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Inspector General Division
 Conducting the Audit:
                                                       Northern Audit Division
                  Program Offices Involved:
                                                       Pesticides ^nd Toxic

                   _


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             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460
                           SEP  30 1992
                                                          OFFICE OF
                                                      THE INSPECTOR GENERAL
  KEMORANDUM

  SUBJECT:  Audit Report No.  E1EPF1-05-0429-2100613
            Labeling of Pesticides
FROM:
  TO:
          /,Kenneth A. Konz
         if'Assistant Inspec
                               General  for Audit
          Linda J. Fisher
          Assistant Administrator for
            Prevention, Pesticides and  Toxic Substances
       Attached is a copy of the  subject report.   This report
  provides important findings and corrective  actions regarding the
  labeling of pesticides.

       This audit report contains findings that describe problems
  th<3 Office of Inspector General (OIG) has identified and
  corrective actions the Agency has agreed to take.   This audit
  report represents the opinion of the OIG.   Final determinations
  on matters in this audit report vill be made by  EPA managers in
  accordance with established EPA audit resolution procedures.
  Accordingly, the findings described in the  audit report do not
  necessarily represent the final EPA position.

  ACTION REQUIRED

       In responding to the draft report, your office provided
  action plans and milestone dates for correcting  the findings.   As
  a  result,  your response to the  report is adequate  in accordance
  with EPA Order 2750.  Therefore, we are closing  out this report
  in our tracking system, effective September 30,  1992.   Please
  track all action plans and milestone dates  in the  Management
  Audit Tracking System.

       We have no objections to the further release  of this report
  to t/ie public.
i
o
Cvj
s
                         HEADQUARTERS
                         ENViWWENTAL PROTECTION AGF.NCY
                         WASHINGTON, D.C. 20460

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     Should you or your staff have any questions or need
additional information, please contact Anthony C. Carrollo,
Divisional Inspector General, Northern Audit Division on  (312)
353-2503.

Attachment

cc:  Douglas D. Campt, Director
       Office of Pesticide Programs (H7501C)
     Michael M. Stahl, Director
       Office of Compliance Monitoring (EN-342)
     Joyce Hay, Audit Liaison (TS-788)
     Anthony C. Carrollo, DIGA-NAD

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                                       Labeling of Pesticides
                      EXECUTIVE SUMMARY
PURPOSE

The Office of Inspector General has completed an audit of the
U.S. Environmental Protection Agency's  (EPA) process for
reviewing and approving pesticide labels.  We decided to
perform this audit because the label provides the user with
important information on how to safely use pesticides.  Our
specific objectives were to determine whether:

  o  EPA's process for reviewing and accepting pesticide
     labeling is adequate to protect human health and the
     environment, and

  o  EPA uses the information obtained from pesticide
     incident reports to protect against further pesticide
     problems.
BACKGROUND

Pesticides are poisons that are designed to kill or repel
c.nimals, plants, or bacteria that are considered to be pests.
However, some pesticides can have unintended effects on
people, pets, wildlife and the environment.  Most pesticide
accidents result from careless use or lack of knowledge about
proper handling of pesticides.  The pesticide label plays a
critical role in providing the user with information on how
to use the pesticide safely.

Before EPA registers a pesticide, EPA must determine that (1)
the label complies with the requirements of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and (2)
the pesticide will not cause unreasonable adverse effects on
the environment.  The decision to register a pesticide is
based on EPA's evaluation of the test data that registrants
provide.  Testing is needed to determine whether a pesticide
has the potential to cause adverse effects on humans,
wildlife, fish and plants.

The* precautionary statements are one of the most important
parts of the pesticide label.  Precautionary statements
include human hazard signal words, child hazard warning,
statement of practical treatment, statement of hazards to
humans and domestic animals, environmental hazard statements,
                           Report NO.  E1EPF1-05-0429-2100613

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                                       Labeling of Pesticides
and physical and chemical hazard statements.  EPA determines
what statements the registrant needs to include on the
pesticide label based on the registrant's test data.
RESULTS-IN-BRIEF

EPA cannot provide the public with assurance that
precautionary statements on many pesticide labels are
adequate to protect humans and the environment from
unreasonable adverse effects.

The Office of Pesticide Program's (OPP) process for reviewing
and accepting pesticide labels did not include verifying that
toxicity studies existed prior to accepting pesticide labels.
In many cases, the toxicity studies would not have been
available even if OPP had attempted to use them.  Due to
certain provisions of FIFRA, pesticides were registered
without requiring a complete set of toxicity studies.  OPP
officials stated that this problem will be corrected during
its pesticide reregistration process.  However,
reregistration is not expected to be completed until the year
2002.

The precautionary statements on many pesticide labels may not
be adequate to protect the user and the environment.  Almost
half the pesticide labels evaluated had missing or inaccurate
precautionary statements.  Other pesticides were missing
statements restricting usage of the pesticide to certified
applicators.

OPP placed little importance on the information in the
incident reports that it received.  However, the incident
reports contained important information on the consequences
of pesticide use.  Incident reports include information on
human and animal deaths and adverse reactions to pesticides.
OPP was not analyzing the incident reports to identify
additional restrictions which may be needed to protect users
and the environment from adverse effects of pesticides.
                              ii
                           Report No.  E1EPF1-05-0429-2100613

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                                       Labeling of Pesticides
PRINCIPAL FINDINGS

EPA Missing Toxicity Studies To Support Precautionary Label
Statements

EPA did not have either the toxicity studies, or the
documentation of its review of those studies, to assure that
correct precautionary statements were printed on many
pesticide labels.  This occurred because the (1) conditional
registration provisions of FIFRA allowed the registration of
substantially similar pesticides without a complete set of
toxicity studies, and (2) reregistration process was not
completed.  Because of this, product managers were not
expected to verify whether toxicity studies were available to
support individual registrations.  As a result, there was
little assurance that pesticide labels contained correct
warning and practical treatment statements.  FIFRA requires
EPA to determine whether individual pesticides can be used
without causing unreasonable adverse effects on the
environment.  Without toxicity studies, OPP's ability to
fulfill its obligation to protect against adverse effects of
pesticides is diminished.

Toxicity studies were unavailable for 58 of 95 pesticides
reviewed.  For 33 pesticides, the toxicity studies could not
be located, but may exist.  In other cases, the pesticides,
or similar pesticides, were registered before EPA required a
fall set of toxicity studies.  According to OPP officials,
the missing studies will be obtained during reregistration.

EPA Accepted Labels With Inaccurate Precautionary Statements

Precautionary stacements for many pesticide products we
reviewed did not meet regulatory requirements.   This occurred
because the OPP did not have procedures to be sure product
managers were consistent in their reviews of pesticide
labels.  As a result, the labeling statements on pesticides
may not adequately protect humans and the environment from
unnecessary adverse effects.
    pesticide labels reviewed were missing various
statements.  For almost half the labels evaluated, there were
precautionary stat«jments which were missing or inaccurate.
For example, several pesticides were missing the statement
"Harmful if absorbed through skin."  Another pesticide was
missing a statement, of practical treatment for eye
irritation.  Two labels reviewed were missing restricted use
                           Report NO.  E1EPF1-05-0429-2100613

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                                       Labeling of Pesticides
 statements.  Also, some label statements did not meet the
 labeling  instructions in registration standards.

 Registrants Did Not Submit Final Printed Labels

 EPA did not have complete copies of final printed labels for
 many pesticides.  This occurred because OPP did not regularly
 follow-up on whether registrants submitted final printed
 labels.  Without the registrants submitting final printed
 labels, OPP had little assurance that the registrant had made
 the required changes to the label.  Also, enforcement
 personnel need an accurate copy of the accepted label to use
 during inspections to determine whether pesticide products
 are properly labeled.

 OPP relied upon the registrant to make requested changes to
 the labels and to submit a copy of the final printed label
 before distributing the pesticide.  We found cases where
 registrants did not make changes OPP requested.  In one case,
 OPP accepted a draft label after the registrant did not (1)
 make previously requested changes and (2) submit a final
 printed label.  In another case, the registrant submitted a
 label to the state which did not include OPP requested
 changes.  The label was missing the statement "Causes
 irreversible eye damage."

 EPA Needs To Make Better Use Of Information In Incident
 Reports

OPP needs to follow-up on significant incidents involving a
pesticide or after a series of incidents indicates a
pesticide is adversely affecting the environment.  However,
OPP was not collecting or analyzing pesticide incident
reports.  This occurred because, until recently, OPP placed
 little importance on the information contained in incident
reports.  As a result, OPP may not have been aware of
pesticides for which registrants need to take additional
action, such as changing label precautions or directions, to
protect the environment.  In July 1992, OPP completed a
system for tracking and analyzing incident reports which may
correct many of the deficiencies that we found.

At the time of our fieldwork, OPP did not (1) centrally
collect, (2)  organize, or (3) follow-up on incident reports
it received.   However, the incident reports contained
 important information on the consequences of pesticide use.
For example,  of 50 incident reports reviewed, 5 described
                              iv
                           Report MO.  E1EPF1-05-0429-2100613

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                                       Labeling of Pesticides
deaths to adults.  OPP also infrequently used information on
incident reports it could obtain from a contractor.  It was
only after 200 incidents in one year, including 26 animal
deaths, that OPP required the registrant to make label
changes to a flea and tick pesticide.
AGENCY ACTIONS AND COMMENTS

The Assistant Administrator stated that this audit was quite
important since labeling is one of the critical functions in
pesticide regulation.  She agreed to improvements in both
labeling and incident information that will address our
concerns.  The Agency is already implementing, or planning to
implement, a number of improvements to strengthen the
labeling program.  For example, OPP:

  o  is organizing all new toxicity studies it receives in
     such a way that the studies which support specific
     registrations can be identified;

  o  will prepare a guide for product managers to use during
     label reviews;

  o  will reinstitute selective audits of final printed
     labels and has requested additional funding to
     facilitate making the accepted labels available to
     enforcement personnel; and

  o  has completed a system for tracking and analyzing
     incident reports.

Ihe Assistant Administrator stated that an essential element
in evaluating the Agency's data and labeling programs is an
accurate characterization of the factors contributing to the
problems with labeling.  She believes that the difficulty the
report identifies, in reconciling the Agency's labeling
decisions with supporting toxicity studies, is an
undesirable, but predictable consequence of the conditional
registration, data compensation and reregistration programs
established by Congress.  The Assistant Administrator stated
that without adequate funding of the reregistration program,
the acquisition of the needed data and labeling decisions
will be delayed beyond the projected completion date of 2002.
                              v

                           Report No.  E1EPF1-05-0429-2100613

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                                       Labeling of Pesticides
PIG EVALUATION

While preparing our report, we met several times with OPP on
the conditional registration and reregistration provisions of
FIFRA.  We incorporated the effect these provisions have had
upon the labeling program to the extent we considered
appropriate.  We agree with the Assistant Administrator that
these FIFRA provisions have impacted OPP's process for
reviewing and accepting labels.  While we recognize these
constraints, additional causes, as described in our report,
also exist.

Notwithstanding these differences, we are in substantial
agreement regarding corrective actions.  As discussed at the
end of each chapter, the Assistant Administrator has proposed
actions that, when implemented, will substantially resolve
our concerns.
                             vi
                           Report  NO.   E1EPF1-05-0429-2100613

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                                       Labeling of Pesticides
                      TABLE OF CONTENTS

EXECUTIVE SUMMARY 	   i

CHAPTERS

  1  INTRODUCTION 	   1

       PURPOSE  	   1

       BACKGROUND 	   1

       SCOPE AND METHODOLOGY	   5

       PRIOR AUDIT COVERAGE   	   8

  2  EPA MISSING TOXICITY STUDIES TO SUPPORT
     PRECAUTIONARY LABEL STATEMENTS 	   9

       EPA BASES PRECAUTIONARY STATEMENTS ON
       TOXICITY STUDIES 	  10

       TOXICITY STUDIES WERE NOT LOCATED OR OPP'S
       REVIEW NOT DOCUMENTED  	  10

       PRODUCTS REGISTERED WITHOUT TOXICITY STUDIES ...  14

       TOXICITY STUDIES WERE FOR A DIFFERENT
       PRODUCT FORMULATION  	  14

       CONCLUSION	15

       AGENCY COMMENTS AND ACTIONS  	  16

       OIG EVALUATION	17

  3  EPA ACCEPTED LABELS WITH INACCURATE
     PRECAUTIONARY STATEMENTS 	  19

       LABELING REGULATIONS REQUIRE PRECAUTIONARY
       STATEMENTS	19

       PRECAUTIONARY STATEMENTS WERE INADEQUATE 	  20

       RESTRICTED USE STATEMENTS MISSING FROM
       PESTICIDE LABELS 	  23



                             vii

                           Report MO.   E1EPF1-05-0429-2100613

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                                     Labeling of Pesticides
              TABLE OF CONTENTS (continued^

     LABELING CHANGES IN REGISTRATION
     STANDARDS NOT ENFORCED 	  24

     ADDITIONAL OPP CONCERNS	26

     CONCLUSION	27

     AGENCY COMMENTS AND ACTIONS  	  27

     OIG EVALUATION	28

4  REGISTRANTS DID NOT SUBMIT FINAL PRINTED LABELS  .  .  31

     REGISTRANTS REQUIRED TO SUBMIT A COMPLETE
     COPY OF LABELS	31

     REGISTRANTS OFTEN DID NOT SUBMIT FINAL
     PRINTED LABELS 	  32

     ENFORCEMENT PERSONNEL NEED ACCURATE COPIES
     OF ACCEPTED LABELS	35

     CONCLUSION	37

     AGENCY COMMENTS AND ACTIONS  	  37

     OIG EVALUATION	38

5  EPA NEEDS TO MAKE BETTER USE OF INFORMATION
   IN INCIDENT REPORTS  	  39

     INCIDENT REPORTS CONTAIN VALUABLE INFORMATION  .  .  39

     OPP'S HANDLING OF INCIDENT REPORTS IT
     RECEIVED WAS NOT ADEQUATE	41

     OPP INFREQUENTLY USED VALUABLE INFORMATION ON
     PESTICIDE INCIDENTS  	  45

     CONCLUSION	47

     AGENCY COMMENTS AND ACTIONS  	  47

     OIG EVALUATION	48
                          viii

                         Report NO.  E1EPP1-05-0429-2100613

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                                       Labeling of Pesticides
                TABLE OF CONTENTS (continued1

