June 9, 2000
Dear Mr. Jones:
The Organic Foods Production Act of 1990 was adopted by Congress after lengthy discussions among organic growers, certifiers, consumers and environmentalists. The U.S. Senate Committee Report, which accompanied the legislation at passage reads,
The Committee believes that it is time for national standards for organic production so that farmers know the rules, so that consumers are sure to get what they pay for, and so national and international trade in organic foods may prosper. Twenty-two states now regulate organic food but no two State laws are alike. While State action represents a positive step forward for the organic foods industry, the differing State laws have also lead to consumer confusion and troubled interstate commerce. U.S. Senate Report 101-357, U.S. Senate, Committee on Agriculture, Nutrition, and Forestry, 101st Congress.
It should be noted that environmentalists and farmworker advocates in the early years supported organic agriculture as effecting good land stewardship and a reduction in hazardous chemical exposures for workers on the farm. The pesticide reform movement, citing pesticide problems associated with chemical agriculture, from groundwater contamination and runoff to drift, always viewed organic as the solution to a serious public health and environmental threat. Those in the movement also recognized the difficulties of bringing a pure product to market, given the huge volume of residual contaminants and daily pesticide use that occurs.
In effect, organic food consumers are buying and supporting environmentally sound agricultural practices, with no real guarantees that the end product will be absolutely pure. Nevertheless, there is an expectation that the inputs associated with organic, whether on the farm or in the processing of organic food, will achieve a higher degree of purity when compared with chemically grown and processed food. Therefore, as a fail-safe measure, Congress required that the pesticide residues in and on organic food be set at a fraction of those allowed in conventional, chemical-intensive agricultural systems.
The Organic Food Production Act of 1990 is a sound law that establishes a firm foundation for moving organic food production and sales to an even higher growth level in the decades ahead. There are those who say that if you push too hard on organic you will create unreasonable parameters that simply cannot be met. On the other side are those who say that a weakening of standards will open them up, making them meaningless. The statute strikes a healthy balance. It is USDA's responsibility to begin implementation. The proposed rule, while embracing the framework of the law, strikes at its very core when relaxing the standards for the introduction of synthetic ingredients. This should not happen. Under the law, not all processed products with a percentage organic ingredients will enjoy a label that describes the overall product as organic on the front label display. So be it. Let's not use the word "organic" to mean something less than organic and then identify "real organic" as "100% organic," as the U.S. Department of Agriculture (USDA) has proposed. That diminishes the term and creates confusion in the market. The label should disclose, not mislead.
The proposed rule mistakenly allows a number of activities and practices that are in strict violation of the Organic Foods Production Act (OFPA). These violations include the following.
I. Allows synthetic chemicals in organic food.
The biggest problem with the proposed regulations is that they would enormously expand the opportunities to use synthetic chemicals in the production of organic food.Under the OFPA, the use of synthetic substances is narrowly circumscribed.The statute was designed to exclude all but a very few synthetic substances from organic production.According to the Senate Report:
The committee does not intend to allow the use of many synthetic substances. This legislation has been carefully written to prevent wide spread exceptions or "loopholes" in the organic standards, which would circumvent the intent of this legislation. (Senate Report 101?357, p. 298.)
OFPA itself states unambiguously: "§2105 National Standards for Organic Production. To be sold or labeled as an organically produced agricultural product under this title agricultural product shall (1) have been produced and handled without the use of synthetic chemicals, except as otherwise provided in this title. . ."
However, the draft regulations create the very loopholes that Congress sought to avoid and do allow the use of many synthetic substances.
USDA's proposed rule still threatens the integrity of organic food and organic food production processes as they have evolved over the years to meet the desires of environment- and health-conscious consumers.The proposed regulations appear to be designed primarily to accommodate agribusiness interests in their entry into the growing market for organic products rather than to respond to the wishes of consumers of organic products to provide maximum protection to the environment and human health.The USDA should revise its proposed rule to be consistent with the authorizing statute, current organic farming, and handling operation practices and the wishes of consumers of organic products.
