Distribution date: 13 April 2007 | Final date for Comment: 24 April 2025

EPA is considering amendments to the current pesticide establishment and production regulations promulgated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to other related FIFRA regulations as needed for producers of PIPs. PIPs are pesticidal substances that are intended to be produced and used in a living plant, or the produce thereof, and the genetic material necessary for the production of such a pesticidal substance, and also include any inert ingredient contained in the plant, or the produce thereof. Given these characteristics, it is possible that PIPs may not be produced in the manner contemplated when the current establishment and production regulations were promulgated for other types of pesticide. In this ANPRM, the Agency provides a list of the general regulatory provisions applicable to PIPs that EPA is considering amending and solicits public comment on the completeness of the list and the scope of any potential changes to these regulations.

Products Covered: Plant-incorporated-protectants (HS:  2920; ICS:  65.100, 13.020)

Regulation Type: Regular notification

Distribution date: 17 April 2007 | Final date for Comment: 24 April 2025

This proposed rule would except from the definitions of "pesticide chemical" and "pesticide chemical residue" under FFDCA section 201(q), food packaging (e.g. paper and paperboard, coatings, adhesives, and polymers) that is treated with a pesticide as defined in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) section 2(u). As a result, such ingredients in food packaging treated with a pesticide would be exempt from regulation under FFDCA section 408 as pesticide chemical residues. Further, a food that bears or contains such ingredients would not be subject to enforcement by the Food and Drug Administration (FDA) under section 402(a)(2) (B) of the FFDCA since the ingredients would no longer be pesticide chemical residues. Instead, such ingredients would be subject to regulation by the FDA as food additives under FFDCA section 409. FDA generally regulates such food additives in food packaging as food contact substances under FFDCA, section 409(h). This proposed rule would expand the scope of the provision in 40 CFR 180.4 which currently applies only to food packaging impregnated with an insect repellent - one type of pesticide. This proposed rule, as with the rule it would amend, only applies to the food packaging materials themselves; it would not otherwise limit EPA's FFDCA jurisdiction over pesticides or limit FDA's jurisdiction over substances subject to FDA regulation as food additives. EPA, in consultation with FDA, and FDA believe this rule would eliminate the duplicative FFDCA jurisdiction and economise federal government resources while continuing to protect human health and the environment. Even after this rule is finalized, under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA would continue to regulate the food packaging as an inert ingredient of the pesticide product and regulate the pesticide active ingredient in the treated food packaging under both FIFRA and the FFDCA. The text of this proposed rule is identical to a direct final rule EPA issued on 6 December 2006. EPA received several comments opposing that direct final rule and therefore withdrew the rule on 25 January 2007, consistent with EPA policy. EPA is now issuing the rule as a proposal for public comment.

Products Covered: Pesticides (HS:  3808;  ICS:  65.100, 67.230, 67.250)

Regulation Type: Regular notification

Distribution date: 17 April 2007 | Final date for Comment: 24 April 2025

This proposed rule would except from the definitions of "pesticide chemical" and "pesticide chemical residue" under FFDCA section 201(q), food packaging (e.g. paper and paperboard, coatings, adhesives, and polymers) that is treated with a pesticide as defined in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) section 2(u). As a result, such ingredients in food packaging treated with a pesticide would be exempt from regulation under FFDCA section 408 as pesticide chemical residues. Further, a food that bears or contains such ingredients would not be subject to enforcement by the Food and Drug Administration (FDA) under section 402(a)(2) (B) of the FFDCA since the ingredients would no longer be pesticide chemical residues. Instead, such ingredients would be subject to regulation by the FDA as food additives under FFDCA section 409. FDA generally regulates such food additives in food packaging as food contact substances under FFDCA, section 409(h). This proposed rule would expand the scope of the provision in 40 CFR 180.4 which currently applies only to food packaging impregnated with an insect repellent - one type of pesticide. This proposed rule, as with the rule it would amend, only applies to the food packaging materials themselves; it would not otherwise limit EPA's FFDCA jurisdiction over pesticides or limit FDA's jurisdiction over substances subject to FDA regulation as food additives. EPA, in consultation with FDA, and FDA believe this rule would eliminate the duplicative FFDCA jurisdiction and economise federal government resources while continuing to protect human health and the environment. Even after this rule is finalized, under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA would continue to regulate the food packaging as an inert ingredient of the pesticide product and regulate the pesticide active ingredient in the treated food packaging under both FIFRA and the FFDCA. The text of this proposed rule is identical to a direct final rule EPA issued on 6 December 2006. EPA received several comments opposing that direct final rule and therefore withdrew the rule on 25 January 2007, consistent with EPA policy. EPA is now issuing the rule as a proposal for public comment.

