Attachment A- 40 CFR Part 169

Attachment A- 40 CFR part 169.pdf

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

Attachment A- 40 CFR Part 169

OMB: 2070-0028

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§ 168.85

40 CFR Ch. I (7–1–21 Edition)

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Summary has been received within 30
days of the date at which such summary is required to be submitted, EPA
will send written notification to the
appropriate government official indicating that no summary was submitted, and may also take enforcement
action against the exporter.

PART 169—BOOKS AND RECORDS
OF PESTICIDE PRODUCTION AND
DISTRIBUTION
Sec.
169.1
169.2
169.3

Definitions.
Maintenance of records.
Inspection.

AUTHORITY: 7 U.S.C. 136f and 136w.

[58 FR 9085, Feb. 18, 1993, as amended at 69
FR 23117, Apr. 28, 2004; 71 FR 35546, June 21,
2006; 72 FR 61029, Oct. 26, 2007]

SOURCE: 45 FR 54338, Aug. 15, 1980, unless
otherwise noted.

§ 168.85

§ 169.1

Other export requirements.

This section describes other requirements found in regulations that apply
to exporters of pesticides, devices, and
active ingredients used in producing a
pesticide.
(a) Recordkeeping and inspection. Exporters of pesticides, devices and active
ingredients must keep records and permit inspections of those records in accordance with part 169 of this chapter.
Exporters must keep records of the
product labeling used, including the
EPA registered labeling, any foreign
labeling on or attached to the product
when shipped, and, as applicable, any
supplemental labeling used. Producers
of pesticides for export shall maintain
these records in a manner that shows
exactly which labels and labeling accompanied each shipment of a pesticide
product to a foreign country. As stated
at § 168.75(c), when research product
identity information appears on the labeling in an encoded manner, information translating the code shall be
maintained in records. These records
shall be maintained for the time period
required by § 169.2(h) of this chapter following the last export of such pesticides. All records required by part 169
of this chapter shall be made available
for inspection and copying by EPA or
its duly authorized representatives.
(b) Pesticide production establishment
requirements. Exporters of pesticides,
devices, and active ingredients must
submit annual reports to EPA in accordance with part 167 of this chapter,
concerning those products that are exported. All products required to be labeled ‘‘Not Registered for Use in the
United States of America’’ must be reported as unregistered production regardless of whether a purchaser acknowledgement statement is required.

Definitions.

Terms used in this part shall have
the meanings set forth for such terms
in the Federal Insecticide, Fungicide,
and Rodenticide Act, as amended. In
addition, as used in this part, the following terms shall have the meanings
set forth below:
(a) Amount of pesticide or active ingredient. The term ‘‘amount of pesticide or
active ingredient’’ means the weight or
volume of the pesticide or active ingredient used in producing a pesticide expressed as weight for solid or semisolid products and as weight or volume
of liquid products.
(b) Batch. The term ‘‘batch’’ means a
quantity of a pesticide product or active ingredient used in producing a pesticide made in one operation or lot or
if made in a continuous or semi-continuous process or cycle, the quantity produced during an interval of time to be
specified by the producer.
(c) Device. The term ‘‘device’’ means
any device or class of device as defined
by the Act and determined by the Administrator to be subject to the provisions of the Act.
(d) Inability. The term ‘‘inability’’
means the incapacity of any person to
maintain, furnish or permit access to
any records under this Act and regulations, where such incapacity arises out
of causes beyond the control and without the fault or negligence of such person. Such causes may include, but are
not restricted to acts of God or of the
public enemy, fires, floods, epidemics,
quarantine restrictions, strikes, and
unusually severe weather, but in every
case, the failure must be beyond the
control and without the fault or negligence of said person.
(e) Producer. The term ‘‘producer’’
means the person, as defined by the

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Environmental Protection Agency

§ 169.2

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Act, who produces or imports any pesticide or device or active ingredient
used in producing a pesticide.
§ 169.2 Maintenance of records.
All producers of pesticides, devices,
or active ingredients used in producing
pesticides subject to this Act, including pesticides produced pursuant to an
experimental use permit and pesticides, devices, and pesticide active ingredients produced for export, shall
maintain the following records:
(a) Records showing the product
name, EPA Registration Number, Experimental Permit Number if the pesticide is produced under an Experimental Use Permit, amounts per batch
and batch identification (numbers, letters, etc.) of all pesticides produced. In
cases where the product is an active ingredient used in producing a pesticide
or where the product is a pesticide
which is not registered, is not the subject of an application for registration,
or is not produced under an Experimental Use Permit, the records shall
also show the complete formula. The
batch identification shall appear on all
production control records. These
records shall be retained for a period of
two (2) years.
(b) Records showing the brand names
and quantities of devices produced.
These records shall be retained for a
period of two (2) years.
(c) Records showing the following information regarding the receipt, by the
producer, of all pesticides, devices, and
active ingredients used in producing
pesticides:
(1) Brand name of the pesticide or device, or common or chemical name of
the pesticide active ingredient;
(2) Name and address of shipper;
(3) Name of delivering carrier;
(4) Date received; and
(5) Quantities received.
These records are not intended to cover
receipt of pesticides used for in-plant
maintenance, extermination, or sanitation programs, etc. Shipping and receiving documents such as invoices,
freight bills, receiving tickets, etc.,
which provide the required information
will be considered satisfactory for the
purposes of this section. These records
shall be retained for a period of two (2)
years.

