April 11, 2014
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20582
Docket No. FDA-2011-N-0921
Submitted online via http://www.regulations.gov
Re: Comments on Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
To the FDA:
The Weston A. Price Foundation (WAPF) is a nonprofit organization with members in every state and internationally. WAPF was founded in 1999 to disseminate the research of Dr. Weston Price, whose studies of isolated nonindustrialized peoples established the parameters of human health and determined the optimum characteristics of human diets. WAPF is dedicated to restoring nutrient-dense foods to the human diet through education, research and activism.
The Farm and Ranch Freedom Alliance (FARFA) is a national nonprofit organization with members in 45 states that supports independent family farmers and protects a healthy and productive food supply for American consumers. FARFA promotes common sense policies for local, diversified agricultural systems.
WAPF and FARFA jointly submit the following comme nts on the Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
Under the National Environmental Policy Act (NEPA), the FDA must take a hard look at the no action alternative, other reasonable alternatives, and mitigation measures to the Proposed Rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (“Proposed Rule”) in its Environmental Impact Statement (EIS). The agency’s analysis must include a rigorous and objective evaluation of all reasonable alternatives, and should compare the net benefit of the proposed action to the environmental impacts presented by alternative courses of action. We urge the FDA to prepare a formal cost-benefit analysis for both the Proposed Rule and its alternatives.
In addition to the comments provided below, FARFA and WAPF urge the agency to consider the issues raised in the comments submitted on the Proposed Rule on November 22, 2013, by our organizations together with the National Family Farm Coalition, Local Foods Association, Western Organization of Resource Councils, the Massachusetts Farm Bureau, and North Carolina Association of Black Lawyers Land Loss Prevention Project.
II. Potential Alternatives
In its announcement of an extension of the comment period on March 11, 2014, the FDA provided, for the first time, a table indicating the alternative actions that it plans to consider in its EIS. WAPF and FARFA urge the agency to consider the potential alternatives discussed below, in addition to the alternatives described in the agency’s notice.
A. The agency should consider a “no action” alternative for the entire Proposed Rule. While FDA’s announcement includes “no action” as an a lternative for specific portions, the agency did not include the alternative of taking no action on the Proposed Rule as a whole. Congress directed the FDA to issue rules based on sound science and risk analysis, and the preamble to the Proposed Rule made it clear that there is insufficient data to do so in a reasonable manner, particularly considering the incredible diversity of agricultural operations across the country.
As part of the no-action alternative for all or portions of the Proposed Rule, the FDA should consider the alternative of non-binding recommendations for a period of several years. This would allow the agency to gather data on current agricultural practices, analyze the data, and assess any actual correlations between specific practices and increased incidences of foodborne illness. The agency could then develop a standard that is based on a true risk-analysis, rather than hypothetical considerations. In addition, the agency could continue to maintain standards through guidance documents, rather than regulatory provisions, which would allow for the standard to be updated more easily if new research becomes available about appropriate standards.
B. On water, the agency should consider additional alternatives to both the proposed microbial standard and the proposed testing frequency.
While the agency lists some alternative microbial standards as potential alternatives, the agency does not indicate how those standards would be set. The agency should specify alternatives based on research that addresses the relationship between foodborne illness to the proposed water quality standards.
With respect to the frequency of testing, even if water meets the required standards, the frequency of the testing for surface water will impose burdens that would encourage the greater use of groundwater or municipal sources, as discussed in the next section. The FDA should therefore consider alternatives for testing frequency, such as requiring testing of water sources no more than three times per growing season. The considered alternatives should also include reducing the frequency of testing based on in itial tests that demonstrate that the water source meets the required standard; in other words, the frequency of testing should be based on the initial results, rather than a one-size-fits-all schedule.
C. On biological soil amendments, the agency should also consider alternatives to its definition of “treated” and “untreated” amendments. As currently written, compost that is made through vermicompost and static composting methods, which are widely used and can produce safe and beneficial products, would be classified as “untreated” and required to be handled the same as raw manure. Moreover, the use of any additive to compost tea, even non-animal products such as molasses, would place it into the category of untreated amendments. These categorizations are not supported by sound science. The exclusion of these valuable soil amendments from the treated category, and the resulting restrictions on their use, has significant environmental and economic consequences, as discussed in the next section.
