The Environmental Protection Agency and the regulation of pesticides

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The Environmental Protection Agency and the regulation of pesticides staff report
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Table of Contents
    Front Cover
        Page i
        Page ii
    Table of Contents
        Page iii
        Page iv
    Introduction
        Page 1
        Page 2
    I. Overview
        Page 3
        Page 4
        Page 5
        Page 6
        Page 7
        Page 8
        Page 9
        Page 10
    II. Poor planning and management
        Page 11
        Page 12
        Page 13
        Page 14
        Page 15
        Page 16
        Page 17
        Page 18
        Page 19
        Page 20
        Page 21
        Page 22
    III. Lengthy delays in correcting serious program deficiencies
        Page 23
        Page 24
        Page 25
        Page 26
        Page 27
        Page 28
        Page 29
        Page 30
        Page 31
        Page 32
        Page 33
        Page 34
    IV. Lepthophos: A case history illustrating the severe inadequacies and deficiencies in EPA's tolerance-setting program
        Page 35
        Page 36
        Page 37
        Page 38
        Page 39
        Page 40
        Page 41
        Page 42
    V. Misleading statements by EPA
        Page 43
        Page 44
        Page 45
        Page 46
        Page 47
        Page 48
    VI. Recommendations
        Page 49
        Page 50
    Back Cover
        Page 51
        Page 52
Full Text
~Cff~L


.~


94TH CONGRESS SENATE
2SII


THE ENVIRONMENTAL PROTECTION AGENCY
AND THE REGULATION OF PESTICIDES





STAFF REPORT

TO THE

SUBCOMMITTEE ON ADMINISTRATIVE PRACTICE
AND PROCEDURE

OF TH

COMMITTEE ON THE JUDICIARY

OF THE

UNITED STATES SENATE

DECEMBER 1976




0.4










Printed for the use of the Committee on the Judiciary


U.S. GOVERNMENT PRINTING OFFICE
79-661 WASHINGTON : 1976
i i








For sie by the Superintendent of D ents, U.S. Government Printing Oice
Washington, D.C. 20402 Price 70 cents
Stock Number 052-07-03S67-5


k I,




























COMMITTEE ON THE JUDICIARY

JAMES 0. EASTLAND, Mississippi, Chairman


JOHN L. McCLELLAN, Arkansas
PHILIP A. HART, Michigan
EDWARD M. KENNEDY, Massachusetts
BIRCH BAYH, Indiana
QUENTIN N. BURDICK, North Dakota
ROBERT C. BYRD, West Virginia
JOHN V. TUNNEY, California
JAMES ABOUREZK, South Dakota


ROMAN L. HRUSKA, Nebraska
HIRAM L. FONG, Hawaii
HUGH SCOTT, Pennsylvania
STROM THURMOND, South Carolina
CHARLES McC. MATHIAS, Jr., Maryland
WILLIAM L. SCOTT, Virginia


SUBCOMMITTEE Ox ADMINISTRATIVE PRACTICE A17D PROCURE

EDWARD M. KENNEDY, Massachusetts, Chairman


PHILIP A. HART, Michigan
BIRCH BAYH, Indiana
QUENTIN N. BURDICK, North Dakota
JOHN V. TUNNEY, California


STROM THURMOND, South Carolina
CHARLES McC. MATHIAS, Jr., Maryland
HUGH SCOTT, Pennsylvania


THOMAS M. SUSMAN, Chief Counsel
Pimir J. BAKES, Jr., Assistant Chief Cou-neel
WALTER J. SHERIDAN, Chielf Inestigator
JAMES F. MICHIE, nvesligaor

(II)























TABLE OF CONTENTS


Psge
Introduction by Senator Kennedy--1
I. Overview --------------------------------------------------- 3
II. Poor Planning and Management-11
III. Lengthy Delays in Correcting Serious Program Deficiencies--------- 23
IV. Lepthophos: A Case History Illustrating the Severe Inadequacies
and Deficiencies in EPA's Tolerance-Setting Program------- 35
V. Misleading Statements by EPA-43
VI. Recommendations- --- 49


Documents cited in this report and other documents relating to the
subcommittee staff's inquiry into regulation of pesticides by the EPA
are contained in a separately bound appendix.


[NOTE: This report was prepared by the majority staff of the subcommittee
and has been neither reviewed nor approved by the Members of the
subcommittee.]


(IM)


















Digitized by the Internet Archive
in 2013












http://archive.org/detaiIs/entalproOOu nit








THE ENVIRONMENTAL PROTECTION AGENCY
AND THE REGULATION OF PESTICIDES
INTRODUCTION
Pestcides have played and continue to play an important role in
increasing agricultural production in America, and around the world.
Pesticides have proved valuable in the past, and may be needed for
some years to come until safer and more effective methods of pest
control are developed. But pesticides are powerful poisons also. A
number of pesticides have the potential for causing such tragic effects
on man and the environment as cancer, birth defects, interference with
biological reproduction, and genetic mutations.
The subcommittee staff's report on pesticide regulation leads me to
conclude that the Environmental Protection Agency has largely
failed in its responsibility to assure the safe use of pesticides as man-
dated by the Congress. As a consequence, EPA has failed the consumer
and the farmer, as well as the pesticide industry.
I find it incredible that a regulatory agency charged with safe-
guarding the public health and the environment would be so sluggish
to recognize and react to so many warnings over the past 5 years. The
EPA was warned and certainly should have known that testing data,
submitted by industry as long as 25 years ago, should not be accepted
at face value in the reregistration of thousands of pesticide products
presently being used on our farms and in our homes. But EPA by and
large ignored these warnings.
Even more alarming is that apparently EPA made a conscious policy
decision sometime in 1973 or 1974 not to evaluate the safety testing
data submitted by pesticide manufacturers. The record behind this
decision is not entirely clear. What is clear, however, is that EPA had
no sound basis upon which to assume that data 15, 20, or 25 years old
was generally good and reliable. EPA has yet to produce one document
which discusses even vaguely the rationale for its decision not to
evaluate data or possible alternatives to that decision. In my view,
EPA's decision in the 1970's not to evaluate safety testing data sub-
mitted in the 1950's and 1960's was irresponsible in light of the dra-
matic improvements science has made in safety testing methodology
and interpretation of testing data.
I fully appreciate the constraints under which EPA was operating
in attempting to perform the pesticide reregistration task. The agency
was faced with a Congressional deadline of October 1976 (later
extended to October 1977) to complete it. Determining whether to
reregister 50,000 pesticide products currently on the market is an
enormous undertaking. EPA was unable to obtain sufficient resources
with which to accomplish the task. These factors have played a lart in
making pesticide regulation a failure. But, EPA must shoulder the
major -share of the blame. Not until very recently did EPA inform
the Congress and the public that these constraints forced the agency
into the untenable and dangerous decision not to evaluate and validate
much of the safety testing data in the reregistration process. In fact,
as the staff report demonstrates, EPA's present tations to Congress
have given a very misleading picture of pesticide regulation.
(1)







I am heartened by the valuable contributions made during the
s:ubcommittee's lengthy inquiry by scores of EPA employees-clerks,
secretaries, scientist, supervisory personnel, and aystorney-all of
'whom showed their dedication to the public health and their commit-
ment to Federal regulation of pesticides. I also appreciate the full
cooperation and assistance extended to the subcommittee staff by
Administrator Russell E. Train and officials within the Office of
Pesticide Programs.
It is most encouraging to see that EPA has already taken steps to
improve the regulation of pesticides, including finalization of a program
to validate data supporting reregistration, organization of EPA's
data files, initiation of a program with the Food and Drug Administra-
tion to audit safety testing results, formation of a Cancer Assessment
Group, and initiation of a program to attract more scientists so as
to improve the agency's expertise in the various scientific disciplines.
It is my hope that this report, in pointing out the many problems
and deficiencies in EPA's pesticide programs, will stimulate within
the executive branch, the Congress, the public sector, and the pesti-
cide industry a renewed commitment to effective and fair regulation
of pesticides in the future.
EDWARD M. KENNEY, iarm.n,
Subcommittee on Admi'nistrative Practice and Procedure.












I. OVERVIEW


The Environmental Protection Agency was established as an inde-
pendent agency on December 2, 1970.1 EPA was created to provide a
central focal point for coordinated and effective governmental action
on behalf of the environment. It is responsible, among other things,
for regulating the use of pesticides through-the administration of the
Federal Insecticide, Fungicide, and Rodenticide Act-(FIFRA) of 1947 2
and sections 408 3 and 409 4 of the Federal Food, Drug, and Cosmetic
Act (FFDCA).
The Congress passed these two laws to protect the public health
and the environment. While pesticides are meant to control insects,
rodents, and other pests and thus increase agricultural production,
the uncontrolled use of these poisonous substances can kill and
cripple humans, farm animals, fish, birds, and other wildlife, can in-
filtrate the food chain, and are potentially hazardous to entire eco-
logical systems. Scientific research undertaken by the pesticide in-
dustry, as well as by Government agencies, demonstrates that possibly
a substantial number of pesticides have the potential for causing in
humans cancer, birth defects, damage to the nervous system, genetic
mutations, interference with biological reproduction, and other
harmful effects.
Proper regulation of pesticides is today more necessary and more
difficult than ever before. The use of these poisons has increased
dramatically since the midsixties, and the business of producing and
marketing them has mushroomed as well. The U.S. market for pesti-
cides in 1974 was $1.9 billion and is expected to climb to $3.3 billion by
1984.5 Production of pesticides inthe U.S. almost doubled in a 9-year
period, from 877 million pounds in 1965 to 1.4 billion pounds in 1974.6
EPA states:
55 percent [of active pesticide ingredients are consumed]
by the agricultural sector; 30 percent by industrial, institutional
and Government users; and 15 percent by home and garden
users. . [and] the use of chemical pesticides is expected to
continue to increase during the next 5 years.7
In light of the pervasiveness of pesticide use, the potential dangers
inherent in that use, and thus the importance of pesticide regulation,
the Subcommittee on Administrative Practice and Procedure began
studying EPA's administration of the FIFRA and sections 408 and
409-of the FFDCA m early January 1976.
I Reorganization lanP No. 3 of 1970.
2 61 Stat. 163 as amended.
3 Pub. L. 83-518, July 22, 1954, chapter 559. 83d Cong., 2d sess., 21 U.S.C. 321.
4 Pub. L. 85-929, Sept. 6, 1958, 21 U.S.C. 321.
s Draft, "Strategy of the Environmental Protection Agency for Controlling the Supply and tse of Pesticides,
1976-81," EPA, July 1976.
6 "The Pesticide Review 1975," USDA, Agricultural Stabilization and Conservation Service, Washing-
ton, July 197R.
7 Note 5. supra.
(3)







An intensive inquiry,' which is still continuing today, has led to
the unfortunate conclusion that pesticides regulation in the United
States is fundamentally deficient. Pesticides regulation has failed to
include many obvious, necessary, and prudent steps to better protect
public health and the environment. Moreover, the severe inadequacies
of pesticide regulation are not attributable in any significant way to
deficient legislation. Rather the principal cause lies with EPA's poor
administration of the program, including its failure to recognize and
correct serious program deficiencies as they arose. In an almost classic
example of poor governmental regulation, EPA's pesticide program
has struck an incorrect and dangerous balance between the sometimes
conflicting demands of limited resources, bureaucratic efficiency and
public health. EPA for 6 years has paid too little attention to
warnings of Government investigators, Congressional reviews, and
even some of its own officials. The result is that several years of regu-
latory effort will have to be completely reexamined, substantially
redone, and fundamentally redirected if the Congress and the public
are to have a reasonable basis to conclude that today's pesticides do
not pose a significant risk to human health and the environment. The
pesticide industry and the Nation's farmers can no longer confidently
rely on EPA's past reviews of pesticide safety testing data, for much
of that work must simply be redone. Moreover, a substantial amount of
time and money has been wasted, and the speedy approval of new
pesticides that are both safe and effective is jeopardized because of
EPA's need to devote resources to substantially redoing its pesticide
reregistration program.
The regulation of pesticides has been fraught with problems since
its beginning in 1947. Prior to the creation of EPA, FIFtRA had been
administered by the Department of Azcullture, and FFDCA, by the
Food and Drug Administration in HEW. Under FIFRA, USDA was
required to register all pesticide products involved in interstate
commerce. However, USDA could not register a pesticide if it left
a residue in or on a raw agricultural product unless FDA was able to
set a "safe" tolerance level, as required by the FFDCA. FDA could re-
fuse to grant a tolerance if that Agency determined that any residue
was dangerous to human health and thus FDA could effectively pro-
hibit USDA from registering the pesticide use.
In the late sixties, the regulation of pesticides came under heavy
criticism. Two reports by the Genera Accounting Office charged that
1coutmfailedtopieae
USDA's registration procedures were inefficient, to place ade-
quate emphasis on pesticide safety, and too often ignored the recom-
mnendations of FDA.'
The fragmentation of authority to regulate pesticides between
USDA and FDA was detrimental to the program. Moreover, a conflict
between the fundamental missions of the two agencies also contributed
heavily to the failure of pesticide regulation. Traditionally, USDA's
1i-ion has been to promote increased food production and, therefore,
* iner this study a the subiommitt*t ha- head testimony from 14 witnesses at 2 Sonat hearings.
The tff has i trvie 147 pnrsnn, IALiy on aiore thaa one occsion, sn that more than 300 separate
interview were cotdicted. E PA and other sorI(1s hve provided the subcommittee with over 1,000 docu-
ments, eh one of which has been reviewo~I by the staf. Th staff h48 also reviewed the work of other
congressional 1 cm( i(ee on the subject of pesticide regulation and hs studied the reports of the GAO on
this program.
Vorrd To Improue RPULJtory Enfofrcimett ProcedUrt$ Jbitob Thatx1ideesd," GAO Report to the Con-
gress Sept. 10, 191's, 11- ;112 i'd Nefd if efsolae Queatholi of *14etv Itohing Certain Rcgistr d Uaes of
ltndane Pstticde Ptlllas," ( A0 10-p'rt to the CongI ess, Feb. 11, litI9, 11-133192.







USDA heavily promoted the use of pesticides to accomplish that mis-
sion. Long-term health concer ns were often subordinate to USDA's
primary goal. FDA, on the other hand, was charged with safeguarding
the p-ublic health. Assigning all pesticide regulation to one agency
helped alleviate bureaucratic overlap and administrative inefficiency;
but Government reorganization did not cure the basic conflict, in as
much as many of the personnel and much of the philosophy from
USDA were simply transferred to the EPA pesticide program in 1970.
In 1972, EPA's pesticide regulatory task was expanded greatly
with the enactment of the Federal Environmental Pesticide Control
Act (FEPCA) 10 which amended FIFRA. In addition to requiring the
processing of new pesticide registration applications and pesticide
residue tolerance petitions, FEPCA requires that all pesticide products
previously registered over the past 30 years-including some 35,000
federally by USDA and by EPA since 1970, and 15,000 by states-be
reviewed and subject to a reregistration process, and classified for
either general or restricted use, or both. This task was directed by
Congress to be accomplished by October 21, 1976.11 The intent of the
Congress in enacting FEPCA was to subject those pesticides approved
under earlier, less stringent safety standards to application of much
improved modern standards. Under FEPCA, Congress placed on
EPA the responsibility to determine whether any of these pesticides
"will perform [their] intended function without unreasonable adverse
effects" 12 on human health and on the environment. If, after an
examination of the risks and benefits, the Administrator of EPA
determines that the pesticide causes "unreasonable adverse effects,"
he may restrict, suspend, or cancel the use of the pesticide.
Following the enactment of FEPCA, pesticide companies were
required to supply for reregistration: (1) animal testing data to show
whether their products had the potential for causing birth defects,
tumors, interference with reproduction capability or other harmful
chronic effects, and (2) data on the exposure to pesticides which might
affect fish and mammals and birds.
The importance of EPA's determining whether the previously
registered 50,000 pesticide products should be reregistered for con-
tinued use cannot be overemphasized. Over the past 22 years, more
than 4,000 tolerances have been granted, allowing residues of many
pesticides to remain in or on such foods as vegetables, meat, milk, and
grains. These substances are then ingested by people and many of
them degrade very slowly. Years later traces are found in human
tissue. The long-term effects of many of these substances are often
quite harmful and in many cases unknown. Recently, for example,
reports have shown that the pesticides Mirex and Kepone are showing
up in human mothers milk. Both have been identified as carcinogens
and, according to EPA, "over the last decade, pesticide monitoring
in humans has confirmed the widespread presence of residues .... In
1973, for instance, adipose (fatty) tissue from 99 percent of the humans
sampled contained Dieldrin. .. 13 a known carcinogen. The use of
Ditdrim was cancelled by EPA in 1975, but a number of other pesti-
cides related in chemical structure remain on the market.
'J Pub. L. 92-516, Oct. 21. 1972, 7 U.S.C. 135.
"Pub. L. 92-516, Oct. 21, 1972, 7 U.S.C. 135.
12 Pub. L. 94-140, Nov. 28, 1975, 7 U.S.C. 136.
13 Note 5, supra.