EXHIBIT

  EXHIBIT 1  PESTICIDE INCIDENT REPORTS REVIEWED  ....  49

APPENDIX

  APPENDIX 1  ASSISTANT ADMINISTRATOR FOR PREVENTION
              PESTICIDES AND TOXIC SUBSTANCES RESPONSE
              TO THE DRAFT REPORT	51



  APPENDIX 2  ABBREVIATIONS 	  63

  APPENDIX 3  DISTRIBUTION  	  64
                              IX

                           Report NO.  E1EPF1-05-0429-2100613

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                             Labeling of Pesticides
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                   x



                Report HO.  E1EPF1-05-0429-2100613

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                                       Labeling of  Pesticides
                          CHAPTER 1

                         INTRODUCTION
PURPOSE

The Office of Inspector General has completed an audit of
EPA's process for reviewing and approving pesticide  labels.
We decided to perform this audit because the label provides
the user with important information on how to safely use
pesticides.  Our specific objectives were to determine
whether:

  o  EPA's process for reviewing and accepting pesticide
     labeling is adequate to protect human health and the
     environment, and

  o  EPA uses the information obtained from pesticide
     incident reports to protect against further pesticide
     problems.
BACKGROUND

Pesticides are chemical or biological substances used to
control unwanted plants, insects, fungi, rodents, or
bacteria.  Pesticide use has contributed to increased
agricultural prodxiction and improved public health through
control of disease-carrying pests.  However, acute and
chronic human health and environmental risks also can be
associated with the use of many of these chemicals.  In
determining whether to permit the marketing of a pesticide
and how to regulate its use, EPA balances such potential
risks against the benefits that may be derived from use of
the chemical.  The goal of EPA's Pesticide Program is to
protect human health and the environment from unreasonable
adverse effects of pesticides.

FIFRA authorized EPA to regulate pesticides and their uses.
FIFRA states that EPA can register a pesticide after EPA
dettjrmines that:

  o  the pesticide's; label, and other material required
     to be submitted, comply with the requirements of
     FIFRA;
                           Report NO.  E1EPF1-05-0429-2100613

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                                        Labeling  of  Pesticides
   o  the pesticide  will  perform  its  intended  function
      without unreasonable  adverse  effects  on  the
      environment; and

   o  when used  in accordance with  widespread  and
      commonly recognized practice, the pesticide will
      not generally  cause unreasonable adverse effects.

The decision to register a pesticide is based on EPA's
evaluation of the test data that registrants  provide.  Tests
are performed to determine whether a pesticide has the
potential to cause  adverse effects on humans, wildlife,  fish
and plants.   Potential human risks are identified by using
results  of laboratory tests.  Human  risks  include acute  toxic
reactions, such as  poisoning and skin and  eye irritation, as
well  as  possible long term effects like cancer, birth
defects,  and reproductive  disorders.  Test data on how a
pesticide behaves in the environment are required so that EPA
can determine,  among other things, whether a  pesticide poses
a threat to  ground  or surface water.

EPA defines  a pesticide  product  to be misbranded if it does
not include  the following  information on the  label:  (1)
ingredient statement, (2)  name,  brand or trademark, (3)
precautionary statements,  (4) directions for  use, (5) name
and address  of  the  manufacturer, (6) net contents, (7) EPA
registration number, (8) EPA establishment number, and (9)
use classification.

The precautionary statements are one of the most important
parts of  the pesticide label.  Precautionary  statements
include human hazard signal words, child hazard warning,
statement  of practical treatment,  statement of hazards to
humans and domestic animals, environmental hazard statements,
and physical  and chemical  hazard statements.  EPA determines
what statements the registrant needs to include on the
pesticide  label based the  registrant's test data.  The human
hazard signal words indicate the level of  the product's
toxicity.
                           Report No.  E1EPF1-05-0429-2100613

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                                                  Labeling of Pesticides
                Figure  1:   Example of  a Pesticide Label
   PRECAUTIONARY
    STATEMENTS
 HAZARDS TO HUMANS
 t DOMESTIC ANIMALS

     CAUTION
  ENVIRONMENTAL
     HAZARDS
    PHYSICAL OR
 CHEMICAL HAZARDS
DIRjJCTIONS FOR USE

It ii ii violation of Federal
liw to UK thii product in a
tnann;r inconiittem with in
labeling.

RE-EHTRY STATEMENT

(IF APPLICABLE)
CROP:
CROP:
CROP:
PRODUCT NAME

  ACTIVE INGREDIENT:	*
  INERT INGREDIENT:  	%

  TOTAL:               100 %
 KEEP OUT OF REACH OF CHILDREN

         CAUTION
   STATEMENT OF PRACTICAL TREATMENT
 IF SWALLOWED

 IF INHALED

 IF ON SKIN

 IF IN EYES
                               SEE SIDE PANEL FOR ADDITIONAL
                               PRECAUTIONARY STATEMENTS
                                                                CROP:
                                       CROP:
                                                                CROP:
                                                                CROP:
  STORAGE
    AND
  DISPOSAL

STORAGE 	
DISPOSAL
                                      WARRANTY STATEMENT
                           MFGBY
                           TOWN, STATE
                           ESTABLISHMENT NO.
                           EPA REGISTRATION NO.
                                       NET CONTENT
                                   Report NO.   E1EPF1-05-0429-2100613

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                                       Labeling of Pesticides
                 Figure 2:  Product Toxicity

      Signal Word         Level of Product Toxicity

      Danger              Extremely toxic or corrosive.  A
                         taste to a teaspoon taken by mouth
                         could kill an average-sized adult.

      Warning             Moderately toxic or irritating.  A
                         teaspoon to an ounce taken by mouth
                         could kill an averaged-sized adult.

      Caution             Minimally toxic or mildly
                         irritating.  An ounce or more taken
                         by mouth could kill an averaged-size
                         adult.

The 1972 FIFRA amendments provided EPA with new authority
over  the use of pesticides.  EPA's enforcement of pesticide
usage is based primarily on the pesticide label.  The 1972
amendments made it a violation of the law to use a product in
a manner inconsistent with the label.  It is also a violation
of FIFRA to distribute a pesticide that is misbranded,
meaning that it does not include the nine statements
mentioned above.

Pesticide Program History

With  the 1972 amendments to FIFRA, Congress mandated that EPA
assess the safety of all previously registered products.
Prior to this, pesticides had been registered using less
stringent scientific testing requirements.   This
comprehensive reevaluation of pesticide safety in light of
modern standards was critical to protecting health and the
environment, and to maintaining public confidence in our food
supply.

In 1980, EPA began a registration standard process.  The
registration standard summarizes the Agency's evaluation of
the available data on an existing active ingredient, and
identified and required submission of additional data.  The
registration standard also set forth the conditions a
registrant had to meet in order for EPA to reregister
pesticide products containing the active ingredient.  These
conditions included modifications to registrations and
labels.
                           Report No.  E1EPF1-05-0429-2100613

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                                       Labeling of Pesticides
By the late 1980's, it became increasingly apparent that,
under the registration standards program, EPA would not be
able to complete reregistation of existing pesticides as
quickly as Congress originally envisioned.  At the pace of
issuing 25 registration standards per year, reregistration
could not have been completed until about 2000.  Growing
public concern about how long it would take to reassess
existing pesticides spurred Congress to act in 1988 to
substantially change EPA's approach.

The reregistration provisions of the 1988 amendments
established mandatory timeframes and duties for
reregistration of pesticides.  EPA was required to review for
reregistration each product containing any active ingredient
registered before November 1, 1984.  If EPA would have met
all the deadlines Congress established, reregistration would
have been completed by 1997.  EPA currently estimates
completing reregistation around the year 2002.

To ensure the equitable treatment of new pesticides which
were substantially similar to products which were part of
reregistration, in 1978 Congress allowed conditional
registration.  FIFRA Section 3(c)(7) states that EPA may
conditionally register a pesticide if it determines that (1)
the pesticide and its proposed use are identical or
substantially similar to any currently registered pesticide,
and (2) approval of the registration will not significantly
increase the risk of any unreasonable adverse effect on the
environment.  In addition, FIFRA Section 3(c)(l)(F) allows
registrants to, instead of performing tests on a pesticide,
roly on previously submitted data or public literature to
support the product registration.  These two sections of
FIFRA contributed to the findings discussed in Chapter 2.
SCOPE AND METHODOLOGY

Our first objective was to determine whether EPA's process
for reviewing and accepting pesticide labeling was adequate
to protect human health and the environment.  To accomplish
th:.s objective, we reviewed the FIFRA law and OPP's
regulations, policies, and procedures for registering
pesticides and the review and approval of pesticide labels.
We also discussed with OPP Headquarters officials in
Washington, DC, the process for reviewing and accepting
pesticide labels.
                              5

                           Report No.  E1EPF1-05-0429-2100613

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                                         Labeling of Pesticides
  To determine whether OPP was following its policies and
  procedures when reviewing labels, we randomly selected a
  sample of 100 active pesticide registrations.  To select our
  sample, we obtained a list of pesticide active ingredients
  from the Pesticide Product Information System (PPIS), dated
  December 10, 1991.  We randomly selected 20 active
  ingredients.  At the request of program management, to
  distribute the active ingredients selected among OPP's 14
  product managers, we agreed to replace two active ingredients
  originally selected.  We obtained a listing from PPIS, dated
  December 18, 1991, of the active registrations which
  contained the 20 active ingredients.  For each of the 20
  active ingredients, we selected 5 registrations, for a total
  of 100 registrations.1   We did  not perform any tests of the
  controls over the PPIS database.

  For each of the 100 registrations, we reviewed pesticide
  registration and toxicity study files to determine whether
  OPP was following its policies and procedures when reviewing
  pesticide labels.  We limited our review to the following
  label statements:  warning, human hazard precautionary,
  environmental hazard precautionary, practical treatment,
  flammability, restricted use, worker protection, and storage
  and disposal.  We performed a cursory review of the rest of
  the label to verify that all statements were included on the
  label, but did not evaluate the adequacy of these statements.
  As criteria for our review, we used the current labeling
  regulation (40 Code of Federal Regulations (CFR) 156) and
  applicable pesticide regulation (PR) notices in effect at the
  time the label was accepted.  To verify our results, we
  discussed them with the responsible OPP product manager.  In
  many cases we also provided the product managers with written
  questions concerning the pesticide labels.

  Our second objective was to determine whether EPA uses the
  information from pesticide incident reports to protect
  against further pesticide problems.  To accomplish this
  objective,  we discussed with OPP's pesticide incident
  response officer, product managers, and regional personnel
  their process for receiving, filing and following-up on
  pesticide incident reports.  We reviewed a sample of 50
     'We  deleted five  registrations  from our sample,  all
including the same active ingredient, because EPA was canceling
the registrations for each of the products.  We did not replace
the five registrations.

                                6

                             Report NO.  E1EPF1-05-0429-2100613

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                                       Labeling of Pesticides
incident reports EPA received between January 1989 and
December 1991.  Because the incident reports were not
organized  (see Chapter 5), we could not  (1) determine the
universe of incident reports received during the time period
or  (2) select & random sample.  We also visited an EPA
contractor in Texas, who  operates the National Pesticide
Telecommunications Network (NPTN), and discussed its
procedures for providing  information to callers concerning
pesticides, and collecting information on pesticide
incidents.

We discussed our audit methodology with OPP management.
Subsequent to the entrance conference on November 19, 1991,
we met with program management three tinges to discuss our
audit methodology:  November 21, 1991; December 11, 1991; and
January 14, 1992.  We distributed position papers to OPP and
"he Office of Compliance  Monitoring (OCM) management on June
;J6 and July 29, 1992.  The position papers included the
registration numbers of all products referred to in the
report.  We discussed the position papers with OPP and OCM on
July 30 and August 10 and 12, 1992.  We also received
written, unsigned, comments from OPP on August 5, 1992.  The
comments were included in the report.

On August 19, 1992, we issued our draft report.  We held an
e:cit conference with the  Assistant Administrator for
Prevention, Pesticides and Toxic Substances on September 25,
IS'92.  The Assistant Administrator responded to our draft
report on September 29, 1992.  After reviewing the response
and conducting th«i exit conference, we made appropriate
changes and finalized our report.  The Assistant
Administrator's response  is included as Appendix 1.  Our
draft report contained recommendations to address the issues
in each finding.  The Assistant Administrator's response
proposed acceptable corrective actions.  As a result, the
final report does not contain additional recommendations.

We performed our audit in accordance with the Government
Auditing Standards issued by the Comptroller General of the
United States (1988 revision).  Our fieldwork was conducted
from December 2, 1991 to  August 3, 1992.  We reviewed OPP's
internal controls over the approval of pesticide labels and
evaluation of incident reports.  We also reviewed OPP's
fiscal year 1990 and 1991 annual reports on internal
controls.   These reports  did not identify any weaknesses in
the internal controls over pesticide labeling.
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                                       Labeling of Pesticides
PRIOR AUDIT COVERAGE

There were no previous audits of pesticide labeling which
applied to our audit objectives.
                              8
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                                       Labeling of Pesticides
                          CHAPTER 2

           EPA MISSING TOXICITY STUDIES TO SUPPORT
                PRECAUTIONARY LABEL  STATEMENTS
EPA did not have either the toxicity studies, or the
documentation of its review of those studies, to assure that
correct precautionary statements were printed on many
pesticide labels.  This occurred because the (l) conditional
registration provisions of FIFRA allowed the registration of
substantially similar pesticides without a complete set of
toxicity studies, and (2) reregistration process was not
completed.  Because of this, product managers were not
expected to verify whether toxicity studies were available to
support individual registrations.  As a result, there was
j.ittle assurance that pesticide labels contained correct
warning and practical treatment statements.  FIFRA requires
EPA to determine whether individual pesticides can be used
without causing unreasonable adverse effects on the
environment.  Without toxicity studies, OPP's ability to
fulfill its obligation to protect against adverse effects of
pesticides is diminished.

