National Food Processors Association (NFPA)

Comments on the National Organic Program 30apr98

April 30, 1998

Eileen S. Stommes
Deputy Administrator
USDA-AMS-TM-NOP
Room 4007-S, Ag Stop 0275
P O Box 96456
Washington, DC 20090-6456

[Docket No. TMD-94-00-2] National Organic Program
62 Federal Register 65850, December 16, 1997

Dear Sir or Madam:

The National Food Processors Association (NFPA) submits the following comments on the docket referenced above.

The National Food Processors Association (NFPA) is the principal scientific trade association representing the $430 billion food processing industry. With three laboratory centers, NFPA is the leading authority on food science and safety for the food industry. For more than 90 years, the food industry has relied on NFPA for government and regulatory affairs representation, scientific research, technical services, education, communications, and crisis management.

NFPA limits it comments to the USDA National Organic Program (USDA-NOP) to the following sections of the proposed rule: General, Definitions, Applicability, Crops, Handling, National List, Labeling, and State Programs.

General

NFPA believes strongly, and urges USDA-NOP to recognize in preamble, that establishing a national standard for organic food production and processing must in no way suggest or imply that organic food products are safer or healthier than conventionally produced food products. The organic program constitutes a life style philosophy associated with the production, processing, and handling of   food products, and food products labeled "organic" represent only a choice for consumers interested in maintaining this life style.

As for a scientific justification for "organic," there is none. Nevertheless NFPA urges USDA-NOP to review the proposed organic rule for scientific consistency. In proposed §205.16(e), the Agency would prohibit sulfites, nitrates, and nitrites from being used in agricultural and processing practices of foods produced under the organic standard. Nevertheless, at proposed §205.22(e)(4) and proposed §205.26, the Agency would allow for the use of sulfur dioxide. It is well known that sulfur dioxide is a sulfite. In fact, FDA regulations governing the declaration of sulfites in foods, at 21 CFR §101.100(a)(4), explicitly names sulfur dioxide within the scope of the rule, together with other permissible sulfiting agents: sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium metabisulfite. NFPA urges USDA-NOP to correct these errors of fact and either amend the general provision to permit the use of all sulfiting agents; specifically permit sulfur dioxide while acknowledging that sulfur dioxide is a sulfite and prohibiting the use of other sulfites; or remove sulfur dioxide from the lists of permitted substances. Equally, NFPA urges USDA-NOP to review this proposed rule for other errors of scientific fact.

Definitions (Proposed §205.2)

NFPA notes that the term "critical control point" is a defined term in FDA and USDA’s HACCP regulations. Under the HACCP regulations, the meaning of "critical control point" is widely divergent from the definition of this term in proposed §205.2. NFPA feels strongly that the term "critical control point" should be reserved as a term specific to the realm of HACCP, as needless confusion will most certainly result if processors and regulatory agencies are forced to use this term as a reference to both a required food safety matter and a voluntary philosophical matter. NFPA strongly urges the USDA-NOP to use the term "organic program control point" rather than "critical control point".

NFPA also notes that "incidental additive" is referenced in FDA food labeling regulations at 21 CFR 101.100(a)(3)(i): "Incidental additives are substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect." The relevance of these incidental additives in FDA’s food labeling regulations is that incidental additives present in a food at insignificant levels, and not having any technical or functional effect in that food, are not required to be included in the ingredient declaration. NFPA objects to the adaptation of this established definition for another purpose in the proposed organic standard. Use of the term "incidental additive" as proposed in the organic standard will serve only to confuse food processors, who have come to learn another meaning for the term. NFPA believes that the term "insignificant additive" may better reflect the meaning of "an additive present in agricultural products at an insignificant level that does not have any technical or functional effect in the product and is therefore not an active ingredient."

Applicability (Proposed §205.3)

At the outset, NFPA strongly urges USDA-NOP to advise in this rule that food products produced and processed under the organic standard must comply with applicable provisions of the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, the Poultry Products Inspection Act, and all other relevant statutes and their implementing regulations, in all respects, especially related to adulteration and misbranding. The absence of such a reference could suggest incorrectly to the unaware that compliance with the provisions of the Organic Foods Production Act and implementing regulations are the only requirements applicable to organic foods. NFPA notes that the provisions of the organic standard would add another layer of compliance for foods produced and processed under the standard, but in no way would the organic standard replace or provide an exemption from any existing requirements that foods be safe, and be labeled in a truthful, non-misleading manner. This fundamental premise should be noted in the organic rule.