79-661-76----2






EPA was quite slow, however, in getting reregistration underway;
slow planning and long delays in drafting regulations and guidelines
mandated by the FEPCA were responsible for keeping actual re-
registration from becoming operational. In fact, the formal prepa-
ration phase of reregistration, which involved the drafting of guidance
packages for pesticide companies who wished to reregister their
products, did not begin until the fall of 1975, some 3 years after
enactment of the FEPCA. Even so, with only a year remaining until
the original Congressional deadline of October 1976, EPA did not
request an extension from Congress. Nevertheless, on November 28,
1975, the Congress decided to extend the deadline until October 21,
1977.4 And, since the fall of 1975 when the program became oper-
ational, EPA has been constrained to halt and redirect it on two
occasions.
As part of the reregistration program, EPA did establish in late
1975 the Office of Special Pesticide Reviews (OSPR), which was
charged with assuring that a thorough evaluation would be performed
on those pesticide chemicals suspected of having the potential to
cause adverse effects on human health and the environment. But,
like EPA's effort to reregister those pesticide chemicals which were
not in the "suspect" category, EPA has had serious difficulties in
getting the OSPR program underway and in making it effective.
As shown in the brief summary which follows, the reregistration
program has to this day never been fully implemented and is unlikely
to be completed in time for the statutory deadline of October 1977. In
fact, it was only recently, in response to the subcommittee's inquiry,
that EPA now estimates it will take approximately 3 years to complete
reregistration.
On January 13, 1976, following months of work in preparing 45
guidance packages, the reregistration program was virtual ly halted
for more than a month. This was done after EPA discovered that
reviews of existing pesticide safety testing data in its files had been
superficial and the program mismanaged. Corrective action was
clearly called for.
During that same week of January 12, 1976, the Office of Pesticide
Programs had assigned four EPA scientists to review a sampling of
existing safety testing reports from animal feeding studies which
pesticide companies had used to justify the initial registrations of
their products, as well as tolerances for residues of their products
in and on foods and feeds. This was the very same type of data that
was required to be reviewed and validated in reregistration. Although
their reviews were performed hastily, the scientists discovered faulty
and incomplete data. This limited review of data was done in prepara-
tion for testimony by Mr. John R. Quarles, Jr., Deputy Administrator
of EPA, who was scheduled to appear, along with representatives
of the Food and Drug Administration and the National Cancer
Institute, before a joint hearing of the Subcommittee on Health and
this subcommittee, which were investigating suspected large-scale
"furn ed yv
problems with the integrity of arfimal feeding studies furisedb
private companies seeking governmental approval of their products.
1" Pub. L. L14-14. Nov. 2S, 1975, 7 U,.S.C. 136.







On January 20, 1976, in hearings before the subcommittees
Mr. Quarles testifed:
There are indications that serious problems may exist
a recent preliminary review of several toxicity studies submitted
to EPA have alerted us to the possibility of serious difficiencies
in the conduct of pesticide testing.15
Following the January 20 hearings, one of the scientists, a
pathologist, was assigned to do more thorough reviews of the data.
He reported to his superiors on March 11, 1976, that of the 24 reports
on safety testing studies he had reviewed, only one was acceptable.
Meanwhile, at about the same time (in mid-March) the reregistra-
tion program was resumed. And, as the Congress had directed in
FEPCA, the program supposedly included reviews of testing studies
to determine whether the data were adequate to support a finding
that each pesticide was safe.
On April 9, 1976, in hearings before the Subcommittees on Health
and Administrative Practice and Procedure, Mr. Russell E. Train,
Administrator of EPA, testified:
[The pathologist's findings] obviously indicated that
EPA must take steps to review more thoroughly the adequacy
of past testing and ensure that future laboratory testing is
properly performed. . EPA will initiate an auditing pro-
gram in which laboratory records of toxicity test reports will be
examined to determine whether they accurately reflect the re-
ported test procedure and results.16
Referring to reregistration, Mr. Train further testified:
Pursuant to the 1972 amendments to the FIFRA, the EPA
is directed to undertake a reappraisal of pesticide products
approved under the earlier FIFRA to determine if they meet a
new statutory test that they will not have the "unreasonable
adverse effects" to man and the environment . On February
17 we published a list of pesticides categorized according to the
acceptability of their supporting data in view of the new
regulations.17
Later, at those same hearings on Apiil 9, Mr. Jeffery Howard, the
former EPA Associate Assistant General Counsel for Pesticides who
had recently resigned stated, "EPA has not carefully scrutinized the
safety testing data submitted to it [by the pesticide companies]."
Ms. Carter Schuth, a scientist in EPA's Office of Toxic Substances,
referred to reregistration in her testimony as a "a production line."
When asked by Chairman Kennedy, "Do you think we are not really
getting the desired goal of comprehensive evaluation [of the data]".
Ms. Schuth responded, "Yes, sir, I think that is a very serious
danger." 18
Following the April 9 hearings, the subcommittee's inquiry con-
tinued, and so did the reregistration program. EPA was sending out
15 Statement of John R. Quarles, Jr., Deputy Administrator, Environmental Protection Agency, before
joint hearings by the Subcommittee on Health and the Subcommittee on Administrative Practice and
Procedure, Jan. 20, 1976.
1S Statement of Russell F. Train, Administrator, Environmental Protection Agency, before joint hearing,
by the Subcommittee on Health and the Subcommittee on Administrative Practice and Procedure, Apr. 9
1976.
1? Ibid.
Is Testimony of Ms. Carter Schuth, scientist, Office of Toxic Substances, Environmental Protection
Agency, before joint hearings by the Subcommittee on Health and the Subcommittee on Administrative
Practice and Procedure, Apr. 9, 1976.







dance packages each week to pesticide companies. The guidance
packages indicated to companies EPA's judgment concerning the
adequacy of data previously submitted by the compares.
On July 1, 1976, Chairman Kennedy wrote a letter 1 to Mr. Train
requesting from the EPA Administrator detailed information on the
depth of data review for reregistration and tolerance-setting. Chair-
man Kennedy, among other things, requested information on the
extent to which EPA had reviewed safety testing data relating to 12
specific pesticide compounds for which reregistration guidance pack-
ages had already been prepared and mailed to the respective
manufacturers.
The reregistration process continued until August 9, 1976, when the
Office of Pesticide Programs halted the process for the second time in
8 months because the review of data was still superficial. As it turned
out, the reregistration program's "review" of the data had consisted
of little more than merely looking for the presence of data. It still
did not approach fulfilling the Congressional intent behind the 1972
FEPCA legislation-namely, to ensure that each of the pesticides
"will perform its intended function without unreasonable adverse
effects" on human health and the environment.
Finally, in a letter dated August 10, 1976, Mr. Train responded to
Chairman Kennedy's letter of July 1, 1976:
EPA currently is rethinking the depth of analysis associated
with its strategy for reregistering pesticides. In particular, we
are taking a second look at the extent to which information in
our files, particularly information pertinent to an assessment of
potential human health hazards of pesticides, should be re-
examined before reregistrations are issued. We originally assumed
that toxicological data in our files were derived from testing
that generally was scientifically sound, that test procedures and
results had been fully and accurately reported, that test reports
generally had been reviewed in accordance with scientific standards
that are still appropriate, and that problems identified by prior
reviewers had been resolved. In light of recent developments,
these assumptions are now questionable.20
Since Augyust 9, 1976, when the reregistration program was halted,
the Office of Pesticide Programs has been working on a plan to fulfill
the mandate of the Congress in providing for a thorough review of
existing safety testing data on all of the 50,000 pesticide products
presently manufactured and marketed in the U.S.
While the reregistration program is of paramount importance in
EPA's mission to protect the public health and the environment
fromn potential hazards of pesticide use, of perhaps equal importance
is the review of the more than 4,000 existing tolerances for m maxium
pesticide residues in or on foods and feeds granted over the past 22
years, as well as a review of the tolerance-setting procedure. For if
much of the data to be reviewed for reregistration purposes is faulty
()r inlcopillete, many of the I)esticide residue tolerances now M effect
may have to be revoked, or at least modified.
10 letter datcd July 1, 1976. from Sten. Edward M. Kennedy, Chairman, Subemnittw on Adinistra-
tive Pracice trnd Procedure, to Mr. Rissell E. Truin, Administrator, Environmental Protction Agency.
- Letter dt0- Auk. 20, 1976 from Mr. Russell F. Train, Administrator, Environmental Protcton
Agency, to S. ii, Edward M. Kwmedy, Chairman, Subcommittee on Health and Subeoznn ttee on Ad-
ministraltivc PrActi.e and Procedure.







In a report to the Congress highly critical of EPA's pesticide
programs, the General Accounting Office recommended that EPA
"periodically review all tolerances and revise as necessary." 21 EPA, in a
letter dated September 17, 1975, responded that it was "very much
concerned about tolerance-setting problems,' 22 and promised to
"turn more of [its] attention to review of the tolerance regulations and
procedures, to reassessment of tolerances already regulated, and to a
comprehensive evaluation of the whole scientific basis for tolerance
setting." 2
However, after more than a year, the Office of Pesticide Programs
still is in the process of organizing and putting in writing its existing
procedures for tolerance-setting. And it was only recently that decisions
were made to begin an "evaluation of the whole scientific basis for
tolerance-setting." 24
In succeeding sections of this report, the staff of the Subcommittee
on Administrative Practice and Procedure documents what it believes
to be the major problems which have led to the crisis in which
pesticide regulation finds itself today. They are: (1) Poor planning
and management; (2) lengthy delays in correcting serious program
deficiencies, and (3) misleading statements to the Congress, GAO, and
the public.
21 "Federal Pesticide Registration Program: Is It Protecting the Public and the Environment Adequately
From Pesticide Hazards?", report to the Congress by the Comptroller General of the U.S., Dec. 4, 1975.
nI/bid.
N Ibid.















II. POOR PLANNING AND MANAGEMENT


Organizational delay
The Office of Pesticide Programs (OPP) basically consists of five
suborganizations: (1) Registration Division; (2) Criteria and Evalua-
tion Division; (3) Technical Services Division; (4) Operations Division;
and (5) Office of Special Pesticide Reviews.25
From the beginning of EPA, the Registration Division has played
the primary role in pesticide regulation within the Office of Pesticide
Programs. Prior to enactment of FEPCA-6 in 1972, the Registration
Division's task was to approve or disapprove applications for new
pesticide registrations, and pesticide residue tolerance petitions.
Following the enactment of FEPCA, OPP was reorganized, with
the newly created Divisions of Criteria and Evaluation, Technical
Services, and Operations serving largely as support to the Registration
Division.
The Office of Special Pesticide Reviews (OSPR) was not created
until December 1975. OSPR's function is to perform indepth risk-
benefit analyses on those pesticides suspected of causing "unreasonable
adverse effects." These analyses are used by the Administrator in
determining basically to what extent the pesticide should remain in
use, or whether it should be removed from the market entirely, as
provided for in FEPCA.27
With the enactment of FEPCA on October 21, 1972, the Congress
required EPA to reregister and classify for general use or restricted
use, or both, by October 21, 1976, the 35,000 pesticide products pre-
viously registered for use by USDA and EPA and 15,000 pesticide
products previously registered by states. FEPCA further directed
EPA to promulgate within 2 years regulations which would fulfill the
new provisions of the Act affecting reregistration, as well as new regis-
trations of pesticide products.
The basic functions of the five suborganizations are as follows: (1) the Registration Division is response
ble for establishing pesticide residue tolerances in and on foods and feeds, and for the registration and re-
registration of pesticides and their use to assure human safety and protection of environmental quality.
(2) The Criteria and Evaluation Division is responsible for establishing standards and criteria for tolerance
setting, and for environmental, human safety, and efficacy standards applicable to product registration, and
for research needs of OPP. (3) The Technical Services Division is charged with providing technical data and
information support to other divisions in OPP, as well as to States and other agencies, and with monitoring
pesticide residue levels in the environment and the effects on humans exposed to pesticides. (4) The Opera-
tions Division is responsible for coordinating OPP's regional activities for implementing the States' certifica-
tion programs for pesticide and investigating pesticide accidents. And (5) the Office of Special Pesticide Re-
views is responsible for assuring that chemicals identified as Rebuttable Presumption Against Registration
(RPAR) cases are properly evaluated and processed.
2 Note 10, supra.
27 Th6 Federal Environmental Pesticide Control Act of 1972 provides that:
If it appears to the Administrator that a pesticide or its labeling or other material required to be sub-
mitted does not comply with the provisions of this Act or, when used in accordance with widespread
and commonly recognized practice, generally causes unreasonable adverse effects on the environment,
the Administrator may issue a notice of his intent either-
(1) to cancel its registration or to change Its classification together with the reasons (including the
factual basis) for his action, or
(2) to hold a hearing to determine whether or not its registration should be canceled or Its classi-
fication changed."; and that
"If the Administrator determines that action is necessary to prevent an imminent hazard during
the time required for cancellation or change in classification proceedings, he may, by order, suspend
the registration of the pesticide immediately.
(11)





12


The planning and management efforts to draft the regulations
necessary for implementation of the reregistration program were
extremely poor from the beginning. A task force was created in Decem-
ber 1972, immediately following enactment of FEPCA, to draft the
regulations. However, there was "difficulty in coordination" between
the task force and those OPP branch chiefs who were to provide
scientific input." In 1973, the drafting of the regulations was turned
over to the branch chiefs. And, from the branch chiefs, the task was
transferred to another task force in April or May 1974.
The regulations themselves were not finalized until August 4,
1975, some 10 months after the Congressional deadline of October 21,
1974. And the reregistration program itself did not begin until October
1975, leaving only 1 year to perform the entire task. However, on
November 28, 1975, the Congress extended the deadline to October
21, 1977.30
Decision to take shortcuts
On October 19, 1976, Edwin L. Johnson, presently the Deputy
Assistant Administrator for OPP, stated that soon after the enact-
ment of FEPCA, the drafting of the regulations was begun, but
"floundered" for 1Y2 years. Johnson said that Henry J. Korp, his
predecessor, and immediate superior at that time, directed him to
"speed up the regulations." Mr. Johnson further stated that this led
to him calling a meeting of OPP managers at Easton, Md., in April
1974.3'
According to Mr. Johnson, the "Easton meeting" was used to
"conceptualize" the regulations and the reregistration process. Mr.
Johnson indicated that because of known constraints, it was decided
at the "Easton meeting" that instead of reviewing each of the thou-
sands of pesticide products for reregistration, products of a similar
chemical structure would be combined into "batches." The 50,000
pesticide products presently on the market are made up of at least
one or a combination of two or more of some 1,400 active pesticide
ingredients.
John B. Ritch, Director of OPP's Registration Division, attended
the "Easton meeting." Mr. Ritch, when asked about resource con-
straints on reregistration which were known at the time of the "Easton
meeting," stated that, as early as 1973 the Registration Division had
requested an additional 100 personnel in order to complete the
reregistration process but, according to Mr. Ritch, the request was
disapproved by the Office of Management and Budget. Mr. Ritch
further stated:
In the spring, of 1974, at the budget review for fiscal year
1975, it was decided that my Divsion would receive only 15 or
20 additional personnel. At that point, we asked ourselves, how
can you do a thorough job on reregistration with so few addi-
tional people, and still meet the Congressional deadline [of
October 1976 for completing the task]? And that's when we
began thinking about shortcuts."
Subcommitteestaff interview of Edwin L. Johnson, Deputy Assistant Administator, Office of Posticide
Programs Environmental Protection Agency, Oct. 19, 1976 [hereafter "Johnson Interview").
29 Note 28, supra, Johnson interview.
3 Note 14, supra.
8Note 28, supra, Johnson Interview.
12 Subcommittee staff interview of John B. Ritch, Director, Registration Division, Office of Pesticide
Programs, Environmental Protection Agency, Oct. 10, 1976.






13


Mr. Johnson briefed John R. Quarles, Deputy Administrator of
EPA, on May 1, 1974, on the "Easton meeting" plan for completing
reregistration by the October 1976 deadline, in spite of resource
constraints.3 A flow chart, which Johnson said was used in the
Quarles briefing, asks the questions:
Does [the pesticide] product have potential long-term [harmful]
effect? [If the answer is yes] Are sufficient data available to
reach [a] [re]registration decision? [If the answer is yes] On [the]
basis of intensive C/B [cost to health and environment vs.
benefit] review, should [the pesticide] product be registered? 34
The flow chart indicates that OPP had intended to do intensive
review of pesticide safety testing data on those pesticides requiring
"intensive C/B analysis." But, the chart also indicated that only
"5 percent" or 2,250 of the 45,000 pesticides, would exhibit "potential
unreasonable adverse long-term effects and, thus, require "intensive
C/B analysis." The chart further stated that "approximately 75
percent of [re]registration actions require no C/B analysis, greatly
facilitating [the] workload," and that for 20 percent of the pesticides,
only "moderate C/B analysis [would be] required [for pesticides] with
potential unreasonable adverse acute effects." When asked how
these figures could be arrived at before anyone had even begun
systematically to examine EPA's voluminous pesticide safety testing
files, Mr. Johnson said, "These were guesstimates based on the
knowledge and experience of our scientists." Mr. Johnson further
stated that Mr. Quarles agreed with the plan.35
Shortly after the Quarles briefing, EPA published "Strategy for
Controlling the Adverse Effects of Pesticides," dated May 1974.
The document, signed by Mr. Quarles for Russell E. Train, Ad-
ministrator of EPA, stated generally how the Agency would perform
the reregistration:
All pesticides that have neither exhibited nor are suspected
of causing significant adverse impacts will be reregistered upon
manufacturer application and without requiring further testing
data. . [Flull testing data, including results of animal
toxicological studies, will be required to support reregistration
petitions for those pesticides suspect because of ingredients or
use history. This group of chemicals may be subject to a complete
review, comparing their benefits and costs, before reregistration....
Emphasis will be placed upon persistent and bioaccumulative
pesticides and those pesticides which potentially present long-
term health risks or special dangers to household users. 11
On October 19, 1976, Edwin L. Johnson, Deputy Assistant Admin-
istrator for OPP, told subcommittee staff, "During the preparation of
the 1974 strategy document, we asked several of our scientists about
the listingg safety testing] data in the files, and they told us it was
generally good." 37
3Note 28, supra, Johnson interview.
4 Memorandum, "Notes on Quarles Briefing," with appended charts, May 1, 1974.
U Note 28, supra, Johnson interview.
"Strategy of the Erwironmental Protection Agency for Controlling the Adverse Effects of Peaticidcs," Office
of Pesticide Programs, Office of Water and Hazardous Materials, Environmental Protection Agency, May
1974.
37 Note 28, supra, Johnson interview.


