Proceedings
of the
First National Symposium
on
Pesticide Labeling
Part II: Questions and Answers
June 3-4, 1974
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PROCEEDINGS
OF THE FIRST NATIONAL SYMPOSIUM
ON PESTICIDE LABELING
JUNE 3-4, 1974
Program Leader
. James J. Bonin
Presidential Fellow
Office of Pesticide Programs
U. S. Environmental Protection Agency
Washington, D. C.
Program Development
John B. Ritch, Jr.
Director, Registration Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D. C.
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Part - II
CONTENTS
Page
Questions and Answers .
Time Factors 1
Advertising; Brochures 3
Registration and Establishment Number 4
Classification ..... 9
Legal Questions 10
Registration Procedures . 26
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TIME FACTORS
Q. On Oct. 21, 1974 when the ITA Lakes over the reflation of
Intrastate pesticides, how much I; lino will he nil owed t.o c I ear-
retail shelves of products not registered with EPA? Will a manu-
facturer be penalized 1f a product he sells In his own state on
Sept. 30th 1s found w stores on Oct. 22nd of 1974, or say six
months later?
A. EPA has not determined as yet how long a time period will
be allowed to clear retail shelves of intrastate pesticides
which have come within the Agency's jurisdiction. The second
part cannot be answered without the first.
2. Q. Attention has been directed to the fact that there is an im-
portant need to expedite labeling...Making needed chemicals avail-
able to the consumer quickly after discovery. What plans does the
EPA have for speeding up the labeling and registration process. (5)
A. We will utilize the product manager as a key person in
expediting label review. The new reorganization plan will also
make work flow more smoothly through the Registration Division.
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3. Q. Why does it take ninety days or more for the EPA to answer a
letter. (6)
A. I am sure that the figure of ninety days is not an average
response time. Many letters are answered within one week of
the time they are.received. Letters dealing with decision
making in problem areas often require more time to answer.
2 ,
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ADVERTISING; BROCHURES
1. Q. Does the new law prevent an advertiser from pointing out that
one pesticide is safer to use than another; that is, less toxic to
humans and the environment?
A. Such safety comparative claims are not acceptable since
they detract from precautionary labeling.
2. Q. Will submitted advertising literature (labeling) be stamped
approved and returned by the same method used in the EPA registered
labels? Have you or will you standardize the enforcement fines -
will this be published?
A. EPA has prepared interim guidelines for assessing civil
penalties that the Regional offices should follow. This sched-
ule would have the regional offices base their assessment of
a civil penalty on gravity of violation, including a firm's
history of violations, size of firm, and ability to stay in
business. This schedule will be published in the Federal
Register in the near future.
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REGISTRATION AND ESTABLISHMENT NUMBER
Q. Should additional labeling material, i.e., a direction book-
let which is registered carry the EPA registration number? What
about carrying the establishment number?
A. Additional labeling material is not required to bear the
establishment registration number. The establishment registra-
tion number is required to appear only on the label or immediate
container of the pesticide.
2. Q. By law, must the EPA registration number and the EPA establish-
ment number appear on a trade journal advertisement?
A. The establishment registration number is not required to
appear in trade journal advertisements. It need appear only
on the label or immediate container of the pesticide.
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3. Q. The addition of the registration establishment number creates
label control problems not the least being extra expense... What
purpose will it serve? Does the establishment number have to appear
on the immediate container label?
The purpose of the establishment registration number is to
enable the Agency to determine the most recent producer of any
given pesticide. This precise identification will also prove
beneficial to producers in the course of EPA enforcement
actions. For example, recalls required for grossly contaminated
or deficient products can readily be pinpointed to a particular
establishment rather than an entire company. The product regis-
tration number does not provide this identification. The estab-
lishment number must appear either on the label or the immediate
container.
4. Q. Does the EPA establishment number have to appear parallel as
does the EPA registration number?
A. The establishment registration number is not required to
be parallel to other statements on the label. The only require-
ment is that this number of of a type size large enough to be
legible.
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5. Q. A pesticide is formulated by a company in Chicago and shipped
to California in bulk for packaging by a second company in Calif.
Should both EPA establishment numbers occur on the container?
A. When the pesticide formulated by a plant in Chicago is
shipped to California in bulk it must bear the Chicago Estab-
lishment Registration number. After it is packaged in Cali-
fornia, it should bear the California establishment number.