Tcxicity studies were unavailable for 58 of 95 pesticides
reviewed.  Some studies were not available because, the
pesticides, or similar pesticides, were registered before EPA
required a full set of toxicity studies.  According to OPP
officials, the missing studies will be obtained during
reregistration.

          Figure 3:  Toxicitv Studies Not Available

          Products for which toxicity studies
            were not found, but may exist              33

          Products for which toxicity studies were
            found, but not OPP's review                 6

          Products for which toxicity studies
            do not exist                               14

          Toxicity studies were for a
            different formulation                       5

          Total                                        58
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                                         Labeling of Pesticides
  EPA BASES PRECAUTIONARY STATEMENTS ON TOXICITYSTUDIES

  OPP determines the precautionary statements required on
  pesticide labels based on toxicity studies.  FIFRA requires
  registrants to submit, or cite references to, these studies
  along with their application for registration.  OPP uses the
  results of five acute toxicity studies  (oral, skin
  absorption, skin irritation, inhalation, and eye) to
  determine the precautionary statements needed on pesticide
  labels.  OPP's Precautionary Review Section, at the product
  manager's request, interprets the study results, placing
  pesticides in one of four toxicity categories for each of the
  five test areas.  The product manager uses this review as the
  basis for accepting pesticide labels.

  For each toxicity category, labeling regulations2 outline the
  required precautionary statements which must appear on the
  pesticide label.  OPP bases the signal word on the highest
  toxicity category assigned, as shown in Figure 4.

             Figure 4:  Pesticide Label Signal Words

          i Toxicity Category
                   2
                   3
                   4
       Word
Danger
Warning
Caution
Caution
           (a)   Categories  are  listed  from highest to lowest
                toxicity.
  TOXICITY STUDIES WERE NOT LOCATED OR OPP'S REVIEW NOT
  DOCUMENTED

  OPP personnel were unable to locate the toxicity studies, or
  their review of the toxicity studies, for over one-third of
  the labels reviewed, as shown in Figure 5.  Without toxicity
  studies, we were unable to verify the accuracy of the
  precautionary statements on the pesticide labels.
     240  CFR 156  "Labeling Requirements  for  Pesticides and
Devices".
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                                       Labeling of Pesticides
     Figure 5:  Toxicitv StudiesNot Located Or Reviewed

          Toxicity studies not located, but may exist     33

          Reviews of toxicity studies not found            6

            Total                                         ^9

Toxicity Studies Not Located

Product managers did not ensure that registrants submitted
toxicity studies before accepting pesticide labels.  We were
unable to locat«i the toxicity studies for 33 of 95 labels.
In some cases, EPA may not have the toxicity studies and  is
requiring registrants to submit them during reregistration.
In other cases, this occurred because the product managers
did not verify that there were toxicity studies to support
the referenced product.  In still other cases, the registrant
may have submitted the studies, but product managers did  not
record a coding system number in the file, and thus could no
longer match the registration to the study.  As a result,  we
could not verify, and OPP has little assurance, that one-
third of the pesticide labels reviewed contained adequate
pirecautionary statements.

F1FRA allows registrants to rely upon the toxicity studies
other registrants submit.  To do this, the product must be
identical or substantially similar to another registered
pesticide.  OPP refers to this as a "me-too" registration.
If OPP determines that, based on the product chemistry, the
pesticide is identical or substantially similar to another
registered pesticide, OPP can register the product without
requiring a complete set of toxicity studies.

When a registrant claimed to have a substantially similar
product, product managers relied upon the label of the
referenced product, rather than toxicity studies, to review
the label.  As a result, one set of toxicity studies may
support several pesticides.  However, product managers did
not ensure there were toxicity studies to support the
referenced product.  In those cases where the registrant
identified the substantially similar product, we reviewed the
referenced product to determine the appropriate toxicity
categories.   In many cases, we were unable to identify the
toxicity studies which supported the referenced product.
Rather than reviewing referenced products' toxicity studies,
product managers used the referenced products' labels to


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                                       Labeling of Pesticides
determine the precautionary statements needed.  Without
reviewing the toxicity studies, project managers cannot be
sure that the precautionary statements on the referenced
product are adequate.

In some cases, we were unable to identify the specific
studies which supported the registration because OPP did not
include a coding system number in the product registration
file.  OPP assigns each study a Master Record Identification
Document (MRID) number.  OPP files toxicity studies by MRID
numbers, separate from the product's registration file.  When
the registration file did not contain the MRID number,
neither the product managers or our auditors could locate the
toxicity studies.  Without the studies, we were unable to
verify the accuracy of the precautionary statements.

Some Missing Studies Will Be Obtained During Rereaistration

OPP officials stated that under the conditional registration
provisions of FIFRA (see Pesticide Program History on page
3), each individual product is not required to be supported
by a complete set of toxicity studies.  Ultimately all
products will be supported by appropriate toxicity studies at
reregistration.  A core set of data will serve labeling needs
of a number of substantially similar products.  Until
reregistration is completed around 2002, EPA will continue to
determine labeling statements for substantially similar
products based upon a core database.  During reregistration,
EPA will group substantially similar products and request
registrants to submit one set of toxicity studies for each
group of substantially similar products.

We recognize that the slow pace of reregistration has
resulted in OPP not yet having toxicity studies for some
pesticides (see page 4).  However, many of the toxicity
studies that we could not find may exist.  Where EPA does
have toxicity studies, EPA should use the studies when
reviewing the precautionary label statements.

OPP accepted precautionary statements for substantially
similar products based on other labels and not on toxicity
studies.  OPP officials justified this practice by stating
that there is generally more than one substantially similar
product which the product manager can rely upon.  However, as
discussed in Chapter 3, we found almost half the pesticides
we reviewed had missing or inaccurate precautionary
statements.  Based on our review, OPP should not rely on the


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                                       Labeling of Pesticides
labels of other products to determine the accuracy of
precautionary statements when toxicity studies are available.

Reviews Of Toxicity Studies Could Not Be Located

For 6 of 95 labels reviewed, we were able to locate the
toxicity studies, but not OPP's review.  The studies contain
the results of the testing the registrants performed.  The
Precautionary Review Section assigns a toxicity category to a
pesticide based on its review of the study.  In six cases we
were unable to Locate documentation of this review.  Without
documentation of the study results, we were unable to
determine how, or if, OPP determined the accuracy of the
precautionary statements.

Improvements Needed In The Documentation Of Studies And
Reviews

£»ome of the studies, and summaries of OPP reviews, that we
were unable to locate may exist.  However, we were unable to
locate them, even with the assistance of product managers.
The Federal Managers' Financial Integrity Act requires that
U. S. General Accounting Office internal control standards be
followed when establishing and maintaining systems of
internal control.  The standard on documentation states that:

     Internal control systems and all transactions and
     other significant events are to be clearly
     documented, and the documentation is to be readily
     available for examination.

OPP requires precautionary statements on pesticide labels to
protect humans and the environment from harmful effects of
pesticides.  Consequently, OPP's process for ensuring the
accuracy of the precautionary statements is significant in
the-, registration of pesticides.  OPP needs to maintain
documentation of how it determined the accuracy of
precautionary statements on pesticide labels.  Toxicity
studies, and OPP's review of the toxicity studies, are vital
to ensuring the adequacy of precautionary statements.

In June 1992, OPP drafted a strategy for improving
information management.  OPP officials stated that the
implementation of this strategy will significantly enhance
OPP's ability to retrieve and use toxicity studies and
reviews.  Until OPP provides further details regarding the
implementation of the strategy, we cannot evaluate whether


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                                       Labeling of Pesticides
OPP's  intended actions will improve the documentation of
toxicity studies and reviews of toxicity studies.
PRODUCTS REGISTERED WITHOUT TOXICITY STUDIES

For 14 of 95 labels reviewed, OPP had not required the
registrants to submit toxicity studies.  At least nine of
these products were registered before EPA required a full set
of toxicity studies.  OPP intends on obtaining many of these
studies during reregistration, which is not scheduled to be
completed until 2002.  In the 14 cases cited:

  o  Five products, each of which contained the active
     ingredient sodium cyanide, did not have toxicity
     studies.  The product manager stated that toxicity
     studies were not required because OPP knew sodium
     cyanide was very toxic.

  o  The other nine products contained ethylene oxide (4) or
     coal tar creosote (5) as the active ingredient.  Product
     managers stated that these long-used active ingredients
     were registered before toxicity studies were required.
     OPP will collect toxicity information on these products
     during reregistration.

Reregistration has been a massive undertaking for OPP and has
proceeded slowly.  In 1972 Congress required OPP to
reregister existing pesticides that were originally
registered before formal scientific and regulatory standards
were established.  In 1988, Congress established for EPA an
accelerated reregistration process.  As of April 1992, OPP
had determined that 14 of 400 active ingredients were
eligible for reregistration.  Neither ethylene oxide nor coal
tar creosote are among the ingredients that have been
reviewed for reregistration eligibility.  Until
reregistration is complete, the precautionary statements on
the labels of products like these will not be supported by
toxicity studies and the label statements may not indicate
the dangers of the pesticide.
TOXICITY STUDIES WERE FOR A DIFFERENT PRODUCT FORMUIATIOK

Of the 95 labels reviewed, in five cases the product
formulation used in the toxicity studies was different from
the current formulation.
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                                       Labeling ofPesticides
  o  In one case, one of the ingredients in the pesticide was
     methanol.  However, the toxicity studies for the
     referenced product were based on a formulation that did
     not contain methanol.  The sole presence of methanol
     should have resulted in more restrictive precautionary
     statements.

  o  In another case, the referenced product was not
     substantially similar to the product being registered.
     One product was 5 percent resmethrin, while the
     referenced product was 40 percent resmethrin.  The
     product manager did not reguire the registrant to
     reference a substantially similar product or submit
     toxicity studies.

  o  In three 'cases, the registrants revised the
     precautionary statements to reflect the removal of a
     toxic inert ingredient.  However, the product manager
     did not reguire the registrants to submit toxicity
     studies to support the change in precautionary
     statements.  EPA registration guidance requires
     registrants to submit acute toxicity data when proposing
     changes to precautionary statements.

opp bases the precautionary statements on the results of five
tDxicity studies.  The results of toxicity studies may change
based on the product's formulation.  OPP needs to be sure
that it relies on products that are in fact substantially
similar or requests the registrants to submit toxicity
studies on the correct product formulation.
CONCLUSION

Before registering a pesticide, FIFRA requires EPA to
determine whether the pesticide can be used without causing
unreasonable adverse effects on the environment.  Toxicity
studies play an important role in establishing the
precautionary statements that pesticide labels must contain.
OPP needs to ensure that toxicity studies are (1) submitted,
(2) reviewed, and (3) serve as the basis for precautionary
statements on pesticides.  When this is not done, EPA cannot
be sure that precautionary statements on pesticide labels are
protecting humans and the environment.

Toxicity studies for some registered products are older than
EPA.  According to OPP officials, many of the older studies


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                                       Labeling of Pesticides
have become obsolete.  Others are in EPA files, but not
organized  in such a way that they can be easily matched to
the products that they support.  As a result, EPA practice is
to have the product managers look at the label, not the
toxicity studies, when reviewing label statements on
substantially similar products.  If they want to find the
studies, they face an intensive search.  EPA intends on
correcting this during reregistration.

EPA needs  to organize the toxicity studies that it has, so
that it can use them to determine the accuracy of
precautionary labeling statements.  However, we recognize
that this  would be a massive undertaking.  Because of the
resource intensive nature of this process, the Agency's
actions need to emphasize organizing future toxicity studies
that it receives.  While not making recommendations about the
current problem, we do not agree with EPA's current process
of relying on labels rather than studies to register
products.
AGENCY COMMENTS AND ACTIONS

The Assistant Administrator agreed to act to resolve the
issues described above.  She added, however, that this
finding does not adequately consider the statutory framework
of conditional registration and reregistration.  According to
the Assistant Administrator, it is these provisions of FIFRA
that allow the apparent weakness of the data base of toxicity
studies to continue.  Only the completion of reregistration
will correct the problem.

The Assistant Administrator agreed that each precautionary
labeling decision should be supported by product-specific
data.  Currently, the Agency does not have such a data base;
data on each product are not available and the data that are
available are often old or obsolete.  According to the
Assistant Administrator, this weakness stems from the
conditional registration provisions of FIFRA which Congress
directed EPA to administer.  The Assistant Administrator
further explained that:

  o  Reregistration was established to systematically collect
     data and review pesticide product regulatory decisions,
     including labeling decisions.
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                                       Labeling  of  Pesticides
  o  Congress recognized that the ongoing registration
     process cannot equitably refuse registration  of  new
     products, which are substantially similar to  existing
     products, while EPA was conducting reregistration.  This
     was the basis for conditional registration.

  o  Data compensation provisions of FIFRA explicitly permit
     registrants to use data from other sources to support
     their registrations.

The Assistant Administrator agreed with our emphasis  on
better organizing and documenting the studies EPA  receives in
the future.  ThtJ Assistant Administrator described changes to
OPP's process for organizing toxicity studies and  EPA reviews
of these studies.  These changes were not in place for many
of the registrations we reviewed.  She stated that OPP will
:ae able to document whether and what type of toxicity studies
»2xist to support particular registrations.  (See Appendix l,
pages 54 and 55, for details.)
OIG EVALUATION

To the extent we considered appropriate, we incorporated the
Agency's position that the statutory framework of FIFRA has
greatly impacted the availability of toxicity studies and the
labeling of pesticides.  The reason toxicity studies were not
available is a combination of FIFRA provisions and data
management problems which OPP can address.  In fact, OPP has
already begun to address the problem of linking toxicity
studies with pesticide registrations.