USDA still fails to understand that it is the process of production rather than results in terms of pesticide residues that distinguishes organic from conventional agriculture-and still violates the legislative intent on prohibited residues allowed in an organic product (as indicated in the Senate Report): " The Committee does not intend, however, that a level greater than 10% of the EPA level or that zero percent of tolerance be approved by the Secretary." The final rules should be process-based, in conformance with OFPA and the NOSB recommendations.
USDA has created open-ended categories of allowable synthetic materials and "inert" ingredients on the National List. The law requires that, "The [National] list established under subsection (a) shall contain an itemization, by specific use or application, of each synthetic substance permitted under subsection (c)(1) or each natural substance prohibited under subsection (c)(2)."[§2118(b)] The law goes on to say, "The National List may provide for the use of substances in an organic farming or handling operation that are otherwise prohibited under this title only if (B) the substance (i) is used in production and contains an active synthetic ingredient in the following categories: copper and sulfur compounds; toxins derived from bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and minerals; livestock parasiticides and medicines and production aids including netting, tree wraps and seals, insect traps, sticky barriers, row covers, and equipment cleansers." [§2118(c)] The list in Section 205.601 and 206.603 violates OFPA, Sections 2105 and 2118(c)(B)(i) and should conform to the list in the law and itemize specific uses, rather than establishing categorical lists of acceptable synthetics.
OFPA designates the categories of substances for possible use in organic farming.
a.Creation of illegal categories of synthetics.
OFPA only authorizes the use of synthetic substances that fall into one of ten specified categories.These categories are copper and sulfur compounds, toxins derived from bacteria, pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and minerals, livestock parasiticides and medicines, and production aids.§ 2118(c)(1)(A)(i).The proposed regulations violate this statutory limitation by proposing synthetics that do not fall into any of these categories, in effect, creating new categories.
Sec. 205.601 contains the following categories of allowed synthetics:
and in 205.603:
The department should only list the 10 categories and than itemize the synthetic substances placed on the National List by specific use or application under those categories.The substances petitioned to the NOSB for National List consideration can only be considered if they are in the ten categories.
b.Allowing categorical use of synthetics in livestock production.
Sec. 205.603 violates OFPA Section 2118(b).It allows categorical use of active synthetic substances, vitamins, minerals and medicines in organic livestock production, without itemizing by specific use or application as required by OFPA.OFPA mandates itemization of each allowed active synthetic substance by specific use or application. USDA has created open-ended categories of allowable synthetic materials and "inert" ingredients on the National List.This should be corrected in the final rule.
c.Allowing synthetics where natural alternatives exist.
The National List may provide for the use of substances in an organic farming or handling operation that are otherwise prohibited under this title only if (A) the Secretary determines . . . that the use of such substances . . . (ii) is necessary to the production or handling of the agricultural product because of unavailability of wholly natural substitute products . . . (OFPA, § 2118(c)).
Sections 205.601 and 205.603 should be changed to reflect that no synthetic substances may be used where there are natural substances that would do the job.Further, all synthetic substances that have natural alternatives should be removed from the list of allowed synthetic substances in the regulations.
The proposal does not create a category for processors, as required by law, for a substance that is "used in handling and is non-synthetic but is not organically produced." [§2118(c)(B)(iii)] This category was created specifically for processed organic food products labeled organic on the front panel containing 95% organic and 5% non-organic and non-synthetic ingredients. The proposal allows the use of synthetic food additives, processing aids, enzymes and ingredients (incidental additives) in processed foods labeled and sold as "organic." However, the law mandates that no synthetic substances may be added during processing of foods labeled organic, saying, "For a handling operation to be certified under this title, each person on such handling operation shall not, with respect to any agricultural product covered by this title (1) add any synthetic ingredient during the processing or any post harvest handling of the product; . . .(4) add any ingredients that are not organically produced in accordance with the title and the applicable organic certification program, unless such ingredients are included on the National List and represent not more than 5 percent of the weight of the total finished product (excluding salt and water). [§2111(a)(1) and (4)] [Handling, by definition, "means to sell, process, or package agricultural products §2103(8)]. Instead, USDA is proposing a new category, 100% organic [§205.301(a)], which will confuse consumers who will see both a "100% organic" and an "organic" product in the market, not knowing that the "organic" product contains synthetic ingredients. Truth in labeling requires differentiation, as the law does, between organic products and those products made with select organic and synthetic ingredients; Section 205.301(b) violates OFPA, Section 2111(a)(1) and (4).
