WILLIAM D. RUCKELSHAUS, ADMINISTRATOR, UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY, APPELLANT V. MONSANTO 01067 A110000COMPANY

   No. 83-196

   In the Supreme Court of the United States

   October Term, 1983

   On appeal from the United States District Court for the Eastern
District of Missouri

   Brief for the appellant

            TABLE OF CONTENTS
   Opinion below
   Jurisdiction
   Constitutional and statutory provisions involved
   Statement
      1. Statutory and regulatory background
      2. The 1972 Amendments
      3. The 1978 Amendments
      4. The proceedings below
   Summary of argument
   Argument:
      I. FIFRA's data consideration and disclosure
          provisions are plainly within the authority of
          Congress to regulate interstate commerce
          A. The data consideration provisions
          B. The data disclosure provisions
      II. FIFRA's data consideration and disclosure
          provisions do not take property in violation of the
          Fifth Amendment
          A. An interest in preserving the exclusive use
              and secrecy of health and safety data required
              under FIFRA does not qualify as property
              protected by the Taking Clause of the
              Fifth Amendment
          B. Even if Monsanto does possess a protected
              property right in its test data, the 1978
              Amendments are not a taking of that
              interest
              1. The data consideration provisions
              2. The data disclosure provisions
      III. Even if FIFRA's data consideration and
          disclosure provisions take Monsanto's property, the
          district court erred in granting injunctive relief
      IV. The constitutional challenges to the
          arbitration and compensation scheme are not
          ripe for resolution and in any event are
          without merit
          A. The district court erred in considering
              Monsanto's constitutional attacks on the
              arbitration and compensation scheme in
              Section 3(c)(1)(D)(ii)
          B. Neither the Due Process Clause nor
              Article III requires invalidation of the
              arbitration and compensation scheme
   Conclusion

                             OPINION BELOW

   The opinion of the district court (J.S. App. 1a-37a) is reported at
564 F.Supp. 552.

                             JURISDICTION

   The judgment of the district court (J.S. App. 39a-40a) was entered
on April 12, 1983.  An amended judgment (J.S. App. 41a-43a) was
entered on May 9, 1983.  The Administrator of the Environmental
Protection Agency filed a notice of appeal to this Court on May 10,
1983 (J.S. App. 44a-46a).  On July 1, 1983, Justice Blackmun extended
the time for docketing the appeal to August 8, 1983.  The
Jurisdictional Statement was filed on August 5,1983, and the Court
noted probable jurisdiction on October 11, 1983 (J.A. 260).  The
jurisdiction of this Court rests on 28 U.S.C. 1252.

                     CONSTITUTIONAL AND STATUTORY

                          PROVISIONS INVOLVED

   The Fifth Amendment to the United States Constitution and the
relevant portions of the Federal Insecticide, Fungicide, and
Rodenticide Act, 7 U.S.C. 136 et seq., are reprinted at J.S. App.
47a-57a.

                          QUESTIONS PRESENTED

   1. Whether Section 3(c)(1)(D) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136a(c)(1)(D) (which
permits applicants to cite and EPA to consider in support of
subsequent applications by other companies, health and safety data
that were submitted to the government in support of initial
applications for pesticide registration), works an unconstitutional
taking of property requiring issuance of injunctive relief.

   2. Whether Sections 3(c)(2)(A) and 10 of FIFRA, 7 U.S.C.
136a(c)(2)(A) and 7 U.S.C. 136h (which require EPA to disclose
publicly health and safety data submitted to the agency in support of
a pesticide registration application), are beyond Congress's power and
constitute an unconstitutional taking of property warranting
injunctive relief.

   3. Whether the constitutionality of the arbitration scheme
established in Section 3(c)(1)(D)(ii) of FIFRA, 7 U.S.C.
136a(c)(1)(D)(ii) (which provides that an original submitter of data
or an applicant who cited that data may initiate binding arbitration
if the parties fail to agree on the amount of compensation) is ripe
for review, and, if so, whether the arbitration provision denies due
process or amounts to an unconstitutional delegation of judicial
power.

                               STATEMENT

   The court below declared unconstitutional several important
provisions of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq., the federal legislation regulating the
marketing and use of pesticides.  As we will show, in enacting FIFRA
Congress struck a measured balance between the need for increased
competition and the need for innovation in the pesticide industry.  In
accomplishing these objectives, the statute also accommodates private
industry's interest in protecting information and the public's
interest in understanding the potential hazards of pesticide products.

   Under FIFRA, persons seeking to market a pesticide product in the
United States first must obtain a registration for the product from
the Environmental Protection Agency (EPA).  7 U.S.C. 136a(a).  Before
issuing the registration, the Administrator of EPA must determine,
inter alia, that the pesticide's use will not cause unreasonable
adverse effects on the environment, taking into account the benefits
as well as the risk to humans or the environment.  7 U.S.C. 136(bb),
136a(c)(5)(C)-(D).  The Administrator bases this determination in part
on test data submitted or cited by the applicant for registration,
data that generally include information on the chemical nature and
structure of the pesticide as well as test results on the potential
dangers of the product.  /1/

   The provisions struck down by the district court were designed to
permit EPA to consider the health and safety data submitted by one
applicant in support of the applications of another company (the "data
consideration provisions), 7 U.S.C. 136a(c)(1)(D);  they also require
EPA to disclose these data to qualifying members of the public (the
"data disclosure" provisions), 7 U.S.C. 136a(c)(2)(A), 136h(b) and
(d).  This case, therefore, relates only to health and safety data;
the case does not involve a company's confidential product formulas or
manufacturing processes, which are protected from disclosure by the
terms of the statute (7 U.S.C. 136h(d)).  Moreover, the protections
afforded by FIFRA are wholly distinct from rights to exclusivity that
a company may enjoy under the patent laws.

                1. Statutory and regulatory background

   The past century has witnessed the transformation of American
agriculture into a large-scale industry characterized by intensive
cultivation of the land.  A major factor in this change, as well as a
contributor to marked improvements in productivity, has been the
widespread use of pesticides to control weeds and crop damage caused
by insects, disease and animals.  See S. Rep. 92-838, 92d Cong., 2d
Sess. 3-4, 6-7 (1972).  Greater use of pesticides has brought not only
the benefit of protecting crops and ensuring high yields, but also the
risk of harm to humans and the environment.  The recognition of this
hazard has been reflected in federal regulation of pesticide use for
nearly 75 years.  In 1910, Congress passed the Federal Insecticide
Act, which made it unlawful to manufacture and sell insecticides that
were adulterated or misbranded as defined by the statute.  Ch. 191, 36
Stat. 331.  The following decades brought dramatic growth in pesticide
research and development, and the states began to regulate pesticides
extensively, leading to the adoption in 1946 of a model state statute,
the uniform Insecticide, Fungicide and Rodenticide Act.  S. Rep.
92-838, supra, at 7;  H.R. Rep. 313, 80th Cong., 1st Sess. 3 (1947).
/2/ These developments led to the enactment in 1947 of the more
comprehensive Federal Insecticide, Fungicide, and Rodenticide Act. Ch.
125, Sec 3, 61 Stat. 166.

   In order to assume greater control over the marketing and use of
pesticides, the 1947 legislation provided for the registration of
pesticides marketed in the United States.  H.R. Rep. 313, supra, at
2-3.  The Act required applicants for registration to submit to the
Secretary of Agriculture certain information regarding the pesticide,
including the label bearing the directions for use and the claims made
for the product, and, "if requested by the Secretary," any test data
underlying the claims on the label.  Sec. 4(a), 61 Stat. 167.  /3/ The
legislation set general standards for the labeling of pesticide
products, including a requirement for a poison label for substances
acutely toxic to humans and a requirement for directions and warnings
that were judged to be necessary and adequate to protect the public
and to prevent injury to humans, other animals and vegegation.  Secs.
2(u)(2)(c) and (d), 3(a)(3), 61 Stat. 165, 166.  A product whose label
did not meet these requirements was classified as misbranded and could
not legally be sold in interstate commerce.  Sec. 3(a)(5), 61 Stat.
166.  /4/

   Thus, the 1947 legislation was primarily a licensing and labeling
statute.  The application for registration could include test data,
although for many years only a limited amount of such data was
required (J.S. App. 25a;  J.A. 219-221).  In addition, the Secretary
of Agriculture was authorized to require the submission of a
pesticide's formula, if he deemed it necessary.  Sec. 4(b), 61 Stat.
167.  The 1947 Act specifically prohibited disclosure of "any
information relative to formulas of products" (Secs. 3(c)(4), 8(c), 61
Stat. 167, 170), but did not address the disclosure of health and
safety data.  /5/ Nor did it address the possible consideration of
such data by agency officials in processing a subsequent application
for the same pesticide.

   Mounting public concern over the long-term effects of pesticides
led to further regulation.  In 1954, Congress amended the Federal
Food, Drug, and Cosmetic Act to regulate pesticide residues in food
products.  21 U.S.C. 346a.  Under these provisions no food products
can be marketed legally if pesticide residues exceed established
tolerances.  21 U.S.C. 331(a), 342(a)(2)(B) and 346a(a).  Persons
seeking to establish a tolerance must submit data disclosing, inter
alia, the name, chemical identity and composition of the pesticide
chemical, as well as reports on its safety. 21 U.S.C. 346a(d)(1).

   In 1959, Congress amended FIFRA to extend regulation to new classes
of substances that had come into common use:  nematocides, defoliants,
dessicants and plant regulators (Pub. L. No. 86-139, Sec. 2, 73 Stat.
286).  And in 1964, acting on the recommendation of a Presidential
Scientific Advisory Committee, Congress eliminated "protest
registration," see n.3, supra, providing instead for administrative
and judicial review of a decision to refuse or cancel a registration
for a pesticide found to be unsafe (Pub. L. No. 88-305, Sec. 2, 78
Stat. 190;  see S. Rep. 92-838, supra, at 8-9).  In 1970, the
Department of Agriculture's FIFRA responsibilities were transferred to
the new Environmental Protection Agency.  Reorganization Plan No. 3 of
1970, 35 Fed. Reg. 15623 (1970).  These various changes were not
sufficient to satisfy the increasing public concern, however, and in
1972 Congress enacted extensive changes in the regulatory scheme.

                        2. The 1972 Amendments

   The comprehensive revision of FIFRA by Congress in 1972 included a
number of measures to provide increased environmental protection.  For
the first time the statute regulated the use of pesticides directly,
as well as their labeling and marketing.  /6/ Congress extended the
reach of the legislation to include pesticides made and sold within a
single state (Secs. 3, 12, 86 Stat.979, 989-990) and added new
provisions for review, cancellation and suspension of registrations
(Sec. 6, 86 Stat. 984).  /7/ These amendments also supplied a new
substantive criterion for registration, that the pesticide would not
cause "unreasonable adverse effects on the environment" (Sec.
3(c)(5)(C)-(D), 86 Stat. 980-981).