79-661-76----3





14

The next major effort by OPP in planning and organizing for the
reregistration program did not begin until February 19T5, 9 months
after the "Easton meeting." The "Grandpierre Task Force," u as it
has come to be known, met almost daily for about 2 weeks, beginning
on February 20, 1975.
Effective planing by the group was constrained by the premise
that reregistration must be completed by October 21, 1976, as had
been mandated by the 1972 amendments to FIFRA.
As one of the participants of the "Grandpierre Task Force" stated,
"The mandate of the task force was to meet the deadline of October
1976 [for completing reregistration] . We were told to do it,
regardless." Another participant explained that:
[When the task force met,] [tihe basic decisions on how we
would approach reregistration had essentially been made at the
'Easton meeting' [9 months earlier]-decisions to shortcut re-
registration.40
The shortcuts included such things as foregoing a product-by-
product review and relying on the review of batches of products
instead;4 deciding not to review thoroughly pesticide labeling which
was to give directions for proper use;" simply assuming, without
really analyzing whether, the pesticides under review were effective
in controlling pests."
Decision not to validate data submitted by manufacturers
On the precise question of reviewing or validating pesticide safety
testing data, the recollections of various participants are sometimes
vague and conflicting. For example, while one participant contends
that they assumed validation would be done," another claims he told
the "Grandpierre" task force that it could not be done within the con-
fines of the original Congressional deadline,5 and still another indicated
that the task force decided that reregistration would merely identify
the presence or absence of data.46 Apart from the accuracy of the
participants' recollections, the simple and clear fact is that the actual
task of reviewing and validating safety testing data was hardly
performed at all or performed superficially at best. And, even though
there were documents 17 prepared following the decisions of the.task
28 Members of the Task Force included: F. L. J. Grandpierre, Chairman of the Task Force, and Director,
Office of Proram Development and Evaluation, OPP; John M. Carley, Assistant to Mr. Grandpierre;
Ronald E. D-reer, Deputy Director, Technical Services Division, OPP1; Douglas D. Campt, Associate
Director, Registration Division, OPP; Richard J. lHeuwinkel, Assistant to the Director, Registration
Division OPP; Dr. Martin 11. Rogoff, Associate Director for Science, Registration Division, OPP; Dr.
William WeN, Chief, Standards and Labeling Section, Registration Division, OPP; and, Dr. William
Roessler, Deputy Director. Criteria and Evalualion Division, OP1.
Subcommittee staff interview of Dr. William Wells, member, "Grandpierre Task Foruce," and chief,
Standards and Laleling Section, Registration Division, OPP, July 30, li976.
0 Subcommit tee staff interview of Douglas D. Campt, member, "Orandplerre Task Force." and As-
ciate Director, Registration Division, OPP, July 21, 1976.
41 Note 4o, supra. Mr. Campt stated that one of the "basic decisions" was to group pesticide products
containing similar chemical ingredients into "batches."
42 Note 31., supra.
41 Note 40, supra.
44t1Sulw1coittee staff interview of Dr. William Wells, member, "Orandpierre Task Force," and chief,
Standards and Labeling Si etion, Rgistration Division, OPP, Sept. 15, 1976.
4 6 Subcommittee stajy interview of Dr. Martin 11. Rogoff, mniember, "(;randplerre Task Force," and
As(.iate lDirecto for Sciece, R(eiDrtioii vision, OP, e pl. '0, 1176.
i I Suwoni te stal interview on July 19, 1I.76, of,( hn M. ( 'aey, who was a member of the Grandpierre
Task h'urce, and wa signed to ma tie he Rregistratlin Task Force in Marh 11.76.
"' The d Iuits included: (!) a Pow chart which refers to the "Review For Sumency OfData,"and,
cordingg to F'. L. J. ( ayidpierre, was used to brief Mr. Quarles and Mr. Train shortly a ter the "Grand-
oi-rrie Task Force" 11 1; ,(2) flow (harts rfsrrig to the validatet ion" of data, which were prepared by Dr.
Martin II, Rof, wh, ftllowi ltg he work of 1 b1e "ridpirie Task lorce," % a-sI to head the
r-r-viristltion program; (3) a d(1inet pri-p-4red hy John M. Uarlcy in March of 1;75, which refers te tho
review ,f) stWiriciy of data" a- being a "scientific review of the data . to determine and d(1cuient
its adequac."







force that might indicate to an observer that data would be reviewed,
the truth is that the person directly responsible for reregistration,
Dr. Martin H. Rogoff, who was also a task force participant, believed
that reregistration:
. meant that we were to confirm that the data was there,
that there were no obvious adverse effects revealed in previous
scientific reviews [of the data], that the dosage levels [in the
animal feeding studies] were satisfactory, and that a no-effect
level [of dosage] had been found. [But] [wie didn't look at the
raw data [from the safety testing animal feeding studies]. 4
The decision, in effect, was to validate the presence of data submitted
over the last 25 years by pesticide manufacturers, and not the adequacy
of the data.
A clear example of EPA's failure to evaluate data resulted in the
agency's determination that there was "sufficient" data for "full" re-
registration of the pesticide 2,4-D. On April 8, 1976, EPA mailed re-
registration guidance packages to manufacturers of 670 products con-
taining 2,4-D for which more than 45 residue tolerances have been
granted on such foods as dairy milk, eggs, poultry, meat, corn, apples,
vegetables, and citrus fruits. The guidance packages cited a 2-year rat
and dog feeding study performed by FDA in 1963 49 as "suflcient"'
to satisfy the "chronic" safety testing requirements for reregistration.
Yet, a summary report on the study in EPA's files stated that there
was "increased tumor formation" in the rats.50 John M. Carley,
Manager of the Reregistration Task Force, stated that he doubts.
that the summary report was even read in the preparation of the
guidance packages.5' An independent pathologist, who reviewed the
raw data on the study at the request of subcommittee staff, concluded
that 2,4-D "is carcinogemc (cancer-causing) in rats." 52
Missing and misplaced testing data
In March 1975, Dr. Rogoff's reregistration task force, initially con-
sisting of two EPA scientists, began preparing for the reregistration
program. R. Bruce Jaeger, a toxicologist, and Dr. Nancy A. Beach, a
chemist, were assigned to search the tolerance petition files, as well as
other data sources to determine whether there were existing data that.
could be used to support reregistration of pesticides, and whether
required (]ata was missing (data gaps).
In a subcommittee staff interview on July 13, 1976, Mr. Jaeger
stated,
We weren't asked [by Dr. Rogoff] to review the data; we
were asked to see if the data was there. And, at first, we weren't
asked to cite the data references.
Dr. Beach stated that it was not until September 1975 that the
task force was instructed to cite data references from EPA's own files
48 Subcommittee staff interview of Dr. Martin H. Rogoff, Oct. 14. 1976.
49 Report, "Pathological Changes in Rats Fed 2,4-Dichlorophenoxyacetic acid for Two Years," by
Robert T. Habermann, D.V.M.. FDA, Mar. 20, 1964. Report, "Patholoqica Changes in Dogs Fed 2,4-
Dichlorophenoxyacetic acid for Two Years," by Robert T. Habermaun, D.V.M.. FDA, Nov. 5, 1963.
50 Summary, Hansen, W. H., et al., Chronic Toxicity of 2,4-Dichlorophenoxyacetic acid in Rats and Dogs.
Toxicol. Apple. Pharmacol. 20, 122-129, 1971.
61 Subcommittee staff interview of John M. Carley, Manager, Reregistration Task Force, Registration
Division, Office of Pesticide Programs, EPA, Dec. 4, 1976.
52 Preliminary Review of Some Oncogenicity Studies for 2,4-Dichlorophenoxyacetic acid, Melvin D.
Reuber, M.D., Dec. 1, 1976.
63 Subcommittee staff interview of R. Bruce Jaeger, July 13, 1976.
54Subcommittee staff interview of Dr. Nancy A. Beach, Oct. 12, 1976.





16


which included the title of the safety testing study and such other in-
formation as who performed the study and when it was performed. As a
result, the task force had to return to the same files a second time to ob-
tain the necessary data references and add them to the 600 or 700
chemical worksheets that had previously been done. The data refer-
ences were needed for citation in reregistration guidance packages
which later would be used to inform pesticide manufacturers of what
was, and what was not, needed in the way of additional data for
reregistration of their products. Not only were the instructions given
to the reviewers clearly inadequate, but the very files they were to
review were seriously disorganized.
It was not until the summer of 1974-2 years after FEPCA-that
the Office of Pesticide Programs made an effort to modernize its
filing system in order to facilitate data retrieval. In the summer
of 1974, OPP contracted with a private firm to develop a computerized
data retrieval system. However, data file reviewers on the reregistra-
tion task force complain that this effort to computerize the data
may have caused more problems than it attempted to solve. The
reviewers have indicated that the computer printouts, which are sup-
posed to identify the specific location of data, are inaccurate. Often,
data have been found to be misfiled, or missing completely.
Ms. Elsie Kelly, a reviewer on the registration task force, stated:
In one file folder I found recently, there was just a table of
contents, and nothing else ...EPA doesn't give enough
importance to the files. . The files are in a mess.
Faulty preparation of guidance packages
One apparent reason for the data files being in such disarray is that
the Office of Pesticide Programs has assigned only two fulltime per-
sonnel to manage the filing operation.
By September of 1975, an additional five or six EPA scientists had
joined the reregistration task force. And, in October, the task force
was further strengthened with the addition of 15 people temporarily
assigned for 90 days (90-day detailees) from the four Divisions in the
Office of Pesticide Programs. These additional personnel were brought
in to begin writing the reregistration guidance packages which would
be sent to pesticide manufacturers.
In a memorandum dated October 8, 1975, Douglas D. Campt,
Associate Director for the Registration Division, listed schedules for
completing 15 guidance packages per week, with the first set of
packages due on October 27, 1975. In addition, the memorandum also
isted the "Inputs and Actions Required from [the] Reregistration
Task Force." among them was:
4. Providing data references for products contained in [pesti-
cide product] batches and subbatches. This should include a
statement that the data referenced has been considered and it
has been determined that products in the batch can be reregistered
based upon this data. M
However, as pointed out earlier in this report, the data was not truly
"considered." Nevertheless, the task force took the data references
iSuc committee staff Interview of Ms. Elsie Kely, sept. 9, 1976.
6 Mmorandum dated Oct. 8, i975, from Douglas 1.- Campt, Associate Director for Registr .ton, Regi-
tration Division, OPP, to John B. Rltch, Director, Registration Division, OP.




17


that had been recorded on the chemical worksheets and used them in
its first effort to draft guidance packages.
Meanwhile, Dr. Rogoff, with assistance from Dr. Orville E. Paynter,
Chief, Toxicology Branch, Registration Division, OPP, and Dr.
Lamar B. Dale, Chief, Metabolic Effects Branch, Criteria and Evalua-
tion Division, OPP, had been determining from the chemical work-
sheets which data was "sufficient" and which data was required (data
gaps) for reregistration. In addition, Dr. Rogoff also had made deter-
mlnations on whether data requirements could be waived, as is pro-
vided for in FEPCA.7
Dr. William Wells, Dr. Rogoff, and Mr. Campt met on January 13,
1976, to select a number of the 45 guidance packages completed by
the reregistration task force for mailing to pesticide manufacturers.
Although February 2, 1976, had been set as the target date for the
first mailing, the January 13 meeting revealed fundamental defects
in the reregistration program.
Dr. Wells described the problems as follows:
We saw that it wasn't possible for us to recommend sending
any of the packages out. It was a big surprise to us. We found
totally unacceptable data citations, [required] data had been
waived with no justification, and the bibliographies [listings of
acceptable data and data gaps] were totally inadequate.58
Mr. Campt stated, "[The guidance packages] were badly done,
resulting in months of work being wasted." Dr. Wells stated that, for
all practical purposes, the reregistration program was halted on
January 13, 1976, because of the unacceptable guidance packages and
other problems which came to light in rapid succession.8
On January 14, 1976, John B. Ritch, Director of Registration
Division, called a meeting "to review progress made toward sending
out the first call-in [guidance] packages on February 2." 61 John M.
Carley, Office of Program Development and Evaluation, OPP, was
among the seven who attended the meeting.
According to a memorandum written by Mr. Carley on January 14,
1976, Mr. Camp and Drs. Wells and Rogoff reported to the meeting
what they had found the day before in their review of the 45 guidance
packages which had been reported to be complete. Mr. Carley's
memorandum stated:
b. Nine commonly occurring deficiencies [were found], of
which the most serious were inadequate rationales for waivers of
data, questionable bibliographies of supporting data citations
(e.g. citations of summaries of RD [Registration Division] re-
views vice [instead of] citations of the data reviewed, question-
able interpretations of the applicability of conditional long-term
[safety testing] data requirements, . 2
67 Pub: L. 92-516, Oct. 21, 1972, 7 U.S.C. 135 states as follows:
The Admi nistrator may exempt from the requirements of this Act by regulation any pesticide which
he determi nes either (1) to be adequately regulated by another Federal agency, or (2) to be of a charartter
which is unnecessary to be subject to this Act in order to carry out the purposes of this Act.
69 Note 44, supra.
69 Note 40, supra.
0Note 44, supra.
61 Memorandum dated Jan. 14, 1976, from John M. Carley, Office of Pesticide Programs, to Edwin L.
lohnson, Deputy Assistant Administrator for Pesticide Programs.
52 Ibid.







Mr. Carley's memorandum further stated that there had been
"serious problems" in "recruiting and training" of the task force,
as well as in:
B. Supervision:
The various individuals on the task force have had to decide
for themselves what to do and how to do it. Assignments have been
of one individual [regardless of his background] to one chemical,
to follow it all the way through. This had led directly to the
wide variations in quality. This has caused the existing
packages to be virtually unreadable piles of miscellaneous bits
and pieces; it's nearly impossible to tell what's there.
C. Quality Control:
There isn't any ....
Dr. Wells stated"4 that the discovery of deficiencies in the guidance
packages led to a meeting 15 on January 15, 1976, to discuss the draft
of the first "call-in Federal Register Notice" which was soon to be
published. The "Notice" had been prepared by Dr. Rogoff. Basically,
the purpose of the "Notice" was to inform pesticide manufacturers
which pesticide chemicals had "sufficient" data required for "full
reregistration" (category I), and which did not (categories II and
II). Dr. Wells said the meeting was held because, as he put it, "we
didn't know if all the [pesticide] chemicals listed in category I [in the
draft Federal Register Notice] belonged there." 0
Dr. Wells said that on January 21, 1976, he and Mr. Campt ex-
amined the chemical worksheets from which the information in the
draft "notice" had been drawn, and on January 22, 1976, recommended
that the "notice" not be published in its then present state.67
Mr. Campt stated that the review of the chemical worksheets
revealed that a number of the pesticide chemicals listed in category I of
the draft "call-in Federal Register Notice" as being "ready" for "full
reregistration" had to be shifted to categories II and III, indicating
that additional data was required, or to category V, indicated that the
data on the chemical had not yet been "assessed." He said it was then
that he and Dr. Wells realized how superficial the review of the safety
testing data files had been.
A hand-written document, entitled "Campt-Wells-Quick Review
of Worksheets--Jan. 1976," questioned numerous data waivers on
pesticide chemicals that had been proposed by Dr. Rogoff.
John M. Carley who at that time was in the Office of Program
Development and Evaluation, OPP, recalls that at least 180 of the
pesticide chemicals had to be removed from category L6
However, a special team was put to work on the guidance packages,
and 8 or 10 were salvaged an maled out during the first week of
February 1976. And the "call-in Notice"" also was hurriedly re-
worked and published in the Federal Register on February 17, 1976.
Mr. Carley stated that there were other "questionable" chemicals
which should have been removed from category I before publication,
03 Ibid.
64 Notv 44, supra.
Os Attending the January 15. 1976 mtwetlng were: Dr. Wells; Mr. Campt; Dr. Rogol; Dr. Jay Turlm, Dep-
uty Dlrector, Olv of Reguhtory atnd Poli Atfairs OPP Irwin Aierbach, Program Analyst, Office
Reguitory and Policy Affairs, OPP; an d Roaald E. Ireer, Acting Director, 0fMee of 8pwlM Pesticide
Reviews, OPP.
6 Note 42, supra.
47 Note 44, supru.
5* Note 46, supr-.
co "DI)a Rtqu frntA to Sripport RoiQtstion (and ReegWstrath) of PeAkide Actirr Ingreiento ( nd Pe-
liminary chdulr of CallIns," Pesticide Programs, Environmental Protection Agency, Fedral Register,
Feb. 17, 1976.





19


but, he added, "there wasn't time enough, and some slipped through
the cracks." Mr. Carley further stated that, in addition, the data gaps
listed in the "notice" also were "fouled up" .70
Reorganization of registration task force
On March 9, 1976, John B. Ritch, Director, Registration Division,
relieved Dr. Rogoff as head of the reregistration task force, and put
Mr. Carley in charge.
Mr. Carley reorganized the task force in an effort to increase
efficiency and productivity. A new and more permanent group of
personnel were assigned to the task force to replace the first group of
90-day detailees who had returned to their respective permanent
positions.
The task force still was faced with an almost impossible task of
completing reregistration by October 1977,'7 and they had to do so
in the face of the disorganized and incomplete data files, inaccurate
data computer printouts, insufficient personnel, and inadequate scien-
tific expertise among the personnel. And, because of these constraints,
there still was no serious attempt to validate the adequacy of the safety
testing data that would be accepted for reregistration of pesticides.
Ms. Elsie Kelly, one of only four toxicologists assigned to the task
force, stated:
You can't expect our [data] reviewers who have a fish and
wildlife background to evaluate a 2-year [animal] feeding study
[to determine if the results showed cancer]. We can't do a thorough
job on reviewing the data. We are playing games with side effects
from pesticides, and with the food for the population.72
In a memorandum dated July, 1976, Alejandro Arce, a task force
reviewer, stated to John Carley, manager of the task force:
I believe that you know the problem, [and] so does every-
body . . The most disturbing thing is to see that no one, or
very few of us have the courage to admit that there is a problem
and be frank about [it] and try to solve it in the proper way . .
Our problem is data. Our DATA is poor[,] disorganized, inac-
curate, lacking[,] etc. [AInd REREGISTRATION is nothing
more than finding the right data . . Out of every 100 pages
of data[,] a very low percentage (I will not dare to say how low)
is usable, understandable or scientific .... Do we have to
accept the data as it is, or do we have the right to comment, and
invalidate it, if it is inaccurate? There are many unanswered
questions about DATA, and while they are unanswered[,I we
will not be able to do the job. 7
Mr. Arce stated to subcommittee staff:
I knew things were being done wrong 6 months ago.;
The first thing we must do is organize the files. Until we do that
it is impossible to validate the data. 7
?0 Note 46, supra.
71 Note 14, supra.
72 Subcommittee staff interview of Ms. Elsie Kelly, toxicologist, reregistration task force, Registration
Division, OPP, Sept. 9, 1976.
73 Memorandum dated July 1976, from Alejandro Arce, reviewer, reregistration task force, Registration
Division, OPP, to John M. Carley, manager, reregistration task force.
74 Subcommittee staff interview of Alejandro Arce, reviewer, reregistration task force, Registration
Division, OPP, Sept. 9, 1976.





