HOLLOWAY, Circuit Judge.
This tragic case arose from the mercury poisoning of four children of a New Mexico family. The source of the poison was meat from a hog which had been fed seed treated with a mercury fungicide. The plaintiffs appeal from a judgment dismissing their suit brought under the Federal Tort Claims Act, 28 U.S.C.A. §§ 1346(b), 2671 et seq., for alleged negligence on the part of Government employees in the registration for interstate sale and approval of the labeling of the fungicide pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.A. § 135 et seq.
The basic facts are not in dispute. Mr. Ernest Huckleby raised hogs as a sideline to his regular work as a janitor in the public schools of Alamogordo, New Mexico. In 1969, he and other local hog-raisers bought grain from the Golden West Seed Company in Clovis to be used as feed for their hogs. They were also given a large amount of "waste" grain which had been partially bagged and stored in a shed on the premises of Golden West. The waste grain included some seeds, pink in color, which had been treated with a mercury fungicide, Panogen 15, to protect the seed before it was planted.
The fungicide was manufactured by Morton Chemical Company, whose name was changed to Nor-Am Agricultural Products, Inc., before this litigation began. Panogen 15 was registered with, and its labeling was approved by, the Pesticides Regulation Division (PRD) of the Department of Agriculture pursuant to the provisions of FIFRA.
Some of the treated grain was mixed with garbage and fed daily to the family's hogs. One of the hogs was slaughtered in the fall of 1969 and the family began eating the meat daily. In early December the first of the Huckleby children became ill; by early January, two more children were similarly stricken, and a fourth was ultimately afflicted.
In mid-January, after an investigation by these authorities, it was determined that the Huckleby children were suffering from organic mercury
Alkyl mercury poisoning does irreversible damage to the central nervous system. It affects sight, speech, locomotion and the ability to grasp objects or otherwise use one's hands properly. The Huckleby children suffered severe permanent injuries as a result of the poisoning,
The Government denied any negligence. It also alleged that PRD employees were exercising due care in the administration of the statute and regulations and hence it was exempt from liability under the exception in 28 U.S.C.A. § 2680(a), and that liability was likewise barred by the discretionary function exception of § 2680(a).
After a lengthy trial the district court found for the Government. The court's opinion essentially found that PRD had evaluated the label in accordance with FIFRA and the regulations as far as specific label items required by the statute and regulations were concerned; that PRD had discretion in that it must make policy judgments as to necessary label contents beyond those specific requirements; that the decision on the need for further testing and investigation of the alkyl mercury compound was a determination within the discretion of the Director of PRD; and that argument as to the failure of PRD to implement the Interdepartmental Agreement was immaterial because cancellation of Panogen's registration was within the Director's discretion.
The court concluded, inter alia, that where the agency performed its duties under the statute, and where the evaluation of the label and the decision to re-register the product involved discretion, even if that discretion was abused, 28 U.S.C.A. § 2680(a) applied and the Government was immune from suit. The action was dismissed and this appeal followed.
Federal Regulation of Pesticides
FIFRA provides the basic framework for the federal regulation of "economic poisons" in interstate commerce.
The Secretary delegated his authority to the Director of PRD. 7 CFR § 362.3 (Jan. 1, 1970).
This registration was good for five years. At the end of this time the Secretary was authorized to cancel the registration, or, if requested by the applicant in accordance with the regulations, the pesticide could be re-registered for another five-year period. 7 U.S.C.A. § 135b(f) (1976 Supp.). However, at any time when an economic poison's labeling was found not to comply with the Act, the Secretary could suspend or cancel the product's registration. 7 U.S.C.A. § 135b(c) (1976).
Mercury, Methylmercury and Panogen 15
Mercury is often combined with organic chemical compounds to form what are known as "organic mercurials." These serve a wide variety of purposes. In agriculture, it was discovered that organic mercurials were effective as fungicides and that methylmercury was one of the most effective. The first reported use of an organic mercurial as a seed treatment to kill plant fungi was reported in 1913. This practice became widespread in the United States and other developed parts of the world by the 1930s.
A typical mercury fungicide will contain both active and inert ingredients. The active ingredient is often a methylmercury combined with another chemical compound in such a way that the active ingredient is then water soluble. This facilitates the fungicide's application on seeds during the treatment process. For example, the only active ingredient in Panogen 15 is Cyano(methylmercuri)guanidine which is a combination of methylmercury and guanidine. This compound comprises 2.2% of the Panogen 15 by weight. The remainder (97.8%) is made up of inert ingredients.