D. On measures related to animal grazing, the agency should include an alternative for a minimum waiting period of 45 days or less.
E. On measures related to animal intrusion, the agency should consider alternatives that address different types of animal intrusion in different ways. The risks posed by small wildlife, such as frogs and squirrels, are different than those posed by animals such as feral hogs. In addition, the burdens imposed on the farmers to exclude the animals, or address the intrusion, are very different. In addition, the agency should consider alternatives that recognize differences in harvesting. Hand harvesting crops poses a lower risk of spreading contamination than machine harvesting, and provides both increased food safety and environmental benefits.
F.On the scope of the proposed rule, the agency should also consider alternatives that base the qualified exemption under the Tester-Hagan amendment, as well as the exclusion of farms under a specified gross sales amount, on the value of covered produce sold, rather than based on the value of all food sold. This interpretation of the qualified exemption is within the agency’s discretion and is consistent with the intent and jurisdictional limits of FSMA. Excluding more small farms from the Rule’s coverage will create fewer environmental impacts.
III. Scope of Impacts
Having identified alternatives to the proposed action, the agency must give a hard look to both the direct and indirect impacts of the proposed action and the alternatives.1 The responsibility for this analysis lies with the agency, not with concerned citizens or nonprofits. When commenting on a proposed action, the public need not conduct a study or intensive research on potential environmental impacts. Instead, it is the agency’s job to study and consider the potential impacts suggested by the public.2
Direct effects are effects caused by the agency action and occur at the same time and place.3 Indirect effects are defined as effects that are caused by the agency action and are later in time or farther removed in distance, but are still “reasonably foreseeable.” Cumulative effects are incremental environmental impacts of the action added to other past, present, and reasonably foreseeable future actions.4 Cumulative impacts can result from individually minor but collectively significant actions taking place over a period of time.
In its March 11th announcement, FDA briefly mentions a few impacts that will be considered, such as the increased use of groundwater. However, given the small number of impacts that are mentioned, we assume that these are provided as examples only, rather than as a comprehensive list. If the agency intended the impacts mentioned in its notice as a comprehensive list of potential impacts, then it has completely failed in its duty to take hard look at all the impacts of the proposed action under NEPA.
Below is a brief discussion of the impacts that need to be carefully analyzed in the EIS. This is not an exhaustive analysis, and it is the agency’s duty to perform the appropriate analysis on all of these issues.
A. Impacts of water requirements
The Proposed Rule creates multiple counterproductive incentives on water use and treatment. It discourages the use of untreated surface water by imposing burdensome testing and quality standards. In so doing, it encourages increased use of other sources, including groundwater and municipal water supplies. It also encourages the chemical treatment of surface waters.
These provisions will have numerous effects, including: (1) increasing the use of groundwater and drawdown of aquifers; (2) increasing the use of municipal and public water supplies, creating increased demand on already-stressed systems; (3) harming the quality of surface waters, as a result of increased use of chemical treatments; (4) harming aquatic life (plant and animal) that will be impacted by the chemically treated runoff; and (5) harming human health due to the increased prevalence of chemicals in the water.
B. Impacts of requirements imposed on biological soil amendments
The Proposed Rule creates incentives for farmer s to use synthetic fertilizers as opposed to biological soil amendments. This is due to the agency’s decision to impose no new requirements on the use of synthetic fertilizers, while at the same time imposing stringent regulations on the handling, conveying, storing, treatment, microbial standards, application method, waiting period before harvest, and reporting of the use of biological soil amendments.
The agency’s proposed waiting period between application of biological soil amendments (both treated and untreated) is one the greatest problems with the Proposed Rule. We urge the agency to pay particularly close attention to the difference in the effects of the Proposed Rule as compared to the shorter waiting periods listed as potential alternatives in the agency’s March 11th notice.
There are many potential impacts to the preference for synthetic fertilizers. Synthetic fertilizers increase agricultural runoff and water pollution. The effects can be significant both locally and nationally, as can be seen in the hypoxic “dead zone” in the Gulf of Mexico. In addition, synthetic fertilizers are linked to soil degradation. As the soil quality degrades, more fertilizer is required, creating a positive feedback loop and a cycle of ever-increasing damage.
