What did the National Environmental Policy Act accomplish?

Synopsis of Law

The National Environmental Policy Act (NEPA) was signed into law in 1970, and established a national policy to protect the environment, created a Council on Environmental Quality (CEQ), and required that environmental impact statements be prepared for major federal actions having a significant effect on the environment. The CEQ's efforts laid the groundwork for almost all current US environmental legislation, except for Superfund and asbestos control legislation. The CEQ also developed guidelines for the environmental impact statement process. The NEPA process resulted in a major change in the way governments deal with environmental issues, and this model has been replicated in whole or in part in 23 states.

2.2.2 NEPA

The FDA has environmental responsibilities under the NEPA of 1969. NEPA requires Federal agencies to take, to the fullest extent possible, environmental considerations into account in the planning and making of their major (subject to judicial review) and final Agency decisions. To implement NEPA, the regulations of the Council on Environmental Quality require Federal agencies to develop their own regulations to comply with the procedures and achieve the goals of the Act (codified in 40 CFR 1500–1508). FDA’s Implementing Procedures are set forth to supplement the regulations of the Council on Environmental Quality (codified in 21 CFR Part 25).

NEPA is a declaration of the nation’s environmental policy and goals. It supplements FDA’s authority under the FFDCA and other public health statutes but it does not supersede these statutes. It does not require substantive FDA decisions to favor environmental protection over other considerations mandated by other statutes the FDA administers. NEPA is a full disclosure statute that requires public involvement and it is a broad statute that considers all aspects of the human environment. In addition, NEPA applies abroad and requires Federal agencies to identify those actions that may have trans-boundary environmental effects. The FDA considers allowing an FCN to become effective to be both a major and a final Agency action and, thus, the FCN process is subject to NEPA considerations.

Other National Laws

Plan Implementation Challenges

After working through the entire NEPA process beginning in the spring of 2005, the plans were released for final public review in the summer of 2008. However, a decision by the USFWS to withdraw the 2008 NSO Recovery Plan and Critical Habitat designation resulted in undercutting the entire multiyear planning investment. In addition, after the fall presidential election, the Governor of Oregon, the USFWS, the National Marine Fisheries Service, and the EPA all expressed concerns with the proposed plans for various reasons, despite being involved from the start as cooperators. The BLM determined that the plans did not implement any action on the ground that would affect ESA-listed species and informed the USFWS and the National Marine Fisheries Service of the no-effect determination and that consultation under § 7(a) (2) of the ESA would occur at the project level. The regulatory agencies originally agreed to this, but later withdrew their agreement.

By the end of 2008, litigation was filed immediately after signing the Records of Decision by environmental interest groups. After the election, the WOPR was never implemented with the plans being withdrawn by the Secretary of the Interior citing legal error in July 2009. It was never determined by a court that an error existed. The government agreed with the claim of the new plaintiffs and did not contest their claim. An alternative strategy could have directed the BLM to correct any possible error(s) by amending the WOPR versus withdrawing the entire plan, thereby reducing costs by using existing analysis and speeding up the revision process.

If the plans had been implemented, new NSO Recovery Plan and Critical Habitat designations would likely have required an immediate revision or amendment of the WOPR plans. Project-level ESA consultation would have redefined WOPR plan management requirements, potentially leading to further plan amendments as the plans were implemented. Withdrawal of WOPR put BLM back under the NWFP, along with continued litigation. Based on the analyses of the No Action Alternative (i.e., the NWFP), the BLM had already determined that the objectives of the NWFP-related RMPs were not being met, leaving the BLM no alternative but to start new RMPs. A new western Oregon planning effort was initiated in 2012 and is currently in process.

1.15.3.3 Establishment and Tracking of National-Scale Water-Relevant Sustainability Metrics

The United States National Environmental Protection Act, 1969 (National Environmental Policy Act), was a visionary piece of legislation that incorporated sustainability concepts long before the more widely accepted Brundtland Commission definition of sustainable development (World Commission on Environment and Development, 1987). National Environmental Protection Act eloquently articulated a policy “to create and maintain conditions under which man and nature can exist in productive harmony, and fulfill the social, economic, and other requirements of present and future generations of Americans.” In many ways, water is a perfect case study for sustainable development. The three legs of the sustainability ‘stool’ metaphor, environment, economy, and society, must be carefully considered to make progress simultaneously and move toward a more sustainable state.