Consequently, NFPA urges USDA-NOP to add a paragraph, designated 205.3(c), as follows:

(c) Any agricultural product that is sold, labeled, or represented as organic shall comply with all applicable provisions of the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, the Poultry Products Inspection Act, and all other relevant statutes and their implementing regulations.

NFPA notes that the proposed organic standard makes no accommodation for non-domesticated (i.e., wild) animals. This means that, according to the rule as proposed, the organic standard would exclude nearly all ocean fish and seafood. NFPA urges USDA-NOP to make provisions to accommodate non-domesticated animals, including ocean fish and seafood, in the organic standard. NFPA does recognize that the National Organic Standards Board intends to develop recommendations for including fish, seafood, and fishery products within the scope of the organic standard. NFPA encourages the expeditious development of such recommendations, but sees no reason why the National Organic Program should delay incorporating these important food products into the organic standard absent the recommendation of the Advisory Committee. Any delay would necessitate a second round of rulemaking, and waste precious government and industry resources better devoted to implementing any final rule.

One accepted goal of organic practices is to minimize the intervention of man in agriculture, and to control strictly any intervention that does occur. Ocean fish and seafood are a class of food animals that live their lives with no human intervention until harvest. NFPA recognizes that certain challenges are presented with respect to certifying the organic status of non-domesticated animals. Nevertheless, one fundamental premise of the proposed organic standard is that actions of nature are presumed to be acceptable. The human interventions and practices that are permitted under the proposed organic standard appear designed to emulate actions of nature as closely as possible. In addition, actions which are consequences of nature appear not to render a food ineligible for organic certification. For example, in the compliance section for the organic rule, proposed §205.430(d)(2) recognizes that prohibited substances at or under the unavoidable residual environmental contamination level were not the result of an intentional application, and that foods with such levels of prohibited substances could be sold or labeled as organically produced.

For this reason, NFPA believes that ocean fish, crustaceans, and other seafood products caught in the wild should be able to be certified organic, provided that such products are held in a manner consistent with the standard from the moment of harvest. Therefore, NFPA recommends that proposed §205.3(a)(2) be changed to read as follows:

(2) Harvested, if a wild crop, in accordance with the requirements specified in Sec. 205.11 and all other applicable requirements of part 205, or if ocean fish, crustaceans or other seafood; and …

Some fishery stocks are managed in whole or in part through aquaculture practices. Such practices can be compatible with the organic standard, provided that the stocks are raised under provisions similar to those proposed for livestock.

Crops. (Proposed §205.8)

In the preamble addressing proposed §205.8, USDA-NOP invites comment with respect to the use of Genetically Engineered Organisms (GEOs) or their products in a system of organic farming and handling. The USDA-NOP specifically invites comments on whether the use of GEOs or their products in organic farming and handling should be permitted, prohibited, or allowed on a case-by-case basis.

NFPA believes strongly that it is appropriate to permit GEOs, the products of modern biotechnology, in organic production and handling, in all instances, including both human food and animal feed applications. There is no scientifically supportable or logical reason to exclude such organisms or their products from the organic standard. Furthermore, NFPA believes that the use of modern biotechnology is fully consistent with the interests reflected in the Senate report language of the Organic Foods Production Act, which states that "... as time goes on, various scientific breakthroughs, including biotechnology techniques, will require scrutiny for their application to organic production. The committee is concerned that production materials keep pace with our evolving knowledge of production systems."

Modern biotechnology has the potential to offer genuine benefits to the organic industry. Modern biotechnology can allow certain traits to be introduced into plants, such as crops with increased resistance to pests, stresses, and diseases. Certain of these engineered traits will result in minimized chemical applications. NFPA believes that modern biotechnology is fully consistent with the goals of organic agriculture and handling, which seeks to prohibit synthetic inputs and to control strictly all non-synthetic inputs. For example, if a more disease- and pest-resistant strain of corn is developed through modern biotechnology, fewer chemicals, even chemicals permitted on the National List, will be required to achieve a viable crop.

