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

Recordkeeping Requirements for Producers of Pesticides under Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (Renewal)

instructions 3540-16

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

OMB: 2070-0028

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United States Environmental Protection Agency
Instructions for Completing EPA Form 3540-16
Pesticide Report for Pesticide-Producing and Device-Producing Establishments
Reporting Year 2007
It is unlawful to knowingly falsify all or part of any pesticide production information reported on EPA
Form 3540-16. (Section 12(a)(2)(M) of FIFRA).
GENERAL INFORMATION
Read all instructions before completing this Form. Type or print clearly in dark ink. Page one of EPA
Form 3540-16 has space to enter two products. If you produce more than two products, use the continuation
page and make as many photocopies of the page, as you need. Electronic copies of these instructions and
the screen-fillable EPA Form 3540-16 can be downloaded from
http://www.epa.gov/compliance/monitoring/programs/fifra/establishments.html.
1. Who must report?
•

Each producer operating an establishment that produces any pesticides, active ingredients, or devices must
submit reports.
o “Producer” means the person who manufactures, prepares, compounds, propagates, or
processes any pesticide or device or active ingredient used in producing a pesticide. (FIFRA §
2)
o “Producer” also means any person, as defined by the Act, “who produces any pesticide, active
ingredient, or device (including packaging, repackaging, labeling and relabeling).” (EPA
regulations at 40 CFR § 167.3)
o “Produce” means to manufacture, prepare, compound, propagate, or process any pesticide or
device or active ingredient used in producing a pesticide. (FIFRA§ 2)
o “Produce” also means to “manufacture, prepare, propagate, compound or process any pesticide,
including any pesticide product pursuant to Section 5 of the Act, any active ingredient or
device, or to package, repackage, label, relabel, or otherwise change the container of any
pesticide or device.” (EPA regulations at 40 CFR § 167.3)
o “Establishment” means any site where a pesticidal product, active ingredient, or device is
produced. Establishment also includes sites which 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.
(See: EPA regulations at 40 CFR § 167.3)

•

Products also requiring reporting include, but are not limited to, the following: unregistered pesticides,
Special Local Need products under FIFRA § 24(c), ozone or ultraviolet light producing devices for
disinfecting, and other devices.

•

Establishments that export from or import into the United States any pesticides, active ingredients, or
devices must report to the Agency. (FIFRA § 17)

•

Establishments with Zero Production or Distribution in 2007. (See #2 below for details)

•

Closed Establishments (Out of business or ceased production). (See #4 below for details)

2. What must be reported?
•

Each producer operating an establishment must submit the following information for each product produced
at the establishment:
o Types and amounts produced in the past calendar year.
o Types and amounts sold or distributed in the past calendar year, regardless of when the product was
produced.
o An estimate of the amount expected to be produced in the current calendar year.

•

Establishments with Zero Production or Distribution in 2007.
o If your establishment did not produce or distribute products subject to this report in 2007, complete
Blocks 1-19, and check (9) the Box in Block 15 where it states “Did Not Produce or Distribute.” Sign
and date the report in Blocks 18 and 19; it is now complete. Submit the report as directed on
Pages 7 and 8.

•

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 Blocks 28, 29 and 30 are zero.
o Custom-blended products (See Common Questions and Answers - Question 8).
o Pesticides that are applied by your establishment=s staff.
o Returned or carryover product from a previous year or inventory as production.

3. When to report:
• Reports are due: On or before March 1, 2008, even if there has been no production.
• Initial Reports: Section 7 of FIFRA requires all registered establishments to submit a 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.
4. Closed Establishments (Out of business or ceased production).
• Enter all production and distribution information for 2007.
• Include a letter on company letterhead with the report stating the establishment is out of business or has
ceased production of pesticides and request the establishment number be inactivated. Note: Your
company will not receive this reporting form in future years.
5. Completing the Report:
• An original signature of a company official is required on the report in Block 18. Enter the date in Block
19.
• For all pages complete at the bottom: “This is Page _____ of _____.”
• Submit completed reports as directed on Pages 7 and 8. Please make copies of the Reports for your records.
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 $6,500 per violation and/or criminal penalties.
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INSTRUCTIONS - COMPLETING THE REPORT