Panogen 15 was first registered with the Department of Agriculture in 1953 and has been re-registered several times since then, mostly recently in 1968. Panogen's registration was suspended in January, 1970, primarily due to the Huckleby incident.
The Panogen 15 sold to the Golden West Seed Company came in 54-gallon drums. The drum label shown to have been in use
Further down under the heading "Precautions" was a statement directed to persons using Panogen 15 to treat seeds. This statement referred to the contents of the tags to be placed on bags of treated seed, and it read in part:
The plaintiffs claim that these and other label components were insufficient to apprise Golden West of the possibility of food-chain poisoning, thus causing their injuries. The alleged negligence of PRD in approving Panogen's labeling is a primary part of the plaintiffs' case.
The Discretionary Function Exception
The district court's ruling was based on 28 U.S.C.A. § 2680(a), which provides that:
The controlling issues on this appeal concern only the emphasized part of § 2680(a), the discretionary function exception. We go directly to these issues since the discretionary function exception is a jurisdictional bar, if it applies. Smith v. United States, 546 F.2d 872 (10th Cir. 1976).
In challenging the adverse ruling under § 2680(a), plaintiffs argue that PRD was not engaged in the exercise of a protected discretionary function in the evaluation and choice of warning and direction language for Panogen 15 labels; that FIFRA and the regulations do not contemplate that public policy judgments will be made by PRD regarding precautionary language; that the record shows that no risk-benefit judgment was made by PRD in such evaluation and choice of the label language; and that the district court erred in finding that PRD judgment on "necessary and if complied with adequate" labeling involved a policy making choice, this finding not being supported by the record. Further, plaintiffs contend that the omissions of PRD personnel in marshalling and submitting facts to the Secretary or his surrogate for consideration of cancellation or suspension of Panogen's registration were unprotected as discretionary functions. Plaintiffs' primary reliance is placed on Griffin v. United States, 500 F.2d 1059 (3d Cir.).
Of course, Dalehite v. United States, 346 U.S. 15, 73 S.Ct. 956, 97 L.Ed. 1427, is our main guide on the discretionary function question. In holding that the functions of Government personnel involved in the nitrate fertilizer export program preceding the Texas City explosion were within the exception, the Court stated, id. at 35-36, 73 S.Ct. at 968:
Plaintiffs argue vigorously that Griffin v. United States, 500 F.2d 1059 (3d Cir.), calls for rejection of the Government's claim of immunity under § 2680(a). There the plaintiff alleged negligence in Government approval of a lot of Sabin oral polio vaccine which later proved to be substandard and produced severe injury. The Third Circuit held that the actions of HEW's Division of Biologic Standards in approving the lot of vaccine were in violation of agency regulations and that at issue was a scientific — but not policy making — determination as to whether each of the criteria listed in the regulation was met.
We agree with the reasoning and the result in the Griffin case. However, in order to determine whether these principles call for rejection of the discretionary function argument in our case, we must focus on the requirements of the statute and the regulations involved here.
There are portions of the requirements on labeling that are specific and mandatory. Here a Category I poison ("highly toxic to man") was involved and mandatory label elements included the skull and crossbones, the word "poison" prominently in red on a background of distinctly contrasting color, and a statement of an antidote for the economic poison. 7 U.S.C.A. § 135a(a)(3); 7 CFR § 362.116(b)(2) (Jan. 1, 1970). However, these parts of the labeling are not at issue on this appeal.
Instead, plaintiffs' claims of negligence and omissions concern other labeling requirements not involving such specific, mandatory items. These other requirements as to warnings, precautionary language and "directions for use" were phrased in terms of general policy standards to be applied by the agency.
In prescribing required warnings and caution statements for labels, the regulations also incorporated the same general standard, i. e., that of statements "necessary and, if complied with, adequate to prevent injury . . ."
Thus, the statute and the regulations staked out only generalized policy standards
We recognize that the Federal Tort Claims Act waives the Government's immunity in sweeping language. United States v. Yellow Cab Co., 340 U.S. 543, 547, 71 S.Ct. 399, 95 L.Ed. 523. Moreover, the exceptions to the waiver are to be narrowly construed. See Dalehite, supra, 346 U.S. at 31 & n. 24, 73 S.Ct. 956; Smith v. United States, 546 F.2d 872, 876 (10th Cir. 1976). We are admonished that in interpreting the exceptions, we should include only those circumstances within the words and reason of the exception. Dalehite, supra, 346 U.S. at 31, 73 S.Ct. 956.