The Chicago number does not apply to the formulated product.
6. Q. A comment on one of D. Campt's slides... "The establishment
number is that of the producer" is somewhat misleading, unless the
"producer" is construed to include the repackager.
A. The question reflects an understanding of the definition
of "producer." It is true that a repackager is considered a
producer for purpose of Section 7. The statement on the slide
could be misleading to an audience unfamiliar with the section.
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7. Q. The EPA establishment number has 17 digits. I don't know of
any 17 digit coding equipment. What is the industry to do? How
can they maintain plant manufacturing flexibility which is needed
during the energy crisis?
A. The Agency has provided that a company may request special
approval of a variation of the format for displaying the estab-
lishment number. The Agency has already granted approval on
several formats which have reduced the length of the number by
as many as six characters. It is acceptable for a number to be
printed without the spaces & hyphens between the letters and
digits to accomplish a reduction in size.
8. Q. As a retailer of pesticides we were required to register and
get an establishment number. We register, but do not produce pesti-
cides. What do we do with this number?
A. A pesticide retailer should not be registered as a producer
if he does not perform any of the activities which are consi-
dered "production" e.g., manufacturing, preparing, processing
or repackaging. If this retailer has registered, he should con-
tact his EPA Regional Office and request that his establishment
number be terminated. The Regional office would need to verify
that his establishment did not need to be registered.
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9. Q. Why is the EPA establishment number needed when the registra-
tion number already indicates the manufacturer?
A. The product registration number does not, in many cases,
correspond to the actual producer of any given producer. The
product registration number designates the registrant while
the establishment number identifies the producer.
10. Q. In October, the 17 digit EPA establishment number must be on
the container. What are contract fillers to do as there are no
coders manufactured over 10 digits? The 17 digits include the
spaces required.
A. If a coder cannot print more than 10 digits, an alternate
method of affixing the establishment number must be used.
Such alternatives are, inter alia, the use of a sticker label
or pressurized labels. See number 10.
11. Q. Will the necessity for.a firm to obtain an EPA establishment
number also automatically require an EPA product registration
number?
A. No. A firm may be producing without holding product
registration.
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CLASSIFICATION
All questions asked within this area are unanswerable at this time.
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LEGAL QUESTIONS
1. Q. What is a minor violation?
A. Minor violations are those violations of a lesser consid-
eration where the Administrator has decided that criminal or
civil proceedings are not necessary to protect the public in-
terest. Corrective action can be achieved through correspon-
dence with the firm. Examples of minor violations are precau-
tionary statements not prominently placed upon a label,
misspelling or typographical errors or small deficiencies
which are not likely to affect the product's effectiveness.
2. Q. Is it illegal to use a pesticide at a lower rate than specified
on the label?
It is illegal to use a pesticide in any manner which is
inconsistent with the labeling such as, at a lower rate than
that specified on the labeling. Discretion remains with EPA
to determine the severity of the violation and whether it
merits assessment of a penalty. The Agency will decide each
matter on a case-hy-case basis allowing the rule of reason to
apply.
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3. Q. Is it illegal to kill insects or diseases not specified on
the label and if so, how does one avoid doing this?
A. It would not be illegal tp kill insects or diseases which
are not specified on the labeling (non-target organisms) if
the product is being used in accordance with the directions on
the label. It would be illegal to kill insects or diseases
which are not specified on the labeling if the product was
being used specifically against these insects or diseases.
Care in selecting the pesticide to be used and in deciding
the time to spray may help avoid indiscriminate killing.
4. Q. Is it illegal to use less applications and/or lower intervals
(i.e., longer intervals than specified on the label)?
It is illegal to use a pesticide in any manner which is
inconsistent with the labeling such as, at a lower rate than
that specified on the labeling. Discretion remains with EPA
to determine the severity of the violation and whether it
merits assessment of a penalty. The Agency will decide each
matter on a case-by-case basis allowing the rule of reason to
apply.
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Q. If the labeling of a pesticide applied to a crop prohibits
feeding any part of the treated crop to livestock, and the pesti-
cide user sells the treated crop as food to a second party, who
then converts the crop to livestock feed use, is either the pesti-
cide user or the crop buyer in violation of section 12(a)(2)(G) of
FIFRA?
