The EPA document outlines regulations for portable refillable containers and repackaging of pesticide products. It discusses requirements for markings, tamper-evident devices, one-way valves, and compliance with DOT standards. The regulations establish new conditions for registrants to authorize repackaging and require them to provide residue removal and acceptable container information to refillers. Implementation of the rules in 2011 will impact many non-compliant minibulks currently in use. Outstanding issues include clarifying durable marking and one-way valve standards.

1. 1 EPA’s Pesticide Container Regulations Requirements for Portable Refillable Containers & Repackaging

2. Outline Overview of Container-Containment Regulations Requirements for Portable Refillable Containers (“Minibulks”) and Repackaging Implications/Issues 2

3. 3 1. Overview of Container-Containment Regulations

4. 4 Overview: Purpose of the Rule Containers Minimize human exposure during container handling Facilitate container disposal and recycling Encourage use of refillable containers

5. Schedule of Compliance Dates August 16, 2009 Nonrefillable containers: Registrants ensure that their nonrefillable containers comply with container standards Containment: Retailers, commercial applicators & custom blenders must have secondary containment around large stationary tanks and containment pads for dispensing areas August 16, 2010 Labels: Registrants ensure that labels have required statements and pesticide users follow container-related directions on label August 16, 2011 Refillable containers: Registrants ensure that their refillable containers comply with container standards Repackaging: Registrants authorize refillers to repackage product and develop & provide certain info to refillers. Refillers obtain & follow registrant info; also inspect, clean & label refillable containers 5

6. Scope – Which Products? All pesticide products other than manufacturing use products, plant-incorporated protectants, and exempt antimicrobials must comply with the refillable container (Subpart C) and repackaging (Subpart D) regulations. 6

7. Scope – Partial Exemption Partial exemption - Antimicrobial pesticides used in swimming pools (if not totally exempt) are exempt from certain requirements: Marking One-way valve/tamper-evident device Repackaging recordkeeping Inspection and cleaning criteria related to marking, one-way valve, and tamper-evident devices. 7

8. Scope - Exemptions The refillable container & repackaging regulations 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. Containers that hold gaseous pesticides. Custom blending. 8

9. 9 2. Requirements for Portable Refillable Containers & Repackaging

10. Refillable Containers Applicability DOT standards Marked with serial number/code Tamper-evident device or one-way valve on each opening “Bulk” tanks: vent and shut-off valve; no sight gauge 10

11. The first question will pertain to: Applicability 11

12. 12 1. Which company/companies do the refillable container regulations identify as being responsible for ensuring that a minibulk meets the standards in the refillable container regulations? The registrant of the pesticide product sold in the minibulk The refiller who repackaged the pesticide product into the minibulk A and B None of the above [§165.40(b)(1)]

13. Answer to Question 1 The registrant of the pesticide product sold in the minibulk. §165.40(b)(1) states that registrants must comply with all of the refillable container requirements and that their products must be sold or distributed in refillable containers (including minibulk and bulk containers) that meet the standards of these regulations. 13

15. FIFRA: Registrant is responsible for pesticide product, which includes the formulation, label and container. So, ultimately the registrant is responsible. 14

16. The following slides will pertain to: Applicability DOT Requirements 15

17. DOT Requirements: Background The pesticide container regulations refer to and adopt some of the Department of Transportation (DOT) Hazardous Materials Regulations. Some - not all - pesticide products are DOT hazardous materials. 16

18. DOT Requirements: Background DOT defines 9 classes of hazardous materials. Common ones for pesticides are: Class 3 – flammable or combustible liquids Class 6.1 – poisonous materials Class 8 – corrosive materials DOT also defines 3 different packing groups (PGs) within the classes. 17

19. DOT Requirements: Background DOT’s Hazardous Materials Regulations cover many topics and requirements that the container regulations do not adopt, such as: Shipping papers, labeling, placarding, emergency response info, carrier requirements (rail, aircraft, vessel, air) Pesticide container regulations focus on packaging, marking and continued qualification/maintenance requirements. 18

20. DOT Requirements and Refillable Container Regulations If a pesticide product is a DOT hazardous material, it must comply with applicable DOT regulations. If a pesticide product is not a DOT hazardous material, it must be packaged in a refillable container that is designed, constructed, and marked to comply with the basic integrity, testing, and other cross-referenced DOT regulations at packing group III level. 19

21. DOT/United Nations Marking In DOT regulations, marking with UN symbol: Can only be used if package fully conforms with requirements - 49 CFR 178.3(b) Certifies that all requirements are met – 49 CFR 178.2(b) A limited number of refillable containers comply with the DOT packing group III standards but are not required to have marking 20

22. The following questions will pertain to: Applicability DOT Requirements Marking 21

23. 22 2a. Does this minibulk meet the marking requirement in §165.45(d)? Why or why not? 2b. If the number was not included in the bottom photo, would this marking comply with the requirement in §165.45(d)? Why or why not?

24. Answer to Question 2a The marking includes a serial number. The issue is whether this sticker counts as durable marking. The examples of durable marking in the reg text are: etching, embossing, ink jetting, stamping, heat stamping, mechanically attaching a plate, molding and marking with durable ink. Durable is “able to withstand wear and tear or decay; lasting.” EPA will have to issue an interpretation this. The sticker is different than the examples provided but probably meets the definition of durable. 23

25. Answer to Question 2b Yes, this marking would still comply. §165.45(d) requires “a serial number or other identifying code…” A bar code counts as an “other identifying code,” although there is still the issue about whether this is durable marking. 24

26. The next set of questions will pertain to: Applicability DOT Requirements Marking Tamper-Evident Device/One-Way Valve 25

27. 26 3. What is the definition of tamper-evident device? (See §165.3.)

