[8] If petitioners' claim is that the DBS made a determination that Orimune complied with regulatory standards, but that the determination was incorrect, the question of the applicability of the discretionary function exception requires a somewhat *545 different analysis. In that event, the question turns on whether the manner and method of determining compliance with the safety standards at issue involve agency judgment of the kind protected by the discretionary function exception. [FN11] Petitioners contend that the determination involves the application of objective scientific standards, see Brief for Petitioners 16-17, whereas the Government asserts that the determination incorporates considerable "policy judgment," Brief for United States 36. In making these assertions, the parties have framed the issue appropriately; application of the discretionary function exception to the claim that the determination of compliance was incorrect hinges on whether the agency officials making that determination permissibly exercise policy choice. The parties, however, have not addressed this question in detail, and they have given us no indication of the way in which the DBS interprets and applies the regulations setting forth the criteria for compliance. Given that these regulations are particularly abstruse, we hesitate to decide the question on the scanty record before us. We therefore leave it to the District Court to decide, if petitioners choose to press this claim, whether agency officials appropriately exercise policy judgment in determining that a vaccine product complies with the relevant safety standards. Page 10 judgment of the kind that the discretionary function exception protects. B The regulatory scheme governing release of vaccine lots is distinct from that governing the issuance of licenses. The former set of regulations places an obligation on manufacturers to examine all vaccine lots prior to distribution to ensure that they comply with regulatory standards. See 21 CFR 546 § 610.1 (1978). [FN12] These regulations, however, do not impose a corresponding duty on the Bureau of Biologics. Although the regulations empower the Bureau to examine any vaccine lot and prevent the distribution of a noncomplying lot, see 21 CFR § 610.2(a) (1978), they do not require the Bureau to take such action in all cases. The regulations generally allow **1964 the Bureau to determine the appropriate manner in which to regulate the release of vaccine lots, rather than mandating certain kinds of agency action. The regulatory scheme governing the release of vaccine lots is substantially similar in this respect to the scheme discussed in United States v. Varig Airlines, 467 U.S. 797, 104 S.Ct. 2755, 81 L.Ed.2d 660 (1984). FN12. The citation is to the regulation in effect at the time Lederle Laboratories released the lot of Orimune containing Kevan Berkovitz's dose. None of the regulations governing the release of vaccine lots has changed significantly since that time. The current regulations dealing with this subject have the same title and section numbers as the regulations cited in the text. [9] Given this regulatory context, the discretionary function exception bars any claims that challenge the Bureau's formulation of policy as to the appropriate way in which to regulate the release of vaccine lots. Cf. id., at 819-820, 104 S.Ct., at 27672768 (holding that discretionary function exception barred claim challenging FAA's decision to establish a spot-checking program). In addition, if the policies and programs formulated by the Bureau allow room for implementing officials to make independent Copr. West 1996 No claim to orig. U.S. govt. works 26-755 97-19 WESTLAW 108 S.Ct. 1954 (Cite as: 486 U.S. 531, *546, 108 S.Ct. 1954, **1964) policy judgments, the discretionary function exception protects the acts taken by those officials in the exercise of this discretion. Cf. id., at 820, 104 S.Ct., at 2767-2768 (holding that discretionary function exception barred claim that employees charged with executing the FAA's spot-checking program made negligent policy judgments respecting the proper inspection of airplanes). The discretionary function exception, however, does not apply if the acts complained of do not involve the permissible exercise of policy discretion. Thus, if the Bureau's policy leaves no room for an official to exercise policy judgment in performing a given act, or if the act simply does *547 not involve the exercise of such judgment, the discretionary function exception does not bar a claim that the act was negligent or wrongful. Cf. Indian Towing Co. v. United States, 350 U.S., at 69, 76 S.Ct., at 126-127 (holding that a negligent failure to maintain a lighthouse in good working order subjected the Government to suit under the FTCA even though the initial decision to undertake and maintain lighthouse service was a discretionary policy judgment). [10] Viewed in light of these principles, petitioners' claim regarding the release of the vaccine lot from which Kevan Berkovitz received his dose survives the Government's motion to dismiss. Petitioners allege that, under the authority granted by the regulations, the Bureau of Biologics has adopted a policy of testing all vaccine lots for compliance with safety standards and preventing the distribution to the public of any lots that fail to comply. Petitioners further allege that notwithstanding this policy, which allegedly leaves no room for implementing officials to exercise independent policy judgment, employees of the Bureau knowingly approved the release of a lot that did not comply with safety standards. App. 13; Brief for Petitioners 20-21; Reply Brief for Petitioners 15-17. Thus, petitioners' complaint is directed at a governmental action that allegedly involved no policy discretion. Petitioners, of course, have not proved their factual allegations, but they are not required to do so on a motion to dismiss. If those allegations are correct--that is, if the Bureau's See policy did not allow the official who took the challenged action to release a noncomplying lot on the basis of policy considerations--the discretionary function exception does not bar the claim. (FN13] Because petitioners may yet show, 548 on the basis of materials obtained in discovery or otherwise, that the conduct challenged here did not involve the permissible exercise of policy discretion, the invocation of the discretionary function exception to dismiss petitioners' lot release claim was improper. 