A. The pesticide user violates the Act and, depending on
his knowledge, the crop buyer could be in violation of
Section 12(a)(2)(G).
6. Q. Is it illegal to use a pesticide at a dosage lower or higher
different than that on the label?
A. It is illegal to use a pesticide in any manner which is
inconsistent with the labeling such as, at a lower rate than
that specified on the labeling. Discretion remains with EPA
to determine the severity of the violation and whether it
merits assessment of a penalty. The Agency will decide each
matter on a case-by-case basis allowing the rule of reason
to apply.
7. Q. Is use of a pesticide at a rate lower than is given on the
label a misuse or inconsistent with the label?
A. Use of a pesticide at a rate lower than that given on
the label is use inconsistent with the label which would be
misuse of the pesticide.
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8. Q. The purpose of a label was stated as "not to cause undue con-
tamination of the environment." Will FEPCA allow usage below the
labeled dosage?
FIFRA, as amended, will allow use of pesticides only at
that rate which is stated on the registered label. Use at a
dosage below that on the label may necessitate additional
applications which would not have been necessary had label
directions been followed.
9. Q. Integrated control employs the use of insecticides at less
than the recommended dosages. Programs are already in practice in
several cases. Is this misuse?
It is illegal to use a pesticide in any manner which is
inconsistent with the labeling such as, at a lower rate than
that specified on the labeling. Discretion remains with EPA
to determine the severity of the violation and whether it
merits assessment of a penalty. The Agency will decide each
matter on a case-by-case basis allowing the rule of reason
to apply.
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10. Q. What does "release for shipment" mean? This pertains to
(1) in inspection procedures, and (2) need for registration of
establishment numbers.
A. Released for shipment pertains to a condition whereupon
a batch or a lot of pesticides are packaged, labeled and have
been placed in an area of the establishment apart from the
manufacturing area, if there be one, for distribution or sale.
11. Q. What is the status of the books and records guidelines?
A. The "Books and Records" regulations are presently under-
going interagency review and are expected to be published a
short time after the start of FY 75.
12. Q. The law states that the label on the container should not be
substantially different from that registered by EPA. What is
meant by "substantially different"?
The term "substantially different" means any deviation
from the registered label which may cause unreasonable ad-
verse effects on the.environment or harm to the user or non-
target organisms including: lesser product effectiveness,
illegal residues, phytotoxicity, and so on.
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13. Q. How do you propose to get uniformity of enforcement between
regions?
Uniformity between the regions has been achieved by the
issuance of internal program direction and strategy from
headquarters as well as such guidance as found in the In-
spectors' and the Case Proceedings Manuals. In addition the
Agency will be issuing Rules of Practice Governing Civil
Penalty Assessments and an Assessment Schedule which will lay
out the rules used by the Regional Offices to assess civil
penalties and conduct hearings.
14. Q. It was stated that "recall is not specific sanction of the
law." Is the recall mechanism; What are the criteria?, the
procedures?
A. There is no explicit "recall" authority given to EPA
through the FIFRA, however EPA can back up its voluntary re-
call requests with its stop sale and seizure authority (Sec-
tion 13 of the Act). In connection with suspension and/or
cancellation of a pesticide or finding of a gross violation
of the Act, EPA may request that the registrant recall the
problem product from the market. EPA will then contact the
registrant to determine whether he intends to recall and to
provide the procedures to be followed for a recall. EPA
regional personnel supervise and monitor the recall until its
completion. The initial decision that a product should be
withdrawn from the market will be based on the information
contained in the product's file, including sample analysis
reports, Office of Pesticides Programs staff evaluation and
other information that may be relevant. Recalls will be
initiated in all cases where the available information indi-
cates that the product is potentially hazardous when used as
directed or ineffective for the purposes claimed.
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15. Q. What if county agents or other officials recommend a chemical
for a use not appearing on the company label. Can the establish-
ment sell it to the customer requesting it?
A. An establishment which sells a pesticide for a use which
does not appear on the label of that pesticide may be in vio-
lation of Section of the Act. In addition, the county agent
who recommends such use may be in violation of State law.
16. Q. Could you please characterize the types of violations being
found under the "civil penalties" program?
A. The types of violation being found under the civil penal-
ties program are the same as those which have historically
been found, that is, non-registration, misbranding, adultera-
tion, as well as some new violations such as use inconsistent
with labeling.
