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Comments on Issue Paper #3,
"Termination of Certification by Private Certifiers."

 

This USDA issue paper, along with two others, were published in the Federal Register October 28, 1998 and are found on the USDA National Organic Program Web site at http://www.ams.usda.gov/nop/. The deadline for submission of public comment is December 14, 1998.

 

The Henry A. Wallace Institute for Alternative Agriculture appreciates this opportunity to analyze options for implementation of the Organic Foods Production Act (OFPA). We support the Department's goal of clear, consistent regulations that stimulate the growth of organic markets, satisfy consumer expectations, and allow organic producers flexibility in making site-specific, real-time management decisions. Our response to the options presented in Issue Paper 3 is consistent with, and an expansion upon, the comments on the Proposed Rules for the National Organic Program (NOP) submitted by the Wallace Institute on April 30, 1998.

A strong, workable enforcement program is a prerequisite for successful implementation of the Organic Foods Production Act (OFPA). For the organic market to continue to grow, consumers must feel confident that certified products are produced and handled in compliance with standards. An enforcement program to address non-compliant product must provide a system of checks and balances which rewards responsible producers while discouraging intentional or accidental misrepresentation. Prevention of fraud was a principal objective behind OFPA's passage. While the Wallace Institute believes that intentional misrepresentation has been rare, the price premiums and fast growth of the market provide sufficient motive and opportunity for fraud. Unfortunately, a few high profile instances of fraud have already hurt the hard earned credibility which the vast majority of organic producers enjoy. Organic consumers and producers alike need an enforcement program which insures that certified product is in compliance with standards and certified producers and handlers are accountable for their actions.

The NOP must: (1) prevent products not in compliance with standards from being sold as organic, and; (2) suspend or revoke the certified status of operations which significantly violate their farm or handling plans. OFPA contains minimal provisions to guide both of these critical functions, providing little specificity regarding the delegation of authority and mechanisms for enforcement. The Senate Report language accompanying the legislation provides some guidance, stating that the Congress's intent in authorizing state and private certifying agents is "to take advantage of the network of existing entities already engaged in certification." The Wallace Institute continues to support shared responsibility for certification between federal, state and private partners as reflected in our comments on the Proposed Rules of the NOP submitted on April 30, 1998. An active collaboration between government and private partners can enhance the enforcement capabilities beyond that which either sector can alone achieve.

Our comments herein elaborate on our April 30th submission but do not address the individual options outlined in Issue Paper 3. The multiple and conflicting interpretations of Issue Paper 3 options discussed at the NOSB's 1998 Washington meeting confused participants and USDA staff alike. Therefore, rather than qualify or condition our responses to specific options, we will use the important substantive issues they address as the focus for our recommendations.

Recommendations

  1. The Wallace Institute strongly recommends that certification be awarded annually. Annual awards confer certified status to producers and handlers for a reasonable period, while preventing the award of perpetual licences that are difficult to revoke from suspect operations. Furthermore, annual certification is consistent with existing state and private programs and would not cause unnecessary disruption in commerce.

  2. The Wallace Institute recommends that the responsibility for conducting investigations of alleged violations under OFPA be held by certifying agents (whether state or private). Certifying agents have the expertise and local access to best ascertain the extent to which violations may have occurred. Certifying agents should conduct investigations based on their own concerns, as well as complaints delivered to them from citizens, state agencies, and the NOP. Demonstration of the ability to conduct an adequate and fair investigation must be a part of the NOP accreditation program. In rare cases when the NOP has reason to believe that a particular certifying agent may have a conflict of interest or other problem that would prevent an adequate investigation, it should forward the complaint to another accredited certifying agent.

  3. The Wallace Institute recommends that notification procedures be established to alert the public when serious investigations of suspect product are underway. Public notification should be issued when, after consultation between certifying agents and the NOP, it is determined that there is strong reason to believe that product on the market is mislabeled as organic. Notification that USDA is conducting an investigation into the potential mislabeling of the product would be given to customers likely to purchase suspect product and could entail notifying brokers, issuing press releases, and other means. Such notifications are consistent with current USDA and FDA practices as well as with certain private and state organic programs. Investigation notifications (as distinct from enforcement actions requiring due process) have been shown to effectively trigger voluntary product recalls.