Modern biotechnology is a technique that allows for precise introduction of such traits into plants, and it reflects no more human intervention than conventional techniques of plant breeding and hybridization. The proposed rule is silent on the appropriateness of hybrid crops or cross-bred livestock in the organic standard, but NFPA points out that modern crop and livestock production would not be possible without hybridization and cross-breeding techniques. Examples of widely hybridized crops include sweet corn, tomatoes, wheat, beans and apples, and virtually all current breeds of cattle, hogs, sheep, chickens and turkeys in production agriculture are the result of cross-breeding. As hybridization, cross-breeding, and the products thereof appear to be permitted in organic production and handling practices, NFPA believes strongly that modern biotechnology and its products are equally appropriate and should be permitted for both human food and animal feed.

Prohibition of widely used products of GEOs, such as recombinant chymosin, would virtually ensure that certain food product categories, such as cheese, would not be represented among organic products.

Handling and Processing Practices (Proposed §205.17)

In the preamble addressing proposed §205.17, USDA-NOP invites public comment with respect to the compatibility of the use of ionizing radiation with a system of organic farming and handling.

NFPA strongly supports the inclusion of ionizing radiation as a treatment for organic produce and processed products. NFPA notes the ionizing radiation is a "minimal" process in that it transforms a food much less than traditional methods such as canning, freezing, and dehydrating. The Food and Drug Administration, which regulates such matters, has deemed irradiation a safe process, and has approved its use on several specific categories of food products. NFPA is committed to promoting the acceptance of food irradiation as a safe and proven process that can help assure safety and quality of food products. NFPA believes this process is as suitable as other processing techniques, and may be more suitable for certain applications.

NFPA believes that science has demonstrated that ionizing radiation is equally effective as alternative treatments, and may be more useful in some respects than such practices and treatments as heat pasteurization. While other techniques may be as effective as irradiation, they may not all be practical or permissible under the organic standard. For example, heat treatment, including classical pasteurization, is effective but impractical for foods intended to be sold fresh or raw, such as fruit and vegetable produce, or raw meat and poultry. For control of insect pests, including pests which affect herbs and spices, fumigation techniques would be effective, but these would not be permitted under the organic standard. In both instances, the use of irradiation could help assure safety and quality of the finished food product.

NFPA believes that irradiation can be a powerful tool to help ensure food safety, which should be of concern to organic agriculture practices that typically use manure in substantial quantities as fertilizer. Some of these organic production practices convey increased health risks, such as potential adulteration of foods by pathogenic microorganisms. The use of irradiation for organic foods should be seen as a safety option to minimize these health risks.

NFPA notes that, while ionizing radiation is regulated by FDA in the context of a food additive, in fact it adds no chemicals to the food. For this reason, NFPA believes that ionizing radiation is a treatment technique wholly compatible with the proposed organic standard.

Among the processing practices proposed as acceptable at §205.17(a), cooking, baking, and heating all involve the use of radiant energy. The proposed rule is silent on, and would appear to permit, all sources of such radiant energy, whether infrared, ultraviolet, or microwave. NFPA maintains that ionizing radiant energy should be equally permitted.

In short, NFPA urges USDA-NOP to recognize ionizing radiation as an effective food safety tool that can allow other objectives of organic production and handling to flourish. NFPA notes that, under the produced organic standard, it would be acceptable to treat crops with compounds of metals such as copper, selenium, or cobalt. In the most widespread use of ionizing radiation, the agent of treatment is the output of a metal isotope, cobalt-60. NFPA believes it would be scientifically insupportable to permit the products of "metal chemistry" in the organic standard and disallow products of "metal physics."

In proposed §205.17(b)(1), USDA-NOP would prohibit organic products from being stored, coated or packaged in a storage container or bin, including packages or packaging materials, that contain a synthetic fungicide, preservative, or fumigant. NFPA objects to the prohibition of packaging materials containing such synthetic substances, specifically "preservatives," for technical reasons. Virtually all flexible packaging materials contain a layer of polyolefin polymer such as polyethylene or polypropylene on the interior, food contact layer to effect heat-sealability for a leak-free enclosure around the product. All of these polyolefinic materials require the use of an antioxidant blended into the resin to prevent oxidative degradation during extrusion and aging at ambient conditions. Preservative substances such as BHA or BHT are commonly used in this application at levels of 200 ppm to 1000 ppm in the polymer resin. Most of these antioxidants typically would be volatilized during the extrusion process. There are synthetic alpha-tocopherols available, which have been used to some extent in the industry as a substitute antioxidant for polyolefin resins, but it is not clear if these would be permitted in food contact packaging under the proposed regulations. The issue of such antioxidant preservatives would also apply to certain types of paper and paperboard packaging materials. Strict prohibition of such compounds that are typically considered preservatives in food contact packaging materials would severely limit the choice of safe packaging materials for organic fresh and processed food products.