17. Q. As the regions are being given enforcement responsibilities,
will enforcement policies be uniform between regions? What control
over the regions will the Federal office have?
Uniformity between the regions has been achieved by the
issuance of internal program direction and strategy from
headquarters as well as such guidance as found in the In-
spectors' and the Case Proceedings Manuals. In addition the
Agency will be issuing Rules of Practice Governing Civil
Penalty Assessments and an Assessment Schedule which will lay
out the rules used by the Regional Offices to assess civil
penalties and conduct hearings.
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18. Q. What is the attitude of the EPA relative to using less than
the amount of a pesticide specified on the label, i.e., using
1 Ib./lOO gallons rather than 1.5 Ib./lOO gallons?
A. It is illegal to use a pesticide in any manner which is
inconsistent with the labeling such as, at a lower rate than
that specified on the labeling. Discretion remains with EPA
to determine the severity of the violation and whether it
merits assessment of a penalty. The Agency will decide each
matter on a case-by-case basis allowing the rule of reason
to apply.
19. Q. What if the company has a registered label and farms it out
for filling (Ex. - aerosol cans) - it could be filled by different
companies in different areas. What establishment number is put
on the printed label?
Each filler is considered a producing establishmnet and
therefore must put its own establishment number on those
products which it fills. This is an example of the case where
the product registration number will be different from the
establishment registration number.
20. Q. When the registered company sends chemicals in bulk for
packaging (Ex. - aerosols), what establishment number on the can?
Bulk chemicals must bear the establishment number of the
bulk producer when shipped to the packager. After packaging
by the second company, the container must bear the establish-
ment number assigned to the packager. The bulk producer's
establishment number no longer applies.
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21. Q. Why should violations be cited for misbranding when small
quantities of a similar pesticide are contained in the same
product, i.e., a product of 5% sevin cross-contaminated with
.005% malathion?
A. A product is misbranded if another pesticide which is
not noted on the label, is found in the product. Undeclared
active ingredients can result in illegal residues and danger
to human health and the environment. The Act requires the
Agency to notify violators of the law, however, the Adminis-
trator may issue warnings for minor violations rather than
proceed with a civil or criminal action.
22. Q. It was stated that the 1974 fiscal objective for enforcement
was to issue approx. 1500 notices of violation, issue an estimated
200 stop sale, use and removal orders: and initiate approx. 500
civil and criminal actions. This is a quota system. Why run an
enforcement program on this basis?
A. The FY 74 pesticide enforcement objectives did not con-
stitute an Agency quota system but were part of an overall
Management By Objectives system. Based on past history, and
given a certain number of establishment inspections, use in-
vestigations, experimental permit monitoring, retail market
surveillance and so on, each region stated that they expected
to uncover an approximate number of violations which would
lead to stop sales, civil and criminal actions, etc. These
figures, number of stop sales, civil/criminal actions, import
detentions, were therefore not objectives in the sense of
quotas which the regions committed to and were held to by
headquarters, but were instead, expected accomplishments.
The Pesticides Enforcement program is based on having certain
objectives which the regions commit to accomplishing such as
establishment inspections, product samples, use surveillance,
and from which a number of violations will most likely arise.
These violations will then be prosecuted according to criteria
as set forth by the Agency.
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23. Q. How are you handling the inspection of registered producer-
establishment not located in the United States?
A. At this point in time the Agency has no plans to inspect
foreign (non-U.S.) pesticide producing establishments. However,
we reserve the right to inspect such establishments at a later
date.
24. Q. A label must be changed by reason of an EPA review, and/or
recent regulations - What is the grace period permitted on old
packages, inventory, labels, etc., before they must be disposed of?
A. EPA is in the process of developing new regulations for
implementing Section 3 of the Act and this question may be
answered by those regulations. At the present time a pesti-
cide can be shipped only under the currently registered label.
25. Q. Does any statute prohibit the manufacture of a pesticide while
registration is still pending?
A. Yes.
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26. Q. In recent years, FDA has entered cooperative agreement with
State regulatory agencies in order to utilize the inspection re-
sources of such agencies. Does the EPA anticipate similar
agreements?
A. EPA has entered into cooperative enforcement agreements
with 5 states to date. In these agreements the States will be
supplementing EPA in the areas of marketplace and use surveil-
lance, as well as the collection and analysis of pesticide
samples. EPA hopes to enter into cooperative agreements with
all States.