20


Wiiam Rabert, a biologist and data reviewer on the task force
stated:
I can cite a report [from the files] on a chronic feeding study,
but I can't evaluate it. This should be given to a toXicologist.75
While there were improvements in the operation of the reregistration
task force beginning in March 1976, most of the improvements were
of a clerical nature,76 and had virtually nothing to do with validation
of pesticide safety testing data by the task force. Yet in hearings
held by the Senate Subcommittees on Health and Administrative
Practice and Procedure on January 20, 1976, John R. Quarles, Jr., had
acknowledged that
intl.ethere are indications that serious problems may exist.
in the conduct of pesticide [safety] testing.77
Treatment of "suspect" pesticides
Shortly after EPA's Reregistration Task Force had gotten off to its
disastrous first start, the agency reorganized and redirected its pro-
gram to suspend and cancel (or reclassify) those pesticides suspected
of causing harmful effects. The Office of Special Pesticide Reviews
(OSPR), established in December 1975, was given the task of assuring
thorough review of these "suspect" pesticide chemicals. OSPR
replaced the Suspect Chemical Review rogram which had already
completed, or was near completing, evaluation of 70 "suspect'
pesticide chemicals, 78 some ofwhich had been under review since
1971.79 Since the creation of OSPR in late 1975, an addition 62
pesticide chemicals have been added to the "suspect" list, bringing
the total to 133.
A lengthy procedure 80 was developed by OSPR to determine,
first of all, whether the continued use of a "suspect" pesticide chemical
should be challenged through issuance of a "rebuttable presumption
against registration" (RPAR), or cleared for reregistration, and
secondly, ifa RPAR were issued, OSPR must coordinate and manage
an iudepth isk-benefit analysis of the use of the "suspect" chemical.
Following the analysis, the Administrator weighs the risks against
the benefits to determine whether the pesticide should be reregistered,
or removed from the market (or reclassified). But, like the Rereg-
istration Task Force, OSPR also has had serious difficulties. As late
a July 1976,1 EPA projected that by December 1976, OSPR would
75 Subcommittee staff interview of William Rabert, reviewer, reregistration task force, Registration
Division, 0 PP, Sept. 0, 1976.
76 The reregistration task force, as it was reconstituted in March 1976, initially spent much of its time
repairing and red rafting the 45 reregistration guidance packages which had been found to be seriously defi-
cient ard lcking in uniformity in Januar- 176; and it "review panel" was created to check the Wack.
ages f,)r stch things us uniformity and Justifications for data waivers.
7 Not( 15, supra.
Memorandum dated Dc. 9, 1975, from the Deputy Assistant Administrator, Office of Pesticide Pro-
grams, to the Administrator, EPA. The posticidos for which reviews had been completed, or were near corn-
pletion, izicluded 2,4,5-T (39 chemicals); ArsCif (15 chemicals); Ltad (one chemical); Deiiane I1exachloride
(one chemic l); L..dare (one chemical); Endrtn (one chemical); Strobane (one chemical); Tozaphew (one
chemical); Carbary! (one chemical); D)DVP (one chemical ; Chlorobeuz-atc (one chemical); EBDC's (6
c h e m i al s) ; a n dI P ic lo r air (o n e c h e mil ic a l) ..... ...
7h Memorandumi daled Dc. 9, 195, from the Deputy Assistant Administrator, Office of Pesticide Pro-
grams, to the Adniilsirator, EPA. Pesticides under review since 1117l included: 2,4,5-T (39 chemicals);
reviiic (1 chemicals); and lead (one chemical).
The RWA R prlovss runs for as long as 3 days: as much its (days for the "pr-RPAR" riod, during
which risks data is colklctd and analyzed, and collection of benflts data is begun; If RPA ris issued, the
next 1) days are ud to give the manufacturer of the pisticide chemical an opportunity torebut the RPAR
through subnis-ion of additlial data, for collection of benefits data, and for EPA to peo risk analysis;
the iwxt 60 days ,re used for risk benefit analysis; 30 days are then givi to USDA, the Scfrice Advisory
Board, the Science Advisory Policy Comnmittt-e when appropriate, and the appropriate House and Senate
('ominitte stal for review and commentS; and an additional 0 days is provided for the Administratorto
make a final df-ision oi whether he intends to cancel or props registration of the pesticide chemical.
R PA t candidate schedule, prepared by the Office of Special Pesieclde Reviews, July 1976.







have decided whether to challenge through the RPAR process the
continued use of 65 of the 133 "suspect" pesticide chemicals, or clear
them for reregistration. However, as of December 8, 1976, EPA had
issued RPAR's on only nine pesticide chemicals; two chemicals
were cleared for reregistration; and voluntary cancellations of five
pesticde chemicals were obtained from manufacturers82
A December 9, 1975 memorandum from the Office of Pesticide
Programs (OPP) to Mr. Train proposing the creation of the Office of
Special Pesticide Reviews, stated:
Pesticides which have already undergone intensive internal
review are scheduled for expedited action; they will be processed
as rapidly as possible .
The memorandum further stated:
Federal Regi8tr notice- ailnouncing either theft the pesticide'
(36 chemicals 8I) will be registered or that a rebuttable presulip-
tion against registration exists will be completed prior to I /17, 76.
However, as of December 8, 1976, some 11 months later, decisions
had not yet been made on whether RPAR's should be issued on 31 86
of the 36 "suspect" pesticide chemicals in order to determine whether
they should remain in use.
In the case of EBDC's, consisting of six of the 31 "suspect" chemicals
for which a decision on RPAR has yet to be made, EPA scientists
first recommended 17 revocation of EBDC's residue tolerances on foods
and cancellation of the use of EBDC's on food crops in 1971. Ethylee
thiourea (ETU), a degradation product of EBDO's, is a carcinogen,
and there presently are more than 70 tolerances established for
residues of EBDC's on such foods as beans, cabbage, lettuce, tomatoes,
peppers, celery, bananas, grapes, and apples. Moreover, it is important
to point out that the issuance Of a RPAR on EBDC's, or any "suspect"
chemical, only initiates the lengthy RPAR process of risk-benefit
analysis, and does not remove the pesticide chemical front the market.
When OSPR was first created in December 1975, it appeared as
though it would be given high priority. However, the support given
to OSPR, until recent months, indicates otherwise. Although EPA
82 As of December 8, 1976, those pesticide chemicals for which RPAR's have ben issued are: (1) Kpuae
(one chemical); (2) Chloroform (one chemical); (3) Chlorobenzdate (one chemical); (4) E'udrin (one chemical):
(5) BHC (one chemical); (6) ,.trychnine (one chemical); (7) Strychlnine Sulfate (one chemical); (8) 1080 (one
chemical); and (9) 1081 (one chemical).
As of December 8, 1976, those pesticide chemicals returned to the Registration Division are: (1) Piclt'ram
(one chemical) and (2) Sperm Oil (one chemical).
As of December 8, 1976, those pesticide chemicals for which OStP R obtained voluntary cancellations from
manufacturers are: (1) OMPA (one chemical); (2) Strobane (one chemical); (3) Aramite (one chemical), (4)
Kepme (technical grade); and (5) BuC (technical grade).
83 Memorandum dated Dtc. 9, 1975, from the Deputy Assistait Administrator, Oflice of Ptstiuide Pro-
grams, to the Ad-ministrator, EPA.
84 The pesticide chemicals listed in the memorandum included: Strobane (one chemical); Tozaphlne (ore
chemical); Carbaryl (one chemical); BIHC (one chemical); Lindaine (one chemical); EJidrin (one cheniicd);
Pictoram (one chemical); FBDC's (6 chemicals); Lead (one chemical); and Arsenic (22 chemicals).
85 Memorandum dated Dec. 9, 1975, from the Deputy Assistant Administrator, Office of Pesticide i'ro-
grams, to the Administrator, EPA.
0 The 31 pesticide chemicals for which decisions on RPAR had not yet Iwcii !iiade Ls of l)ec. 8, 1976, arS.
Toxaphtne (one chemical); Carbaryl (one chemical); Liwune (oI( chemical); EADU' (six chemiicals); Laid
(one chemical); and Arsenic (21 chemicals).
7 Memorandum dated Oct. 5, 1971, from Drew M. Baker, Jr., Chief, Petitions Control Branch, i'eticidel>
Tolerances Division EPA, to F. J. McFarland, Acting Director, Pesticides Tolerances Division, EI'A.
Memorandum dated Oct. 5, 1971, from Clara H1. Williams, Ph.1)., Chief, Toxicology Branch, Peticides
Tolerances Division, EPA, to Frank J. McFarland, Acting Director, Pesticides Tolkrales )iv ision, E 1'A.
Memorandum dated Oct. 7, 1971, from F. 3. McFarland, Acting Director, P1eticides Toleraces l)ivisioii,
EPA, to Dr. William M. Upholt, Deputy Assistant Adiisdiraor for Pesticides Progranms, FPA.


79-61M-76-4





22


had authorized 43 positions for OSFR in April 1976, it was forced to
operate for 9 months, through September 1976, at only 25 percent of
its authorized strength. Ronald E. Dreer, Acting Director of OSPR
since its creation, states that OSPR also has had serious difficulty in
obtaining on a timely basis thorough reviews of safety testing data
relating to human health hazard from the Criteria and Evaluation
Validation Comninittee.8s OSPR relies upon the validation reviews in
determining whether to issue RPAR's.
As a result of inadequate priority and resources given to OSPR,
evaluation of "suspect" pesticide chemicals, some of which were
identified years ago, has been still further delayed.

CONCLUSIONS
Poor playing and management with respect to pesticide regulation
within EPA is illustrated by:
(1) the lengthy delays in organizing its reregistration program ;
(2) the policy decisions of top agency officials to take shortcuts,
expecially the decision to restrict the scope of health hazard evaluations
which could not be supported by data in the agency files;
(3) the failure to adequately assemble and organize the agency's own
files on safety testing data;
(4) the failure to remove from critical data review positions personnel
who lacked adequate expertise to perform the scientific analyses
required;
(5) the failure to correct the woeful inadequacies as they came to
light;
(6) EPA's slowness in giving adequate priority and resources to
the Office of Special Pesticide Reviews; and
(7) the failure to inform the Congress and the public that the
agency, largely because of resource constraints, could not adequately
evaluate the safety testing data for reregistration of pesticides.
EPA today still lacks the resources, personnel and capability to
perform the statutory requirement of ensuring the safety of pesticide,
while at the same time performing speedy registration and
reregistration.
The Criteria and Evaluotion VaIidation Committee is made up of the branch chiefs of the Criteria and
Evluation I)iviion, Olice of Pesticide Progrms, EPA.












IlI. LENGTHY DELAYS IN CORRECTING SERIOUS
PROGRAM DEFICIENCIES
Regulation of pesticide use by the Federal Government is critically
dependent on the safety testing data submitted by the firms that
manufacture and market pesticides. EPA's pesticide program cannot
even begin to fulfill its purpose if the data upon which it relies for
regulatory decisions are deficient, incomplete, or otherwise faulty.
EPA almost exclusively relies upon data submitted by the pesticide
companies. This data is the informational linchpin in the agency's
regulatory program. Yet, in spite of repeated warnings beginning at
least 5 years ago that the data it was relying upon was faulty, EPA has
failed to take corrective action designed to discover and supplement
faulty data. Attempts to improve these program deficiencies have
fallen victim to unnecessary delays. And, as a result, the pesticide
rerecistration program is in a state of chaos, and the American people
cannot be reasonably a sured that the Federal Government is pro-
tecting them from pesticides that pose a serious threat to their health.
Early warnings went unheeded by EPA
Official criticisms of the adequacy of data and data reviews used to
support Federal approval of pesticides began many years ago. In
1969, the House Committee on Government Operations issued a re-
port, "Deficiencies in Administration of Federal Insecticide, Fungicide,
and Rodenticide Act" (Fountain report),"9 which strongly criticized
the administration of the pesticide laws by USDA. The report, among
other things, concluded:
Numerous pesticide products have been approved for registra-
tion over objections of the Department of Health, Education, and
Welfare [FDA] as to their safety without compliance with re-
quired procedures for resolving such safety questions.90
The report recommended that "USDA take prompt action to make
certain that pesticide products are not registered or reregistered unless
there is adequate assurance that they are safe and effective." "
As a result of this criticism, regulation of pesticides was transferred to
the newly created EPA in 1970. Also in 1969, the Report of the [HEW]
Secretary's Commission on Pesticides and Their Relationship to
Environmental Health (Mrak report)92 was published. This report
criticized the adequacy of data which had been accepted to register
pesticides by concluding that much of this data did not demonstrate
that the chemicals posed no serious human health hazards, and ac-
cordingly recommended that "immediate steps be taken to require
orderly testing of tumoragenicity" of many specific pesticides."
89 "Deficiencies in Administration of Federal Irascticide, Fungicide, and Rodenticide Aet," by the House
Committee on Government Operations, based on a study made by its Intergovernmental Relations Sub-
committee, L. H. Fountain, Chairman, Nov. 13, 1969.
90Ibid.
V1 Ibid.
92 Report of the Secretary's Commission on Pesticides and Their Relationship to En vironmental Health,
Parts I and II, U.S. Department of Health, Education, and Welfare, December 1969.
"Ibid.
(23)






24


Following these official warnings of data deficiencies, EPA's own
limited actions confirmed the inadequacies of existing pesticide safety
testing data.
One of the earnest warnings arising out of EPA's own limited ac-
lions came a early 1971, when the agency's own review" revealed
deficiencies in the data that had previously been used to register the
pesticides Aidrin and Dieldrin. and hieptachlor. The review showed
that the three pesticides had the potential for causing cancer, and
ultimately led to the removal of Aidrin and Dicidrin from the market
in October 1974.1
In 1974, an EPA review of data, which had previously been ac-
cepted by EPA as proving the safety of the pesticide Chilordane,
revealed that the chemical in fact had the potential for causing
cancer. Most uses of Heptachlor/Chlordane were suspended in Decem-
ber 1975.97
EPA received formal and additional warning in the late summer
of 1975 front the General Accounting Office in a report which
concluded:
Adequate data supporting the safety of many pesticide toler-
,aces have not been submitted, and data on many pesticide
residues is not available.8
The GAO report recommended that EPA review the "adequacy"
(f the data used to Sul)l)ort "all existing tolerances," and that the
agency "require manufacturers to submit any missing data." ,
EPA agreed with GAO's criticisms, and stated that it would imple-
ment the recommendations.c
It is important to point out that much of the very same data which
have been relied upon over the past 22 years to make findings of the
safety of pesticide residue tolerances also have been used to support re-
registration of pesticides. Nevertheless, as pointed out in section II
of this report, the review of the data for reregistration, from the
begining of the reregistration program in October 1975 to its collapse
in Aigust 1976, has been at best superficial. And EPA has yet to begin
a systematic review of the more than 4,000 existing tolerances for
iesticide residues on numerous food and feed commodities.
Recton dtcatiows of "serious probtein-" in safety testing
In early January 1976, shortly before reregstration was hated be-
(ause of superficial d1ata review, the subcommittee invited John R.
Quarles, Jr., Deputy Administrator of EPA, to testify at hearings
4heduled for January 20, 1976. Mr. Quarles was invitd to testily
along with ri)resentativ(Js of the Food and Drug Administration and
the national Cancer Institute. Previous joint inquiry by the Sub-
coMiimttees on Health and A(iministrative Practice and Procedure
into 14)A's approval of new drugs had revealed that the reports to
1)A on safety testing of drugs in animals performed by at least two
"4 Or. Melvin I. R'U Lwb a jathology rwisiliat to E'A, reviewed the tl sue s1jt(s friou ninl fetIng
stlis w, AldHrilu iDdrin and epl-lor in 1971 at the request of EPA.
,5 Aldriu heldrll tuje were Suspended by order of the Administrator, EPA, Oct. 1, 1974, 89 F.R. 372M,
Oct. IS. 174l.
WDr. lvii I). RIOUhtr, 'L aLiolog cousultit to EPA, reviewed th tissue slides from ain l fading
1tudts on .$herdane in 1974 at the request of EPA.
' Mt useW of It I) /(,da Chlordane wr suspended by order of the A dinistrator, E PA, Doe. 24, 1075,
'L clarified by order of thi Admindstrator, EPA Jan. 1N, 1978, 41 F.R. 7552, Feb. 19, 1976.
4No4 9, ,ijpra. A dr-l ol the OAt report was trznsmitted to EPA in tho smilmr of 1975.
Ibid. ....
' Note 9, upra. EI'A resprnnded to thi, () draft reprt in a 1otter dated Sept. 17, 1976.






25

private laboratories were suspect. Like FDA, EPA relies upon reports
from private laboratories to determine whether pesticides released
into the environment have the potential for causing harmful effects.
Shortly before Mr. Quarles was to testify, EPA's Office of Pesticide
Programs (OPP) hastily organized an effort "to make a preliminary
determination as to whether there [was] any evidence of irregularity
or impropriety in pesticide testing." 101 An "action plan" called for a
Small group" of EPA and outside scientists to review pesticide safety
testing reports submitted by manufacturers on the 43 pesticide active
ingredients for which residue tolerances had been established on "the
greatest numbers of (food and feed) commodities." 102
Dr. Melvin D. Reuber, a pathologist consultant to EPA, verbally
presented the preliminary findings of the data review to a group of
agency personnel who were preparing Mr. Quarles' testimony. Dr.
Reuber told the group that the review thus far had revealed such
deficiencies as inadequate pathology (lack of adequate examination
of tissue from animals fed the pesticides in tests), poorly tabulated and
summarized data, and insufficient data from which to make a judg-
ment. He advised the group that review of the data should be pursued
further. "I
Mr. Quarles gave the following testimony before the subcommittee
on January 20, 1976:
[Tlhere are indications that serious problems may exist. For
example, in recent hearings on Heptachior/Chlordane '1 and
Aidrin]Dieldrin,'06 we found that many of the laboratories which
had completed chronic toxicity [safety testing] studies performed
extremely conservative histologic examinations. In virtually
every instance, independent pathologists diagnosed many more
cancerous and precancerous tumors in the test animals than did
the original laboratory pathologists.
These situations coupled with a recent preliminary review of
several toxicity studies submitted to EPA have alerted us to the
possibility of serious deficiencies in the conduct of pesticide
testing. '6
Mr. Quarles failed to mention that some of these "indications" of
"serious problems" dated as far back as 1971.
Mr. Quarles further testified:
We . have now undertaken a crash effort which we will
attempt to carry out within the next 4 to 6 weeks . [and]
primarily we will be conducting reviews of the test data that we
have.107
10 Memorandum dated January 1976, from Edwin L. Johnson, Deputy Director Office of Pasticide Pro-
grams, to Alvin L. Aim, Assistant Administrator for Planning and Management, kPA.
12Ibid.
1Subcommittee staff interviews of Dr. Melvin D. Reuber, consultant to EPA, on Feb. 6, 1976, and Oct.
12, 1976.
10 EPA conducted administrative hearings from August 1975 to December 1975 on the proposed sus-
pension of Ileptachlor/Cblordane uses. Administrative hearings for cancellation of Heptachlor/Chlordane
uses began in February 1975, and are still continuing.
103 EPA conducted administrative hearings from April 1971 to August 1974 on the proposed suspension
of Aldrin/Dieldrin uses. Administrative hearings for cancellation of Aldrin/Dieldrin uses were held from
July 1975 to February 1976.
l Testimony of John R. Quarles, Jr., Deputy Administrator, Environmental Protection Agency, before
Joint hearings by the Subcommittee on Uealth and the Subcommittee on Administrative Practice and
Procedure, Jan. 20, 1976.
10 Ibid.