NFPA also requests clarification in proposed §205.17, as well as proposed §205.19, regarding potential cross-contact between organic products and other products which may be processed using the same machinery or equipment. Existing regulations and procedures for Good Manufacturing Practices, detailed in FDA regulations at 21 CFR part 110, should be adequate for maintaining the integrity of a batch of organic processed product which may be processed following other products. Cleanout procedures for equipment and machinery used to process organic food products should not be more stringent than for other foods. More rigorous procedures for organic products are not supported by scientific criteria. Furthermore, existing FDA-defined Good Manufacturing Practices for storage of raw materials and finished products equally should apply to organic food products.

National List (Proposed §205.26)

NFPA requests clarification from the National Organic Program regarding the scope of the class "nutrient supplements" identified on the list of Non-agricultural substances allowed as ingredients in or on processed products labeled as organic or made with certain organic ingredients. NFPA specifically requests that the National Organic Program affirm that this class notation signifies that vitamins and minerals may be added to organic processed products. The addition of vitamins and minerals is permitted under the FDA fortification policy at 21 CFR §104.20, and is required for certain foods with FDA standards of identity, such as enriched cereal grain products at 21 CFR Part 137. NFPA believes that addition of vitamins and minerals in organic foods should be permitted to the extent that such addition complies with FDA and FSIS regulations.

Labeling. Proposed Subpart C

NFPA urges the USDA-NOP to discuss in the preamble to any reproposal or final rule resulting from this proposal that use of the term "organic" in any form does not exempt a food product so labeled from any other labeling requirements under the authority of the U.S. Food and Drug Administration and the USDA Food Safety and Inspection Service. In addition, NFPA specifically requests that the National Organic Program discuss in any further regulatory documents the manner in which organic labeling requirements are consistent with the long-standing labeling policies established by FDA and FSIS.

NFPA urges USDA-NOP to consult with the FDA and FSIS on the types of statements which may be considered false or misleading on organic foods because they are otherwise defined. For example, the terms "natural" and "all natural" commonly are used in association with the term "organic", but are not necessarily synonymous with organic. FDA has articulated its policy position on the use of "natural" (58 FR 2302 at 2407, January 6, 1993). Use of non-synthetic colors from natural sources in organic food products, permissible under the proposed organic standard, would disqualify an FDA-regulated food product from using the term "natural."

Additionally, a statement that the organic food was a "healthy" food selection would require that the food comply with the definitions for the claim "healthy" at 21 CFR § 101.65(d)(2) or 9 CFR §317.363.

Finally, in this regard, USDA-NOP should be aware of the types of statements that FDA and FSIS have determined would misbrand a food, such as those under the provisions of 21 CFR §101.9(k). Included in this FDA rule among the types of statements which would render a food misbranded are claims: that a balanced diet of ordinary foods cannot supply adequate amounts of nutrients; that the lack of optimum nutritive quality of a food, by reason of the soil on which that food was grown, is or may be responsible for an inadequacy or deficiency in the quality of the daily diet; that the food has dietary properties when such properties are of no significant value or need in human nutrition; that a natural vitamin in a food is superior to an added or synthetic vitamin or to differentiate in any way between vitamins naturally present from those added. In addition, 21 CFR §101.18(a) prohibits representations on one food which are false or misleading with respect to another food. Use of such statements to imply that an organic food product is more nutritious, safer, or even "better," than one produced through conventional means likely would rendered the organic product misbranded. Proponents of organic production and processing practices may well be tempted to make such claims for their products, and it would be in the interest of USDA-NOP to advise that such statements would misbrand the food.

NFPA believes that these principles regarding truthful and non-misleading labeling, and the higher order authorities of FDA and FSIS, should also guide decisions on prohibited statements under proposed §205.103 and §205.104

Proposed §205.103

Proposed §205.103 addresses the use of terms or statements that directly or indirectly imply that a product is organically produced and handled, and would prohibit all such terms unless they are used only for an agricultural product, including an ingredient, that has been produced and handled in accordance with the Organic Foods Production Act and implementing regulations thereof.

