health hazard exists which can
be attributed to such use. Depending on

9513

the scientific knowledge available at that fecivenec under specific criteria establied by the Food and DrugAdministratime concerning (1) the colonization and
the guidelines included in
R.factor transfer from animel to man, tion based onthe FDA task force on the
and (2) increased pathogenicity due to the reportpf
toxin-linkage with R-factor, the Com- use of antibiotics in animal feed. All
missioner may require further Investiga- persons or firms previously marketing
tions of these or any other pertinent Identical, related, or similar products not
questions as a condition of continued ap- the subject of an approved new animal
aniproval of such use notwithstanding a drug application must submit a new1973,
finding that no apparent human health mni drug application by July 19, the
if marketing is to continue during
hazard exists.
Interim. New animal drug entities vith
3. By no later than 2 years following antibacterial activity not previously
the effective date of this order, all drug marketed, now pending approval or subefficacy data shall be submitted for any mitted for approval prior to, on, or folfeed-use combination product containing lowing the effective date of this publicaan antibiotic or sulfonanmide drug and tion, shall satisfy such criteria prior to
any feed-use single ingredient antibiotic approvml.
or sulfonamide product not reviewed by
(b) Any person interested In develop-'
the National Academy of Sclences-Na- ing data which will support retaining
tional Research Council drug efficacy approval for such uses of such antibstudy covering drugs marketed between otio and sulfonamide drugs pursuant to
1938 and 1962.
section 512(1) of the Federal Food, Drug;
Criteria for demonstrating safety and and Comnetic Act shall submit to the
efficacy of a'product under this approach Commissioner the following:
have been developed by the FDA for use
(1) By July 19, 1973, records and reby firms wishing to undertake studies, ports of completed, ongoing, or planned
and-are available upon request.
studies, including protocols, on the tetraThis course of action and the criteria cyclines, streptomycin, d-ydrostreptareferred to have been reviewed in Joint mycin, penicillin, and the suffonamides
consultation between the agency and and for all other antibiotic and sulfonaofficers of the Canadian Health Protec- mide drus, by October 17, 1973- The
tion Branch In order to facilitate the Food and Drug Administration encourdevelopment of a policy generally appll- ages sponsors to consult with the Bureau.
cable to both countries.
of Veterinary Medicine on protocol deThe Commissioner recognizes the dif- sign and plans for future studies.
(2) By April 20, 1974, data fron comficulty of establishing conclusively within
2 years that no human health hazard pleted studies on the tetracyclines,
exists from subtherapeutic use In animal streptomycin. dhydrostreptomycin, the
feeds- of antibacterial drugs. Balanced sulfonamides and penicillin assessing the
against this difficulty Is the fact that effect of the subtherapeutic use of the
every expert committee that has re- drug In feed on the salmonella reservoir
viewed this issue has concluded In gen- In the target animal as compared tathat;
eral terms that a potential or theoretical in nonmedlcated controls. Failure to
human health hazard exists. The Com- complete the salmbnela studies for any
missioner therefore concludes that the of these drugs by that time will be
2-year time period is reasonable under grounds for proceeding to immediately
the circumstances The Commissioner withdraw approval
(3) By April 20, 19-75, data satisfyng
further concludes that continued marketing after 2 years is contingent upon all other specified criteria for safety and
a favorable benefit-risk status following effectiveness, including the effect on the
a thorough evaluation of all the data salmonella reservolr, for any antibiotic
subsubmitted to date on the particular or sulfonamide drugs approved for Drug
therapeutic use in animal feed-&
product.
for any
Therefore, pursuant to provisions of efficacy data shall be submitted containcombination product
the Federal Food, Drug, and Cosmetic feed-usa drug and any feed-use single
Act (sees. 512, 701(a), 52 Stat. 1055, 83 Ing such antibiotic or sulfonamide not
Stat. 343-351; 21 U.S.C. 360b, 371(a)) ingredientby the National Academy of
and under authority delegated to the reviewed
Council drug
Commissioner (21 CFR 2.120), part 135 Sciences-National Research
covering drugs marketed
is amended by adding thereto the fol- eficacy study and 19862.
between 1938
lowing new section:
(4) Progress reports on studies under§ 135.109 Antibiotic and sulfonamido way every January 1 and July 1 until
completion.
drugs in the feed of animals.
(c) Failure on the part of any sponsor
(a) The Commissioner of Food and
Drugs will propose to revoke currently to comply with any of the provisions of
approved subtherapeutlo (increased rate paragraph (b) of this section for any of
of gain, disease prevention, etc.) uses In the antibacterial drugs included in subanimal feed of antibiotic and sulfona- praaphs (b) (1) of this section, or inmide drugs whether granted by approval terim results indicating a health hazard,
of new animal drug applications, master will be considered as grounds for imfiles and/or antibiotic or food additive mediately proceeding to withdraw apregulations, by no later than 2 years folof that drug for use In. animal
lowing the effective date of this order, proval
feeds under section 512(1) of the
unless data are submitted which resolve
conclusively the issues concerning their act In the case of fallure to, submit
safety to man and animal and their ef- required records and reports and under

