2VAC5-690-150. Refillers who are not registrants.

Part IV. Standards for Repackaging Pesticide Products into Refillable Containers

2VAC5-690-110. General provisions.

A. The regulations in Part IV (2VAC5-690-110 et seq.) of this chapter establish requirements for repackaging some pesticide products into refillable containers for distribution or sale.

B. The following persons must comply with the regulations in Part IV of this chapter:

1. A registrant who distributes or sells a pesticide product in refillable containers;

2. A registrant who distributes or sells pesticide products to a refiller that is not part of the registrant's company for repackaging into refillable containers; or

3. A refiller of a pesticide product that is not the registrant of the pesticide product.

Each pesticide product that is subject to the regulations in Part IV of this chapter as set out in 2VAC5-690-120 and that is distributed or sold in a refillable container must be distributed or sold in compliance with the standards of these regulations.

Statutory Authority

§ 3.2-3906 of the Code of Virginia; 40 CFR Part 165.

Historical Notes

Derived from Virginia Register Volume 30, Issue 6, eff. January 2, 2014.

2VAC5-690-120. Scope of pesticide products included.

A. The regulations in Part IV (2VAC5-690-110 et seq.) of this chapter do not apply to manufacturing use products as defined in 40 CFR 158.153(h).

B. The regulations in Part IV of this chapter do not apply to plant-incorporated protectants as defined in 40 CFR 174.3.

C. The regulations in Part IV of this chapter do not apply to a pesticide product if it satisfies all of the following conditions:

1. The pesticide product meets one of the following two criteria:

a. The pesticide product is an antimicrobial pesticide as defined in § 2(mm) of FIFRA (7 USC § 136(mm)); or

b. The pesticide product (i) is intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and (ii) in the intended use is subject to a tolerance under § 408 of the Federal Food, Drug, and Cosmetic Act (21 USC § 346a) or a food additive regulation under § 409 of the Federal Food, Drug, and Cosmetic Act (21 USC § 348).

2. The labeling of the pesticide product includes directions for use on a site in at least one of the following antimicrobial product use categories: food handling/storage establishments premises and equipment; commercial, institutional, and industrial premises and equipment; residential and public access premises; medical premises and equipment; human drinking water systems; materials preservatives; industrial processes and water systems; antifouling coatings; wood preservatives; or swimming pools.

3. The pesticide product is not a hazardous waste as set out in 40 CFR Part 261 when the pesticide product is intended to be disposed.

4. EPA has not specifically determined that the pesticide product must be subject to the regulations in Part IV of this chapter to prevent an unreasonable adverse effect on the environment according to the provisions of subsection F of this section.

D. For the purposes of Part IV of this chapter, an antimicrobial swimming pool product is a pesticide product that satisfies both of the following conditions:

1. The pesticide product is intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime.

2. The labeling of the pesticide product includes directions for use on only a site or sites in the antimicrobial product use category of swimming pools.

E. An antimicrobial swimming pool product that is not exempt by subsection A, B, or C of this section must comply with all of the regulations in Part IV of this chapter except for the following requirements:

Requirement	Requirement for registrants who distribute or sell directly in refillable containers	Requirement for refillers who are not registrants
Recordkeeping specific to each instance of repackaging	2VAC5-690-130 J 2	2VAC5-690-150 K 2
Container inspection: criteria regarding a serial number or other identifying code	2VAC5-690-130 F 2	2VAC5-690-150 G 2
Container inspection: criteria regarding one-way valve or tamper-evident device	2VAC5-690-130 F 3	2VAC5-690-150 G 3
Cleaning requirement: criteria regarding one-way valve or tamper-evident device	2VAC5-690-130 G 1	2VAC5-690-150 H 1
Cleaning if the one-way valve or tamper-evident device is not intact	2VAC5-690-130 H	2VAC5-690-150 I

F. As established in 40 CFR 165.63(e), EPA may determine that an antimicrobial pesticide product otherwise exempted must be subject to the regulations in Part IV of this chapter.