Sections 205.601 and 205.603 allow residual chlorine levels in the water up to "the maximum residual disinfectant limit under the Safe Drinking Water Act."Since the SDWA limit is set at a level that balances the risks from microbial pathogens and disinfection byproducts, it is not an appropriate limit on water used in cases where that balancing is not necessary.This is another example of the problems associated with open-ended categories of allowed synthetics and the failure to perform case-by-case evaluations.
e.Allowing synthetics in food processing and confusing the consumer by creating unauthorized organic product labeling categories.
Sec. 205.600, 205.605(b), 205.270(c)(3), and 205.301(b) violate OFPA Section 2105 and 2107(b)(1)(C) and 2111(a) and (a)(1) through (4), Section 2118 (b), (c)(1) and (A) and (B)(iii).They allow for use of synthetic food additives, processing aids, enzymes and ingredients (incidental additives) in processed foods labeled and sold as "organic." Potentially undermines consumer trust in "organic" and opens a backdoor to GMOs in organic food.OFPA mandates no synthetic substances may be added during processing of organic food.
The proposed regulations allow the use of synthetic food additives, processing aids, enzymes and ingredients (incidental additives) in processed foods labeled and sold as "organic." However, the law mandates that no synthetic substances may be added during processing of foods labeled organic, saying, "For a handling operation to be certified under this title, each person on such handling operation shall not, with respect to any agricultural product covered by this title (1) add any synthetic ingredient during the processing or any post harvest handling of the product; . . .(4) add any ingredients that are not organically produced in accordance with the title and the applicable organic certification program, unless such ingredients are included on the National List and represent not more than 5 percent of the weight of the total finished product (excluding salt and water). [§2111(a)(1) and (4)] [Handling, by definition, "means to sell, process, or package agricultural products §2103(8)]. Instead, USDA is proposing a new category, 100% organic [§205.301(a)], which will confuse consumers who will see both a "100% organic" and an "organic" product in the market, not knowing that the "organic" product contains synthetic ingredients.
Truth in labeling requires differentiation, as the law does, between organic products and those products made with select organic and synthetic ingredients, that Section 205.301(b) violates OFPA, Section 2111(a)(1) and (4).
Each one of the listed substances needs to be examined against the definition of "synthetic" included in OFPA and then excluded if they are a "synthetic."Only natural (non-synthetic) substances not organically produced can be petitioned, reviewed and evaluated according to the National List procedures outlined in OFPA.Under OFPA the items in this class of substances used in processing do not need to be itemized by specific use or application in processed foods.OFPA 2118(b).
II. Allows unauthorized categories on the National List.
We were glad to see that USDA took heed of public comments asking that USDA respect the Organic Foods Production Act (OFPA) mandate that only the National Organic Standards Board (NOSB) may propose substances for inclusion on the National List of synthetic substances permitted in the production of organic products.The National List proposed in this draft is better than that in the earlier draft, but still seriously and fundamentally flawed.(See comments on National List below.)
USDA still fails to understand the purpose of the National List.OFPA Section 2118 requires that the list contain "an itemization, by specific use or application of each synthetic substance permitted."It also states, "The National List may provide for the use of substances in an organic farming or handling operation that are otherwise prohibited under this title only if:
"(A) the Secretary determines,
in consultation with the Secretary of Health and Human Services and the
Administrator of the Environmental Protection Agency, that the use of
(i) would not be harmful to human health or the environment;
(ii) is necessary to the production or handling of the agricultural product because of unavailability of wholly natural substitute products; and
(iii) is consistent with organic farming and handling; . . ."
Use of the language "only if" mandates the Secretary to determine that each requirement identified in Section 2118(c)(A)(i), (ii) and (iii) is met, before a synthetic substance is considered for inclusion on the National List.
Thus, the National List cannot be a list of synthetic substances "generally recognized as safe," but can only be considered if identified in Section 2118(c)(B)(i) for use in farm production or as a synthetic inert, Section 2118(c)(B)(ii) in an approved pesticide and must be based on case-by-case determinations of safety, need, and consistency with organic methods.