   In addition, Congress revamped the registration procedures and
addressed the issues of consideration and disclosure of submitted
data, which had generated considerable controversy.  For many years
after the passage of the 1947 Act, the Department of Agriculture
required only limited health and safety data.  J.S. App. 25a;  J.A.
219-221.  Advances in scientific knowledge and analytical techniques,
however, led to more stringent requirements.  In 1971, the pesticide
industry told Congress that increasingly rigorous administrative
criteria for registration had required them to submit more extensive,
and costly, safety and health data.  Federal Pesticide Control Act of
1971:  Hearings Before the House Comm. on Agriculture, 92d Cong., 1st
Sess. 331 (1971).  See Def't Exh. DDD at 60.  The Department of
Agriculture (and later EPA) adopted the practice of considering data
submitted by one company when reviewing subsequent applications by
others for registration of the same or a similar pesticide.  This
practice was well known to the companies involved.  During
congressional consideration of the 1972 Amendments, the industry's
trade association, the National Agricultural Chemicals Association
(NACA), acknowledged that (Federal Environmental Pesticide Control
Act:  Hearings Before the Subcomm. on Agricultural Research and
General Legislation of the Senate Comm. on Agriculture and Forestry,
92d Cong., 2d Sess., Pt. II, 245 (1972)):

         Under the present law registration information submitted to
      the Administrator has not routinely been made available for
      public inspection.  Such information has, however, as a matter
      of practice but without statutory authority, been considered by
      the Administrator to support the registration of the same or a
      similar product by another registrant.  /(8)/

   In the industry's view, this practice, coupled with proposals for
public disclosure of health and safety data, would have had a negative
effect on research and development.  NACA asked Congress to create
proprietary rights in the data in the form of a statutory right to
exclusive use of the data for the purpose of registration.  Federal
Pesticide Control Act of 1971:  Hearings Before the House Comm. on
Agriculture, supra, at 331;  J.A. 70-74, 81-82.  The House passed such
a restriction (H.R. 10729, 92d Cong., 1st Sess. Sec. 3(c)(2)(D)
(1971), over the objection of several Members that it was an
unwarranted extension of patent protection and generally
anticompetitive.  H.R. Rep. 92-511, 92d Cong., 1st Sess. 69 (remarks
of Rep. Foley), 72 (remarks of Rep. Dow) (1971):  117 Cong. Rec.
39978, 40034, 40061 (1971).

   The Senate bill, as reported by the Senate Committee on Agriculture
and Forestry, retained the exclusive use provision because the
committee thought proprietary rights would encourage research.  S.
Rep. 92-838, supra, at 6.  Other Senators strongly objected to the new
proposal.  They believed this change in the registration process would
require wasteful duplication of testing and raise barriers to entry
into the pesticide market that exceeded the protection provided by the
patent laws.  S. Rep. 92-970, 92d Cong., 2d Sess. 12 (1972).  The
Senate Committee on Commerce, to whom the bill was also referred,
struck the exclusive use provision;  this action was supported by the
Department of Justice and EPA.  Id. at 2, 12-13;  S. Rep. 92-838 (Pt.
II), 92d Cong., 2d Sess.21 (1972).

   This conflict in the Senate was resolved by a compromise that was
intended to provide both an incentive for research and a means for
maintaining entry of competitors into the market.  S. Rep. 92-838, Pt.
II, supra, at 69, 71-73.  The two committees decided on a mandatory
data licensing scheme under which EPA could consider studies submitted
by one company in support of the application of another firm, so long
as the second company offered to compensate the original data
submitter.  Id. at 71-73.  The amount of compensation would be
determined either through negotiation between the parties, or, if that
failed, by EPA order subject to judicial review.  Pub. L. No. 92-516,
Sec. 3, 86 Stat. 979.  The compromise was accepted by the full Senate
and acceded to by the House during the conference.  H.R. Conf. Rep.
92-1540, 92d Cong., 2d Sess. 9, 31 (1972).

   At the same time, Congress added a new Section 10 (86 Stat. 989) to
govern public disclosure of data submitted in support of applications
for registration.  This provision allowed applicants to designate
portions of submitted data as "trade secrets or commercial or
financial information" and it prohibited EPA from publicly disclosing
such information.  Moreover, the data consideration provision (Sec.
3(c)(1)(D)) provided that any "trade secret" data that could not be
publicly disclosed under Section 10 could not be considered by EPA at
all to support another registration application, unless the original
submitter consented.  86 Stat. 979.  Thus, the data consideration/
mandatory licensing scheme would apply only to data that fell outside
the scope of "trade secret" protection under Section 10.

   The 1972 Amendments, however, failed to define "trade secrets," and
failed to specify an effective date.  The latter question was resolved
in 1975 when Congress amended Section 3(c)(1)(D) to provide that the
mandatory licensing provisions applied only to data submitted on or
after January 1, 1970.  Pub. L. No. 94-140, 89 Stat. 751.  /9/ The
definition of "trade secrets" was left to the EPA Administrator and
the courts.

   EPA maintained that in the 1972 and 1975 Amendments Congress had
intended to give trade secret protection to only a narrow range of
information -- principally statements of formulas and manufacturing
processes -- that did not include health and safety data.  Such data,
therefore, could be disclosed to the public and could be considered by
EPA in support of registration applications.  In a series of lawsuits,
data-submitting firms challenged EPA's interpretations and obtained
several decisions holding that the "trade secret" prohibition in the
1972 Act applied to any data, including health and safety data, that
met the expansive definition of "trade secret" set forth in the
Restatement of Torts Sec. 757 (1939).  E.g., Chevron Chemical Co. v.
Costle, 443 F.Supp. 1024 (N.D. Cal. 1978);  Mobay Chemical Corp. v.
Costle, 447 F.Supp. 811 (W.D. Mo. 1978).  As a result of these
decisions, the "trade secret" prohibition in Section 10 operated to
bar public access to much of the data on which EPA based its decisions
to register pesticides and the corresponding prohibition in Section
3(c)(1)(D) allowed data-submitters to prevent any other firm from
obtaining registrations for products that were the same or
substantially similar to previously registered products unless the
second firm duplicated the data supporting the first registration, or
it was determined, after perhaps years of litigation, that particular
items were not trade secrets.  In part because of such "trade secret"
controversies, "the process of registering new pesticides simply
ground to a halt." Chevron Chemical Co. v. Costle, 499 F. Supp. 732
(D. Del. 1980), aff'd on other grounds, 641 F.2d 104, 111 (3d Cir.),
cert. denied, 452 U.S. 961 (1981).  /10/ See H.R. Rep. 95-663, 95th
Cong., 1st Sess. 18 (1977):  S. Rep. 95-334, 95th Cong., 1st Sess. 3
(1977).

                        3. The 1978 Amendments

   Faced with this breakdown in the registration program, Congress, in
the Federal Pesticide Act of 1978 (1978 Amendments) (7 U.S.C. 136 et
seq.), comprehensively revised the FIFRA data consideration and
disclosure provisions.  The 1978 Amendments abolished the 1972
prohibition on agency consideration of "trade secret" data because it
had operated to discourage small potential competitors from entering
the market by requiring them to duplicate health and safety tests for
products similar to those already registered.  /11/ Congress was
concerned that FIFRA, in practice, acted as a de facto extension of
patents beyond the statutory period of protection. See, e.g., S. Rep.
95-334, supra, at 8, 30-31.

   In order to promote competition and eliminate needless duplicative
testing of pesticide chemicals like those already registered (see S.
Rep. 95-334, supra, at 30-31), Congress established a new registration
scheme.  The costs of developing health and safety data are now spread
among all beneficiaries of the data;  at the same time, innovation
incentives are provided by exclusive use and compensation provisions
that are independent of whatever protections a company may have under
the patent laws (ibid.).  Under the 1978 Amendments, applicants are
granted a 10-year period of exclusive use for data on new active
ingredients contained in pesticides registered after September 30,
1978.  Sec. 3(c)(1)(D)(i), 7 U.S.C. 136a(c)(1)(D)(i).  All other data
submitted after December 31, 1969, may be cited and considered in
support of another application for 15 years following the original
submission, if the applicant offers to compensate the original
submitter.  Sec. 3(c)(1)(D)(ii), 7 U.S.C. 136a(c)(1)(D)(ii).  In these
instances, the data are not disclosed to the latter applicant but are
viewed only by EPA personnel.  /12/ The later applicant, in order to
cite the data, must offer to compensate the original submitter;  if
the parties cannot agree on the amount of compensation, either may
initiate binding arbitration proceedings.  /13/ Data that do not
qualify for either the 10-year period of exclusive use or the 15-year
period of compensation may be considered by EPA without limitation.
Sec. 3(c)(1)(D)(ii), 7 U.S.C. 136a(c)(1)(D)(iii).  All of these
provisions operate independently of the patent laws, so chemicals or
products that are patented by the original data submitter may not be
copied by other companies for 17 years (35 U.S.C. Supp. V) 154).
Thus, the data consideration provisions come into play only when the
chemical or product is not patentable or when patent protection has
expired.

   The 1978 Amendments also added a new provision, Section 10(d) (7
U.S.C. 136h(d)), that provides for disclosure of all health and safety
data to qualified requesters.  /14/ This provision was designed to
enable members of the public to assess for themselves the hazards
posed by pesticide products and to participate in and evaluate EPA's
registration decisions.  See, e.g., H.R. Rep. 95-663, 95th Cong., 1st
Sess. 18 (1977);  123 Cong. Rec. 25711 (1977) (remarks of Sen.
Kennedy).  The same Section, however, prohibits EPA from disclosing
information that would reveal "manufacturing or quality control
processes" or certain details pertaining to "deliberately added" inert
ingredients unless "the Administrator has first determined that
disclosure is necessary to protect against an unreasonable risk of
injury to health or the environment." In addition, Section 10(g), 7
U.S.C. 136h(g), generally prohibits EPA from disclosing data to
representatives of foreign or multinational pesticide companies,
unless the original submitter consents.  Sec. 10(g), 7 U.S.C. 136h(g).
 /15/

                       4. The proceedings below

   In its complaint in this case (J.A. 15-28), Monsanto sought
injunctive and declaratory relief from the operation of the data
consideration provisions of Section 3(c)(1)(D), 7 U.S.C.
136a(c)(1)(D), and the disclosure provisions of Section 10, 7 U.S.C.
136h, and related Section 3(c)(2)(A), 7 U.S.C. 136a(c)(2)(A).
Monsanto alleged that the data consideration provision, Section
3(c)(1)(D), constitutes a "taking" of property for a private purpose
without just compensation, in violation of the Fifth Amendment, and
that the data disclosure provisions, Sections 3(c)(2)(A) and 10, are
beyond Congress's Commerce Clause powers and effectuate a taking
without just compensation in violation of the Fifth Amendment.  The
complaint further alleged that the arbitration scheme provided by
Section 3(c)(1)(D)(ii) violates the company's due process rights and
constitutes an unconstitutional delegation of judicial power.

   Following a bench trial, the district court ruled in favor of
Monsanto.  The court concluded that the data consideration and
disclosure provisions of FIFRA are beyond Congress's Commerce Clause
powers and constitute an unconstitutional taking of property in
violation of the Fifth Amendment.  The court held that Monsanto has a
state-protected property right (based on the trade secret definition
in the Restatement of Torts Sec. 757 (1939)) in the data it submits to
EPA, which precludes EPA from considering Monsanto's data in support
of another person's registration application or from disclosing the
data publicly.  Section 3(c)(1)(D), the court concluded, appropriates
Monsanto's "fundamental right * * * to exclude" others from use of its
property, furthers private rather than public purposes, and operates
as an unconstitutional taking of Monsanto's property (J.S. App.
31a-32a).  The court also found that FIFRA's disclosure provisions
(Secs. 3(c)(2)(A) and 10) "effectively destroy" Monsanto's property,
adding that disclosure is "beyond Congress' regulatory powers" because
the public interest is satisfied by EPA's analysis of the pesticide's
hazards and by the labeling requirements under FIFRA (J.S. App.
32a-33a).  The court further concluded that Congress had withdrawn the
Tucker Act remedy, which would ordinarily provide Monsanto with "just
compensation," on the ground that the compensation and exclusive use
provisions of Section 3 (7 U.S.C. 136a) "were intended to be the sole
compensation for any taking" (J.S. App. 35a).  Finally, the court held
(id. at 34a) that the data-compensation scheme established in Section
3 is unconstitutional because it does not provide "just compensation"
and because it denies Monsanto "due process" and amounts to an
unconstitutional delegation of judicial power.  The court recognized
(J.S. App. 36a-37a) that every other court that had considered these
issues had held FIFRA constitutional, but chose not to follow those
decisions.

