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 C
TO DECLARATION OF
JENNIFER A. SORENSON
Antibiotic and Sulfonamide Drugs in Animal Feeds,
37 Fed. Reg. 2444 (1972)

2444

PROPOSED RULE MAKING

effect of suspension or terminatton of
contributions, effect of merger or termination of the plan, the provisions governIng administration of the plan, a description of the management and Investment
of plan funds, and other provisions relating to the rights or obligations of participants or beneficiaries.
It is proposed also, that administrators
of pension plans who have previously
filed a plan description will be required
to file a new plan description, or file an
amendment to the plan description previously filed, in order that the information referred to herein will be available to
participants and beneficiaries of such
plans.
Additionally, it is proposed to require
administrators of pension benefit plans
to notify participants that copies of the
description of the plan, and the latest
annual report required by section 7 of the
Act, are available for examination by any
participant or beneficiary at the principal office of the plan, and that a copy
of .the plan description and an adequate
summary of the latest annual report will
be mailed to a participant or beneficiary
on written request. Whenever such plan
Is amended it is also proposed that administrators must notify participants as
to the subject of the amendment(s),
that the amendment(s) will be available
in the principal office, and will be mailed
on written request.
Interested persons are invited to submit written data, views, or comments regarding the proposed rule to the Assistant
Secretary of Labor for Labor-MWanagement Relations, U.S. Department of
Labor, Washington, D.C. 20210, within 30
days of publication of this notice in the

hours during which such reports will bg
available for examination, and indicate
that a copy of the description of the plan
and an adequate summary of the annual
report will be delivered to a plan participant or beneficiary upon receipt of a
written request therefor by the administrator of the plan. Whenever such plan
is amended the plan administrator shall
cause participants to be notified in writing as to the subject of the amendment(s), and that a copy of the amendments(s) will be made available for examination at the principal office of the
plan, or upon written request delivered
to a participant or beneficiary.
3. Section 460.2 is amended by designating the existing section as paragraph
(a) and adding a paragraph (b) to read
as follows:
§460.2 Content of reports-signature
or certification.

(b) In addition the administrator of
each pension benefit plan shall, as part
of the Form D-1' and in accordance
with the instructions contained in the
form, file a comprehensive description of
the provisions of the plan relating to the
eligibility requirements to participate
under the plan; vesting provisions, including conditions under which vested
benefits may be divested; sources of contributions, amount, periods when due,
whether by check off or direct payment;
benefits provided under the plan and the
method by which they ate computed;
procedures to be followed in presenting
claims for benefits and for appealing
denial of claims; the effect of suspension
or termination of contributions; the efFEDERAL REGISTER.
fect of merger or termination of the plan;
Copies of the amendatory material to details as to the administration of the
the Form D-1 may be obtained by writ- plan; a description of the management
ing to the Office of Public Information, and investment of plan funds; and other
U.S. Department of Labor, Washington, provisions which relate to the rights
D.C. 20210. All written materials or sug- or *obligations of participants or benegestions submitted in response to this ficiaries under the plan. Such informsnotice of proposed rule making will be tion shall be written in a manner calavailable for public Inspection in Room culated to be understood by the average
401, American National Bank Building, participant or beneficiary. If plan book8701 Georgia Avenue, Silver Spring, MD, lets are distributed to participants or
during regular business hours.
booklets should inAccordingly, it is proposed herewith to beneficiaries such
elude the information provided for in
amend 29 CFR Part 460 as follows:
this paragraph.
1. The Authority for issuing Part 460
4. Section 460.5 is hereby amended by
s amended to read as follows:
changing the heading of the section and
ArTorom: The provisions of this Part 460 by adding a new paragraph (c) as
issued under sections 5, 6, 7, 8, 72 Stat. 999,
1000, 1002, 76 Stat. 36, 37; 29 U.S.C. 304, 305, follows:
300, 307; Secretary's Order 16-68 (33 P.R. § 460.5
Filing plan description amend15574).
ments.
2. A new § 460.1a is hereby added to
29 CFR Part 460 to read as follows:
(c) Administrators of pension plans
§ 460.1a Notification of availability of who have previously submitted a plan
plan descriptions and annual reports. description pursuant to § 460.2 but which
does not include a description of the plan
The administrator of any employee as provided for in paragraph (b) of
pension benefit plan subject to the Wel- § 460.2 shall submit a revised descripfare and Pension Plans Disclosure Act tion of the plan containing information
shall notify the participants of such plan provided for in paragraph (b) of § 460.2
In writing that pursuant to the provisions on revised Form D-1 incorporating all
of section 8 of the Act, participants or current information recluired therein, or
beneficiaries are entitled to examine shall submit an addendum to the Form
copies of the description of the plan and
the latest annual report at the principal D-1 originally filed, containing the inoffice of the plan. Such notice shall iden'Fled as part of the original document.
tify the location of such office, and the

formation required under partgrapli (b)
of § 460.2 and questions 13 and 14 of the
Form D-1 as revised. Such new description or such addendum shall be iubmited to the Office of Labor-Manaement and Welfare-Pension Report:, T,
Department of Labor, Washlngton, D.C.
20210, within 120 days after the effective
date of this paragraph.
Signed at Washington, D.C., this 27th
day of January 1972.
W. J. Usiny, Jr.,
Assistant Secretary o1 Labor
for Labor-ManagementRelation".
[FR Doe.72-1415 Filed l-31-72;8:40 a ml

