EPA730-N-96-002
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JUH 3 1996
OFFICE OF
PREVENTION. PESTICIDES AND
TOXIC SUBSTANCES
Pesticide Regulation (PR) NOTICE 96-4
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND.REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION:
SUBJECT:
Persons Responsible for Federal Registration and Reregistration of Pesticide
Products
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.
Recyclsd/Rocyclabla .Printed with Vegetable Oil Based Inks on 100% Recycled Paper (40% Postconsumer)
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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
1 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 ; 1, 1979), 40. CFR
lS8.640(b)(l>rsee 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.l) (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 CFR. §
152.112(f), and contain specific examples of label statements that are considered false or
misleading and thus render a label misbranded. 40 CFR. § 156.10(a)(5). Additionally, the
regulations have requirements for warning statements and mandate that pesticide products have
adequate use directions. 40 CFR. § 156.10(h) and (i).
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B. .State Preemption Under FIFRA. ' ' -
FIFRA permits states br,o,ad 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." 7U.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 Gvanamid. 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 effecf, as
super-EPA review boards that could question the adequacy ofthe 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-749:1 . " - '> v.: .'
f. . '. Bother. .cases inyo lying, crop dam^gg ..that v Goy-rts-i. have =;at .;.-;
least "part iaily dismissed, on ,'the grpund ,of, .FIFRA !p;reempti,p.n,. ;. ...,,
include: ''Miller V; : E . I .' bupbrit " De JSTemours " &' Co . ,_ '&80 F.' Sy.pp'.,, ,]',
" ~ " ' '* "'
_ .
47 ' {.S-.-lJ-y 'Miss i; l'9-9!^-) '' -(dartiage^ to crops)"; ~lh re" Pup6nt-Benia£e' ,
>B;3:tiaation; 859 F.' S'lipp, -"619- ;(D.! Puerto" Rib'o : isg^O-'Xsame-) > ' ' : ' "'
Ail&-sta.te,--tlns.urance Go:*.; -vj, P0o.lt itoei-Product's'-, .Jnfa 'j /'> 8 4'6 F- : Supp .' '
499 (E.D. La. 1994), ; (damage, caused' .by , fire1 aijd: .expl-osion). ;,; '"',; .<'
Trinity Mountain Seed :1Co . y..-. MSP. Acryet ..-. ,844, F,..;.SfUpp>.- '597 . (Df ;.
Idaho ig'g^r^j damage, caused- 'tq seed .potatoes). ;'. ,. Quad. . R, Farms , v;, ,.:,:
Attterican :-Cv'a!natn'id 'Co i."J." '84:6' F^ 'Suppl 694'"' (D/ 'Mip.nA J.993),. '.(damage V; .
to rotated crop); Casper v. E.I, du Pont de Nembu'fs & Cof: JB'06 F.
Supp. 903 (E.D. Wash. 1992) (damage to crops) ; Clubine v. American
CVanamid. Co. , , .SS^.^N.W.^d. 385- ; (Iowa a-995') (s'stme)"-; Wa'd'lin'crtdn'- v".
Miles. Inc-.... 1995; .Te.nn... .Ap.p.,,» ILEXIS;;(7.$a, ;(Gt.:' App .; '-.IS 95) ^(termite :=
infestation damage); Goodwin v. Bacon, 127 Wash. 2d 50, 896 P.2d
673 (1995) (damage to crops) .
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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 Congress1 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 CFR. § 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.
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40 CFR. § 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 EP As 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
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