   The district court enjoined EPA from implementing "in any manner,
directly or indirectly," FIFRA Sections 3(c)(1)(D) and (2)(A), 10(b)
and (d) (J.S. App. 40a).  In addition, it specifically enjoined "any
use or consideration of or disclosure to any other person of any of
(Monsanto's) information, research and test data, whenever submitted *
* * unless (EPA) shall have first obtained (Monsanto's) express
written permission" (ibid.).  Both EPA and Monsanto moved to amend the
judgment.  EPA sought to clarify that the judgment did not preclude
release of Monsanto's health and safety data to other agencies of the
federal government or to Congress.  EPA also moved for a stay pending
appeal to this Court.  Monsanto asked the court to add a new paragraph
to the judgment specifying that EPA could process registrations for
those manufacturers that can generate their own data or obtain the
data from another manufacturer.  On May 9, 1983, the district court
issued an amended judgment that accommodated both EPA's and Monsanto's
requests for amendment but denied EPA's motion for a stay (J.S. App.
41a-43a).  EPA's subsequent motion in this Court for a stay pending
appeal was denied.  No. A-1066 (July 27, 1983) (Blackmun, Circuit
Justice).

                          SUMMARY OF ARGUMENT

   I. The statutory provisions that permit EPA to consider previously
submitted data in reviewing later pesticide applications were enacted
as part of a carefully crafted scheme designed to achieve two
principal objectives:  to assure the safety and efficacy of
potentially hazardous pesticides and to promote competition in the
industry.  Since the time and expense involved in performing the
requisite health and safety tests could act as a barrier to entry,
discouraging less affluent firms from reaching the market, Congress
struck a legislative balance.  While the predicate testing remains
essential to the initial approval of a pesticide, it was deemed
unnecessary to require these tests to be duplicated for subsequent
registrations of products with the same or similar composition.  In
this way, the need to preserve public health and safety standards was
accommodated with the desire to avoid the adverse economic impact of
forcing potential competitors to reinvent the wheel for each product.
At the same time, Congress afforded some incentives for innovators.
First, the innovator retains the protection of the patent laws where
applicable:  his invention may not be copied for 17 years.  Second,
FIFRA provides a period of exclusive use and a scheme of compensation
for original data submitters, so that certain information cannot be
relied upon by potential competitors for 10 years and when such
reliance is available the innovator may be compensated for his testing
expenses.

   Substantial public policies similarly underlie the data disclosure
provisions.  While confidential product formulas and manufacturing
practices cannot be disclosed, FIFRA allows qualified members of the
public to obtain certain health and safety data.  Such disclosure may
not be made to representatives of multinational companies, a
restriction that bars access to most, if not all, of Monsanto's
competitors in the research and development of pesticides (J.S. App.
21a).  The disclosure that is permitted allows interested members of
the public to participate in the agency decisionmaking process and
affords the opportunity to assess in a meaningful way the risks
attendant upon pesticide use.

   In light of the public purposes advanced by this regulatory scheme,
the district court erred in concluding that these provisions of FIFRA
exceed Congress's power under the Commerce Clause to regulate the
pesticide industry.

   II. A. The district court was also incorrect in ruling that FIFRA's
data consideration and disclosure provisions constitute a taking of
property in violation of the Fifth Amendment.  Although it correctly
determined that Monsanto did not possess a federally-created property
interest in its health and safety data, the court nevertheless found
that such a right existed under Missouri law.  The court's analysis is
flawed.  First, the court failed to recognize that whatever rights
Monsanto held prior to the time it submitted data to EPA, those rights
became subject to the federal regulatory scheme when Monsanto chose to
make its submissions in order to obtain commercially valuable
pesticide registrations.  Second, because the challenged provisions
are part of a comprehensive and uniform federal scheme regulating the
use of data submitted pursuant to that scheme, state laws are
preempted to the extent that they are in irreconcilable conflict with
the functioning of that scheme.  And, even if state law continues to
govern, the court misconstrued the limited protection afforded by
state trade secrecy law.

   Accordingly, Monsanto retained no cognizable property interest
under the Fifth Amendment in the health and safety data it submitted
to EPA, and that is dispositive of its Fifth Amendment claim.

   B. Even if it is determined that Monsanto retained a protected
property interest, FIFRA does not cause a "taking" of property within
the meaning of the Fifth Amendment.  When the nature of the government
action, and the strong public policies it fosters, is weighed against
the limited impact on Monsanto (which retains significant rights and
benefits), it is clear that no taking has occurred.  Monsanto's
assertions boil down to nothing more than unilateral expectations of
competitive advantage flowing from the federal regulatory scheme
itself.  This provides no foundation for a taking claim.

   III. Since, in our view, no taking has occurred, the Court need not
reach Monsanto's remaining contentions.  But even if FIFRA is deemed
to cause a taking of property, the district erred in granting
injunctive relief.  Where, as here, EPA's actions are authorized by
statute and serve an important public purpose, the only remaining
issue relating to the availability of injunctive relief is whether
just compensation will be provided.  While FIFRA affords Monsanto a
measure of compensation from private parties who seek to rely on the
data consideration provisions in obtaining "me-too" registrations, a
claim against the government for just compensation remains available
under the Tucker Act, 28 U.S.C. 1491, since Congress evinced no intent
to withdraw that remedy.  The district court's conclusion to the
contrary is incorrect.

   IV. The district court should not have entertained Monsanto's
attack on the arbitration and compensation scheme in Section
3(c)(1)(D)(ii).  This issue is not ripe for adjudication because
Monsanto has not yet been involved in the arbitration process.  Thus,
the question is hypothetical at this point and any disposition would
be merely advisory.  Should Monsanto later have occasion to proceed
through the arbitration scheme, and should it be dissatisfied with the
result, it could seek judicial relief.

   In any event, the arbitration and compensation scheme fully
satisfies the standards established by this Court, and thus offends
neither the Due Process Clause nor Article III.  Indeed, it is quite
similar to other adjudicatory mechanisms this Court has upheld for the
determination of statutorily-created rights.

                               ARGUMENT

 I. FIFRA'S DATA CONSIDERATION AND DISCLOSURE PROVISIONS ARE PLAINLY
WITHIN THE AUTHORITY of CONGRESS TO REGULATE INTERSTATE COMMERCE

   Although the district court acknowledged that Congress's purpose in
enacting the data consideration and disclosure provisions was to
promote competition in the marketplace and to vindicate the public's
right to information about the harmful effects of pesticide products
(J.S. App. 13a-14a, 17a), the court incorrectly concluded that these
statutory provisions were beyond the authority conferred on Congress
by the Commerce Clause of the Constitution (J.S. App. 32a-34a, 39a).
The court did not, and could not, hold the pesticide industry immune
from congressional regulation on the ground that it does not engage in
or affect interstate commerce.  Rather, the court simply disagreed
with Congress's policy judgment that the particular statutory
provisions at issue serve the public interest.  But it is Congress,
rather than the courts, that is empowered by the Commerce Clause to
determine what regulation of the manufacture and use of pesticides
will promote the public health and welfare.

   It is, for example, long established that Congress may properly act
"to prevent the flow of commerce from working harm to the people of
the nation." Mulford v. Smith, 307 U.S. 38, 48 (1939).  And this Court
has held on many occasions that there need only be some rational basis
for congressional action in order to sustain an exercise of the
plenary authority granted to Congress by the Commerce Clause.  See,
e.g., United States v. Darby, 312 U.S. 100, 121 (1941).  More
particularly, this Court has consistently upheld, as authorized by the
commerce power, federal legislation regulating business competition or
activities causing potential environmental damage, the two primary
purposes served by the statutory provisions at issue here.  Hodel v.
Indiana, 452 U.S. 314, 329 (1981);  Hodel v. Virginia Surface Mining &
Reclamation Ass'n, 452 U.S. 264, 282 (1981);  Bowman Transp., Inc. v.
Arkansas-Best Freight System, Inc., 419 U.S. 281, 298 (1974);
Northern Securities Co. v. United States, 193 U.S. 197, 337-338
(1904).

   Nor is it unusual for Congress to require, as a condition of
participating in commerce, that persons supply information to federal
agencies that they might otherwise choose not to disclose.  For
example, firms seeking to sell securities to the public (15 U.S.C.
77aa, 77eee(c)), to manufacture or sell pharmaceuticals (Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. 355(a), (b) and (j);  21 U.S.C.
360(j);  21 C.F.R. 314.1), to acquire another company
(Hart-Scott-Rodino Antitrust Improvements Act of 1976, 15 U.S.C. 18a;
16 C.F.R. 803.1), or to secure a government procurement contract (10
U.S.C. 2313(b);  42 U.S.C. 254(c)) are subject to reporting or records
access requirements.  The data thus obtained become part of the pool
of information available to the recipient federal agency in conducting
its business.  And, in certain circumstances, such information is
available to persons outside the government (e.g., 15 U.S.C. 77f(d);
21 U.S.C. 360(f);  21 U.S.C. 379;  5 U.S.C. 552).  This familiar
method of regulating commerce is particularly suitable to the
manufacture and marketing of potentially hazardous substances such as
pesticides.

                 A. The data consideration provisions

   From the beginning of its consideration of the appropriate use by
EPA of data submitted by pesticide registrants, Congress has been
concerned with the statute's impact on the competitive structure of
the pesticide industry.  Although in 1972 the Senate Committee on
Agriculture and Forestry wanted to grant exclusive proprietary rights
to data submitters, S. Rep. 92-838, supra, at 6, the Committee on
Commerce was concerned that such a provision would raise undesirable
barriers to entry in the pesticide market and that it would also
compel unnecessarily duplicative expenditures for testing similar
products.  S. Rep. No. 92-970, supra, at 12.  /16/ The compromise
struck by the two committees, which then became law, provided for
mandatory licensing, with compensation, of testing data previously
submitted.  By providing for reliance by other companies on the data
and the sharing of costs, Congress was plainly acting on its
conclusion that data submitters should not have the monopoly benefits
of an exclusive use provision.  In addition, Congress intended to
avoid the "wasteful, time-consuming, and costly process" of requiring
subsequent applicants to reinvent the wheel in order to market a
previously approved product.  S. Rep. 92-838 (Pt. II), supra, at
72-73.

   As noted above, see page 11, supra, judicial interpretations of the
trade secrets provision of the 1972 Amendments had thwarted Congress's
intent to assure a competitive market for pesticides and to promote
the efficiency of the registration process.  In 1977, the House
Committee on Agriculture recognized that the lack of clarity in the
1972 legislation had spawned litigation that had brought the
registration process to a standstill.  H.R. Rep. 95-663, supra, at 18.
 In the Committee's view, it was Congress's task to strike (ibid.):

         a careful balance between the interests of the small
      formulator and the need for encouraging competition in the
      pesticide business, on the one hand, and the need to assure the
      continued research and development of new pesticides * * *.
      /(17)/

   The Senate was equally concerned with the impact of the 1972
Amendments on competition.  S. Rep. 95-334, 95th Cong., 1st Sess. 3-4
(1977).  The Committee on Agriculture, Nutrition and Forestry found
there were about 400 manufacturers of basic pesticide chemicals, but
that there were only some 40 firms that engage in the development of
new pesticide products and that normally generate the health and
safety data necessary for registration (id. at 27).  In addition,
there are thousands of small firms that buy pesticide chemicals for
formulation into end-use products but that do little, if any, of the
costly testing necessary to obtain a registration.  Id. at 28.  See
id. at 34 (study prepared by Office of Pesticide Programs, EPA).  The
Committee noted (id. at 30-31) (emphasis added),

         The current law in essence treats every firm in exactly the
      same way and every registration as an autonomous entity.  This
      has resulted in duplication of costs and significant reduction
      in competition.  This was not the intent of the Congress in
      passing the 1972 amendments.  Unfortunately, it is the result.

