Questions and Answers Concerning Establishment Registration for Producers,
Repackagers, and Relabelers of Pesticides or Pesticide Devices
Registering Establishments
- Who must have an Environmental Protection Agency (EPA)
Establishment Number?
- Why must an EPA Establishment Number be assigned to
each producing facility?
- How do I obtain an EPA Establishment Number?
- What are the numbers on a pesticide label and how
are they related to each other?
- What is Supplemental Distribution?
- What is the difference between a supplemental
registration and a private label?
- What is the definition of "produce?"
- What is the definition of a "producing
establishment?"
Annual Pesticide Establishment Reports
- Who is required to report on a yearly basis?
- What is required to be reported?
- I have several EPA registered products, but I do
not produce all of the products each year. Do I have to fill out all
the information on each product whether I produced that product this
year or not?
- I have a registered product which is produced
under contract at another registered pesticide producing establishment:
Who is responsible for reporting?
- As a newly registered establishment I recently
submitted an Initial Report. Am I also required to submit a yearly report
that is due on March 1st as well?
- If I do not receive a blank pesticide producing
report from U.S. EPA , am I still responsible to submit a yearly report?
- What part of my report is considered confidential?
- Why are the reports sent to my headquarters
office instead of directly to the registered establishment(s)?
- What is the collected data used for?
- My establishment has undergone a number
of operating changes recently. Do I have to notify the US EPA of these
changes?
- I have had an EPA Establishment number for
five years and I haven't produced or repackaged any pesticides for the
past four years. Do I still need to fill out the form?
- What are the consequences if I do not file
my yearly report by the March 1st deadline?
Registering Establishments
1. Who must have an Environmental Protection
Agency (EPA) Establishment Number?
Anyone who produces pesticides or pesticide devices must have a separate
number assigned by EPA for each producing location.
2. Why must an EPA Establishment Number be
assigned to each producing facility?
Section
156.10 of 40 Code of Federal Regulations (C.F.R.) 
requires that the EPA Establishment Number of the final establishment
in which it was produced must appear on the label or immediate container
of each pesticide product released for shipment from the producing establishment.
3. How do I obtain an EPA Establishment Number?
Use the Pesticide Report for Pesticide-Producing and Device-Producing
Establishment (EPA Form 3540-16) to report annual production. Forms
and instructions are available for download.
You may also contact the Pesticide Section of the
EPA Regional Office which has jurisdiction over your company headquarters'
site location for an application.
4. What are the numbers on the pesticide label
and how are they related to each other?
- A company number is a unique number
assigned by the United States Environmental Protection Agency (US EPA),
to an individual or company who submits an application to register a
pesticide product , an application for supplemental registration of
a registered pesticide, or to register a pesticide producing establishment
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
This number is up to 6 digits long. (Example: 987654)
- An establishment number is a unique number assigned by the
US EPA, to a site where a pesticide product, active ingredient, or device
is produced, after the Agency has reviewed and accepted a completed
application to register a pesticide
producing establishment. The establishment registration number is
a unique registration number assigned to each and every site that has
registered to produce pesticides. The establishment registration number
consists of the company number, state abbreviation, and serial number.
(Example: 987654-IL-001 is the establishment registration number assigned
to the first site, located in the State of Illinois, registered by the
company assigned the company number 987654. 987654-OH-003 is the third
site owned and operated by the company in Ohio.)
- An EPA registration number is a unique number assigned by the
US EPA, to a pesticide product, after the Agency has reviewed and accepted
a complete application
to register a pesticide product, from a registrant. The EPA registration
number consists of the company number and serial number. This number
can also be referred to as a primary registration number. (Example:
987654-010 is the registration number that EPA has assigned to the tenth
pesticide product registered to the company assigned the company number
987654.)
- A distributor number is the same as a company number (see
above). The company number is referred to as a distributor number
when it is used as part of a supplemental registration number.
5. What is Supplemental
Distribution?
Supplemental
distribution occurs when a registrant agrees to sell or distribute his
registered product under another person's name and address (the distributor).
The supplemental registration number (also referred to as the distributor
registration number) consists of the primary EPA registration number and
the distributor's company number. (Example: 987654-010- 43210 is the supplemental
registration number, where 987654-010 is the primary registration number
and the distributor is the company assigned to 43210.)
6. What is the difference between a supplemental
registration and a private label?
There is no difference between a supplemental registration and
a private label. Both terms are used by industry and US EPA interchangeably,
to describe a specific type of pesticide product registration. Additional,
synonymous terms include "distributor label", and "distributor
registration".
7. What is the definition of "produce?"
To manufacture, prepare, propagate, compound or process any pesticide,
any active ingredient or device including pesticides produced under an
experimental use permit. The definition of produce also includes to package,
repackage, label, relabel or otherwise change the container of any pesticide
or device.