26


"Crah program" is scated down
Following the hearings, EPA set up a "Working Group on Pesticide
Testing." s On February 9, 1976, the Chairman of the new Working
Group recommended that a group of scientists and statisticians
examine testing reports "on 58 randomly selected pesticide chemicals
for which residue tolerances [had] been established," and that
following the examination of the test reports, the findings should be
compared with the previous reviews for tolerance setting in order "to
determine the extent to which the original reviewers [at FDA and
EPA] identified the same errors and to ascertain the action taken in
such cases." 109
On February 11, 1976, at the first meeting of the Working Group,
"concern"l was expressed over the data being used for reregistration of
pesticides.110
Then, on February 17, 1976, FDA suggested to EPA that, based
on FDA's experience, an audit of test records at the laboratories
would prove to be more fruitful than a review of test reports only.''
And following that meeting, EPA expanded its plan to include a
laboratory audit plan.
Subsequently, XTr. Quarles commitment to the subcommittee on
January 20 to undertake a "crash effort" to conduct reviews of test
data in EPA's files was scaled down considerably. As it turned out,
Dr. Reuber alone was assigned to examine the files on only 23 of the
originally chosen 58 pesticide chemicals. Moreover, Dr. Reuber was
not assigned the task until mid-February, almost a month following
the January 20 hearings, and he was able to spend less than 3 weeks
reviewing the safety testing reports.
Serious problems in safety testing are confirmed
Dr. Reuber revealed to the Working Group on March 11, 1976,
that, even in his very limited and scaled down review, he had dis-
covered an alarming number of serious deficiencies in the testing
reports, as well as a lack of sufficient data from which a judgment
could be made. Among the deficiencies he noted were: (1) too few
animals used in some of the tests; (2) incomplete examination of the
animal tissue; and (3) in one study, the number of rats at the end of
the test period was larger than the number of rats at the beginning of
the test."2 Dr. Reuber's findings further confirmed in more detail what
306 Memorandum dated Jan. 22, 1976, front Edwin L. Johnson, Deputy Assistant Administrator, Office of
Pestcide Pro.rams, to Dr. Roy Albert, Chairman, Caer ssssent Group, EPA, Alvin L. Al-, Assist-
ant AdIministrator for Planning and Management, EPA, Jeffrey E. Howard, Assistant General (ounsel,
EPA, Augustine E. Conroy, II, Director, Pesticides Enforcement Division, Office of Enforcement,
EPA, and John B. Ritch, Director, Refistration Division, OPP, EPA.
Members of the Working Group included: Erwin L. Auorbach, Chairman of the Wori Group
Program Analyt for OPP; Dr. Orville E. Paynter, Chief, Toxicology Branch, Registration Divison, OPP;
Dr. Williar I. Preston, Deputy Director Criteria and Evaluation Dvlsion, OPP; Anthony
Cortese, Office of 1'lanning and Evaluation, O1ce of Planning and Management; Doreen Hill, Health
Effects Officer, Office of Rearch and Ieveopment; Bigham Kennedy, staff attorney, Office of General
Counsel; Kenneth utteriAn, Ecologist, Pesticides Enforcelnent Division, Office of Enforcement; and
Ms. Carter Schuth, Scienti4, Office of Toxic Suhstances.
'O Memorandum dated Feb, 9, 1976, fnrn Irwin L. Auerbach, Chairman, Worldng (roup on Pe.sticide
Tetting, and Program Analyst, OPP, to the EPA Working Group on Pesicide Testing.
I ) Memorandurm dated Mar. 30, 1976, from Ms. Carter Schuth, member, Working Group on Pesticide
Tmstng, and scientist, 01hce, of 'Ioxic Substances, EPIA, to Dr. Michael J. Prival, Acting Chief, Chemical
Testing Branch, Office of Toxic Substances, EPA.
M Mem orandum dated "wvek of 2/23/76" from Anthony 1). Cortese, member, Working Group on Psticide
Testing to Alvin L. A I, Assisiant A administrator for Planning and Manaement, EPA.
16 Subcommittee staff interviews of Dr. Melvin D. Reuber, pathology consultant to EPA, on Mar. 5,
1976, and Oct. 12, 1976.





2V7


he and three other scientists had previously discovered prior to the
January 20 hearings.
However, Dr. Reuber was never asked to examine the prior re-
views performed by FDA and EPA scientists relating to the testing
reports on the 23 pesticides he had evaluated. The purpose for ex-
amining the prior reviews, contained in the "correspondence files,"
as the chairman of the Working Group on Pesticide Testing had
stated in his memorandum of February 9, 1976, would have been
"to determine the extent to which the original reviewers identified
[deficiencies in the test reports]," and more importantly, "to ascertain
the action taken in such cases." 113
In the meantime, by March 11, 1976, the reregistration task force,
without having evaluated the previously submitted data, had already
mailed to manufacturers guidance packages for 393 pesticide products
advising that existing data was "sufficient" for reregistration, and
which additional data was required.114 And of the 393 products, 136
relied upon data which Dr. Reuber's scaled down review had found
deficient.
The Working Group on Pesticide Testing met for the third time on
March 17, 1976. Among those in attendance were Dr. George Whit-
more of the Registration Division's Toxicology Branch, and Dr.
Martin H. Rogoff, who had been relieved as head of the Reregistra-
tion Task Force on March 9, 1976. A memorandum by Ms. Carter
Schuth, a member of the Working Group, stated that at the meeting:
[Drs. Whitmore and Rogoff] both objected strongly to Reuber's
findings. Whitmore [said] that the data [is not] as bad as Reuber
described. . [Dr. Rogoff] assured the Work Group members
that all the problems that have been mentioned are being taken
care of in the reregistration process.115
Failure to follow up in a timely and adeTuate manner
It was not until April 5, 1976, almost a month after Dr. Reuber had
reported serious deficiencies in the testing reports to the Working
Group on Pesticide Testing, that there was any attempt to examine
the correspondence files which contained prior reviews of data sub-
mitted by manufacturers. One person, Ms. Carter Schuth, a member of
the Working Group, was assigned to review only a small sampling of
correspondence files in preparation for Mr. Train's testimony before
this subcommittee scheduled for April 9, 1976. On April 7, 1976,
Ms. Schuth reported 116 her findings which indicated that FDA and
EPA scientists, in prior reviews (some dating back to the early fifties),
had discovered deficiencies in the testing reports similar to those
113 Note 109, supra.
114 List of Guidance Packages Mailed to Registrants, dated Aug. 5, 1976, and issued by the Standards and
Labeling Section, Registration Division, EPA.
115 Note 110, supra.
M Memorandum dated Apr. 7, 1976, from Ms. Carter Schuth, member, Working Group on Pesticide
Testing, and scientist, Office of Toxic Substances, EPA, to Irwin L. Auerbach, Chairman, Working
Group on Pesticide Testing, and Program Analyst, OPP, EPA.
117 The deficiencies included:
1. Low survival rate of experimental animals; 2. Premature sacrifice of animals or termination of experi-
ment; 3. "Uneven" number of animals in (testing) groups; 4. Failure of petitioner to report statistical
significance of differences in experimental (those fed the pesticide) and control (those not fed the pes-
ticide) animals; 5. (Pesticide) (d)ose level too low; and 6. Inadequate bistopathological examination of
(animal) tissues; questionable histopathological findings; failure to report histopathology on all tissues
sectioned; failure to perform histopathological examination of tumors in control animals; and tumors
termed benign without histopathological examination.





28


which had been cited by Dr. Reuber after his examination of the
reports in late February and early March. But, prior to the April 9
hearings, no attempt was made, as had been suggested on Feb-
ruary 9, 1 to determine what action had been taken.
The hearings on April 9, 1976, were held as a followup to the Janu-
arv 20 hearings at which Mr. Quarles had testified that "there are
indications that serious problems may exist" in pesticide safety test-
iig and that EPA had "undertaken a (4 to 6-week) crash effort"
to better determine the severity of deficiencies in previously submitted
testing reports and data."' On April 9, 1976, Mr. Train submitted to
the subcommittee an "interim" report on Dr. Reuber's review of
safety testing reports in which Dr. Reuber stated that, because of
"severe time restrictions placed on [his] effort," he had been unable to
write an "in-depth review of each of the [pesticide] chemicals," and
that he was unable to analyze whatever raw data was available on
the tests.20 An EPA "statement" attached to Dr. Reuber's report
pointed out that FDA and EPA scientists, in prior reviews, also had
cited deficiencies similar to those discovered by Dr. Reuber, and the
"statement" went on to say:
Such deficiencies commonly are the basis for EPA requests that
petitioners (manufacturers) provide additional information and/
or clarification.121
EPA testified before the April 9 hearings as follows:
Senator KENNEDY. Can you tell us when the reviewers did
pick those (deficiencies) up, (and) what action was taken? Did
you consider that?
Mr. [Edwin L.] JOHNSON.22 We have considered it. That is
an aspect, as I have indicated, we have not had sufficient time
to get into in any detail.
Senator KENNEDY. Your reviewers found these discrepancies
and you have indicated that many of these discrepancies were
significant, but you are unable to tell us now what was really
done about it after these discrepancies were found. Do I under-
stand you correctly?
Mr. JOHNSON. I cannot tell you in detail what was done.
That is one of the things we are looking into.
Mr. Train testified that EPA hoped to begin an "auditing program
[by July 1, 19761 in which laboratory records of toxicity test reports
will be examined to determine whether they accurately reflect the
reported test procedures and results." 124 1t was not until December
1976 that a limited pilot auditing program 121 finally got underway,
In spite of the fact that by April 9, 1976, EPA had gone ahead and
I See text ackompanying ziote 1W.), supra.
SNotv 106, supra.
RovePiew of Toxicity Test Results Submitted in Support of Pesticide Tolvrance Peot tions, by Melvin 1).
Reubr, M.D., for the U.S. Envirorunental Protection Agency 0111cc of Pesticide Program, Apr. 9, 1976
SNoto 120, supra. EPA stztmnIWlt regarding Dr. Reuber's report. Apr. 9, 19176.
I: I)epulty Assiitau t. AdImiiistrato ,Office of Pesticide Programs, EPA.
I Testimony before Joint hearings by the Subheonmittee on Health and the Siubtronimee on Admwin-
isrative Practice aid Procedure, Apr. 9, 1976.
12 Ibid.
"- Initially, EPA's inatenion wi to have the laboratorivs audited by a private contractor. However, iii
June 197, EPA hgan nJegotiatil with FI)A to perform the audit-;, since FDA was undertaking a s8milar
program and could perform EPA labor's atory audis at a lower cot than a private contrator FDA has
znforlnloI suibrolhmmittom !iff1 1hat a "pilot" laora ory audit ogrmm was scheduled to begin on or about
I)e enber 1, 1976, with a full ocale prigmn to follow ill about 3 months.






29


mailed reregistration guidance packages to the manufacturers of
1,257 pesticide products without having validated the testing data
cited in the packages as being "sufficient."
Following the April 9 hearings, the chairman of the Working
Group on Pesticide Testing urged that EPA take the following action:
Case histories on at least some of the pesticides covered by
Dr. Reuber's review must be prepared. EPA can anticipate that,
sooner or later, it will be called upon to specify what actions have
been taken over the past 25 years on the basis of the test reports
that Dr. Reuber reviewed.126
EPA's subsequent effort to answer the critical question of what
action had been taken on deficiencies in testing reports and data was
grossly inadequate. In mid-April, 1976, Ms. Carter Schuth, alone
and on a parttime basis, was assigned to begin reviewing the corre-
spondence files which contained the prior reviews of data by FDA
and EPA scientists.
EPA's belated examination reveals that agency failed to act on inadequate
safety data.
By early May 1976, EPA had uncovered some alarming facts in
the first review of correspondence files pertaining to Methoxychlor, a
pesticide chemical of which approximately 10-million pounds have
been produced in the U.S. annually in recent years, and for which 79
food and feed residue tolerances had been established since 1955.
Ms. Schuth found that over the years prior reviews by FDA and EPA
scientists had criticized the safety testing that had been done on the
pesticide, as well as the interpretation of the testing results. In fact,
on several occasions reviewers had called for repeating certain animal
feeding studies in order to determine the safety of Methoxychlor, but
apparently there was no followup by EPA.127 Moreover, an FDA
pathologist in 1969 had concluded, after reviewing a feeding study
utilizing mice, that Methoxychlor was a carcinogen (cancer-causing),128
and in 1972 two EPA pathologists reached the same conclusion.'29
Nevertheless, the 79 residue tolerances established since 1955 have
thus far gone unchallenged by EPA, despite EPA's findings in other
cases that there is no known safe level of exposure to chemical car-
cinogens. Moreover, in October 1973, EPA granted a residue toler-
ance for Jethoxychlor in cow's milk for human consumption.30 In
addition, much of the very same data criticized in previous reviews
was cited as "sufficient" in reregistration guidance packages that had
been mailed on March 9, 1976, to manufacturers of 72 pesticide
products containing Methoxychlor.'3'
By early June 1976, Ms. Schuth had completed a review of the
correspondence files on Captan, a widely used pesticide chemical of
which approximately 18 million pounds have been produced annually
126 Memorandum dated Apr. 13, 1976, from Irwin L. Auerbach, Chairman, Working Group on Pesticide
Testing, and Program Analyst, OPP, to Edwin L. Johnson, Deputy Assistant Administrator, OPP.
127 Note 20, supra. Attachment No. 1, "Review of the Tolerance Correspondence Files for Nlethoxychlor."
See appendix.
128 Memorandum dated Sept. 15, 1969, from Dr. M. Adrian Gross, Bureau of Science, FDA, to Dr. 0. G.
Fitzhugh, Toxicological Adviser, Bureau of Science, FDA, "SUBJECT: Project 2-00)3-04-Chronic Toxicity
of Chlorinated Hydrocarbon Pesticides-DDT and Methoxychlor-Analysis of Pathology Results."
128 Note 127, supra.
130 Ibid.
Is' Note 114, supra.





30


in the U.S. in recent years and for which 70 food and feed tolerances
have been granted for residues on such foods as apples, beans, carrots,
lettuce, grapes, and corn. A notice 132 published by EPA in the Federal
Register on February 17, 1976, had placed Captan in "category I,"
indicating that data previously submitted by the manufacturer had
met all requirements for "full" reregistration. Yet, as in the case of
M11ethoxychior, prior reviews had criticized the data submitted to prove
the safety of Captan, and additional data were requested, but the
record indicates that none were provided. The Schuth review further
revealed that in 1969, "interim" Captan tolerances for five food com-
modities had been granted for a period of 6 months on the condition
that data needed to prove the safety of the tolerances would be pro-
vided by January 1, 1970. However, the data was never provided, and
the "interim" tolerances on pineapples, potatoes, beans, almond hulls,
and almond nuts are still in force today, 6 years later.133
The third and final review performed by Ms. Schuth was on the
Ferbam correspondence files, which was completed in mid-June 1976.
Once again, it was shown that data, which had previously been ac-
cepted in support of 64 Ferbam residue tolerances on food commodities,
had also been criticized by FDA and EPA reviewers. 114 And, on April 14
1976, guidance packages citing the questionable data as "sufficient"
for reregistration had been mailed to manufacturers of 45 pesticide
products containing Ferbam.35
High level personnelfail to take timely action
By early June 1976, Edwin L. Johnson, Deputy Assistant Ad-
ministrator, Office of Pesticide Programs, had been briefed verbally
on the findings of the Schuth reviews, and, finally, in writing on
June 28, 1976:
A limited examination of the files already has indicated that
FDA/EPA scientists in the past raised what appear to be serious
questions about the adequacy of toxicological data; in the cases
reviewed thus far, there is no record to indicate that these ques-
tions ever were resolved. Reregistration is the appropriate mech-
anism for dealing with them. No matter how the legislative history
is read, EPA would be hard put to rationalize a decision to dis-
regard information in its own files, particularly after recognizing
that such information may in many cases raise questions as to
whether reregistration should be issued.'
It was recommended to Mr. Johnson that an "ad hoc gup .,,
be set up immediately" to review the correspondence fles on 'all
other pesticides for which there are-or were-tolerances or exemptions
from tolerance requirements," and that a "concrete plan" for the
Registration Task Force to consider the findings of the reviews "be
prepared as soon as possible." 1
"3 Note 69. supra.
3 Note 127, supra. Attachment No. 2, "Review of the Tolerance Correspondence Files for Captain." See
appenlix.
134 Note '20, Train letter, supra. Attachment No. 3, "Review of the Tolerance Correspondence Files for
Fertmm. Se appendix.
I Note 114, supra.
'm Mpnorandui dated June 28,1976, from Irwin L. Auerbach, Ms. Carter Bchutb, and Bih Kenedy
to Edwin L. Johnsn, Deputy Assistant Administrator, Office of Pesticide Programs,
13 Ibid.








