Pesticide Registration (PR) Notice 84-1: Clarification of Label Improvement Program for Farmworker Safety and Pesticide Storage and Disposal Instructions
Notice:Pesticide Registration Notice (PR) 2007- 4 superseeds part of this document. Consult PR 2007- 4, Section V. "Effect on Previously Issued PR Notices" for specific information.
February 17, 1984
Notice To: Manufactures, Formulators, Distributors, and Registrants of Pesticides
Attention: Persons Responsible for Federal Registration of Pesticides
Subject: Clarification of Label Improvement Program for Farmworker Safety and Pesticide Storage and Disposal Instructions
This is intended to clarify the Agency's intentions regarding the Pesticide Label Improvement Program (LIP) for Farmworker Safety (PR Notice 83-2) and Pesticide Storage and Disposal Instructions (PR Notice 83-3) issued on March 26, 1983.
I. Revision to PR Notice 83-2 - Farmworker Safety
EPA received numerous inquiries relating to the compliance date for labeling. Specifically, registrants asked for clarification of the term "released for shipment", since the definition contained in the PR Notice appeared to conflict with that contained in Policy and Criteria Notice (PCN) 2030.1. EPA's intent in PR Notice 83-2 regarding "release for shipment" was to be consistent with P.N. 2030.1. To eliminate confusion, the Compliance Section of the PR Notice (III. page 5) is revised to delete the phrase "that is, out of the registrants physical possession." The new language for this section is as follows:
"It is the responsibility of the registrants to ensure that the labels of their products, including distributor products, contain specific instructions pertaining to farm worker safety. Existing stocks of products in channels of trade prior to December 31, 1984, need not be relabeled. All products released for shipment on or after December 31, 1984, must meet the requirements of this Notice, or they will be deemed to be misbranded under FIFRA Section 2(q)(1)(G). Failure to revise product labeling in accordance with this Notice may result in the initiation of cancellation proceedings."
In developing this directive, EPA fully intended that affected products which have been released for shipment into channels of commerce before December 31, 1984 would not be required to meet the terms of the PR Notice. All affected products that are released for shipment after that date must meet the requirements of the PR Notice.
II. Clarification of PR Notice 83-3 - Pesticide Storage and Disposal Instructions
A. Consistency with RCRA Requirements
Some commenters noted that the hazardous waste related statements in PR Notice 83-3 were unnecessary since most products covered by the Notice are exempt from the Resource Conservation and Recovery Act (RCRA) pursuant to RCRA's small generator, farmer, and household exemptions. It is true that RCRA exempts most of the products covered by this notice from its hazardous waste regulations. However, 40 CFR Part 165, promulgated under FIFRA, contains recommendations intended to assure that storage and disposal of pesticide products is done in a manner which protects the public health and safety. Thus, the statements in the notice are necessary to improve consistency of labeling as mandated under FIFRA, even for those products which would otherwise be exempt under RCRA.
B. Institutional and Industrial Products
Several comments received noted that the PR Notice identifies specific label statements for household use products and that these statements may be equally applicable to certain industrial and institutional products. EPA intended to include under the household use section of the PR Notice, those products which have "domestic uses," as defined in 40 CFR 162.3(m)(1-4) and products whose use patterns and container size are similar to those defined as "domestic use." Thus, for the purposes of this PR Notice, the definition for household use patterns includes products which are marketed in containers sizes similar to products intended for household use, and are used in public areas such as office buildings, retail stores, hotels, and schools, and hospital patient care areas, as well as products intended for use in home gardens and lawns.
C. Alternative Generic Disposal Label Statements for Household/Domestic Use Products
A large number of commenters noted that the language for the disposal statements used in PR Notice 83-3 were not appropriate for many of the household/domestic use products and that registrants would have to resort to the label amendment process. They voiced a concern that the use of the label amendment process for such a large number of products would overwhelm EPA's limited resources and lengthen the review time to the point that it would be impossible for registrants to comply with the compliance deadline. Many of the comments received also emphasized that the most commonly recognized practice for disposing of household/domestic use products was by municipal trash collection. To promote a more efficient transition for revising product labeling, one commenter proposed using more specific language such as the following generic disposal statement:
"Do not reuse empty container (bottle, can, bucket). Wrap (container) and put in trash."
The agency agrees that this statement is an acceptable alternative for disposal instructions for household/domestic use products marketed in containers 1 gallon or less for liquids (except for bleach products up to 1 1Ú2 gallons) and 5 pounds or less for dry material (except for lawn fertilizer-herbicide products up to 25 pounds). Thus, no application for amended registration or notification to the Agency will be required if you choose to use either the exact wording contained in the alternative generic disposal statement or the language specified in PR Notice 83-3 for household/domestic use products.
