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Pesticide Registration (PR) Notice 96-4: Label Statements Involving Product Efficacy and Potential for Harm to Property
Resources
June 3, 1996
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
ATTENTION: Persons Responsible for Federal Registration and Reregistration of Pesticide Products
SUBJECT: Label Statements Involving Product Efficacy and Potential for Harm to Property
I. INTRODUCTION
This notice explains EPA procedures in approving pesticide
labels that include claims relating to the efficacy of
agricultural pesticides and provides a warning to growers
regarding reliance on label statements regarding pesticide
efficacy. EPA is issuing this notice at this time to correct a
misunderstanding regarding the FIFRA label approval process and
efficacy claims that is reflected in a series of court decisions
concerning the preemptive effect of FIFRA.
II. LEGAL FRAMEWORK
A. Registration and the Label Approval Process
EPA approves pesticide labels in the process of registering
a pesticide under FIFRA. FIFRA specifies that EPA shall register
a pesticide if:
(1) its composition is such as to warrant the proposed
claims for it;
(2) its labeling and other material required to be submitted
comply with the requirements of this Act;
(3) it will perform its intended function without
unreasonable adverse effects on the environment; and
(4) when used in accordance with widespread and commonly
recognized practice it will not generally cause unreasonable
adverse effects on the environment.
7 U.S.C. 136c(c)(5). Although the first registration
requirement identified above mandates that EPA consider efficacy
of label claims, Congress, in 1978, explicitly gave EPA the
authority to waive that requirement. FIFRA states:
In considering an application for the registration of a
pesticide, the Administrator may waive data requirements
pertaining to efficacy, in which event the Administrator may
register the pesticide without determining that the
pesticide's composition is such as to warrant proposed
claims of efficacy.
7 U.S.C. 136c(c)(5). The legislative history explains that
Congress believed that product performance issues for
agricultural pesticides were adequately addressed by information
from government and university sources and market forces:
This authority [to waive efficacy data] will be used most
commonly with respect to agricultural pesticides, due to the
high level of knowledge concerning pesticidal efficacy that
prevails in the agricultural community, the existence of
means for communicating efficacy information to users, the
organizational expertise of the Department of Agriculture,
the extension services, and the universities in this area,
and the stake the industry has in marketing products that
are efficacious.
S. Rpt. 95-334, 95th Cong., 1st Sess. 20 (July 6, 1977).
EPA has acted under this authority to waive, by regulation,
data requirements as to efficacy issues for all agricultural
pesticides. 44 Fed. Reg. 27932, 27938 (col. 3) (May 11, 1979);
40 CFR 158.640(b)(1); see also 47 Fed. Reg. 57624 (December 27,
1982). EPA concluded that agriculture pesticides are
"effectively regulated by the marketplace," 44 Fed. Reg. 27932,
27938 (col. 3) (May 11, 1979), and that waiving review of the
efficacy of agricultural pesticides in the registration process
would enable the Agency to focus of its "primary mandate under
FIFRA": investigating "the health and safety aspects of
pesticides." 47 Fed. Reg. 53192 (November 24, 1982); 47 Fed.
Reg. 40659, 40661 (col.1) (September 15, 1982). EPA pointed to
private legal actions for damages as one factor that would ensure
that pesticide manufacturers sold an efficacious product:
"pesticide producers are aware that they are potentially subject
to damage suits by the user community if their products prove
ineffective in actual use." 47 Fed. Reg. 40659, 40661 (col.2)
(September 15, 1982).
EPA has also, by regulation, promulgated various
requirements pertaining to pesticide labels. These regulations
bar the registration of any pesticide with a misbranded label, 40
C.F.R. 152.112(f), and contain specific examples of label
statements that are considered false or misleading and thus
render a label misbranded. 40 C.F.R. 156.10(a)(5).
Additionally, the regulations have requirements for warning
statements and mandate that pesticide products have adequate use
directions. 40 C.F.R. 156.10(h) and (i).
B. State Preemption Under FIFRA
FIFRA permits states broad authority to regulate pesticides
but makes it unlawful for states that undertake such regulation
to "impose or continue in effect any requirements for labeling or
packaging in addition to or different from those required under
this Act." 7 U.S.C. 136v(b). A number of federal court
decisions have held that this preemption of state authority as to
pesticide labels bars damage claims in state court by growers
against pesticide manufacturers. The courts have reasoned that
allowing such a claim by a grower would be, in effect, permitting
the state to impose label requirements "in addition to or
different from" the federally-approved label.
III. LABEL APPROVAL AND PESTICIDAL EFFICACY
There have been several recent preemption decisions
involving claims by growers concerning pesticidal efficacy or
property damage caused by a pesticide. For example, in Taylor Ag
Industries v. Pure-Gro, 54 F.3d 555 (9th Cir. 1995), several
growers sued the manufacturers and distributor of a pesticide
that the growers alleged had damaged their cotton crop even
though they had applied the pesticide according to the label
directions. The court denied the growers' claims on the ground
that allowing recovery of damages would interfere indirectly with
EPA's "rigorous label-approval process." Id. at 560. In
Welchert v. American Cyanamid, Inc., 59 F.3d 69 (8th Cir. 1995),
and Worm v. American Cyanamid, Inc. 5 F.3d 744 (4th Cir. 1993),
growers sued a pesticide manufacturer seeking recovery for harm
to crops allegedly caused when the manufacturer's herbicide
remained in the soil and damaged rotated crops. Both courts
dismissed the growers' claims noting that EPA's labeling
regulations required instructions on rotational crop
restrictions. The courts reasoned that to permit such lawsuits
"would be to allow state courts to sit, in effect, as super-EPA
review boards that could question the adequacy of the EPA's
determination of whether a pesticide registrant successfully
complied with the specific labeling requirements of its own
regulations." Welchert, 59 F.3d at 73; Worm, 5 F.3d at 749.
