timely action on an EUP application by EPA. In fact, this language was not even contained in Section 5 as it was originally enacted in the 1972 amendments, but rather was only recently added in the 1978 amendments. Section 10 of Pub. L. 95-396, 92 Stat. at 828. Moreover, the legislative history of the 1978 amendments demonstrates that the change in language was merely intended to provide a specific time deadline for EPA to act on applications for EUPs, not to prohibit EPA from considering data other than that submitted by the EUP applicant. H.R. Rep. No. 95-663, 95th Cong., 1st Sess. at 30-31; see also S. Rep. No. 95-1188, 95th Cong. 2d Sess. at 48 (Conference Report).
Further, there is nothing in EPA's regulations implementing the EUP program, 40 C.F.R. § 172.1 et seq., which requires the EUP applicant to submit all its own data. While 40 C.F.R. § 172.4(b)(vi) does require an EUP applicant to describe any tests of the product and their results which have been "conducted by the applicant," again, this section does not require that all tests which would support the EUP must be done by the applicant.
C. Do the Data-Consideration Restrictions Contained in Section 3(c)(1)(D) Apply to Applications for EUP's Under Section 5?
The most critical -- and most difficult -- question before us is the applicability of the data consideration restrictions contained in Section 3(c)(1)(D), described supra, to applications for EUPs under § 5. Rohm & Haas, pointing to the elaborate restrictions contained in § 3, obviously designed to protect proprietary rights and to encourage research and development, argues with great force that, in light of the importance of the EUP to the full registration process, see Part IV.B, supra, it would result in virtual emasculation of the congressional policies underlying § 3 if its Blazer registration data could be relied upon by the EPA to award Mobil an EUP.
However, abstract notions of policy are not helpful in the exercise of statutory construction unless they are rooted in Congressional intent. Defendants' policy arguments -- inter alia that Congress' main objective in passing FIFRA was to achieve safe and effective registration of pesticides, not to protect a manufacturer's test data -- are also forceful.
We must therefore rely upon the statutory language, and where that is opaque, upon the Congressional intent as reflected by the legislative history and analysis of the statutory scheme.
Defendants' primary argument is bottomed on the fact that the language of § 3(c) specifically limits the application of that section (including the data consideration restrictions) to applications for registration. Section 5 contains no such restrictions, and defendants say that if Congress had meant them to apply to § 5, it would have inserted a cross-reference. This argument is more than a makeweight, in terms of ordinary statutory constructional principles. It is elevated to considerable, indeed determinative significance in light of the legislative history with which we have been supplied by counsel. That history is set forth extensively in the EPA's brief, to which House, Senate, and Conference Reports were attached.
Inter alia that history shows that Congress was quite familiar with FIFRA, which was amended three times in seven years, and was familiar with EPA's interpretation of FIFRA in terms of its ability to rely upon data submitted by previous applicants. Those facts would suggest that when Congress confined the data consideration restrictions to § 3 it did so intentionally. What is more convincing, however, is the legislative history itself. FIFRA originally had no data consideration restrictions. They were inserted in the statute at the behest of the industry. But the various hearings and reports in which the data consideration restrictions were discussed, including those relating to the 1978 Amendments, in which § 3(c)(1)(D) was completely rewritten, all refer to registration, even though the EUP procedures were known to all concerned. We shall not extend the discussion here by relating the legislative history; it is covered amply in defendants' briefs.
The final version of § 3(c)(1)(D) was a compromise between House and Senate versions. Section 3(c)(1)(D)(ii) does mention "data submitted by an applicant or registrant to support an application for registration, experimental use permit,. . .", and provides that the Administrator may, without permission of the original data submitter, consider any item of data in support of an application by any other person without payment of compensation. Section 3(c)(1)(D)(i) does not mention EUP's in its provision that, with respect to pesticides containing active ingredients that are initially registered after September 30, 1978, data submitted to support the application for the original registration of the pesticide shall not, without permission of the original data submitter, be considered by the Administrator to support an application by another person for a ten-year period.
