Recordkeeping Requirements for Producers of Pesticides under section 8 of the Federal Insecticide, Fungicide, and Rodenti- cide Act (FIFRA)

OMB Control No. 2070-0078
Expires 5/31/2012

United States Environmental Protection Agency
Instructions for Completing EPA Form 3540-16
Pesticide Report for Pesticide-Producing and Device-Producing Establishments
Reporting Year 2010
It is unlawful to knowingly falsify all or part of any pesticide or device production information
reported on EPA Form 3540-16. (FIFRA §12(a)(2)(M))

General Information
Read all instructions before completing this form. Type or print clearly in dark ink. This form
may also be filled out and printed on-line. Page one has space to enter one product. Use the “Add
additional page” button at the bottom of the on-line screen-fillable form and add as many pages as
necessary to report all products. Each “Additional” page has space for four (4) products. Please make
sure you number each page. If you add too many pages, click the “Remove Extra Page” button to
remove the last page added. See the Pesticide Establishment Registration and Reporting web page for
the instructions and the form.
http://www.epa.gov/compliance/monitoring/programs/fifra/establishments.html
1. Who must report?
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All domestic and foreign producing establishments, regardless of whether or not the establishment
produced or distributed a pesticide, active ingredient or device must submit a report. (FIFRA §§ 7
and 17)

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Establishments with zero production or distribution in 2010. If your establishment did not produce
or distribute products subject to this report in 2010:
o Complete Items 1-27 and Items 40-43.
o Check “No” in Item 14.

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Establishments that closed, went out of business or ceased production.
o Report all production and distribution during 2010.
o See Number 7 for information on terminating your establishment’s registration.

2. Definitions
o Producer—any person, as defined by FIFRA, “who produces any pesticide, active
ingredient, or device (including packaging, repackaging, labeling and relabeling).”
(40 CFR §167.3)
o Produce—“manufacture, prepare, propagate, compound or process any pesticide,
including any pesticide product pursuant to FIFRA §5, any active ingredient or device, or
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to package, repackage, label, relabel or otherwise change the container of any pesticide or
device.” (40 CFR §167.3)
o Establishment—Includes:
o Any site where a pesticidal product, active ingredient or device is produced.
o Sites that are independently owned or operated regardless of whether such site is
domestic and producing a pesticidal product for export only or whether the site is
foreign and producing a pesticidal product for import into the United States.
(40 CFR §167.3)
o Sites that produce a pesticidal product for use under an Experimental Use Permit,
FIFRA Section 18 Emergency Exemption or Section 24(c) Special Local Needs
registration, must report. (40 CFR §167.20)
o Sites that produce unregistered pesticidal products for export from the US.
o Custom Blender—any establishment that provides the service of mixing registered
pesticides to a customer’s specifications, specifically:
o a pesticide-pesticide blend
o a pesticide-fertilizer blend
o a pesticide-animal feed mixture
when
o the blend is not held in inventory
o the pesticide used in producing the blend bears labeling that does not prohibit the use
of the pesticide in the blend
o the blend is delivered to the end-user with a copy of the labeling of the pesticide used
in producing the blend and a statement specifying the composition of the mixture
If these conditions are not met, the establishment does not meet the definition of "custom
blender" and must comply with FIFRA Section 7 requirements.

NOTE

A facility where only custom blending activities take place is not considered a pesticideproducing establishment and therefore does not need to be registered. Please see the Pesticide
Establishment Registration and Reporting FAQ for more information.
http://www.epa.gov/compliance/resources/monitoring/fifra/faqestablishment.html

3. What must be reported?
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Each producer operating an establishment must submit the following information for each pesticide,
active ingredient or device produced at your establishment: (Please note that production and
distribution of unregistered pesticides must be reported. See 40 CFR § 152.30).
o Types and amounts produced in 2010.
o Types and amounts sold or distributed in 2010, regardless of when the product was
produced.
o An estimate of the amount expected to be produced in 2011.

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DO NOT REPORT:
o Production, distribution or sale of products NOT produced or repackaged by your
establishment (e.g., no changes are made to the product formulation, container or
label).
o Products shipped from your supplier directly to your customer.
o Any products for which Items 36, 37 and 38 are zero.
o Pesticides that are applied by your staff.
o Returned inventory or carryover product from a previous year.
o Custom-blended products.

4. When to report:
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Annual Reports are due: On or before March 1, 2011, even if there has been no production.

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Initial Reports: FIFRA §7 requires all registered establishments to submit an initial report to the
U.S. EPA 30 days after receipt of notification of establishment registration. Failure to file the initial
report is an unlawful act and may result in termination of the establishment’s registration or your
ability to import into the United States until you have fulfilled your reporting responsibility.

