Disclosure of Pesticide Safety Data: A Viable Compromise At Last?

Peter O. Safir and Glenn E. Davis

Mr. Safir is a partner and Mr. Davis an associate in the firm of Kleinfeld, Kaplan & Becker, Washington, D.C.

On August 11, 1982 the House of Representatives passed a bill amending and extending the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).¹ The bill would make several important changes in the statute, but one of the most significant is its attempt to resolve the long-running battle over public access to data on pesticide safety submitted by manufacturers to the Environmental Protection Agency (EPA) as a part of the pesticide registration process. Industry has long fought to protect the safety data, which are commercially valuable because they are essential to the marketability of these chemical products, while public interest groups and others have struggled equally hard for open disclosure to make possible independent analysis of the adequacy of the safety studies. The battle has raged alternately in the courts and in Congress, with 1978 amendments to FIFRA requiring disclosure and industry stalling implementation with a series of suits and administrative and legislative initiatives. Recent court decisions indicating that the legal challenges might ultimately not succeed gave added impetus to industry efforts to amend the statute. The bill that passed the House might be a workable compromise because it gives industry increased protection while allowing what appears to be meaningful public access to safety data and giving environmentalists victories on other sections of the statute. Whether the compromise holds up in the Senate remains to be seen. Environmentalists find the new disclosure conditions so complex as to stifle meaningful review of the safety data, while industry, in spite of its fear of court-ordered implementation of the current disclosure rules, is not satisfied with the new protections offered in the House-passed bill.

Background

The Need for Public Access vs. the Need for Confidentiality

Companies wishing to market pesticides in the United States must develop, at the cost of considerable time and expense, extensive data supporting the safety and effectiveness of their products. These data are submitted to EPA,² which under FIFRA must register the pesticide if it is effective, appropriately labeled, and will not cause "unreasonable adverse effects on the environment."³ The data developed and submitted by the pesticide producer are the primary source of information upon which EPA makes its determination of the existence or absence of "unreasonable adverse effects."⁴

Pesticide producers invest millions of dollars annually in developing these data and have in the past submitted them to government agencies with the expectation that the data, which are considered trade secrets by the companies, would be maintained in confidence and not released publicly. Their fear has been that uncontrolled public disclosure of pesticide safety data would seriously impair the competitive advantage held by innovative companies that have developed and registered the pesticides. Their competitors might be able to use the data either to gain insights into a registrant's research directions or techniques or use the data in registering pesticides in foreign countries. This, in turn, would lessen the incentive to invest funds in pesticide research to the detriment of all concerned.

On the other hand, as a result of the safety determinations made on the basis of these data by EPA, there is widespread exposure of a basically unknowing populace to enormous quantities of pesticides. It has been estimated that over 1.4 billion pounds of pesticides are produced each year, with approximately 1,400 individual active ingredients being formulated into approximately 40,000 so-called "end use" products.⁵ Yet the data upon which the safety determinations are made have not been generally available to the public. Without ready access to the safety data generated by the pesticide producers, the public must depend upon the federal agency which screens the data, which agency must in turn depend upon the integrity of those sponsoring and conducting the safety studies.

In the 1960s and early 1970s public confidence in the safety of pesticides and in the ability of governmental agencies to make proper pesticide safety determinations declined dramatically. During this period, individuals and public interest organizations began questioning as well as actively opposing government determinations as to pesticide safety.⁶ Organizations such as the Environmental Defense Fund (EDF), the Natural Resources Defense Council (NRDC), the National Audubon Society (NAS), and labor unions demanded independent, non-governmental review of pesticide data.

The demands for release of pesticide data grew in intensity as the result of disclosures that called into question the safety of hundreds of pesticides already on the market. In the mid-1970s federal investigations and inspections disclosed that data from tests performed by Industrial Bio-Test Laboratories of Illinois (IBT), the nation's largest private pesticide testing laboratory, were tainted by fraudulent research practices.⁷ Subsequently, [12 ELR 15018] EPA determined that numerous health and safety tests performed by IBT were invalid.⁸

The implications of the IBT revelations were summarized by the AFL-CIO and the NRDC in April 1982 in a joint statement:

Some 200 pesticides registered on the basis of IBT studies continue in use in the United States and access to these studies is not being made available. Without such access, there is no way of knowing whether the testing has been conducted thoroughly and the data honestly presented to the regulating agency.⁹

Continued nondisclosure of safety data was not what Congress intended when it amended FIFRA in 1978. Under amended § 10 of FIFRA,¹⁰ EPA is required to disclose to the public safety studies in support of registered or previously registered desticides. However, despite the fact that these disclosure provisions have been in the statute for four years, to date they have scarcely been implemented. The pesticide industry and its allies, including farmers and other user groups, concerned over the lack of protection in § 10 against commercial misuse of safety data released to the public, blocked implementation of the public disclosure requirements through a series of challenges in the courts.

Congress is now reconsidering the problem and there is a possibility that it will scale back the § 10 disclosure provisions. A review of the existing disclosure provisions of FIFRA, coupled with an examination of the reasons why they have never really been implemented in spite of the general agreement by all concerned that some public access to pesticide safety data is necessary, illuminates the issues to be considered by Congress in the final stages of debating FIFRA amendments this year.