As designated by OFPA, the NOSB and the Secretary are directed to consider on only three classes of substances for inclusion on the National List.The managers of the Senate-House Conferee Report state that the National List may include exemptions for substances otherwise prohibited but which the National Organic Standards Board and the Secretary determine are harmless to human health and the environment, are necessary because of the unavailability of wholly natural substitute products, and are determined to be consistent with organic farming practices. Such exemptions, however must meet one of the following three criteria:
(1) the substance is used in production and contains a synthetic active ingredient in the following categories: copper and sulfur compounds; toxins derived from bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and minerals; livestock parasiticides and medicines and production aids including netting, tree wraps and seals, insect traps, sticky barriers, row covers, and equipment cleansers;
(2) the substance contains synthetic inert ingredients; or
(3) the substance is used in processing and is non-synthetic but not organically produced.
The USDA should note, OFPA does not provide on the National List for a class of synthetic substances to be used in processed foods labeled and sold as "organically produced." OFPA does mandate establishment of a class of substances that: " is used in processing and is non-synthetic but not organically produced."
The National List cannot be a list of substances "generally recognized as safe", but must be based on case-by-case determinations of safety, need, and consistency with organic methods. The list in Sec 205.601 and 206.603 violates OFPA, Sections 2105 and 2118(c)(B)(i) and should conform to the list in the law and itemize specific uses, rather than establishing categorical lists of acceptable synthetics.
III. Allows genetically engineered ingredients in organic food.
Under "excluded methods," instead of excluding the practice of genetic engineering and defining genetically modified organisms (GMOs) as a synthetic product, USDA leaves the door open for its use. Sections 205.2, .605(b), .270(c)(3), .301(b), and .606 violate OFPA Sections 2105, 2107 and 2118.
The NOSB recommended a prohibition on the use of genetic engineering because genetically engineered organisms and the products of such organisms are "synthetic." The NOSB also recommended a comprehensive definition of genetic engineering. This was done to ensure that the recommended prohibition on genetically engineered foods, processes, and inputs encompasses all potential genetic engineering techniques. NOSB, Final Recommendation Addendum 25, "Definitions and Interpretations" (November 1, 1995).The USDA's proposed § 205.2 does not define genetically engineered organismsexplicitlybut clouds the definition under "excluded methods."The proposed definition "excluded methods" rejects the NOSB's broad definition of genetic engineering and replaces it with a narrower one.For complete clarity, genetically engineered organisms and their derivatives need to be defined in the final rule as "synthetic" by USDA, thus legally establishing their prohibition under OFPA.Should the USDA's definition be in the final rule, it would seriously pervert the meaning of any prohibition on genetic engineering.
IV. Creates new definitions in conflict with OFPA.
The Proposal (Sec. 205.2) creates definitions which are in conflict with OFPA:"allowed synthetic," "audit trail," "claims," '"commercially available," "excluded methods," "handling operation," "inspection," "livestock," "non-agricultural substance," "system of organic production and handling," "unavoidable residual environmental contamination" and "wild crops."
V. Allows inerts as a category without determination of safety and need.
In the proposed National OrganicProgram Rule, USDA states its intention to allow the use of EPA's List 4 Inerts as Allowed Substances for the production and handling of organic food... unless specifically prohibited.
As explained above, the National List cannot be a list of substances generally allowed.Rather, the decision to allow individual substances must be based on a case-by-case determination of safety, need, and consistency with organic methods and OFPA.
As USDA notes in the preamble, greater disclosure of the contents of formulated products is essential for the use of those materials in organic agriculture.USDA must realize that it is in the driver's seat on this issue.All that is required to obtain complete disclosure is for USDA to prohibit the use of any formulated product that does not fully disclose all ingredients or contains any ingredients not specifically permitted by the rule.Sec. 205.601(m), 206.607(d)(1)(2) and (3) violate OFPA Section 2118(b), (c)(1) and (A) and (B)(ii).
VI. Allows sewage sludge.
Concerned with residue levels of heavy metals, pesticides and contaminants such as PCBs, the NOSB specifically found that "sewage sludge" was "synthetic" and "unacceptable for use in organic crop production." "Summary of NOSB Recommendations for Materials Considered at Indianapolis, IN" (September 1996).Public comment overwhelmingly concurred.While use of sewage sludge is prohibited, the use of toxic sewage sludge ash is not, which might be interpreted as an allowance of municipal sewer sludge ash.
