[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR165.70]

[Page 206-209]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 165_PESTICIDE MANAGEMENT AND DISPOSAL--Table of Contents
 
 Subpart D_Standards for Repackaging Pesticide Products into Refillable 
 
Sec. 165.70  Refillers who are not registrants.

    (a) Must I comply with the standards in this section? You must 
comply with the standards in this section if you are a refiller of a 
pesticide product and you are not the registrant of the pesticide 
product.
    (b) Under what conditions can I repackage a registrant's pesticide 
product into refillable containers? A registrant may allow you to 
repackage the registrant's pesticide product into refillable containers 
and to distribute or sell such repackaged product under the registrant's 
existing registration if all of the following conditions are satisfied:
    (1) The repackaging results in no change to the pesticide 
formulation.
    (2) One of the following conditions regarding a registered refilling 
establishment is satisfied:

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    (i) The pesticide product is repackaged at a refilling establishment 
registered with EPA as required by Sec. 167.20 of this chapter.
    (ii) The pesticide product is repackaged at the site of a user who 
intends to use or apply the product by a refilling establishment 
registered with EPA as required by Sec. 167.20 of this chapter.
    (3) The registrant has entered into a written contract with you to 
repackage the pesticide product and to use the label of the registrant's 
pesticide product.
    (4) The pesticide product is repackaged only into refillable 
containers that meet the standards of subpart C of this part.
    (5) The pesticide product is labeled with the product's label with 
no changes except the addition of an appropriate net contents statement 
and the refillers EPA establishment number.
    (c) What violations are applicable to illegal repackaging? 
Repackaging a pesticide product for distribution or sale without either 
obtaining a registration or meeting all of the conditions in paragraph 
(b) of this section is a violation of section 12 of the Act. Both you 
and the pesticide product's registrant may be liable for violations 
pertaining to the repackaged product.
    (d) Am I responsible for product integrity? Yes, you are responsible 
for the pesticide product that you distribute or sell in refillable 
containers not being adulterated or different from the composition 
described in its confidential statement of formula that is required 
under FIFRA section 3.
    (e) What requirements must I follow regarding repackaging a 
pesticide product into refillable containers? You must comply with all 
of the following provisions.
    (1) Your establishment must be registered with EPA as a producing 
establishment as required by Sec. 167.20 of this chapter.
    (2) You must not change the pesticide formulation unless you have a 
registration for the new formulation.
    (3) You must repackage a pesticide product only into a refillable 
container that is identified on the description of acceptable containers 
for that pesticide product provided by the registrant.
    (4) You may repackage any quantity of a pesticide product into a 
refillable container up to the rated capacity of the container. In 
addition, there are no general limits on the size of the refillable 
containers that you can use.
    (5) You must have all of the following items at your establishment 
before repackaging a pesticide product into any refillable container for 
distribution or sale:
    (i) The written contract from the pesticide product's registrant.
    (ii) The pesticide product's label and labeling.
    (iii) The registrant's written refilling residue removal procedure 
for the pesticide product.
    (iv) The registrant's written description of acceptable containers 
for the pesticide product.
    (6) Before repackaging a pesticide product into any refillable 
container for distribution or sale, you must identify the pesticide 
product previously contained in the refillable container to determine 
whether a residue removal procedure must be conducted in accordance with 
paragraph (g) of this section. You may identify the previous pesticide 
product by referring to the label or labeling.
    (7) You must inspect each refillable container according to 
paragraph (f) of this section.
    (8) You must clean each refillable container according to paragraph 
(g) or (h) of this section, if required by either paragraph.
    (9) You must ensure that each refillable container is properly 
labeled according to paragraph (i) of this section.
    (10) You must maintain records in accordance with paragraph (j) of 
this section.
    (11) You must maintain records as required by part 169 of this 
chapter.
    (12) You must report as required by part 167 of this chapter.
    (13) The stationary pesticide containers at your establishment must 
meet the standards in Sec. 165.45(f).
    (14) You may be required to comply with the containment standards in 
subpart E of this part.
    (f) How must I inspect refillable containers? Before repackaging a 
pesticide product into any refillable container, you must visually 
inspect the exterior