FEDERAL REGISTER, VOL 38, NO. 76--FRIDAY, APR1 20, 1973

HeinOnline -- 38 Fed. Reg. 9813 1973

9814

RULES AND REGULATIONS

section 512(e) where new information narcotic controlled substance, the prepa- Abuse Prevention
and Control Act of
shows that such drug is not shown to be ration or mixture is
formulated in such 1970 (21 U.S.C. 821 and 871(b)) and
safe.
a manner that it incorporates methods delegated to the Director of the Bureau
(d) Criteria based upon the guidelines of denaturing or other
means so that of Narcotics and Dangerous Drugs by
laid down by the task force may be ob- the preparation or mixture is not
liable § 0.100 of title 28 of the Code of Fcdoral
tained from the Food and Drug Adminis- to be abused, and
so that the narcotic Regulations, the
tration, Bureau of Veterinary Medicine, substance cannot in
Director hereby orders
5600 Fishers Lane, Rockville, Md. 20852. moved. The Director practice be re- that part 308 of title 21 of the Code of
further finds that
(e) Reports as specified in this section exemption of the following
chemical Federal Regulations be amended a4
shall be submitted to: Food and Drug preparations and mixtures
is consistent follows:
Administration, Bureau of Veterinary with the public
health and safety as well
a. By amending § 308.24(t) by adding
Medicine, Office of the Assistant to the as the needs of researchers,
chemical the following chemical preparations:
Director for Antibiotics in Animal Feeds, analysis, and suppliers
of these products.
5600 Fishers Lane, Rockville, Md. 20852.
§ 308.24 Exempt chemical preparations,
Therefore, under the
(f) Following the completion of the in the Attorney Generalauthority vested
by sections 301
requirements of paragraphs (a) and (b) and 501(b) of the Comprehensive
(i) * * *
Drug
of this section and the studies provided
for therein:
Manufacturer or supplier
Product name and supplier's catalog
Form of product
(1) Those antibiotic and sulfonamide
Dato of
No.
application
drugs which fail to meet the prescribed
criteria for subtherapeutic ,uses but
which are found to be effective 'for thera- American
Hospital Supply Corp. Fibrin Monomer Control, Catalog Bottle: 1.5 ml ........ 10, 1473
Fob.
peutic purposes will be permitted in feed
(Dade Dlvision).
Nos. B4233-30and B4233-38.

only for high-level, short-term therapeu-

tic use and only by or on the order of a
licensed veterinarian.
(2) Animal feeds containing antibacterial drugs permitted to remain in use
for subtherapeutic purposes shall be labeled to include a statement of the quantity of such drugs.

Effective date.-This order shall be ef-

fective on April 20, 1973.
(Secs. 512, 701(a), 52 Stat. 1055, 82 Stat.'343-

Do -----------------------------I-X (Normal Range),
Moni-Trol
Catalog Nos.
B5
1-------------------------_-Vial: 5ml ...............13, 1073
Mar.
B516-5 .............................
Vial: 10 ml.
Do-----B-106-3
---------------------Bottle: 20 mI.
.............................-- (Abnormal Range),
oul-IIrol
H-X
Catalog Nos.
-................
-510-2
Vial: 5 ml ...............
Do,
B5106-6 ----------------------------Vial: 10 ml.
B 10&4
No.........................
. Bottle: 2Z ml.
Do-----........... . Thyroxine Buffer No.BBW3-2 -------55
Ian, 22,
Do------------------ - Thyroxine Buffer No. B030-6 ------ Dottle: 24 ml............Do. 1073
Bottle:
ml ...........

Analytical Chemists, Inc ----

SodiumBarbital Buffer, Catalog Nos. Vial: 20.0fg-----------..Aug. 14, 1072
1-6100 and 1-5200.
Agarose Universal Electrophoresis Plate: 5 ml ..............
Do.
Film, Catalog No. 1-1000.

Do ----------------------------

51; 21 U.S.C. 360b, 371 (a).)