8. What is the definition of
a "producing establishment?"
Any site where a pesticidal product, active ingredient, or device
is produced, regardless of whether such site is independently owned or
operated, and regardless of whether such site is domestic or producing
a pesticidal product for export only, or whether the site is foreign and
producing any pesticidal product for import into the United States.
Annual Pesticide Establishment Reports
1.
Who is required to report on a yearly basis?
Each producer operating an establishment must submit the reports.
2.
What is required to be reported?
Each registered establishment must report the types and amounts
of pesticides, active ingredients, or pesticide devices produced (which
includes repackaged/relabeled products) during the past year; the amount
of pesticides, active ingredients or pesticide devices distributed/sold
last year (regardless of when you produced the product); and an estimate
of the amount of pesticides, active ingredients or pesticide devices you
expect to produce in the coming year. (Custom blends are not required
to be reported as production). Examples of pesticidal products required
to be reported include:
- active ingredients (Note: producers of multi-use chemicals must report
the amount of production of the multi-use chemical for which the producer
knows is being used for a pesticidal purpose);
- intermediate pesticides;
- end-use pesticides (either primary registrations, EPA Reg. No. 987654-010
or supplemental registrations, EPA Reg. No. 987654-010-43210);
- pesticides transferred from bulk containers to mini-bulk containers
and distributed/sold in mini-bulk containers;
- two or more pesticide products shrink-wrapped together and sold as
a multi-pack.
3. I have several EPA registered products, but
I do not produce all of the products each year. Do I have to fill out
all the information on each product whether I produced that product this
year or not?
There is no need to list registered products that were not produced in
the reporting year.
4.
I have a registered product that is produced under contract at another
registered pesticide producing establishment. Who is responsible for reporting?
The Establishment that produces the product is responsible for
reporting production.
5.
As a newly registered establishment I recently submitted an Initial Report.
Am I also required to submit a yearly report that is due on March 1st
as well?
Yes, all registered establishments are required to submit a report
by the March 1st annual deadline, regardless of whether that establishment
submitted an Initial Report that same year.
6. If I do not receive a blank pesticide producing
report from US EPA, am I still responsible to submit a yearly report?
Yes, US EPA headquarters sends out the reports as a compliance
assistance measure but it is still your responsibility to obtain a report.
If you fail to receive a report contact your company headquarters. You
may also download the Pesticide Report for Pesticide-Producing and Device-Producing
Establishment (EPA Form 3540-16) to report annual production. Forms
and instructions are available in PDF, Word, and WordPerfect formats.
7. What part of my report is considered confidential?
Under Section 7 (d), information reported in Items 24,25,26, and
27 are treated as business confidential.
8. Why are the reports sent to my headquarters
office instead of directly to the registered establishment(s)?
The reports are sent to the company headquarters pursuant to the
regulations. Your company headquarters is ultimately the party responsible
for filing the report with US EPA by March 1st of every year.
9.
What is the collected data used for?
The data are used to support risk-benefit analyses and well as
compliance and enforcement activities.
10. My establishment has undergone
a number of operating changes recently. Do I have to notify the US EPA
of these changes?
Yes. It is the responsibility of the owner or designated officer
of the company to inform the US EPA of any operational changes that occur
at an establishment, which differ from previous operations that were first
reported on the initial application to register the establishment. Such
changes include:
- a change in ownership and/or company name
- a change in the establishment street (site) address
- a change in the establishment mailing address
- a change in the establishment officer who is the person identified
by the company as the responsible or designated individual authorized
to discuss and report matters regarding pesticide production with the
US EPA
- a change in telephone number
- the purchase of a new pesticide producing establishment (facility)
- the sale of an existing pesticide producing establishment (facility)
- a change in company headquarters address.
Any of these operational changes must be reported to the US EPA within
thirty (30) days of their occurrence. These changes must be provided to
the US EPA, in writing, on company letterhead and signed by an officer
of the company.
A registered establishment can continue to produce pesticides during
this 30-day notification period.
Once the US EPA receives the written notification of operating changes,
the Agency will proceed with inactivating old or obsolete establishment
registration numbers; adding and registering new establishments and/or
amending our records for the establishment(s) in question.
11.
I have had an EPA Establishment number for five years and I haven't produced
or repackaged any pesticides for the past four years. Do I still need
to fill out the form?
Yes,
you are required to fill out a production form stating ‘No Production"
on line 24. If you wish to inactivate your number, include with your report
a letter on your company's letterhead, signed by an officer of your company
stating your desire to inactivate your Establishment Registration. If
you wish to reactivate your number in the future it can be changed very
quickly by just sending us a notice on your company letterhead requesting
reactivation.
12.
What are the consequences if I do not file my yearly report by the March
1st deadline?
The possible consequences include a warning letter, civil or criminal
fines, and possible termination of your establishment registration.
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