11 FN13. The Government's own argument before this Court provides some support for petitioners' allegation regarding the Bureau's policy. The Government indicated that the Bureau reviews each lot of vaccine and decides whether it complies with safety standards. See Tr. of Oral Arg. 42. The Government further suggested that if an employee knew that a lot did not comply with these standards, he would have no discretion to approve the release of the lot. See id., at 31-32. IV For the foregoing reasons, the Court of Appeals erred in holding that the discretionary **1965 function exception required the dismissal of petitioners' claims respecting the licensing of Orimune and the release of a particular vaccine lot. The judgment of the Court of Appeals is accordingly reversed, and the case is remanded for further proceedings consistent with this opinion. It is so ordered. END OF DOCUMENT Copr. West 1996 No claim to orig. U.S. govt. works WESTLAW Richard D. Myerscough June 28, 1996 House Subcommittee on Aviation 2251 Rayburn HOB Washington, D.C. 20515-1006 Dear Chairman Duncan, I am writing to express my concern and disappointment in the way ValuJet Airlines was attacked by both the News Media and our Nations Elected Officials, (Politicians). I believe this unprecedented attack and closing of our company was a direct result of political pressure. I believe it has everything to do with whose territory we are serving and competing in ...and is further fed with Union PAC monies. I believe it has nothing to do with public safety. I am a pilot with ValuJet Airlines and I have been a professional pilot for more than 18 years. I have trained and flown in the Military, 121 and 135 Air Carrier Operations and part 91 General Aviation Operations. I have enclosed my resume for your reference. My training and experience is probably the average at ValuJet, ...meaning, there are those who have much more experience, and some who have less experience, and I believe the media and Union propaganda which says our pilots are less trained, less experienced and some how less qualified and inferior has been greatly exaggerated. I believe a sample check of the experience levels and backgrounds of those pilots hired at ValuJet compared to those hired at the "Major Airlines" will prove my point. If the outsourcing of our training and maintenance is a safety issue worthy of closing our airline, when both are FAA inspected and approved, then the problem is not with ValuJet or our way of doing business, but elsewhere. Besides, I believe neither of those issues will prove to be a cause of our tragic accident last month. I further believe, that if the FAA were to perform the type of inspection and deliberate slowdown tactics which I and others perceived as political harassment, which delayed and interrupted our flight schedule to the point we could not maintain half our normal flight schedule with twice as many airplanes needed to do it with, ...they would find similar discrepancies. One of your own inspectors, who was hired by USA Today, admitted the same. ValuJet has proven to be of great benefit and has filled a long awaited need in Air Transportation, ...especially for people like myself who look for good value in service and product. I shop at Walmart and find quality, name brand products, at lower prices and ...millions like me do the same. So I find nothing to be ashamed about when we call ourselves the "Walmart of the Airlines." Now I could go to the Sax's, Macy's, and Dillard's, of the Airlines and pay the higher prices, ...and sometimes I do, ...but when I need something that Walmart has ....why should I go anywhere else? What about you...? Do you shop at Walmart? We are nice to have around, ...aren't we. Thankfully I was always glad that we had a choice in our Nation. That is... until most recently. Page Two As a professional in my field, I strive to always do my best and that includes doing it SAFELY. Just think about it, ... it's in everybody's best interest, including mine, to do it that way. In our profession, those who don't, or can't, do not last very long and we do a lot of testing, practice and study to insure we do it right. In short, we tend to police ourselves, and take great pride in always wanting to do it right. We certainly are not perfect, and regardless of how much the government tries to cover their behinds through law making, we never will be perfect, ...because as humans, we make mistakes. However, I contend that even as imperfect as we are, I would rather have a human being who has the capacity to think, feel, love, and make mistakes, flying my airplanes, than a machine. Machines and computers never break down or make mistakes...do they. Now I believe in "Our Republic", and I am thankful we still can worship God and exercise our liberties as a free people. I will fight any people or government, outside or in our nation, which would try to oppress and take away those freedoms. However, I strongly believe that in the exercise of our freedom, we need to demand responsibility for our actions. I believe freedom without responsibility brings corruption and destruction. As one of our elected servants, I hope you believe the same. I know, to our shame, there are many who do not hold to a Republic, and are self-serving rather than servants of the people. I believe it is because of self-serving politicians that my company is not in the skies today, and I am demanding that "JUSTICE" be done and given in our behalf. Also I believe because of the great harm and lack of trust created by the slander of certain political persons and media towards our airline... a nationwide apology and news blitz with the facts of the accident and professional actions of the flight crew should be published and broadcast with equal intensity as those who falsely accused. The Bible speaks of this type of injustice, when it says "A bribe corrupts justice", and "The people cry out when the wicked are in control." I appeal to you, in the name of my Lord, Jesus, to do all you can do... to see justice served on our behalf, and in behalf of the flying public, who deserve and cry out for our service and product. Politics has no place in our business, and corrupt politics is the shame and fall of our once great nation. I have enclosed some articles which I found most interesting regarding our political plight which I felt speaks to the issues. I hope they give you some insight. Thank you for your time and interest in this matter. Sincerely, Rick Myerscough Enclosures I have been watching the recent safety hearings regarding Valujet Airlines and would like to make the following comment: With so many cargo only airlines such as DHL,UPS, and FEDEX why do we allow hazardous materials/dangerous goods to be shipped on U.S. passenger airlines? In the interest of airline passenger safety, I recommend that the transport of all hazardous materials/dangerous goods be prohibited on aircraft carrying passengers. Sincerely, ший William K. Jeter Captain, American Airlines |