In spite of the various problems, high level personnel in EPA ap-
parently never demanded timely explanations from those most familiar
with the programs' shortcomings. Mr. Quarles was not briefed 138 on
the problems in the reregistration and tolerance setting programs until
July 12, 1976, over a month after the inadequacies in these programs
had become evident to the Office of Pesticide Programs, and 12 days
following Chairman Kennedy's written request to Mr. Train for in-
formation on the two programs. And, it was not until July 28, 1976,
that the Office of Pesticide Programs briefed Mr. Train on the
gross inadequacies of the safety testing data reviews in the reregis-
tration program.19 When Mr. Train finally did focus on these problems,
the information he received was in many respects quite accurate. He
was candidly informed that the original assumptions underpinning
EPA's regulatory efforts in the pesticide area were simply invalid.
EPA had assumed that pesticide safety testing had been properly
performed, that test data had been reviewed according to current and
valid scientific standards, and that even those problems with the data
which had been identified by previous reviewers had been resolved
or corrected.
The facts, of course, were far different than the assumptions, and
these facts were pointed out to Mr. Train in late July.140 The problem,
however, was that the facts were presented as something entirely
new and surprising, when they had actually been known to the agency
for quite some time. The 1969 Fountain report, the 1969 Mrak re ort,
the AldriniDieldrin and Chlordane/Heptachlor cases spanning From
1971 to 1975, and the GAO report to the Congress in late 1975 could
have left no doubt in anyone's mind that there were serious deficiencies
with data EPA had relied upon to reregister pesticides and grant
residue tolerances. And, since the Schuth reviews of the correspondence
files had begun almost 4 months prior to the briefing of Mr. Train
on July 28, 1976, and completed by mid-June 1976, it was hardly
accurate on July 28 to characterize all this as "new developments."
On July 28, 1976, Mr. Train also was told:
Scientific and regulatory standards have changed substantially
over the past 25 years. Not only are more tests required; in addi-
tion, testing is expected to be more thorough and sophisticated.
Techniques for detecting adverse effects have improved. Scientific
thinking regarding interpretation of observed changes in test
animals has changed.'4'
It is hard to understand how this obvious observation was not
known to EPA at the time of its formation in 1970 [one year after the
Fountain and Mrak reports], and in 1974 when the initial assumptions
concerxing the adequacy of data were made, or in January 1976 when
Mr.. Quarles testified before the subcommittee, or in April 1976
when Mr. Train testified before the subcommittee.
Failure to commit adequate or appropriate resources to correct problems
Finally, on July 28, what EPA proposed to do about all this had in
fact been recommended, but not acted upon, nearly a month earlier.
131 Memorandum dated July 9, 1976, from Irwin L. Auerbach, Chairman, Working Group on Pesticide
Testing, to Edwin L. Johnson, Deputy Assistant Administrator, Office of Pesticide Programs.
130 Paper entitled "Briefing for the Administrator," July 28, 1976, Office of Pesticide Programs, EPA.
140 Ibid
141 Note 139, supra.





32


An "ad hoe" group, consisting of six Registration Division personnel,
was told to examine correspondence files on additional pesticides-to
pick up where Ms. Schuth left off in mid-June 1976. However, the
group was plagued with serious difficulties from the very start. At
least two of the reviewers, an entomologist and a plant pathologist,
did not have sufficient expertise to determine whether prior reviewers
had dealt adequately with deficiencies in hunian safety testing data.
Moreover, the group also was seriously hampered by the data files
themselves, which were, and still are, incomplete and disorganized.
Yet, in spite of the many obstacles confronting the "ad hoc" group
during its 2 months of work, it did discover deficiencies and question-
able decisions in prior reviews of safety testing data similar to those
which had been revealed in the Schuth reports 3 months earlier.
The reregistration program collapses and EPA concedes
Finally, on August 9, 1976, the reregistration program was halted 2
for the second time in 8 months. The collapse of the program came
after 72 reregistration guidance packages, covering 2,527 pesticide
products, had been mailed to manufacturers without the safety
testing data, cited in the packages as "sufficient" for reregistration,
having been adequately validated.
In early August, personnel were assigned to formulate revisions in
the reregistration program, and shortly thereafter put forth a number
of recommendations, including: (1) the compilation of a "chemical
review file" for each pesticide chemical, which would include such
new information as summaries of prior reviews, use history, inputs
from other sources (outside the agency), and the compiler's observa-
tions, notes, and comments; and (2) the creation of a chemical review
file "review panel," which wouldjpass on the adequacy of all of the
data and information collected." This proposal was approved by
those responsible for the programi4
On August 20, 1976, in a letter to Chairman Kennedy, Mr. Train,
citing "recent developments," confessed that the "assumptions" under
which the program had been conducted were "questionable," and stated:
We have, therefore, determined that prior reviews of toxicological
data must be examined and assessed as an integral part of the
reregistration process. ... It is expected that a detailed plan
will be completed early next month. [Emphasis added.]
Mr. Train further stated:
We have not yet undertaken a systematic review of the
tolerance petition files to determine whether to suspend or modify
existing tolerances. A thorough review in this area is needed and
will be undertaken after the reregistration process is finished.""
[Emphasis added.)
2'Memorandum dat4d August 9, 1976, from Dz)uglas D. Campt, Associate Director, Registration Divi-
sion, OPP, to Product ranch Chiefs and Acting Chief Product Control Branch, Registration Division.
'4 Meminondum date( Augst 10, 1976, from Douglas D. Campt, Associate Director Registration Divi-
sion, OPP, Ir. William Wells, Chief, Standards and Labeling Sction, Registration Division, OPP, and
John M. Carley, Man;ger, Rereistration Taqk Force, Registration Division, 0PP, to John B. hitch,
Director, Rlgistration Division, OP'.
14 MemoNrndum dated August 13, 1,76, from Edwin L. Johnson, Deputy Assistant Administrator, OPP,
to John 13. Rich, Directur, Registration Division, OPP.
J48 Note 2o, supra.
IdNote 20, supra.






33


However, the "detailed plan" referred to by Mr. Train, and pre-
sented to Mr. Quarles on September 3, 1976, projected that, with a
work force increased from 23 to 56 personnel, reregistration would
not be completed until July 1979.'47 This would have meant that a
"systematic review" of residue tolerances would be delayed for an
additional 3 years. Yet, in September 1975, EPA had promised GAO
that it would begin a "reassessment of tolerances." 148
Tolerance-setting program also deficient
Although the subcommittee concentrated its inquiry on the re-
registration program, it appears that the same problems that have
plagued reregistration also plague EPA's tolerance-setting program.
The setting of tolerances for pesticide residues in and on foods and
feeds is, of course, an EPA responsibility as vital as reregistration,
and faults in the former have potentially disastrous implications for
human health. Yet, as of September 1976, EPA proposed not to begin
performing a "systematic review" of the more than 4,000 existing
residue tolerances until 1979.
The tolerance-setting program, like reregistration, appears to
receive EPA attention only when it is criticized and questioned by
outside parties. In 1975, for example, the GAO's criticism of EPA's
tolerance-setting procedure did lead to the drafting of an EPA paper
in late 1975 on the "United States Pesticide Tolerance System." 149
The paper was an attempt to describe in detail the standards and
criteria for setting pesticide residue tolerances in and on foods and
feeds, something which had never been done in the history of the
agency. However, this important task was given very low priority,
and has yet to be completed. One of the authors of the first draft of the
paper wrote later:
Further development of the manuscript will be given low
priority unless you believe the additional effort is worth the
candle. The protracted clearances through OGC [Office of
General Counsel], FDA and USDA and the delay in publication
might cause the paper to be obsolete anyway.150
It was not until the summer of 1976, 8 months later, that work on the
paper was resumed, and it is not expected to be completed until early
January 1977.
After repeated inquiries from subcommittee staff this fall, the Office
of Pesticide Programs has promised to perform a limited review of
tolerances beginning on January 1, 1977, in conjunction with the
reregistration program. EPA hopes to commence a systematic review
of previously set tolerances by the beginning of 1978, after completing
an assessment of the scientific basis for establishing tolerances.
147 Paper entitled "Briefing Agenda-Sept. 3, 1976," Office of Pesticide Programs, EPA.
143 Note 21, supra.
149 Paper entitled "United States Pesticide Tolerance System," November 11, 1975, by Dr. Orville E.
Paynter, Joseph G. Cummings, and Dr. Martin H. Rogoff, Registration Division, EPA.
1Modum dated December 18, 1976, from Dr. Orville E. Paynter, Chief Toxicology Branch,
Registration Division, OPP, to Dr. Martin H. Rogoff, Pesticides Science Officer, Registration Division,
OPP, and Joseph G. Cummings, Chief, Chemistry Branch, Registration Division, OPP.






34


CONCLUSIONS
EPA failed to recognize and respond to early and repeated warnings
that the data it was relying upon were faulty and incomplete. As a
result, EPA went ahead and approved as "sufficient" data for reregis-
tration of numerous pesticide products-data which may not only
prove to be insufficient, but may also prove the products to be unsafe.
Moreover, EPA failed to consider previous critiques of safety testing
data in its own files, and in most instances failed to even read the
critiques. Top-level agency personnel dragged their feet in responding
to these problems as they became known, and the meager responses
to correct the problems have been too little too late.
The reregistration program's deficiencies also infect the tolerance-
setting program. The net effect of these deficiencies is the probability
that many of these pesticide products now on the market would be
found to be unsafe if EPA regulated pesticides the way it is required
to under the law.
EPA's failure to validate testing data for purposes of reregistering
pesticides has caused needless and costly delay in determining to what
extent pesticides currently on the market cause such adverse effects as
cancer, birth defects and interference with biological reproduction.
This delay has potentially prolonged the widespread use of some
poisons dangerous to health and the environment, and will result in
unnecessarily raising the costs of compliance for pesticide manu
factures.
Despite its promise to GAO in September 1975, EPA has yet to
begin a review of the more than 4,000 pesticide residue tolerances
previously set in and on foods and feeds, and therefore has prolonged
the exposure of humans, animals, and the environment to pesticide
residues which may be harmful.












IV. LEPTOPHOS: A CASE HISTORY ILLUSTRATING THE
SEVERE INADEQUACIES AND DEFICIENCIES IN EPA'S
TOLERANCE-SETTIN G PROGRAM
The problems plaguing EPA's tolerance-setting program and their
implications for human health can be illustrated by examining the
case of the pesticide Leptophos. Leptophos or Phosvel, as it is also
called, is one of some 300 pesticide chemicals for which EPA has set
tolerances for residues in and on food and feed commodities consumed
in the United States. The superficiality of EPA's scientific review in
granting tolerances for Leptophos is quite typical of its entire program.
Whether the health dangers of Leptophos are also typical of other
pesticides for which tolerances are in effect is impossible to determine
unless EPA undertakes a systematic review of previously granted
tolerances on other pesticides.
Granting of tolerances
In 1973 and 1974, while EPA was evaluating the Leptophos safety
testing data submitted by Velsicol, EPA received repeated warnings
from scientists, within and outside the agency, that Leptophos was
neurotoxic in mammals and fowl. These warnings were based on
studies and data not included in Velsicol's data submissions to EPA.
These warnings included:
1. A letter from a World Health Organization scientist, dated
November 19, 1971, stated:
[E]valuation for neurotoxicity was carried out and this com-
ound [Leptophos] was shown to give neurotoxic effects in
hens. . .
On the basis of this data this compound should not be used in
vector control work, and therefore further evaluation in the
WHO Program should not be carried out; 151
2. Results of an experiment conducted in 1973 at an EPA labora-
tory, in which adult hens were injected with Leptophos, indicated that
the pesticide was capable of inducing the delayed neurotoxic symptoms
of leg weakness and paralysis; 112
3. A scientific article describing an experiment performed in 1973 at
Alexandria University in Egypt, in which roosters were fed Leptophos,
concluded:
I [T]he present results clearly demonstrate that Leptophos
causes delayed neurotoxic effects when administered orally to
male chickens. Since it is assumed that a compound showing
151 Letter dated November 19, 1971, from A. R. Stiles, scientist (chemist-biochemist), vector biology and
control, World Health Organization, to Dr. R. L. Metcalf.
152 Memorandum dated July 13, 1973, from Dr. Ronald L. Baron, Primate and Pesticide Effects Labora-
tory, Perrine, Fla., EPA, to Dr. Clara Williams, Chief, Toxicology Branch, Registration Division, OPP,
EPA.
(35)





36


such activity might produce the same effect in man, Leptophos
requires careful consideration before it is allowed to be freely
used; "3
4. On April 8, 1974, at a conference arranged and attended by
EPA scientists, Dr. Wendell Kilgore, Chairman, Toxicology Depart-
ment, University of Calif ornia-Davis, revealed that Leptophos had
presumably resulted in the accidental fatal poisoning of some 1,200
to 1,300 water buffalo in Egypt in 1971 or 1972. Dr. Kilgore also
reported that symptoms of paralysis, similar to those observed in
the accidental poisoning episode, were produced in an experiment
performed by the Egyptian Government in which Leptophos was
fedto small groups of water buffalo;M-
5. On April 12, 1974, EPA scientists met with Dr. Abdel-Moneim
Makky, Egyptian Ministry of Health, who confirmed through first-
hand kowledge what Dr. Kilgore had related to EPA on April 8,
1974; 155 and,
6. A letter dated April 30, 1974, from Dr. Robert L. Metcalf,
Professor, Department of Entomology, University of Illinois, to an
EPA scientist stated:
At a recent pesticide meeting in Bellagio, Italy . Dr.
John Barnes, Chief Toxicologist, WHO, indicated publicly
that his original tests on Leptophos showed clearly that it was
neurotoxic a number of years ago. 'm
Yet, EPA chose to discount all of this evidence, including its own
study conducted in 1973, which seriously undermined Velsicol's
claims that Leptophos was safe. Instead, EPA chose to credit and
rely upon reports developed for and submitted by Velsicol-all of
which concluded that Leptophos was safe. And, on May 31, 1974,
EPA granted tolerances for Leptophos in and on tomatoes and lettuce.
Decision to seek revocation of tolerances
The next step would have been for EPA to register Leptophos
products for use on those two commodities in the U.S. However,
the controversy over Leptophos persisted inside and outside EPA.
On July 30, 1974, 2 months after EPA had granted the tolerances,
the agency finally concluded that there was a need to reevaluate
all available safety testing data pertaining to Leptophos.'57 This
reevaluation consisted of performing analyses which EPA had never
bothered to perform ill the first place before granting the tolerances.
It revealed that an early test "" submitted to EPA by Velsicol and
relied upon to award the tolerances did in fact show evidence of
Is' "NeurotwAc Effect of Leptophos," by M. 1. Abon-Donia, et al., Department of Plant Protection
College of Agriculture, Alvxamdria tUniversity, Alexandria (Egypt), May 21, 1973, Exporientia 0, 63, 1974.
15 Memorandum for the file dated April 25, 1974, from Dr. Gunter Zweig. Chief, Chemistry Branch,
Crileari and Evaluation I)ivision, OP .
t Memorandum for the flhi dated May 6, 1974, Dr. Gunter Zweig, Chief, Chemistry Branch, Criteria
and Evaluation )ivision, i1''.
-4 Letter dated April 30, 1974, fiora Dr. Robert L. Metcalf, Professor, Department of EntomAogy,
UnivePrity of Illinois at Urhana-Champ ign, to Dr. Donna Kuroda, Scientist, Office of Research and
Development, E PA.
15 Memor!idum dated Junly 3), 1,74, from Dr. Clarm 11. Wiliam, Chief, Toxicoligy Branch, Registration
DivFkion, 011', to Dr. Marh RIooff. Pestiide Sciene Ofieer. R(itralion Division, OPP.
M Reprt-lhenyeli aviudv Chilkviis, 1IBT No. J7162, from Industrial Bio-Test Laboratories,
Inc., Northbrook, M11., to Velieol ('hmical Corporation, July 29, 196.





37


neurotoxicity.19 Moreover, a repetition of the test clearly showed
that Leptophos produced delayed neurotoxic effects.6' In addition,
a new look'6' at EPA's own test conducted in 1973 confirmed what
had already been stated by an EPA scientist in 1973-that Leptophos
"is capable of inducing a delayed neurotoxic effect." 162 EPA's re-
evaluation also elicited scientific opinions from Europe that Leptophos
was so toxic that it would never be registered there for use on food.63
in May 1975, a year after the tolerances had been approved,
EPA finally decided to act upon the results of its reevaluation, and
proposed to revoke the Leptophos tolerances.164
Velsicol opposes revocation in spite of evidence of harmful effects
Velsicol vigorously opposed EPA's proposed revocation of the
Leptophos tolerances. In a letter dated June 24, 1975, to EPA, the
company argued that the tolerances had been properly granted, and
invoked a provision of the Federal Food, Drug and Cosmetic Act
which required EPA to form a scientific advisory committee to con-
sider the proposed revocation.165 However, before sending this letter,
Velsicol had received the following information from its medical
consultant on June 9, 1975:
As you know, it has recently come to our attention that there
have been a series of unusual central nervous system illnesses
occurring amongst the employees of (the Bayport, Texas, plant
which manufactures Leptophos). Apparently most of the illnesses
occurred among those who were in contact with [Leptophos].
[One of the workers], who was employed . for approximately
4 months in the late winter and early spring of 1974, . began
to develop a series of bizarre central nervous system symptoms
which was followed by his being hospitalized . with the
diagnosis of encephalomyelitis for 8 months. At that time the
patient was severely ill, almost died, and was then left with a
number of serious residual nervous system deficits. In addition,
there have been at least two individuals employed in this shop
who had a diagnosis of multiple sclerosis, another with a history
of seizures and hallucinations, and fairly recently still another with
a diagnosis of encephalitis. . I advise that the company
seriously consider halting the manufacture of [Leptophos] until
these matters are clarified. 166
1 Note 158, supra. The report concluded that examination of tissue from chickens fed Leptophos "did
not reveal any evidence of demyelination [nerve damage] in any of the chickens tested." However, the body
of the report included numerous descriptions of such neurotoxic symptoms as: "no control of legs;" "very
unsteady;" "cannot remain standing;" and "extreme staggering."
Following a review of the tissue slides in mid-August, 1974, Dr. Howard Richardson, an EPA pathologist
concluded in a memorandum, to "The Record", dated August 27, 1974: "The [tissue] sections of the nerves
were, highly questionable and unreadable. . In . my opinion these [tissue] slides have been impossible
to evaluate from the time they were prepared."
160 Memorandum dated November 15, 1974, from Dr. Howard L. Richardson, Chief of Pathology, Office of
Pesticide Programs, EPA, to Henry J. Korp, Deputy Assistant Administrator, OPP.
161 Memorandum dated August 19, 1974, from Dr. Kent Davis, Pathologist, Registration Division, OPP,
to Dr. Clara H. Williams, Chief, Toxicology Branch, Registration Division, OPP.
162 Note 152, supra.
1W Memorandum, undated, European itinerary of Howard L. Richardson, M.D., and Mary B. Richard-
son, M.D., September 4, thin October 9, 1975.
161 Leptophos, proposed revocation of tolerance, 40 F.R. 22817, May 27, 1975.
165 Letter dated June 24, 1975, from Ralph F. Anderson, Vice President, Research, Velsicol Chemical
Corp., to the Administrator, EPA.
36 Letter dated June 9, 1975, from John E. Kasik, M.D., Consultant, Velsicol Chemical Corp., to Charles
Calo, Manager, Toxicology Research, Velsicol Chemical Corp.