Although the precise definition and meaning of sustainability is always a topic of lively debate, in the context of water, it is much easier to comprehend the exact goal. Simply stated, an effort is being made to place the United States on a trajectory where there is enough water for all needs for all time. Importantly, to prevent the transfer of risk from one place to another, one must also consider impacts to water quantity and water quality that occur elsewhere because of domestic development patterns, consumption, and other needs.

Development and tracking of sustainability metrics with a water focus could provide a useful tool by which the country could gauge progress in moving toward a more sustainable water future. The National Report on the Environment could be used as a vehicle for reporting this information. Sikdar provides a framework for development of sustainability metrics (Sikdar, 2003). The adoption of any metric must be supported by high-quality information, which is currently a significant barrier. As in any management endeavor, what gets measured gets done.

3.2 Implementing Environmental Planning

Environmental planning embraces more than the various studies that environmental planners perform in the process of preparing a comprehensive plan. It includes a careful assessment and selection of the most appropriate strategies of implementing the various goals of environmental planning and protection. Among the most important, with examples from the American experience, are:

3.1 Regulations in the USA

The USA regulates land application of sludge at the federal, state, and local level. The National Environmental Policy Act of 1969 regulated municipal wastewater sludge utilization and disposal systems to protect the environment (USEPA, 1979). The USEPA is the main federal regulative authority for promulgating and enforcing regulations on land application of sludge (USEPA, 1983). The EPA is responsible for regulating sludge management defined by the Resource Conservation and Recovery Act of 1976 (RCRA) and the Clean Water Act of 1977 (CWA). In 1979, the USEPA highlighted the utilization of sludge based on three end-use groups (USEPA, 1979): as a soil amendment, as a source of heat, and as a source of other useful products. Sludge has been used for reclamation of disturbed lands such as strip-mined lands and gravel pits. The importance of sludge to stabilize bankspoils and moving sand dunes, and as a nutrient supplier to cover crops for reclaimed lands, was emphasized in the USEPA's 1979 guidelines (USEPA, 1979). The USEPA guidelines in 1983 identified four options for safe disposal of sludge: agricultural utilization, land reclamation, forest utilization, and dedicated land utilization (USEPA, 1983). Strip mine lands, mine tailings, and other disturbed or marginal lands have been considered for the purpose of land revegetation and reclamation (USEPA, 1983). The EPA has indicated that these sludge disposal options are not mutually exclusive. For instance, dedicated land disposal sites for sludge can be used for agriculture. However, production of agricultural crops and forests, or improvement of soil characteristics, are considered of secondary importance for sludge utilization, compared to use on dedicated lands, due to the higher annual application rates of lower quality sludge that can be placed on dedicated land, which are not possible with the other three options. The use of sludge on dedicated lands leads to the risk of phytotoxicity with excess metals and salts (Qasim, 1998; USEPA, 1983). Because at dedicated land disposal sites transportation of pollutants elsewhere through erosion, leaching, and volatilization occurs, it has been suggested that physical removal of contaminants in soils by plants (ie, phytoremediation) be used, and this allows the conversion of dedicated land disposal sites into potential lands for agriculture (Mclaughlin et al., 2000). The USEPA's 1983 guidelines give typical requirements for sludge that can be used for land rehabilitation, as follows (USEPA, 1983):

Apply sludge in a one-time application (ie, sludge is not applied again to the same land area in the future). However, if sludge is used again in a postsludge application, guidelines related to the Federal Surface Mining Control and Reclamation Act of 1977, as well as other federal and state guidelines of land application of sludge, should be considered. Usually, if additional applications occur they are likely to be at intervals of 5–10 years apart. This one-time application reduces potential harmful impacts on vegetation (phytotoxicity).

Reduce or eliminate commercial fertilizer use.

Allow soil to support vegetation to retard erosion.

Alleviate existing degradation on disturbed land by pertinent sludge application and management.

The USEPA's part 503 regulation provides comprehensive requirements for 10 heavy metals (As, Cd, Cr, Cu, Pb, Hg, Mo, Ni, Se, Zn) and pathogen or vector attraction reduction requirements for the utilization of biosolids on land including sites to be reclaimed (USEPA, 1994a). Pollutant concentration limits in the sludge have been described for these 10 metals with their respective ceiling concentration limits in the soil. If a limit for any metal is exceeded, the biosolids cannot be applied to land until such time that the ceiling limits are no longer exceeded. However, if metal concentrations in biosolids are above the concentration limits but below the ceiling limits, biosolids can be land applied until the cumulative metal loadings allowed are reached. However, the USEPA's part 503 standards do not describe the effect on each metal of soil type, plant species, bioaccumulation potential, and retention (ie, effect of precipitation) in soils (Ritter, 2000). The USEPA part 503 regulations give limited information on sludge application on highly acidic (pHc < 5.0) soils, and, therefore, using these guidelines for acidic soils is not recommended (Whatmuff, 2002). The United States National Research Council (NRC) has independently reviewed the USEPA's part 503 regulations and recommends that occurrence of pharmaceuticals and personal care products (PPCPs) in biosolids should be investigated (Jones-Lepp and Stevens, 2007).