(d) Records showing the following information regarding the shipment of
all pesticides, devices, and active ingredients used in producing pesticides:
(1) Brand name of pesticide or device,
or the common or chemical name of
the pesticide active ingredient;
(2) Name and address of consignee;
(3) Where the pesticide is produced
pursuant to an experimental use permit (FIFRA section 5), a special exemption (section 18), or a special local
need (section 24), the information required under these sections and any
regulations promulgated thereto regarding the distribution of such pesticides;
(4) Name of originating carrier;
(5) Date shipped or delivered for shipment; and
(6) Quantities shipped or delivered for
shipment.
Such records are required regardless of
whether any shipment or receipt of
shipment is between plants owned or
otherwise controlled by the same person. Shipping and receiving documents
such as invoices, freight bills, receiving
tickets, etc., which provide the required information will be considered
satisfactory for purposes of this section. These records shall be retained
for a period of two (2) years.
(e) Inventory records with respect to
the types and amounts of pesticides or
pesticide active ingredients, or quantities of devices in stock which he has
produced. These records may be disposed of when a more current inventory record is prepared.
(f) Copies of all domestic advertising
of the restricted uses of any pesticide
registered for restricted use which the
producer caused to have prepared, including any radio or television scripts
for all such pesticides. These records
shall be retained for a period of two (2)
years.
(g) Copies of all guarantees given
pursuant to section 12(a)(2)(C) of the
Act. These records shall be retained for
a period of one (1) year after expiration
of the guarantee.
(h) In the case of all pesticides, devices, and active ingredients used in
producing pesticides intended solely
for export to any foreign country:
(1) Copies of the specification or directions of the foreign purchaser for

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§ 169.3

40 CFR Ch. I (7–1–21 Edition)

the production of such pesticides, devices, or pesticide active ingredients;
(2) Copies of labels or labeling required to comply with section 17(a)(1)
of the Act; and
(3) For any pesticide other than a
pesticide registered under section 3 or
sold under section 6(a)(1) of the Act,
copies of a statement signed by the foreign purchaser of the pesticide acknowledging that the purchaser understands that such pesticide is not registered for use in the United States and
cannot be sold in the United States
under this Act.
These records shall be retained for a
period of 2 years after expiration of the
contract.
(i) Records on the method of disposal
(burial, incineration, etc.) date or dates
of disposal, location of the disposal
sites, and the types and amounts of
pesticides or pesticide active ingredients disposed of by the producer or his
contractor. With regard to the disposal
of containers accumulated during production, the Agency will consider satisfactory a statement, attested to by a
responsible firm official, describing in
general terms the method and location
of disposal, e.g., all containers are
taken periodically to a certain site.
Records of deviations from normal
practice must be maintained. In addition, any records on the disposal of pesticides or pesticide active ingredients
and/or containers specified pursuant to
section 19 of the Act and any regulations promulgated thereto shall also be
maintained. The above requirements
apply to those products bearing label
instructions for disposal and to any
other products specified under any regulations promulgated pursuant to section 19. These records shall be retained
for twenty (20) years or may be forwarded after three (3) years to the Environmental Protection Agency Regional Administrator for maintenance.
Notwithstanding these record keeping
requirements, whenever any producer
of pesticides or pesticide active ingredients is complying with a rule promulgated under the authority of the Resource Conservation and Recovery Act
of 1976 (RCRA) (Pub. L. 94–580, 90 Stat.
2795, October 21, 1976), for the handling
or disposal of hazardous wastes, as defined by RCRA or any regulations pro-