CIO


Moreover, a report 167 to Velsicol, dated June 20, 1975, from the
same medical consultant described the illnesses of a dozen employees
who had suffered such symptoms as: paralysis (in at least three cases),
impotence, confusion, lethargy, severe ataxia (lack of coordination),
weakness, sweating, difficulty in swallowing, and vomiting. One of the
workers, employed at the plant from January 10, 1974, to May 28,
1974, was able to walk only "with the assistance of double leg braces
and walking canes," following hospitalization. Another employee, who
had worked at the plant for 3 months, until May 13, 1975, was hos-
pitalized in critical condition on May 14, 1975. According to the
report, as of mid-June 1975, the employee was still not able to walk.
The report concluded:
I think the preponderance of the evidence is that all the cases
had the same type of illness, either acutely or chronically, and the
etiology was related to their job and their contact with
[Leptophos]. 16
The medical consultant's report, among other things, recommended
that:
. at this time a discrete investigation be made of all the
employees who have been in contact with [Leptophos], but who
are no longer employed at Bayport, be made. . I would
also recommend that at this time a regular survey of the health
of all the employees of Velsicol engaged in the manufacturing of
pesticides be made. 169
However, neither the report nor the information supplied by the
medical consultant was included or referred to in Velsicol's letter of
June 24, 1975, challenging EPA's proposal to revoke the Leptophos
tolerances. In addition, Velsicol continued to manufacture and
market Leptophos for use outside the United States-on foods that
were subsequently consumed within the U.S. The company did,
however, begin to take some steps to reduce the exposure of its
employees to Leptophos at its Bayport plant.
In October 1975, a second medical consultant recommended that
Velsicol "begin a search for all previous exposures," and either
stop production of the material or store it until [Velsicol] can better
determine complete implication of its use." 170 But not until Novem-
ber 19, 1975, 171 5 months after it had received the report from the
first medical consultant, did Velsicol inform EPA of illnesses suffered
by some employees "which may have been related to Leptophos
exposure." 172 Moreover, neurological examination of the plant's
10 Report dated June 20, 1W5, from 3. E. Iasik, M.D., Ph. D., Consultant, Velsicol Chemical Corp., to
Charles Calo, Vel.col Chemical Corp.
8 Note 167, supra.
10 Note 167, supra.
170 Letter dated Oct. 21, 1975, from 0. (. Alexander,M .D., Consultant to Velsicol Chemical Corp., to
N-1l R. Mitchell, General Counsel, Velsicol Chemical Cor.
M Letter dated November 1(j, 1975, fro Neil R. Mitchell, 'ice President-Lega, Velsicol Chemical Corp.,
to Franklin 1). R. Gee, (Product Niaager for Leptophos) Insecticide Fungicide Branch, Registration Di-
vision, EPA.
The letter stated: "Velsicol has instituted a program of complete neurological examinations for all current
plant workers (in Novemer 1J75). .. Should the examnintions reveal a true pattern Of illness related to
exposure to Leptophos in the packaging-warehouse area, efforts to locate and examine aU former workers in
that plant area will initiated. Veolicol will alSo review the situation with those domestic companies that
have formulated Leptophos for exprt....
Velsicol intends to submit to EPA the full medical report and as analysis of Leptophos exposure levels as
soon a they are completed as part of the record for the (EPA) advisory committee.
172 Ibid.





39


current employees was not begun until November 1975,17 and pro-
duction of Leptophos was not halted until January 1976,174 shortly
after inspectors from the National Institute for Occupational Safety
and Heath (NIOSH) had made known to Velsicol their intentions to
inspect the plant in February.75
Velsicol received preliminary results in the spring of 1976 on the
neurological examinations of its workers who were employed at the
Leptophos plant when the examinations were begun in November
1975. The preliminary findings showed that at least two of the workers
had suffered from neurotoxic effects. One of the cases involved a 26
year old worker who, after 2 years of working at the Leptophos plant,
suffered from drowsiness, numbness from the waist down, and unknown
prospects for recovery.76 This information prompted a third recom-
mendation to Velsicol, this time from a NIOSH medical officer in
May 1976, that former workers, who had been employed at the
Leptophos plant prior to the beginning of the neurological examinations
in November 1975, also be checked for health status.177 This recom-
mendation was ignored.
Advisory committee was not given full facts in a timely fashion
Meanwhile, the Leptophos advisory committee,178 which was em-
paneled to review EPA's proposed revocation of the Leptophos
tolerances on lettuce and tomatoes, held its first hearings on July 20,
1976. Although EPA, weeks prior to the hearings, had sent to the com-
mittee members a substantial amount of data and documents pertain-
ing to Leptophos, the agency personnel had failed to include the Velsicol
submission179 of November 19, 1975 describing the illnesses suffered by
some employees. That same submission stated that Velsicol intended
"to submit to EPA the full medical report and an analysis of Leptophos
exposure levels as soon as they (were) completed as part of the record
for the [Leptophos] advisory committee." IS
During the first day of hearings on July 20, 1976, both EPA and
Velsicol representatives spent considerable time outlining the regu-
latory and use history of Leptophos, and the safety testing of the
pesticide utilizing animals. EPA confessed to the committee that the
safety testing data "had not been adequately considered" prior to
the agency's granting of the tolerances in 1974.181 However, in con-
nection with information on exposure of Velsicol's employees to
173 Report dated April 2,1976, by H. L. Markel, Jr., P. E., C.S.P., regional industrial hygienist, National
Institute of Occupational Safety and Health, HEW.
174 Ibid.
176 Ibid.
176 Memorandum dated May 26,1976, from Shiro Tanaka, M.D., Medical Officer, Medical Section, Hazard
Evaluations and Technical Assistance Branch, National Institute of Occupational Safety and Health,
HEW, to the Director, Division of Surveillance and Hazard Evaluations and Field Studies, NIOSH, HEW.
177 Note, 166, supra.
174 Julius M. Coon, Ph.D., M.D., Chairman, Leptophos advisory committee, emeritus professor of phar-
maology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, Pa.; Seymour L. Friess.
Ph.D., Chairman, Environmental Biosciences Department, Naval Medical Research Institute, Bethesda,
Md.; Tetsuo R. Fukuto, Ph.D., Professor of Entomology, Chemistry, and Insect Toxicology, Department
of Entomology, University of California, Riverside, Cal.; Bernard P. McNamara, Ph.D., Chief, Toxicology
Division, Biomedicals Laboratory, U.S. Army Material Command, Edgewood Arsenal, Md.; and Gerald
M. Rosen, Ph.D., Assistant Professor of Pharmacology, Department of Physiology and Pharmacology,
Duke University Medical Center, Durham, N.C.
170 Note 171, supra;
1Note 171, supra.
"'Testimony of Dr. William Upholt, Senior Science Adviser to the Assistant Administrator for Water
and Hazardous Materials, EPA, before the Leptophos Advisory Committee (empaneled by EPA), July 20,
1976.










Leptophos, some of which was more than a year old, company officials
volunteered very little to the committee. Velsicol's representatives
minimized the degree of their knowledge in testifying before the
advisory committee. According to a draft of a prepared statement '
for the committee, the company's "fullest" statement volunteered to
the committee on the dangers Velsicol had known about for over a
year was as follows:

We have noted certain cases, still unresolved, which, if related
to Leptophos, may have been the result of inadvertent exposure
to high levels of technical material. A report is in preparation
which deals with our domestic manufacturing experience and
will be made available to the Committee and EPA by August 20,
1976. 3
Neither the company officials nor EPA personnel at the July 1976
hearings mentioned, much less produced, the November 19, 1975,
submission by Velsicol which gave some detail on "a variety of ill-
nesses" suffered by workers at the Leptophos plant. 8 Moreover,
both EPA and the company failed to reveal to the committee at the
July hearings that medical officers from the National Institute for
Occupational Safety and Health had inspected the Leptophos plant
in February 1976, and had preliminarily found that "at least five (5)
employees were listed as possible chemical exposures," and that
"several previous employees (were) reported to have filed a Texas
Workmen's Compensation claim for their illnesses." 186 On July 21,
1976, when the advisory committee requested that Velsicol submit
as soon as possible whatever "rough data" the company possessed
relating to the effects of Leptophos on humans, a Velsicol representa-
tive stated that he did not know what was available.)'
Nearly a month after the advisory committee hearings, Velsicol
withdrew 187 its al)plications for registration of the company's Leptophos
pesticide products and on the same day, August 17, 1976, Velsicol
submitted to EPA the documents 188 ,ome of which dated back more
18? The actual stateent delivered to the advisory conmnlttee wis lost along with the reporter's tape of
mo-t of Velsicol's testimony before the committee.
' Draft statement, "Meetinlg with Leptophos Science Advisory Connittie," Velsicol Chemical Corpo-
ration, July 20, 1976.
191 Note 171, supra.
165 Note 173, supra.
IM Testimony of Charles Calo, Velsicol Chemical Corp., before the Leptophos Advisory Committee
(emnaneled by EPA), July 21, 1,;76.
17 Letter daed August 17, 1976, from Thomas R. Loy, Manager, Rlgulatory Activites. Research De-
partment, Velsico! Chemical Corp., to Franklin D. R. Gee, Product Manag& 16, Ihnse lde-Rodenticlde
Branch, R0eristration l)ivi-Aon, Environmental Protection Agency.
JS The documents included:
(1) Letter daed June 19, 1975, from John E. Kacik, M. D., Consultant, Velsicol Chemical ., to Charles
Calo. Manager, Toxicoloy Reseillch, Ve! ii!c Chemical Corp.; (2) Report dated Jul from J. E.
Kasik, M. D., Ph.D., Consultant, Vlsicol Chemical Corp., to Charles Calo, Velsicol Chemical Corp.;
(3) lntercfice Communication dated Jue 15, 1975, from Jim lacker (Velscol Chemical Corp.) to Larry
Goodin (VaAlwo Chemical Corp.); (4) Letter dated October 24, 1975, froim G. G. Alexander, M. D.,
(Medical Consultant to Velsicol), to Neil R. Mitchell, General Counsel, Vel l Chemical Corp.;(5) Letter
dated November 12, 1975, from( G. G. Altxander, M. D., (Medical Consultant to Velsicol), to William S.
Fields, M. D., ChAirman, Dpartment of Neurology, University of Texas, College of Mediinte-ouston;
(6) Letter dat November 12, 1975, from 6. G. Alexander, M. D. (Medical Consultant to Velsicob), to
Ne4l I. Mitchell, Attorney at Law, Velsicol Chemical Company; (7) Letter dated November 28, 1975,
from G. G. Altxakr, M.)D. (Mecilal Cons'taint to Velsicol). to Nell R. Mitchell, Attorney at Law,
Veleiol Chemnili Company; (8) Letter dated March 10, 1976. from 6. (. Alexander, M. D. (Medical Con-
Sultant to Vel-ieol), to Jim A. hacker, Velsicol Chemical Corp.; (1n Letter dated July 29, 196 from G. 6,
Alexander, M. D. (Medical Consultant to Velsicol), to Neil Mitchell, Vice President, Lega Department
Vebsicol Chemical Corp.; (10) industrial Hygiene Survey--Ex su re to Phosvel (Teptos), d
for Velsicol Chemical Corpration by Stephen R. Levitan, Ph. D., Environmental abiSh -
rock Corp., M-ch 10, 1176; (11) Report on an Inspection of the Velsicol Chemical Corp. Leptophos manu-
fwtrig plant i Iyport, Tet,. by 11. 1,. %Mj-kpl, Jr., P. E., C. S. P., Regional Industrial ylgienist,
NIJOSH, April 2, 1976; (12) Repors of medical tests performed on employees of Velsicol Chemical Corp.
dating from Decemher 22, 1971, to May 2'-, 1,176; (13) Report dated August 12, 1976, "Technical Leptophos
Maziufacturlnglayport, Texa." from Velsiccl Chemical Corp. to the Environmental Protection Agency;
and (14) "Draft" (Report), "Velsicol (helciird Corp., Phosvel (I*ptophos) Manufacturing, Bayport,
Texas, June 1976.





41


than a year) relating to exposure of Velsicol employees to Leptophos.
The next day Velsicol wrote the advisory committee saying that it
had Withdrawn its registration application:
Under the circumstances, Velsicol feels that it must hereby
withdraww its request for the Advisory Committee appointed to
consider Leptophos tolerances."
Enclosed with the letter were the same documents 190 supplied to
EPA on August 17, 1976, relating to the exposure of workers to
Leptophos, and certain other documents requested by the committee.
Despite Velsicol's decision to "withdraw its request," the Advisory
Committee publicly released its report on Leptophos, noting that:
There are indications that neurological effects have occurred in
workers involved in the manufacturing, packaging and application
of Leptophos.91
The committee recommended that "the currently existing tolerances
(on lettuce and tomatoes) should be revoked," ani that "additional
toxicity data should be obtained before new tolerances are estab-
lished.' 192 EPA adopted the recommendations and published a
notice 193 in the Federal Register on November 22, 1976, to revoke the
Leptophos tolerances.
Vels icol delayed implementing recommendations to examine ex-employees
Although it had been recommended to Velsicol by a medical con-
sultant in June of 1975, by NIOSH in May 1976, and by Dr. G. G.
Alexander, a second medical consultant to the company, in October
1975, that Velsicol check the health of former employees who were
exposed to Leptophos, Dr. Alexander wrote to the company on
July 29, 1976, and stated:
I see no additional benefit to the people who have been
in your employ by your making an active attempt to identify
toxicity of your products to them. 194
It was only very recently that Velsicol decided after all to check
the health of its former employees. In fact, the decision to do so was
communicated to the National Institute for Occupational Safety and
Health on November 22, 1976,115 3 days after the subcommittee staff
had asked legal counsel for Velsicol why such a project had not yet been
undertaken. Subsequently, on December 1, 1976, NIOSH stated that
it intends to conduct its own medical survey of former employees of
Velsicol's Leptophos plant.
Leptophos has been consumed in the United States
As a final note, it is important to point out that, while Leptophos
was never registered by EPA for use on tomatoes and lettuce crops
in the United States, the agency's issuance of the residue tolerances
M Letter dated August 18, 1976, from Ralph F. Anderson, Vice President-Research, Velsicol Chemical
Corp., to David Bowen, Secretariat, Leptophos Scientific Advisory Committee, Environmental Protection
Agency.
190 Note 188, supra.
191 The Report of The Leptophos Advisory Committee to the Administrator, U.S. Environmental Pro-
tection Agency, October 1976.
192 Ibid.
193 Repeal of Tolerance for the Posticide Chemical Leptophos, 41 F. R. 51400, November 22, 1976.
194 Letter dated July 29, 1976, from G. G. Alexander, MI.D. (Medical Consultant to Velsicol), to Neil
Mitchell, Vice President, Legal Department, Velsicol Chemical Corp.
195 Memorandum dated Nov. 22, 1976, from John F. Finkiea, M.D., Director, N Institute for Oc-
cupational Safety and Health, to "The Record."






42


in 1974 did permit the import of these Leptophos-treated commodities
into the United States from other countries.
In the case of Mexico, from which the United States imported
624-million pounds of tomatoes this year alone, not only have Amer-
ican consumers been eating Leptopkos-contaminated tomatoes from
that country since 1972, but also Leptophos-contaxinated beans,
peppers, cucumbers, peas, cantaloupe, egg plant and squash, for
which tolerances have never been chanted by EPA."' It is impossible
to determine to what extent the various commodities imported from
Mexico have been contaminated with Leptophos, since, according to
FDA, some 35,668 shipments of agricultural commodities crossed
the border into the U.S. during the last Mexican growing season alone,
from October 1, 1975, through August 1, 1976. And FDA, which is
responsible for monitoring pesticide residues on such imports, was
able to sample only 650 of the shipments this year, and 265 shipments
(excluding strawberries) in 1975.
The Mexican Government states that the use of Leptoo on food
crops was banned in that country in April of this year. However,
according to Velsicol, Leptophos was sold to 29 countries 197 around the
world in 1976, and since 1971, to 50 countries "I8 at one time or
another, which raises the possibility that the U.S. may stiU be import-
ing Leptophos-contaminated foodstuffs from other countries.