G. The regulations in Part IV of this chapter apply to all pesticide products other than manufacturing use products, plant-incorporated protectants, and antimicrobial products that are exempt under subsection C of this section. Antimicrobial products covered under subsection E of this section are subject to the regulations indicated in that subsection.

H. In this section, the term "pesticide product" or "pesticide" refers only to a pesticide product or a pesticide that is subject to the regulations in Part IV of this chapter as described in subsections A through G of this section.

1. The regulations in Part IV of this chapter do not apply to transport vehicles that contain pesticide in pesticide-holding tanks that are an integral part of the transport vehicle and that are the primary containment for the pesticide.

2. Custom blending is not subject to the regulations in Part IV of this chapter.

3. The regulations in Part IV of this chapter do not apply to containers that hold pesticides that are gaseous at atmospheric temperature and pressure.

Statutory Authority

§ 3.2-3906 of the Code of Virginia; 40 CFR Part 165.

Historical Notes

Derived from Virginia Register Volume 30, Issue 6, eff. January 2, 2014.

2VAC5-690-130. Registrants who distribute or sell pesticide products in refillable containers.

A. In this section, the term "pesticide product" or "pesticide" refers only to a pesticide product or a pesticide that is subject to the regulations in Part IV of this chapter as described in 2VAC5-690-120 A through G.

B. Any registrant who distributes or sells pesticide products in refillable containers and any registrant who conducts all of the repackaging for a pesticide product and does not distribute or sell the pesticide product to a refiller that is not part of the registrant's company for repackaging into refillable containers must comply with this section. Any registrant that repackages a product directly into refillable containers for sale or distribution and also sells or distributes other quantities of that product to an independent refiller for repackaging must meet the requirements in this section for those quantities the registrant distributes or sells directly and the requirements in 2VAC5-690-140 for those quantities that the registrant distributes or sells to an independent refiller.

C. A registrant is responsible for the pesticide product that the registrant distributes or sells in refillable containers not being adulterated or different from the composition described in its confidential statement of formula that is required under § 3 of FIFRA (7 USC § 136a).

D. For each pesticide product distributed or sold in refillable containers, the registrant must develop both of the following documents in writing.

1. The registrant must develop a refilling residue removal procedure that describes how to remove pesticide residue from a refillable container (portable or stationary pesticide container) before it is refilled.

a. The refilling residue removal procedure must be adequate to ensure that the composition of the pesticide product does not differ at the time of its distribution or sale from the composition described in its confidential statement of formula that is required under § 3 of FIFRA (7 USC § 136a).

b. If the refilling residue removal procedure requires the use of a solvent other than the diluent used for applying the pesticide as specified on the labeling under "Directions for Use," or if there is no diluent used for application, the refilling residue removal procedure must describe how to manage any rinsate resulting from the procedure in accordance with applicable federal and state regulations.

2. The registrant must develop a description of acceptable refillable containers (portable or stationary pesticide containers) that can be used for distributing or selling that pesticide product.

a. An acceptable container is one that the registrant has determined meets the standards in Part III (2VAC5-690-70 et seq.) of this chapter and is compatible with the pesticide formulation intended to be distributed and sold using the refillable container.

b. The registrant must identify the containers by specifying the container materials of construction that are compatible with the pesticide formulation and specifying information necessary to confirm compliance with the refillable container requirements in Part III of this chapter.

E. A refiller at a registrant's establishment that repackages a pesticide product into refillable containers for distribution or sale must comply with all of the following provisions.

1. The establishment must be registered with EPA as a producing establishment as required by 40 CFR 167.20.

2. The refiller must not change the pesticide formulation unless the refiller has a registration for the new formulation.

3. The refiller must repackage a pesticide product only into a refillable container that is identified on the registrant's description of acceptable containers for that pesticide product.