Public Access to Pesticide Safety Data, 1947-1978: The Trend Toward Disclosure

The public was barred from access to the safety data underlying pesticide registrations under early federal pesticide legislation. At least as far back as 1939, pesticide producers had conducted tests to substantiate the safety and efficacy of their products, but until 1947, the date of enactment of the first version of FIFRA, there was no requirement that such tests be submitted to any federal agency. Considered little more than a labeling law,¹¹ the 1947 version of FIFRA nevertheless authorized the Department of Agriculture (USDA) to require submission of pesticide safety data. This law was silent on whether such data were to be treated as trade secrets, but it did not prohibit the USDA from publicly disclosing test results.¹² However, under regulations the USDA held these data in confidence.¹³

In 1972 Congress enacted the Federal Environmental Pesticide Control Act, substantially amending FIFRA to increase EPA's powers to regulate pesticides. The 1972 amendments also contained a general mandate in § 10 that data received by EPA were to be made available to the public within 30 days after registration of a pesticide.¹⁴ However, public disclosure of information that, in the judgment of the EPA Administrator, contained or related to "trade secrets or [confidential] commercial or financial information" was prohibited.¹⁵ As the amended Act failed to define "trade secrets," clarification was left to the Administrator and the courts.

EPA took the position that the 1972 amendments restricted disclosure of only a narrow range of data such as pesticide formulae and manufacturing processes.¹⁶ Under EPA's interpretation, "trade secret" data did not include studies assessing safety, a position later codified in the 1978 FIFRA amendments.

EPA's administrative interpretation of "trade secrets" was challenged by industry in a series of lawsuits, with no little success. Several district courts held that safety data might be considered "trade secrets" if they met the requisites of that term as set forth in § 757, comment b, of the RESTATEMENT OF TORTS.¹⁷ Because of the "standoff" that was created by the EPA/industry dispute and the producers' lawsuits, there was no substantial public disclosure of safety data.

Disclosure Provisions in the 1978 Version of § 10

In 1978 Congress again substantially amended FIFRA,¹⁸ seeking to resolve the dispute in favor of disclosure. Section 10 continued to prohibit disclosure of "trade secrets or commercial or financial information,"¹⁹ but was amended to include a significant new "limitation." Data on safety to humans and other mammals, fish, wildlife, plants, animals, and soil were explicitly required to be disclosed to the public.²⁰ Important exceptions to this limitation were designed (1) to ensure that use of data by EPA to support the registrations [12 ELR 15019] of competing pesticide companies was governed by the § 3²¹ compensation provisions; (2) to prevent disclosure of the manufacturing and formula data; (3) to ensure that the data submitter was notified of any proposed disclosure; and (4) to prevent disclosure of data to foreign or multinational pesticide producers.²² Aside from these important protections, however, the statute now specifically required disclosure of safety data to the public, as had other recently enacted environmental legislation such as the Toxic Substances Control Act (TSCA).²³

The 1978 amendments thus should have led to disclosure of the safety data underlying pesticide registrations. In actually, however, because of the opposition of the pesticide industry and the change to an EPA administration which has not been an aggressive proponent of disclosure, § 10 has never been effectively implemented.

The Disclosure Controversy: The Early Rounds

Industry Suits to Block Disclosure

The objection of industry to public disclosure of safety data was a fundamental and legitimate fear that uncontrolled access to data developed at great cost and effort by innovative manufacturers and essential for registration of valuable products would be exploited by competing pesticide producers. Several of these concerns were articulated in a recent report of the House Committee on Agriculture:

The Committee recognizes that uncontrolled disclosure of pesticide safety and health data could result in two basic types of economic harm to the industry. Uncontrolled discloure could in a number of inter-related ways lead to the loss of the competitive advantages sought for and attained by firms who are successful in developing unique scientific technological innovations. In addition there is the potential for competing firms to use another company's data to gain pesticide registrations in foreign countries.²⁴

These and other industry fears led to a series of maneuvers that have (1) effectively blocked implementation of § 10; (2) prevented effective release of data sought by public interest, health, and labor groups; and (3) led to lengthy and often brutal debates in Congress concerning proposed amendments to § 10 that could significantly limit public access to data available under the existing version of the statute.

The pesticide industry began challenging disclosure of pesticide safety data by EPA soon after enactment of the 1972 FIFRA amendments. Those suits essentially challenged the administrative determination (in the face of a statutory ambiguity) that safety data were for the most part disclosable (i.e., not trade secrets). While many of those suits were pending, the statutory ambiguity evanesced with enactment of the provision in the 1978 amendments specifically requiring release of safety data. This development resulted immediately in an increase in the number and intensity of lawsuits by manufacturers anxious to protect their data. In certain actions already pending, the complaints were amended to encompass requests that the 1978 amendments to § 10 be declared unconstitutional.²⁵ Other companies quickly followed with new suits specifically challenging the § 10 public disclosure provisions.

In these suits, the pesticide producers argued basically that the amended § 10 public disclosure provisions are an unconstitutional taking of property under the Fifth Amendment to the United States Constitution.²⁶ The companies met with initial success in obtaining preliminary injunctions or agreements with EPA which forbade public disclosure of the subject data. On the merits, however, the industry has thus far failed to convince the courts that § 10 is unconstitutional.

In one major suit, Union Carbide Agricultural Products Co. v. Costle,²⁷ the district court issued a preliminary injunction against disclosure (or use) of pesticide data by EPA on the ground that disclosure and use without just compensation violates the Fifth Amendment.²⁸ On appeal, the Second Circuit vacated the injunction on the ground that the district court had improperly applied the standards for issuance of a preliminary injunction. In reversing the district court's order, the court stated somewhat ambiguously:

To complicate the problem in the instant case, a distinction must be made between EPA's use of appellee's data and its disclosure of the data to the public. The district court erroneously treated use and disclosure alike for purposes of the temporary injunction.²⁹

Following denial of a petition for a writ of certiorari, the injunctions and stays against disclosure or use of data that had previously been obtained by the plaintiffs were dissolved and the case went back to the district court for trial on the merits where it resides as of August 18, 1982.