As stated in our conclusion, no reasonable actions, besides
reregistration, could be taken on toxicity studies previously
received.  For future toxicity studies OPP receives, the
Assistant Administrator's actions will assure that, for new
pesticide registrations, OPP can identify toxicity studies to
support them.
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                             Labeling of Pesticides
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                                       Labeling of Pesticides
                          CHAPTER 3

             EPA ACCEPTED LABELS WITH INACCURATE
                   PRECAUTIONARY STATEMENTS
Precautionary statements for many pesticide products we
reviewed did not meet regulatory requirements.  This occurred
because the OPP did not have procedures to be sure product
managers were consistent in their reviews of pesticide
labels.  As a result, the labeling statements on pesticides
may not adequately protect humans and the environment from
unnecessary adverse effects.

The pesticide labels reviewed were missing various
statements.  For almost half the labels evaluated, there were
precautionary statements which were missing or inaccurate.
For example, several pesticides were missing the statement
"Harmful if absorbed through skin."  Another pesticide was
missing a statement of practical treatment for eye
irritation.  Two labels reviewed were missing restricted use
statements.  Also, some label statements did not meet the
labeling instructions in registration standards.
LABELING REGULATIONS REQUIRE PRECAUTIONARY STATEMENTS

Labeling regulations, as contained in 40 CFR Part 156
"Labeling Requirements for Pesticides and Devices," give
guidelines for the information needed on pesticide labels.
FIFRA requires precautionary statements on pesticides to
better protect humans, animals and the environment from
harmful effects of pesticides.  EPA bases the level of the
precautionary statement on the results of the registrant's
toxicity studies.  Toxicity categories range from 1 (highest)
to 4 (lowest).  Figure 6 gives an example, taken from 40 CFR
156.10, of how eye precautionary statements would vary for
each toxicity category.
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                                         Labeling of Pesticides
          Figure 6:   Exampleof Precautionary Statements
Toxicity
Category
l
2
3
4
Precautionary Statement
Corrosive, causes eye damage. Do not get in
eyes. Wear goggles or face shield when
handling. Harmful or fatal if swallowed.
[Appropriate first aid statement required.]
Causes eye irritation. Do not get in eyes.
Harmful if swallowed. [Appropriate first aid
statement required. ]
Avoid contact with eyes. In case of contact
immediately flush eyes. Get medical attention
if irritation persists.
[No precautionary statements required. ]
  PRECAUTIONARY STATEMENTS WERE INACCURATE

  The precautionary statements OPP accepted on almost half the
  labels evaluated were inaccurate.  This occurred because OPP
  did not have procedures for product managers to use when
  reviewing pesticide labels.  Instead, product managers used
  past experience and a combination of pesticide regulations
  and policies when reviewing pesticide labels.  Also, OPP had
  not finalized some of the regulations the product managers
  were using.  This resulted in (1) labels not including
  accurate precautions, and (2) inconsistencies between labels
  of similar products.

  We found deficiencies with the following types of statements:
  (1) human hazard precautionary,   (2) environmental hazard
  precautionary, and (3) practical treatment.3 *  Because
  toxicity studies were missing (see Chapter 2), we were only
  able to evaluate the precautionary statements for 37 of 95
  labels reviewed.
     3In  this  Chapter,  we will  refer  to  the  three types of
statements as precautionary statements.

     *The other  statements we reviewed for which we did not find
deficiencies were:  signal word, flammability statement, worker
protection statement, and statements on storage and disposal.

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                                       Labeling of Pesticides
            Figure 7:  Results of Our Evaluation of
                     Precautionary Label Statements
     Statements were accurate
     Statements were inaccurate

       Total
Labels  Percent
  20      54
  22     100
As shown in Figure 7, one or more precautionary statements on
17 of 37 labels evaluated were not accurate.  For example:

  o  The labels for six products did not contain a human
     hazard precautionary statement for skin toxicity.  Each
     of the products were toxicity category 3 and should have
     included a statement such as "Harmful if absorbed
     through skin."

  o  The labels for five products, each containing the same
     active ingredient, did not include statements of
     practical treatment for inhalation hazards.  The
     products were toxicity category 3, for which the
     regulations require such a statement.

  o  Two products were missing environmental hazard
     statements.  The products should have contained a
     statement such as "This pesticide is toxic to fish."5

  o  One product did not have a statement of practical
     treatment for eye irritation.  The product was toxicity
     category 2, for which the regulations require a
     statement of practical treatment.  An example of a
     practical treatment statement would be "If in eyes:
     Hold eyes open and flush with a steady, gentle stream of
     water for 15 minutes."

We discussed our evaluation of the labels with product
managers.  Product managers agreed that the statements were
missing from the labels.  Some product managers stated that
they would act immediately to correct the label, while others
stated that OPP would correct the label during
reregistration.  Considering that OPP does not plan to
complete reregistration until 2002,  more immediate action
should be taken to correct the labels.
   sThe  label  for  one  product  was  corrected  during  our  review.

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                                       Labeling of Pesticides
 Even though product managers agreed with our evaluation of
 the precautionary statements, OPP officials gave several
 additional reasons why precautionary statements may not
 conform to current policies.  First, product managers have
 the discretion to approve a variety of precautionary
 statements that may differ from the typical statements
 contained in the regulations.  Second, because products are
 approved over a long period of time, there is an inherent
 inconsistency created as new products are registered if older
 products are not updated.  We agree that these issues may
 account for why precautionary statements differ from what is
 contained in OPP regulations, however, neither of these
 issues contributed to the inaccurate statements found during
 our review.

 Combination of Policies Used In Label Reviews

 EPA product managers used a combination of current
 regulations, proposed regulations, and pesticide regulation
 notices when reviewing and accepting pesticide labels.  Not
 finalizing the regulations creates the potential for
 uncertainty for the registrants and makes it difficult for
 them to understand the wording needed on a pesticide label.

 Pesticide regulation notices are issued to registrants when
 OPP wants to make changes in the registration process.  One
 way OPP used regulation notices was to carry out a label
 improvement program.  OPP began the label improvement program
 in 1980 to upgrade pesticide labeling to further protect
 human health and the environment.  OPP has recently issued
 label improvement program notices for such things as revising
 label statements for products containing Deet (a particular
 active ingredient) and false and misleading statements on
 labels.  However, with regulation notices and all other
 labeling instructions and regulations, OPP must rely on the
registrants for voluntary compliance, or use the cancellation
process to compel compliance.

 In 1984,  OPP proposed to revise and expand the labeling
regulations included in 40 CFR Part 156, but never finalized
the revisions.  OPP management believed that the revision was
needed to provide a more comprehensive description of
pesticide labeling requirements.  The planned revisions would
 also result in better quality labeling for users.  In the
areas of precautionary statements, OPP proposed to revise
 criteria used to place pesticides in toxicity categories,
 expanded the human hazard precautionary statements, and added


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                                       Labeling of Pesticides
recommended practical treatment statements.  According to  OPP
officials, they did not finalize the regulations because of
other priorities.  Even though OPP did not finalize the
revisions to the regulations, product managers used the
proposed revisions when reviewing pesticide labels.
Registrants were aware that OPP used the proposed regulations
and generally followed them in order to get product managers
to approve registrations and amendments.

OPP officials agreed that revising the regulations may result
in improved labeling because (1) registrants are more apt  to
comply with regulations, (2) enforcement actions will be
easier to sustain if requirements are regulatory, and (3)
courts generally give greater deference to regulations than
policies.

Procedures Needed For Label Reviews

There were no procedures for product managers to use when
reviewing pesticide labels.  Not having procedures can result
in inconsistencies in how product managers review labels.
Also, product managers may be giving conflicting instructions
to registrants on labels.  In the past, product managers used
a checklist for the review of registrations, including the
label review.  However, as pesticide products became more
complex, the checklist fell into disuse.  OPP has recognized
the value of having procedures for label reviews.  During
1992, OPP planned to develop a procedures manual for label
reviews.
RESTRICTED USE STATEMENTS MISSING FROM PESTICIDE LABELS

Of the 95 labels reviewed, EPA had determined that 16 should
be classified as restricted use pesticides.  Two of the 16
labels reviewed were missing restricted use statements.
FIFRA states that if EPA determines that a particular
pesticide, or uses of a pesticide, may generally cause
unreasonable adverse effects on the environment, the
pesticide may be classified as restricted use.  Restricted
use pesticides can only be used by certified applicators or
undtsr the direct supervision of a certified applicator.
Labcding regulations require restricted use pesticides to
have the following statements on the front of the label:
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                                         Labeling of Pesticides
               RESTRiCTEE) USE PESTICIDE
            .  ,.                        .    only lay • ,•-••• . ••
       :'•.. \ .-;Cer*ified Applicators or persons under tiheir :: .;
       direct supervision and only for those uses covered
                 '                                      " ''
  Of the 16 pesticides EPA had determined should have
  restricted use statements:

    o  One product containing coal tar creosote as the active
       ingredient did not have a restricted use statement.
       Other products with coal tar creosote were properly
       labeled as restricted use pesticides.

    o  One product contained the statement MFor use by only
       professional or certified applicators ...", but was  not
       clearly labeled as a restricted use pesticide.   The
       product manager agreed that the product  was a restricted
       use pesticide.6

  OPP classifies products as restricted use pesticides when it
  determines the product will cause unreasonable adverse
  effects if it is used without this restriction.   OPP needs to
  take the necessary steps to be sure that registrants properly
  label all restricted use pesticides.
  LABELING CHANGES IN REGISTRATION STANDARDS NOT ENFORCED

  OPP is waiting until products are reregistered to implement
  labeling changes identified in registration standards.   OPP
  issued the registration standards during the 1980's.  The
  registration standards summarized OPP's review of available
  data on the active ingredient and identified the label
  statements which were needed based on the available data.
  When registrants request label changes for products which
     'The registrant was disputing with EPA over the restricted
use statement.

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                                         Labeling of Pesticides
  have registration standards, product managers do not verify
  that labels comply with the standards.  Since reregistration
  will not be completed until about 2002, OPP should not wait
  to implement label changes identified in the registration
  standards,

  Product managers do not always verify that labels comply with
  registration standards when accepting pesticide labels.  As
  discussed in Chapter 2, toxicity studies were not available
  for 58 of 95 products reviewed.  OPP had issued registration
  standards for 27 of the 58 products without toxicity studies.
  Of the 27 products, the precautionary statements on 12 of the
  labels did not comply with the registration standard.
  Product managers stated that they had not checked for
  compliance with the registration standard because the
  standard was applicable only to manufacturing use products7.
  T.ie product managers stated that those labels which did not
  comply with the registration standard would be corrected
  during reregistration, when all product labels are updated.

  During the 1980's OPP was systematically reevaluating older
  existing pesticides through a registration standards program.
  By 1988, OPP issued 194 registration standards8.   The
  registration standard summarized OPP's evaluation of
  available data on an existing chemical, identified and
  required registrants to submit additional data, and set forth
  conditions the registrant needed to meet in order to
  reregister a product.  The registration standard typically
  included modifications to labels.  Some standards were only
  applicable to manufacturing use products, while other
  standards were applicable to both manufacturing use and end
  use products.

  The registration standards contain conflicting information on
  their applicability to end use products.  For the products
  reviewed against the registration standards, the section
  "Products Subject To This Standard" said that end use
  products were subject to the labeling changes.  Also, the
     7Meinufacturing use products are pesticides used solely to
manufacture other pesticides.

     *The  1988  FIFRA amendments revised EPA's process for
reevaluciting existing pesticides.  Those pesticides with
registration standards became List A in the reregistration
process.

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                                                    Labeling of Pesticides
              section of the standard  concerning  labeling often  included
              specific label language  for  end use products.  The product
              manager's statement  that the standard was not applicable to
              end use products  was taken from the introduction to the
              standard which states "The Agency will apply the provisions
              of  the  Registration  Standard to end use products if necessary
              to  protect man and the environment."

              When EPA issued the  registration standards, it recognized
              that additional label precautions may be necessary to protect
              human health  and  the environment.   EPA issued the
              registration  standards during the mid-1980's.  EPA's current
              estimate for  completing  reregistration is around 2002.  At
              least ten years will have passed from when EPA issued the
              standard to when  EPA completes reregistration.  This is a
              long time for products to remain in use when EPA had
              indications that  the label precautions were not adequate.
              Registrants continually  submit label revisions for products
              subject to the registration  standards.  Correcting the label
              statements now will  further  protect the public and
              environment until EPA completes reregistration.
             ADDITIONAL OPP CONCERNS

             OPP officials stated that the lack of direct authority to
             enforce compliance with labeling regulations makes
             enforcement difficult.  It is not a violation of FIFRA for
             registrants not to comply with OPP regulations.  However, OPP
             has two other options for taking an enforcement action when a
             registrant does not revise its pesticide label:

                  Under FIFRA Section 6(b), OPP can cancel the
                  registration for products that do not make requested
                  label changes.  To do this, OPP must prove not making
                  the label changes will cause unreasonable adverse
                  effects.  In addition, the law allows a registrant to
                  request a hearing.

                  Under FIFRA Section 12, OPP can bring a misbranding
                  action against any one who distributes or sells a
                  pesticide that does not contain proper precautionary
                  statements.  To bring a misbranding action, OPP must
                  prove that the product was distributed without required
                  changes and that the label changes were necessary to
                  adequately protect the public health or the environment.
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                                       Labeling of Pesticides
According to OPP officials, both of these enforcement actions
can be cumbersome and resource intensive.  As a result, OPP
generally tries to obtain registrant compliance without
taking formal enforcement actions.  OPP is working with
Congress to give EPA the authority to directly enforce
compliance with any regulation, including labeling
regulations.
CONCLUSION

FIFRA requires OPP to ensure that registered pesticides, when
used according to label directions, will not generally cause
unreasonable adverse effects.  OPP uses precautionary
statements to warn users of the potential harmful effects of
pesticides.  Yet, almost half of the pesticide labels that we
reviewed did not have accurate precautionary statements.
Also, important restricted use statements were missing from
some pesticides.  OPP needs to be sure the precautionary
statements are accurate and will protect human health and the
environment.
AGENCY COMMENTS AND ACTIONS

The Assistant Administrator agreed to act to resolve the
issues described above.  The Assistant Administrator
acknowledged that product precautionary labeling may not
precisely conform to the labeling regulations.  OPP agreed
that it lacks clear written procedures for product managers
to use in reviewing and accepting labeling statements.
However, according to the Assistant Administrator, this was
not the most significant reason for labeling inconsistency,
and its correction will not necessarily ensure a constant and
strict conformity with labeling guidelines in the future.