4. The refiller 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 the refiller can use.

5. The refiller must have all of the following items at the establishment before repackaging a pesticide product into any refillable container for distribution or sale:

a. The pesticide product's label and labeling;

b. The written refilling residue removal procedure for the pesticide product; and

c. The written description of acceptable containers for the pesticide product.

6. Before repackaging a pesticide product into any refillable container for distribution or sale, the refiller must identify the pesticide product previously contained in the refillable container to determine whether a residue removal procedure must be conducted in accordance with subsection G of this section. The refiller may identify the previous pesticide product by referring to the label or labeling.

7. The refiller must inspect each refillable container according to subsection F of this section.

8. The refiller must clean each refillable container according to subsection G or H of this section, if required by either subsection.

9. The refiller must ensure that each refillable container is properly labeled according to subsection I of this section.

10. The establishment must maintain records in accordance with subsection J of this section.

11. The establishment must maintain records as required by 40 CFR Part 169.

12. The establishment must report as required by 40 CFR Part 167.

F. Before repackaging a pesticide product into any refillable container, a refiller at a registrant's establishment must visually inspect the exterior 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 subdivision 1 of this subsection exists, the container fails the inspection and must not be refilled unless the container is repaired, reconditioned, or remanufactured in compliance with the relevant USDOT requirement. If the condition in subdivision 2 or 3 of this subsection (or both) exists, the container fails the inspection and must not be refilled until the container meets the standards specified in Part III of this chapter. The conditions are:

1. The integrity of the container is compromised in at least one of the following ways:

a. The container shows signs of rupture or other damage that reduces its structural integrity;

b. The container has visible pitting, significant reduction in material thickness, metal fatigue, damaged threads or closures, or other significant defects;

c. The container has cracks, warpage, corrosion, or any other damage that might render it unsafe for transportation; or

d. 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 2VAC5-690-90 B through E, 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. A refiller at a registrant's establishment 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 subdivisions 1 and either 2 or 3 of this subsection 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:

a. 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.

b. 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 § 3 of FIFRA (7 USC § 136a). 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. As required in subsection G of this section, a refiller at a registrant's establishment must clean each refillable container that has a tamper-evident device that is not intact 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. Before distributing or selling a pesticide product in a refillable container, a refiller 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 40 CFR Part 156. In particular, the refiller must ensure that the net contents statement and EPA establishment number appear on the label.

J. Each establishment of a registrant that repackages a pesticide product into refillable containers for distribution or sale must maintain all of the records listed in this section in addition to the applicable records identified in 40 CFR Part 167 and 40 CFR Part 169. The establishment must furnish these records for inspection and copying within 72 hours of request by an employee of VDACS.

1. For each pesticide product distributed or sold in refillable containers, both of the following records must be maintained for the current operating year and for three years afterwards:

a. The written refilling residue removal procedure for the pesticide product; and

b. The written description of acceptable containers for the pesticide product.

2. Each time a refiller at a registrant's establishment repackages a pesticide product into a refillable container and distributes or sells the product, the following records must be generated and maintained for at least three years after the date of repackaging:

a. The EPA registration number of the pesticide product distributed or sold in the refillable container;

b. The date of the repackaging; and

c. The serial number or other identifying code of the refillable container.

Statutory Authority

§ 3.2-3906 of the Code of Virginia; 40 CFR Part 165.

Historical Notes

Derived from Virginia Register Volume 30, Issue 6, eff. January 2, 2014.

2VAC5-690-140. Registrants who distribute or sell pesticide products to refillers for repackaging.

B. A registrant who distributes or sells pesticide products to a refiller that is not part of the registrant's company for repackaging into refillable containers must comply with the standards in this section.

C. A registrant may allow a refiller 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:

a. The pesticide product is repackaged at a refilling establishment registered with EPA as required by 40 CFR 167.20.

b. The pesticide product is repackaged by a refilling establishment registered with EPA as required by 40 CFR 167.20 at the site of a user who intends to use or apply the product.