In Petrolite Corp. v. EPA,³⁰ an individual pesticide producer sought preliminary injunctive relief against disclosure [12 ELR 15020] of its registration data, arguing that § 10 was an unconstitutional taking. The district court, per Judge Harold H. Greene, rejected the Fifth Amendment argument,³¹ but the plaintiff did not appeal.

The most recent decision squarely discussing the constitutionality of the public disclosure provisions of § 10 is also the most important and most definitive to date. That case, Mobay Chemical Corp. v. Gorsuch,³² involved a consolidated appeal of cases brought by Mobay Chemical Corporation and Pennwalt Corporation challenging the § 10 disclosure provisions, among other aspects of the statute, and EPA's implementing regulations (including the Agency's conditional registration and data compensation regulations).

On appeal Mobay argued, inter alia, that § 10: (1) is a taking of valuable property which is beyond the "Commerce Clause" powers accorded Congress in the Constitution; (2) is a taking of property without due process of law under the Fifth Amendment; and (3) is, together with FIFRA § 3's data compensation provisions, a taking of property without just compensation.³³ Mobay summarized its complaints in arguing that "[p]rior to the 1978 amendment, Mobay's research was its private library, access to which Mobay controlled. The 1978 amendments make this library public, extending to Mobay only a library card in exchange for the property exacted from it."³⁴

In its decision, the Third Circuit first noted that similar constitutional challenges to FIFRA's data compensation ("use") provisions had previously been rejected by that court in Chevron Chemical Co. v. Costle.³⁵ In Chevron the court had reviewed at length the legislative history of the 1978 amendments and their predecessors and had analyzed the claims of deprivation of property. It has then rejected the constitutional challenges, concluding that, in the "use" context, registrants do not have a property interest in data submitted to the EPA beyond that conferred by FIFRA itself.

In the Mobay decision, the court noted: "As a panel, we are bounded by Chevron."³⁶ It stated:

Pennwalt and Mobay attempt to place FIFRA's disclosure provision beyond the Chevron holding. Although that case did not decide whether the EPA's disclosure of data constitutes a taking, the same rationale applies to this issue with equal force. As we said in Chevron an applicant has no "continuing property interest, beyond that provided by federal law, applicable to material furnished to a federal agency as a precondition to selling a product in interstate commerce." 641 F.2d at 116.

An applicant may retain his property rights in data by not disclosing it to anyone. But no taking occurs if the applicant chooses to present the information to the government in exchange for a registration with substantial commercial value.³⁷

The court reasoned that FIFRA's disclosure provisions are not an unconstitutional taking because they are not a blanket authorization for the EPA to release confidential information. This is because § 10 limits public disclosure of test data to such matters as the effects of pesticides on human, animal, and plant life, and it specifically forbids disclosure of information concerning manufacturing or quality control processes, details of methods for testing inert ingredients added to pesticides, and the identity or quantity of such inert ingredients. Significantly, the court ruled that

The principle of limited disclosure that Congress applied in § 10 is neither startling nor new. Pesticides serve a useful and important function, but they also may present significant hazards. The public has a very real interest in their use and abuse and may justifiably assert a need to have sufficient information for protection. Congress balanced the understandable desire of the manufacturers to keep their experimental results confidential against the public interest in protecting the health of the community. Both positions were pressed vigorously before Congress, and it adopted a middle ground by providing for limited disclosure. This legislative action was well within constitutional boundaries and we sustain it here.³⁸

Similar suits challenging the constitutionality of § 10 are pending in the other courts. See Monsanto Chemical Co. v. Gorsuch,³⁹ American Cyanamid Co. v. Gorsuch,⁴⁰ and Thompson-Hayward Chemical Co. v. Gorsuch.⁴¹ As indicated in the accompanying notes, orders and/or stipulations in certain of these cases preclude disclosure of the relevant companies' pesticide data.⁴²

While pending cases may produce different results, to date the pesticide industry has been unsuccessful in overturning § 10 on grounds of unconstitutionality. In terms of blocking disclosure, however, the companies have [12 ELR 15021] successfully used injunctions, temporary stays, and agreements with EPA to block and effective disclosure under § 10.

The "Reading Room" I: Industry's Legislative Initiative

Dissolution in mid-1981 of the last Union Carbide injunction and stay and, perhaps, fear of ultimate defeat on the merits of the constitutional attack on § 10 led the National Agricultural Chemicals Association (NACA) and a number of its members to try on another front to stop the general implementation of § 10 disclosures. The first prong of this initiative involved an effort to have § 10 amended so that it would better protect those registering new products from commercial misuse of their safety data.

Specifically, the industry proposed that the statute be amended to have data made available in a public "reading room," with the registrant supplying summaries rather than actual raw data, particularly when such data could reveal information the registrant wanted to keep confidential.

The proposed amendment proved to be highly controversial. Public interest groups and health and safety officials generally opposed the reading room concept and limiting data disclosure to summaries, arguing that access to the full data was essential to substantiate claims made by the registrant and to assess the adequacy of health effects testing.⁴³

On February 4, 1982 at a public hearing on the proposed FIFRA amendments before the Department Operations, Research, and Foreign Agriculture Subcommittee of the House of Representatives' Committee on Agriculture,⁴⁴ representatives of unions and environmental groups uniformly opposed the reading room concept. Their testimony called it an unreasonable abridgment of the public's right to access to safety data — a right guaranteed under the 1978 FIFRA amendments. They stressed the procedural difficulties of the proposed amendments, including additional burdens on EPA, a lack of clarity in how one applies for information, uncertainties in screening who would use the rooms and under what conditions, and problems in controlling disclosure of data.⁴⁵

EPA also opposed the reading room concept. As John Hernandez, Deputy Administrator, testified before the Subcommittee:

The Agency had to be concerned about the reading room proposal and the use of health data summaries. While this change would not directly affect the Agency's ability to administer the pesticide registration program, it could lead to a destruction of public confidence in our decisions.