27. Q. Please review the methods of objection by the enforcement
agency with regards to: civil action, criminal action, and fines.
Also, what is the recourse open to the manufacturer?
A. Under section 14(a) of the Act, the Agency is empowered
to assess a civil penalty in the event of violations of any
provision of the Act. In accordance with the interim Rules
of Practice governing this section, published September 20,
1973 (38 F.R. 26345), a manufacturer who receives a civil com-
plaint proposing to assess a civil penalty under section
14(a)(2) is entitled at his discretion to request a public
hearing or to engage in settlement discussion with the Agency.
In the event a criminal action is pursued under section 14(b),
the defendant-manufacturer has recourse to remedies in a court
of law.
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28. Q. Can herbicides be used at a rate lower than those stated on
the label under certain conditions (climatic such as high
temperatures)?
It is illegal to use a pesticide in any manner which is
inconsistent with the labeling such as, at a lower rate than
that specified on the labeling. Discretion remains with EPA
to determine the severity of the violation and whether it
merits assessment of a penalty. The Agency will decide each
matter on a case-by-case basis allowing the rule of reason
to apply.
29. Q. Is EPA going to issue guidelines or regulations defining what
is meant by "use inconsistent with the label"? If EPA is not going
to do this, how will users know whether a particular deviation from
the label is legal or illegal?
A. EPA has stated publicly what its position is with re-
gards "use inconsistent with the label" and that is, such use
is illegal. EPA does not intend to publish regulations or
guidelines defining this, however, the question may be ad-
dressed in various enforcement pamphlets which are being pre-
pared. Pesticide users should be aware however that any
deviation from the labeling directions will be considered a
violation of the Act.
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30. Q. What is the legal meaning for "release for shipment"? Does it
include intrastate transfers from the plant to remote warehouses?
A. Pesticides which are ready for movement from a manufactur-
ing plant to a remote warehouse would be considered "released
for shipment."
31. Q. If "produce" means propagate or distribute, wouldn't ware-
houses have to be registered as "producing establishments"?
A. No. Warehouses, in the narrow sense of the word, are not
considered producing establishments.
32. Q. If a pesticide is produced at a registered establishment for
export only, is it necessary to have the product registered?
A. No. Pesticides intended solely for export are required
only to meet the specifications or directions of the foreign
purchaser. The exported product is not required to be regis-
tered although the establishment in which it is produced
must be registered.
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33. Q. What is the acceptable manufacturing tolerance (%) for devia-
tion form the label declaration of active ingredients?
A. Any deviation from the label declaration of active Inqro-
dients found in a formulated product could be considered, at
the very least, a minor violation. The amount of deficiency
or overage, the degree of hazard, and the affect on the prod-
uct's effectiveness, all enter into the decision process as
to how serious the deviation is.
34. Q. Is any deficiency regardless of how small, considered a
violation?
Yes. However very small violations may not result in
ties.
penalties
35. Q. Section 9(c)(3) permits the use of warning for minor violations
in lieu of instituting proceedings for prosecution ... if public
interest can be best served. Does the same apply, i.e., under sec-
tion 14(a) for assessment of civil penalties?
A. Under the Act, there are numerous actions which are author-
ized to be pursued in response to violations, including crimi-
nal and civil penalties under section 14, cancellation and/or
suspension under section 6, and notices of warning under sec-
tion 9(c)(3). In the event a violation is deemed to be so
minor as not to warrant criminal or civil action under section
14, a section 9(c)(3) warning citation may be issued.
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36. Q. Are State and Federal sample analysis programs to be coordi-
nated or will both be working independently?
EPA has entered into cooperative enforcement agreements
with 5 states to date. In these agreements the States will be
supplementing EPA in the areas of marketplace and use surveil-
lance, as well as the collection and analysis of pesticide
samples. EPA hopes to enter into cooperative agreements with
all States.
37. Q. In the past nine months there has been an increase in plant
inspections, enforcement actions, increased requests for data de-
signed to help the enforcement of FIFRA. Does the pesticides en-
forcement division have a plan for detailed education of the
manufacturers?