While biological soil amendments increase the health of the plants, such that fewer pesticides and herbicides are needed (whether natural or synthetic), synthetic fertilizers have the opposite effect. Thus, increased use of synthetic fertilizers in place of biological soil amendments also increases the use of pesticides and herbicides. These chemicals are typically reliant on fossil fuel use for their synthesis. In addition to the energy used in their production, most of the treatments would have to occur off-farm, requiring transportation to and from the farm. These chemicals also carry well-documented human health risks.
The reduced use of animal wastes such as manure will also have environmental impacts. If less is used in agriculture due to the new regulations, the manure from the millions of livestock in this country must still be disposed of somehow. This has significant negative implications for water quality and land use.
The Proposed Rule also creates a preference for physical (heat) or chemical treatments that sterilize biological soil amendments of animal origin, by removing most of the restrictions on their use after treatment. This has multiple environmental implications. Untreated biological soil amendments add a rich diversity of microorganisms to the soil, creating improved water infiltration and water-holding capacity, reduced runoff, reduced loss of topsoil, and more; encouraging the use of treated, sterile soil amendments in their place will have concomitant reductions in environmental benefits.
The Proposed Rule will particularly discourage the use of compost teas, which will carry additional environmental impacts. The classification of compost tea with additives as “untreated biological soil amendments,” and the restrictions on how such amendments can be applied, effectively bars any foliar uses. Foliar uses of compost tea have been used successfully by many farmers to control fungal diseases and stimulate healthy plants. The inability to use them will thus lead to an increase in the use of toxic fungicides and other chemicals during the growing season. This has negative implications for air and water quality, as well as human health.
Biological soil amendments are the basis of healthy, sustainable agriculture and carry multiple benefits for both the environment and human health. The track record of these amendments with respect to food safety does not justify the onerous restrictions created by the Proposed Rule. Instead of protecting human health, the proposed restrictions would harm human health and the environment by increasing the use of synthetic fertilizers, pesticides, and fungicides.
C. Impacts of animal grazing provisions
The Proposed Rule restricts the use of grazing animals by imposing new requirements and an uncertain waiting period between the time during which an animal can graze an area and the time during which produce can be grown in that area. The Proposed Rule implies that the waiting period would be the same as that for manure applications, namely 9 months.
The restriction on allowing the use of grazing animals on land used for growing produce will discourage the practice of diversified livestock/produce operations. This will harm the environment in two ways.
First, at least some percentage of farmers who currently graze their livestock on land that is also used for produce will switch to confining their animals. Confinement of livestock causes numerous environmental harms. First, the waste generated by such operations frequently contaminates water sources, to the detriment of aquatic plant and animal life. The raising of crops to feed animals in confinement increases soil erosion and chemical usage, compared with allowing animals to graze on pastures. Confinement operations are more energy-intensive, in part due to the need to transport feed to, and waste away from, such operations. Numerous harms to human health also result, including the increased use of antibiotiocs that leads to antibiotic-resistant bacteria, increased health problems among workers and neighbors of such operations, and the reduced nutritional value of the products from such operations. From a food safety perspective, the increased incidence of E. coli 0157H:7 from confinement operations works contrary to the goals of FSMA.
Second, the limitations on grazing animals on land used for growing produce will reduce the acreage that is used for combined crop and animal production. This will in turn reduce soil fertility and health. Diversified operations are the most efficient and ecologically sound way to raise food over the long-term. Diversified operations provide increased carbon sequestration, improved water capture, reduced runoff and erosion, and a reduced need for inputs (organic and synthetic). Placing burdens on diversified operations will discourage their establishment and continuation, harming the environment in multiple ways.
D. Impacts from wildlife provisions
If there is a reasonable probability that working animals will contaminate covered produce, the Proposed Rule requires a farmer to take “measures” to prevent the introduction of foreseeable hazards such as animal feces, but the agency does not specify what those measures are.
The FDA is clearly trying to avoid the criticisms that have been leveled at the Leafy Green Marketing Agreement. In the preamble, the agency states that it does “not intend for proposed §112.11 to suggest that you would need to take measures to exclude animals from outdoor growing areas, to destroy animal habitats near your out door growing areas, to clear farm borders around outdoor growing areas or drainages, or to take any action that would violate applicable environmental laws or regulations.”5 Yet nowhere does FDA explain what measures the farmers should take to meet the vague standards in the proposed rule, and it would be difficult to comply with a strict interpretation of those standards without taking at least some such measures.