3. The registrant has entered into a written contract with the refiller 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 Part III (2VAC5-690-70 et seq.) of this chapter.

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 refiller's EPA establishment number.

D. Repackaging a pesticide product for distribution or sale without either obtaining a registration or meeting all of the conditions in subsection C of this section is a violation of § 12 of FIFRA (7 USC § 136j). Both the registrant and the refiller that is repackaging the registrant's pesticide product under written contract with the registrant may be liable for violations pertaining to the repackaged product.

E. A registrant that allows a refiller to repackage the registrant's product as specified in subsection C of this section must provide the written contract referred to in subdivision C 3 of this section to the refiller before the registrant distributes or sells the pesticide product to the refiller.

F. A registrant is responsible for the pesticide product that the registrant distributes or sells to a refiller that is not part of the registrant's company for repackaging into refillable containers not being adulterated or different from the composition described in its confidential statement of formula that is required under § 3 of FIFRA (7 USC § 136a).

G. For each pesticide product distributed or sold in refillable containers, the registrant must develop both of the following documents in writing.

b. If the refilling residue removal procedure requires the use of a solvent other than the diluent used for applying the pesticide as specified on the labeling under "Directions for Use," or if there is no diluents used for application, the refilling residue removal procedure must describe how to manage any rinsate resulting from the procedure in accordance with applicable federal and state regulations.

2. The registrant must develop a description of acceptable refillable containers (portable or stationary pesticide containers) that can be used for distributing or selling that pesticide product.

a. An acceptable container is one that the registrant has determined meets the standards Part III of this chapter and is compatible with the pesticide formulation intended to be distributed and sold using the refillable container.

H. A registrant must provide the refiller with all of the following information and documentation before or at the time of distribution or sale of the registrant's pesticide product to the refiller:

1. The registrant's written refilling residue removal procedure for the pesticide product;

2. The registrant's written description of acceptable containers for the pesticide product; and

3. The pesticide product's label and labeling.

I. A registrant must maintain all of the records listed in this section for the current operating year and for three years afterwards. A registrant must furnish these records for inspection and copying within 72 hours of request by an employee of VDACS:

1. Each written contract entered into with a refiller for repackaging the registrant's pesticide product into refillable containers;

2. The registrant's written refilling residue removal procedure for the pesticide product; and

3. The registrant's written description of acceptable containers for the pesticide product.

Statutory Authority

§ 3.2-3906 of the Code of Virginia; 40 CFR Part 165.

Historical Notes

Derived from Virginia Register Volume 30, Issue 6, eff. January 2, 2014.

2VAC5-690-150. Refillers who are not registrants.

B. A refiller of a pesticide product that is not the registrant of the pesticide product must comply with the standards in this section.

1. The repackaging results in no change to the pesticide formulation.

2. One of the following conditions regarding a registered refilling establishment is satisfied:

a. The pesticide product is repackaged at a refilling establishment registered with EPA as required by 40 CFR 167.20.

b. The pesticide product is repackaged by a refilling establishment registered with EPA as required by 40 CFR 167.20 at the site of a user who intends to use or apply the product.

3. The registrant has entered into a written contract with the refiller 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 Part III (2VAC5-690-70 et seq.) of this chapter.

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 refiller's EPA establishment number.

D. Repackaging a pesticide product for distribution or sale without either obtaining a registration or meeting all of the conditions in subsection C of this section is a violation of § 12 of FIFRA (7 USC § 136j). Both the refiller and the pesticide product's registrant may be liable for violations pertaining to the repackaged product.

E. A refiller is responsible for the pesticide product that the refiller distributes or sells in refillable containers not being adulterated or different from the composition described in its confidential statement of formula that is required under § 3 of FIFRA (7 USC § 136a).

F. A refiller must comply with all of the following provisions.

1. The refiller's establishment must be registered with EPA as a producing establishment as required by 40 CFR 167.20.

2. The refiller must not change the pesticide formulation unless the refiller has a registration for the new formulation.