Limiting access to pesticide data summaries could be viewed by some as an attempt to limit public scrutiny of the decisionmaking process. If people are to accept the risk/benefit approach which is fundamental to the regulation of pesticides, the public must know what information is available and understand the decisionmaking process and its complexities. Such understanding and acceptance can only be developed if information about pesticide health effects is open to public scrutiny.⁴⁶

Because of the controversial nature of the reading room proposal, it was eventually dropped. In discussing the failure of what had started out as a "compromise" between industry and the public interest groups, Congressman Brown observed:

[W]e have achieved a middle ground by equally compromising the attainment of legitimate interests of the industry and public interest groups. In effect, we started at zero and went backwards.⁴⁷

The "Reading Room" II: Proposed Administrative Action

Even while the "compromise" reading room proposal seemed alive, the pesticide industry and its allies took another tack to protect confidential research data.They proposed that EPA implement the pending "reading room" amendments administratively without awaiting enactment of legislation. Representatives of 11 major pesticide producers and the NACA petitioned EPA, on October 29 and 30, 1981 respectively, to implement the "reading room" proposal immediately. In the words of one of the petitions:

As a result of oversight hearings on FIFRA by the House Agriculture Committee, Subcommittee on Department Operations, Research and Foreign Agriculture, it is expected that section 10 of FIFRA will soon be amended to provide specific protective procedures for confidential pesticide research data. These procedures, which it appears are acceptable to industry, EPA and Congress, will permit carefully controlled access to the data by the public in "reading rooms" in EPA offices, but will block all pesticide producers from obtaining access to the data.A version of such procedures is set forth in detail in the draft legislative amendments to section 10 ….

Petitioners request that EPA now administratively adopt procedures for public access consistent with those set forth in the statutory amendments, pending their enactment.⁴⁸

Concerned representatives of groups favoring disclosure, whose opposition to the reading room concept by now had crystalized, were unequivocal in their opposition to the industry petitions. They called advance implementation of the proposed § 10 amendments an illegal attempt to repeal the existing statutory disclosure provisions.⁴⁹

In the Agency's initial response to the petitions, Edwin L. Johnson, Director of EPA's Office of Pesticide Programs, said in December 1981 that the two petitions were being given "careful consideration."⁵⁰ Eventually the Agency concluded it lacked authority to carry out the proposal. The pesticide industry's two October 1981 petitions for administrative "implementation" of the "reading room" concept were denied by Dr. John A. Todhunter, EPA's Assistant Administrator for Pesticides and Toxic Substances, in letters dated June 8, 1982. In both letters, Dr. Todhunter stated:

[12 ELR 15022]

The Agency has determined to deny the petition, because EPA has concluded that it is legally required by current law to continue to follow the procedures set forth in 40 CFR Part 2 and in the Notice of Interim Procedures (43 Fed. Reg. 59060, December 19, 1978), and that the Agency has no legal authority to adopt in interim procedures proposed in your petition.⁵¹

The Alleged Disclosure "Moratorium"

Reports soon began to surface, however, that while Dr. Todhunter believed EPA could not legally implement the statutory amendments prospectively, he could informally "handle" the disclosure problem so as to protect the interests of industry.⁵² Indeed, it was reported in early 1982 that Dr. Todhunter had acknowledged that a "moratorium" on § 10 disclosures was in effect.⁵³ Whether the allegations of the existence of a moratorium were correct or not, the fact remained the rudimentary implementation of § 10 continued to be blocked because of the collective effects of delays in EPA's processing of Freedom of Information Act (FOIA) requests for data, the slow pace of Congress' consideration of amendments to § 10, and EPA's "careful consideration" of the industry petitions.

A consortium of environmental, labor, and other groups attacked the alleged moratorium. They charged that it was precipated in part by their early 1982 FOIA request to EPA.⁵⁴ That request asked for "all documents relating to carcinogenicity, mutagenicity, neurotoxicity and teratogenicity and other reproductive effects" in the registration files of 11 pesticides: Captan, toxaphene, ethylene dibromide, dimethoate, Temik, benomyl, carbon disulfide, carbon tetrachloride, TOK, lindane, and methyl bromide. Data concerning 2,4,5-T were also requested.⁵⁵ Among these 11 chemicals are some of the most widely used and controversial of pesticides.

Unsatisfied with EPA's cursory response to the FOIA report, the requestors filed suit in the U.S. District Court for the District of Columbia on April 29, 1982, alleging that the Agency's failure to reply fully and within the statutory time limit was in violation of the FOIA and § 10 of FIFRA.

The pleadings and other papers in AFL-CIO v. Gorsuch⁵⁶ indicate that the suit is an attempt to compel the Agency to implement the existing § 10 disclosure provisions. The complaint, for example, alleges upon information and belief the existence of a "moratorium" on data disclosure which, it avers, was "established by EPA to prevent the disclosure of health and safety reports submitted by registrants."⁵⁷ In an affidavit submitted to resist AFL-CIO's proposed deposition of him, Dr. Todhunter specifically denied that he gave orders to slow down the processing of FOIA requests and otherwise stated that he has no specific knowledge of a "moratorium."⁵⁸ Existence of the "moratorium" was thus clearly placed in issue by the action.