                      * * * * *

         The amendments also avoid an extension of the patent rights
      on chemicals.  More importantly, these amendments eliminate
      FIFRA's most severe regulatory impact on the industry -- the
      anti-competitive effects of de facto "exclusive use." /(18)/

   It is apparent, then, that Congress reasonably viewed the costs
associated with duplicating health and safety data as a significant
barrier to entry into the pesticide market, and that its efforts to
diminish this barrier effect were rationally related to its objective
of fostering competition.  See Hodel v. Virginia Surface Mining &
Reclamation Ass'n, 452 U.S. at 282;  Bowman Transp., Inc. v.
Arkansas-Best Freight System, 419 U.S. at 298;  United States v.
Darby, 312 U.S. 100, 121 (1941).

   The district court, ignoring the careful balance Congress struck,
instead made its own assessment of the effect of the data
consideration provisions and its own determination of the competitive
structure of the industry.  Because it concluded that Monsanto's
competitors would benefit from the statute, the court found that only
private, rather than public, purposes were served by the legislation
(J.S. App. 32a).  That is not factually or legally accurate.  Almost
any effort to foster competition is likely to have the effect of
benefitting potential competitors, but that fact does not diminish the
public nature of the benefits that accrue from increased competition.
Moreover, it is well within Congress's powers to employ a regulatory
scheme that benefits private persons as a means of achieving its
legitimate purposes.  Berman v. Parker, 348 U.S. 26, 32-34 (1954).
The district court's view that Congress had misjudged the extent of
competition in the pesticide industry provided no legitimate basis for
overturning the congressional exercise of the commerce power.  The
legislative history shows that Congress had an adequate basis for
concluding that an exclusive use provision (prohibiting EPA from
considering prior data in support of subsequent applications) would
have undesirable anticompetitive effects.  Plainly, the court below
erred in displacing Congress's judgment in favor of the court's own
view of the matter.  Hodel v. Indiana, 452 U.S. at 326.  Lastly, the
court ignored Congress's express desire to eliminate unnecessary
duplicative testing as a means of promoting an efficient and effective
registration scheme.  See S. Rep. 95-334, supra, at 3-4, 7.  This
provides an independent basis, apart from the desire to encourage
competition, for the data consideration provisions.

                   B. The data disclosure provisions

   Congress's decision to provide for the disclosure of health and
safety data is also a legitimate exercise of the commerce power.
Congress repeatedly declared that the potential hazards of pesticide
use justified recognition of the public's right to complete
information on the safety and efficacy of these items of commerce.  S.
Rep. 95-334, supra, at 4, 13;  H.R. Rep. 95-663, supra, at 18-19, 42.
Disclosure of this information allows members of the public to decide
whether and how to use these often inherently dangerous products.  The
release of this information also informs the public of the basis of
EPA's decision to permit the product to be put on the market, and
facilitates the public's participation in proceedings under the Act.
/19/ See National Fertilizer Association v. Bradley, 301 U.S. 178
(1937);  Corn Products Refining Co. v. Eddy, 249 U.S. 427, 431 (1919).

   The district court concluded, however, that the public need only
rely on EPA's decision to register the product and that the public
does not require any more information than what is found on the label
(J.S. App. 33a).  Once again the court impermissibly substituted its
judgment for that of Congress.  Hodel v. Indiana, 452 U.S. at 326.
Moreover, as the district court itself noted (J.S. App. 24a), the
label does not provide complete information (J.A. 213-214, 231-232).
Neither the label nor the fact EPA has registered the product supplies
a bssis for understanding or evaluating EPA's conclusion that the
product will not cause unreasonable adverse effects on the
environment.  /20/ See 7 U.S.C. 136a(c)(5) and (7).  Thus, there was
ample reason for Congress to rely here on the desirability (recognized
by this Court in other contexts) of facilitating public participation
in regulatory decisions by making information available to the public.
 See, e.g., FCC v. Schreiber, 381 U.S. 279 (1965);  Utah Fuel Co. v.
National Bituminous Coal Comm'n, 306 U.S. 56, 60-62 (1939).
Consequently, the district court erred in holding that Congress
exceeded its authority by permitting disclosure of safety and health
data.

 II. FIFRA'S DATA CONSIDERATION AND DISCLOSURE PROVISIONS DO NOT TAKE
PROPERTY IN VIOLATION OF THE FIFTH AMENDMENT

 A. An interest in preserving the exclusive use and secrecy of health
and safety data required under FIFRA does not qualify as property
protected by the Taking Clause of the Fifth Amendment

   The district court's declaration that Sections 3(c)(1)(D) and 10 of
FIFRA are unconstitutional rested in part on its determination that
Monsanto had an interest in its health and safety data that qualifies
as property under the Taking Clause of the Fifth Amendment.  Although
the court properly rejected Monsanto's claim of a federally-created
property right in these data, it accepted the contention that Monsanto
has an interest created and protected by state law in maintaining the
secrecy and exclusive use of these data and that this interest is
property protected by the Fifth Amendment (J.S. App. 29a-30a).  The
district court found (ibid.) a basis for this right in Missouri law,
which provides a right to protect trade secrets based on the
Restatement of Torts Sec. 757 (1939).  See Sandlin v. Johnson, 141
F.2d 660 (8th Cir. 1944).

   1. Even if the district court were correct in concluding that
Monsanto possessed trade secret protection under state law, that
finding would not be dispositive of the issues in this case.  We start
from the common ground that while the data remained exclusively in
Monsanto's hands any trade secrets contained in the data would enjoy
whatever protections state law afforded.  But when Monsanto chose to
reveal the data to EPA in exchange for commercially valuable pesticide
registrations, it accepted the conditions attendant upon issuance of
the registrations.  In Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470
(1974), this Court held that state trade secret laws are not preempted
as a general matter by the federal patent laws, but the decision
acknowledges that Congress possesses the power to supersede such state
laws.  Id. at 493.  Where, as here, Congress has plainly rejected the
expansive definition of "trade secrets" contained in the Restatement
and has prescribed a uniform procedure for processing registration
data, it would contravene the Supremacy Clause for state law to
"'stand() as an obstacle to the accomplishment and execution of the
full purposes and objectives of Congress.'" Id. at 479 (quoting Hines
v. Davidowitz, 312 U.S. 52, 67 (1941)).  See Hancock v. Train, 426
U.S. 167, 179-180 (1976).  /21/

   FIFRA comprehensively defines the rights and obligations of EPA
with respect to submitted health and safety data.  It does so in a
manner that necessarily preempts conflicting state laws.  Indeed, the
proper functioning of the registration scheme depends upon uniform
application to all data;  it cannot, nor did Congress intend it to,
vary depending on whether data are submitted from a Missouri company
or a firm based in another state.  As a result, any continuing right
to confidentiality in the data Monsanto submitted to EPA is solely a
question of federal law.  Chevron Chemical Co. v. Costle, 641 F.2d
104, 116 (3d Cir.), cert. denied, 452 U.S. 961 (1981).

   Moreover, the dominance of federal authority in this area is
especially strong because the statute defines the duties of a federal
agency and its employees.  As this Court has held, state law rules
cannot regulate the functions of the United States without its
consent.  EPA v. California, 426 U.S. 200, 211 (1976):  Hancock v.
Train, supra, 426 U.S. at 178;  United States v. Georgia Public
Service Commission, 371 U.S. 285, 293 (1963):  United States v. County
of Allegheny, 322 U.S. 174, 183 (1944).  /22/

   2. In addition to its error in relying on Missouri law, the
district court was also incorrect in finding that FIFRA contravenes
the objectives of trade secret protection under state law.  The
district court relied on the Restatement of Torts definition of "trade
secrets," as "any formula, pattern, device or compilation of
information which is used in one's business, and which gives him an
opportunity to obtain an advantage over competitors who do not know or
use it." Id. Sec. 757, comment b.  The protection afforded by law to
this interest is significantly limited, however, since the basis of
liability to the trade secret owner is the breach of a general duty of
good faith.  Id. at comment a.  Thus, one who discloses or uses trade
secret information is liable to the owner only if there is some
impropriety associated with the acquisition of the secret (e.g., a
breach of a contractual obligation or a breach of confidence arising
from a relationship such as that between an employer and employee).
Id. Sec. 757.  As this Court has recognized, one policy underlying the
law of trade secret protection is the need to maintain recognized
standards of commercial ethics, Kewanee Oil Co. v. Bicron Corp., 416
U.S. at 481, and therefore protection is provided only when those
standards have been breached.  /23/ This unique characteristic of the
legal protection provided to trade secrets has led this Court to
recognize that the interest of a trade secret owner should not be
analyzed as property in the traditional sense.  E.I. Du Pont de
Nemours Powder Co. v. Masland, 244 U.S. 100, 102 (1917) (Holmes, J.).
Indeed the Restatement of Torts, relied on by Monsanto and the
district court, also concludes that the interest of a trade secret
owner is not a property interest but merely an interest in ensuring
the maintenance of ethical business dealings.  Id. Sec. 757, comment
a.  Thus, any protection is based exclusively on the legal obligations
of the particular persons who obtain the secret and therefore have the
power to disclose or use it.  As we have shown, in this case it is
federal law (prescribed in detail by Congress) rather than state law
that is the source of these obligations.  /24/

   3. The simple fact remains that whatever protections were available
to Monsanto prior to its submission of data to EPA, it chose to forgo
them in order to obtain registrations.  Monsanto cannot properly
contend that the history and administration of FIFRA created any
reasonable expectation to the contrary.  Prior to the 1972 Amendments,
there were no statutory provisions regarding the consideration of
previously submitted data in support of another application for
registration.  Contrary to the views of the district court, the
practice of the Department of Agriculture (and EPA when it took over
the administration of the program in 1970) was to grant subsequent
"me-too" registrations for pesticides without requiring the
duplication of supporting data that had been previously submitted.
/25/

   The desire to change prior practice and to offset the increasing
cost burden of producing registration data was the basis for the
industry's request to Congress in 1971 for a right to exclusive use of
health and safety data submitted in support of a registration.  This
proposal was opposed by members of Congress, the Department of
Justice, and EPA, who were concerned that an exclusive-use provision
would have undesirable anticompetitive effects and force wasteful
duplication.  S. Rep. 92-970, supra, at 12-13:  S. Rep. 92-838 (Pt.
II), supra, at 12-13, 69.  The compromise reached by Congress provided
for compensation to a data submitter when its data were considered by
EPA in connection with another application.  Thus, contrary to the
hopes of Monsanto and some other companies, the 1972 Amendments did
not provide for a right of unlimited exclusive use and did not, as a
general matter, prohibit EPA from considering previously submitted
data.

   In enacting these changes, however, Congress excluded from the use
and compensation scheme all data that were protected from disclosure
by Section 10(b) as a trade secret, a term that was not defined by the
statute.  The 1978 Amendments represent Congress's attempt to rectify
the situation created by judicial decisions interpreting the term
"trade secret" in the 1972 Amendments in an overly broad manner (see
pages 11-13, supra).  It is evident from this history that far from
possessing a long-standing, investment-backed expectation in
preventing the use of health and safety data to approve registrations
of other companies, the pesticide industry experienced a period when
data requirements were less rigorous and when subsequent registrations
were commonly based on another company's data;  then, when the cost of
producing such data increased significantly, the industry sought from
Congress compensating benefits for its efforts.  To the extent
Congress rejected this request, it is plain that Congress defeated
only a "unilateral expectation * * * (and) not a property interest
entitled to protection" under the Fifth Amendment.  Webb's Fabulous
Pharmacies, Inc. v. Beckwith, 449 U.S. 155, 161 (1980).  It is on this
basis that the Third Circuit has rejected the contention that a data
submitter under FIFRA has any property interest protected by the Fifth
Amendment.  Mobay Chemical Corp. v. Gorsuch, 682 F.2d 419, 423 (3d
Cir.), cert. denied, No. 82-241 (Nov. 8, 1982);  Chevron Chemical Co.
v. Costle, 641 F.2d 104, 116, cert. denied, 452 U.S. 961 (1981).