In addition to the EPA's regulations at the federal level, the Office of Surface Mining Reclamation and Enforcement (OSMRE) has been established under the Federal Surface Mining Control and Reclamation Act of 1977 (OSMRE, 2015). The OSMRE has strict regulations concerning revegetation for rehabilitation of disturbed lands from mining (Sopper and Kerr, 1980a). Although there are recommended performance standards for meeting the revegetation requirements under this Act, no information or guidelines are given for the use of biowastes in mine spoils reclamation.

The Pennsylvania Department of Environmental Resources (PDER) is an example of a state level body that gives guidelines specifically related to sludge utilization for mine spoil rehabilitation. They were published in 1977 with the title, “Interim Guidelines for Sewage Sludge Use for Land Reclamation” (PDER, 1977). The PDER issued these specific guidelines because by that time around 97,000 ha had been disturbed from uncontrolled mining or inadequately rehabilitated land due to strip mining of coal in Pennsylvania (Sopper and Kerr, 1980a). The PDER's guidelines and requirements give information for sludge application rates. For instance, the PDER recommends a maximum sludge application rate of 134 dry tons/ha should be used to provide nitrogen to degraded lands during the reclamation process. Trace elements loading rates to soil were recommended separately for land reclamation and for farming (Sopper et al., 1980b). The PDER guidelines include soil pH adjustment, such as the utilization of lime to immobilize trace metals thereby reducing their phytotoxicity. Some of the requirements attached to the PDER guidelines emphasize proper sludge application procedures, including the use of suitable lands, climatic conditions for sludge application, and how to incorporate sludge into different types of soils. They also give environmental risk factors (ie, distance to the rivers, land slope, and dairy cattle management).

At the local governmental level (ie, municipalities), some of the deed restrictions and ordinances are more stringent than the federal level restrictions (USEPA, 1979). For example, when sludge is used on land as a fertilizer for food crop cultivation, some of the local rules require sludge to be analyzed more frequently than required by the federal regulations (USEPA, 1979).

FCN Data Requirements

The key components of an FCN are consistent with the previous food additive petition requirements. That is, an FCN must be supported by the necessary chemistry data, toxicology data, and in some cases, an environmental assessment. With respect to chemistry data, an FCN must include complete information regarding the identity and composition of the food contact substance and how it is produced. To satisfy this requirement, information on the substance's chemical name, structure, and molecular formula, including its Chemical Abstracts Service (CAS) Registry Number, is essential. In addition, analytical data, such as infrared (IR), ultraviolet (UV), or nuclear magnetic resonance (NMR) spectra, are needed to further identify the food contact substance.

Although such data are recognized as proprietary and are kept confidential by FDA, FCNs must also include a description of the manufacturing process, including a list of the reagents, solvents, catalysts, and purification aids used in the manufacturing process and the relevant amounts used, and the reports of any migration tests that have been performed.

A critical aspect of an FCN is determining the amount of the food contact substance that is expected to enter the human diet. This is because the safety of the food contact substance is confirmed by considering the available toxicity data on the substance in the context of the potential level of dietary exposure to the substance. The dietary concentration or Estimated Dietary Intake (EDI) can be calculated by multiplying the amount of the food contact substance expected to migrate to food by the approximate fraction of the daily diet expected to contact the food contact substance. The expected level of migration can be estimated by “worst case” calculations, or it can be determined by the results of actual testing conducted by exposing specimens of the food contact material to appropriate food-simulating solvents (see Table 1) under conditions that simulate the most severe conditions of use proposed for the substance. Submitters of FCNs need to estimate the cumulative EDI (i.e., the CEDI) from all sources of exposure, rather than just the EDI from the use that is the subject of the notification.

Table 1. Classification of Food Types and Recommended Food Simulants for Food Contact Articles in the US

Food Types I, II, IVB, VIB and VIIB: 10% ethanol, for aqueous and acidic foods.

Food Types VIA, VIC: 10 or 50% ethanol,a for low- and high-alcoholic foods.

Food Types III, IVA, V, VIIA, IX: Food oil (e.g., corn oil), HB307, Miglyol 812, or others,b for fatty foods.