USDA-NOP requested comments on what terms or phrases, other than organic or "made with certain organic ingredients," could directly or indirectly imply that a product was organically produced and handled and the rationale for the allowance of their use. Examples of terms or phrases which USDA-NOP listed as possibly implying directly or indirectly that a product is organically produced and handled include: "produced without synthetic pesticides," "produced without synthetic fertilizers," "raised without synthetic chemicals," "pesticide-free farm," "no drugs or growth hormones used," "raised without antibiotics," "raised without hormones," "no growth stimulants administered," "ecologically produced," "sustainably harvested," and "humanely raised."

These and similar terms could be valid statements, if made in truthful and non-misleading manner, which may represent independent consumer understanding and value, and may not necessarily imply "organic." NFPA recommends that, before USDA-NOP proposes a list of phrases deemed synonymous with "organic," the Agency should conduct research with consumers to assess their understanding of such terms. NFPA also notes that if these or any phrases are used in a manner to suggest or imply that foods so labeled are safer or healthier than foods without such statements, or to represent any material difference compared to foods without such statements, they may well be deemed misleading, even if true. Only those statements which, in context, would be considered false or misleading should be prohibited from the labels of food products, including foods which are not produced under the organic standard.

NFPA believes that proposed §205.103 requires the USDA-NOP to prepare a First Amendment analysis, as this section purports to limit label statements which may otherwise be truthful and non-misleading. NFPA believes that this analysis would be essential if USDA-NOP lists any phrases prohibited in association with organic labeling. NFPA believes that developing a list of prohibited synonyms for "organic" is a far more serious Constitutional matter than mere Agency uncertainty about "what terms and phrases should appropriately be placed on such a list."

Requirements of State Programs (Proposed §205.401)

NFPA strongly supports the concept that any promulgated food standard should be nationally uniform. NFPA’s position in this regard extends to the organic standard. NFPA asserts that the concept of a nationally uniform standard is fundamental to the Organic Foods Production Act. Consequently, NFPA supports provisions in the proposed rule that would require that a State organic program must meet the provisions of the national regulations and the mandate of the Act. However, NFPA opposes provisions that a State organic program that meets the requirements of the National Organic Program regulations and the Act also could contain more restrictive requirements governing the production and handling of organic agricultural products. Despite the proposed provisions, whereby USDA would require that any additional State requirements must be consistent with the Act and the national regulations, NFPA strongly believes that allowing any differences between the National Organic Program and State programs would render the national standard irrelevant.

NFPA recommends that USDA require a substantial burden of proof to demonstrate the need for a different standard, for any State seeking approval for an organic standard that differs in any material respect from the national standard. NFPA believes that any such State should demonstrate affirmatively the manner by which the different State standard is consistent with the national standard, and must make a positive showing of how the different standard is designed to address a particular need unique to the State’s circumstances. NFPA believes that USDA should reject any State request for a different standard unless it meets this considerable burden. U.S. food laws and regulations contain a precedent for such an approach, in FDA regulations at 21 CFR §100.1, regarding State petitions for exemption from the preemption afforded by certain sections of the Federal Food, Drug and Cosmetic Act.

States should not be able to set a different organic standard simply as a matter of local preference. Unless state organic standards are identical with the national standard, essentially there is no national standard. If States are permitted to set more rigorous requirements for organic, then individual States could promote their programs as "More ‘organic’ than the National Organic Program." Such promotions will serve only to confuse consumers. NFPA urges USDA-NOP to strengthen the National Organic Program through an interpretation of the provisions of the statute to favor the national program over differing State programs. USDA should clarify that having State standards consistent with the national standard means they must be identical to the national standard with respect to scope, permitted and prohibited substances and practices, and certification requirements.

Thank you for the opportunity to comment on this important issue.

Sincerely,

Regina Hildwine
Director, Food Labeling and Standards
Regulatory Affairs

1 May Editorial -- "Organic" Standards:  Well Said
2. Regina Hildwine, NFPA, remarks at the 1998 National Food Policy Conference
"USDA's Proposed 'Organic' Standard: What's It All About?"