In Brief

Lynn L. Bergeson

Pope Enters GMO Controversy
Pope John Paul II announced on November 12, 2000, that the use of genetically modified organisms is contrary to God’s will. Speaking on November 12 at a mass dedicated to farmers, the Pope urged agricultural management people to "resist" the temptations posed by high productivity and profit when these benefits will compromise nature. Italy’s Green Party applauded the announcement. Industry’s biotechnology sector is dismayed, but not surprised.

PAN Announces New Pesticide Database
The Pesticide Action Network (PAN) announced the creation of the PAN Pesticide Database, a new database providing information on the health hazards, regulatory status, and toxicity of pesticides to plants and animals. The database is available on the Internet at <http://www.pesticideinfo.org/>. The database contains information from sources such as the United States Environmental Protection Agency (EPA), the National Toxicology Program (NTP), the National Institutes of Health (NIH), and the World Health Organization (WHO). The database provides information for approximately 5,100 active ingredients and their transformation products, as well as adjuvants and solvents used in pesticide products. Information is also included from the EPA and California Department of Pesticide Regulation (DPR) product databases.

Users may search the database by chemical name, CAS number, EPA PC code, or DPR Chemical Code. Users may also search for use type (i.e., insecticide, herbicide, fungicide, fumigant), human toxicity category (i.e., bad actor chemicals, known/probable carcinogens, suspected endocrine disruptors), regulatory category (i.e., EPA registered, California registered, WHO obsolete pesticide), and chemical classification (i.e., organochlorine, halogenated organic, organophosphorus). The database will soon include expanded pesticide product information, enabling the user to search by product name, registration status, and manufacturer, in addition to pesticide use information for California by crop, chemical, and geographic region.

Recent Developments in FQPA Lawsuit
On October 30, 2000, in American Farm Bureau v. EPA, D.D.C., No. 99-01405, the U.S. District Court for the District of Columbia rejected requests by the United States Environmental Protection Agency (EPA) and the Natural Resources Defense Council, Inc. (NRDC) to dismiss industry claims that EPA should issue rules, not science policies, under the Food Quality Protection Act (FQPA). This ruling affirms industry’s right to challenge science policies issued by EPA under FQPA. Pesticide manufacturers and agricultural grower groups asked the court to prevent EPA from applying a "percentile of exposure policy" in its acute dietary risk assessments, and in the establishment or reassessment of pesticide residue limits or registrations, unless officials conducted a rulemaking to implement that policy. Industry also asked that EPA be prevented from applying an FQPA safety factor in setting tolerances, or residue limits on food, unless EPA promulgates a rule.

Based on EPA and NRDC motions, the court dismissed an industry request that EPA formally collect data for its pesticide risk assessments under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The judge ruled that these industry claims were premature, and industry may raise these claims again in the future if EPA makes pesticide regulatory decisions in the absence of data. The October 30, 2000, ruling upheld industry’s right to challenge EPA’s cancellation order on uses of methyl parathion. The ruling also allows an industry challenge to EPA on EPA’s earlier failure to promulgate regulations on emergency pesticide uses under FIFRA Section 18, although this claim is now moot because EPA has promulgated a Section 18 rule.

The judge also found that EPA’s tolerance reassessment schedule and endocrine disruptor screening test schedule were not binding on specific pesticide products. In particular, the court found that an August 4, 1997, EPA tolerance reassessment schedule did not provide that all pesticides listed in "Group 1" had to be reassessed by August 1999 under FQPA. Instead, "generally" these pesticides would receive priority in the reassessment process.

This ruling may undermine a separate NRDC challenge to EPA in another case. In August and September 2000, NRDC and other public interest groups filed suits against EPA challenging its approach to FQPA implementation in the Northern District of California (NRDC v. Browner, No. C99-3701 (N.D. Cal.)) and the U.S. Court of Appeals for the Ninth Circuit (United Farm Workers of America v. Browner, No. 99-71143 (9th Cir.)). The Ninth Circuit case has been dismissed on jurisdictional grounds.

The case began in 1999 when 18 organizations, including the American Farm Bureau Federation and other grower groups, Agricultural Retailers Association, and American Crop Protection Association (ACPA) and other pesticide industry groups, filed suit. EPA and NRDC asked the court to dismiss industry’s science policy claims. Industry briefs on the remaining claims are expected to be filed in January or February 2001. If industry prevails on its science policy claims, EPA will not be able to use the policies to reassess or revoke pesticide tolerances or registrations unless it first promulgates them as regulations.