VII. Allows residues of pesticides equivalent to chemically grown food.
Food contaminated with pesticide residues determined to be average for the nation will be labeled organic, despite the recommendation that residues be no greater than 5% of the legal limit. Section 205.671(a) ignores the National Organic Standards Board recommendation under OFPA Section 2119(k)(5) and pesticide residues should be the lesser of 5% or the average residue detected (estimated national mean).
Section 205.671(a) and the definition of "unavoidable residual environmental contamination in Section 205.2 ignore the National Organic Standards Board recommendation under OFPA Section 2119(k)(5) that pesticide residues "shall not contain pesticide residues in excess of the FDA action level or 5% of the EPA tolerance.If, for a specific pesticide, detection at 5% of the EPA tolerance is not technically feasible, the pesticide residue level shall be the lowest level of detection attainable for that pesticide.In such situations, the certifying agent shall survey the regionally available accredited laboratories and select the laboratory with the analytical procedures capable of detecting the lowest level for the pesticide."
Using the "estimated national mean" would only cover the top three pesticides used nationally on the specific crop grossly limiting residue monitoring and authority of federal, State and accredited certifiers of raw and processed organically produced products.
VIII. May allow ionizing radiation (irradiation).
NOSB's Final Recommendation, Addendum Number 7, "Organic Good Manufacturing Practices" (April 25, 1995) states that ionizing radiation (irradiation) may not be used in the handling of organic food.Although this draft of the standards prohibits ionizing radiation, it fails to define it.This oversight must be corrected.
IX. Allows temporary variances from the law.
This loophole allows prohibited practices. Section 205.290(a) violates OFPA Sections 2102, 2105, and 2106.They create variances not allowed under OFPA. They do not conform to NOSB emergency spray and feed recommendations.Allowing certified farms, processors and distributors to seek variances from USDA to allow the use of prohibited practices and substances and still label products as "organically produced" is not consistent with OFPA.
Emergency spray and feed variances were the only NOSB final recommendations to USDA.Section 205.671(a) would allow food contaminated with pesticide residues determined to be average for the nation to be labeled organic, despite the recommendation that residues be no greater than 5% of the legal limit. Section 205.671(a) ignores the National Organic Standards Board recommendation under OFPA Section 2119(k)(5).Pesticide residues should be the lesser of 5% or the average.
X. Allows sodium fluoride.
The List 4 of Inerts includes sodium fluoride (NaF), but NaF should be specifically prohibited for use in the Rule for a number of reasons:
* Because fluoride is "pesticidally active" and "of toxicological concern", it never should have been on EPA's List 4 Inerts (nonactive ingredients).
* Section 6508 (c)1 of the Organic Foods Production Act of 1990 says producers shall not use "natural poisons such as arsenic or lead salts that have long-term effects and persist in the environment." Fluoride is in this category.
* The broad spectrum of fluoride's toxic abilities makes it especially inappropriate for use in sustainable, organic agriculture.
* Fluoride is a persistent, non-degradable poison that moves through the environment and accumulates in the soil and organisms. It damages crops, livestock, wildlife, and human health.
The National OrganicProgram proposed rule allows the use of all of the substances on EPA's List 4 of "inert" substances. Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), "inerts" include anything in a pesticide formulation not claimed as an "active ingredient" for killing a target organism, even if these "other" substances were also toxic and pesticidal. Some, especially cumulative poisons, have no place in organic activities and sustainable agriculture.
OFPA directs the NOSB and USDA to determine use of synthetic inert ingredients in allowed synthetic or natural pesticides on a case by case basis.Each synthetic inert included in the National List must be itemized by specific use or application.The Proposed Rule is in violation of OFPA and should be corrected in the Final Rule.