We must hold here, however, that the functions on which the negligence claims are founded are within the words and reason of the exception. Evaluation of the labeling did involve scientific as well as public policy considerations, but it was not confined to a narrow scientific function such as evaluating the vaccine under specified criteria in the Griffin case. The examination of the labeling under such standards as that of "necessary and if complied with adequate for protection of the public . . ." called for a judgment in the discretionary area. See Hendry v. United States, 418 F.2d 774, 783 (2d Cir.); Coastwise Packet Co. v. United States, 277 F.Supp. 920 (D.Mass.), aff'd 398 F.2d 77 (1st Cir.), cert. denied, 393 U.S. 937, 89 S.Ct. 300, 21 L.Ed.2d 274. Therefore we must agree with the district court that the discretionary function exception applies.
A further argument made by the plaintiffs is based on the testimony of Dr. Hays, Director of PRD from 1966 to 1970. This testimony was to the effect that risk-benefit analysis, which was utilized by the agency when it made decisions on registration and cancellation of economic poisons, was not used when considering the adequacy of labels. He agreed that the best warning and most adequate directions on labels
Plaintiffs press one final argument which is unrelated to labeling but deals instead with the authority to suspend or cancel the product's registration. They contend that omissions of PRD personnel in failing to marshal and submit facts to the Secretary or his delegate for a decision on cancellation were not protected as discretionary functions. Plaintiffs say that there was nothing more than a pro forma compliance with the statute in 1968 when Panogen 15 was re-registered and thus no policy judgment was exercised at all.
We note first that the decision-making as to possible suspension or cancellation does implicate a policy choice based on substantive standards of product safety in terms of protection of the public and impact on living man. See Continental Chemiste Corp. v. Ruckelshaus, supra, 461 F.2d at 335-36. Whether such discretion is exercised and possibly abused, or whether there is a failure to exercise the discretion, such acts or omissions related to the cancellation function are within the terms of the exception provided by § 2680(a).
We feel the claims and proof relating to alleged failure to marshal and submit data to the Secretary or to his surrogate, the Director of PRD, fall in the same category.
Dalehite, supra, 346 U.S. at 36, 73 S.Ct. at 968.
In sum, we must agree with the ruling of the district court.
Appendix to follow.
Panogen 15 is recommended for the control of diseases caused by organisms carried on the seed, such as: Seed-borne stinking smut or bunt of wheat, oat smut and seed-borne oat blight
This product is toxic to fish and wildlife. Keep out of any body of water. Treated seeds exposed on soil surface will be hazardous to birds and other wildlife. Rinse equipment and containers and dispose of wastes by burying in non-crop lands away from water supplies.
Wear goggles or face shield to protect eyes from splashing while handling fungicide.
Do not breathe fumes from treated seed or from disinfectant.
Do not apply this fungicide to seed indoors unless there is thorough ventilation.
Do not handle the fungicide or treated seed with bare hands. Wash off promptly with plenty of soap and water any fungicide that accumulates on the skin.
Do not eat or smoke while using this fungicide. Wash hands before eating or smoking.
Seed treated with Panogen 15 must be labeled as follows: "This seed treated with methylmercury dicyandiamide" in 8 point or larger. The actual rate of treatment must also be stated or the words "at the rate recommended by the manufacturer." The words "Poison Treated" must appear in type not less than 1/4" in red on a white background and a skull and crossbones at least 1/2" must be shown. The statement "Do not use this seed for food, feed or oil purposes" must appear in 8 point or larger.
Treated seed should be stored in well-ventilated areas. Do not store near food or feed supplies. Do not use bags or other containers which have contained treated seed for packaging food or feed.
Keep container tightly closed except when removing contents. Store in a well-ventilated area.
Before discarding empty container wash thoroughly with water and detergent. Discard in a safe place.
Panogen 15 may be somewhat corrosive to aluminum, copper, zinc, or alloys of these metals.
Do not permit solutions of Panogen 15 to remain in contact with these metals for extended periods of time.
THIS LABEL MUST NOT BE REMOVED OR RENDERED ILLEGIBLE.
DIRECTIONS FOR USE
Seed should be cleaned and must be well cured before treatment.
Panogen 15 is delivered ready for use in any Panogen Seed Treater.
Panogen 15 can be used in other treaters designed to apply liquids at the appropriate dosage rates.