3. The refiller 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.

5. The refiller must have all of the following items at the refiller's establishment before repackaging a pesticide product into any refillable container for distribution or sale:

a. The written contract referred to in subdivision C 3 of this section from the pesticide product's registrant;

b. The pesticide product's label and labeling;

c. The registrant's written refilling residue removal procedure for the pesticide product; and

d. 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, the refiller must identify the pesticide product previously contained in the refillable container to determine whether a residue removal procedure must be conducted in accordance with subsection H of this section. The refiller may identify the previous pesticide product by referring to the label or labeling.

7. The refiller must inspect each refillable container according to subsection G of this section.

8. The refiller must clean each refillable container according to subsection H or I of this section, if required by either subsection.

9. The refiller must ensure that each refillable container is properly labeled according to subsection J of this section.

10. The refiller must maintain records in accordance with subsection K of this section.

11. The refiller must maintain records as required by 40 CFR Part 169.

12. The refiller must report as required by 40 CFR Part 167.

13. The stationary pesticide containers at the refiller's establishment must meet the standards in 2VAC5-690-90 G.

14. The refiller may be required to comply with the containment standards in Part V (2VAC5-690-160 et seq.) of this chapter.

G. Before repackaging a pesticide product into any refillable container, a refiller must visually inspect the exterior 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 subdivision 1 of this subsection exists, the container fails the inspection and must not be refilled unless the container is repaired, reconditioned, or remanufactured in compliance with the relevant USDOT requirement. If the condition in subdivision 2 or 3 of this subsection (or both) exists, the container fails the inspection and must not be refilled until the container meets the standards specified in Part III (2VAC5-690-70 et seq.) of this chapter. The conditions are the following:

1. The integrity of the container is compromised in at least one of the following ways:

a. The container shows signs of rupture or other damage that reduces its structural integrity;

b. The container has visible pitting, significant reduction in material thickness, metal fatigue, damaged threads or closures, or other significant defects;

c. The container has cracks, warpage, corrosion, or any other damage that might render it unsafe for transportation; or

d. 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 2VAC5-690-90 B through E, 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.

H. A refiller 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 subdivisions 1 and either 2 or 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.

a. 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.

I. As required in subsection H of this section, a refiller must clean each refillable container that has a tamper-evident device that is not intact 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.

J. Before distributing or selling a pesticide product in a refillable container, a refiller 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 40 CFR Part 156. In particular, a refiller must ensure that the net contents statement and EPA establishment number appear on the label.

K. A refiller must maintain all of the records listed in this section in addition to the applicable records identified in 40 CFR Part 167 and 40 CFR Part 169. A refiller must furnish these records for inspection and copying within 72 hours of request by an employee of VDACS.

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 three years after that:

a. The written contract from the pesticide product's registrant for the pesticide product;

b. The written refilling residue removal procedure for the pesticide product; and

c. The written description of acceptable containers for the pesticide product.

2. Each time a refiller repackages a pesticide product into a refillable container and distributes or sells the product, the following records must be generated and maintained for at least three years after the date of repackaging:

a. The EPA registration number of the pesticide product distributed or sold in the refillable container;

b. The date of the repackaging; and

c. The serial number or other identifying code of the refillable container.

Statutory Authority

§ 3.2-3906 of the Code of Virginia; 40 CFR Part 165.

Historical Notes

Derived from Virginia Register Volume 30, Issue 6, eff. January 2, 2014.

Website addresses provided in the Virginia Administrative Code to documents incorporated by reference are for the reader's convenience only, may not necessarily be active or current, and should not be relied upon. To ensure the information incorporated by reference is accurate, the reader is encouraged to use the source document described in the regulation.

As a service to the public, the Virginia Administrative Code is provided online by the Virginia General Assembly. We are unable to answer legal questions or respond to requests for legal advice, including application of law to specific fact. To understand and protect your legal rights, you should consult an attorney.