   The principal value of the data to Monsanto is the competitive
advantage derived from obtaining a registration.  But the ultimate
source of that value is not the effort and money expended by Monsanto
but the legislative decision to create a licensing scheme, which
created the potential for an economic advantage in having a
registration.  Even though the result of that decision may have been
to generate expectations of competitive gain, Congress has the
unfettered power to adjust the consequences of its decision (or even
to rescind the registration requirement altogether), as this Court has
recognized.  In Reichelderfer v. Quinn, 287 U.S. 315 (1932), the Court
rejected the contention that neighboring landowners had a property
right in the continued dedication of land taken to establish Rock
Creek Park in the District of Columbia.  As the Court noted (287 U.S.
at 319):

         Beyond the traditional boundaries of the common law only some
      imperative justification in policy will lead the courts to
      recognize in old values new property rights.  * * * The case is
      clear where the question is not private rights alone, but the
      value was both created and diminished as an incident of the
      operations of the government.  For if the enjoyment of a benefit
      thus derived from the public acts of government were a source of
      legal rights to have it perpetuated, the power of government
      would be exhausted by their exercise.

   Since Monsanto's expectations, no matter how strong, were created
as an incident to "the public acts of government," there is no warrant
to accord them the status of a property interest protected by the
Taking Clause.

   The same is true with respect to the data disclosure provisions.
The data submitted under FIFRA prior to 1972 were generally not
disclosed to the public, although the statute itself expressly
protected only product formulas, see page 5 & note 5, supra.
Notwithstanding any expectation that may have arisen, the 1978
Amendments requiring disclosure do not defeat an interest of
independent significance.  As the district court found, the data are
generated primarily for registration purposes (J.S. App. 21a). the
competitive edge lies in the contribution the data make to obtaining a
registration.  But the statute specifically provides for the
circumstances under which a particular company's data may or may not
be considered, and these provisions operate independently of any
authority to disclose the information.  We have shown that Monsanto
may not depend on its unilateral expectations to upset these rules,
and in these circumstances, disclosure or nondisclosure no longer
functions to control the primary business use of the data.  There
remains, then, no basis for concluding that the continued secrecy of
this information is a substantial property interest protected by the
Fifth Amendment.

 B. Even if Monsanto does possess a protected property right in its
test data, the 1978 Amendments are not a taking of that interest

   Even if this Court were to conclude that Monsanto's expectations in
controlling the use and disclosure of its data amounted to a protected
property interest, the operation of the 1978 Amendments do not "take"
this property within the meaning of the Fifth Amendment.  Although
this Court has on many occasions considered whether a governmental
action constituted a taking, no simple formula for adjudging such
claims has been established.  Penn Central Transp. Co. v. New York
City, 438 U.S. 104, 123-124 (1978).  The essence of the inquiry is a
weighing of the private interests against the public interest to
determine if "justice and fairness" require the government to
compensate for the economic injuries caused by governmental action.
Agins v. City of Tiburon, 447 U.S. 255, 260-261, 262-263 (1980);
Andrus v. Allard, 444 U.S. 51, 66 (1979);  Penn Central, 438 U.S. at
124.

   Among the factors to be considered in any particular case is the
economic effect on the claimant, specifically the extent to which the
government's action interferes with "distinct investment-backed
expectations." Penn Central, 438 U.S. at 124.  An important
consideration is whether the regulation destroys all property rights
or renders the claimant unable to derive any economic benefit from the
property.  Andrus v. Allard, 444 U.S. at 65-67.  "(W)here an owner
possesses a full 'bundle' of property rights, the destruction of one
'strand' of the bundle is not a taking, because the aggregate must be
viewed in its entirety." Id. at 65-66.

   Equally important, however, is the nature of the government action,
since interference caused by a "public program adjusting the benefits
and burdens of economic life to promote the common good," in contrast
to a physical invasion or appropriation of property, more readily
passes constitutional muster.  444 U.S. at 65-66.  The Court, after
weighing the public interest and the public purposes served by the
alleged taking, has sustained government actions that have had the
effect of destroying or severely affecting property interests.
Goldblatt v. Hempstead, 369 U.S. 590 (1962) (ordinance that
effectively prohibited continuation of pre-existing business of sand
and gravel mining);  United States v. Central Eureka Mining Co., 357
U.S. 155, 166-168 (1958) (government order prohibiting operation of
private gold mines for two years);  Miller v. Schoene, 276 U.S. 272,
279 (1928) (government order to destroy cedar trees that threatened to
inflict disease on nearby commercial apple orchards).  When tested
against the standards developed and applied by this Court, Monsanto's
claim of a taking must be rejected, as it has been by every court
other than the court below that has considered the question.  See
Mobay Chemical Corp. v. Costle;  supra.; Pennwalt Corp. v. Gorsuch,
No. 80-2400 (W.D. Pa. July 23, 1982), aff'd as a companion case in
Mobay, supra;  Chevron Chemical Co. v. Costle, 499 F.Supp. 732 (D.
Del. 1980), aff'd on other grounds, 641 F.2d 104 (3d Cir.), cert.
denied, 452 U.S. 961 (1981);  Petrolite Corp. v. EPA, 519 F. Supp. 966
(D. D.C. 1981).  See also Union Carbide Agricultural Products Co. v.
Costle, 632 F.2d 1014 (2d Cir. 1980), cert. denied, 450 U.S. 996
(1981).

                 1. The data consideration provisions

   Section 3(c)(1)(D) defeats Monsanto's claimed expectation that it
would retain control of the exclusive use of its health and safety
data.  As we have shown (pages 31-32, supra), these expectations do
not provide a foundation for a taking claim.  Moreover, the district
court found that despite the enactment of the 1978 Amendments,
Monsanto continues to expand its research and development and to
submit data to EPA (J.S. App. 21a;  J.A. 106, 213).  Thus, even if
these expectations technically qualify as a property interest, they
are so insubstantial that even their total destruction should count
for little when reckoned against the public interest served by the
legislation.

   In addition, there is, of course, no physical invasion as might be
the case with real property, but there is also no appropriation of
Monsanto's property by the government.  The government does not market
pesticides;  it uses the data in furtherance of the
congressionally-created regulatory scheme.  While other companies may
obtain a registration on the basis of Monsanto's data, Section
3(c)(1)(D) does not afford those companies any other rights in this
information.  Nor are they entitled to examine the data under this
subsection.

   The district court reasoned (J.S. App. 31a-32a) that Section
3(c)(1)(D) completely destroys Monsanto's "fundamental right * * * to
exclude" others from its property and, therefore, that a taking had
been established.  But this Court has unequivocally held that
interference with the right to exclude does not by itself constitute a
taking.  Pruneyard Shopping Center v. Robins, 447 U.S. 74, 84 (1980).
The "right to exclude" is merely one "strand" in Monsanto's "bundle"
of rights.  As the district court recognized, Monsanto retains
significant rights in its data (J.S. App. 18a, 21a, 23a).  First,
Monsanto used its data to obtain valuable registrations for its
products and Section 3(c)(1)(D) does not interfere with its continuing
right to market those products.  Second, Monsanto retains the right to
exploit the data to develop new products or new uses for old products
and to obtain domestic or foreign registrations for them (J.S. App.
18a, 21a;  J.A. 212).  Third, Monsanto retains the right to use the
data outside the registration process for purposes such as advertising
and marketing its products, defending claims against its products, and
enhancing its reputation in the agricultural and scientific
communities (J.S. App. 21a, 23a;  J.A. 77, 209-212;  Tr. 268-269).
Since Monsanto has not lost these significant rights in its data, the
limited interference Congress has mandated does not constitute a
taking.  Pruneyard Shopping Center v. Robins, 447 U.S. at 84;  Andrus
v. Allard, 444 U.S. at 65-66.  /26/

   Other factors also show that the economic impact on Monsanto is not
so substantial as to warrant a conclusion that the statute takes its
property.  The value of Monsanto's "right to exclude" is in reality
only an element of the competitive position Monsanto enjoys in the
marketplace.  It is therefore appropriate to assess the impact of the
statute on the entire range of competitive advantages Monsanto enjoys.
 On this score, the interference is not nearly so devastating as
Monsanto asserts.  The district court concluded that the company
retains its primary sources of competitive advantage, including its
product and use patents, its advertising and marketing techniques, and
lead-time advantages not related to the exclusive use or secrecy of
data (J.S. App. 18a-21a;  J.A. 93, 102, 106-108, 136-137, 159-160,
164-165, 188-189, 204-206, 209-210).

   Moreover, companies like Monsanto won from Congress a measure of
protection for their data and the competitive advantage that the
information may provide.  Monsanto retains a 10-year exclusive use
period for data submitted on any new active ingredient registered
after 1978 and is entitled to compensation for use of other data
submitted after 1969 for a 15-year period.  These valuable replacement
rights mitigate the burden of government action and militate strongly
against a conclusion of a taking.  Penn Central, 438 U.S. at 137.  An
additional benefit that Monsanto gains under the statute is the
reciprocal right to rely on its competitors' data to obtain
registrations and to enter the market with a particular pesticide
product.  The statute thus "secures an average reciprocity of
advantage" and may be sustained on this basis as well.  Pennsylvania
Coal Co. v. Mahon, 260 U.S. 393, 415 (1922).

   It is clear from this survey that the principal competitive impact
of the data consideration provisions is to reduce barriers to entry by
allowing subsequent applicants to obtain registrations for products
not covered by patents without duplicating test data EPA already has
in its possession.  This procompetitive impulse is, of course,
precisely what Congress intended and is fully consonant with the
purpose of the patent laws to foster competitive imitation once the
17-year period of exclusivity has expired.  It is not unexpected that
such an increase in competition will affect the market position of an
innovator who had enjoyed a statutory monopoly, and may lead to
reduced profits.  But, "loss of future profits -- unaccompanied by any
physical property restriction -- provides a slender reed upon which to
rest a takings claim." Andrus v. Allard, 444 U.S. at 66.

                   2. The data disclosure provisions

   Similarly, the limited interference, if any, with Monsanto's use of
its data that is attributable to the data disclosure provisions does
not constitute a taking.  What is at issue here is only the disclosure
of health and safety data to certain classes of persons.  Section 10
prevents, except in limited circumstances, the disclosure of a
company's confidential product formulas and information about
manufacturing and quality control processes.  7 U.S.C. 136h(d)(1)(A),
(B) and (C).  Moreover, Section 10(g) prohibits the knowing disclosure
of any information to foreign or multinational businesses engaged in
pesticide production or marketing.  7 U.S.C. 136h(g).  /27/ Nor does
the fact of disclosure by itself place Monsanto at a competitive
disadvantage in relation to other applicants for registration since
the data consideration provisions permit EPA to rely on Monsanto's
data to issue other registrations without the applicant having seen
the data.

   Moreover, Monsanto retains other significant rights to exploit the
data that do not depend on the continued confidentiality of the
information.  As the district court concluded (J.S. App. 21a),
Monsanto developed the data primarily to obtain pesticide
registrations, which are commercially valuable marketing licenses.
Disclosure of data does not affect the continuation of Monsanto's
registrations;  nor does it prevent the company from using previously
submitted data to obtain registration for new products or new uses for
approved products.  Indeed, as noted, see pages 34, supra, Monsanto's
research and development efforts have accelerated, rather than
diminished, since the passage of the 1978 Amendments.

