The proposal stipulates at 205.509(c)(2)(ii) that members of a peer review panel must include at least two members from the peer review pool who possess sufficient expertise. OTA supports this requirement. The peer review pool should be composed of participants with active, current experience in organic certification. OTA notes that, in order to be in compliance with ISO Guide 61, section 2.3.1, persons who conduct audits (site evaluations) cannot be involved in making the accreditation decision.
Amend Section 205.510(c)(2) to read:
“(2) Following receipt of the information submitted by the certifying agent in accordance with paragraph (a) of this section, the results of the initial site evaluation, annual NOP evaluation reports and mini-visits, and, if applicable….”
Under section 205.510(c)(1), evaluation of certifying agents occurs once every five years. This should be amended to include annual reports and “mini-visits” to be compliant with ISO Guide 61, section 3.5.1, which states “the accreditation body shall have an established documented program, consistent with the accreditation granted, for carrying out periodic surveillance and reassessment at sufficiently close intervals to verify that its accredited body continues to comply with the accreditation requirements. In most cases it is unlikely that a period greater than one year would satisfy the surveillance requirements of this clause.” In the rapidly changing world of organic production, certification, and marketing, OTA is concerned that evaluating certifying agents once every five years is not sufficient.
Subpart G - Administrative
Section 205.600 does not contain or reference OFPA or NOSB criteria to evaluate crops and processing materials. OTA supports the inclusion of criteria for crops listed in OFPA section 6518(m), and criteria for processing further elaborated by the NOSB in February of 1999. These criteria should be inserted in section 205.600; per each National List section of the Rule; or at 205.607, “Amending the National List.”
If “excluded methods” are to be classified as synthetic, OTA advocates that they should be clearly prohibited in the criteria used to evaluate materials, and that there should be a general prohibition on GM sources of all National List allowed items. A statement such as, “They are not genetically engineered/modified,” would need to be added to each of the criteria sections listed below.
During compilation of the AOS, OTA used the evaluation criteria recommended by NOSB. Those criteria are presented below for inclusion in the rule:
Evaluation criteria for materials used in crop production.
The evaluation of materials for use in crop production shall be based on:
1. The potential of such substances for detrimental chemical interactions with other materials used in organic farming systems;
2. The toxicity and mode of action of the substance and of its breakdown products or any contaminants, and their persistence and areas of concentration in the environment;
3. The probability of environmental contamination during manufacture, use, misuse or disposal of such substance;
4. The effect of the substance on human health;
5. The effects of the substance on biological and chemical interactions in the agroecosystem, including the physiological effects of the substance on soil organisms (including the salt index and solubility of the soil), crops, and livestock;
6. The alternatives to using the substance in terms of practices or other available materials; and
7. Its compatibility with the principles of organic production.
Evaluation criteria for materials used in livestock production.
The evaluation of materials for use in livestock production shall be based on the following criteria:
1. If the material is ingested as feed, it shall not contain plastic pellets, manure, or urea;
2. Whether the material stimulates growth or production by acting as a growth stimulator, such as a hormone, antibiotic, synthetic trace element, or by other similar action;
3. The potential for interaction with other materials ingested, administered, or applied to organic livestock, pasture, or living areas;
4. Toxicity and mode of action of the substance, and of its breakdown products or any contaminants. Consideration of the substance's persistence and concentration in the environment includes the fate through excretion and accumulation within the animal's tissues;
5. The environmental effects of its manufacture, use, misuse, or disposal;
6. The potential direct and indirect human health effects arising from the use of the substance in livestock. If the substance is controlled by the FDA, this would include the characteristics of the substance identified in the Food Animal Residue Avoidance Database (FARAD); and whether or not that substance is used in humans;
7. Whether or not the substance has physiological effects on livestock. This includes any changes the substance causes in natural behavior, the incidence of stress-related illnesses, or other effects that impede the normal functioning of animals. The value of the substance to relieve pain and to provide humane treatment must be evaluated against the potential use of the substance to conceal symptoms that would otherwise require treatment with a prohibited substance and diversion to conventional market;
8. The alternatives to the substance available, including cultural and management practices; non-synthetic or organically produced sources; and other materials; and
9. Its compatibility with the principles of organic production. This includes ways that the material is used in a system where livestock are integrated into land and water management.
Evaluation criteria for materials used in organic handling operations.