Blocks 1-19.Name and Location of Company Headquarters and Producing Establishment
Blocks 1-5.
Enter the company name and headquarters mailing address of the producing establishment.
Block 6.
Enter telephone number of company official responsible for the report.
Block 7.
If company name or mailing address has changed from the previous year, enter a check (9) in
the box.
Blocks 8-13. A label showing the establishment SITE information should appear in Blocks 8-13. CORRECT
IF WRONG.
Block 14.
If establishment name or site address has changed from the previous year, enter a check (9) in
the box.
Block 15.
Use this block to report that NO PRODUCTION OR DISTRIBUTION took place in 2007.
Do not list products which you did not produce or distribute.
Block 16.
Enter name of company official signing report (should match Block 18).
Block 17.
Enter title of company official signing report (should be the title of person signing Block 18).
Block 18.
Original signature of the company official. If pages are numbered 1 of XX, etc., only 1st page
must be signed.
Block 19.
Enter date report is signed. If there was ANo Production,@ the report is complete.

Block 20 - Product Code
Enter 1 — if product is registered with EPA.
Enter 2 — if product registration is pending.
Enter 3 — if product is an Experimental Use Permit.
Enter 4 — if product is a pesticide device, an unregistered pesticide, or 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)
Block 21 - EPA Product Registration No.
Product Code 1— Enter EPA Registration No. (as it appears on product label) (See NOTE below on reporting
production of multiple distributor registrations).
Product Code 2 — Enter EPA File Symbol assigned to product.
Product Code 3 — Enter the Experimental Use Permit number.
Product Code 4 — For DEVICES, leave Block 21 blank.
For UNREGISTERED PESTICIDES, leave Block 21 blank, and attach the chemical
formulation of the product, 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.
For stand-alone SLN REGISTRATIONS, enter the SLN registration number in Block 21
(e.g., SLN-CA-890022). A “stand-alone@ SLN is one for which there are no uses other
than the 24(c) uses.

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NOTE: Reporting Distributor Registrations.
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 add Aand supplementals@ following the product name. On a
separate paper, list the basic registration number with each distributor company
number and brand name, and attach it to the report.
Block 22 - Product Name. List the most common brand name. If marketed under alternate brand names, add
the wording Aand alternate brand names@ (AABN@) and report total production under all names for the
formulation.

Block 23 - Product Classification
Classifications for Devices
13 Device
14 Water Purifier - Point of Use
Classifications for Pesticides
01 Insecticide
02
04 Herbicide
05
07 Plant Regulator
08
10 Antifouling Paint
11
21 Insecticide-Fungicide
44

Fungicide
Algaecide
Defoliant, Desiccant
Animal Repellent
Herbicide-Fungicide

15 Water Purifier - Small System

03
06
09
12

Rodenticide
Nematocide
Disinfectant, Germicide, Sanitizer
Other Pesticides (includes Insect
Repellents & Slug Baits)

16 Multi-Use Active Ingredient (Chemicals that have both pesticidal and non-pesticidal uses). Producers are
required to register both the product and their establishment(s) and report production on an annual basis
under Section 7 of FIFRA 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. These chemicals do not have an EPA Reg. No. (This Classification is rarely
appropriate.)

Block 24 - Product Type. Describe the type of product:
Enter 1 — Technical material or active ingredient for Manufacturing Use Only products
Enter 2 — End-use product (this includes products where the formulation has been blended, diluted, or
changed)
Enter 3 — Repackaged or relabeled (does not include any blending, dilution or change in the formulation)
Enter 4 — Device

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Block 25 - Market Sold or Distributed To
Domestic Establishments
Enter 1 — if all the product was marketed in the United States.
Enter 2 — if the product was marketed both in the United States and exported from the United States.
Enter 3 — if all the product was exported from the United States.
Foreign Establishments
Enter 1 — if the product was exported to or marketed in the United States.
DO NOT REPORT products that were sold to countries other than the United States.