5. Completing the Report:
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Enter the company official’s or authorized agent’s Name and Title (Items 40 & 41).
An original signature of a company official or authorized agent is required on the report in Item 42.
Enter the date in Item 43.
For all pages complete at the bottom: “This is Page _____ of _____.”
Submit completed reports as directed on Page 9. Please make a copy of the report for your records.
EPA will not accept any copies (xeroxed, faxed or electronic document formats) of the initial
or annual reports (EPA Form 3540-16).

6. What if I fail to file this production report?
Failure to file an initial or annual production report is a violation of FIFRA, and may result in
termination of the establishment’s registration, civil penalties up to $7,500 per violation and/or
criminal penalties. It may also affect your ability to import until you are in compliance.
7. How to terminate your establishment’s registration:

8.

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Send a letter on company letterhead with this report stating the establishment is out of
business or has ceased production of pesticides, active ingredients or devices requesting that
your establishment number be terminated.

•

If EPA terminates your domestic establishment registration, it is illegal to sell or distribute
any pesticide, active ingredient or device in the United States or to export a product out of the
United States. If EPA terminates your foreign establishment registration, it is illegal for you
to import any pesticide, active ingredient or device into to the United States.

Additional Information is available at Pesticide Establishment—Registration and Reporting
Questions at: http://www.epa.gov/compliance/resources/monitoring/fifra/faqestablishment.html.
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General Instructions
Establishment Information: (Items 1 through 14)
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Item 1—Establishment Name: Enter the producing establishment name.
Item 2—Establishment Number: Enter the producing establishment number.
Item 3 to 6—Establishment Site Address: Enter the SITE address, not a post office box or
route number, where your establishment is located. For foreign establishments, zip code is
equivalent to postal code, post code or postcode.
Item 7 to 10—Establishment Mailing Address: Enter the mailing address for the
establishment if different from the site address.
Item 11—Telephone Number: Enter the phone number for the establishment. For foreign
establishments, please provide the country code.
Item 12—Email: Enter your email address.
Item 13—If the establishment name or site address has changed from the previous year, enter a
check (X) in the box.
Item 14— Did you produce or distribute in 2010? Check the appropriate box.
Note: If you checked the “No” box, do not fill in items 28 through 39.

NOTE: For items
5, 9, 18
and 22.

Foreign country abbreviation codes are available at:
http://www.epa.gov/compliance/resources/publications/monitoring/fifra/fgnestablis
hments.html
Please contact U.S. EPA Headquarters 011-202-564-4203 if you do not see the
appropriate country code listed.

Company Information: (Items 15 through 27)
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Item 15—Company Name: Enter the company name.
Item 16 to 19—Company Site Address: Enter the company’s headquarter address.
Item 20 to 23—Company Mailing Address: Enter the mailing address for the company if
different from the company site address.
Item 24—Telephone Number: Enter the phone number for the company. For foreign
companies, please provide the country code.
Item 25—Email: Enter your email address.
Item 26—If company name or site address has changed from the previous year, enter a check
(X) in the box.
Item 27 — If Authorized Agent name or mailing address has changed from the previous year,
enter a check (X) in the box. Please attach your company’s request to change the authorized
agent on company letterhead and send to the appropriate EPA office listed on Page 9.

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Pesticide Production Information: (Items 28 through 39)

NOTE

Foreign Establishments – You must report production for products exported to or marketed
in the United States. If your establishment produced a pesticide, active ingredient or device
and sold some of the product in countries other than the United States, do not report this
portion of your production and distribution. For example, if you produce 10,000 pounds of a
product and sell 9,000 to other countries and 1,000 pounds to the United States; you should
report 1,000 produced and 1,000 distributed.

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Item 28—Product Code:
o Enter 1 — if product is registered with EPA.
o Enter 2 — if product registration is pending.
o Enter 3 — if product is an Experimental Use Permit.
o Enter 4 — if product is a device.
o Enter 5 — if product is a Special Local Need (SLN) registration.
“Special Local Need (SLN)” means an existing or imminent pest problem
within a State for which the State lead agency, based upon satisfactory
supporting information, has determined that an appropriate federally registered
pesticide product is not sufficiently available. (See: EPA regulations at 40 CFR
§162.151)
o Enter 6 — if product is an Unregistered Pesticide. Attach the formulation of the product to
the end of the report showing the product’s active and inert ingredients; their common
names; their CAS Registry numbers (if available); and the percentage, by weight, of each
ingredient (must total 100%). Multiple formulations may appear on the same page; clearly
identify each by product name.