A synthetic ingredient, processing aid, or food additive may be used if (criteria adopted by NOSB in February, 1999):
1. An equivalent substance cannot be produced from a natural source and the material has no substitutes that are organic ingredients;
2. Its manufacture, use, and disposal does not have significant adverse effects on the environment;
3. The nutritional quality of the food is maintained and the material itself, or its breakdown products, do not have any adverse effect on human health;
4. Its primary purpose is not as a preservative or to be used only to recreate/improve flavors, colors, textures, or nutritive value lost during processing, except as required by FDA Standards of Identity for vitamin and/or mineral fortification;
5. It is Generally Regarded as Safe (GRAS) by FDA when used in accordance with Good Manufacturing Practices (GMP), and contains no residues of heavy metals or other contaminants in excess of 5% of the tolerances established by FDA;
6. Its use is compatible with the principles of organic handling; and
7. There is no alternative approved method or substance to produce a similar product and use of the substance is limited to the minimum quantity required to achieve the process.
104. 205.601, 602, 603, and 604
OTA stresses the importance of NOSB review, before implementation of the Law, of materials now being allowed and used for organic crop and livestock production, for inclusion on the National List.
The proposed rule includes, among synthetic substances allowed for use in organic crop production, “EPA List 4 - Inerts of Minimal Concern” [205.601(m)].
The rule has no parallel listing for inerts under 205.603 or 205.605 for livestock and handling. Inerts used in livestock and handling materials will need to be addressed by the NOSB.
The proposed rule limits the allowance of inerts to only those with synthetic actives on the National List. OFPA states that the National List may provide for use of substances in organic farming that are otherwise prohibited only if:
“6517(c)(1(B)(ii) the substance is used in production and contains substances used in production and contains synthetic inert ingredients that are not classified by the Administrator of the Environmental Protection Agency as inerts of toxicological concern.”
OFPA does not specifically limit inerts to use with synthetic actives appearing on the List. OTA recommends that the inert ingredients policy be extended to all EPA registered pesticides—those that are non-synthetic and not appearing on the National List of prohibited non-synthetics as well as those synthetics on the allowed non-synthetics list. This includes such permitted natural substances as Bacillus thuringiensis sprays, neem oil, and kaolin clay.
The NOSB discussion of a suitable inerts policy focused on the substances contained on the EPA’s four lists, and the implications of including or excluding a given substance or class of substances. The first proposed rule allowed everything except for what is on List 1. The re-proposed rule allows List 4—without reference to 4A or 4B, although the preamble refers to this list as ‘Inerts of Minimal Concern,” which is now the title of List 4A.
OTA supports full public disclosure of inert ingredients in all pesticides, not only those that are used in organic farming. OTA encourages the USDA to continue to support efforts to require full public disclosure of all inerts by the EPA in order that OFPA is implemented fairly and honestly.
OTA advocates that NOSB be permitted to prohibit specific List 4 inerts, if evidence or a petition is presented to justify such an action. This is consistent with the policy adopted by the NOSB in Feb. 99 and provides a check on any questionable or very slow rulings by EPA. OTA endorses the following NOSB policy:
“Inert ingredients on EPA Lists 1 and 2 shall be prohibited for use in organic production and handling effective on the date of implementation of the final rule. Synthetic inerts on EPA List 3 shall be prohibited if not specifically approved by the NOSB. This approval process will be completed and published by January 1, 2002. Any inert currently in use in organic production that is not approved by the NOSB will be banned within 18 months after the review is completed and published. To that goal, inerts on EPA List 3 used in products that have active ingredients approved for organic production shall be reviewed by the NOSB on a case-by-case basis for possible inclusion on the National List. The NOSB recommends that inerts on List 4 generally be allowed unless explicitly recommended for prohibition.” (NOSB, February, 1999)
Amend to read:
“(11) Parasiticides - Ivermectin - Prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation. Milk or milk products from a treated animal cannot be labeled as provided for in subpart D of this part for 90 days following treatment. In breeder stock, treatment cannot occur during the last third of gestation or during lactation if the progeny will be sold as organic”
Rationale: Section 205.603(a)(11) does not prohibit practiced application during lactation to breeder stock.
OTA encourages the USDA to support the NOSB in reviewing materials that are currently being used in the processing of organic products, but not on the proposed National List. It is imperative that these materials be brought before the NOSB in a prompt and efficient manner.
OTA requests that the following materials or annotations be placed on National List as previously recommended by the NOSB:
205.605(b)(7) Calcium Phosphates (monobasic and dibasic): The NOSB recommended that calcium phosphate (mono-, di-, tri-) be included on the National List. Add tribasic calcium phosphate to National List.