Wheat, oats, barley, rye, sorghum ............. ½ fl. oz. per bu. Cotton Acid delinted ............................ 2 fl. oz. per 100 lbs. Machine delinted ......................... 3 fl. oz. per 100 lbs. Fuzzy ................................. 4½ fl. oz. per 100 lbs. Rice .......................................... ½ fl. oz. per bu. Flax ............................................. 1½ fl. oz. per Beet seed (segmented) ...................... 4 fl. oz. per 100 lbs. Peanuts ..................................... 2¼ fl. oz./100 lbs. Safflower
*................................ 1½-2 fl. oz./100 lbs. Field corn, sweet corn ....................... 2-4 fl. oz./100 lbs. Beans, peas, soybeans **...................... 3-4 fl. oz./100 lbs.
For extended periods of storage in large bins, seed should be aerated.
IMPORTANT: READ BEFORE PURCHASE OR USE
Purchase or use of this product shall constitute acceptance of the following terms of sale. Morton Chemical Company (Morton) warrants that this product conforms to the chemical descriptions on this label and is reasonably fit for the purposes specified hereon. By way of limitation but not in derogation of the directions and statements printed on this label, Seller makes no warranty and no represent and Morton makes no further warranty or representation, expressed or implied, including but not limited to any warranty as to MERCHANTABILITY, and no agent of Morton is authorized to do so except in writing, with a specific reference to the foregoing warranty. Since neither Seller nor Morton has any control over the handling, storage, use or conditions of use of this product, Buyer or user assumes all risks and liability arising from handling, storage or use of this product under abnormal conditions or not in strict compliance with the directions and precautionary statements hereon. All claims related to the purchase, handling, storage or use of this product shall be barred unless written notice is given to Morton within 30 days after the loss is discovered. Liability of the Seller or Morton for any damages arising from a breach of this warranty shall be limited to exclude consequential commercial damages.
The son, Amos, is blind, his speech is greatly impaired, he walks with great uncertainty, and he cannot use his hands effectively. His disabilities are also permanent.
The other daughter, Ernestine, and the baby, Michael, are blind and neither can walk or talk. These conditions are permanent.
A fungicide is an economic poison. See 7 U.S.C.A. § 135(a), (d). Throughout this opinion the terms "economic poison" and "pesticide" will be used interchangeably.
The first attempt at federal regulation of pesticides was the Insecticide Act of 1910 which prohibited the interstate sale of any insecticide or fungicide which was adulterated or misbranded within the meaning of the statute. 36 Stat. 331 (1910). This Act was repealed when FIFRA was enacted in 1947. 61 Stat. 163.
The passage of FIFRA added several important components to the federal scheme of pesticide regulation including controls over label language and the requirement that an economic poison be registered with the Secretary of Agriculture before it could be marketed in interstate commerce. See generally H.Rep. 313 (80th Cong., 1st Sess.), 1947 U.S.Code & Cong.Serv., pp. 1200-06. The Act was substantially strengthened by amendments in 1964. 78 Stat. 197; and see H.Rep. 1125 (88th Cong., 2d Sess.), 1964 U.S.Code Cong. & Admin.News, pp. 2166-67. Further amendments have occurred but they came after the period with which we are concerned.
Further 7 CFR § 362.116 (Jan. 1, 1970) provided:
In particular, we note that in dealing with warnings and precautions for organic mercury compounds the regulations have a significant provision that "[d]ue to wide variation in characteristics each product must be considered individually." 7 CFR § 362.116(d) (Mercury Compounds) (iii) (Jan. 1, 1970) (Emphasis added).
See also 7 CFR § 362.105(b)(5) (Jan. 1, 1970), pertaining to directions for use, which requires that the directions include:
There is a related argument that there was further proof of negligence, unprotected by the discretionary function exception, in the failure of the Department of Agriculture to implement a "Memorandum of Agreement between Secretary of Agriculture, Secretary of the Interior, and Secretary of Health, Education and Welfare," 29 Fed.Reg. 5808 (May 1, 1964). The argument is that the Department of Agriculture failed to implement the agreement which called for exchange of information and conferences on pesticide problems. The district court did find that the agreement was never implemented with regard to Public Health Service objections to pesticides. Nevertheless, we agree with the court that the agreement did not modify the substantive provisions of FIFRA. The function of cancellation remained unchanged, and any omissions or negligence in exercising that function were protected by § 2680(a).