According to the Assistant Administrator, the difficulty lies
in compelling registrants to make label changes.  After
initial registration, the Agency's ability to compel label
changes is constrained because FIFRA Section 12 does not give
EPA the authority to directly enforce labeling regulations.
This weakness in FIFRA is a major consideration driving
program choices.  EPA must enforce its labeling regulations
throagh either cancellation of the product's registration or
a missbranding enforcement action.  While it does not
absolutely prohibit obtaining label changes, the statutory
mechanisms are cumbersome and time-consuming.  The Assistant


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                                         Labeling of Pesticides
  Administrator stated that the Administration continues to
  propose legislation to obtain changes in FIFRA which would
  enhance EPA's ability to ensure labeling is accurate and
  consistent.

  To address the issues raised in this chapter, the Assistant
  Administrator stated that OPP:

    1. had established the Center for Excellence for Labeling
       to focus on labeling problems.  The Center plans to
       develop, by September 1993, a labeling review guide for
       product managers.

    2. will issue by October 30, 1992, a memorandum to branch
       chiefs regarding verifying compliance with registration
       standards.  This will be done for new products and
       amendments to the extent that the requirements in the
       registration standards are applied to end use products.

    3. will request registrants of the products with labels we
       found to be inaccurate to correct their labels.  OPP
       will issue letters to the registrants by October 31,
       1992.9

  The Assistant Administrator stated that before EPA revises
  its labeling regulations (40 CFR Part 156)  to reflect what is
  currently required on labels, it is important to collect,
  analyze, and disseminate current labeling policy.  The Center
  for Excellence for Labeling expects to complete this task by
  March 31,  1993.  At that time, OPP will decide whether and
  when the labeling regulations will be revised.
  PIG EVALUATION

  He agree that the difficulty in requiring labeling changes
  can contribute to label inconsistencies.  In the cases we
  reviewed, however, we did not find that the lack of authority
  to compel registrants to modify their labels was the cause of
  the inaccuracy in the labels.  These were not cases where EPA
  requested a change and the registrant refused.  Instead, in
  these cases, statements were missing from the labels and EPA
  had not informed the registrants of these deficiencies.
     *We provided OPP with a  listing  of the registration numbers
for the labels referred to in this chapter on June 26, 1992.

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                                       Labeling of Pesticides
The Assistant Administrator has proposed actions that, when
implemented, will substantially resolve the issues presented
in this chapter.
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                                         Labeling of Pesticides
                            CHAPTER 4

         REGISTRANTS DID NOT SUBMIT FINAL PRINTED LABELS
  EPA did not have complete copies of final printed labels for
  many pesticides.  This occurred because OPP did not regularly
  follow-up on whether registrants submitted final printed
  labels.  Without the registrants submitting final printed
  labels, OPP had little assurance that the registrant had made
  the required changes to the label.  Also, enforcement
  personnel need an accurate copy of the accepted label to use
  cturing inspections to determine whether pesticide products
  are properly labeled.

  OPP relied upon the registrant to make requested changes to
  t:^e labels and to submit a copy of the final printed label
  before distributing the pesticide.  We found cases where
  registrants did not make changes OPP requested.  In one case,
  OPP accepted a draft label after the registrant did not (1)
  make previously requested changes and (2) submit a final
  printed label.  In another case, the registrant submitted a
  label to the state which did not include OPP requested
  changes.  The label was missing the statement "Causes
  irreversible eye damage."
  REGISTRANTS REQUIRED TO SUBMIT A COMPLETE COPY OF LABELS

  FIFRA Section 3(c) requires that, as a condition of
  registration, the registrant submit a complete copy of the
  pesticide label.  EPA's labeling regulations  (40 CFR Part
  156.) also require that registrants submit copies of final
  printed labels.  Prior to 1982, OPP required that both draft
  and final printed labels be reviewed and approved before a
  registration was granted.10  The registrant could not market
  the product until OPP approved the final printed label.  This
  resulted in delays in marketing pesticide products.

  In 1382, OPP issued a regulation notice (Pesticide Regulation
  Notice 82-2) changing its procedures for approving pesticide
  registrations.  Prior to this, registrants had indicated that
  they were prepared to assume responsibility for producing
     l°References to pesticide registrations also include
amendments to registrations.

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                                         Labeling of Pesticides
  accurate final printed labels if it would result in OPP
  making faster registration decisions.  With the issuance of
  the regulation notice, OPP no longer routinely required
  registrants to submit final printed labels before approving
  the registration.  However, as a condition of registration,
  OPP required the registrant to (1) make the label changes OPP
  requested and (2) submit a final printed label before the
  product was released for shipment.  In the regulation notice,
  OPP stated that it would selectively audit final printed
  labels to ensure registrants' compliance.  Also, OPP would
  require a final printed label before approving the
  registration if the registrant had previously not made the
  required changes".
  REGISTRANTS OFTEN DID NOT SUBMIT FINAL PRINTED LABELS

  In many cases, the registrants had not submitted final
  printed labels, as shown in Figure 8.
     11 EPA subsequently formalized its policy to review draft
labeling and included it in 40 CFR 152.108.

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                                         Labeling of Pesticides
            Figure 8:   Most Current Label in OFF Files

                                             Number Percent
    Final printed label                        54     57

    Draft label with no additional
      changes to be made12                      17     18

    Total cases with final printed label
      or complete draft label                  71

    No final printed label:
     Draft label with additional
     OPP requested changes                     15     16

    Draft label with changes inserted           9      9

    Total cases with no final printed label    24

    Total labels reviewed                      £5    100

  OPP did not systematically follow-up to be sure that
  registrants submitted final printed labels.  Product managers
  stated that (l) they did not check for final printed labels
  or (2) Pesticide Regulation Notice 82-2 did not require
  registrants to submit final printed labels.  We do not agree
  with the product managers' interpretation of the regulation
  notice.  The regulation notice does allow for approval of a
  registration based on a draft label, but does require that
  the registrant submit a final printed label.  Without the
  registrants submitting final printed labels, OPP has little
  assurance that registrants make requested changes to labels.

  In some cases, the product managers stated that if the files
  did :iot contain final printed labels it was because the
  registrant had not released the product for shipment.  When
  OPP accepted changes to pesticide labels, it did not give a
  time frame for when ithe registrant must change its labels.
  Even though OPP may not specify a deadline for registrants to
  revise their labels, 40 CFR 152.130(c) states that when
  registrants initiate a label change, they may distribute the
     12 According to OPP officials, when a registrant has
submitted a draft label for which no additional changes are
needed, the importance of obtaining the final printed label is
reduced.

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                                        Labeling of  Pesticides
product under  the previously approved labeling for  18  months.
For changes  OPP initiates to further protect users  or  the
environment, the regulations allow OPP to establish a
deadline  for using a revised label.  When label changes are
made to protect human health and the environment, OPP  needs
to give the  registrant a deadline for making the  label
changes.

We found  cases where registrants did not make changes  OPP
requested.   For example,  in one case, OPP accepted  a draft
label after  the registrant did not (1) make previously
requested changes and (2)  submit a final printed  label.

     In 1988,  OPP accepted a draft label with a use on
     cockroaches deleted as follows:

          PERIMETER TREATMENT:  To prevent infestation of
          buildings by Ants,             Crickets,
          Earwigs, and Sowbugs  (Pillbugs),  ...

     In the  letter approving the registration, OPP  required
     the  registrant to submit a copy of the final printed
     label before shipping the product.  The registrant did
     not  submit a final printed label.  In 1990,  the
     registrant submitted a draft label which looked as
     follows:

          PERIMETER TREATMENT:  To prevent infestation of
          buildings by Ants,  Cockroaches,  Crickets,
          Earwigs, and Sowbugs  (Pillbugs),  ...

     In a letter to the company,  OPP stated that the label
     was unacceptable,  and that the use on cockroaches was to
     be deleted.   The registrant resubmitted a draft label
     with the  use on cockroaches again deleted as follows:

          PERIMETER TREATMENT:  To prevent infestation of
          buildings by Ants,             Crickets,
          Earwigs, and Sowbugs  (Pillbugs},  ...

     On September 24,  1990,  OPP accepted the draft  label.
     Again,  the  registrant did not submit the final  printed
     label.   Because EPA does not follow-up on submission of
     final printed labels,  EPA cannot be sure that  the final
     label will  not include a use on cockroaches.   When asked
     about submission of the final label, the product  manager
     stated that it was not his responsibility to check to
     see if the  registrant submitted a final printed label.
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                                       Labeling of Pesticides
Contrary to the product manager's statement, OPP needs to be
sure that registrants submit copies of the final printed
labels.

The 1982 regulation notice, and 40 CFR 152.108, stated that
OPP would selectively review final printed labels to ensure
that registrants submitted final printed labels and made all
OPP requested changes.  However, OPP has not been performing
this type of review.  A selective review of final printed
labels would give OPP assurance that registrants (1) submit
•:he final printed labels, and  (2) make all changes OPP
requests.

In those cases where there was no final printed label, OPP
did not always notify the registrant that (1) they were
required to submit a final printed label and (2) enforcement
action could be taken if the label was not submitted.

 Figure 9:   Registrant Notified to Submit  Final Printed Label

  Registrant notified to submit a final printed
    label and of the potential for enforcement action  15

  Registrant notified to submit a final printed
    label, but not of the potential for
    enforcement action                                  8

  Registrant not notified to submit a final printed
     label                                             18

  Total

The registrant was responsible for submitting a final printed
label, even if there were no additional changes needed to the
draft label.  When OPP notifies the registrant that the draft
label is accepted, OPP needs to remind registrants of their
responsibility to submit final printed labels.  OPP stated in
the regulation notice that if the registrant does not submit
a final printed label prior to the product's release for
shipment,  FIFRA section 6(e)  allows OPP to propose to cancel
the registration.
ENFORCEMENT PERSONNEL NEED ACCURATE COPIES OF ACCEPTED LABELS

;Final printed labels, or accurate copies of EPA accepted
labels, would assist enforcement personnel in ensuring


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                                         Labeling of Pesticides
  registrants' compliance with labeling requirements.
  Headquarters and regional enforcement personnel stated that
  the lack of final printed labels or accepted labels created
  an enforcement problem.  The states, which have primary
  enforcement responsibility, need accurate copies of EPA
  accepted labels to use during inspections.

  Accurate copies of accepted labels are needed to conduct
  producer establishment and marketplace inspections.  EPA's
  pesticide inspection manual lists as the first objective of
  producer establishment inspections is to "ensure industry
  compliance with ... labeling requirements before the products
  are distributed—"  Also, the first objective of marketplace
  inspections is "to detect and obtain samples of unregistered
  or misbranded pesticides being marketed."13

  State Inspectors Did Not Have Accepted Pesticide Labels

  State personnel generally perform pesticide inspections.
  Generally,  the states get copies of the pesticide labels from
  the producers who sell pesticides in their state.  Our review
  found that the states may not have the same pesticide labels
  that EPA has accepted.  As a result, the states are not using
  the EPA accepted labels to ensure compliance with labeling
  requirements.

  He obtained 17 pesticide labels from various states and
  compared the state label with the EPA accepted label.  Seven
  of 17 (41 percent) state labels were different from the EPA
  accepted label.  Some of the differences were significant.

    o  For one pesticide, OPP recommended in February 1991
       significant label changes based on new studies to
       support reregistration.  The label changes included (1)
       restricting usage to professional turf maintenance
       personnel, landscaping, or commercial applicators, and
       (2) revising the precautionary statement to read:
       "Causes irreversible eye damage."  OPP accepted the
       draft label on May 6, 1991.  The registrant did not
       submit a final printed label.

       The registrant renewed its license with the state of
       Oregon in December 1991.  The label the registrant
     13A pesticide is misbranded if it does not display a proper
label or if the label contains false or misleading information.

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                                       Labeling of Pesticides
     submitted to the state did not include the revisions OPP
     had requested ten months earlier.  The state's label
     neither restricted the usage of the pesticide nor warned
     the user of irreversible eye damage.  Instead, for eye
     irritation, the state's label read: "Causes eye  ...
     irritation."

  o  For another pesticide, the EPA accepted label read "Keep
     pets and grazing animals out of treated area for 24
     hours following application."  The state of Missouri's
     label for this product does not include the statement.

EPA needs to ensure that the states have copies of the EPA
accepted labels to use during enforcement inspections.
CONCLUSION

Registrants are required to submit a complete copy of the
posticide label.  OPP needs to be sure that registrants
submit final printed labels that include all warning and
precautionary statements.  Inspectors also need an accurate
copy of the EPA accepted label during inspections.  OPP needs
a systematic way of verifying that registrants submit copies
of the final printed labels.  If OPP does not verify that
registrants submit final printed labels, OPP cannot be sure
that registrants are revising their labels.
AGENCY COMMENTS AND ACTIONS

The Assistant Administrator agreed to act to resolve the
issues discussed above.  She also agreed that OPP's current
policies and rules require the submission of a final printed
label prior to marketing, and that OPP has not been
conssistent either in assuring that this was done, or in
selectively reviewing such labeling for compliance with
necessary changes.

The Assistant Administrator stated that OPP:

  1. will reinstitute its selective audit of final printed
     labels.  By January 31, 1993, OPP will develop a
     Standard Operating Procedure describing how it will
     conduct the process.  During fiscal 1993, OPP intends to
     review and verify accuracy of at least 50 product labels
     under the new process.  Thereafter, OPP will evaluate


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                                                     Labeling of  Pesticides
                   the results of the selective  review  to  determine whether
                   any changes are needed in the audit  process.