These court decisions are based on the premise that, in
approving labels for agricultural pesticides, EPA examines, or at
least has the obligation to examine, the efficacy of the
pesticide and related issues such as the potential for the
pesticide to cause property damage. The courts, however, have
not taken into account the plain language of the statute on this
issue and have misinterpreted the thrust of EPA's regulations.
As noted above, in actual fact, EPA, with Congress' approval,
stopped evaluating pesticide efficacy for routine label approvals
almost two decades ago. Further, as explained below, EPA's
regulations do not require a review of efficacy of property
damage issues for agricultural pesticides.
EPA's labeling regulations must be interpreted in light of
the statutory requirements for registration and EPA's waiver of
the requirement for efficacy data on agricultural pesticides.
Because efficacy data is not reviewed as part of the registration
of agricultural pesticides, it would be incorrect to contend that
the label approval process involves an examination of the
efficacy of the pesticide. Rather, the label approval process is
centered on the issue of the whether label, including the
specification of use sites and the directions for use on the
label, meets the core requirement for registration: that the
pesticide not cause "unreasonable adverse effects on the
environment." That term is defined as "any unreasonable risk to
man or the environment . . . ." 7 U.S.C. 136(bb).
Accordingly, the primary focus in the label approval process for
agricultural pesticides involves assessing and regulating the
potential risks to humans and the environment posed by such
pesticides.
To this end, EPA applies the requirements in its labeling
regulations with an eye to risk not efficacy issues. This is
illustrated by how EPA applies label requirements regarding
pesticide use sites and directions for the use of pesticides
including directions concerning rotational crops. Label
regulations require that pesticide use sites (e.g., specific
crops, animals, etc.) be listed on the label because assessment
of the dietary risk of pesticides is based on the foods that
legally may contain the pesticide, and, under FIFRA, the label
establishes the legal limits on use of a pesticide. 7 U.S.C.
136j(a)(2)(G). Use sites are not reviewed as to the pesticide's
efficacy for those crops. The label regulations address the
directions for use of a pesticide for the purpose of insuring
that pesticide applicators and farmworkers are adequately
protected. Additionally, directions for use establish legal
limits as to the amounts of pesticide that may be applied and
thus allow EPA to control and estimate dietary exposure. EPA
does not check to see whether application equipment mentioned in
directions for use will be harmed or whether other property
damage might occur. For example, the label regulations on
directions for use specify that rotation crop restrictions are
required when needed "to prevent unreasonable adverse effects
upon the environment." 40 C.F.R. 156.10(i)(2)(x). Such
restrictions are needed for certain pesticides to prevent uptake
of residual pesticide residues from the soil into crops for which
the pesticide is not registered. EPA's concern is that the
consumption of the rotated crop would increase dietary exposure
to the pesticide residue. Rotational crop restrictions are not
reviewed to determine if the rotated crop would be injured by the
residual pesticide residues.
An additional requirement for registration, noted above, is
that the pesticide's labeling comply with the Act. Separately,
EPA, by regulation, has required that labeling not be misbranded.
40 C.F.R. 152.112(f). However, these registration requirements
should not be read as reintroducing efficacy concerns into the
label approval process. Having directly given EPA the authority
to disregard efficacy issues, Congress could not have intended
that, once EPA exercised this authority, the same efficacy issues
would come in through the back door of the label approval
process. Under the statute and its regulations, EPA still must
determine in registering a pesticide if the pesticide's label
complies with FIFRA or is misbranded but, unless EPA reinstates
the requirement to submit efficacy data (either generally or with
regard to a particular pesticide), that compliance and
misbranding inquiry will generally not extend to the evaluation
of the efficacy of the pesticide.
Efficacy and property damage issues are at times relevant to
the continued registration of a pesticide. FIFRA's "unreasonable
adverse effects" standard requires EPA to take into account
"economic, social, and environmental costs and benefits of the
use of any pesticide." 7 U.S.C. 136(bb). A pesticide's
efficacy and its potential to cause property damage are factors
to be considered in determining the economic benefit a pesticide
provides to farmers. However, in light of EPA's waiver of the
efficacy data requirement for initial registration, these issues
would generally only arise following the registration of the
pesticide, including approval of the pesticide label. For
example, if a pesticide manufacturer were to learn that one its
registered pesticides was causing property damage, the
manufacturer would be obligated to report that information under
section 6(a)(2) of the statute. 7 U.S.C. 136c(a)(2).
Additionally, if EPA discovers new risk concerns with an already-
registered pesticide, it might examine efficacy data with regard
to the pesticide in making an evaluation under the unreasonable
adverse effects standard to determine if the product's
registration should be cancelled or suspended.
IV. CONCLUSION
EPA hopes this Notice will be useful to courts, the
regulated community, and pesticide users. EPA believes this
Notice should be helpful to courts in preemption cases that
involve EPA's labeling regulations. For example, some courts
have mistakenly assumed that EPA's labeling regulations
concerning the directions for use of a pesticide have an efficacy
component. Further, other courts have erroneously concluded that
because a pesticide label contained warnings regarding property
damage that EPA had necessarily evaluated such warnings and found
them to be truthful and adequate. As to registrants and
applicants for registration, this Notice is intended to confirm
that EPA has not altered its regulation relating to the waiver of
efficacy data requirements for the registration of agricultural
pesticides. Finally, as to pesticide users this Notice is
intended to clarify that EPA's approval of a pesticide label does
not reflect any determination on the part of EPA that the
pesticide will be efficacious or will not damage crops or cause
other property damage.
Daniel M. Barolo
Director, Office of Pesticide Programs