In order to avoid running afoul of these vague requirements, many farmers will resort to taking actions to simply exclude all wildlife, including destroying nearby wildlife habitat and clearing farm borders. Farm borders, such as intentionally planted hedgerows that provide habitat for beneficial insects, enhance natural biological control with a concomitant reduction in pesticide usage. Their removal would be contrary to the goals of multiple existing government programs, including promoting biodiversity under the National Organic Program and pollinator habitat
incentives promoted by USDA-NRCS.
E. Impacts from multiple rule provisions combined.
As a whole, the Proposed Rules’ provisions on soil amendments, domestic livestock, and wildlife create a strong disincentive against organic and sustainable agricultural methods. In its EIS, the FDA needs to address the impact of reducing the amount of acreage used in organic and sustainable production. Given that the Proposed Rule places no burdens at all on the use of synthetic chemicals (fertilizers, herbicides, and pesticides), but does place extensive burdens on the use of sustainable soil amendments (manure, compost, compost teas, etc), it will undoubtedly lead to some farmers converting from organic and sustainable production to conventional chemical-based agricultural methods.
In addressing this issue, is it vital to include consideration of acreage that is being farmed with sustainable methods, but is not certified organic. If anything, these farmers will face even greater pressures than certified organic farmers to convert to chemical methods because they (1) do not receive the organic premium price, and (2) are less likely to have a record-keeping system in place (since organic farmers are already required to keep records) and would face even greater costs attributable to the new requirements
The loss of acreage in organic and sustainable production, to be replaced by either housing developments or chemical-based agriculture, will have numerous serious environmental impacts:
• Water use: organic and sustainable methods can reduce the amount of water needed to grow cops;
• Water quality: runoff from synthetic fertilizers, herbicides, and pesticides harms aquatic plant and animal life, and has human health implications;
• Land: shifting to chemical agriculture will degrade soil quality, increase erosion, increase soil compaction, and decrease biodiversity both in the soil and above it;
• Energy: synthetic chemical inputs require energy produce, often in the form of petroleum products;
• Human health: increased used of toxic chemicals will have health effects on farmers, agricultural workers, rural communities, and those who consume the products.
The Proposed Rule will also have negative human health impacts due to the overall burdens placed on farmers, whatever growing methods they use. By FDA’s own admission, implementation of the rule as proposed will discourage new farmers from starting. It is also certain that at least some farmers will go out of business due to the new costly requirements. This has direct environmental impacts, due to the issue of land use; for example, the FDA should analyze the impact of the Proposed Rule’s costs on the loss of farmland to development. Indirectly, this is likely to also reduce Americans’ access to fresh, local, healthy foods, with numerous health consequences.
In addition, while the Proposed Rule’s provisions apply to imported foods in theory, it is predictable that foreign farmers will not be held to all the requirements in practice. The Proposed Rule will thus increase our reliance on imported foods. Increasing out reliance on imported foods means even greater use of fossil fuels for long-distance transportation, with the attending energy cost and harm to air quality. Reliance on imported foods also has health and food safety consequences.
The use of land for agriculture is inextricably tied to the quality of our environment. Farms can provide significant environmental benefits: rainwater capture, carbon sequestration, wildlife habitat, improved air quality, and much more. Depending on the management, farms can also cause significant environmental harms: the spread of toxic chemicals in our air and water, runoff of chemicals that degrade water quality, massive use of fossil fuels, and much more. Both types of management also carry implications for human health, from the questions of availability of fresh produce to the spread of antibiotic-resistant bacteria. FDA’s proposed rule for growing and harvesting produce creates significant incentives for management decisions that harm the environment and human health. It is vital that the agency look closely at all of these issues, in addition to those already identified in the agency’s notice, and ensure that any final action is based on sound science and consideration of all the relevant factors.
Judith McGeary Sally Fallon Morell
Executive Director President
Farm and Ranch Freedom Alliance Weston A. Price Foundation
1. 40 C.F.R. § 1508.25.
2. See Friends of the Clearwater v. Dombeck, 222 F.3d 552, 559 (9thCir. 2000).
3. 40 C.F.R. §1508.8.
4. 40 C.F.R. § 1508.7.
5. See 78 Fed. Reg. at 3552.🖨️ Print post
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