Fruit Waxes: The NOSB recommended that carnauba wax and wood rosin be added to the National List. The National List does not include any reference to fruit waxes, although they are mentioned in the preamble.
Natural Flavors: The NOSB recommended (Austin, October, 1995, Sligh, p. 162) that natural flavors that met certain strict criteria be allowed for use in foods labeled as “organic,” and natural flavors that met less strict criteria be allowed for use in foods labeled as “made with organic ingredients.” NOP proposed rule does not include any references to natural flavors except in the preamble on page 13553 as “organic liquid flavoring extracts.”
Replace current wording of (205.605)(a)(11) with: “Must be derived from edible, nontoxic, non-EM plants, nonpathogenic, non-EM fungi, or nonpathogenic, non-EM bacteria.”
Rationale: The NOSB has clearly recommended that enzymes included on the National List (205.605)(a)(11) be produced by non-genetically engineered means. Genetically engineered or genetically modified has been defined in the rule under “excluded methods” (205.2). There are some methods, (e.g. doubling, etc.), however, that could be used in the engineering of enzymes that have not been included in the definition. To effectively preclude their use the OTA recommends that "non-EM" be added to the annotation for enzymes.
Rewrite as: “Nutrient Vitamins and Minerals, Synthetic. Allowed only as required by other regulations or when recommended by an independent professional organization and used according to guidance provided in 21 CFR 104.20, Nutritional Quality Guidelines for Food.”
Rationale: NOSB generally considered food to be the best source of nutrient vitamins and minerals. Historically, organic food has not been fortified, except in a few specific cases. Laws designed to protect the public health preempt organic standards. Items like white flour and skim milk will have vitamins and minerals added to restore the nutritional profile. NOSB also recognized that organic processors fortify certain foods based upon dietary recommendations made for a specific segment of the population, such as weaning infants.
The existing NOSB recommendation (Austin, October, 1995, Sligh, p. 161 and p. 183) states that nutrient vitamins and minerals are allowed for use in organic foods for enrichment or fortification when required by regulation or recommended by an independent professional organization. Although this FDA guidance states as principles that:
“FDA does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce, meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages”,
it does contain guidelines to allow for synthetic fortification in a number of scenarios that are not required by law.
OTA is not opposed to the addition of some nutritional supplements to organic food, when required by law or specifically approved on the National List. OTA also is not opposed to the reference to voluntary labeling standards for nutritional supplementation. OTA does express concern with the potential for abuse and would like to see greater oversight over bases used to fortify or enrich certain foods. As with natural flavors, verification of the sources, and the incidental additives-—particularly artificial preservatives—requires careful and attentive oversight to ensure that prohibited materials are not being introduced into foods labeled as organic.
111. New subsection 205.605(b)(35)
Insert a new subsection “205.605(b)(35): Sulfur dioxide – less than 100 ppm for wine only.” Change the numbers of “Tocopherols” and Xanthan gum” to (36) and (37), respectively.
Rationale: AOS 220.127.116.11.C)1)e) states that sulfur dioxide should be allowed: “in wine only at levels of 100 ppm or less, with level of free sulfites not exceeding 35 ppm in the final product, and finished product may only be labeled “made with organic ingredients.”
The NOSB also recommended that sulfur dioxide be allowed for use in wine labeled as “made with organically grown grapes.” NOP proposed rule cites the statutory prohibition of sulfites and does not add sulfur dioxide to the National List.
The Proposed rule released 3/13/00 will, if implemented as written, have drastic unintended consequences for the growing and sales of organic wine grapes in the US and abroad. In contrast to the earlier proposed rules and more recent NOSB recommendations, the current text would not allow any wine made from organic grapes that contains added sulfur dioxide (SO2 ) to be labeled as either "organic wine" or "wine from organic grapes".
The last Proposed rule allowed wine from organic grapes with added SO2 under 100 ppm total sulfites to be labeled as "organic wine", as recommended by NOSB. (Orlando, April, 1995, Sligh, p. 183). In 1998, NOSB revised their recommendation to only allow wine from organic grapes with no added SO2 to be labeled "organic wine". Wines containing under 100 ppm total sulfites from added SO2 would be allowed the label "wine from organic grapes". The Organic Trade Association's American Organic Standards followed this recommendation in 1999. The recent USDA Rule completely ignores and negates years of study and debate within the organic industry on this issue that resulted in prior NOSB positions.
OTA estimates that at least 80% of the wines made from organic grapes in the US are bottled with added sulfur dioxide. These also are the most stable and salable of the organic wines available today. To eliminate these wines from the market would drastically reduce the incentive for wine grape certification.