Products Covered: Pesticides (HS:  3808;  ICS:  65.100, 67.230, 67.250)

Regulation Type: Regular notification

Distribution date: 19 April 2007 | Final date for Comment: 24 April 2025

To require pre-export testing for norovirus on all consignments of frozen oysters, whether in whole-shell, half-shell or oyster meat. The competent authorities of the exporting countries are to certify that the consignments to be exported to Singapore have been tested and found free of norovirus. This is in addition to the current requirements of a health certificate to be issued by a relevant Government authority stating that: (a) the oysters were harvested from approved waters and processed in an approved establishment/plant in a sanitary and hygienic manner; (b) the oysters have not been treated with chemical preservatives and additives injurious to health; and (c) the product is fit for human consumption.

Products Covered: Frozen whole-shell oyster, frozen half-shell oyster and frozen oyster meat under HS 03071010 & 03071020

Regulation Type: Regular notification

Distribution date: 19 April 2007 | Final date for Comment: 24 April 2025

To require pre-export testing for norovirus on all consignments of frozen oysters, whether in whole-shell, half-shell or oyster meat. The competent authorities of the exporting countries are to certify that the consignments to be exported to Singapore have been tested and found free of norovirus. This is in addition to the current requirements of a health certificate to be issued by a relevant Government authority stating that: (a) the oysters were harvested from approved waters and processed in an approved establishment/plant in a sanitary and hygienic manner; (b) the oysters have not been treated with chemical preservatives and additives injurious to health; and (c) the product is fit for human consumption.

Products Covered: Frozen whole-shell oyster, frozen half-shell oyster and frozen oyster meat under HS 03071010 & 03071020

Regulation Type: Regular notification

Distribution date: 20 April 2007 | Final date for Comment: 24 April 2025

This draft Decision of Council of Ministers schedules the permission of the import of the waste included in the “Green list” for recycling, which is in accordance with the Directive 94/721/EC on the supervision and control of shipments of waste within, into and out of the European Community. Regardless of whether or not wastes are included on this list, they may not be moved as green wastes if they are contaminated by other materials to an extent which: (a) increases the risks associated with the waste sufficiently to render it appropriate for inclusion in the amber or red lists, or (b) prevents the recovery of the waste in an environmentally sound manner.

Products Covered: Green list of waste that will be allowed to be moved within, imported into and exported out of the European Community

Regulation Type: Regular notification

Distribution date: 20 April 2007 | Final date for Comment: 24 April 2025

This draft Decision of Council of Ministers schedules the permission of the import of the waste included in the “Green list” for recycling, which is in accordance with the Directive 94/721/EC on the supervision and control of shipments of waste within, into and out of the European Community. Regardless of whether or not wastes are included on this list, they may not be moved as green wastes if they are contaminated by other materials to an extent which: (a) increases the risks associated with the waste sufficiently to render it appropriate for inclusion in the amber or red lists, or (b) prevents the recovery of the waste in an environmentally sound manner.

Products Covered: Green list of waste that will be allowed to be moved within, imported into and exported out of the European Community

Regulation Type: Regular notification

Distribution date: 25 April 2007 | Final date for Comment: 24 April 2025

EPA is proposing to exempt from Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements plant-incorporated protectants derived from plant viral coat protein genes (PVCP-PIPs) when the PVCP-PIP meets specified criteria. EPA is proposing this exemption because the Agency believes that the PVCP-PIPs covered by this exemption would be of a character which is unnecessary to be subject to FIFRA in order to carry out the purposes of the Act.

Products Covered: Protectants Derived From Plant Viral Coat Protein (PVCP-PIPs) Gene(s) (HS:  2920;  ICS:  65.100, 13.020)

Regulation Type: Regular notification

Distribution date: 25 April 2007 | Final date for Comment: 24 April 2025

EPA is proposing to exempt from Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements plant-incorporated protectants derived from plant viral coat protein genes (PVCP-PIPs) when the PVCP-PIP meets specified criteria. EPA is proposing this exemption because the Agency believes that the PVCP-PIPs covered by this exemption would be of a character which is unnecessary to be subject to FIFRA in order to carry out the purposes of the Act.

Products Covered: Protectants Derived From Plant Viral Coat Protein (PVCP-PIPs) Gene(s) (HS:  2920;  ICS:  65.100, 13.020)

Regulation Type: Regular notification

Distribution date: 25 April 2007 | Final date for Comment: 24 April 2025

EPA is proposing to exempt from the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 requirement of a tolerance, residues of coat proteins from viruses that naturally infect plants that humans consume when such coat proteins are produced in living plants as part of a plant-incorporated protectant (PIP) and the criteria proposed for this exemption are met. EPA believes there is a reasonable certainty that no harm will result from aggregate exposure to such residues, including all anticipated dietary exposures and all other exposures for which there is reliable information. This proposed exemption would eliminate the need to establish a maximum permissible level in food for these residues.

Products Covered: Plant Viral Coat Proteins (HS:  2920;  ICS:  65.100)

Regulation Type: Regular notification