   Monsanto simply has not made out a case of substantial and
particularized interference with its interest in maintaining the
secrecy of health and safety data that were submitted to the federal
government.  The public interest served by this provision, on the
other hand, is quite substantial.  Congress found here an overriding
public policy to promote knowledge about the safety and efficacy of
pesticide products, many of which are inherently dangerous.  See page
34, supra.  In addition to permitting members of the public to
evaluate and adjust their own exposure to pesticides, the disclosure
provisions also allow the public to stand on the same footing as the
agency and the industry in proceedings under the statute.  This Court
has recognized the propriety and, indeed, the desirability of
obtaining public input by making information on regulatory decisions
available to the public.  See, e.g., FCC v. Schreiber, 381 U.S. 279
(1965);  Utah Fuel Co. v. National Bituminous Coal Comm'n, 306 U.S.
56, 60-62 (1939).

   The district court's contrary conclusion was based on its
determination that the product label and the registration provide all
the protection and information the public needs.  The courts, however,
are not at liberty to dismiss so cavalierly the contrary conclusions
of Congress.  Hodel v. Indiana, 452 U.S. at 326.  Moreover, the
district court was wrong.  Neither the fact of registration nor the
label provides all the information necessary for persons who use or
are exposed to pesticides to evaluate fully their safety in particular
applications.  Cf. Federal Security Administrator v. Quaker Oats Co.,
318 U.S. 218, 229-231 (1943).

   Furthermore, this Court's decisions have long-since established the
basic proposition that there is a legitimate public interest in
requiring disclosure of trade secrets or proprietary information for
the benefit of consumers that will defeat a taking claim.  The Court
has sustained a state statute, designed to foster agriculture within
the state, that required the disclosure of the proportions of
ingredients in a fertilizer mixture, National Fertilizer Association
v. Bradley, 301 U.S. 178, 182 (1937), and has approved a similar
requirement to disclose the ingredients of table syrup.  Corn Products
Refining Co. v. Eddy, 249 U.S. 427, 431 (1919). In rejecting claims
that these statutory disclosure provisions unlawfully deprived
companies of property, the Court declared in language fully applicable
here that (249 U.S. at 431-432):

         it is too plain for argument that a manufacturer or vendor
      has no constitutional right to sell goods without giving to the
      purchaser fair information of what it is that is being sold.
      The right of a manufacturer to maintain secrecy as to his
      compounds and processes must be held subject to the right of the
      State, in the exercise of its police power and in the promotion
      of fair dealings, to require that the nature of the product be
      fairly set forth.  /(28)/

   Monsanto has not demonstrated that the balance Congress struck
between the interest in secrecy and the public's right to be informed
of the risks inherent in pesticides was so destructive of its
expectations that it may escape the rule of Corn Products and National
Fertilizers Association.  /29/ Although Congress had made a limited
adjustment in Monsanto's rights regarding the data, the company must
bear that burden in exchange for "the advantage of living and doing
business in a civilized community.'" Andrus v. Allard, 444 U.S. at 67
(quoting Pennsylvania Coal Co. v. Mahon, 260 U.S. 393, 422 (1922)
(Brandeis, J., dissenting)).

 III. EVEN IF FIFRA'S DATA CONSIDERATION AND DISCLOSURE PROVISIONS
TAKE MONSANTO'S PROPERTY, THE DISTRICT COURT ERRED IN GRANTING
INJUNCTIVE RELIEF

   As we have shown, Sections 3(a)(1)(D) and 10 do not cause a
"taking" of Monsanto's property.  But even if the district court's
contrary conclusion were correct, Monsanto would not be entitled to
injunctive relief.  A taking of private property may not be enjoined
as unconstitutional if the taking has been duly authorized, if it
serves a public purpose, and if the owner will be able to receive just
compensation for the property taken.  See, e.g., Duke Power Co. v.
Carolina Environmental Study Group, Inc., 438 U.S. 59, 94 n.39 (1978);
 Regional Rail Reorganization Act Cases, 419 U.S. 102, 126-127 and
n.16 (1974);  Larson v. Domestic & Foreign Commerce Corp., 337 U.S.
682, 697 n.18 (1949).  In this case, all three of these conditions are
satisfied.

   It is not disputed that EPA's consideration and disclosure of
Monsanto's data are duly authorized by Sections 3(c)(1)(D) and 10.
Moreover, as we have shown, pages 20-27, supra, both sections serve
important public purposes.  Thus, the only remaining issue is whether
just compensation will be provided.  As we will discuss, the statute
provides some measure of compensation under the data consideration
provisions.  In addition, the Tucker Act, 28 U.S.C. 1491, provides
Monsanto the means to obtain whatever additional just compensation is
due for any "taking." See Chevron Chemical Co. v. Costle, 499 F.Supp.
at 742-743.  See also Union Carbide Agricultural Products Co. v.
Costle, 632 F.2d at 1019;  Dow Chemical Corp. v. Costle, 464 F. Supp.
395, 399 (E.D. Mich. 1978).

   The district court erred in holding that Congress withdrew the
Tucker Act remedy when it enacted FIFRA.  The dispositive inquiry is
"not whether the (challenged statute) expresses an affirmative showing
of congressional intent to permit recourse to a Tucker Act remedy * *
*," but rather whether Congress has "withdrawn the Tucker Act grant of
jurisdiction to the Court of Claims to hear a suit involving the
(challenged statute) 'founded . . . upon the Constitution.'" Regional
Rail Reorganization Act Cases, 419 U.S. at 126 (emphasis in original).
 This rule of construction is based on the general principle that
"whether or not the United States so intended," a taking claim is one
"founded upon the Constitution" within the meaning of the Tucker Act
and therefore within the Claims Court's jurisdiction.  419 U.S. at 126
(emphasis supplied);  United States v. Causby, 328 U.S. 256, 267
(1946).  As this Court stated in Yearsley v. W.A. Ross Construction
Co., 309 U.S. 18, 21 (1940):

         (I)f the authorized action * * * does constitute a taking of
      property for which there must be just compensation under the
      Fifth Amendment, the Government has impliedly promised to pay
      that compensation and has afforded a remedy for its recovery by
      suit in the Court of Claims.

   In this case, there is no indication in the statute or its history
that Congress intended to impair the jurisdiction of the Claims Court
by withdrawing the Tucker Act remedy.  No language in FIFRA amends the
Tucker Act, or otherwise purports to deny the liability of the United
States.  There is no discussion in the legislative history indicating
that Congress thought any taking under the Fifth Amendment would
occur, much less that the United States should curtail the waiver of
its sovereign immunity against compensation claims.  /30/

   The district court mistakenly relied on the statute's creation of a
procedure for original data submitters to obtain compensation from
subsequent applicants.  It is certainly not a necessary inference from
this statutory mechanism for spreading among private parties the cost
of testing pesticides that Congress also intended to extinguish any
claims against the United States.  To be sure, Congress provided for
what it thought was an appropriate reward for the use of a company's
health and safety data.  But that fact does not support a conclusion
that Congress also blocked a company's recourse for losses for which
the Constitution requires compensation and which were not fully offset
by the amounts awarded under the statutory compensation scheme.
Regional Rail Reorganization Act Cases, supra;  Pennsylvania v. ICC,
535 F.2d 91, 97-98 (D.C. Cir. 1976).

   This Court considered a similar situation in the Regional Rail
Reorganization Act Cases, supra.  There Congress had sought to solve a
major rail transportation crisis by reorganizing several major
railroads into a single system operated by a private,
state-incorporated entity.  419 U.S. at 108-111.  As part of this
plan, certain rail properties were to be transferred to the new
corporation.  Congress explicitly recognized that the Fifth Amendment
would require just compensation for this transfer and provided for
compensation in the form of securities of the new corporation, certain
government-backed obligations and other benefits.  419 U.S. at 111.
In disposing of a claim that the resulting compensation would not meet
the constitutional minimum, this Court concluded that Congress's
express consideration of and provision for compensation due under the
Fifth Amendment did not support an inference that it had withdrawn the
remedy under the Tucker Act to make up any constitutional shortfall in
the statutory compensation.  419 U.S. at 128-131.  In the instant
case, the support for such an inference is even weaker because
Congress did not expressly consider any question of compensation due
under the Fifth Amendment.  /31/ Thus, even if the data disclosure and
consideration provisions do work a "taking" of Monsanto's property, it
was erroneous for the district court to enjoin their implementation as
unconstitutional -- at least in the absence of willingness by the
United States as a litigant to have the statutory scheme enjoined
rather than to provide by means of the Tucker Act remedy whatever
compensation is constitutionally required.  Regional Rail
Reorganization Act Cases, 419 U.S. at 102;  Chevron Chemical Co. v.
Costle, 499 F.Supp. at 742-743.

 IV. THE CONSTITUTIONAL CHALLENGES TO THE ARBITRATION AND COMPENSATION
SCHEME ARE NOT RIPE FOR RESOLUTION AND IN ANY EVENT ARE WITHOUT MERIT

 A. The district court erred in considering Monsanto's constitutional
attackes on the arbitration and compensation scheme in Section
3(c)(1)(D)(ii)

   In addition to holding that the statute unconstitutionally takes
Monsanto's property, the district court invalidated the arbitration
and compensation scheme provided for in Section 3(c)(1)(D)(ii).  Since
Congress determined that health and safety testing data need be
submitted only once for a particular pesticide, that provision was
intended to allocate the costs of performing the tests among all
companies who seek to have EPA consider the data in passing on
registration applications.  If a company submits data for which the
statute requires compensation, the firm that is seeking to have EPA
consider the data must make an offer of compensation to the original
submitter.  7 U.S.C. 136a(c)(1)(D)(ii).  If the parties cannot agree
on the amount of compensation, either party may initiate binding
arbitration through the Federal Mediation and Conciliation Service.
Ibid.  The decision of the arbitrator is final and unreviewable except
in the case of "fraud, misrepresentation, or other misconduct" by the
parties or the arbitrator.  Ibid.  The district court concluded (J.S.
App. 34a-36a) that this provision was invalid because:  (1) it did not
provide the constitutionally required just compensation;  (2) it
offended the Due Process Clause;  and (3) it delegated judicial power
to a non-Article III forum.  The attack on this provision, however,
was premature since Monsanto did not allege or establish that it had
been injured by an actual arbitration under the statute.  In these
circumstances, the issues were not ripe for review.

   Ripeness is a threshold element of Article III's requirement of a
case or controversy.  See Duke Power Co. v. Carolina Environmental
Study Group, Inc. 438 U.S. at 81;  Regional Rail Reorganization Act
Cases, 419 U.S. at 138.  Accordingly, federal courts are without
jurisdiction to adjudicate hypothetical disagreements or abstract
claims before action has been taken that has a concrete effect on an
aggrieved party.  Abbott Laboratories v. Gardner, 387 U.S. 136,
148-149 (1967);  Toilet Goods Association v. Gardner, 387 U.S. 158,
164 (1967).  To determine if a question is ripe for review, the Court
must consider the "fitness of the issues for judicial decision" and
weigh that consideration against "the hardship to the parties of
withholding court consideration." Abbott Laboratories v. Gardner, 387
U.S. at 149.

   In this case, the asserted claims of unconstitutionality are
premature in the absence of a specific arbitration award.  The statute
itself inflicts no harm on Monsanto.  The company claims that the
alleged defects in the statute will prevent it from receiving the
compensation that is due under the statute and the Constitution, but
that conclusion depends entirely on the amount Monsanto may receive in
any given case.  /32/ The matter is wholly speculative at present.
/33/ If the amount awarded to Monsanto in any future arbitration is
satisfactory, there would be no occasion to decide whether the process
comported with the Fifth Amendment or whether an Article III judge was
required to make or review the award.

   Precisely the same considerations led this Court to dismiss as
premature a similar attack on a statutory requirement for binding
arbitration.  Babbitt v. United Farm Workers Nat'l Union, 442 U.S.289,
304-305 (1979).  In that case, an Arizona statute required binding
arbitration of a labor dispute between farm workers and agricultural
employers if there was a strike and if the employer responded by
obtaining a temporary restraining order enjoining the strike.  The
Court held that so long as there was a possibility of settling such
disputes through negotiation and without the need to invoke the
challenged arbitration procedures, "any ruling on the compulsory
arbitration provision would be wholly advisory." 442 U.S. at 305.