In any other wine producing country this figure would be above 98%. Since the USDA Organic Program began, the Bureau of Alcohol, Tobacco, and Firearms (BATF) has only allowed use of the term "wine from organic grapes" on any wine label submitted with or without added SO2 as long as organic certification of the grapes was documented. European Community organic standards also allow wines from organic grapes to be so labeled regardless of use of SO2 . A growing number of US organic wines are exported to the EEC with the "made from organic grapes" label and hundreds of foreign wines are now imported into the US with the same designation.
Sulfur in some form has been used in winemaking for centuries and probably dates back to the Greco-Roman period when its cleansing properties were widely known. In addition to its anti-bacterial action, sulfur retards oxidation in wines. Oxidation inevitably causes browning and loss of flavor particularly in white or rose wines. Sulfur dioxide binds free oxygen molecules, reducing and delaying the oxidation for years. It is usually added to wine in a gaseous or diluted form before bottling. If winemakers use the natural form, as all organic winemakers do, rather than synthetic potassium metabisulfites, they are not actually adding sulfites to the product.
Sulfites are formed in the wine when added sulfur dioxide reacts with water in the wine. In addition, amounts of completely natural sulfites are created in wine during fermentation through changes to sulfates existing in grapes. The prohibition in the Organic Foods Production Act (OFPA) specifically rejects "added sulfites," not added sulfur dioxide. In addition, sulfur is allowed in organic agricultural use for anti-fungal applications.
The same section of text in the OFPA (Section 6510(a)) that "prohibits the adding of sulfites" to organic products also says that a handler "shall not... add any synthetic ingredient during the processing or any post harvest handling of the product." It is clear that the NOSB and the Secretary have seen their way to exemptions from this wording for many processed organic foods, as is clearly allowed in Section 6517(c). There is no more weight to OFPA’s prohibition on sulfites than there is for any synthetic additive. Thus the rationale that sulfites are prohibited in OFPA fails on two counts for organic wines. One, that sulfites are not actually added, and two, that they are no more prohibited than dozens of synthetic additives that are on the National List. The NOSB has followed this reasoning in decisions in 1995 and 1998 and so recommended to the USDA.
By any standard in OFPA, sulfur dioxide should be allowed in organic wines. Used in the manner required for wine production, sulfur dioxide is not harmful to the environment or to human health, and it is necessary to production of any commercially viable quantities of high quality wine. Wine is not a product that can be sold within a month or two of bottling. It simply is not possible given the public expectations of wine stability and the current distribution system, and is not desirable for wine quality. The only drawback to this irreplaceable additive is the allergenic nature for about 4% of the population. The FDA acted to protect this population in 1988 when all foods containing sulfites were required to show clear and visible warnings such as "Contains Sulfites." Since that time, all organic wines which contain sulfites have shown this warning and the organic industry has used significant resources in telling its customers that some organic wines have added sulfur and some do not. Some organic pretzels have added salt and some do not, but the customers do not believe that one is more organic than the other. Customers also have come to this understanding, since all wines with over 10 ppm total SO2 show the mandatory warning label. Those allergic to sulfur seek out the organic wines without added SO2, and other customers have a wider choice of organic wines, including all imports that require a longer time from winery to shelf.
Customers seeking organic wines without added SO2 now know that they risk buying a fragile wine; most organic wine buyers seek a more stable product that nonetheless gives them the guarantee of certified organic grapes and all the consequent value involved in that choice.
Organic wines are being held to a standard more strict than any other commodity. Most organic wines in fact contain no other ingredient than organic grapes and a maximum 80 ppm or less than .0001% of total sulfites from both added SO2 and natural sulfates. How can organic wine producers not tell our customers that this wine from 99.999% organic grapes is in fact "made from organic grapes," when many other foods with only 50% organic ingredients will be touting their "organic" composition? How can consumers expect a vineyard to continue certification when the vineyard will not even be able to tell the simple truth of grape origin to the customer? Wine grapes have had the most certified acreage of any organic crop in California for several years, although total acreage has dropped recently, perhaps due to the continued lack of clarity on organic standards and their effect on grape sales. This ruling would devastate the sales of certified grapes, since the great majority of wineries making wine from these grapes use SO2 and will not pay a premium for organic grapes without the privilege of informing customers of this quality.