28. Answer to Question 3 A tamper-evident device is a device which can be visually inspected to determine if a container has been opened. 27

29. 28 4. These photos show several openings on minibulk containers. Do these comply with §165.45(e)?

30. Answer to Question 4 Yes, each opening (other than a vent) has a tamper-evident device. So the containers comply with the requirement to have a tamper-evident device, a one-way valve, or both. 29

31. 30 5. What is the definition of one-way valve? (See §165.3.)

32. Answer to Question 5 A one-way valve means a valve that is designed and constructed to allow virtually unrestricted flow in one direction and no flow in the opposite direction, thus allowing the withdrawal of material from, but not the introduction of material into, a container. 31

33. 32 6. The valve at the bottom of this minibulk is not a one-way valve. (There is a tamper-evident device on the valve.) Does this minibulk comply with the requirement in §165.45(e)?

34. Answer to Question 6 Yes, the opening has a tamper-evident device, so it complies with the requirement to have a tamper-evident device, a one-way valve, or both. 33

35. 34 7. The end user has to break the tamper-evident device to remove pesticide from the minibulk through this valve. When the minibulk is returned, would the refiller have to clean the minibulk before refilling it with the same pesticide product? (See §165.70(g) and (h).) Why or why not?

36. Answer to Question 7 Yes, the refiller would have to rinse the container even if he refills it with the same product. The container does not meet the criterion in §165.70(g)(1): “If required, each tamper-evident device and one-way valve is intact.” The user could have put another material in the container, which could cause cross-contamination. . 35

37. 36 8. This refillable container has a tamper-evident device on the “fill” opening near the front of the container. For the large opening in the center, the end user has a specially-designed device that connects to this opening, which is the only way to remove pesticide product from this opening. The device has a one-way valve in it. Does this container comply with §165.45(e)?

38. Answer to Question 8 Yes,§165.45(e) says that the one-way valve may be located in a device or system separate from the container if the device or system is the only foreseeable way to withdraw pesticide from the container. 37

39. 38 Repackaging Registrants Authorize refillers to repackage their product;develop and provide certain information Refillers Obtain and follow registrant info Inspect, clean, and label containers

40. 39 Bulk Policy vs. Repackaging Regulations The conditions for a registrant to allow an independent refiller to repackage its product are set out in §165.67(b) for registrants and in §165.70(b) for independent refillers. These conditions are intended to assure that the purposes of registration would be satisfied, as in the 1977 Bulk Policy. In addition, other requirements in the repackaging regulations revise or change criteria in the Bulk Policy. The Bulk Policy will be rescinded when the repackaging regulations go into effect in August 2011.

41. 40 Repackaging Regs vs. Bulk Policy 9. For each of the conditions for allowing repackaging by an independent refiller (see §165.67(b) & §165.70(b)), assess whether the condition is the same as, similar to or different than the Bulk Policy. The repackaging results in no change to the pesticide formulation. The pesticide product is repackaged at a refilling establishment registered with EPA as required by § 167.20 of this chapter OR the product is repackaged by a registered refilling establishment at the site of a user who intends to use or apply the product.

42. 41 Repackaging Regs vs. Bulk Policy 9. (cont.) For each of the conditions for allowing repackaging by an independent refiller, assess whether the condition is the same as, similar to or different than the Bulk Policy. The registrant and independent refiller have entered into a written contract to repackage the pesticide product and to use the product’s label. The pesticide product is repackaged only into refillable containers that meet the refillable container standards. 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.

43. Answer to Question 9 No change in formulation – same At or by a registered establishment – same Entered into a written contract – similar; Bulk Policy allows “written authorization” Refillable container that complies with regs – different (new) Labeled appropriately - same 42

45. Adequate to ensure product integrity 43

47. Must identify container(s) by specifying materials of construction that are compatible & information to confirm compliance with refillable container regs44

48. 3. Implications/Issues 45

49. Implications There are many minibulks currently being used that do not meet the refillable container requirements: DOT PG III standards Marking Tamper-evident device/one-way valve Registrant’s description of acceptable containers 46

50. Implications Can those minibulks be used after August 16, 2011? If minibulk does not comply with DOT PG III standards – No, it cannot be used. Can the tank be retrofitted to comply with marking (serial number) and tamper-evident device/one-way valve requirement? Is the container included on the registrant’s list of acceptable container? Will the container pass the visual inspection? 47

51. Implications If containers cannot be used, they should be safely recycled or disposed of. While outside the scope of the regs, EPA wants to support minibulk recycling to the extent possible: EPA HQ: Education, provide information, answer questions, on-going discussions, etc. Region 5: Project to develop guidance for properly preparing minibulks for recycling Region 9: Project to support minibulk recycling program 48

52. Issues Outstanding questions: Clarify “durable marking” for serial number Definition/standards for one-way valves Is a pump an opening and, if so, do existing pumps comply with the requirement for one-way valves and tamper-evident devices? Many questions about DOT requirements 49

53. Contact Information EPA web site: http://www.epa.gov/pesticides/regulating/containers.htm Nancy Fitz, 703-305-7385 Jeanne Kasai, 703-308-3240 David Stangel, 202-564-4162 Email: last name.first name@epa.gov, e.g., fitz.nancy@epa.gov 50