   In addition, there is no hardship to Monsanto in withholding
judicial review at this time.  If and when Monsanto receives an award
that in its view is inadequate and illegal, the company may bring an
action to challenge the award and present its constitutional claims in
that proceeding.  /34/ The expense and inconvenience of pursuing the
arbitration procedures and bringing an action in the district court is
not the kind of hardship that would avoid a finding that the claim is
currently premature.  See FTC v. Standard Oil Co., 449 U.S. 232, 234
(1980).

 B. Neither the Due Process Clause nor Article III requires
invalidation of the arbitration and compensation scheme

   Even if Monsanto's claims were ripe for review, the district court
erred on the merits.  First, binding arbitration of statutorily
created entitlements does not offend due process.  Hardware Dealers
Mutual Fire Insurance Co. v. Glidden Co., 284 U.S. 151, 157-158 (1931)
(state statute mandating arbitration of the amount of loss under
insurance policy).  See also Andrews v. Louisville & N. RR., 406 U.S.
320, 322 (1972) (compulsory arbitration provision of the Railway Labor
Act for minor disputes, 45 U.S.C. 153 First (i)).  Nor do the
statute's limitations on judicial review call for a different result.
In Crane v. Hahlo, 258 U.S. 142 (1922), this Court upheld a statute
that declared that compensation awards for damage caused by municipal
construction work were final and unreviewable.  The Court concluded
that as long as the process was efficient and the courts could remedy
jurisdictional defects, fraud or willful misconduct of the board
making the awards, the statute satisfied the Due Process Clause.  258
U.S. at 147-148.  See Edwards v. St. Louis-S.F. R.R., 361 F.2d 946,
955 (7th Cir. 1966).  See also Switchmen's Union v. National Mediation
Board, 320 U.S. 297, 300-301 (1943);  Ludwig Honold Mfg. Co. v.
Fletcher, 405 F.2d 1123, 1127-1128 (3d Cir. 1969).

   There is no basis for the district court's further conclusion that
the statute is unconstitutionally vague for failing to provide
standards for determining the measure of compensation.  The 1972
Amendments provided for the right to "reasonable compensation for
providing the test data to be relied upon." Sec. 3(c)(1)(D), 86 Stat.
980.  The stated purpose was to spread the costs of data development
(S. Rep. 92-838 (Pt. II), supra, at 69).  The intended measure of
compensation was plainly the equitable division of those costs.  In
1978, Congress substantially altered the procedural aspects of the
arbitration and compensation scheme, assigning the determination of
the amount of compensation to the parties and the arbitrator rather
than to EPA.  See pages 12-13, supra.  It is clear from the
legislative history, however, that no change in the expected measure
of compensation was intended.  See S. Rep. 95-334, supra, at 7-8.
Senator Leahy explained in floor debate that the scheme "protects the
data developer's right to recover his data generation costs * * *."
123 Cong. Rec. 25706 (1977) (emphasis added).  Contrary to the
district court's conclusion, a constitutionally satisfactory measure
for compensation under Section 3(c)(1)(D), the equitable division of
data development costs, can be derived from the statute and its
history.

   Finally, it does not violate Article III of the Constitution to
assign the resolution of a compensation dispute to an arbitrator whose
decision is subject to limited judicial review.  /35/ This Court has
frequently upheld laws delegating the determination of
statutorily-created rights to administrative bodies without any
judicial review.  See South Carolina v. Katzenbach, 383 U.S. 301, 333
(1966);  Switchmen's Union v. National Mediation Board, 320 U.S. at
300-301, 303.  See also Andrews v. Louisville & N. R.R., Supra;  Crane
v. Hahlo, supra.  /36/

                              CONCLUSION

   The judgment of the district court should be reversed and the case
remanded with instructions to vacate the injunction and to dismiss the
complaint

   Respectfully submitted.

   REX E. LEE

      Solicitor General

   ANTHONY C. LIOTTA

      Acting Assistant Attorney General

   LAWRENCE G. WALLACE

      Deputy Solicitor General

   MARY L. WALKER

      Deputy Assistant Attorney General

   JERROLD J. GANZFRIED

      Assistant to the Solicitor General

   RAYMOND N. ZAGONE

   ANNE S. ALMY

   JOHN A. BRYSON

      Attorneys

   A. JAMES BARNES

      General Counsel

   EDWARD C. GRAY

   MARCIA E. MULKEY

   ROBERT S. McLAUGHLIN

      Attorneys Environmental Protection Agency

   DECEMBER 1983

   /1/ The health and safety data required for registration consist of
the following major types of studies:  (1) acute toxicity studies,
which define how poisonous the pesticide is when ingested, inhaled, or
applied to the skin or eyes;  (2) chronic toxicity studies, which are
used to determine if chronic exposure to the pesticide will have any
long-term health effects such as causing cancer or birth defects;  (3)
residue studies, which describe the level of the pesticide and its
degradation products which remain in food products;  (4) environmental
chemistry studies, which are used to determine how much of the
pesticide and its degradation products remain in the environment after
application;  and (5) fish and wildlife studies, which define how
toxic the pesticide is to fish and wildlife which may be exposed to
the pesticide after application in the environment.  See J.S. App.
17a;  47 Fed. Reg. 53192-53221 (1982).

   /2/ The use of pesticides also became widespread in nonagricultural
contexts.  For example, pesticides, as defined by FIFRA (7 U.S.C.
136(u)), include household insecticides, lawn and garden pesticides,
swimming pool chemicals, industrial pesticides, termite treatments,
and fumigants.

   /3/ Section 3(a)(1) of the statute made it illegal to market an
unregistered pesticide in interstate commerce.  61 Stat. 166.  While
the Secretary could initially refuse a registration by notifying an
applicant that the application did not comply with the substantive
requirements of the law, the applicant could then force the issuance
of a registration merely by filing a protest ("protest registration").
 Sec. 4(c), 61 Stat. 168.  In such a case, however, a registrant was
subject to increased penalties for any subsequent conviction for
offenses relating to matters about which the Secretary had warned the
registrant.  Sec. 8(b), 61 Stat. 170.

4 /4/ In addition to these categories of misbranding, Congress
declared a product misbranded if it was an insecticide, fungicide or
herbicide that would be injurious to humans, other animals or
vegetation "when used as directed or in accordance with commonly
recognized practice." Sec. 2(u)(2)(g), 61 Stat. 165-166.

   /5/ As a matter of practice, however, the Department of Agriculture
did not publicly disclose any of this information.

   /6/ Pursuant to Section 12(2)(G) of the amended Act, it was
unlawful to use a pesticide contrary to its labeling, 86 Stat. 990.
In addition, the Administrator was authorized to register a pesticide
for restricted use only.  Section 3(d)(1), 86 Stat. 981.  Under
certain circumstances, application of a restricted use pesticide was
required to be directed by persons certified as applicators under the
statute.  Secs. 3(d)(1)(C), 4, 86 Stat. 981, 983.

   /7/ The statute also upgraded the enforcement mechanisms by
requiring registration of pesticide-producing establishments and
authorizing their inspection (Secs. 7, 9, 86 Stat. 987, 988);  by
authorizing stop sale, use or removal orders for pesticides in
violation of the Act (Sec. 13, 86 Stat. 991) and by providing for
civil penalties in addition to criminal enforcement (Sec. 14, 86 Stat.
992).

   /8/ See J.A. 70-74.  Although the court below found that the
Department of Agriculture had a policy against considering data
developed by one company to support another company's registration
(J.S. App. 26a), this finding cannot undermine the basis upon which
Congress legislated in 1972.  Moreover, the evidence in this case
refutes this finding.  Testimony by employees who processed
applications for registration established that they routinely depended
on the knowledge that sufficient health and safety data had been
generated to support a prior registration when they approved a
subsequent application for the same or a similar chemical (J.A.
219-227, 228-230, 234-245).  Indeed, the Department of Agriculture
even published a list of those pesticides that would require no
additional toxicological data for registration.  The purpose of this
publication, "Interpretation 18," was to facilitate subsequent
registrations (J.A. 236-237, 240).  The only contrary evidence in this
case came from the prior testimony of two former Department of
Agriculture officials.  But that testimony was not only directly
contradicted by that of Harold Alford, who was employed as an
Assistant Director of the USDA Registration Division (J.A. 98-101), it
also was rejected by the court in which it was originally introduced.
See Mobay Chemical Corp. v. Costle, 517 F. Supp. 252 and 517 F. Supp.
254, 267 n.11 (W.D. Pa. 1981), aff'd, 682 F.2d 419 (3d Cir.), cert.
denied, No. 82-241 (Nov. 8, 1982).  The district court in Mobay, as
well as every court (other than the court below) that has considered
the matter, concluded that all previously submitted data were regarded
by the Department of Agriculture and EPA as available for approving
subsequent applications.  Chevron Chemical Co. v. Costle, 641 F.2d
104, 109 (3d Cir.), cert. denied, 452 U.S. 961 (1981);  Amchem
Products, Inc. v. GAF Corp., 391 F. Supp. 124, 128 (N.D. Ga. 1975),
remanded 529 F.2d 1297 (5th Cir. 1976).  Accordingly, the district
court's contrary finding should be rejected as clearly erroneous.

   /9/ Section 3(c)(1)(D), as amended in 1975, was challenged by an
original data submitter on the ground that Section 3(c)(1)(D) caused
an unconstitutional taking of its property rights in the data it had
submitted prior to January 1, 1970.  This claim was rejected by a
three-judge court, which held that Section 3(c)(1)(D) did not "take"
any property rights.  Mobay Chemical Corp. v. Costle, 12 Env't Rep.
Cas. (BNA) 1572 (W.D. Mo. 1978).  A direct appeal to this Court under
28 U.S.C. 1253 was dismissed on the ground that the three-judge court
had been improperly convened.  439 U.S. 320 (1979).

   /10/ See generally, Schulberg, The Proposed FIFRA Amendments of
1977:  Untangling the Knot of Pesticide Registration, 2 Harv. Envtl.
L. Rev. 342 (1977).

   /11/ Most of the pesticide products for which registration is
sought contain active ingredients that are also contained in
previously registered products.  Because the first registrant(s) of
products containing a particular active ingredient normally will have
supplied substantial amounts of health and safety data.  EPA's files
contain much data relevant to subsequent decisions whether to register
other products containing the same ingredient.  As the district court
found, most of the testing and research is done by a few, relatively
large firms, of which Monsanto is one (J.S. App. 4a).

   /12/ The later applicant need not have, and usually will not have,
obtained or seen a copy of the original submitter's data in order to
cite the data in support of the application.  EPA makes public lists
of persons who have submitted data along with general descriptions of
the information.  Applicants may use these lists to determine what
data to cite.

   /13/ The decisions of the arbitrator may be overturned for "fraud,
misrepresentation, or other misconduct." 7 U.S.C. 136a(c)(1)(D)(ii).

   /14/ While Section 3(c)(2)(A) also requires the Administrator to
make registration data available to the public, that Section is
subject to Section 10, which specifically provides for the disclosure
of the data at issue in this case.  See 7 U.S.C. 136a(c)(2)(A),
136h(d)(1).  For the purposes of this brief, references to Section 10
shall be deemed to include Section 3(c)(2)(A) as well.  Under Section
10(d)(1), 7 U.S.C. 136h(d)(1), EPA must, on request, disclose to
qualified requestors "(a)ll information concerning the objectives,
methodology, results, or significance of any test or experiment
performed on or with a registered or previously registered pesticide
or its separate ingredients, impurities, or degradation products, and
any information concerning the effects of such pesticide on any
organisms or the behavior of such pesticides in the environment,
including, but not limited to, data on safety to fish and wildlife,
humans and other mammals, plants, animals, and soil, and studies on
persistence, translocation, and fate in the environment, and
metabolism."