The EPA elucidates these provisions with aid of a useful distinction - between the category of data covered and the type of regulatory activity to which the requirements are to be applied. In Section (ii), the reference to EUP support data refers to the type of data covered. There is nothing in Section 3(c)(1)(D) (or of course in Section 5) about applying the data restrictions to EUP applications as a type of regulatory activity. Notwithstanding Rohm & Haas' contention that the House Bill which is said to have focused on ownership rights in submitted data prevailed over the Senate version, there is no indication even in the House Bill, in terms of the type of regulatory activity to which the requirements apply, that it was concerned with EUP proceedings. By the same token, the passage in the Conference Report on which Rohm & Haas relies
is subject to the same distinction. That distinction undermines Rohm & Haas' argument.
In sum, although Section 3(c)(1)(D), which deals with registrations, provides data submitters with economic protection against "me-too registrants " who had relied on their data, it does not apply to the issuance of EUP's. It is plain that Congress knew what it was doing when it failed to make the restrictions applicable. This conclusion still leaves us with the question whether this failure comports with the apparent Congressional solicitude for proprietary rights in research and development data. We conclude that since an EUP does not allow the permit holder to compete commercially against any data submitter upon whose data EPA has relied in connection with the issuance of the EUP, Congress saw no reason to apply the restrictions, notwithstanding the "leg-up" the me-too applicant may obtain. Moreover, the data used in connection with the EUP is entitled to protection when the EUP ripens into full registration.
Additionally, given the shortage of personnel in EPA and what we perceive to be the overriding Congressional concern of achieving safe and effective registration of new pesticides, the failure to apply the data consideration restrictions to EUPs would appear to comport with sound policy notions. Plaintiff's position cannot therefore prevail.
Having thus concluded, we note our uneasiness that our decision results in some erosion of the proprietary rights of data submitters such as Rohm & Haas, thus creating tension with one of the Congressional policies in the area. However, if values or policies in this field are to be reordered, or if brighter lines are to be drawn, it is for Congress to do so, and not this Court.
D. MUST THE EUP BE DENIED FOR FAILURE TO AWAIT COMMENT FOLLOWING THE FEDERAL REGISTER PUBLICATION?
We have explained in Part IV.D supra why the Federal Register problem is essentially mooted, and why Rohm & Haas has no standing to complain about it. We hasten to observe that, notwithstanding our acceptance of EPA's position that it was not necessary that the Federal Register notice be published, we would, but for the circumstances noted, enforce the consequences of that publication. See, inter alia, Sharon Steel Corp. v. EPA, 597 F.2d 377, 381 (3d Cir. 1979); National Tour Brokers Association v. U. S., 192 U.S. App. D.C. 287, 591 F.2d 896, 902 (D.C. Cir. 1978); Texaco, Inc. v. F.P.C., 412 F.2d 740, 744-45 (3d Cir. 1969).
For all the foregoing reasons, relief must be denied and judgment entered for the defendants. However, it is possible that the Court of Appeals may disagree with us. Therefore, in order that issuance of the EUP and prompt dispatch of Tackle to the test sites across the country and application of it to the soybean crop not render nugatory the plaintiff's claim even if it succeeds on appeal, we shall stay our order and prohibit EPA from issuing the EUP until such time as the Court of Appeals acts upon a motion for injunctive relief pending appeal which plaintiffs must file in the Court of Appeals by Noon tomorrow. Were it not for the exigent circumstances, we would not grant interim relief.
An appropriate Order follows.
EDWARD R. BECKER, J.
AND NOW, this 18th day of May, 1981, upon consideration of the foregoing opinion, it is hereby ORDERED that the plaintiff's Motion for Declaratory Judgment, Temporary Restraining Order, Preliminary and Permanent Injunction is DENIED and that judgment be entered in favor of the defendants. It is further ORDERED that the effect of this judgment is stayed and EPA is prohibited from issuing the EUP until the Court of Appeals acts upon plaintiff's motion for injunctive relief pending appeal, said motion and appeal to be filed by May 19, 1981 at noon.
BY THE COURT:
Edward R. Becker, J.