The IBT scandal also figures in the lawsuit. The AFL-CIO's pleadings cite "the wholesale falsification of registration data by Industrial Bio-Test Aboratories" to justify their need to depose Dr. Thdhunter concerning his knowledge of the requested data.⁵⁹ In addition, the plaintiffs contend that pesticides still being marketed were supported by IBT data which, in their opinion, fully justifies release of these and other data for full public review. In discovery requests made later during their lawsuit, they demanded copies of all information linking IBT data with the 11 pesticides which were the subject of their FOIA request.⁶⁰

The AFL-CIO action remains pending as of this writing. Discovery is in progress, but negotiations are underway to settle out of court.⁶¹ The impact of the lawsuit will depend to a significant degree on the outcome of Congress' current attempts to amend FIFRA. But should these attempts fail this session, a decision in AFL-CIO could well force full implementation of the § 10 disclosure requirements.

The disclosure Controversy: Legislative Action

H.R. 5203

With the AFL-CIO action still pending and the Agency still not releasing data under § 10, legislation now pending in Congress is of crucial concern to industry, environmental and labor groups, and the general public. The latest proposed amendments to § 10 arose in early 1982 from the ashes of the failed "reading room" proposal. The initial drafts were apparently worked out by the EPA and NACA.⁶² On February 26, 1982 a meeting was held between representatives of the EPA, NACA, NRDC, NAS, AFL-CIO, and others at which the new proposal was discussed. Emerging from that meeting, NRDC's Jacqueline Warren said that the EPA/NACA draft § 10 proposals were unacceptable and, apparently apeaking for all of the environmental, health, and labor groups at the meeting, noted the general feeling that these groups should not negotiate away the as yet undelivered benefits they have under the existing version of § 10.⁶³

[12 ELR 15023]

The EPA/NACA amendments to § 10 were subsequently the subject to extensive and often rancorous debate before the House Subcommittee. The amendments were vigorously supported by industry as vital to protecting trade secrets from falling into the hands of unscrupulous competitors. They were just as stridently opposed by the public interest groups as a significant shrinkage of the public's rights under § 10. After passage of the amendments in committee, three committee members⁶⁴ inserted the following observation as "Supplemental Views" in H.R. REP. NO. 97-566:

If the purpose of these Section 10 amendments is to protect pesticide manufacturers from competitors, they fail abysmally because they do not protect trade secrets any more than does the current law. But, if the purpose of the Section 10 amendments is to limit, as much as possible, public and independent scientific review of pesticide health and safety studies, they are an unqualified success.⁶⁵

Ultimately, a portion of the provisions most onerous to the public interest groups — namely, those allowing withholding for five years of data concerning "innovative methods and technology" — were, in a surprise move, stricken from the FIFRA bill when the remainder of the § 10 amendments passed the full House of Representatives.⁶⁶ These and other controversial provisions, however, remain in the Senate version of the FIFRA amendments, and the status of the amendments as a whole remains unresolved as of this writing.⁶⁷

The proposed amendments tothe § 10 disclosure rules have five key features which will be the focus of intense debate in the Senate and, should the become law, the subject in all probability of litigation. Each is discussed below.

Innovative Methods and Technology

The most controversial feature of the proposed amendments may be the absence of a provision giving extra protection to "innovative methods and technology." Such a provision failed to pass the full House, but a version remains in the Senate bill. Under it, "innovative methods and technology" which are not publicly known and which would provide a significant advantage to competitors would receive an extra measure of protection from disclosure for five years. The term "innovative methods and technology" is intended to cover methods employed in obtaining product and environmental chemistry, residue or metabolism data, and would include data on most metabolites of the active ingredient, data which is of tremendous importance in testing new chemicals.

The precise conditions on disclosure of such data would be established by EPA in separate regulations. The proposed amendment specifies that the information would be made available to a smaller circle of people than could receive other data. Data containing innovative methods or technology would be available only to scientists acting on behalf of federal or state agencies, independent scientists who work in the field to which the data pertain, and scientists and staff representatives acting on behalf of nonprofit health, environmental, or labor organizations who wish to conduct a peer review or replicate a study. The scientists and representatives would be free to communicate with each other and with EPA, and in judicial or administrative proceedings, concerning such data. A summary of the data could be requested and the EPA Scientific Advisory Panel could be required to review the data and issue recommendations to the Administrator that such information be made available to the public on the same basis as other health and safety data if necessary in the public interest. If the Administrator concurred, the data would be made so available.

The report of the House Committee on Agriculture justified the extra protection afforded "innovative methods and technology" on several grounds. The report stated that the purpose of providing additional protection for these data is to enhance the probability that the research and development investments required for the discovery of new pesticides would eventually prove profitable. It argued that innovative chemical and analytic methodologies are particularly valuable tools needed to extend current pesticide labels to cover specialty and minor crop pest control needs, and that the historic inability of pesticide manufacturers to justify investments in minor-use product development remains one of the most stubborn problems raised by FIFRA. The proposed extra protection, therefore, is to assure an "innovative" firm five years of additional lead time during which it can expect to capture benefits flowing from the development of new methodologies.⁶⁸

In the committee report, the minority views of Congressmen Weaver, Bedell, and Daschle took a somewhat less charitable view of the industry proposals. Their report asserted that the proposals restrict free discussion of any information pertaining to "innovative methods or technology." In so doing, the minority report claimed, notonly is the public's right to know preempted, but peer review is substantially restricted by the onerous conditions on communication among scientists, thereby significantly increasing the possibility of public health risks which might otherwise be identified and prevented.⁶⁹

Other criticism came from the NAS which was especially concerned about attempts to define "innovative methods and technology":

In both House and Senate language, innovative method or technology must be new, not otherwise available to the public and "used for the purpose of obtaining product chemistry, and environmental chemistry, residue chemistry, or metabolism data."