A. EPA will be publishing various pamphlets which should
serve to educate the public (including pesticides producers)
as to the role of enforcement in regards to the FIFRA. In
addition EPA inspectors in the course of conducting establish-
ment inspections have been instructed to discuss the new amend-
ments to the Act and to distribute copies of the Act, regula-
tions and any other relevant information. This along with the
publicity that EPA gets when an enforcement action is taken
has helped to educate the pesticide producers.
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38. Q. How many times has section 12 of FEPCA been used to prosecute
parties who have misused a pesticide?
A. At the end of fiscal 1974, it was estimated there had
been no more than ten actions brought under section 12(a)(2)(G)
of the Act for use inconsistent with label directions.
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REGISTRATION PROCEDURES
Q. EPA personnel enjoy using the phrase "unreasonable adverse
effects to the environment." Please define. Why use such an unde-
fined phrase in a basic explanation of EPA policy or requirements?
The term "unreasonable adverse effects" is defined under
section 2(bb) of the Federal Insecticide, Fungicide, and
Rodenticide Act as "Any unreasonable risk to man or the environ-
ment, taking into account the economic, social, and environmental
costs and benefits of the use of any pesticide."
2. Q. What is the environmental protection benefit of using the mini-
mum dosage specified by labeling for a pesticide, instead of using
an even lower dosage which the user knows is adequate for his crop
protection purposes?
A. Dosages submitted to the EPA for registration of specific
pests are backed up by objective data. If lower dosages will
do an effective job then data supporting this should be sub-
mitted for our review.
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3. Q. Is it permissible to include both "pounds and kilograms" on
the same label? Would it be permissible to go exclusively to the
metric system on the label?
A. At this point and time it would not be permissible to use
the metric exclusively on the label. In developing the Sec-
tion 3 regulations, consideration is being given to whether
or not we are prepared to, at this time, permit the use of both
systems of measurement on the labeling. A phase-in program
will probably be the method if we go to the metric system.
The Section 3 regulations will speak more clearly on this
issue.
4. Q. Which federal agency has jurisdiction when a product has an
EPA registration number but is considered a drug by the FDA?
A. The FDA and the EPA have published in the Federal Register
an Interagency agreement concerning areas of mutual responsi-
bility relating to products that are pesticides and drugs.
This agreement lists products that are considered primarily a
drug and those considered primarily a pesticide. Those prod-
ucts considered primarily a drug would be handled by FDA and
those considered primarily a pesticide would be handled by
EPA, however, in no case would either agency accept a product
unless and until the other Agency has informed it that the
product is in compliance with the laws administered by that
Agency.
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5. Q. Is it feasible to have the same person handle all dealings on
any particular application as a means of establishing better
communications?
A. Yes, the product manager will function along this line of
reasoning. However, it is impossible for one person to do
everything.
6. Q. Several observations and comments have been made regarding
labeling of devices. I understand EPA does not register devices,
however. How then does EPA handle labeling of devices? How is
misbranding and illegal use of devices determined?
A. Under Section 25(c)(4) of the Act the Administrator by
regulation may specify by regulation which classes of devices
shall be subject to the provisions of section 2(q)(l) of the
Act with regard to misbranding and to section 7 requiring
registration of establishments producing such devices. As of
this time no regulations pursuant to Section 25(c)(4) have
been issued.
7. Q. Why is no speaker nominated from insecticide formulators?
A. Due to time limitations, we felt that one speaker repre-
senting a specific area of expertise would be sufficient or
in some cases one person speaking for many disciplines. We
know that this meeting could not and did not represent each
and every person who would have liked to have been heard, how-
ever regional meeting will accomplish many things not accom-
plished here.
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8. Q. What may a producer do to modify EPA thinking regarding
labeling found to be inadequate through field or practical
experience to avoid possible misuse or excessive hazard?
A. Should a producer determine that current directions for
use reflected in his accepted labeling may be insufficient
to avoid misuse or hazard, it is incumbent upon him to bring
that matter to the Agency's attention. He should seek expedi-
tious review of labeling revisions designed to ameliorate
possible hazards or misuse.
9. Q. Does the label have to state "For aerial application"? Do
all pest and hosts for which a material will be used have to appear
on the label and/or labeling?
A. A label must bear directions for aerial application if
that mode of application is to be used. If a pest being con-
trolled by chemical Z is not oh a label for chemical z then
the applicator is misusing the pesticide.