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Item 29—EPA Product Registration Number Information:
o Product Code 1— Enter EPA Registration No. (as it appears on product label)
(See NOTE below on reporting production of multiple distributor
registrations).
o Product Code 2 — Enter EPA File Symbol assigned to product.
o Product Code 3 — Enter the Experimental Use Permit number.
o Product Code 4 — For devices, leave Item 29 blank.
o Product Code 5 — For stand-alone SLN Registrations, enter the SLN registration number
in Item 29 (e.g., SLN-CA-890022). A “stand-alone” SLN is one for
which there are no uses other than the 24(c) uses.
o Product Code 6 — For Unregistered Pesticides, leave Item 29 blank.

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Reporting Distributor Registrations:

NOTE

If you produce multiple pesticide products under the same basic EPA registration number
(such as distributor products):
Report the total quantities for all distributor products under the basic EPA
registration number, and following the product name add “and supplementals.” On a
separate paper, list the basic registration number with each distributor company
number and brand name and attach it to the report.

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Item 30—Product Name:
List the most common brand name. If marketed under alternate brand names, add the wording
“and alternate brand names” or “ABN” and report total production under all names for the
formulation.

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Item 31—Product Classifications: Enter the code that best describes the product’s use.
o Classification for Devices
51 Device
o Classifications for Pesticides
04 Insect Repellant
18 Sterilizer
27 Fungicide
34 Herbicide
38 Antifoulant
54 Rodenticide
61 Molluscicide (e.g. slug bait)

07
20
28
36
43
57
69

Antimicrobial
Disinfectant
Nematocide
Defoliant
Insecticide
Animal Repellant
Water Purifier

09
21
29
37
49
59

Attractant
Sanitizer
Fumigant
Desiccant
Plant Growth Regulator
Algaecide

99 Multi-Use Active Ingredient (Chemicals that have both pesticidal and non-pesticidal
uses). These chemicals do not have an EPA Reg. No. (This classification is rarely
appropriate. Producers are required to register both the product and their
establishment(s) and report production on an annual basis under FIFRA §7, if a
producer has actual or constructive knowledge that a chemical or substance they
produce is used or intended for use as an active ingredient in the manufacture of a
pesticide. These producers are required to report only the amount of the chemical or
substance manufactured and distributed or sold for pesticidal purposes.
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Item 32—Product Type:
o Enter 1 — Technical formulations or active ingredient for Manufacturing Use Only
products.
o Enter 2 — End-use product (this includes products where the formulation has been
blended, diluted, or changed).
o Enter 3 — Repackaged or relabeled (does not include any blending, dilution or change in
the formulation).
o Enter 4 — Device.

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Item 33—Market Sold or Distributed To:
o Enter 1 — if all the product was marketed in the United States.
o Enter 2 — if the product was marketed both in the United States and exported from the
United States.
o Enter 3 — if all the product was exported from the United States.

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Item 34—RUP Status:
o Enter 1 — Product label states RESTRICTED USE PESTICIDE at the top of the front
label panel.
o Enter 2 — All other products.

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Item 35—Unit of Measurement:
o
o
o
o
o

G = Gallons
K = Kilograms
L = Liters
P = Pounds
T = Tons

o U = Units

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(liquid chemical product)
(dry, solid, liquid or gaseous chemical product)
(liquid chemical product)
(dry, solid, liquid or gaseous chemical product)
(short ton = 2,000 lbs. or 907.2 kilograms) (dry, solid or gaseous
chemical product)
(devices and pesticides that the label does not declare as gallons, pounds,
liters, kilograms or tons)

Item 36—Amount Produced in 2010:
o Do not include amounts that are custom blended or applied to a crop, commodity or site by
your staff.
o Round all quantities to the nearest whole number.

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Item 37—Amount Sold or Distributed in 2010 - United States:
o Enter only those products sold or distributed that were produced by your establishment,
regardless of when the product was produced.
o Do not include amounts that are custom blended or applied to a crop, commodity or site by
your staff.
o Foreign producers should enter only the amount of product or number of devices exported
to the United States.
o Round all quantities to the nearest whole number.

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Item 38—Amount Sold or Distributed in 2010 to Foreign Markets (Exported):
o Enter the quantity exported from the United States in 2010, regardless of when the product
was produced.
o Round all quantities to the nearest whole number.
o Foreign establishments enter “0” in Item 38.

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Item 39—Amount (Estimated) to be Produced in 2011:
o Enter an estimate of the quantity to be produced in 2011.
o Round all quantities to the nearest whole number.

Signature Certification: (Items 40 through 43)
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Items 40 and 41—Name and Title of Company Official or Authorized Agent: Please enter
the name and title of the person who is responsible for your establishment’s compliance with
the requirements of FIFRA §7. Note: If you are the authorized agent submitting this report,
please enter your name and title.

