PRN 96-3: Pesticide Products Used to Disinsect Aircraft
May 14, 1996
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
Attention: Persons Responsible for Federal Registration and Reregistration of Pesticide Products
Subject: Pesticide Products Used to Disinsect Aircraft
This Notice specifies labeling changes for any pesticide product (insecticide) used for disinsecting aircraft. Based on incident information associated with the use of insecticide spray products being used in occupied aircraft cabins, the Agency has concluded that, in order to remain in compliance with the requirements of the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA), registrants of insecticide sprays registered for use in any portion of aircraft should revise the labeling for such products according to the requirements described in this Notice. Registrants who choose to revise labeling in accordance with this Notice should submit amendments or notifications to EPA within 90 days of date of issuance of this Notice.
All insecticides within the scope of the Notice distributed or sold by registrants and supplemental registrants should bear labeling which is consistent with this Notice by October 1, 1997. All products distributed or sold by persons other than registrants or supplemental registrants after October 1, 1999 should bear revised labeling required by this Notice. Products which do not comply with these dates are subject to enforcement action under FIFRA sections 12 and 14.
The Agency has received information which raises questions concerning the potential human health risks associated with the use of insecticide spray products in occupied aircraft cabins. In addition, the Agency doubts that the benefits associated with this use exceed the risks of such use. The Agency believes that the use of insecticide spray products in occupied cabins may result in unreasonable adverse effects on the environment. Products that pose unreasonable adverse effects to the environment do not meet FIFRA's standard for registration, and are subject to cancellation under section 6(b) of the statute.
Attachment A lists insecticide products which are known to be registered for use in aircraft. While a few products are registered specifically for occupied aircraft cabins, most are registered for cargo holds and areas other than cabins. However, some products have labeling which does not specifically state where the product may be applied in the aircraft; such products conceivably could be applied in occupied cabins. To protect the public from possible unreasonable adverse effects from exposure to insecticides applied in occupied aircraft cabins, the Agency is adopting the policy specified in Section III.
The requirements of this Notice apply to any end-use insecticide product registered for disinsecting aircraft.
Policy And Requirements
To prevent unnecessary risks to aircraft passengers, the Agency will not register disinsecting products for use in occupied aircraft cabins unless data submitted and accepted by the Agency demonstrate that the use in occupied aircraft cabins does not pose unreasonable adverse effects to the environment. In addition, EPA will require that all labels of insecticide products registered for aircraft be carefully worded to make clear where the product may or may not be applied.
Registrants of disinsection products with labels that explicitly permit use in occupied cabins and who seek to continue that use must generate data and/or provide relevant information to demonstrate that the use in occupied cabins does not pose unreasonable adverse effects to human health. Such registrants will receive a data call-in within 90 days from issuance of this Notice. The Agency expects that such a data call-in will include requests for information on both the risks associated with use of insecticide products in occupied aircraft cabins and the benefits associated with such use. Alternatively, a registrant of a product which is registered for use in occupied aircraft cabins may choose one of the following options to eliminate that use of the product and avoid the requirement to submit data:
The Agency believes that the incremental costs of making the label changes specified above are outweighed by the benefits of ensuring the proper use of these particular registered pesticides.
- For products registered for use in aircraft other than in occupied cabins, include in the Directions for Use the statement: "Do not use in aircraft cabins." Remove all contradictory language.
- Delete all aircraft uses from the label. Registrants of products which are registered for use in aircraft in areas other than occupied aircraft cabins should assure that their labeling is clear as to where the product may be used and should adopt the labeling statement in Option 1. above as well. Alternatively, a registrant may delete the aircraft use from the product altogether as in Option 2. above.
What To Do To Comply
Registrants who are subject to this notice and who do not intend to retain a product's use in occupied aircraft cabins should take one of the following actions within 90 days of issuance of this Notice:
- Amend the product labeling according to option 1 of Section III of this Notice by submitting an Application for Registration denoting "Notification" on the form (EPA Form 8570-1), a copy of the revised labeling and a certification statement. A photocopy of the EPA application form is acceptable; an original form is not needed. The following certification statement should appear on the application: "Notification of label change per PR Notice 96-3."
"This notification is consistent with the provision of PR Notice 96-3 and EPA regulations at 40 CFR 152.46, and no other changes have been made to the labeling or the confidential statement of formula of this product. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if this notification is not consistent with the terms of PR Notice 96-3 and 40 CFR 152.46, this product may be in violation of FIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 of FIFRA."
Changes in label text should be clearly marked so that they can be photocopied. The Agency will screen a Notification within 30 days of receipt and inform the registrant if the submission cannot be processed as a Notification. If the registrant chooses option 1 no other label changes may be made at the same time.
- Amend the product labeling delete all aircraft uses (option 2) by submitting an application for amended registration and five copies of the proposed labeling, identifying the requested changes. The application for amendment must be accepted by the Agency prior to sale or distribution of the product with the amended label.
If no response is received within 90 days for any insecticide product on the attached list or which otherwise bears aircraft use, EPA will issue a data call-in to the registrant of that product or any other insecticide spray product which can reasonably be interpreted to be used in occupied aircraft.
Final printed labeling must be submitted as part of the amendment or notification process, or separately in accordance with PR Notice 82-2, before the product with the revised label may be distributed in commerce.
Products covered by this Notice, but found not to be in compliance, may be subject to cancellation or enforcement action as appropriate.
All insecticides within the scope of the Notice distributed or sold by registrants and supplemental registrants should bear labeling which is consistent with this Notice by October 1, 1997. All products distributed or sold by persons other than registrants or supplemental registrants after October 1, 1999 should bear revised labeling required by this Notice. Products which do not comply with these dates are subject to enforcement action under FIFRA sections 12 and 14
Listing of Insecticide Products Used in Aircraft
We removed the list of products that was originally included with this notice. The list was outdated and could be confusing.