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10. Q. A pesticide is approved for use on Plant "A" for control of
Pest "X", but not for Pest "Y" even though it will control pest
"Y" (possibly even better than Pest "X"). What is EPA's attitude
toward use of the pesticide to control Pest "X" from the stand-
point of food plants, ornamental plants, commercial operations,
and home owner?
A. It is illegal to use a pesticide in any manner which is
inconsistent with the labeling such as, at a lower rate than
that specified on the labeling. Discretion remains with EPA
to determine the severity of the violation and whether it
merits assessment of a penalty. The Agency will decide each
matter on a case-by-case basis allowing the rule of reason
to apply.
11. Q. Have you heard of the study which determined that children
seem attracted to the skull and crossbones on labels because of
its remainder of pirates? I heard of this from a public relations
firm.
A. No, we have not. If you know of such studies please
submit them to the new Standards and Labeling Section in
the Registration Division.
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12. Q. How do I determine whether to apply to USDA for approval of
a product versus applying to EPA for a registration number?
A. The EPA has taken over all pesticide registration func-
tions from the USDA per Presidential Order which created us
into an Agency on December 2, 1970. The USDA no longer
registers pesticides.
13. Q. Can labels be printed and used with changes... such as com-
pany name change, brand name change, and layout of label as long
as no other changes are made? These labels would be sent to EPA
on the amended form.
A. Any changes in your label and/or labeling must be approved
by the EPA before entering it can be used in interstate
commerce.
14. Q. What new regulations might we see in the next few years
governing the disposal of pesticide containers?
A. Recommended procedures for disposal and storage of pesti-
cides and containers have been published pursuant to section
19(a) of the Act (39 F.R. 15236). These procedures will be
modified and updated as circumstances dictate. It is antici-
pated that label revisions will be required of certain products
to reflect disposal procedures pursuant to registration
requirements.
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15. Q. If the active Ingredient 1s produced at one location and the
formulated product containing that active Ingredient 1s preferred
at another location, which location is the pesticide establishment?
A. Both locations are producing establishments. The active
ingredient must bear the establishment number of the ingre-
dient producer when shipped to be formulator. After formula-
tion, the product will bear the establishment number assigned
to the site of formulation.
16. Q. You suggest that insects (and other pests) be grouped together
to simplify labeling. Would you include Green Bugs under aphids?
Would you also include green peach aphids under aphids?
A. Unless a pesticide is effective against all the aphids
known to be pests on a particular crop, separate listings of
the individual aphids would be required. This would include
green peach aphids.
17. Q. Can mites (either as a group or specific species) be claimed
as a pest on livestock and the product sold for mange control?
A. Mites can be claimed as pests on livestock and the product
sold for mange control if in fact the data support the claim.
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18. Q. I would like to receive clarification on current status of
pesticide registration as it relates to use in eating establish-
ments. How does the crack and crevice policy relate to this?
A. A statement of policy with respect to use of insecticides
in food handling establishments was published in the Federal
Register on August 10, 1973 (38 F.R. 21685). Use of residual
pesticides for treatment of cranks and crevices in food hand-
ling establishments in addition to uses authorized on the
labels of such products was permitted with respect to a dis-
crete list of sixteen products. Such use was conditional
on immediate application fo'r registration of such product and
registration within six months of the notice date, or no later
than February 2, 1974.
19. Q. If a material is registered and the label states "ornamentals
including..." is the material limited to those hosts named?
A. It is limited to ornamentals of the type illustrated by
these named.
20. Q. On the net contents statement, what are the accepted limits
above and below the stated net?
A. There are no acceptable limits above or below the stated
net weight.
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21. Q. The slide on label requirements indicated that the address
of both the producer and the company produced are required — is
this correct?
A. Only one address is required on a label. An unqualified
name and address given on the label is considered to be that
of the manufacturer. If the registrants name appears on the
label and the registrant is not the manufacturer, or if the
name of the person for whom the pesticide was manufactured
appears on the label, it must be qualified by appropriate
wording, such as "packed for...", "distributed by...", or
"sold by..." to show that the name is not that of the
manufacturer.
22. Q. What if a company manufactures a chemical with wide usage.
On his label, he claims only a few of them, A bid is taken for ;
the chemical being manufactured, but the material will be used for
some insect that does not appear on the registered label. Can he
sell the material as long as it is the chemical requested?
A. The label registered must bear claims for all insects
to be controlled at point of application.
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