In addition to the effect on organic grape growing in the US, the rule would severely limit sales of US organic wines worldwide, as our standards would not even allow producers to mention organic grapes on the label, in complete contrast to other worldwide agreements. In addition foreign producers would lose hundreds of products currently sold in the US according to the existing rule that allows "made from...". The ability of BATF to enforce this rule would also be a challenge, since thousands of labels are already approved using the "wine from organic grapes" statement.
Although there are still consumers who do not understand the use of or origin of SO2 in wine, and they may sincerely prefer to not have "organic wine" with any added sulfur, the OFPA is not supposed to increase public misperceptions at the expense of organic agriculture. Part of the role of USDA and the organic industry is to educate the public about organic foods and appropriate expectations for their processing and quality. The advantages to our quality of life from a wine from organic grapes far exceed any question of added sulfites or the lack of them.
The inclusion of a prohibition on sulfites and two other substances (nitrates and nitrites) in the original OFPA was an aberration from the intent and form of the Act, since use of all other substances was to be decided through a fair and comprehensive evaluation process. Whatever decision led to this OFPA wording inevitably bypassed a reasoned dialogue on usage of these additives. All other foods and their requisite processing aids were allowed a full hearing before NOSB and USDA. The organic wine grape industry struggled with this clause for almost ten years and arrived at a fair resolution with the 1995 and 1998 NOSB recommendations. To now reverse this process and risk the loss of this entire segment of the organic industry is unacceptable.
The terminology of section 205.620, “State Programs,” confuses “State organic certification programs” and “State organic programs.” It is unclear if this section applies only to States which act as certifying agents, or if it also covers State organic programs. It is also unclear if States can have additional requirements, and take enforcement actions, without establishing certification programs. In order to clarify, strike the word “certification” from the definition “State organic certification program” in section 205.102 and in sections 205.620, 621 and 622, if this section is intended to cover State organic programs. State certifying agents are adequately defined and covered elsewhere in the proposed rule.
113. New section 205.623
Insert a new section:
“Section 205.623. Requirements of State organic programs without certification.
(a) A State organic program that has a regulatory impact on organic producers, regardless of whether or not the program includes certification, must be approved by the Secretary.”
Section 205.660 “Compliance,” deals only with de-certification and de-accreditation. It does not address investigation and enforcement of non-certified, excluded, and exempt operations making “organic” claims. How are consumers to be assured that exempt and excluded operations are in compliance with applicable provisions of OFPA and these rules? A registration system needs to be implemented for all operations which are exempt and/or excluded from certification requirements. Without some kind of registration requirement, there is no accountability for these types of operations. Such operators should be required to register with a local Federal, State or County Agriculture Department office. They should receive a copy of the regulation, sign an affidavit stating that they meet the applicable requirements of the regulation, and attest that their operation meets the provisions under which it is granted exempt or excluded status. Such a system will hold exempt and excluded operations accountable, allow for effective compliance and enforcement, increase consumer confidence, and gather important market data. As the California State program demonstrates, this kind of system can be implemented and enforced.
In section 205.662(e), no penalties are assigned other than suspension and de-certification. There is no ability to “stop sales” or recall misbranded or fraudulently produced products. OFPA, section 6519(a) states, “Any person who knowingly sells or labels a product as organic, except in accordance with this chapter, shall be subject to a civil penalty of not more than $10,000.” There needs to be a citation or reference to the OFPA requirements concerning violations. There also needs to be regulatory language developed to implement the violations section of OFPA.
“Any dispute with respect to proposed suspension or revocation of certification under this part shall, at the request of the applicant for certification or certified operation, be mediated pursuant to 7 CFR part 11 and 205.681 of this chapter. Any agreement reached during or as a result of the mediation process shall be in compliance with the Act and these regulations. The Secretary may review any mediated agreement for conformity to the Act and these regulations. Date of received Notice to the applicant of the Secretary’s decision per review for “Act conformity”, will for 7 CFR part 11 purposes, be the final day of mediation.”
Rationale for comments numbered 116, 117, 124, and 125:
Rationale: These changes solve three major problems in the Proposed Rule:
1) The problem of conflict of interest between the NOP administrator hearing appeals and administering the program decisions at the same time, and the potential for conflict of interest between private certifiers having to go to their competitor (the State) for appeals;
2) the USDA proposal of sending plaintiffs to an administrative law judge (ALJ), which is overly expensive and formal; and
3) the lack of a uniform process in the Proposed Rule, appeals being heard in some cases by states and in others by USDA.