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Items 42 and 43—Signature of Company Official or Authorized Agent: The company
official and/or authorized agent listed in Item 40 must sign and date the report in order for it to
be complete.

Confidentiality. Under FIFRA §7(d) [7 USC §136e], information reported in Items 36, 37, 38 and 39
of EPA Form 3540-16 will be treated as business confidential, subject to the provisions of FIFRA §10
[7 USC §136h]. You are not required to assert a claim of confidentiality for this information.
If you wish to assert a claim of confidentiality for other information you have provided on this form,
you must identify by the box number(s) information for which you are asserting a claim of
confidentiality. Information so designated will be disclosed by the EPA only to the extent allowed by,
and by means of, the procedures set forth in 40 CFR Part 2. If you do not claim the information as
confidential upon submission of the report, it may be made available to the public without further
notice to you.
Public Reporting Burden. The time required to complete this report is estimated to average one hour
and 26 minutes, per response, including reviewing instructions, searching data sources, gathering and
maintaining data needed, and completing review and collection of information. Send comments
regarding this burden estimate or other aspects related to this information collection, including
suggestions for reducing this burden, to: Director, Collection Strategies Division, U.S. Environmental
Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, DC 20460. Include the OMB
control number in any correspondence. Do not send the completed 3540-16 form to the above
address.

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Where to Submit Reports
DOMESTIC PRODUCERS:

Submit reports to the following EPA Regional Office where your company
headquarters is located.

States/Terr.
Covered

EPA Regional Offices

EPA Regional Offices

States/Terr.
Covered

U.S. EPA Region 1
Kan Tham
Toxics and Pesticides Unit
(OES05-4)
5 Post Office Square, Suite 100
Boston, MA 02109-3912
Telephone: 617-918-1872

CT, MA
ME, NH
RI, VT

U.S. EPA Region 6
Chuck Ruple
Pesticides Section (6PD-P)
1445 Ross Avenue
Dallas, TX 75202-2733
Telephone: 214-665-6534

AR, LA
NM, OK
TX

U.S. EPA Region 2
Michael Kramer
Pesticides Team (MS-500)
2890 Woodbridge Avenue
Edison, NJ 08837-3679
Telephone: 732-321-6610

NJ, NY
PR, VI

U.S. EPA Region 7
Delbert Kelley
Pesticides Section (WWPD/TOPE/PEST)
901 N. 5th Street
Kansas City, KS 66101-2798
Telephone: 913-551-7371

IA, KS
MO, NE

U.S. EPA Region 3
Kyla Townsend-McIntyre
Pesticides and Asbestos Programs Branch (3LC62)
1650 Arch Street
Philadelphia, PA 19103-2029
Telephone: 215-814-2045

DC, DE
MD, PA
VA, WV

U.S. EPA Region 8
Kathleen Craig
Enforcement Division (8ENF-PJ)
1595 Wynkoop
Denver, CO 80202
Telephone: 303-312-6049

CO, MT
ND, SD
UT, WY

U.S. EPA Region 4
Jacquelyn Wilkerson
Chemical Products & Asbestos Section (APTMD)
61 Forsyth Street, SW
Atlanta, GA 30303-8960
Telephone: 404-562-9011

AL, FL
GA, KY
MS, NC
SC, TN

U.S. EPA Region 9
Glenda Dugan
Pesticides Office (CED-5)
75 Hawthorne Street
San Francisco, CA 94105-3901
Telephone: 415-947-4204

AZ, CA
GU, HI
MP, NV

U.S. EPA Region 5
Gail Muffitt
PTCS (LC-8J)
77 W. Jackson Blvd.
Chicago, IL 60604-3507
Telephone: 312-886-6008

IL, IN
MI, MN
OH, WI

U.S. EPA Region 10
Erin Halbert
Pesticides and Toxics Unit (OCE-084)
1200 Sixth Avenue, Suite 900
Seattle, WA 98101-1128
Telephone: 206-553-4627

AK, ID
OR, WA

FOREIGN PRODUCERS:

Submit reports to the following EPA Washington, DC address:

U.S. Postal Service Mail Address

Courier Delivery Address

Michelle Stevenson
U.S. Environmental Protection Agency
Agriculture Division (2225A)
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001 USA
Telephone: 202-564-4203

Michelle Stevenson
U.S. Environmental Protection Agency
Agriculture Division
Ariel Rios Building -- South
1200 Pennsylvania Avenue, NW, Room 6102
Washington, DC 20004 USA

NOTE:

The Agency does not notify you when your report is received. To ensure the Agency
receives the report, you may wish to send it by certified or registered mail, return receipt
requested.

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