CONCLUSIONS
EPA's approval in 1974 of residue tolerances for Leptophos in and
on lettuce and tomatoes did much to encourage the use of the pesti-
cide in other countries, such as Mexico and Egypt, since much of the
world looks to the United States as the leader in science.
EPA's issuance of the tolerances for Leptophos admittedly without
having adequately evaluated the safety testing data was unjustified,
and serves as a clear example of the agency's superficial treatment of
such critical data. The result is that American consumers, as well as
consumers of other nations, have been exposed to a demonstrably
hazardous material.
D' Report, "FDA Findings of Leptophos Residues in Food," prepared by Bureau of Foods, FDA, Dec. 8,
1976.
7,Summary of Phosvel (Leptophos) Shipped In Export, Provided by Harvey Gold, Velsicol Chemical
Corp., Iee. 13, 1976. Countries to which Velsicol exported Leptophos in 1976 are: Argentina, lritish West
Indies, Canada, Colurbia, Costa Rica, Dominican Republic, El Salvador, Ethiopia, French West Africa,
(iuatem ia, Guyana, Honduras, India, Indonisia, Iran, Ivory Coast, Japan, Malaysia, Mexico, New Zea-
land, Niearvgua, Paklstan, Panama, Spain, Sudan Syria, Taiwan, Thailand, and Venezuela.
I' Note 1-7, supra. Countries to which Velsicol Ias exported Leptophos at onetime another since 1971
are: Argentina, Australia, Brazil, l3ritish Guiana, British Weyt Indies, Canada, China, Columbia, Costa
Ilica, Cyprus, Doininicani Republic, Egypt, El Salvador, Ethiopia, France, French Wet Africa, breeve,
(I ntemala, d uyana, Haiti., Holland, 1iondurfts, India, Indonesia, Iran, Israel, Ivory Coast, Japan, Jordan,
Kenya, Korea, Lebanon, Malaysia, Mexico, New Zealand, Nicaragua, Pakistan, Pana, ?hllppines,
Sparii Sri Lanka, Sulan, Syria, Taiwan, Thailand, Turkey, Union of South Africa, Venezuela, Vict Nam ,
and West Pakistan.












V. MISLEADING STATEMENTS BY EPA


The EPA has misled the Congress, the General Accounting Office,
and the public regarding its pesticide programs. The EPA through
public statements and other means fostered the impression that it
was thoroughly reviewing all pesticide testing data submitted by the
pesticide industry to determine whether the use of any of the 50,000
pesticide products already on the market cause "unreasonable adverse
effects" 9on human health and on the environment. As demonstrated
in section 2 of this report, the subcommittee's inquiry has revealed that
EPA's "review" of data bearing on the question of safety over 2,500
pesticide products as of August 9, 1976, was designed and executed
in a superficial manner. "Review" and "validation" consisted in most
instances of little more than the clerical function of checking for the
presence of data in the Agency's files. Despite several indications
that data submitted by the pesticide industry could not be relied upon
without a thorough review and analysis, the EPA neglected to subject
data to anything approaching scientific scrutiny. In fact, for purposes
of reregistration the agency chose to ignore and failed even to read the
comments of previous reviewers who had often criticized and ques-
tioned the accuracy and completeness of the very same data that EPA
was relying on to support reregistrations. Nevertheless, the EPA on
many occasions gave the impression to those outside the agency that
reregistration was being conducted in a thorough manner. The clear,
foreseeable and natural consequences of these statements were to
mislead the Congress, the General Accounting Office, and the public.
The subcommittee's inquiry revealed the following examples:
1. The General Accounting Office proposed report of July 18, 1975
specifically criticized the fact that there were deficiencies in data sub-
mitted to EPA to support registration and tolerances.20 EPA's
response to these criticisms was m the form of a memorandum under
the signature of Edwin L. Johnson, Deputy Assistant Administrator
for Pesticide Programs. In the September 1975 response, EPA made
the following statements:
[I]n preparation for reregistration, the data base supporting
the safety of each registered active ingredient has been reviewed,
and any gaps have been identified.201
If the data are not submitted, the registrations involved will
lapse. If data are submitted, then the acceptance of the registra-
tion will be judged on the basis of data.22
[Wie determined to concentrate resources in the area of highest
priority, which is potential human hazard. A double standard
was created in the regulations, limiting the scope of data require-
19 Pub. L. 92-518, Oct. 21, 1972.
2w Draft GAO report of July 18, 1975. Report to the Congress by the Comptroller General of the United
States, dated Dec. 4, 1975, "Federal Pesticide Registration Program: Is It Protecting the Public and the
Environment Adequately from Pesticide Hazards?"
201 Ibid.,
m Ibid.,
(43)





44


ments for reregistration to safety data; including hazard to fish
and birds, chronic mammalian effects, oncogenesis, terato
genesis, and reproduction studies .203
(a) Before reregistration applications are solicited from the
resist rants, EPA reviews a group of products similar in chemistry
and use.
(b) This review considers the sufficiency of supporting data...
[Emphasis added.]
2. EPA challenged GAO's "finding" that "EPA has moved slowly
to implement the reregistration provisions of amended FIFRA, and
thus will not meet the statutory deadline (initially set by the Congress
as October 1976). In his September 11, 1975 response to the GAO
report, Mr. Johnson stated:
While the workload burden of reregistration is admittedly
great, we are less certain than GAO that the statutory deadline
of October 1976 cannot be met, or at least closely approached.0
On October 7, 1976, a GAO auditor, assigned to the GAO audit
team at EPA explained that GAO's finding that EPA could not
meet the statutory deadline was based primarily on the premise
that adequate review and validation of data submitted in support
of reregistration could not be completed by October 1, 1976. He further
explained that EPA never revealed that it was not validating the
data. He stated:
It was only recently, within the last 2 weeks, that we learned
they weren't validating data. It's apparent now that all along
all they intended to do was to check for the presence of data
not doing a thorough review to see if the data was adequate.4
3. Mr. Russell E. Train, Administrator of EPA, testified before
joint hearings on April 9, 1976 as follows:
Senator KENNEDY. What about the things that have been
apl oved today that are out in the homes, that are all across
this land, that are being used on various kinds of food products
which are being ingested by the American people? How do we
know what has been approved now by the EPA is really safe
for the American people?
Mr. TRAIN. Obviously, you don't know. The fact is we are
in the process of reregistering all 35,000-plus of those products
at the present time, a process which we hope to conclude by
October 1977.
Senator KENNEDY. What does that mean to you when yOu,
the person who has the responsibility, when you say you don't
know how safe these are in terms of the American public? What
does that iean to you? And what should that mean to the
American l)eople? t
Mr. TRAIN. It means to me we should do a very careful job
of reregitratiou, of reviewing .the data, and where there is any
question about the data, and in many of these cases where we
~'Ibid.
:3 Pub,. L, 12 ,16 as amended by Pub. L. 14-10 which amended deadline to Oct. 21, 1977.
'6 Note 21, supra.
0 Sulwonxinittee staff interview, Oct. 1, 1,976.






45


have already determined that in our view the original data is not
fully adequate, we have already put parties on notice and will
be including these in the rebuttable presumption (against regis-
tration) approach that the manufacturers, the registrants, have to
come in and carry the burden of proof of establishing safety....
Pursuant to the 1972 amendments to the FIFRA, the EPA
is directed to undertake a reappraisal of pesticide products
approved under the earlier FIFRA to determine if they meet a
new statutory test that they will not have the "unreasonable
adverse effects" to man and the environment. . In conclusion
Mr. Chairman, I believe that we at EPA have taken a number
of steps which will ensure that the data received from pesticide
manufacturers is of appropriate quality so that we can make
the important regulatory decisions that are mandated by Fed-
eral law. We view this as a vital function of our agency.s
4. In a letter to subcommittee staff, dated April 16, 1976, James M.
Conlon, Associate Deputy Assistant Administrator for Pesticide
Programs, stated:
The reregistration process now underway, which Mr. Train
described in his statement to the subcommittee last week, will
provide an opportunity to reexamine the adequacy of the sup-
porting data in EPA's files and, where necessary, to obtain
additional data.2
5. The EPA was one of nine agencies examined over the past 2
years by House Subcommittee on Oversight and Investigations,
chaired by Representative John E. Moss. One of the primary focuses
of that inquiry was the effectiveness of EPA's regulation of pesticides.
Chairman Moss wrote a detailed letter to Mr. Train on June 9, 1976,
requesting certain information regarding EPA's Office of Pesticide
Programs.
A. Question 2(h) posed to Mr. Train in that letter asked:
The Office of Special Pesticide Review subjects candidates
for rebuttable presumption to intensive chemical by chemical
review of all data. . This intensive review is designed to
verify the data that may support restriction on use or removal
from the marketplace of a pesticide. Is there a comparable
intensive review of all data advanced by registration applicants
to support a determination to place a pesticide on the market
(i.e. registration) or keep a pesticide on the market (i.e. reregistra-
tion?) If not, why not? 210
A working draft, dated June 29, 1976, of Mr. Train's reply to Chairman
Moss' interrogatories was obtained by the subcommittee.
The draft response to Chairman Moss's question contained the
following statement:
In short, data submitted in support of new [registrations] or
continued registrations [reregistrations] are all reviewed com-
20 Testimony of Russell E. Train, Administrator, Environmental Protection Agency, before joint hear-
ings by the Subcommittee on Health and the Subcommittee on Administrative Practice and Procedure,
Apr. 9,1976.
201 Letter dated Apr. 16, 1976, from James V. Conlon, Associate Deputy Assistant Administrator for Pesti-
cide Programs, EPA, to Jim Michie, Subcommittee on Administrative Practice and Procedure.
210 Letter dated June 9, 1976, from John E. MAoss, Chairman. Subcommittee on Oversight and Investiha
tions, House of Representatives, to Russell E. Train. Administrator, Environmental Protection Agency.





46


pletely to determine whether or not the, product may pose un-
reasonable risks.2"
In a memorandum obtained by the staff dated June 30, 1976,
Mr. Irwin L. Auerbach, program analyst, Office of Regulatory and
Policy Affairs, Office of Pesticide Programs, commented on the work-
ing draft's response to Chairman Moss' questions 2(h) as follows:
Question 2(h): The statement that 'data submitted in support
of new or continued registrations are all reviewed completely'
is questionable. EPA's review for reregistration is cursory. It
does not include an in-depth examination and evaluation of data
previously submitted. Nor does it include any examination of the
comments made by previous reviewers at the time that such
data were submitted.22 [Emphasis added.]
After Auerbach's comments, the draft response was redrafted and
incorporated in a letter from Mr. Train dated August 3, 1976. In spite
of Auerbach's criticism of the draft response the final response of
August 3 to question 2(h) which was submitted to chairman Moss
on August 3, 1976 was substantially similar to the draft response and
contained the following statement:
In short, data submitted in support of new [registrations]
or continued registrations [reregistrations] are all reviewed to
determine whether or not the product may pose unreasonable
adverse effects.213
Although Mr. Auerbach was Chairman of EPA's Working Group
on Pesticide Testing, his comments were not included in the Agency's
response to Chairman Moss' inquiry.
Chairman Moss in his letter of June 9, 1976 posed another question
to Mr. Train:
On May 12, 1976, the Center for Continuing Education
sponsored a seminar on the registration and regulation of pesti-
cides at which Dr. Jay Turim, Deputy Director, Office of egu-
latory and Policy Affairs, Office of Pesticide Programs, Environ-
mental Protection Agency. . indicated that if 4 minutes were
spent on each pesticide that must be registered by EPA, one man
year would be consumed. What does this portend insofar as the
quality of safety review the public can anticipate EPA will
conduct on pesticides it registers is concerned? 214
Responding to Chairman Moss' question 6(f), the working draft
stated:
The actual, physical review of any particular product's
reregistration application may, in fact, be brief, as Dr. Turim
indicated during the 'May 12, 1976, Center for Continuing
Education seminar on the registration and regulation of pesti-
cides. However, it is a serious error to consider this basically
clerical task to represent the essence or entirety of the review
procedlure. The substantive work in assessing a pesticide's
safety is done during the development of the guidance packages
A Draft of EPA responses to questions of Chairman Moss, prepared by EPA person, dated June 29,
1976.
?13 Memorandum dated June .0 1976, from Irwin L. Auerbach, program analyst, Offilcof Regulatory and
Policy Affairs, OPP, to Susan Sherman, Chief, Exterral Affairs, OPP.
SLetter dated Aug. 3, 1976, from Ru ell E. Train, Administrator, Environmental Protection Agency, to
John E. Mosq, Chairman, Subcominttee on Oversight and Investigations, House of Representatives.
31 Note 210, supra.





47


for the various product groupings or batches based on similar
formulation and broad use patterns. The guidance package
includes proposed classification of the products in a batch,
requisite wording of precautionary statements on labeling,
acceptable statements on storage and disposal, and guidance
on data requirements. This information cannot be provided
without a thorough knowledge of the product's chemical charac-
teristics, associated risks, uses, and probable sources of exposure.
Guidance on data requirements is thus the result of an extensive
review of data previously submitted to determine if they are
sufficient and to identify data gaps which must be filled. Clearly,
the guidance package is the product of considerable time and
effort devoted in a systematic fashion to assessing pesticide
safety.215
In his June 30 memorandum, Mr. Auerbach commented on the
draft response as follows:
Question 6(f): The long paragraph on page 13 of the
draft reply gives a misleading impression about reregistration.
Preparation of guidance packages involves only cursory review oj
scientific data in EPA's files. See my comments on Question 2(h).
Ed [Edwin L.] Johnson [Deputy Assistant Administrator for
Pesticide Programs] is now aware that where more intensive
reviews have been made, problems have been identified that were
not noted by the Reregistration Task Force. I do not know how
he would answer this question in light of these recent develop-
ments. I do know that I would not answer it the way it's done in
the draft.216 [Emphasis added.]
Nevertheless, EPA's final response to question 6(f), submitted to
Chairman Moss on August 3, 1976, read as follows:
The actual, physical review of any particular product's reregis-
tration application may, in fact, be brief, as Dr. Turim indicated
during the May 12, 1976, Center for Continuing Education
seminar on the registration and regulation of pesticides. However,
it is a serious error to consider this basically clerical task to repre-
sent the essence or entirety of the review procedure. The sub-
stantive work in assessing a pesticide's safety is done during the
development of the guidance packages for the various product
groupings or batches based on similar formulation and broad use
patterns. The guidance package includes proposed classification
of the products in a batch, requisite wording or precautionary
statements on labeling, acceptable statements on storage and
disposal, and guidance on data requirements. It is our intent
during the reregistration process to classify products, update
labeling, identify data gaps, and review data on hand to the
extent that we are assured that the problem pesticides will
receive proper attention. We intend to revise our procedures
when necessary as experience is gained during reregistration and
difficult areas are identified. The average time spent on individual
aplications is thus irrelevant to the quality of the review and
t e commensurate public protection.217
213 Note 211, supra.
216 Note 212, supra.
317 Note 213, supra.





48

Here again, although Mr. Auerbach severely criticized the draft
response, and characterized it as "misleading," the final response
from EPA to Chairman Moss was virtually unchanged from the draft.

CONCLUSION
One EPA official described EPA's behavior by commenting that
"the stuff that's been written on the way reregistration is done was
carefully worded to skirt the issue of thorough review." The record is
more than adequate to support that characterization. And, even if
unintentional, as EPA claims, EPA's statements regarding the re-
registration program were clearly misleading.











VI. RECOMMENDATIONS


1. Thorough and expert review of all safety testing data on pesticides
should be done for each compound prior to registering, reregistering, or
granting tolerances. This is a fairly self-evident recommendation but
EPA has simply not performed the reviews. Two quite elementary
steps must be taken immediately. First, EPA must organize its own
data files and in some cases find missing data files. Second, it must
require its reviewers to read the files, including the correspondence
fies that contain the comments of prior reviewers. The embarrassing
fact is that EPA in many cases cannot even find the material it is
charged with assessing, and it has systematically failed to even read
relevant material it possessed.
2. In connection with the first recommendation, the safety testing
data underlying previously granted residue tolerances should expedi-
tiously be subject to the same thorough scientific review as the data
used for reregistration. In addition, the EPA should immediately
expedite the development and finalization of regulatory procedures for
setting tolerances, and those procedures should fully reflect the find-
ings of this report.
3. The data submitted by manufacturers should be made public as a
matter of course. The material to be withheld from public scrutiny
should be narrowly defined, consistent with statutory definitions of
confidential material, and the burden of identifying with particularity
material claimed to be confidential should be imposed on the manu-
facturers as a condition to EPA accepting data submissions. Timely
public access to safety testing data has the potential for subjecting that
data to additional scientific scrutiny by public interest groups, other
Government agencies, independent scientists with an academic or
other interest in a particular compound, and perhaps on occasion by the
scientific personnel of competing pesticide companies. In any case,
scrutiny of the data over and above what EPA can provide will sharpen
the analyses and improve the regulatory effort. It might also provide
some incentive for the companies to develop more accurate data and
the EPA to improve the quality of its own internal reviews.
4. In connection with ensuring that it will have a better data base,
the EPA should expeditiously establish and implement an effective
program to evaluate the testing procedures of and accuracy of data
developed by laboratories utilized by pesticide manufacturers sub-
ntting data to EPA. There have been serious problems experienced by
the FDA in this regard and, since pesticide companies use some of the
same labs used by drug companies, there is every reason to urge
EPA to investigate and closely monitor the labs that develop pesticide
safety data.
In this connection, EPA should start vigorously investigating
whether the pesticide manufacturers are disclosing all relevant safety
data to EPA in a timely fashion. The performance of the Velsicol
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50


Chemical Corporation in its production of Leptophos, to cite just one
example, clearly indicates that the agency is not receiving critically
important information on the health effects of some pesticides.
The problem of the falsification and withholding of safety data is one
that is best addressed (A) through continual and systematic monitoring
of the pesticide companies and the laboratories, and (B) swift and effec-
tive sanctions for violations, including criminal prosecution for inten-
tional violations in this area. Currently, EPA has neither committed
the resources nor mustered the will to police these problems.
5. Scientific talent should be utilized in a more effective marner.
EPA should consider the possibility of developing a health-risk office,
peopled by the best available scientific talent, and independent of any
particular regulatory program-whether it be pesticides, toxic sub-
stances or pure water. The health-risk office would be charged with
reviewing safety testing data developed from other sources, most
notably pesticide manufacturers, and would have some capability to
develop data on its own. Its mission would be to use its scientists to
ferret out and assess health and environmental risks. They would not
be required to assess benefits.
6. Qualified scientific and management personnel should occupy the
appropriate positions in the pesticide program. This is, of course, easier
said than done. Although the agency must share part of the blame for
unqualified personnel, a large part of the problem is the inability to
attract first-class scientists because of inadequate financial induce-
ments and civil service rules. The built-in impediments to such a
recruiting program are not primarily the fault of EPA, but the EPA
and other agencies facing similar problems should develop a plan to
attract top-flight scientific talent and present that plan to the Congress
for action. The Congress itself should be receptive to changes in civil
service rules and Government pay ceilings that are carefully drawn to
alleviate demonstrable shortcomings in the Government's ability to
attract and keep the best scientists.







UNIVERSITY OF FLORIDA


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