Monsanto v. Durnell · ¶156

Here, by contrast, Monsanto does not need the EPA’s “special permission and assistance” to add a cancer warning. Like all pesticide manufacturers, Monsanto bears primary responsibility for maintaining the warnings on its label. See Bates, 544 U. S., at 438 (“[M]anufacturers have a continuing obligation to adhere to FIFRA’s labeling requirements”). To the extent it needs the EPA’s approval at all (more on that below), all it must do is submit an application for an amended registration that reflects the labeling change, which the EPA “shall” approve as long as the change does not violate FIFRA. §136a(f )(1); see 40 CFR §152.44(a). This is a far cry from the contingent chain of approvals a generic drug manufacturer was required to secure in PLIVA.

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