[[Page 208]]

and (if possible) the interior of the container and the exterior of 
appurtenances. The purpose of the inspection is to determine whether the 
container meets the necessary criteria with respect to continued 
container integrity, required markings, and openings. If the condition 
in paragraph (f)(1) of this section exists, the container fails the 
inspection and must not be refilled unless the container is repaired, 
reconditioned, or remanufactured in compliance with the relevant DOT 
requirement. If the condition in paragraph (f)(2) or (f)(3) of this 
section exists (or both), the container fails the inspection and must 
not be refilled until the container meets the standards specified in 
subpart C of this part. The conditions are:
    (1) The integrity of the container is compromised in at least one of 
the following ways:
    (i) The container shows signs of rupture or other damage which 
reduces its structural integrity.
    (ii) The container has visible pitting, significant reduction in 
material thickness, metal fatigue, damaged threads or closures, or other 
significant defects.
    (iii) The container has cracks, warpage, corrosion or any other 
damage which might render it unsafe for transportation.
    (iv) There is damage to the fittings, valves, tamper-evident devices 
or other appurtenances that may cause failure of the container.
    (2) The container does not bear the markings required by Sec. 
165.45(a), (b) and (d), or such markings are not legible.
    (3) The container does not have an intact and functioning one-way 
valve or tamper-evident device on each opening other than a vent, if 
required.
    (g) How must I clean refillable containers? You must clean each 
refillable container by conducting the pesticide product's refilling 
residue removal procedure before repackaging the pesticide product into 
the refillable container, unless the conditions in paragraph (g)(1) of 
this section and either paragraph (g)(2) or (g)(3) of this section are 
satisfied:
    (1) If required, each tamper-evident device and one-way valve is 
intact.
    (2) The refillable container is being refilled with the same 
pesticide product.
    (3) Both of the following conditions are satisfied.
    (i) The container previously held a pesticide product with a single 
active ingredient and is being used to repackage a pesticide product 
with the same single active ingredient.
    (ii) There is no change that would cause the composition of the 
product being repackaged to differ from the composition described in its 
confidential statement of formula that is required under FIFRA section 
3. Examples of unallowable changes include the active ingredient 
concentration increasing or decreasing beyond the limits established by 
the confidential statement of formula or a reaction or interaction 
between the pesticide product being repackaged and the residue remaining 
in the container.
    (h) How must I clean a refillable container that has a broken (non-
intact) tamper-evident device or one-way valve? As required in paragraph 
(g) of this section, you must clean each refillable container that has a 
tamper-evident device or one-way valve that is not intact by conducting 
the pesticide product's refilling residue removal procedure before 
repackaging the pesticide product into the refillable container. In 
addition, other procedures may be necessary to assure that product 
integrity is maintained in such cases.
    (i) How must I label refillable containers? Before distributing or 
selling a pesticide product in a refillable container, you must ensure 
that the label of the pesticide product is securely attached to the 
refillable container such that the label can reasonably be expected to 
remain affixed during the foreseeable conditions and period of use. The 
label and labeling must comply in all respects with the requirements of 
part 156 of this chapter. In particular, you must ensure that the net 
contents statement and EPA establishment number appear on the label.
    (j) What recordkeeping must I do? You must maintain all of the 
records listed in this section in addition to the applicable records 
identified in parts 167 and 169 of this chapter. You must furnish

[[Page 209]]

these records for inspection and copying upon request by an employee of 
EPA or any entity designated by EPA, such as a State, another political 
subdivision or a Tribe.
    (1) For each pesticide product distributed or sold in refillable 
containers, all of the following records must be maintained for the 
current operating year and for 3 years after that:
    (i) The written contract from the pesticide product's registrant for 
the pesticide product.
    (ii) The written refilling residue removal procedure for the 
pesticide product.
    (iii) The written description of acceptable containers for the 
pesticide product.
    (2) Each time you repackage a pesticide product into a refillable 
container and distribute or sell the product, the following records must 
be generated and maintained for at least 3 years after the date of 
repackaging:
    (i) The EPA registration number of the pesticide product distributed 
or sold in the refillable container.
    (ii) The date of the repackaging.
    (iii) The serial number of the refillable container.