DEPARTPEHT OF HEALTH,
EDUCATION, AND WELFARE
Food and Drug Administration
[21 CFR Part 135 1
ANTIBIOTIC AND SULFONAMIDE
DRUGS IN ANIMAL FEEDS
Proposed Statement of Policy
In April, 1970 the Commhssloner of
Food and Drugs established a Task Force
of scientists to undertake a comprehensive review of the use of antibiotic drugs;
in animal feeds. The scientists included
ten specialists on infectious diseases and
animal science from the Food and Drug
Administration (FDA), the National Institutes of Health, the U.S. Department
of Agriculture, and the Center for Disease Control and five representatives
from universities and industry.
The Task Force was eatblished on the
recommendation of the FDA Science Advisory Committee following ito reviev of
a report issued by the Government of
Great Britain on the use of ant-iblotics
in veterinary medicine and animal hitbandry. The British study, known as the
Swann Committee Report, recommended
that antibiotics should be divided -into
"feed" antibiotics and "therapeutic" antibiotics and that only those antibiotics
not used for treatment of diseases In man
should be allowed in animal feeds at the
so-called growth promotion level.
The Food and Drug Administration ho
been studying the effects of low-level
feeding of antibiotics to animals for a
number of years, has held symposia, and
has consulted with outside experts to review the nonmedical uses of antibloticm
in animal feeds. The results of thts;o
studies and other documentation formed
the background for the Task Force
deliberations.
The Task Force concluded that the
current conditions relating to its study
are:

1. The use of antibiotic and sulfonamide drugs, especially in growth promotant and subtherapeutlo amotmts,
favors the selection and development of
single and multiple antibiotic resistant
and R-factor bearing bacteria.

FEDERAL REGISTER, VOL. 37, NO. 21-TUESDAY, FEBRUARY 1, 1972

HeinOnline -- 37 Fed. Reg. 2444 1972

2445

PROPOSED RULE MAKING
2. Animals which have received
either subtherapeutic and /or therapeutic amounts of antibiotic and sulfonamide'drugs in feeds may serve as a reservoir of antibiotic resistant pathogens
and nonpathogens. These reservoirs of
pathogens can produce human infections.
3. The prevalence of multiresistant
R-factor bearing pathogenic and nonpathogenic bacteria in animals has increased and has been related to the use
of antibiotics and sulfonamide drugs.
4. Organisms resistant to antibacterial
agents have been found on meat and
meat products.
5. There has been an increase in the
prevalence of antibiotic and sulfonamide
resistant bacteria in man.
The Task Force identified three primary areas of concern, human health
hazard, animal health hazard, and antibiotic effectiveness. Guidelines for establishing criteria were developed which
must be considered with regard to the
addition of growth promotant or subtherapeutic levels of antibacterial agents
to animal feeds.
Based upon extensive documentation
the Task Force concluded that:
1. Human illnesses and death have
been reported due to both antibioticsensitive and antibiotic-resistant bacteria of animal origin. Food-producing
animals constitute a major reservoir of
certain bacteria (e.g., Salmonella) pathogenic for man. Evidence suggests that
the use of certain antibiotics in food-producing animals promotes an increase in
the animal reservoir of Salmonella
through promotion of cross-colonization
and infection, prolongation of the carrier state, and relapse of disease. Furthermore, the use of some antibiotics in animals produces a marked increase in the
prevalence of R-factor containing bacteria which may be transmissible to man's
enteric flora. These observations lead
to the logical conclusion, though not
fully documented, that such practices
give rise to a human health hazard.
2. The continuous feeding of certain
antibiotics to animals has-been reported
to compromise the treatment of certain
animal diseases. Additional information
is needed to quantitate the extent of this
problem- Epidemiological and controlled
challenge studies are needed to determine
the relationship of the use of antibiotics
in animal feeds and the subsequent
treatment of diseases in animals which
have been fed antibiotics, 3. The categorization of antibiotics
into those for human and those for animal use should be based on scientific
evaluations of the efficacy of each use
and the impact that the use will have
on all aspects of the public health. Such
categorization must not result in compromising the availability of effective
antimicrobials for humans or animals.
However, it is the consensus of the Task
Force that it would be highly desirable
that in the future, a group of antibacterial agents be reserved exclusively
for human use.
4. Limiting the types of antibiotics
permitted in animal feeds is a step toward controlling the numbers of microorganisms resistant to antibiotics. Re-