NET Announces Report on Chemical Pollution Affecting Child Development and Learning
The National Environmental Trust, Physicians for Social Responsibility, and The Learning Disabilities Association of America recently released a report entitled Polluting Our Future: Chemical Pollution in the U.S. that Affects Child Development and Learning, which examines the U.S. Environmental Protection Agency’s (EPA) 1998 Toxics Release Inventory (TRI) data, among other information, to estimate the total likely emissions of developmental and neurological toxins in the U.S. The report includes national information about releases of developmental and neurological toxins, a ranking of states, and information about the top releasing counties, industries, and facilities in each of the 50 states. The report and related materials can be found on the Internet at <http://www.environet.policy.net/health/neighborhood/cehfuture/>.

According to the report, in 1998 U.S. companies reported to the TRI that they released into the nation’s air and water approximately 1.2 billion pounds of chemicals (more than half – 53% – of all toxic chemicals reported to the TRI) that are classified as known or suspected developmental or neurological toxins. The report further states that the reported emissions account for only an estimated 5% of all chemical releases in the country. The chemical manufacturing industry was reported to be the single largest industrial source of developmental and neurological toxin emissions (to the air and water) in the U.S. (see Table 5).

The report sets forth in Table 2 the top 20 chemicals released to the air and water, in Table 7 the top 20 (of 45 total) developmental toxins released to the air and water, and in Table 8 the top 20 (of 278 total) neurotoxins released to air and water. Of the top 20 chemicals reported by the TRI as released into the environment in the largest quantities in 1998 (see Table 2), approximately three-quarters are listed as known or suspected developmental toxins or neurotoxins.

The report also discusses the findings of a National Academy of Sciences (NAS) panel released this year. The NAS panel estimated that approximately 3% of developmental and neurological defects in children are caused by exposure to known toxic substances. This means that "360,000 U.S. children (1 in every 200 U.S. children) suffer from developmental or neurological deficits caused by exposure to known toxic substances." The NAS panel also estimated that an additional 25% of all developmental and neurological defects in children are caused by environmental factors working in combination with a genetic predisposition, and that toxic substances play an important but undetermined contributory role. The report states that these estimates "should be considered conservative."

According to the report, the National Environmental Trust, Physicians for Social Responsibility, and The Learning Disabilities Association of America recommend that the following policies be adopted to address the risk to children from developmental and neurological toxins:

! Pre-Market Screening of New Chemicals – New chemicals should be tested and found to have no effect or potential effect on the physical or brain development of children before they are allowed into commerce.

• Mandatory Testing of Existing Chemicals – Chemicals produced in high volumes, to which children and childbearing adults are routinely exposed, should be tested for safety.
• Labeling at the Point of Exposure – All users and manufacturers should be required to post warning labels on products and near facilities emitting substances currently in commerce that may have developmental or neurological effects.
• Better Pollution Reporting – Reporting thresholds for developmental and neurological toxins should be lowered so "more information would become available to the public, and releases of these substances would likely be reduced over time."
• Regulating Electric Power Plants for Air Pollution – EPA should treat the electric power industry, which is the nation’s largest source of industrial air pollution that is not regulated for toxic chemical emissions, like other major industries by requiring it to adhere to specific limits on toxic air pollution.
• Exposure and Disease Monitoring – A program should be implemented to monitor the developmental and neurological toxins in the bodies of representative samplings of children and women and to record the incidence of developmental and neurological disabilities in the general population.

EPA Issues Guidance on Reportability of Attorney’s Opinions and Conclusions on FIFRA Section 6(a)(2)
On September 15, 2000, the United States Environmental Protection Agency (EPA) released Pesticide Registration (PR) Notice 2000-8 entitled Reportability of Attorneys’ Opinions and Conclusions Under 40 CFR Part 159 and FIFRA Section 6(a)(2). The guidance document was also filed with the United States District Court for the District of Columbia as part of a pending lawsuit challenging certain provisions of EPA’s regulatory implementation of FIFRA Section 6(a)(2). American Crop Protection Ass’n v. EPA, No. 1:00CV00811(JR) (D.D.C. Sept. 20, 2000).

Under FIFRA Section 6(a)(2), if at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects of the pesticide on human health or the environment, the registrant must submit such information to EPA. EPA has set out its interpretation of FIFRA Section 6(a)(2) in five documents, issued between 1997 and 1998. These documents include a September 19, 1997, final rule which represents the core implementation provisions constituting EPA’s FIFRA Section 6(a)(2) policy, and various additional documents and technical corrections interpreting the reporting provisions. EPA’s interpretation is codified at 40 C.F.R. Part 159.

The American Crop Protection Association, the American Chemistry Council (formerly the Chemical Manufacturers Association), and the American Corporate Counsel Association filed suit this past May asking the court to declare part of EPA’s adverse effects reporting regulations invalid. Specifically, petitioners challenged 40 C.F.R. § 159.158(a) which, according to petitioners, requires companies to disclose "opinion information" protected by the attorney-client privilege. The parties have filed cross motions for summary judgment. In its memorandum supporting its motion, EPA asserts that the rule does not require registrants to report communications with their attorneys. According to EPA, otherwise reportable facts provided to an attorney are not protected by the attorney-client privilege. PR Notice 2000-8 was also filed with the court by EPA, presumably as further clarification of EPA’s interpretation of 40 C.F.R. Part 159.

PR Notice 2000-8
Under PR Notice 2000-8, EPA makes three fundamental points:

• Opinions and conclusions rendered as the professional legal judgment of an attorney are not relevant to EPA’s assessment of the risks or benefits of a pesticide and are not required to be reported under part 159.
• Opinions and conclusions of attorneys other than the attorney’s professional legal judgment can be reported under part 159.
• Factual information upon which an attorney’s professional legal judgment is based must be reported if it meets the criteria of part 159.

Each of these points is discussed below.

Opinions and conclusions are irrelevant – According to EPA, Part 159 requires the reporting of certain toxicological and ecological studies. Information must be reported only if it meets the requirements of 40 C.F.R. § 158.159. The most relevant provision in this regulation is that information is reportable if it contains "information relevant to the assessment of the risk or benefits" of a pesticide. According to EPA, the Agency’s primary purpose in assessing the risks and benefits of a pesticide is to determine whether the pesticide meets the criteria for registration under FIFRA Section 3. An attorney’s professional judgment, however, is defined in the Model Code of Professional Responsibility as the attorney’s "educated ability to relate the general body and philosophy of law to a specific legal problem of a client" and hence is of limited utility to EPA. EPA believes "that the professional legal judgment of an attorney is sufficiently unlikely to contribute to EPA’s understanding of whether a pesticide presents unreasonable adverse effects on the environment. Therefore, opinions and conclusions rendered as the professional legal judgment of an attorney, as defined in the Model Code, need not be reported under part 159."

Opinions and Conclusions That May Be Reportable Under Part 159 – Opinions and conclusions of attorneys other than the attorneys’ professional legal judgment can be reportable under Part 159 in certain circumstances. EPA states that attorneys may perform tasks that "result in opinions and conclusions that are not strictly the professional legal judgment of an attorney." According to EPA, those opinions and conclusions may be reportable under Part 159. Specifically, EPA writes:

If a person is involved in "the development, testing, sale or registration of a pesticide" or "could be reasonably expected to come into possession of information otherwise reportable," § 159.155(d) provides that any conclusion or opinion held by that person would be possessed or received by the registrant and must be reported – regardless of whether that person might also happen to be an attorney. Collecting information about the risks and benefits of a pesticide and obtaining reviews of data by expert consultants or activities commonly performed by persons other than attorneys, and are also activities that are very likely to produce information that is reportable under part 159. Registrants cannot shield themselves from the reporting requirements of part 159 by putting attorneys in the front lines of their information gathering apparatus.

Factual Information – Factual information upon which an attorney’s professional judgment is based is reportable if it meets the criteria in Part 159. EPA states that while opinions and conclusions rendered in the professional legal judgment of an attorney need not be reported under Part 159, factual information underlying those opinions must be reported if such information meets the criteria of Part 159. EPA provides this example: while an attorney’s opinion as to the legal sufficiency of an adverse effect allegation would not be reportable, the allegations themselves would be reported pursuant to 40 C.F.R. § 159.184. Also, where an attorney engages outside experts to review and advise on the effects of a pesticide on a registrant’s behalf, "the experts’ opinions and conclusions may be subject to reporting."

It is unclear as of this writing what effect, if any, the issuance of PR Notice 2000-8 may have on the litigation. Oral arguments were scheduled for October 26, 2000, on the cross motions for summary judgment. According to trade press articles, industry groups have stated that attorneys will be "hampered in preparing cases for litigation because of fear the information could be used against them by opposing parties, because of the EPA rule." Daily Environment Report, BNA, September 25, 2000, page A-5.

The short answer is while the PR Notice clarifies to some extent EPA’s interpretation of the reporting obligations under FIFRA Section 6(a)(2) as they relate to the professional legal judgment of an attorney, it is unlikely that the PR Notice’s issuance will significantly impact the litigation one way or another.