                2.  will issue a memorandum to branch  chiefs  and  product
                   managers requiring OFF to give registrants  a  specific
                   date for making label  changes when the  changes may
                   affect human health and the environment and are not
                   covered by OPP's existing stocks policy.  OPP will issue
                   the memorandum by October 30,  1992.

                3.  has requested funding  to  facilitate  making  EPA accepted
                   labels available to EPA and state  enforcement personnel.
                   At  the time of the response,  decisions  on funding  had
                   not yet been made.   If funding is  not available, OPP
                   will continue its current practice of supplying
                   microfiche copies of labels to the Regions.

                4.  will require registrants  to submit final  printed labels
                   for those products where  we found  OPP did not have final
                   printed labels.14  OPP  will issue letters  to registrants
                   by  October 31,  1992.
             PIG EVALUATION

             The Assistant Administrator has proposed actions that, when
             implemented, will substantially resolve the issues presented
             in this chapter.
                14We provided OPP with a listing of the registration numbers
           for the labels referred to in this chapter on June 26,  1992.

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                                       Labeling of Pesticides
                          CHAPTER 5

         EPA NEEDS TO MAKE BETTER USE OF INFORMATION
                     IN INCIDENT REPORTS

OPP needs to follow-up on significant incidents involving a
pesticide or after a series of incidents indicates a
pesticide is adversely affecting the environment.  However,
OPP was not collecting or analyzing pesticide incident
reports.  This occurred because, until recently, OPP placed
little importance on the information contained in incident
reports.  As a result, OPP may not have been aware of
pesticides for which registrants need to take additional
action, such as changing label precautions or directions, to
protect the environment.  In July 1992, OPP completed a
system for tracking and analyzing incident reports which may
correct many of the deficiencies that we found.

A'- the time of our fieldwork, OPP did not (1) centrally
collect, (2) organize, or (3) follow-up on incident reports
it received.  However, the incident reports contained
inportant information on the consequences of pesticide use.
For example, of 50 incident reports reviewed, 5 described
deaths to adults.  OPP also infrequently used information on
incident reports it could obtain from a contractor.  It was
only after 200 incidents in one year, including 26 animal
deaths, that OPP required the registrant to make label
changes to a flea and tick pesticide.
INCIDENT REPORTS CONTAIN VALUABLE INFORMATION

FIFRA Section 6(a)(2) requires registrants to notify EPA
whenever they obtain information that a pesticide may cause
unreasonable adverse effects on the environment.  In
addition, the generail public and medical personnel
voluntarily report to EPA incidents involving pesticides.

FIFRA allows the Agency to register pesticide products only
if they will not adversely affect man and the environment.
FIFRA, Section 3(c}(5) states that EPA is to consider when
registering a pesticide whether:

     it will perform its intended function without
     unreasonable adverse effects on the environment;
     eind
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                                       Labeling of Pesticides
     when used  in  accordance with widespread and
     commonly recognized practice it will not generally
     cause unreasonable adverse effects on the
     environment.

 Incident reports sometimes describe serious consequences of
 pesticide use and  misuse.  For example, we reviewed a sample
 of 50 incident  reports the response officer received between
 January 1989 and December 1991.  As shown in Exhibit 1, most
 of the incidents describe human or animal deaths or adverse
 reactions.  For example, the 20 human cases included 5 adult
 deaths, 1 child death, and 1 miscarriage.  Nineteen cases
 described pet deaths or adverse reactions.  Some cases
 involved multiple  deaths, including one case involving the
 death of a cat  and her litter of kittens.  The cases
 describing bird and fish kills again involved multiple
 deaths.  For example, two of the bird kills involved about 20
 birds each; the fish kill was estimated at several thousand
 pounds.

 Some of the adverse reactions resulted from intentional or
 accidental misuse  of the product.  For example, one of the
 adult deaths was a suicide.  The child death resulted from
 the child drinking a pesticide left in a bucket.  Other
 cases,  though, may indicate problems with a pesticide or its
 label.   For example, one pet owner wrote that a product's
 label directions did not match the directions in the box.

 Even though OPP did not regularly analyze incident reports,
 in some cases EPA had decided to require registrants to place
additional precautions on the pesticide label based on
reported incidents.  However, OPP took action only after
there were significant incidents.  For example:

  o  During 1987, the National Animal Pollution Control
     Center,  an EPA subcontractor, received almost 500
     incident reports of dogs and cats having adverse
     reactions to a flea and tick pesticide.   The incidents
     included 75 animal deaths.  Because of the high number
     of incidents,  OPP required additional testing of the
     pesticide.   In 1988,  the registrant stopped distributing
     the pesticide.  The registrant reintroduced the
     pesticide in 1989 with additional label precautions.

  o  From incident reports,  OPP found that adverse reactions
     were occurring from the use of flying insect sprays
     containing the active ingredient DEET.   The adverse


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                                       Labeling of Pesticides
     reactions resulted from accidental exposure by spraying
     the pesticide into the eye and by applying the pesticide
     too often.  As a result, in 1991, OPP required
     additional labeling statements for some end-use products
     containing the active ingredient DEBT.

  o  In July 1991, a train derailed and spilled metam sodium
     into a California river.  The spill killed all plants
     and fish in a 40 mile stretch of the river.  As a result
     of this incident and EPA's review of the registrant's
     studies, EPA and a number registrants worked together to
     revise the pesticide label, and canceled all home-use
     products containing metam sodium.

These examples illustrate that incidents can point out needed
label changes, and that OPP has acted based on incidents in
the past.

OPP's pesticide incident response officer and OPP's product
managers are responsible for collecting information on
incidents and ensuring that pesticides are not causing
unreasonable adverse effects.  In 1978, OPP appointed a
person as the pesticide incident response officer.  The
incident response officer is to serve as the focal point for
receiving, tracking, and monitoring all pesticide incidents.
OPP product managers are responsible for identifying
chemicals that pose unreasonable adverse effects and
arranging for reviews of pesticide labels to ensure that they
are adequate to protect human health and the environment.
OPP'S HANDLING OF INCIDENT REPORTS IT RECEIVED WAS NOT
ADEQUATE

The incident response officer was not (1) collecting, (2)
organizing, or (3) following-up on all incident reports.
This occurred because OPP had (1) no procedures for handling
incident reports, and (2) placed little importance on the
information in incident reports.  Without adequate processing
of incident reports, OPP cannot use the information to
identify pesticides that may be adversely affecting the
environment.

Incidents Reports Not Centrally Collected

Various OPP divisions, regional offices, and state agencies
may receive incident reports.  However, the various offices


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                                       Labeling of Pesticides
do not routinely forward the information to the incident
response officer.  The incident response officer needs to be
aware of all incidents involving a pesticide to have an
accurate record of incidents.  This will allow OPP to
identify significant trends in incident reports and possible
label deficiencies.  Without centralized collection, OPP had
only a limited picture of how pesticides were adversely
affecting the environment.

OPP did not have procedures which required its product
managers to forward incident reports to the incident response
officer.  Some product managers reviewed incident reports
before sending the information to the incident response
officer.  Others forwarded the incident report to the
incident response officer without reviewing the information.
One product manager placed the reports directly in the
registration file without sending the information to the
incident response officer.  Without a central receiving
point, OPP was not aware of all incidents reported for a
particular pesticide.

Regional and state offices also receive reports of pesticide
incidents.  However, the incident response officer generally
did not receive information on pesticide incidents from the
regions and states.  The regions report some incidents to
OCM,  but this information was not forwarded to the incident
response officer.  Regions and states need to forward reports
to the incident response officer in order to have a complete
record of pesticide incidents.

Incident Reports Not Organized

For more than 10 years, OPP had not organized incident
reports in any useable manner.   Some of the reports the
incident response officer received were placed in unmarked
folders.  Others were stored in file cabinets, but not
necessarily in any specific order.  Still others were stored
loosely in boxes or on top of desks and file cabinets in the
incident response officer's office.  The files did not
contain unique identification numbers.  There was no way to
identify all incidents relating to a specific active
ingredient or product.  Because OPP did not organize the
incident reports, it could not use the incident reports to
identify pesticides that may be adversely affecting humans
and the environment.
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                                         Labeling of Pesticides
  OPP previously entered incidents into the Pesticide Incident
  Monitoring System.  During the mid 1970's, OPP discontinued
  the system because of a shortage of staff and funding.  By
  not organizing the incident reports in a centralized system,
  OPP was left without the capability of obtaining accurate
  incident information.

  Product managers consistently told us that a computer system
  capable of sorting and tracking incidents would be a great
  benefit during label reviews.  With such a system OPP could
  identify pesticides that were frequently mentioned in
  incident reports.  Because OPP did not organize incident
  reports, product managers could not use the reports to
  identify potential weaknesses in labeling statements.

  GPP has taken stejps to improve the organization of new
  incident reports it receives.  Since September 1991, OPP has
  placed all incidents received from registrants and others on
  microfiche.  In July 1992, OPP also implemented a
  computerized incident report system15.  Based on the
  ir,formation in the system, OPP can produce statistical
  reports concerning incident reports.

  Incident Reports Not Followed-up

  Although incident reports can involve human and animal deaths
  and adverse reactions, the incident response officer and
  product managers did not routinely follow-up on incident
  reports.  OPP had no requirements that the incident response
  officer or product managers obtain additional information on
  reported incidents.  Without adequate follow-up of reported
  incidents, OPP did not have accurate information on how
  pesticides adversely affected man and the environment.

  Some incident reports contain detailed information on the
  incident, while others may include only limited information.
  As a result, OPP needs to follow-up on information in
  incident reports where the registrant or public provided too
  little information for OPP to determine the extent of the
  problsm.  The incident response officer can refer cases to
  the Registration Division, the Special Review and
  Reregz.stration Division, and the Office of Compliance
     15 We did not evaluate the information in the incident report
system because it was not implemented until the end of our
fieldworK.

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                                         Labeling of Pesticides
  Monitoring.  However, the incident response officer seldom
  referred incident reports for further action.  In those cases
  where the incidents were referred for further action, there
  was little documentation in OFF files as to the actions
  taken.

  OPP does not necessarily need to follow-up on each pesticide
  incident.  OPP needs to follow-up on significant incidents or
  after a series of incidents indicates a significant problem.
  However, because OPP did not centrally collect or organize
  incident reports, it could not determine when a pattern had
  developed that pointed out a problem that needed further
  investigation.

  Recent Actions To Improve Handling of Incident Reports

  After the July 1991 metam sodium spill in California,
  Congress held hearings16 concerning EPA's review of
  information on adverse effects of pesticides received from
  registrants.  As a result, OPP began to establish procedures
  for reviewing adverse effect information received from
  registrants and incident reports received from other sources.

  In October 1991, OPP established a workgroup, referred to as
  a SWAT team, to address the problems in the handling of
  adverse effect and incident information.  OPP identified
  similar problems with handling incident reports as discussed
  in this report.  In July 1992, OPP completed procedures for
  handling incident reports.  The procedures included:

    o  A flowchart for handling incident reports, including
       identification of responsible persons or offices.

    o  criteria for screening incident reports in order to
       identify incidents needing additional review or OPP
       action.

    o  Format for recording information obtained over the
       telephone on incident reports.

  OPP has also developed and implemented a computerized
  incident reports system.  All incident reports are now input
  into the computer system.  Based on the information in the
     "Joint hearing before the House Committees on Government
Operations and Agriculture on October 31, 1991.

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                                       Labeling of Pesticides
system, OPP can produce statistical reports concerning
incident reports.  These new procedures and the incident
reports system should correct the deficiencies found during
our review.
OPP INFREQUENTLY USED VALUABLE INFORMATION ON PESTICIDE
INCIDENTS

OPP infrequently used information on pesticides incidents
available from its contractor.  The contractor's information
indicated trends in pesticide incidents.  Because OPP
infrequently requested the contractor's information, the
information was not used to identify pesticides for which
action was needed to further protect the environment.

CPP has a five year contract, worth about $825,000 per year,
with Texas Tech University (Lubbock, Texas) to operate NPTN.
N.PTN is a 24-hour pesticide hotline that provides callers
with information on the use and effects of pesticides.  Calls
rsmge from routine requests for information about a pesticide
to emergencies involving humans or animals.  NPTN receives
calls from all over the United States.  NPTN inputs
information on all calls into a computer system.  When the
call involves a pesticide incident, NPTN records information
such as the pesticide used; whether it affected humans,
animals or the environment; extent of adverse affects; and
how the pesticide was used.  NPTN provides OPP with quarterly
reports on the number and nature of the calls they receive.
For incidents, NPTN provides information on the active
ingredient involved and whether it affected humans, animals,
or the environment.  NPTN maintains statistics on calls
received on a particular active ingredient or product for at
least the past eight years.

NPTN statistics show that the pesticide active ingredients
used in most incidents have generally remained the same over
the past eight years, as shown in Figure 10.
                              45

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                                         Labeling of Pesticides
                 Figure 10:  Number of Incident Reports
                             Bv Active Ingredient
                           1984-1991
                      Third Quarter
                      Fiscal Year 1991
  Active Ingredient

  Chlorpyrifos
  Chlordane"
  Diazinon17
  Malathion
  Carbaryl
  2,4-D17
  Pyrethrins
  Glyphosate
  Lindane17
  fiendiocarb
Number of
Incidents

  3642
  3166
  2517
  1472
   737
   673
   591
   569
   558
   508
Ranking

   1
   2
   3
   4
   5
   6
   7
   8
   9
  10
Number of
Incidents
191
54
129
58
39
30
12
26
(not
12

Ranking
1
4
2
3
5
6
14
8
listed)
14
  These statistics reflect only those incidents reported to
  NPTN.  This may be only a small fraction of the pesticide
  incidents that occur.  These chemicals also represent some of
  the most frequently used home-use pesticides.  From this
  information there does appear to be a trend in the active
  ingredients that commonly cause adverse effects on humans and
  the environment.  Information on specific incidents is
  readily available from NPTN.  However, prior to fiscal year
  1992, NPTN received only 13 requests from EPA for additional
  information.