The type of toxicology data required to clear the proposed use of a given substance will depend on the nature of the food contact substance and the CEDI for the substance. (Like other jurisdictions, FDA uses a tiered approach to toxicity data requirements, but unlike other jurisdictions, the tiers are based on dietary exposure values rather than migration values.)

For substances with CEDIs under 0.5 ppb, no toxicology data is required, although relevant data must be submitted if available. For exposures between 0.5 ppb and 50 ppb, two genotoxicity studies (a bacterial mutagenicity assay plus an in vitro cytogenetic damage or mouse lymphoma assay) are needed. Where the intake exceeds 50 ppb but is below 1 ppm, a third genotoxicity study (in addition to the two noted above) in the form of an in vivo chromosomal aberration study is recommended, as well as two subchronic (90-day) studies (one in a rodent and one in a non-rodent animal), as historically required for these exposures.

For food contact substances that may be present in the diet at a level in excess of 1 ppm, a full range of toxicity studies is generally required, including chronic (2-year) toxicity/carcinogenicity studies in rats and mice, a 1-year feeding study in dogs, and multi-generation reproductive studies in rats. (where cumulative dietary exposure exceeds this 1 ppm level, FDA generally will require the filing of a food additive petition instead of an FCN). The required data can be studies undertaken by the FCN submitter, or existing studies in the open literature, where available and applicable to the intended use. It is important to realize that a full accounting of all known toxicology data relevant to oral exposure for the food contact substance must be included in an FCN, regardless of the CEDI level.

Finally, an environmental assessment (EA) is required unless the food contact substance is exempt under an applicable categorical exclusion. The EA requirement stems from the National Environmental Policy Act (NEPA),14 which requires federal agencies to assess the potential environmental impact of their “major” actions. FDA considers this requirement to apply to FCNs; therefore, FDA requires an FCN to include information on the potential environmental impact of the FCN clearance so that the agency can make a finding of no significant impact, or, if needed, complete an environmental impact statement. Notably, FDA has promulgated a regulation that provides certain categorical exclusions from the environmental assessment requirements. The categorical exclusions include (1) substances that constitute less than 5% of the food contact article, provided that the substance is intended to remain with the finished packaging material through use by consumers, (2) components of coatings for food packaging materials, and (3) substances that are used in food contact articles intended for repeated use.

If there are questions or concerns regarding the data required for a given FCN, a pre-notification consultation (PNC) with FDA can be very useful. A PNC allows a submitter to obtain FDA's advice prior to filing an FCN and can help avoid questions during the review period.

3 Environmental Policy

Many accomplishments of the environmentalist movement have come at the local or national rather than international level, and through the efforts of mainstream political parties rather than greens themselves. Examples range from the 1970 National Environmental Policy Act (NEPA) and the Environmental Protection Agency (EPA) in the USA to the 1989 Dutch National Environmental Policy Plan. The latter sort of regulatory regime is praised as more flexible and consultative and, because of that, more capable of altering pollution-generating practices. The US EPA is criticized for its inflexible ‘command-and-control’ approach and a fixation with ‘end of the pipe’ solutions, stopping pollutants from being released into the environment at the very end of the process rather than preventing them from being created in the first place (Dryzek 1997, Chap. 8, Weale 1992). Economists urge the replacement of regulatory policies with economic incentives, tradeable pollution permits, and the like (Pearce et al. 1989). It turns out, though, that even relatively toothless reporting requirements, such as the Environmental Impact Statements required by the US NEPA, can be surprisingly effective at ‘making bureaucracies think’ about the environmental consequences of their proposed actions (Taylor 1974).

Many environmental problems transcend national boundaries, however. Coordinated international action is then required, but that need not necessarily be universal in form. Early in these debates, George Kennan (1970) pointed out that most threats to the global environment come from the ‘rich men's club,’ and coordinated action among a majority of rich countries would go a very long way toward reducing those threats, whether or not others decline to join. Some of the most promising international agreements—notably, the 1987 Montreal Protocol restricting emission of ozone-destroying chlorofluorocarbons (CFCs)—are structured in precisely this way.

Institutionally, the 1972 Stockholm Convention led to the creation of a formal United National Environmental Program, based in Nairobi. Much of the impetus for international environmental protection has, however, come through the loosely coordinated actions of nongovernmental organizations (NGOs). Some of those are coalitions of environmental activist organizations, while others represent coalitions of scientists in an ‘epistemic community’ driving the development of policies such as those embodied in the 1987 Montreal Protocol (Haas et al. 1993).