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.1 By this time, state and federal health authorities had been called in to determine whether an epidemic might be starting.

In mid-January, after an investigation by these authorities, it was determined that the Huckleby children were suffering from organic mercury2 poisoning as a result of their eating the meat from the hog which had been fed the grain treated with Panogen 15.3 Thus a "food-chain" poisoning was involved.

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,4 as the district court found.

After an administrative claim was denied, plaintiffs brought this suit under the Federal Tort Claims Act.5 Their main claims of negligence were that the failure of PRD to require a label with an adequate warning of the danger of food-chain poisoning, and the failure to cancel the registration of Panogen 15 on the basis of known facts, were a proximate cause of the injuries; that the registration would have been cancelled had PRD followed an Interdepartmental Agreement among the Departments of Agriculture, Interior and HEW; and that the number of Public Health Service objections to PRD over the registration of products containing organic mercury compounds should have led to testing and investigation on the adequacy of the labels.

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.6 The Act requires that every economic poison must be registered with the Secretary of Agriculture before it can be marketed in interstate commerce. 7 U.S.C.A. § 135b(a). In order to have his product registered under the Act, an applicant had to demonstrate to the satisfaction of the Secretary7 that his economic poison is effective as claimed and that it meets the safety requirements of the Act. 7 U.S.C.A. § 135b(b).

The Secretary delegated his authority to the Director of PRD. 7 CFR § 362.3 (Jan. 1, 1970).8 In order for a product to be registered, the manufacturer was required to submit to PRD an application for registration which included copies of the proposed labeling and the results of tests which measured the product's toxicity and efficacy. 7 U.S.C.A. § 135b(a); 7 CFR § 362.10(c) (Jan. 1, 1970). The application was evaluated by three separate groups within PRD. First, the "new chemicals evaluation staff" reviewed the label for accuracy in such areas as ingredient statements, chemical composition and chemical nomenclature. Second, the "product evaluation staff" reviewed the test data and the labels for the purpose of evaluating statements on the poison's effectiveness in the control of pests and other plant diseases. Third, the "pesticides safety evaluation staff" reviewed the toxicological data relating to the product's safety with respect to man and animals, and determined which warnings and precautionary statements should be placed on the label. When the poison's labeling was approved and the Secretary found that the claims for the product were warranted, he registered the product. 7 U.S.C.A. § 135b(b).

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 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.10

The Panogen 15 sold to the Golden West Seed Company came in 54-gallon drums. The drum label shown to have been in use at about the time of these injuries is reproduced in the appendix to this opinion.11 The most pertinent parts of the label to note for our purposes are the following warnings under the caption "Caution":

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 noncrop lands away from water supplies.

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 statement 'Do not use this seed for food, feed or oil purposes' must appear in 8 point or larger.12

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 district court's ruling was based on 28 U.S.C.A. § 2680(a), which provides that:

§ 2680. Exceptions

The provisions of this chapter and section 1346(b) of this title shall not apply to

(a) Any claim based upon an act or omission of an employee of the Government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused. (Emphasis added).

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:It is unnecessary to define, apart from this case, precisely where discretion ends. It is enough to hold, as we do, that the 'discretionary function or duty' that cannot form a basis for suit under the Tort Claims Act includes more than the initiation of programs and activities. It also includes determinations made by executives or administrators in establishing plans, specifications or schedules of operations. Where there is room for policy judgment and decision there is discretion. It necessarily follows that acts of subordinates in carrying out the operations of government in accordance with official directions cannot be actionable.

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.13 Thus the discretionary function exception was held not to apply.

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.14

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.15 For example, 7 U.S.C.A. § 135(z)(2)(c) and (d) provided that an economic poison is "misbranded":

(c) if the labeling accompanying it does not contain directions for use which are necessary and if complied with adequate for the protection of the public ;

(d) if the label does not contain a warning or caution statement which may be necessary and if complied with adequate to prevent injury to living man and other vertebrate animals, vegetation, and useful invertebrate animals; (Emphasis added).

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 . . ."16

Thus, the statute and the regulations staked out only generalized policy standards for the precautions, warnings and directions for use. To enforce these standards, and give content and meaning to them, the agency was required to make policy judgments in evaluating the adequacy of the labeling. See Stearns Electric Paste Co. v. EPA, 461 F.2d 293, 310 (7th Cir.); Continental Chemiste Corp. v. Ruckelshaus, 461 F.2d 331, 336 (7th Cir.). We feel this is true as to all components of the labeling complained of by the plaintiffs the warnings, precautions and directions for use. Thus this case is unlike Griffin where scientific measurement against given specific standards was involved not a determination in general terms for the protection of the public safety.17

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 would be required "regardless of toxicity or (the) risk-benefit ratio." XVIII R. 825-26. The plaintiffs say that the testimony shows that no discretionary function was exercised with respect to labeling requirements. We cannot agree. The fact that the highest standards would be observed in judging the adequacy of labels does not alter our view that the generalized requirements for labels "necessary and if complied with adequate for protection of the public," 7 U.S.C.A. § 135(z)(2)(c), necessitated the exercise of discretionary judgment.

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.18 These actions are an integral part of the process for any possible cancellation or suspension of a registration. If we accepted plaintiffs' argument that such acts of negligence or such omissions of staff personnel are unprotected, then

. . . the protection of § 2680(a) would fail at the time it would be needed, that is, when a subordinate performs or fails to perform a causal step, each action or nonaction being directed by the superior, exercising, perhaps abusing, discretion.

Dalehite, supra, 346 U.S. at 36, 73 S. Ct. at 968.

In sum, we must agree with the ruling of the district court.19 As Judge Bratton concluded his opinion on this tragedy, he expressed these thoughts with which we are in full agreement and which we hope will move those who can do so to provide special relief:

It is with regret that the issues in this case are resolved against the plaintiffs. The Huckleby tragedy is very painful to observe, and the damage to the Huckleby children defies adequate articulation. The additional burdens placed upon the family by the accident are so great that they compel the hope that private relief will be available to this stricken family through Congressional action.

AFFIRMED.

Appendix to follow.

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE