Unlike the Clean Air Act, Clean Water Act, RCRA, and Superfund, which deal generally with wastes created by manufacturing and other daily activities, the statutes covered in this section impose regulatory controls on the manufacture, sale, distribution, and use of particular chemicals and may, in certain situations, also impose requirements on the disposal of wastes associated with these products.

Regulation of Pesticides

Prior to the formation of EPA in 1970, pesticides including a wide range of substances intended to kill insects, rodents, weeds, or bacteria were regulated by the U.S. Department of Agriculture. In 1972, about the time EPA was assuming responsibility for the regulation of pesticides, Congress enacted the Federal Environmental Pesticide Control Act, which substantially changed the procedures by which pesticides are regulated under FIFRA. Applications for the registration of any new chemical, which is necessary to sell or distribute it domestically, must be accompanied by information sufficient for EPA to determine in advance of registration that the product will provide its intended benefits without imposing unreasonable risks to human health and the environment. Sufficient information also must be submitted to EPA to establish tolerances for residues of substances that will be used on feed crops.

Since 1972, the statute has been amended several times, and EPA s regulatory programs have imposed increasingly stringent requirements on both new registrants and companies holding registrations that pre-date those requirements. Pursuant to federal legislation, EPA is now reviewing all of these earlier registrations to determine whether they satisfy today s more stringent requirements. If a threshold determination indicates that a product exceeds certain criteria for determining hazards, EPA will conduct a "special review" consisting of a detailed determination of a particular product s risk. This review may result in an EPA decision to suspend or cancel a product. The registrant may challenge such an EPA decision in an adjudicatory administrative hearing, which in turn is subject to court review.

In 1996, after many years of debate, Congress passed the Food Quality Protection Act of 1996 which amended both FIFRA and the Federal Food, Drug and Cosmetic Act ("FFDCA"). The FFDCA amendments repealed the Delaney Clause which had prohibited the establishment of food additive tolerances for pesticides which caused cancer in laboratory animals. Under the new legislation, a uniform safety standard will be applied to pesticide residues in both raw agricultural commodities and in processed food. That standard requires EPA to determine that the pesticide residues are "safe" a term defined in this new legislation as meaning a "reasonable certainty of no harm." The amendments place a significant new burden upon EPA and can be expected to generate significant EPA rulemaking and resulting litigation.

Morgan Lewis FIFRA Activities

• Handling of pesticide registrations, including "genetically engineered" products.
• Defense against EPA enforcement actions alleging mislabeling or sale of unregistered products.
• Advice on requirements for obtaining new registrations or expanding uses of existing products.
• Advice on re-registration data call-ins and registration standards.
• Advice and litigation on "environmental claims" on pesticide labeling and advertising.
• Representations at hearings before EPA precipitated by the issuance of Notices of Intent to Suspend.
• Advice and litigation on data compensation and arbitration issues.
• Advice on reporting "unreasonable adverse effects" under section 6(a)(2).
• Representation before EPA on special reviews.
• Advice regarding policy on ground water contamination by pesticides.

All aspects of legal work involving pesticides require extensive knowledge of the complex procedures that the EPA Office of Pesticide Programs uses to evaluate products. Steven Schatzow, former Director of EPA s Office of Pesticide Programs, is especially well-qualified to address all aspects of the pesticide registration process, from initial submittals to reviews of existing chemicals. He has developed an active practice representing several dozen companies before EPA on a wide range of pesticide regulatory questions.

The Toxic Substances Control Act (TSCA) was enacted in 1976. With few exceptions for substances such as pesticides and FDA-approved materials, TSCA applies to all chemicals manufactured in or imported into the United States. Pursuant to TSCA, EPA has compiled an inventory of more than 75,000 chemicals that have been commercially imported into or manufactured or processed in the United States since 1975. Persons wishing to manufacture or import substances not included on this chemical inventory must file premanufacture notices (PMNs) with EPA at least 90 days before manufacturing or import activities commence. Complete and partial exemptions to the PMN filing requirement apply for chemical substances manufactured or imported for test marketing purposes or research and development. Exemptions also apply to chemical substances that are polymers, are used in low volumes or under conditions of low environmental release and human exposure, or are formed incidental to the normal storage, use or disposal of other chemicals. In addition, persons who process or otherwise use chemical substances have certain obligations to ensure that these substances are included on the TSCA inventory.

TSCA authorizes EPA to promulgate significant new use rules (SNURs) limiting how manufacturers, importers and processors may produce, handle and/or distribute substances on the chemical inventory. A person intending to produce, handle and/or distribute a chemical substance in a manner not permitted by a SNUR for the substance must first file a significant new use notice (SNUN) with EPA. As with PMNs, SNUNs must be filed at least 90 days before the restricted activity begins. Exemptions similar to those for PMN reporting also apply to SNUN reporting.

Pursuant to TSCA, EPA has established various testing rules as well as recordkeeping and reporting requirements that apply to persons who manufacture, import or process chemical substances. For example, EPA has promulgated a Preliminary Assessment Information Rule (PAIR), a health and safety study reporting rule, and other chemical-specific reporting rules that apply to manufacturers, importers and processors. Other rules require manufacturers, importers and processors to keep records of certain allegations by persons that chemical substances have caused significant adverse reactions, and to immediately report to EPA any information that a particular chemical substance poses a substantial risk to human health or the environment. In addition, EPA has issued rules requiring importers and exporters of chemical substances to file certain notices with the Agency upon import or export.

TSCA also singles out a few chemicals for extensive regulation, such as polychlorinated biphenyls (PCBs) and asbestos-containing materials. EPA has issued numerous rules governing these and other substances that have been designated by the Agency as posing a risk of injury to health or the environment. In addition, EPA has promulgated regulations under TSCA that apply to sellers, landlords, real estate brokers and managers of certain residential dwellings that may be contaminated with lead paint. These regulations require the disclosure of specified information regarding lead-based paint hazards.

Persons who violate TSCA or any regulations promulgated thereunder may be subjected to civil penalties of up to $27,500 for each day the violation continues. Persons who are criminally convicted of knowingly or willfully violating TSCA may be fined up to $25,000 per day, imprisoned for up to one year, or both.

• Advice regarding premanufacture notices (PMNs) and significant new use notices (SNUNs).
• Assistance with various reporting and recordkeeping requirements, including the following: Section 8(e) substantial risk information reporting, Section 8(d) health and safety data reporting, preliminary assessment information rule (PAIR) reporting, inventory update rule reporting, and Section 8(c) significant adverse reaction recordkeeping.
• Guidance with respect to Section 13 import certification and Section 12 export notification issues.
• Answers to questions about EPA s regulations governing PCBs, asbestos and lead-based paint hazards.
• Defense against EPA administrative complaints and Department of Justice civil and criminal actions under TSCA.
• Performance of TSCA compliance audits and preparation of TSCA compliance manuals for companies and/or facilities.

Kenneth Rubin, Steven Schatzow, and Scott Bovino regularly assist clients in dealing with a broad range of TSCA matters and Bill Lewis has focused on regulation of asbestos. The Firm s monthly environmental newsletter identifies those chemicals for which EPA has established special testing, reporting and/or recordkeeping requirements. The Firm also has prepared an easy-to-follow TSCA compliance manual which can be tailored to the operations of any company or facility that handles chemical substances. Finally, the Firm s Spill Reporting Procedures Manual contains important information on how to satisfy the requirement under Section 8(e) of TSCA that EPA be notified immediately about chemical substances that are found to pose a significant risk to health or the environment.

The U.S. Food and Drug Administration has jurisdiction to enforce the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Sections 301-395, including the Pesticide Residues Amendment of 1954, the Food Additives Amendment of 1958, the Color Additives Amendment of 1960, the Drug Amendments of 1962, the New Animal Drug Amendments of 1968, the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990 and related 1992 Amendments, the Dietary Supplement Health and Education Act of 1994, and, most recently, the Food and Drug Administration Modernization Act of 1997. Other major laws under the jurisdiction of FDA include the Radiation Control for Health and Safety Act of 1968, section 351(a) of the Public Health Service Act (concerning biological products), the Orphan Drug Act of 1983, the Drug Price Competition and Patent Term Restoration Act of 1984, the Infant Formula Act of 1986, the Prescription Drug Marketing Act of 1988, the Generic Animal Drug Price Competition and Patent Term Restoration Act of 1988, the Nutrition Labeling and Education Act of 1990, and the FDA Export Reform and Enhancement Act of 1996.

• Development, manufacturing, testing, marketing, and distribution of chemical and biological substances for pharmaceutical, food additive, and medical device applications.
• Advice regarding FDA regulatory approaches to new processes and products.
• Civil and criminal compliance and enforcement actions and recalls.
• FDA-related corporate due diligence and contract and licensing assistance.
• Advice with respect to regulatory issues in the European Union.

The FDA/Product Regulation Practice Group in the Washington office, led by Steve Mahinka, Kathryn Gleason and Kathleen Sanzo, provides counseling and litigation support with respect to all issues arising under the FFDCA and related laws, including pre-market development, testing, manufacturing, marketing, and promotion of products regulated by the FDA. In addition, the practice group has had significant experience with multistate enforcement, other aspects of chemical substance regulation, and Consumer Product Safety Commission matters.