A fair and effective appeals system is essential to the success and integrity of NOP and to the accreditation process. Independence and objectivity being of prime importance, OTA makes the following recommendations to the Secretary:
1. Any person adversely affected by the NOP action or decision must be given the opportunity to appeal that determination. The Secretary must, in all cases, have the final decision making authority in the administrative review process.
2. In the interest of fairness, independent hearing officers who are not responsible for the implementation and administration of NOP must conduct appeals. Because AMS is responsible for this program, the use of hearing officers who are employed or under the authority or control of AMS presents a problem of conflict of interest. To protect the integrity of the appeals process, and to ensure fairness of these determinations, OTA recommends that an independent USDA Appeals Division be used. This recommendation is not meant to imply the establishment of a separate USDA Appeals Division for organic production, but to strongly recommend the necessity for an independent review process and for organic production to be included in NAD.
3. To ensure an expedited appeals process, and because food products are seasonal and some are highly perishable, organic farmers, certifiers, handlers, and processors must be given the opportunity to correct any conditions resulting in an adverse decision by NOP so that they can continue to carry out their business activities and avoid undue economic losses due to the inability to market their products.
4. It is essential that all persons adversely affected by NOP be notified, in a timely manner, that they have the right of appeal. Therefore OTA recommends requiring written notification regarding all adverse decisions, such notification to include an explanation of the reasons for the decision and a timely notice of appeals rights and procedures.
5. To ensure that this appeals system is end-user friendly and that the knowledge of appeals rights are readily available and simple to understand, OTA recommends that at the accreditation and certification application stages, appeal information must be provided to applicants. This informational brochure must include in easy-to-understand language the following: appeals rights and procedures; timelines for due process; and all phone numbers, personnel and addresses necessary to exercise these rights.
6. Furthermore, OTA urges USDA to keep the NOSB apprised in a timely manner of the activities of the appeals system, on a quarterly basis. This information should include: the number and kinds of appeals, any outcomes, and any problems arising from this process that may need new or revised recommendations to USDA.
The proposed regulation is consistent with statutory authority. First, 7 USC Section 6991, the statute authorizing NAD, holds that the term agency means any agency of the Department designated by the Secretary. Thus, it is within the Secretary’s discretion to designate the National Organic Program as an agency for the purposes of NAD.
Second, OFPA, in Section 6520, authorizes the Secretary to create an expedited administrative appeal procedure. It is within the Secretary’s discretion, therefore, to use the NAD procedure, and it is not required that the Secretary use the ALJ system found in the Department’s Uniform Rules of Practice.
(a) A state program’s governing State official must promptly notify the Secretary of commencement of any enforcement proceeding against a certified operation and forward to the Secretary a copy of each notice issued.
(b) A noncompliance proceeding, brought by a State program’s governing State official against a certified operation, shall be appealable pursuant to the appeal procedures at 7 CFR Part 11 and 205.681 of this chapter.
(c) (same as March 13, 2000 Proposed Rules)
Rationale: Please see rationale under comment #116.
OTA supports the significant change in this section, which now states that residue tests may be required “when there is reasonable cause to believe” that an organic product has come in contact with a prohibited substance. This is consistent with current industry practice. It meets consumer and producer expectations, without imposing undue burdens. OTA requests that some wording changes be made to this section, however.
In the first sentence of 205.670(b), after “agent may require preharvest or postharvest testing of any”, delete the phrase, “agricultural input used or ”. After “reasonable cause to believe” delete “agricultural input or”.
Rationale: The purpose of residue testing under the OFPA is to assure that organically produced agricultural products do not contain pesticide residues or residues of other prohibited substances that exceed specified tolerances. As currently worded, Section 205.670(b) also requires the testing of “agricultural inputs” (substances or materials used in organic production and handling – as defined in Section 205.2) that are believed to have been contacted by a prohibited substance. This would require organic certifying agents to test many non-organic “agricultural inputs” such as seeds, raw materials used for compost, manure, and mulching materials such as straw, sawdust, and plastic. All such materials are likely to have come in contact with a prohibited substance before being purchased/used by the organic farmer. Testing “agricultural inputs” is unnecessary, burdensome, expensive, and is not current industry practice.
Replace “agricultural product” with “organically produced agricultural product.” Replace the second “product” with “organic product”.
Rationale: The purpose of residue testing under the OFPA is to assure that organically produced agricultural products that are sold as organic do not contain pesticide residues or residues of other prohibited substances that exceed specified tolerances. As currently worded, Section 205.670 (b) requires the testing of “any” agricultural product. This includes non-organic agricultural products used in products labeled “made with organic (specified ingredients).” This would require organic certifying agents to test all non-organic ingredients used in such products when “they have reasonable cause to believe they have come in contact with a prohibited substance,” because they are likely to have come in contact with a prohibited pesticide. Testing of these non-organic ingredients is unnecessary, burdensome, expensive, and is not current industry practice.