Block 26 - Use Classification
Enter 1 — Product label states RESTRICTED USE PESTICIDE at the top of the front label panel.
Enter 2 — All other pesticides and devices.
Block 27 - Unit of Measurement
G = Gallons
K = Kilograms
L = Liters
P = Pounds
T = Tons
U = Units

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

Block 28 - Amount Produced in 2007
•

Do not include amounts that are custom blended or applied to a crop, commodity or site by your
staff.

•

Round all quantities to the nearest whole number.

Block 29 - Amount Sold or Distributed in 2007 - United States
• Enter only those products sold or distributed that were produced by your establishment, regardless of
when the product was produced.
•

Do not include amounts that are custom blended or applied to a crop, commodity or site by your
staff.

•

Foreign producers should enter only the amount of product or number of devices exported to the
United States.

•

Round all quantities to the nearest whole number.
5

Block 30 - Amount Sold or Distributed in 2007 to Foreign Markets (Exported)
•

Enter the quantity exported from the United States in 2007, regardless of when the product was
produced.

•

Foreign establishments should leave Block 30 blank.

•

Round all quantities to the nearest whole number.

Block 31 - Amount (Estimated) to be Produced in 2008
•

Enter an estimate of the quantity to be produced in 2008.

•

Round all quantities to the nearest whole number.

Confidentiality. Under FIFRA Section 7(d) [7 U.S.C. § 136e], information reported in Items 28, 29, 30
and 31 of EPA Form 3540-16 will be treated as business confidential, subject to the provisions of FIFRA
Section 10 [7 U.S.C. § 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, OP/ORMI Regulatory Information Division (2137), U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, D.C. 20460, Attention:
Desk Officer for EPA, and to the Paperwork Reduction Project, Office of Information and Regulatory
Management Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503.

6

WHERE TO SUBMIT REPORTS
EPA Regional Offices

States/Territory Covered

U.S. EPA Region 1
Kan Tham
Toxics and Pesticides Unit (SEP)
One Congress Street, Suite 1100
Boston, MA 02114-2023
Telephone: 617-918-1872

CT, MA, ME, NH, RI, VT

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 3
Kyla Townsend-McIntyre
Pesticides Programs Branch (3WC32)
1650 Arch Street
Philadelphia, PA 19103-2029
Telephone: 215-814-2045

DE, DC, MD, PA, VA, WV

U.S. EPA Region 4
Jacquelyn Wilkerson
PCB & Chemical Products Mgmt. 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 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 6
Chuck Ruple
Pesticides Section (6PD-P)
1445 Ross Avenue
Dallas, TX 75202-2733
Telephone: 214-665-6534

AR, LA, NM, OK, TX

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EPA Regional Offices

States/Territories Covered

U.S. EPA Region 7
Joy Haff
Toxics & Pesticides Branch (WWPD/TOPE)
901 N. 5th Street
Kansas City, KS 66101-2798
Telephone: 913-551-7752

IA, KS, MO, NE

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

AZ, CA, HI, NV, GU, MP

U.S. EPA Region 10
Erin Halbert
Pesticides and Toxics Unit (OCE-084)
1200 Sixth Avenue, Suite 900
Seattle, WA 98101-3140
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
Michelle Stevenson
US Environmental Protection Agency
US Environmental Protection Agency
Agriculture Division (2225A)
Agriculture Division
1200 Pennsylvania Avenue, NW
Ariel Rios South Building
Washington, DC 20460-0001 USA
1200 Pennsylvania Avenue, NW, Room 6102
Telephone: 202-564-4203
Washington, DC 20004 USA
Email: [email protected]
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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File Typeapplication/pdf
File TitleInstructions for completing EPA Form 3540-16
Subjectcompliance, monitoring, pesticide, establishment, report, form, annual production, device, section 7, SSTS
AuthorEPA/OECA/OC/AgD - 78104
File Modified2008-01-14
File Created2007-11-14

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