This provision redefines what is disclosable under Section 10(d) by defining legally disclosable environmental data under wraps as "innovative methodology." Even worse, it appears to be a smoke screen by which to deny [12 ELR 15024] access to environmental data currently disclosable under Section 10(d).⁷⁰

Environmental groups also expressed the fear that the vagueness of the term "innovative methods and technology" would lead to endless litigation by the pesticide industry that could forestall implementation of the statute and regulations.

In a statement prepared for presentation before the Senate Committee on Agriculture, Nutrition, and Forestry, NACA President Dr. Jack Early responded to these and other criticisms of the § 10 amendments:

The bill assures members of the public full access to health and safety information, including innovative scientific methods, so that they may monitor EPA's pesticide decisionmaking. The proposed legislation does however place controls on the copying and transfer of data, and on the persons given access to innovative methods, to ensure that the data are not improperly given to competitors, such as pesticide producers and registrants, who could use the information for commercial purposes.⁷¹

Whether one accepts this statement as true or not, the "Innovative methods and technology" section discussed above would result in a significant tightening of the disclosure provisions in § 10.

Health and Safety Data

The basic protective provision in the House-passed bill requires that any information in a study concerning the health, safety, or environmental effects of a product could be freely communicated and publicly discussed, but a verbatim copy of a study could not be transferred to any pesticide producer or a person acting on its behalf.

Disclosure to Pesticide Producers

The amendments would extend the existing § 10 prohibition against disclosure of safety data to multinational pesticide producers to prohibit such disclosure to employees or agents of any (i.e., domestic) pesticide producer or to any other person who intends to disclose the data to any such person, unless the data submitter has consented to such disclosure or the data are needed in administrative adjudicatory hearings or court litigation.

Regulations

Underthe FIFRA amendments passed by the House, EPA would be required to issue disclosure regulations under which all persons (except competitors and their employees), including employees of federal and state agencies and scientific personnel representing employees of a pesticide producer or the employee's trade union, may obtain from EPA a copy of health, safety, and environmental data. However, to prevent the data from being disclosed to competitors, the EPA regulations would have to impose conditions on further copying and transfer of data by such persons in accordance with detailed principles and procedures governing disclosure. On paper, such requirements appear to be an essential part of the scheme to keep safety data from falling into the wrong hands, but environmental groups have opposed them as making it practically impossible to get adequate review of the data.

Private Right of Action and Civil Penalties

Perhaps the most powerful data protection provision in H.R. 5203 is the "private cause of action"⁷² in proposed § 10(h). This subsection would provide authority for a cause of action by a data submitter who may be adversely affected by the violation (or threatened violation) of § 10 by another person (other than a federal or state official) who is acting willfully in furtherance of a commercial purpose. In other words, the subsection would permit an action against a person authorized under amended § 10 to receive safety data who "leaks" it to a pesticide company. An appropriate court could prevent and restrain such a violation of § 10, award damages for the violation, or both. Treble actual damages must be awarded, and in cases of gross violation the court could award punitive damages.A data submitter could also bring an action in an appropriate United States district court against any agency official specifically to enforce this section. A violator acting in furtherance of a commercial purpose could also be assessed a civil penalty of up to $100,000 by the Administrator or be subject to criminal prosecution.

The industry has argued that the proposed private right of action is necessary as an encouragement to self-policing under the Act. Public interest groups have criticized it as an unnecessary dividend for industry, which is otherwise the chief beneficiary of the proposed amendments.

Conclusion

As of this writing, a version of the bill without the "innovative methods and technology" provisions has passed the House, and a version with those provisions is under consideration in the Senate.⁷³ Because of the controversial nature of these and other portions of the proposed § 10 amendments, it is at least a possibility that no § 10 amendments will pass during the present session of Congress. This would leave the existing § 10 in effect and would perhaps add new impetus and impact to the pending AFL-CIO suit which is seeking to force EPA to release data under § 10 as presently written.

Because of the widespread exposure of the public to pesticides and because of the perceived past failures of government agencies to provide adequate protection from pesticides, the public has an undeniably legitimate interest in disclosure of health and safety data, at leastto independent, non-governmental scientists. Pesticide workers, pesticide users, and consumers — the "exposed" — are, because of events such as the IBT scandals and the concomitant decline of public confidence in governmental decisionmaking, unlikely to be satisfied until there is some method of data disclosure which is both statutorily mandated and administratively implemented. Pesticide producers, on the other hand, invest millions of dollars in developing these data and have a legitimate interest in preventing uncontrolled public disclosure of pesticide safety data because of the likelihood that such data, once disclosed, will fall into the hands of, and ultimately benefit, both foreign and domestic competitors.

The basic premise underlying public access to industry data on which pesticide registrations are based is that better, fairer, and, perhaps, more trustworthy decisions will result if the decisionmaker and the data submitter know [12 ELR 15025] that the data are available to disinterested third party scrutiny. The basic premise underlying government protection to commercially valuable proprietary data is that innovation should not be discouraged and the competitive advantage must not be needlessly compromised. The amendments to § 10 as passed by the House are consistent with both these premises. They assure that the crucial safety data surrounding the registration of pesticides are available to those who are seriously interested in obtaining and reviewing them, yet unavailable to those who are merely casually curious or who would commercially abuse them. This is accomplished through necessary procedural safeguards. Under this scheme, those groups demanding unrestricted public access and those groups demanding total protection of valuable proprietary information may each remain dissatisfied, but the legitimate objectives of each are addressed.Whether this system is, in fact, enacted and works in practice remains to be seen.

1. 7 U.S.C. §§ 136-136y, ELR STAT. & REG. 42301. To be technically correct, we are referring to the provisions of the Federal Environmental Pesticide Control Act of 1972 (FEPCA), as amended by the Federal Pesticide Act of 1978. FEPCA established a comprehensive regulatory program which was to replace the existing FIFRA scheme. Although FEPCA amended FIFRA and the latter name was to be preserved (see note after 7 U.S.C. § 136, ELR STAT. & REG. 42309) the original non-supplanted provisions of FIFRA remain codified at 7 U.S.C. §§ 135-135k, ELR STAT. & REG. 42303.