Delete the last sentence of section 205.670(b).
The last sentence of section 205.670(b) says that residue tests must be conducted at the governing State official or certifying agent’s “own expense”. This constitutes micro-management by the USDA. The rule does not need to state who will pay for residue tests. At the present time, residue analyses are paid for by producers, buyers, brokers, certifiers, and government residue testing programs. There is no need for this level of detail on this issue.
OTA applauds NOP for changing this section for the better, from the last proposed rule.
Nonetheless, section 205.670(d)(2) requires all results of residue testing on organic products to be available for public access. While public access to such information is likely a legal requirement, USDA must assure OTA that confidential business information, including the name of the certified organic producer or handler, associated with specific residue testing results, is not disclosed to the public. This information, or perhaps only confirmed residues in excess of the limit, should be available to certifiers but aside from that should be treated as confidential business information.
Rationale: Public disclosure of the confidential business information associated with every residue test conducted under NOP will create enormous business disruption for organic producers and handlers.
Sections 205.670 and 205.671 of the proposed rule establish a standard and procedure to address pesticide contamination in organic food. These sections address several specific requirements in OFPA:
“A requirement for periodic testing of certified products for pesticides, non-organic residue or natural toxicants by certification agents” 6506(a)(6);
“A system of residue testing to test products sold or labeled as organically produced” 6511(a);
“Pre-harvest and post harvest tissue testing of organic food for suspected contaminants; 6511(a, b), and
“The standard that will be applied to determine the level where a food can no longer be certified and labeled as organic because of the presence of Unavoidable Residual Environmental Contamination (UREC)” 6511(c)(2)(B).”
Organic certification is not a pesticide-free claim. However, residue testing has a place in organic certification. It is a valuable tool for detecting fraud; a deterrent for farmers who might be tempted to commit fraud; a means to assure those who purchase organic food that the residue levels for organic food are not exceeded; and a way to monitor environmental contamination. For these reasons, OTA supports the National Organic Program’s proposed development of a residue testing program, as discussed above. To the greatest extent possible, the program needs to build upon existing knowledge and experience, both among members of the organic community as well as within government pesticide residue testing programs.
Synthetic pesticides have been the primary contaminants of concern in organic certification. Other contaminants of concern include pathogenic organisms; heavy metals from mined minerals and recycled products; and, more recently, genes from GMOs. The intent of these provisions is to provide a clear, empirical, enforceable standard for pesticide residues in organic food. Certifiers need to be able to distinguish an instance of suspected improper use of an unlisted pesticide from those situations where food is contaminated with a prohibited substance through no fault of the grower. Such inadvertent contamination can arise from drift from a nearby treated field or the presence of persistent residues in soil.
Most certifiers and State programs currently set a limit based on a factor of the EPA tolerance of between 5 and 10 percent. At least one private certifier set a tolerance of no pesticide residues detected at a specified limit of detection. The National Organic Standards Board (NOSB) recommended that the threshold be set at five percent of EPA tolerance. (Santa Fe, June, 1994, Sligh, pp. 130-134).
The original proposed rule set the level at the EPA pesticide residue tolerance level (62 Fed. Reg. 65933 and 62 Fed. Reg. 65957-65958). Many organizations and individuals, including OTA, criticized this proposal as too lax. That first proposed rule allowed of pesticide residues in organic food at levels higher than most existing organic standards. The previous proposed rule made no distinction between the direct intentional application of pesticides and incidental contamination. In response to these criticisms, the re-proposed rule sets the standard for a given crop/food-pesticide combination at the Estimated National Mean (ENM) of positive samples found in the USDA’s Pesticide Data Program (PDP).
Preliminary analysis of the PDP and ENM levels, conducted by the Organic Materials Review Institute, (OMRI), indicates that the new proposal is generally stricter than the 5% of EPA tolerance standard recommended by the NOSB, and much stricter than EPA tolerance proposed by NOP in 1997.
Given the scope of the USDA’s PDP program, there are hundreds of crop-pesticide combinations for which there are no PDP data, and hence no ENM. In the final rule, USDA must speak to how it will deal with such cases, since certifiers will certainty be confronted with many such cases. One approach could draw upon the average ratio values reported. For contaminants and/or crops not tested by PDP, the final rule could establish a “Provisional Certification Action Level” (PCAL) equal to the tolerance level divided by the average ratio value.