   /15/ Most, if not all, of the major pesticide companies are
multinational and therefore are precluded by this Section from
obtaining such data.  J.A. 208;  J.S. App. 4a.

   /16/ S. Rep. 92-970, supra, at 12, states:

         In effect, whether or not a pesticide has patent protection,
      a manufacturer wishing to register a pesticide previously
      registered would have to duplicate the required test data.  As
      patent protection is granted to a substantial number of
      pesticides, this provision of the bill imposes requirements on
      subsequent producers beyond the licensing fees that a
      patent-holder may receive.  In the extreme, a monopoly in the
      production of a pesticide could ensue if competitors are unable
      to afford the sometimes costly safety and efficacy tests.

   /17/ The House bill proposed to achieve that balance by generally
providing for a five-year exclusive period followed by a five-year
compensation period for test data.  H.R. 8681, 95th Cong., 1st Sess.
Sec. 2a(1977).  See H.R. Rep. 95-663, supra, at 18.

   /18/ To achieve these ends, the Senate Committee recommended no
restriction on the consideration of test data by EPA for other
applications, but provided a right of compensation for seven years
after the submission of the data.  S. Rep. 95-334, supra, at 7-8.  The
conference committee, departing from both the Senate and the House
versions, settled on the scheme set out in Section 3(c)(1)(D), 7
U.S.C. 136a(c)(1)(D).  S. Conf. Rep. 95-1188, 95th Cong., 2d Sess.
29-31 (1978).

   /19/ As the district court found (J.S. App. 22a), because of the
health and safety significance of the data submitted in support of an
application for a pesticide registration, EPA often receives requests
for access to this information from environmental organizations
interested in protecting humans and the environment from the adverse
effects of these pesticide chemicals, from farmworker unions that
serve to protect the interest of farmworkers who are directly exposed
to the pesticides used in the fields where they work, and from union
groups that represent the chemical workers who manufacture pesticides
(J.A. 249-250, 251-252).  Moreover, FIFRA specifically provides for
public participation in EPA's decisionmaking process.  Members of the
public may petition EPA to take regulatory action.  See 7 U.S.C. 136a.
 They may comment in rulemaking proceedings and on other regulatory
actions.  See, e.g., 7 U.S.C. 136a(b).  And they may petition for the
commencement of, and participate in, administrative hearings to cancel
or deny a pesticide registration.  See, e.g., 7 U.S.C. 136d(d);  40
C.F.R. 164.31.

   /20/ This determination requires the Administrator to assess the
"risk to man or the environment, taking into account the economic,
social, and environmental costs and benefits of the use of any
pesticide." 7 U.S.C. 136(bb).  Of necessity, this determination is a
generalized one that will not always apply to every individual
instance of the use of a pesticide.  A member of the public,
therefore, may well have need of the underlying data to evaluate the
risk of individual exposure.  J.A. 213-214.

   /21/ The fact that the Court has held that the federal patent laws
have not preempted state trade secret laws, Kewanee Oil Co. v. Bicron
Corp., supra, does not control the preemption question under FIFRA.
In Kewanee, this Court had to examine the objectives of the patent and
trade secret laws for irreconcilable conflict because the patent law
does not explicitly address the role of trade secrets.  416 U.S. at
480.  In FIFRA, Congress has specifically addressed this question and
clearly intended to prescribe uniform rules with respect to the use of
pesticide registration data.

   /22/ Congress's practice of setting the exclusive standard for
disclosure of information submitted to federal officials has a lengthy
history.  The Trade Secrets Act, 18 U.S.C. 1905, prohibits disclosure
by federal officials "to any extent not authorized by law." That
statute was enacted in 1948 as a codification of earlier laws.  See
Chrysler Corp. v. Brown, 441 U.S. 281, 294-298 (1979).

   /23/ In this respect, then, trade secret protection differs
significantly from the benefits accruing to the holder of a patent;
the patentee's right to exclude the use of the invention runs "against
the world" and liability for infringement does not depend on a breach
of good faith.  See Kewanee Oil Co. v. Bicron Corp., 416 U.S. at
489-490;  35 U.S.C. (Supp. V) 154.

   /24/ Indeed, the Restatement of Torts explicitly recognizes that a
person may have a privilege to disclose or use a trade secret and that
such a privilege may be created by law "in order to promote some
public interest" (id. Sec. 757, comment d).  Thus, disclosure or use
of a trade secret pursuant to a federal law would be privileged
conduct under the rule relied on by Monsanto and the district court.

   /25/ As shown above, see page 8 & note 8, supra, the record here is
so overwhelming on this point that the district court's contrary
finding must be deemed clearly erroneous.  This Court is not precluded
by its Rule 15.1(a) from rejecting this determination, since the legal
question whether the 1978 Amendments took property within the meaning
of the Fifth Amendment fairly comprises the subsidiary question of the
reasonableness of Monsanto's expectations in 1972.

   /26/ See Gannon, FIFRA and the "Taking" of Trade Secrets, 8 B.C.
Envtl. Aff. L. Rev. 593, 632-636 (1980).

   /27/ The district court found that most, if not all, of the large
firms that do research and testing on pesticides are engaged in
foreign or multinational pesticide marketing (J.S. App. 4a;  J.A.
208).

   /28/ See 301 U.S. at 182.

   /29/ A similar balance has been struck in a great number of federal
statutes that authorize or require public disclosure of information
submitted by private firms to the government.  We have already
referred (pages 20-21, supra) to federal statutes that require firms
seeking to engage in regulated activity to disclose data they might
otherwise choose not to reveal.  In addition, many federal statutes
provide for disclosure of allegedly "trade secret" information
concerning potential hazards to public health.  For example,
notwithstanding trade secrecy claims, the Toxic Substances Control Act
requires public disclosure of "health and safety data" concerning
chemical substances and mixtures of "health and safety data"
concerning chemical substances and mixtures distributed in commerce
(except for manufacturing processes and some formula information), 15
U.S.C. 2613(b);  the Clean Air Act requires disclosure of "emission
data," 42 U.S.C. (Supp. V) 7607(a)(1);  the Federal Water Pollution
Control Act requires disclosure of "effluent data," 33 U.S.C. 1318(b);
 and the Safe Drinking Water Act requires disclosure of all data
concerning drinking water contaminants, 42 U.S.C. 300j-4(d).  See also
42 U.S.C. 263g(d), requiring disclosure of trade secret data
concerning radiation emissions from electronic products such as
microwave ovens;  42 U.S.C. 5413(c)(5), requiring disclosure of trade
secret data concerning safety-related defects in mobile homes;  46
U.S.C. 1464(d), authorizing disclosure of trade secret information
regarding safety defects in boats and boating equipment;  and 15
U.S.C. 2217, authorizing trade secret fire protection information to
be disclosed when "necessary in order to protect health and safety."

   /30/ Monsanto has relied on a floor statement of Senator Leahy
containing the phrase "just compensation." 123 Cong. Rec. 25709 (1977)
(Mot. to Aff. 26).  The statement contains no reference to the Fifth
Amendment or the Tucker Act and appears to represent nothing more than
the Senator's view that compensation awarded under the arbitration
scheme should be fair and reasonable.  Moreover, this issue had been
raised in litigation under the 1972 and 1975 Amendments.  In 1976,
well before the consideration and passage of the 1978 Amendments, one
district court had denied a preliminary injunction on a taking claim
because of its determination that the Tucker Act remedy had not been
withdrawn.  Dow Chemical Corp. v. Train, 423 F. Supp. 1359, 1364 (E.D.
Mich. 1976).

   /31/ The district court's other reasons for finding a congressional
intent to foreclose relief under the Tucker Act are also without
merit.  It is of no significance that no monies were allocated for
compensation (see J.S. App. 36a).  Such an appropriation is not
customary and is not a prerequisite to jurisdiction of the Claims
Court under the Tucker Act.  See Yearsley v. W.A. Ross Constr. Co.,
309 U.S. at 21 (in the case of a taking, the government impliedly
promises to pay);  Hurley v. Kincaid, 285 U.S. 95, 104 (1932)
(compensation need not precede the taking).  Finally, the district
court's view (J.S. App. 36a) that the Tucker Act is not an adequate
remedy because FIFRA works an "immediate taking of Monsanto's property
as of the passage of the amendments of FIFRA" is unfounded.
Obviously, if any taking occurs, it occurs only when EPA actually
considers Monsanto's data to support another application or discloses
the data.  FIFRA itself does not automatically confiscate Monsanto's
data.  FIFRA merely provides for EPA's consideration and disclosure of
the data under specified circumstances.

   /32/ Monsanto's claim that the arbitration procedure will not
provide the just compensation required by the Fifth Amendment is
precluded by the availability of the Tucker Act remedy.  See pages
41-44, supra.

   /33/ Monsanto would suffer concrete injury only after a series of
discrete, independent events.  First, a company must apply for a
registration and seek to rely on data submitted by Monsanto and
compensable under Section 3(c)(1)(D).  Second, that company must make
a compensation offer to Monsanto.  Third, EPA must decide to grant the
registration.  Fourth, Monsanto and the other company must fail to
reach agreement on the amount of compensation.  Fifth, arbitration
must be initiated and the arbitrator must make an award.  At any stage
of such proceedings, Monsanto's statutory right to compensation may
not mature or may be fully satisfied.  It is apparent that no
immediate injury is caused by the enactment of the statute and that
such injury is not the inexorable result of the legislation.  The
existence of the many possible contingencies shows that the claimed
injury is speculative and the issues presented hypothetical.  See
Toilet Goods Association, v. Gardner, 387 U.S. 163-164.

   /34/ One such proceeding, not involving Monsanto, is currently
pending in the United States District Court for the District of
Columbia.  PPG Industries, Inc. v. Stauffer Chemical Co., C.A. No.
83-1941 (filed July 7, 1983).  Plaintiff in that action has attacked
Section 3(c)(1)(D) as unconstitutional under the Due Process Clause,
the Taking Clause and Article III.

   /35/ This Court's recent decision in Northern Pipeline Construction
Co. v. Marathon Pipe Line Co., 458 U.S. 50 (1982), is not to the
contrary.  The vice of the 1978 Bankruptcy Act was the assignment to
the bankruptcy courts of the authority to adjudicate traditional
common law rights (id. at 81-86);  the challenged provisions of FIFRA
deal only with a statutorily-created right of recent vintage.  Indeed,
the plurality in Northern Pipeline reaffirmed Congress's
constitutional authority to proceed in this manner (id. at 83
(footnote omitted)):

         (W)hen Congress creates a statutory right, it clearly has the
      discretion, in defining that right, to create presumptions, or
      assign burdens of proof, or prescribe remedies;  it may also
      provide that persons seeking to vindicate that right must do so
      before particularized tribunals created to perform the
      specialized adjudicative tasks related to that right.

   Thus, both the court below and the district court in Union Carbide
Agricultural Products Co. v. Ruckelshaus, 571 F. Supp. 117 (S.D. N.Y.
1983), erred in relying on Northern Pipeline to strike down the
arbitration provision.

   /36/ Moreover, even if this Court were to resolve the Article III
issue in Monsanto's favor, that would not justify enjoining the
entirety of Section 3(c)(1)(D), but only the limitation on judicial
review contained in the fourth sentence of Section 3(c)(1)(D)(ii).
See 2 C. Sands, Statutes and Statutory Construction Sec. 44.04 (4th
ed. 1973);  7 U.S.C. 136x (severability).  In this respect, the
judgment entered on November 29, 1983 in Union Carbide Agricultural
Products Co. v. Ruckelshaus, supra, was too broad since it barred EPA
from considering any data that would be subject to the arbitration
provisions in Section 3(c)(1)(D)(ii).