D. Approval of Alternative Label Language
Even with the option of using generic label language regarding storage and disposal instructions for household/domestic use products, many commenters contend that a large number of registrants would still have to propose alternative language for these and other products and submit it for approval under the label amendment process. These commenters state that approval of alternative language does not require the level of review as with other label amendments and can be handled more efficiently through an exchange of letters than submission of a formal amendment. The Agency agrees. Therefore, while registrants proposing alternative label language must submit it to EPA for prior approval, they will not be required to submit an application for amended registration (EPA Form 8570-1). Requests proposing alternative language pertaining to storage and disposal instructions for household/domestic use products should be submitted in letter format and directed to the appropriate Product Manager in the Registration Division.
E. Extension of Compliance Deadline for Household/Domestic Use Products
Many commenters noted that the label instructions for disposal of household/domestic use pesticides should not be treated under disposal standards designed for other pesticides. They contend that household/domestic use products are not as hazardous in terms of introducing additional risks into the environment because they are disposed of by municipal trash collection rather than being discharged directly into the environment. They also pointed out that because the disposal of household/domestic use products is not as hazardous as with other pesticide products, the compliance deadline could be extended without an appreciable increase in risk. Thus by extending the compliance deadline, the economic burden of revising product labels could be reduced, since industry costs would be spread over a longer period of time.
EPA agrees that the disposal risks for household/domestic use products are different from those for other pesticides and that the economic burden to industry may be reduced by extending the compliance deadline for label instructions about storage and disposal for these products without any appreciable increase in risk. Thus, the compliance date for all household/domestic use products is extended from December 31, 1984 until December 31, 1985. All household/domestic use products released for shipment after December 31, 1985 must meet the requirements of PR Notice 83-3 and those specified in this Notice or they will be deemed to be misbranded under FIFRA Section 2 (q)(1)(g).
F. Relationship of PR Notice to Registration Standards
The Storage and Disposal requirements listed in this PR Notice reflect the Agency's latest thinking regarding the adequacy of such statements. Thus, the statements supersede similar statements contained in previously issued Registration Standard guidance packages. However, in some cases, the label statements in previously issued Registration Standards have been determined to either replace portions of PR Notice 83-3 or to be used in addition to the requirements of PR Notice 83-3. The statements are listed in Attachment A to this Notice. Storage and disposal statements contained in Registration Standards guidance packages issued after March 26, 1983 take precedence over the applicable storage and disposal statements contained in PR Notice 83-3.
III. Issuance of Subsequent Label Improvement Program Notices
It is RD's policy to minimize the number of overlapping compliance dates for label changes to the maximum extent possible. If it becomes necessary to issue another Label Improvement Program directive before December 31, 1984, or December 31, 1985 for storage and disposal statements on household/domestic use products, the compliance dates for PR Notice 83-2 and 83-3 for those products affected by the subsequent Notice will be extended to the compliance date of the subsequent Notice.
IV. Further Information
Questions on this Notice may be directed to the appropriate Product Manager or Richard King, Program Coordination Staff, Registration Division, at (703) 557-0592.
The Notice was signed:
Douglas D. Campt, Director
Registration Division (TS - 767)
List of Registration Guidance Packages Which Have Label Language That Takes Precedence over Applicable Storage and Disposal Statements Contained in PR Notice 83-3.
|Chemical||Statement in Registration Standard||Remarks|
|Aspon||Label must be modified to include a warning against transporting or storage in unlined steel containers.||Unique to Aspon; these statements take precedence over storage guidelines in the PR Notice.|
|Terrazole||All manufacturing use products must contain the statement, 'This product is corrosive to steel and many other metals. Do not transport or store in unlined metal containers."||Unique to Terrazole; these statements take precedence over the storage guidelines in the PR Notice for manufacturing use products only.|
|This product is a Restricted Use Product and must bear the precautionary statement, "Not for use or storage in or around inhabited areas."||This statement must be used in addition to the storage guidelines in the PR Notice.|
|Ethoxyquin||Storage and disposal instructions must bear this statement, "Open dumping is prohibited."||This statement must be used in addition to the disposal statement listed in the PR Notice.|
|Store only in cool, dry locked, and ventilated room. Protect from moisture, open flames or heat.||This statement is in addition to the Storage Guidelines in the PR Notice.|
Humans and Domestic Animals Statement
|Store in a dry place. Do not store around the home.||These statements are in addition to the Storage Guidelines in the PR Notice.|
Storage and Disposal
|Keep this product in a tightly dosed container, when not in use. Store in cool dry, well-ventilated area away from heat or open flame. In case of decomposition, isolate container (if possible) and flood area with large amounts of water to dissolve all material before discarding this container but place in trash collection. Do not contaminate food or feed by storage, disposal, or cleaning of equipment.||Unique to Sodium and Calcium hypochlorite salts. These statements take precedence over the Storage and Disposal guidance in PR Notice 83-3.|
Precautionary label language listed in Registration Standards for use in section of the label other than Storage and Disposal (e.g. Environmental Hazards, use restrictions, and special use patterns) may not be used in place of the labeling requirements for storage and disposal instructions listed in the PR Notice.