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Inspector General Division
Conducting the Audit:
Northern Audit Division
Program Offices Involved:
Pesticides ^nd Toxic
_
-------
-------
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
-------
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
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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
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x
Report HO. E1EPF1-05-0429-2100613
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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
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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.
7
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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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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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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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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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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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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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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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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
27
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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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The Assistant Administrator has proposed actions that, when
implemented, will substantially resolve the issues presented
in this chapter.
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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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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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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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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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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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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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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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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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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
41
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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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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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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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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.
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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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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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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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APPENDIX 1
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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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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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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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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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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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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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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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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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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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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)
64
Report MO. E1EPF1-05-0429-2100613
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