search is needed to investigate methods
for improving weight gain and feed efficiency with drug agents and animal
husbandry practices which do not cause
the development of organisms reztant
to antimicrobials.
5. When drug withdrawal times are not
adhered to, antibiotic residues may be
present in meat and meat products.
The Task Force therefore recommended that the following restrictions be
placed into effect regarding the use of
antibacterial agents in animal feeds at
growth promotion and subtherapeutic
levels:
1. Antimicrobial agents used in human
clinical medicine that fail to meet the
criteria based upon the guidelines referred to above be prohibited from use
in animal feeds by the following dates:
Tetracyclines, streptomycin, dihydrostreptomycin, sulfonamides and penicillins in poultry by January 1, 1973, and
in swine, cattle, and sheep by July 1,
1973; all other antimicrobial agents used
in human clinical medicine and aproved for use in animal feeds by December 31, 1973.
2. Following the dates indicated,
tetracycline,
streptomycin, dihydrostreptomycin, neomycin, spectinomycin,
penicillins, and the sulfonamides shall be
reserved for therapy unless they meet
the criteria established on the bass of
the Task Force's guidelines In regard to
the safety and efficacy for growth promotion or any subtherapeutic use; and
furthermore, these antimicrobials, when
used at therapeutic levels and for shortterm treatments be administered only by
or on the order of a licensed veterinarian.
3. That antibiotics which select for
bacteria resistant to the antibiotics
most critically needed for therapy of
man and animals be prohibited from use
in animal feeds. In this category at the
present time are: chlorampheniol,
semisynthetic penicillins, gentamicin,
and kanamycin. Other antibiotics which
have proven to be effective and ezsental
for the therapy of certain animal diseases and which select for R-factor medicated multiple resistance be available
for short-term use at therapeutic levels
but only by a veterinarian or on his
prescription.
4. That labeling for medicated feeds
be required to state the amount of antibiotic in the final, feed for all levels including growth levels.
Therefore, pursuant to the authority
vested in the Secretary of Health, Education, and Welfare by the Federal Food,
Drug, and Cosmetic Act (sees. 512,
701(a), 52 Stat. 1055, 82 Stat.. 343-51;
21 U..C. 360b, 371(a)) and under the
authority delegated to the Commlimloner
(21 CFR 2.120), it is proposed that Part
135 be amended by adding thereto the
following new section:
§ 135.109 Antibiotie and sulfonnmide
drugs in animal feeds.
(a) The Commissioner will propose to
revoke currently permitted uses of subtherapeutic and/or growth promotant
uses of antibacterial agents in feeds,
whether granted by approval of new animal drug applications, master files and/

or antibiotic or food additive regulations,
whn such drugs are also used in human
clinical medicine, unless data are submitted which establish their safety and
effectiveness under specific criteria based
on the guidelines contained in the Report
of the FDA Task Force on the Use of
Antibiotics in Animal Feeds.
(b) Within 30 days following the effective date of this regulation any person interested in retaining approval of
tetracyclines, streptomycin, dihydrostreptomycin, sulfonamides, and penicillins for use in poultry after January 1,
1973, or in swine, cattle, and sheep after
July 1, 1973, or of all other such approved
antibiotics after December 31, 1973, shall
satisfy the Commissioner in writing that
studies adequate and appropriate to meet
the prescribed criteria have been undertaken. Progress reports shall be filed on
such studies every January 1 and July 1
until completion.
(c) Following implementation of the
requirements of paragraphs (a) and (b)
of this section:
(1) Those antibacterial drugs which
fail to meet the prescribed criteria will be
reserved for high-level, short-term use
and shall be used only by or on the order
of a licensed veterinarian.
(2) Animal feeds containing antibacterial drugs permitted to remain in use
for growth promotion and/or subtherapeutic purposes shall be labeled to include
a statement of the quantity of such drugs
in finished feeds.
Interested persons may, within 60 days
after publication hereof in the FEDEPAL
REzsTEn, file with the Hearing Clerk,
Department of Health, Education, and
Welfare, Room 6-88, 5600 Fishers Lane,
Rockville, Md. 20852, written comments
(preferably in quintuplicate) regarding
this proposal. Comments may be accompanled by a memorandum or brief in support thereof. Received comments may be
seen in the above office during working
hours, Monday through Friday.
Dated: January 25, 1972.
CULrLs C. EDwArDS,

Commissionerof Food and Drugs.
[F, DoR'c2-1416 FlIed 1-31-72; 9:46 aml

Social and Rehabilitation Service
[ 45 CFR Parts 220, 222 ]
SERVICE PROGRAMS FOR FAMILIES
AND CHILDREN AND FOR AGED,
BLIND, OR DISABLED PERSONS
Notice of Proposed Rule Making
Notice Is hereby- given that the rez-

ulations set forth in tentative form be-

low are proposed by the Administrator,
Social and Rehabilitation Service, with
the approval of the Secretary of Health,
Education, and Welfare. The proposed
regulatlons define organizational separation of services from assistance payments and require States to develop plans
for and to implement such ssparation.
Prior to the adoption of the proposed
reulations, consideration will be given to
any comments, suggestions, or objections
thereto which are submitted in writing

FEDERAL REGISTER, VOL. 37, NO. 21-TUESDAY, FEBRUARY 1, 1972

HeinOnline -- 37 Fed. Reg. 2445 1972