2. The United States Department of Agriculture (USDA) was responsible for administration of FIFRA until 1970 at which time that responsibility passed to EPA. Reorg. Plan 3 of 1970, 3 C.F.R. § 1072 (1966-1970 compilation), reprinted in 5 U.S.C. app., at 609 (1970), and in 84 Stat. 2086 (1970).

3. 7 U.S.C. § 136a(c)(5)(C)-(D), ELR STAT. & REG. 42311.

4. H.R. REG. NO. 566, 97th Cong., 2d Sess. 41 (1982).

5. S. REP. NO. 334, 95th Cong., 1st Sess. 27-28, 34 (1977).

6. H.R. REP. 566, at 41.

7. Preclinical and Clinical Testing by the Pharmaceutical Industry, Hearings before the Subcomm. on Health and Scientific Research of the Comm. on Human Resources, 95th Cong., 1st Sess. pt. 4 (1977).

8. "Quarterly Report on the I.B.T. Program, 4th Quarter Fiscal Year 1981," Memorandum from Marcia Williams, Special Pesticide Review Division, to Edwin L. Johnson, Office of Pesticide Programs, EPA.

9. Quoted in PESTICIDE AND TOXIC CHEMICAL NEWS, May 5, 1982, at 12.

10. 7 U.S.C. § 136h, ELR STAT. & REG. 42315.

11. H.R. REP. NO. 511, 92d Cong., 1st Sess. 4 (1971).

12. Union Carbide Agricultural Products Co. v. Costle, 632 F.2d 1014, 1016, 10 ELR 20846, 20847] (2d Cir. 1980), cert. denied, 450 U.S. 965 (1981).

13. See, e.g., 7 C.F.R. § 1.3(b)(1) (1949) (providing that data submitted to support pesticide registrations not be made available to persons outside the agency); 7 C.F.R. § 1.4(b)(15) (1962) (providing that data concerning products and formulations provided by industry in connection with registration are administratively confidential); 7 C.F.R. § 370.13(d) (1968) (providing that trade secrets, scientific and technical data on products, process or methods, and data in research studies are confidential). See Union Carbide, 632 F.2d at 1016, 10 ELR at 20847.

14. 7 U.S.C. § 136a(c)(2)(A), ELR STAT. & REG. 42310.

15. 7 U.S.C. § 136(h), ELR STAT. & REG. 42315.

16. See discussion in Mobay Chemical Corp. v. Costle, 447 F. Supp. 811, 816-17 (W.D. Mo. 1978), appeal dismissed, 439 U.S. 320 (1979).

17. See, e.g., Mobay Chemical Corp., 447 F. Supp. at 824-27; Chevron Chemical Co. v. Costle, 443 F. Supp. 1024, 1031-32, 8 ELR 20362, 20364 (N.D. Cal. 1978); Dow Chemical Co. v. Costle, No. 76-10087 (E.D. Mich. Nov. 16, 1977).

18. Federal Pesticide Act of 1978, Pub. L. 95-396, 92 Stat. 819.

19. 7 U.S.C. § 136h(b), ELR STAT. & REG. 42315.

20. 7 U.S.C. § 136h(d), ELR STAT. & REG. 42315.

21. 7 U.S.C. § 136a(c)(1)(D)(ii), ELR STAT. & REG. 42310.

22. 7 U.S.C. § 136h(d) & (g), ELR STAT. & REG. 42315. It should be noted that under the present version of § 10 there is no specific prohibition against disclosure of safety data to domestic, non-multinational pesticide producers (as there would be under the 1981-82 FIFRA bills,) but "use of such data for any registration purpose," e.g., by a domestic pesticide producer to support or obtain a pesticide registration, is subject to the data compensation provisions of § 3. 7 U.S.C. § 136h(d)(1), ELR STAT. & REG. 42315.

23. 15 U.S.C. §§ 2601-2629, ELR STAT. & REG. 41335. TSCA allows public disclosure of "health and safety" data concerning chemical substances and mixtures distributed in commerce. 15 U.S.C. § 2613(b), ELR STAT. & REG. 41346.

24. H.R. REP. 566, at 42.

25. See, e.g., the amended complaints in Amchem Products, Inc. v. EPA, No. 76 Civ. 2913 (S.D.N.Y.) (which ultimately became the Union Carbide case in the Second Circuit).

26. These suits invariably also challenged on constitutional grounds the 1978 amendments to § 3 (the "use" provisions) under which EPA could rely upon the data of one pesticide producer to support the registration of another producer's pesticide. As indicated in note 22, supra, the § 3 provisions are related to the § 10 disclosure provisions. Discussion of the § 3 issues is, however, beyond the scope of this article.

27. See note 12, supra.

28. For a discussion of the FIFRA taking cases, see Comment, Constitutional Challenges to FIFRA's Use and Disclosure Safeguards Yield Mixed Results, 11 ELR 10157 (1981); see also Note, FIFRA and the Taking of Trade Secrets, 8 B.C. ENVTL. AFF. L. REV. 593 (1980).

29. Union Carbide, 632 F.2d at 1018, 10 ELR at 20848 (emphasis added).

30. 519 F. Supp. 966, 11 ELR 20751 (D.D.C. 1981).

31. 519 F. Supp. at 972-73, 11 ELR at 20754.

32. 12 ELR 20776 (3d Cir. June 22, 1982), petition for cert. filed August 11, 1982.