  OPP had taken action on some active ingredients because of a
  large number of incidents.  One example of where OPP has
  taken action on the chemicals listed above is Chlorpyrifos.
  In 1984, OPP requested the registrant to perform additional
  testing on Chlorpyrifos, the chemical most frequently
  mentioned in NPTN incident reports.  OPP's review of these
  tests did not show that there was enough of a problem to
  require additional labeling changes.  Even though OPP did not
  find any problems with the first set of tests, OPP requested
  additional testing in 1991 because there was still additional
     17OPP is reviewing or had reviewed each of these chemicals as
part of the special review process.  Special review is EPA's
process for determining whether the use of a pesticide poses
unreasonable adverse effects to humans or the environment.

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                                       Labeling of Pesticides
information needed to evaluate the safety of the
chlorpyrifos.  EPA is awaiting the results of this testing.
As noted in the chart, OPP is taking action on several other
chemicals through the special review process.

OPP pays NPTN to provide information to the public concerning
pesticides.  As part of this, NPTN collects and summarizes
information on incident reports.  However, EPA infrequently
used the information from NPTN.   As a result, certain
pesticides may persist in adversely affecting the
environment.  EPA needs to act more often upon the
information NPTN collects.
CONCLUSION

EPA is entrusted with the responsibility to protect the
public and environment from unreasonable adverse effects of
pesticides.  The public reports to EPA real life incidents of
when pesticides may be adversely affecting the environment.
These reports can be of great value to the Agency.  However,
OPP did not routinely analyze the incident reports it
received, or use the information its contractor provided.
OPP has recently improved its ability to collect and analyze
incident reports.  OPP now needs to use the information it
collects to identify problem pesticides, and to protect the
public and environment from unreasonable adverse affects of
thiise pesticides.
AGENCY COMMENTS AND ACTIONS

During our review, the Agency took action to improve its
ability to collect and analyze incident reports.  In
responding to the draft report, the Assistant Administrator
stated that OPP has requested NPTN to collect more precise
information from callers concerning potential incidents.

Although agreeing with our recommendations, the Assistant
Administrator also discussed limitations associated with
incident report data.  The Assistant Administrator stated
that the report focused on incidents reported voluntarily and
not those registrants are required to report under FIFRA
Section 6(a)(2).  According to the Assistant Administrator,
•the type of information obtained from voluntarily reported
incidents is unlikely to sustain a regulatory decision.  The
quality and quantity of information needed is significantly


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                                       Labeling of Pesticides
greater than that unverified, poorly documented incident
reports provide.

In regards to NPTN, the Assistant Administrator stated that
it is primarily intended to provide information to the public
rather than to receive incident reports.  OPP has verbally
requested NPTN to collect more precise information from
callers about potential incidents.  OPP will provide written
procedures, including what data elements to collect, to NPTN
by the end of October 1992.  Even though NPTN will be
collecting additional information, it will not substitute for
OPP follow-up, and will not reduce the resources needed for
integrating incident information into regulatory decision
making.
OIG EVALUATION

The Assistant Administrator has proposed actions that, when
implemented, will substantially resolve the issues presented
in this chapter.
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                                  Labeling of Pesticides
                                             EXHIBIT 1
                                             Page 1 of 1
         PESTICIDE INCIDENT REPORTS REVIEWED
     Cases

Human reactions
  Adult deaths
  Child deaths
  Adult adverse reactions
  Child adverse reactions
  Miscarriages
     Total human reactions

Pet reactions
  Cat deaths
  Dog deaths
  Cage bird deaths
  Dog adverse reactions
  Unidentified pet reaction
     Total pet reactions

Wildlife reactions
  Bird kill
  Fish kill
     Total wildlife reactions

Other
  Fire
  Plant kill
  General
     Total other

Total incidents reviewed
Incidents
     5
     l
    10
     3
     1
    20
     9
     3
     1
     5
     1
    19
     5
     I
     6
     1
     1
     3_
     5


    50
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                             Labeling of Pesticides
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                   SO



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                              Labeling  of Pesticides
                                           APPENDIX 1
                                           Page 1  of 11

            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                       WASHINGTON, D.C. 20460
                                                   PREVENTION. PESTCiOES
                                                   AMD TQIC SUBSTANCES
                        SEP 29 1992
MEMORANDUM

SUBJECT:  Draft Report on jf^be^ing

FROM:
TO:
                      her
          Assistant Administrator

          Kenneth A. Konz
          Assistant Inspector General for Audit
     My office has reviewed the draft report entitled Labeling of
Pesticides, which has evaluated certain aspects of the Office of
Pesticide Program's (OPP) process for reviewing data and labeling
for adequacy under the Federal Insecticide,  Fungicide and
Rodenticide Act (FIFRA).  The report also evaluated the program's
incident reporting systems.  This review is  quite important since
labeling is one of the critical functions in the regulation of
pesticides, serving as both an enforcement and an information
vehicle to reduce the risks posed by pesticide use.  Incident
information serves to highlight trends in pesticide use and
effects that merit particular attention by EPA.

     The report recommends a number of improvements in both
labeling and incident information that are sound, and for the
most part achievable.  In fact, the recommendations are by no
means surprising or unexpected, and, as we indicate below, we are
planning or already implementing a number of improvements in our
processes to strengthen our labeling programs.  It should be
recognized, however, that the improvements recommended in the
report would impose a heavy resource burden  on the program.
Allocation of resources to these specific areas would have to be
considered in the light of broader program priorities.   He
welcome the recommendations of the report as a means of focussing
on these problems and on the resources needed to rectify them.

     My staff have worked extensively with yours, and, as the
report indicates,  we have provided them with substantial comment
on several occasions.  He appreciate their willingness to meet
with us and hear our concerns.  In this report, these discussions
have measurably improved the accuracy and quality of the report
and allowed both the IG and OPP to arrive at a mutual
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                                Labeling of Pesticides
                                             APPENDIX 1
                                             Page  2 of 11
understanding of the nature of the problems.  I believe that,
in future audits, the IG should seek substantive discussions with
the program even earlier in the process.

GENERAL OBSERVATIONS

     An essential element in evaluating the Agency's data and
labeling programs is an accurate characterization of the factors
contributing to the problems with labeling.  In particular,  the
report should emphasize even more that the FIFRA mandates are in
large measure responsible for the situation that the report
identifies.  If these are not accurately reflected,  the report
could appear to call into question the adequacy of the Agency's
labeling program for protection of public health.  By explaining
how the fundamental statutory directives of FIFRA affect the
labeling program, the problems with labeling and its underlying
databases are cast in the proper perspective.   We believe that
the difficulty the report identifies in reconciling the Agency's
labeling decisions with a supporting database are an undesirable,
but predictable consequence of the conditional registration,  data
compensation and reregistration programs established by Congress.
And while reregistration is the Congressionaliy mandated program
intended to correct the "lack of data" problem, and
reregistration is well underway, our resources for this program
must be taken into account in determining how rapidly the
correction can be accomplished.  Without adequate funding of the
reregistration program, the acquisition of the needed data and
the labeling decisions will be delayed well beyond the FIFRA
projected completion date for reregistration.

     Moreover,  the report should emphasize the statutory
constraints upon EPA's ability to compel registrant  compliance
with labeling decisions.  The cumbersome means of effecting  label
changes is a key factor that influences how we administer the
labeling program now,  and,  ultimately,  a large factor in how well
we will be able to accomplish some of the improvements the report
recommends,  in assessing the program's use of incident
information, the report clearly identifies an area which deserves
and has received greater attention,  but where the remaining
hurdle to a comprehensive program is funding for information
management systems.

     In sum, while we agree with the types of problems the report
identifies, we believe that they are not generally indicative  of
program management or administrative weaknesses.  The solutions
rest largely on legislative changes to FIFRA and increased
funding for the current reregistration and information management
programs.
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                                Labeling of Pesticides
                                            APPENDIX 1
                                            Page  3 of 11
CHAPTER 2.  EPA MISSING TOXICITY STUDIES TO SUPPORT PRECAUTIONARY
STATEMENTS.

CONCLUSIONS:

     The report, in several subsections, claims that OPP could
not locate its toxicity studies, or its reviews of toxicity
studies, in support of precautionary labeling.   The report goes
on to conclude that OPP improperly registered products without
such studies, or by improperly relying on studies on a different
product formulation.  The report attributes this problem to OPP's
failing to verify study existence and location at the time of
registration.

     As my staff has previously explained in meetings and
comments, the report does not adequately describe how the
statutory framework of conditional registration and
reregistration apply to its findings on the availability of
toxicity data.  The  explanation under Pesticide Program History
of reregistration, conditional registration, and data
compensation, does not consider the implications of these
provisions for OPP's regulatory programs.  In fact, in
administering the reregistration, conditional registration and
data compensation provisions of FIFRA as it has, EPA is operating
consistently  under longstanding Congressional  directives, which
have been reiterated in successive FIFRA amendments.  As a
result, Chapter 2 conclusions misidentify the problem and its
causes.

     Tide report concludes that EPA should "ensure that toxicity
studies are (1) submitted, (2) reviewed, and (3) serve as the
basis for precautionary statements on pesticides."  However,
under the reregistration mandate of FIFRA sec.  4, the conditional
registration scheme of FIFRA sec. 3(c)(7) and the data
compensation provisions of FIFRA sec. (3)(c)(1)(F), toxicity
studies are not necessarily required to be submitted or reviewed
prior to registration, and therefore cannot always serve as the
basis for precautionary statements of currently registered
products.

     We agree that each precautionary labeling  decision should be
supported by product-specific data which the Agency could
identify as the basis for that decision.  Currently, we do not
have such a data base; data on each product are not available and
the data that are available are often old or obsolete.  This
weakness, however, stems from the conditional registration scheme
which Congress statutorily directed us to administer:

     •Reregistration was established to rectify this situation:
to systematically collect data and review pesticide product
regulator!' decisions (including labeling decisions).  This is a
lengthy process, as the report acknowledges in  citing the length
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                                Labeling of Pesticides
                                             APPENDIX 1
                                             Page  4 of 11
 of time it has  taken  the Agency to complete the preliminary data
 call-in portions  of reregistration.

      •Congress  also recognized that the ongoing registration
 process cannot  equitably refuse registration to new products that
 are substantially similar to existing products while  EPA is
 awaiting new data, and thus authorized conditional registration
 while data are  being  developed.

      •Finally,  Congress recognized that because many products are
 substantially similar to one another, requiring data on each
 individual product would be duplicative and wasteful of both data
 development and review resources.  Data compensation provisions
 explicitly permit registrants to cite data from other sources
 that support their registrations.

     It  is the  meshing of these three provisions that allows the
 apparent weakness of  the data base to continue,  and it is only
 the completion  of reregistration that will cure the problem.
 Reregistration  is a lengthy process.   As the report states,  the
 current estimate  for  accomplishing reregistration is 2002; the
 program has been  hindered by lack of funding which could speed
 our task.   I have testified before Congress on the shortfall in
 resources  to meet our statutory targets.   Without additional
 funding, reregistration will take longer than Congress projected.

 RECOMMENDATIONS - CHAPTER 2.

     The report recognizes the resource-intensive nature of
 attempting  to locate,  organize, document,  and link existing
 toxicity studies to existing products for the purpose of
 verifying  labeling decisions.   Consequently the  report makes no
 recommendations about existing studies but focusses on better
 organization and documentation of studies to be  received in  the
 future.   We agree generally with this emphasis.

 RECOMMENDATIONS 2.1 AND 2.2:  The report recommends that OPP
 "organize toxicity studies,  starting  in fiscal year 1993,  in such
 a way that OPP can easily locate and  use the studies when making
 labeling decisions regarding substantially similar products."
 The report recommends that OPP record the location of each
 toxicity study,  and further document  the results of the review.

     OPP currently organizes its data by Master  Record
 Identification Number in the Pesticide Data Management System.
The MRID number is placed on the data itself,  and in the review
 of the data by scientists.   In the past,  reviews were located in
 registration files,  and were difficult to locate for use with
 subsequent products,   storage in registration files also meant
 that a study review could be lost for all  practical purposes if
the registration file  was retired.  Since 1991,  OPP has instead
been storing paper copies of reviews  separate from product files.
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                                Labeling of Pesticides
                                            APPENDIX  1
                                            Page  5 of 11
We have also been cataloging the reviews on a d-base system which
stores all study reviews and is searchable by registration
number.  Finally, since 1990 the results of toxicity study
reviews  (the toxicity category information by route of exposure)
have been included on the Pesticide Registration Action Tracking
System (PRATS) which allows a reviewer to determine by
registration number the acute toxicity characteristics of the
product for use in determining whether another product is
substantially similar.

     We believe that the combination of these systems addresses
the iG's concern about linkage of supporting data to individual
precautionary labeling decisions.  OPP will be able to document
whether and what type of database exists in support of a
particular set of precautionary statements.

CHAPTER 3.  EPA ACCEPTED LABELS WITH INACCURATE PRECAUTIONARY
STATEMENTS.

CONCLUSIONS:

     The report identified 17 products that were not accurately
labeled when compared with our labeling regulations.  This is not
an unexpected finding; OPP acknowledges that product
precautionary labeling may not precisely conform to the labeling
regulations.  Further, inconsistencies among similar products
become apparent when compared systematically rather than product
by product.  These findings, however, are less significant than
the underlying causes of the reasons for inaccuracy and
inconsistency.  The report attributes the discrepancies to the
lack of procedures for Product Managers to use in making labeling
decisions and to the fact that EPA has not finalized a set of
labeling regulations that Product Managers use.

     OPP agrees that it lacks clear written procedures for
Product Managers to use in reviewing and accepting labeling
statements.  By providing such instructions,  one source of
inaccuracy and inconsistency should be eliminated.   Some of the
products identified in the report as having inaccurate labeling
undoubtedly could be attributed to this cause.   However,  this is
not the most significant reason for labeling inconsistency,  and
its correction will not necessarily ensure a constant and strict
conformity with Agency specifications for labeling of future
products.