  4. The Wallace Institute recommends that product recall procedures be established. If there is sufficient reason to believe that product labeled as organic presents a safety problem, certifying agents should notify the NOP who, in turn, would work with other Federal partners to issue a mandatory product recall. While the authority for product recall is vague under the OFPA, there is nothing to prevent the Secretary from issuing such recalls under OFPA and, more significantly, such authority is clearly found under other statutory regimes. Certifying agents and State Governing Officials would work in partnership with the Secretary to ensure expeditious removal of product.

  5. The Wallace Institute recommends that a schedule of financial penalties be developed. OFPA authorizes fines, up to $10,000, for violations under the Act. No guidance is provided as to whether such fines are to be issued per violation, per day, etc. The NOP, in consultation with the NOSB, should develop a graduated penalty schedule that sets appropriate fines for (1) violations of standards; (2) failure to pay certification fees; and (3) failure to provide requested information. Such a fine schedule should take into account the size of operations so to ensure that large scale operations are not able to discount such fines as the "cost of doing business" while, at the same time, small operations are not unnecessarily put out of business (especially when violations are unintentional). We further recommend that such fines be imposed immediately with the onus on the alleged violator to choose between acknowledging the violation and paying the assessed fine or requesting a hearing to contest the allegation—either option must be executed within a prescribed time. Akin to how traffic violations are commonly handled, this would help limit enforcement hearings to only those cases where violations are contested.

  6. The Wallace Institute recommends that probation and suspension of certification be added to the array of enforcement options under the NOP. Unintentional violations under OFPA which are too serious to be dealt with by financial penalties alone but which seem not to merit the ultimate enforcement action—termination of certification—should be responded to by probabations or suspensions of certification for various periods up to three years. For example, if an operator unintentionally uses a synthetic material not on the National List, that operation could not be certified again for a period of three years. While probation and suspension would be identical to termination in their effect on the ability to operate, these penalties would not convey the same level of intent or violation and potentially be a less significant barrier to reentering the organic market once the period of suspension elapsed. Furthermore, under certain state and private programs, probation and suspension are already used, meaning that such penalties already play a significant role in enforcement.

  7. The Wallace Institute recommends that the authority to suspend or revoke certification be the responsibility of the Secretary. We envision an enforcement program in which certifying agents act as prosecutors in that they are responsible for developing accusations (or responding to them) and investigating the alleged violations. As the prosecutors they, with the support of and in concert with the NOP, present the evidence to impartial Administrative Law Judges who, in turn, render decisions. When appropriate, USDA may elect to have a State agency convene a judgement hearing; however, that State agency should not be same agency that certifies organic operations. The guiding principle of enforcement, consistent with due process, should be that the prosecutor and judge be separate entities.

  8. The Wallace Institute recommends that enforcement timetables be established to compel NOP action. Bureaucracies are known for slow response times which is worrisome since consumer protection requires swift enforcement action by USDA. To ensure expeditious action, deadlines should be set for USDA enforcement actions (e.g., 90 days for a hearing before an Administrative Law Judge). Such timetables should be designed to protect consumers from fraudulent activities as well as provide due process to alleged violators who may suffer business and reputation losses while awaiting judgement. If established timetables are not met, private individuals would then have the right to file a "Mandamas Action" claim in the Federal Court of the District of Columbia to compel USDA action.

DISCUSSION

Statutory Provisions of the OFPA for Violations of Standards

The OFPA outlines procedures to investigate, adjudicate, and appeal violations that constitute misuse of the organic label and could result in the revocation of certification from producers and handlers. Section 6519 "Violations of Chapter" identifies actions that constitute misuse of the organic label and establishes parameters for penalizing offenders. The exact separation of power between certifying agents, State governing officials, and the Secretary, however, is somewhat ambiguous.