33. Appellant's [Mobay's] Brief and Addendum, at 17-28; Appellant's [Mobay's] Reply Brief, at 12-18, Mobay Chemical Corp. v. Gorsuch, Nos. 18-2190 and 81-2191 (3d Cir.).

34. Appellant's [Mobay's] Reply Brief, at 12-13.

35. 641 F.2d 104, 11 ELR 20156 (3d Cir.), cert. denied, 452 U.S. 961 (1981).

36. 12 ELR at 20778.

37. Id.

38. Id. The Mobay decision is also significant because the court held that in promulgating the conditional registration and data compensation regulations EPA had failed to follow applicable Administrative Procedure Act (APA) notice and comment rulemaking procedures. However, the court declined to invalidate those rules, giving the Agency six months to repromulgate in accordance with APA procedures. Id. at 20780. As noted in note 33, supra, a petition for a writ of certiorari was filed by Mobay on August 11, 1982.

39. No. 79-0366-C(1), ELR PEND. LIT. 65625 (E.D. Mo. filed Mar. 30, 1979). In this case, a pre-trial order precludes disclosure of data unless 60 days' advance notice is given the plaintiff by EPA.

40. No. 77-226 (D. N.J. filed Feb. 3, 1977). In the Cyanamid case a stipulation in lieu of an injunction precludes disclosure of the plaintiff's data. The government has sent the district court a copy of the Third Circuit's decision in Mobay Chemical Corp. v. Gorsuch, contending that that opinion is dispositive in the Cyanamid action.

41. No. 79-2308 (D. Kan. filed Nov. 15, 1979). This case is at the pre-trial stage.

42. See notes 40 and 41, supra. See also Government's Answer at 5-6, AFL-CIO v. Gorsuch, No. 82-1195, ELR PEND. LIT. 65755 (D.D.C. filed Apr. 29, 1982), for a listing as of June 1, 1982 of those pending suits where EPA believes itself precluded from disclosing pesticide data.

43. H.R. REP. 566, at 79.

44. Hereinafter referred to as "Subcommittee."

45. H.R. REP. 566, at 96.

46. H.R. REP. 566, at 81.

47. Quoted in PESTICIDE AND TOXIC CHEMICAL NEWS, Dec. 16, 1981, at 15.

48. Letter from Kenneth W. Weinstein, Counsel for Petitioners, to Anne M. Gorsuch, Administrator, EPA (Oct. 29, 1981), at 2 (emphasis added).

49. See PESTICIDE AND TOXIC CHEMICAL NEWS, Feb. 10, 1982, at 29; Complaint, AFL-CIO v. Gorsuch, at 7.

50. Quoted in PESTICIDE AND TOXIC CHEMICAL NEWS, Dec. 2, 1981, at 2.

51. Letter from John A. Todhunter to Kenneth W. Weinstein (June 8, 1982), at 1; Letter from John A. Todhunter to Dr. Jack D. Early, President, NACA (June 8, 1982), at 1.

52. PESTICIDE AND TOXIC CHEMICAL NEWS, Jan. 27, 1982, at 7-8.

53. Legal Times of Washington, Feb. 22, 1982, at 11.

54. Letter from Al Meyerhoff and Stephen P. Berzon, Counsel for AFL-CIO, Consumers Union of the United States, Inc., NRDC, EDF, The Sierra Club, Friends of the Earth, International Chemical Workers Union, AFL-CIO, National Coalition Against Misuse of Pesticides, California Agrarian Action Project, and California Rural Legal Assistance, to Anne Gorsuch, Administrator, EPA (Feb. 2, 1982).

55. Id. at 1.

56. See note 42, supra.

57. Complaint for Declaratory Judgment and Injunctive Relief at 21, AFL-CIO v. Gorsuch.

58. Affidavit of John A. Todhunter at 2, attached to Supplementary Memorandum in Support or Motion for a Protective Order, AFL-CIO v. Gorsuch.

59. Memorandum of Points and Authorities in Opposition to Defendants' Motion for a Protective Order at 2, 5, AFL-CIO v. Gorsuch.

60. Notice of Taking Deposition Pursuant to Subpoena Duces Tecum at 5, AFL-CIO v. Gorsuch.

61. PESTICIDE AND TOXIC CHEMICAL NEWS, May 16, 1982, at 2; June 30, 1982, at 15; and July 28, 1982, at 2.

62. See PESTICIDE AND TOXIC CHEMICAL NEWS, Mar. 3, 1982, at 30; Legal Times of Washington, Feb. 22, 1982, at 11.

63. PESTICIDE AND TOXIC CHEMICAL NEWS, Mar. 3, 1982, at 30.

64. Jim Weaver (D-Or.), Berkley Bedell (D-Iowa), and Tom Daschle (D-S.D.).

65. H.R. REP. 566, at 235.

66. See H.R. 5203, 97th Cong., 2d Sess. § 5 (1982) (as passed by the House of Representatives). The environmental groups won on several other key issues. A provision preempting state statutes more stringent than the federal law was not passed while another provision allowing citizen suits (for injunctive relief only) to enforce FIFRA passed. See Legal Times of Washington, August 16, 1982, at 4.

67. S. 2620, 97th Cong., 2d Sess. § 5 (1982).

68. H.R. REP. 566, at 43.

69. H.R. REP. 566, at 234.

70. Testimony of Maureen K. Hinkle, NAS, quoted in PESTICIDE AND TOXIC CHEMICAL NEWS, June 23, 1982, at 22.

71. Testimony of Dr. Jack Early, NACA, quoted in PESTICIDE AND TOXIC CHEMICAL NEWS, June 23, 1982, at 21.

72. So-called by the House report. See H.R. REP. 566, at 65.

73. S 2620, 97th Cong. 2d Sess. § 5 (1982).