     The more intractable problem,  mentioned but not highlighted
in the report, is the difficulty of compelling labeling changes.
We recognize the need to correct or update labeling,  both because
products are reviewed over time and because policies and guidance
evolve over time.   A licensing based statute,  by the very nature
of its product-by-product review,  fosters inconsistency.   It is
in riFRA that the difficulty lies.


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                                Labeling of Pesticides
                                             APPENDIX 1
                                             Page 6 of 11
     Except during initial registration, the Agency's ability to
 compel changes in labeling that registrants do not agree to make
 is  constrained by the fact that FIFRA does not provide for
 directly enforceable labeling regulations under section 12.  EPA
 must enforce  its labeling regulations in the same manner that it
 requires labeling changes not prescribed by regulation
 (cancellation or nisbranding enforcement).  This weakness in
 FIFRA is a major consideration driving program choices.  While
 not an absolute bar to obtaining label changes, the statutory
 mechanisms are cumbersome and time-consuming.  Thus, in most
 situations where OPP issues a policy document affecting the
 labeling of a large number of products at one time, we rely on a
 voluntary compliance strategy rather than a cancellation-based
 strategy or enforcement of nisbranding provisions.  As a result,
 the program chooses to issue its labeling standards by a less
 costly and faster method.  The report identifies accurately the
 result—a variety of non-regulatory documents such as PR Notices
 and Registration standards—but ascribes to regulations greater
 weight than they actually possess under FIFRA.

     The Administration has proposed in the past,  and had
 rejected, a legislative proposal that would give EPA direct
 authority to  compel compliance with regulations,  including
 labeling regulations.   A second legislative solution,  contained
 in the Administration's current proposal, is to streamline the
 cancellation process to make it faster and less cumbersome.
 Speeding up the cancellation process would allow OPP to use it
 more effectively as a tool to obtain compliance.   Either
 legislative change would enhance our ability to ensure  that
 labeling is accurate and consistent.

 RECOMMENDATION 3.1:   OPPTS should continue to develop and
 implement procedures for reviewing pesticide labels. The
 procedures should include verifying compliance with appropriate
 registration standards.

RESPONSE:  in December 1991,  EPA established a Center for
 Excellence for Labeling to focus on labeling problems.   The
charge of the group was to collect, evaluate and update policies
 and procedures; to provide training materials; and to improve
 consistency and quality in the label review process. As its
 first project, the group is collecting all available policies and
procedures and developing labeling review guide for Product
Managers.  The guide will review the different parts of the label
 It should be  noted, however, that the Office of General Counsel
is currently researching whether the misbranding provisions  of
FIFRA can be interpreted to limit challenges to natters  resolved
in rulemaking.  If so,  OPF may  reassess  the value  of issuing
labeling standards through regulation.
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                                Labeling of Pesticides
                                            APPENDIX  1
                                            Page  7 of 11
step-by-step and will refer readers to the sources of information
and policy affecting their decisions in each area.  This effort
is planned for completion by September 1993.

     With respect to verifying compliance with Registration
Stardard labeling requirements, OPP will do so for new products
and amendments to the extent that the requirements applied to end
use products.  A memo to Branch Chiefs to this effect will be
issued by October 30, 1992.

RECOMMENDATION 3.2:  OPPTS should revise 40 CFR Part 156,
"Labeling Requirements for Pesticides and Devices," to reflect
what it is currently requiring on pesticide labels.

RESPONSE:  OPP believes that the efforts by the Labeling Center
for Excellence to collect, analyze and disseminate current policy
is a necessary first step before revising its  labeling
regulations.  The program expects to complete this initial task
by March 31, 1993.  Thereafter, we will decide whether and when
to revise labeling regulations.    However, until the benefits of
regulations are demonstrably greater than other labeling standard
documents, considering the time and resources needed to
promulgate them, they will not be a high priority for the program
among other competing activities.

RECOMMENDATION 3.3:  OPPTS should require registrants to correct
the precautionary and restricted use statements,  or document why
changes were not needed,  for those labels referred to in this
chapter.

RESPONSE:  OPP agrees with this recommendation,  and will issue
letters by October 30, 1992, to affected registrants requesting
them to correct their labels.

CHAPTER 4.  REGISTRANTS DID NOT SUBMIT FINAL PRINTED LABELS.

CONCLUSION:

     The report concludes that EPA did not have complete copies
of final printed labels for many pesticides, contrary to its
policy as expressed in PR Notice 82-2.  (Regulations in 40  CFR 152
do not require submission of final printed labeling,  but current
labeling regulations in 40 CFR 156 do).   The report cites  a need
for final printed labeling to  ensure that directed corrections
are actually made.  The report cites instances in which OPP
registration files did not contain a final printed label,  or
contained only a draft accepted label with changes.   The report
suggests that,  since OPP only  selectively reviews final printed
labeling for compliance,  it should at a minimum set compliance
deadlines for registrants to make changes that affect health and
safety.
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                                            APPENDIX  1
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     Further, the report concludes that opp was not consistently
providing final printed or accepted labels to enforcement
personnel, such as State inspectors who needed to verify
compliance in the field.  The report finds that in some cases
registrants submitted to States (who also conduct registration
programs at the State level) labels that did not comport with the
OPP accepted label.  However, the report correctly recognizes
that it is not the particular form of the label that is critical
for enforcement, but that fact that the label is documented as
accepted by the Agency.

     opp agrees that its current policies and rules require the
submission of a final printed label prior to marketing, and that
OPP has not been consistent either in assuring that this was
done, or in selectively reviewing such labeling for compliance
with necessary changes.

RECOMMENDATION 4.1:  OPPTS should implement a system,  similar to
what the Office of Pesticides outlined in PR Notice 82-2,  to
ensure that registrants submit final printed labels.   The system
should include notification of registrant's obligation to submit
final printed labels, establishment of timeframes for health and
environment-related changes, and a verification of compliance
with needed changes.

RESPONSE:  OPP believes that registrants have adequate notice of
their obligation to submit final printed labeling.   PR Notice 82-
2, describes the Agency's policy of requiring the submission of
final printed labeling, which the Agency will selectively review.
Moreover, the Notice of Registration issued at the time of
registration contains a statement to this effect.

     With respect to the establishment of timeframes  for label
revisions,  we agree that such policies are necessary,  and have
established them.   As the report notes,  registrant-initiated
requests to revise human or environmental hazard precautionary
statements are subject to 40 CFR 152.130, which sets  an 18-month
timeframe for the use of old labeling.   In addition,  in June
1991, EPA issued in the Federal  Register a Statement  of Policy on
Existing Stocks of Pesticides (56 FR 29362),  which sets out when
and how the Agency will establish timeframes for labeling changes
under various circumstances,  including Agency-initiated health
and safety labeling.

     When OPP identifies a label revision that may affect human
health or the environment,  OPP will notify the registrant of the
needed label change and specify  a date by which the registrant
must respond.   RD will issue a memorandum to this effect to
Branch Chiefs and Product Managers by October 30,  1992.
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                                            APPENDIX  I
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     With respect to verifying that registrants submit final
printed labels and make the changes requested,  OPP will
reinstitute its selective audit of final printed labels.   By
January 31, 1993, OPP will develop a Standard Operating Procedure
describing how it will conduct the process.   During FY 93,  OPP
intends to review and verify accuracy of at  least 50 product
labels under the new process.  Thereafter, OPP will evaluate the
results of the selective review to determine whether any changes
are needed in the audit process.

RECOMMENDATION 4.2:  OPPTS should make EPA accepted labels
available to EPA and State enforcement personnel.

RESPONSE:  On a quarterly basis, OPP provides an updated version
of the Compact Label File on microfiche to the Regional Offices.
OPP does not provide this microfiche directly to States because
of the cost of reproducing the microfiche.   However,  States have
access to accepted labeling through the Regional Offices.   OPP
has conducted a feasibility study on the possibility of supplying
the Compact Label File using CD-ROM technology.   The study
concluded that it is feasible to do so, and  once a complete set
of accepted labels is developed the cost of  updating via CD-ROM
technology would be considerably less than using microform
technology.  The Program Management and Support Division (PMSD)
of OPP has proposed $200,000 in funding for  this conversion for
FY93.

     OPP has also identified as an FY 93 priority in the
Information Management Strategy other priorities that would lay
the foundation for enhanced future availability of labels  and
label information within the pesticide regulatory community,
which includes states:

     •Under the goal of Minimizing Barriers  to Pesticide
Information Sharing Within the Regulatory Community,  OPP has
identified the task of providing access to the OPP/OCM IAN by
Regions and other regulatory partners.  PMSD has proposed  $25,000
in intramural funding to begin this work,  which would link
regions directly to Headquarters systems containing product and
label information.

     •Under the goal of Managing Information for Maximum Feasible
Reliability,  OPP has included the objective  of  defining a
rigorous structure for electronic submission and dissemination of
full label content.  PMSD has proposed 0.2 FTE,  but no funding,
in FY93 for this project.   This task would pave  the way for
future electronic transmission of label content  (but not imaging)
to the enforcement community.

     No decisions on funding or resources for Information
Management in FY93 have yet been made.  If funding is not
available for these projects in FY93,  OPP will  continue its


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                                10
current practice of supplying microfiche copies to Regions.
Although cumbersome, the current system does provide a basic
level of access to labels.

RECOMMENDATION 4.3:  OPPTS should require registrants to submit
final printed labels for those products referred to in the
report.

RESPONSE:  OPP agrees, and will issue such letters to registrants
by October 30, 1992.

CHAPTER 5.  EPA NEEDS TO MAKE BETTER USE OF INFORMATION IN
INCIDENT REPORTS.

CONCLUSION:

     The report concludes that OPP did not in the past centrally
collect, organize, follow-up, or use information reported to the
program by the public.  The report claims that OPP placed little
importance on such information,  which, it asserts,  could identify
problem pesticides where OPP could direct registrants to change
label precautions.
The report acknowledges a number of recent improvements in OPP's
administration of its incident information systems which correct
most of the deficiencies the report cites.

     The report focussed on OPP's handling of incident reports
available from the National Pesticide Telecommunication Network
(NPTN) system, and not those provided through the mandatory
6(a)(2)  program.   Voluntary incident information is important to
our regulatory programs,  but the report should fully describe the
value and limitations of such data for regulatory purposes.   The
type of information gained from  such reports is unlikely
independently to sustain a regulatory decision.  The quality and
quantity of information needed is significantly greater than that
provided by unverified, poorly documented incident reports.

     Because the NPTN is primarily intended to provide
information to the public rather than receive incident reports,
it is not asked to perform the intensive follow up needed to
yield useful incident information,   opp must assess the
significance of NPTN information and conduct follow up with NPTN
callers,  a resource-intensive process of uncertain success,
reserved only for incident reports of serious adverse effects.
For those which do not warrant followup or where followup
provides insufficient information,  however,  the aggregation of
incident reports can indicate trends in pesticide effects,
exposures,  or particular chemicals that should be further
evaluated for regulatory action, including improved labeling.
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                                11
     RECOMMENDATION 5.1:  OPPTS should review information from
the National Pesticide Telecommunication Network when determining
whether incident reports indicate a need for Agency action.

     RESPONSE:  OPPTS agrees with this recommendation,  and has
already implemented information management systems which will
permit it to readily access such data for review and
consideration in regulatory decisionmaking.

       We have requested NPTN to collect more precise information
from callers with potential incident information.   Oral guidance
has been provided on the types of information to collect.
Written procedures including what data elements to collect will
be provided by the end of October.  It should be emphasized  that
this additional information collection by NPTN will primarily
assist OPP in determining which incidents warrant  followup and
make followup easier, but does not substitute for OPP followup,
and will not reduce the resources needed for integrating incident
information into regulatory decisionmaking.

     In addition, as the report acknowledges,  OPP has implemented
improved procedures for processing and evaluating  incident
reports?.  Among them is the Incident Data System (IDS).   Incident
reports arriving since June 1992 have been loaded  into the
system.  Among other functions, IDS serves as a tool to aggregate
incident reports by chemical, product, location,  effect,  etc.  to
determine if trends of concern are emerging.   It can identify
areas that may warrant more detailed data generation or
investigation.  These may lead to label changes.   While NPTN data
also yield aggregate reports of interest,  IDS is expected to
provide more and better aggregate report capabilities.

     In order to increase the size of the data base of  incident
reports to support aggregate reporting, OPP  management  is
considering the feasibility of loading the backlog of existing
paper records of incident reports into IDS.   This  effort is
estimated to cost $250,000 and is under consideration in the OPP
resource allocation process.  While cost is  not the only factor
in analyzing the feasibility of loading the  paper  records, it is
important to recognize the substantial expense related  to
acquisition,  entry and maintenance of quality information.
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                                                  APPENDIX 2
                                                  Page 1 of 1

                        ABBREVIATIONS

CFR       Code of Federal Regulations

EPA       Environmental Protection Agency

?IFRA     Federal Insecticide, Fungicide, and Rodenticide Act

MRID      Master Record Identification Number

KPTN      National Pesticide Telecommunications Network

OCM       Office of Compliance Monitoring

OPP       Office of Pesticide Programs

PPIS      Pesticide Product Information System
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                         DISTRIBUTION
 Inspector General  (A-109)

 Assistant Administrator for Prevention,
  Pesticides and Toxic Substances  (TS-788)

 Agency Followup Official  (PM-208)
  Attention:  Assistant Administrator for the Office of
              Administration and Resources Management

 Agency Followup Coordinator (H-3304)
  Attention:  Director, Resource Management Division

 Audit Followup Coordinator
  Office of Program Management Operation (TS-788)

 Associate Administrator for Regional Operations
  and State/Local Relations (H-1501)

 Associate Administrator for Communications and
  Public Affairs (A-100)

Associate Administrator for Congressional and
  Legislative Affairs (A-103)

Headquarters Library (PM-211A)
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