XI. Allows unreasonable fees and adverse impact on small farms.
The NOSB recommended that the USDA use appropriated funds to cover the cost of the first round of accreditation. NOSB, Final Recommendation, "Standards and Procedures Governing the Accreditation of Organic Certification Organizations" (June 4, 1994). It was the NOSB's intention that these costs then be analyzed so a fair and equitable fee structure could be established for the next round of accreditation.Under proposed §§ 205.640 - 205.642, USDA neglects to establish "reasonable fees" annually for farm/site/wild crop production and handling operation certification.Without NOSB and USDA determination of what fees are reasonable, how can reasonable fees be charged?A valid Regulatory Flexibility Act annual analysis cannot be made without the annual farm and handling operation fee projection.(OFPA mandates "reasonable fees" for all participants in the Program.)
Many organic producers are small, local operations that make little money from the sale of organic produce, but that nonetheless perform a vital service by supplying such products to a local market.The fees proposed by the USDA are excessive for such farming operations.The USDA should impose fees on a sliding scale based on a farmer's income so as not to drive these farmers out of business and deprive consumers of the benefits of these operations.The federal Regulatory Flexibility Act as amended provides the legal basis for applying different requirements and cost to different size operations.
Sec. 205.203(c)(3), 205.306(b), 205.670(b) violate OFPA Section 2113.They place undue regulatory burden on certified organic farms by requiring each farm to conform to Code 317 compost guidelines; by requiring lot numbers on all "non-retail containers used for shipping or storage of produce/perishable products;" and proposes the residue testing of organic farm and handling operation "agricultural inputs."(OFPA does not mandate any of these.)
Sec. 205.504(b)(5) violates OFPA Section 2107(a)(9).OFPA mandates USDA to: "Provide for public access to certification documents and lab analysis."The USDA Proposal falls short of the OFPA.("Certification documents and laboratory analysis" minus "business related information" are required under OFPA to be supplied to all seeking the information.)
XII. Allows inconsistencies of plans and prohibited substances.
The National List content, guidelines, procedures, requirements and evaluation criteria rating system are not explained.Criteria for determining equivalency of imported "organically produced" products with US standards and certification is absent.Fiber handling operations, honeybees, wild aquatic and terrestrial animal standards, requirements for "split operations" are not proposed.USDA has not accepted the NOSB's Final Recommendations for uniform organic farm, livestock and handling operation plans and that limit ALL prohibited substances in organic products to 5% of EPA tolerances.
XIII. Allows exclusion from certification for restaurants and retail food establishments.
The law clearly requires certification for "any operation or portion of an operation (except final retailers of agricultural products that do not process agricultural products) that (A) receives or otherwise acquires agricultural products; and (B) processes, packages or stores such products." [§2103(10)] Section 205.101(b)(1) and (2) violates Sections 2103(10) and 2107.
XIV. Allows non-edible livestock products, but not non-edible fiber crops, like cotton and flax, to be labeled organic.
The proposal allows livestock fibers like wool, mohair to be sold as "organically produced" and does not allow crop biers like cotton and flax to be sold in the same way.The allowance under Section 205.236(3) is discriminatory if it is not extended to fiber, as well.
XV. Allows confinement for poultry, hogs and other livestock.
The proposal allows for the intensive and perpetual confinement depending on "stage of production." Section 205.239(a) must define "stage of production" and "pasture."
XVI. Allows unfair labor standards.
USDA must respond to the many comments made in response to the first set of proposed regulations regarding fair labor standards on certified organic farms.
XVII. USDA commitment to organic agriculture
While organic agriculture has been the best example of a successful and sustainable agricultural system in United States agriculture during the past 50 years, the USDA has shown a disproportionate commitment to conventional agriculture and biotechnology.Organic agriculture needs full funding in proportion to its market share.Last year the USDA paid out $25 billion to conventional agriculture, including emergency funds for farmers.To make the long overdue transition to organic agriculture-which is needed to save America's family farms-the USDA must allocate billions of dollars, not a mere six million dollars as the current proposed organic regulations call for, to ensure a sustainable and equitable future.
We look forward to the adoption of a system that nutures the growth of organic agriculture and builds on the solid foundation of organic agricultural systems that are embodied in the Organic Foods Production Act. For this to happen, USDA must follow the law and adhere to the standards that it contains. USDA's failure to enforce the law through its regulation will undermine the growth of organic agriculture by undermining public trust in the process and outcome. We urge USDA to adhere to the legal requirements of OFPA through the rulemaking process and look forward to working with you on implementation.
Thank you for your attention and response to our comments.