Dated April 16,1973.
SnEaxvm GARDNER,
Acting Commissionerof
Food and Drugs.
[FR Doc.73-7555 Filed 4 -19-73;8:45 am]
CHAPTER 1I-BUREAU OF NARCOTICS
AND DANGEROUS DRUGS, DEPARTMENT OF JUSTICE
PART 308-SCHEDULES OF CONTROLLED
SUBSTANCES
Exempt Chemical Preparations
The Director of the Bureau of Narcotics and Dangerous Drugs has received
applications pursuant to § 308.23 of title
21 of the Code of Federal Regulations
requesting that several chemical preparations containing controlled substances
be granted the exemptions provided for
in § 308.24 of title 21 of the Code of Federal Regulations.
The Director hereby finds that each of
the following chemical preparations and
mixtures is intended for laboratory, industrial, education, or special research
purposes, 'is not intended for general
administration to a human being or
other animal, and either (a) contains
no narcotic controlled substance and is
packaged in such a form or concentration that the package quantity does not
present any significant potential for

abuse, or (b) contains either a narcotic
or nonnarcotic controlled substance and
one or more adulterating or denaturing
agents in such a manner, combination,
quantity, proportion, or concentration,
that the preparation or mixture does
not present any potential for abuse. If
the preparation or mixture contains a

Blo-Reagents &Diagnostics, Inc.... Prochox No. 700-225
------------- Vial: 25 ml .------ .Mar 0, I173
Do ---------------------------Prochex No.1, No. 701-025
.. ....
d
d-o--...
..
Do,
Do ---------------------------Prochex No. I (Alternate Formula)
do.......--- .
.'.....
Do,
No. 702-025.
Do ---------------------------Prochex No. 2,
No. 703-025 _do----------------Do.
Do
----------------- Prochx No.3, No. 701-025_------------do................
Do.
Do....--------------------Prochex No. 4, No. 70-025 ------------- do ...................
Do,
Do ---------------------------- Prohex No. 5, No. 700-025 -------------- do ..................
Do.
Do----------.---------------Prochex No. 0, No. 707-02 -------------- do ...................
Do.
Do ---------------------------Prochex No. 7, No. 708-025 -----------do...................
Do.
Do ---------------------------Prochox No. 8,No. 709-025 -----------do ..................Do.
Blo-Reagonts & Diagnostics, Inc-..
Prochex No. 9, No. 710-025 -------------- do ...................
Do,
Do---------------------------Prochex No. 10, No. 711-025
do-------------do ..................
Do.
Do---------------------------PrOchex No. 10 (Alternate Formula) -- do ................Do,
No. 712-025.
Do--------------------------Proex No. 11, No. 713-025 ------------- do ...................
Do,
Do--------------------------Prochax No. 12, No. 714-025 -------------- do------D.
Do,
Do ---------------------------Prochox No. 13, No. 715-025------------ do ...................
DO-,
Do ....
...------------------Prochex No. 14, No. 716-025 -----------do----------------..
.....
Do.
Do ---------------------------Prochex No. 15, No. 717-025 ------------ do...................
Do.
Do---------------------------Prohex No. 15, (Alternate Formula) -...do ..................
Do,
No. 718-M25.
Do -------------------------Prochex No. 16, 719-025 -------------- do...................
No.
Do.
Do ----Prochex No. 18, No. 721-025
---------------d ...................
Do,
Do ---------------------------Prochex No. 19, No. 722-025 ----------- d----.......
d
........... Do.
Do ---------------------------- Prochox No. 20, No. 723-025 ------------- do ...................
Do.
Brinlanann Instruments, Inc --Brinkmami Drug Sceen Standard A_ Vial: 1 MIl-----------.I'al.
Do --------------------------- Brnkmann Drug Sceen Standard B---- do............-.... 20,1973
::
'Do,
Do
--------------------- Bnkmann Drug Screen Standard C ---- do...................
Do,
Do---------------rlnnann Drug Screen Standard D .........................
do
Do.
E. R. Squibb & Sons, Inc

---Thyrostat-4 Kit, Catalog No. 00125 .............................
Fb, 10, lt3
To include:
(e Thyrostat-4 Standard Solution. Vial: 7 nl.
......
(b)Thyrostat-4 Buffer SolutionB._ottle: 00 ml ............

Instrumentation Laboratory, Inc.. Tris-Barbhtal Buffer No. 33205 - Vial: 12 dram-.---Feb. 21,1971
Do--.---- ---------------- Barbital Buffer (B-2) No. 33205 .... .do-.------------.............
Do.
Do ---------.------ -------DTA-Barbtal Buffer No. 33207..........
do...................
Do,
Do - . ----------------- Barbltal-Acetate Buffer No. 33208---------...................
..---do
Do,
Millipore Corp--------------.

Barbltal Buffer Solution No. XE21- Bottle: 120ml........... .an.
000-iZ

b: By amending § 308.24(1) by deleting

the following chemical preparation:
§ 308.24

(1)

)

* **

Fxempt chemical preparations.
*

*

FEDERAL REGISTER, VOL 38, NO. 76--FRIDAY, APRIL 20, 1973

HeinOnline -- 38 Fed. Reg. 9814 1973

S

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12,1473