The source of contamination of organic food is often drift from another crop. It is common in such a case for the residues from a drift incident to have no corresponding tolerance or action level for the active ingredient on that crop. USDA needs to establish or recommend a mechanism for certifiers to deal with these circumstances in setting a PCAL. Given that pesticide drift is handled on a state-by-state basis, the USDA standard will need to work for organic farmers in different situations of drift incidents—nuisance, negligence, mandated spray programs, and chemical trespass.
If there is a tolerance for the same pesticide in a closely related crop, that tolerance level, or some portion of it, could be used for the purposes of establishing the PCAL. Alternatively, the ENM for a certain pesticide on all similar fruits could be used in setting the PCAL for a given fruit.
If no ENM is comparable for similar crops, the only other alternative would be to determine whether there are structurally and functionally similar pesticides for which there are tolerances on the crop in question. In general, NOP should add safety factors for certifiers in establishing tolerances and guidelines for enforcement against fraud under this section of the rule.
Furthermore, section 205.671 states that unavoidable residual environmental contamination (UREC) levels will be “determined by the Administrator.” No further guidance is given. UREC levels are not specified, even though products will not be able to be sold as organic if they exceed the UREC levels. This is a critical issue that must be resolved in consultation with the NOSB, as required by OFPA section 6518(k)(5), before the rule is implemented.
123. New subsection 205.672(b), reorder current sections
Insert a new subsection 205.672(b), and reorder the current sections:
“(b) The certifying agent must monitor production operations that have been subjected to a Federal or State emergency pest eradication or disease treatment program, and may require testing of following crops, or an extended transition period for affected production sites, if residue test results indicate the presence of a prohibited substance.”
Rationale: Section 205.672 does not clearly establish that a transition period may be needed after contamination of an organic operation by a government mandated spray program. There may be a need for a case by case determination by the certifying agent, but no guidance is given on how the transition period should be determined. This clarifies the section by directing certifying agents to monitor operations that have been subjected to government mandated spray programs.
Persons subject to the Act who believe they are adversely affected by a noncompliance proceeding decision of the National Organic Program’s Manager or a certifying agent may appeal such decision under the provisions of this chapter in accordance with 7 CFR part 11.
Rationale: See rationale under comment #116.
125. 205.681 Appeals.
(a) Certification appeals. An applicant for certification may appeal a certifying agent’s notice of denial of certification, and a certified operation may appeal a certifying agent’s notification of proposed suspension or revocation of certification to NAD.
(1) If NAD sustains a certification applicant’s or certified operation’s appeal of a certifying agent’s decision, the applicant will be issued organic certification, or a certified operation will continue its certification, as applicable to the operation. The act of sustaining the appeal shall not be an adverse action subject to appeal by the affected certifying agent. To ensure an expedited appeal process 7 CFR Sections 11.9(a)(2) and 11.9(d)(2)(i) shall not apply under this chapter.
(2) If NAD denies an appeal, a formal administrative proceeding will be initiated to deny, suspend, or revoke the certification. Such proceeding shall be conducted pursuant to the Department’s Uniform Rules of Practice.
(b) Accreditation appeals. An applicant for accreditation and an accredited certifying agent may appeal a Program Manager’s denial of accreditation or proposed suspension or revocation of accreditation to NAD.
(1) If NAD sustains an appeal, an applicant will be issued accreditation, or a certifying agent will continue its accreditation, as applicable to the operation.
(2) If NAD denies an appeal, a formal administrative proceeding to deny, suspend, or revoke the accreditation will be initiated. Such proceeding shall be conducted pursuant to the Department’s Uniform Rules of Practice.
(c) Appeals of compliance decisions. To obtain a hearing under 7 CFR Section 11.8, a participant personally request such hearing not later than 30 days after the date on which the participant first received notice of the adverse decision and other provisions in accordance with 7 CFR Section 11.6. Decisions to deny, suspend, or revoke a certification or accreditation will become final and nonappealable unless the decision is appealed in a timely manner.
(d) All appeals to NAD must be filed in writing under provisions of 7 CFR Section 11.
Proposed Revision of 7 CFR Part 11:
(1) To the definitions in 7 CFR Section 11.1, “Agency,” add:
(13) National Organic Program of the Agricultural Marketing Service
(2) To 11.9 add:
(f) Director review is not available for hearing officer decisions regarding the National Organic Program of the Agricultural Marketing Service.
Rationale: Please see rationale under comment #116.