mulgated thereunder, such producer
will no longer be required to maintain
records in accordance with this subsection.
(j) Records of any tests conducted on
human beings whether performed by
the producer himself or authorized and/
or paid for by the producer. Such
records shall include: The names and
addresses of subjects tested, dates of
tests, types of tests, written consent of
subjects to test, and all information
and instructions given to the subjects
regarding the nature and purpose of
the tests and of any physical and mental health consequences which were
reasonably foreseen therefrom, and any
adverse effects of the test on the subjects, including any such effects coming to the attention of the producer
after completion of the tests. These
records shall be retained for twenty
(20) years or may be forwarded after
three (3) years to the Environmental
Protection Agency Regional Administrator for maintenance.
(k) Records containing research data
relating to registered pesticides including all test reports submitted to the
Agency in support of registration or in
support of a tolerance petition, all underlying raw data, and interpretations
and evaluations thereof, whether in the
possession of the producer or in the
possession of the independent testing
facility or laboratory (if any) which
performed such tests on behalf of the
producer. These records shall be retained as long as the registration is
valid and the producer is in business.
[45 FR 54338, Aug. 15, 1980, as amended at 58
FR 9090, Feb. 18, 1993]

§ 169.3

Inspection.

(a) Producers. Any producer of any
pesticide, device, or active ingredient
used in producing a pesticide which is
subject to this Act shall, upon request
of any officer or employee of the Agency or of any State or political subdivision, duly designated by the Administrator, furnish or permit such person
at all reasonable times to have access
to and to copy all records required to
be maintained by this part, including
records in the possession of an independent testing facility or laboratory
which performed tests on behalf of the

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Environmental Protection Agency

Pt. 170

producer. Such inspection will be conducted in accordance with procedures
detailed in section 8(b) of the Act.
(b) Distributors, carriers, dealers,
etc. Any distributor, carrier, dealer, or
any other person who sells or offers for
sale, delivers or offers for delivery any
pesticide, device, or active ingredient
used in producing a pesticide which is
subject to this Act, shall, upon request
of any officer or employee of the Agency or of any State or political subdivision, duly designated by the Administrator, furnish or permit such person
at all reasonable times to have access
to and copy all records showing the delivery or holding of such pesticide, device, or active ingredient used in producing a pesticide, including the quantity, the date of shipment and receipt,
and the name and address of the consignor and consignee, and any guarantee received pursuant to section
12(b)(1) of the Act.
(c) Confidentiality. Any record which
is subject to the regulations under this
part, and which may be confidential,
shall be treated in accordance with the
provisions of section 10 of the Act. The
availability to the public of information provided to, or otherwise obtained
by, the Administrator under this part
shall be governed by part 2 of this
chapter.
(d) Inability. (1) In the event of the inability of any person to produce
records containing the information required to be maintained, furnished for
inspection, or given access to, all other
records and information regarding the
same shall be provided.
(2) Where no such inability exists and
any such person fails to give access to
and permit copying of such records as
required, such failure shall be deemed a
refusal to keep records required or a refusal to allow the inspection of any
such records or both.

PART 170—WORKER PROTECTION
STANDARD

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Subpart A—General Provisions
Sec.
170.1
170.2
170.3
170.7
170.9

Scope and purpose.
Implementation and expiration dates.
Definitions.
General duties and prohibited actions.
Violations of this part.

Subpart B—Standard for Workers
170.102 Applicability of this subpart.
170.103 Exceptions.
170.104 Exemptions.
170.110 Restrictions associated with pesticide applications.
170.112 Entry restrictions.
170.120 Notice of applications.
170.122 Providing specific information about
applications.
170.124 Notice of applications to handler
employers.
170.130 Pesticide safety training for workers.
170.135 Posted pesticide safety information.
170.150 Decontamination.
170.160 Emergency assistance.

Subpart C—Standard for Pesticide
Handlers
170.202 Applicability of this subpart.
170.203 Exceptions.
170.204 Exemptions.
170.210 Restrictions during applications.
170.222 Providing specific information about
applications.
170.224 Notice of applications to agricultural employers.
170.230 Pesticide safety training for handlers.
170.232 Knowledge of labeling and site-specific information.
170.234 Safe operation of equipment.
170.235 Posted pesticide safety information.
170.240 Personal protective equipment.
170.250 Decontamination.
170.260 Emergency assistance.

Subpart D—General Provisions
§ 170.301 Scope and purpose.
§ 170.303 Applicability of this part.
§ 170.305 Definitions.
§ 170.309 Agricultural employer duties.
§ 170.311 Display requirements for pesticide
safety information and pesticide application and hazard information.
§ 170.313 Commercial pesticide handler employer duties.
§ 170.315 Prohibited actions.
§ 170.317 Violations of this part.

Subpart E—Requirements for Protection of
Agricultural Workers
§ 170.401 Training requirements for workers.
§ 170.403 Establishment-specific information
for workers.
§ 170.405 Entry restrictions associated with
pesticide applications.
§ 170.407 Worker entry restrictions after pesticide applications.
§ 170.409 Oral and posted notification of
worker entry restrictions.
§ 170.411 Decontamination supplies for workers.

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