Authority to Remove Suspect Product The law states that products intentionally treated with prohibited substances or containing excessive unavoidable residual environmental contamination "shall not be sold or labeled as organically produced." Under Section 6511(c)(1-2), "Compliance Review", the OFPA establishes procedures to determine when removal of the organic label is warranted and indicates that the Secretary, the applicable governing State official, or the certifying agent is empowered to conduct an investigation resulting in the removal of an organic label.

Authority to Revoke Certification from Suspect Operations The Secretary is vested, by law, with the ultimate authority to run the NOP. While Senate Report language cites the importance of utilizing experienced state and private certifying agents, there is no requirement in OFPA, or under USDA administrative procedures, for the Secretary to delegate the authority to revoke certification to either state or private certifying agents. In fact, no existing federal food safety or labeling enforcement program delegates to a third party the responsibility to act on the government's behalf. That said, there is also no prohibition in OFPA on such a delegation and no mandate that administration of the OFPA mimic other Federal food safety and labeling programs. Section 6520(a) "Administrative Appeal" does, however, provide to the Secretary the sole authority for establishing an expedited administrative appeals procedure under which persons may appeal a compliance review action.

Penalties Enforcement provisions within the OFPA can be used to foster compliance by making non-compliance prohibitively damaging to an operation's finances or business reputation. By statute, knowingly selling or labeling as organic any product not produced in compliance with the NOP standards is punishable by a civil penalty of up to $10,000. Perhaps more significantly, the Secretary can make any farm or handling operation in which the offending individuals have an interest ineligible for certification. Sections 6519(c)(1)(C) and 6519(c)(2) authorize the Secretary to deny certification for a period of up to five years to any operation in which an individual having committed a violation of the OFPA has an interest. The risk of losing certification for a full five years provides a strong incentive for producers and handlers to rigorously pursue compliance and document it. The flexibility for determining the period of ineligibility (the penalty can be entirely waived as well) provides the Secretary discretion to recommend punishment appropriate to the violation.

Constraints The Secretary's powers to impose penalties under the OFPA, like all federal regulatory enforcement mechanisms, is contingent upon the due process protections which alleged violators must be provided. Section 6519(c)(1)(C) requires that due process, including notification of the Department's intent and an opportunity to be heard, is a prerequisite for enforcement actions. The absence of a detailed enforcement mechanism for misrepresented product under OFPA is likely a reflection of the limited authority which the federal government has overall to remove all kinds of non-compliant products, even those representing an immediate health risk, from the market.

Recommendations of the National Organic Standards Board

Two NOSB actions are relevant to the issues addressed in these comments. The Board's recommendations from its 1994 New Mexico meeting addressed the powers and responsibilities of accredited certifying agents. The principal intent of the recommendations was to secure functional, well-defined conditions under which state and private certifying agents could participate in the NOP. The NOSB stated that "Accredited certifying agents will be responsible for determining whether organic producers and/or handlers are in compliance with OFPA standards and requirements." So complete is the NOSB's delegation of decision making authority for certification that it recommended that "The Certifying Agent must have competency in enforcing its decisions and adjudicating appeals of its decisions." This recommendation would vest responsibility to deny or terminate certification with accredited private certifying agents and require them to respond to appeals. The intent of the recommendations was to bring experienced private certifying agents into the NOP with the authority they traditionally exercised. The provisions pertaining to enforcing decisions and adjudicating appeals were designed to foster dispute resolution on the local level without direct federal intervention. At its 1998 Washington meeting, the NOSB decided to expand its enforcement recommendation in response to consumer demand, expressed in comments to the Proposed Rules, that provisions be established to remove suspect product expeditiously from the organic market. The NOSB's Accreditation Committee is drafting recommendations on removal of suspect product; we urge the USDA to work with the Board to address this important issue in the coming months.

Public Comment on Enforcement Provisions in the Proposed Rules

Numerous comments on the Proposed Rules challenged the USDA's plan for terminating certification. The NOP's Proposed Rules search engine identifies 102 comments for Section 205.219, Termination of Certification. These comments were nearly unanimous in their contention that certifying agents should retain the authority to revoke the status of operations suspected of violating provisions of the national standards. The many additional comments which voiced support for the NOSB recommendations were also endorsing delegation of authority to accredited state and private certifying agents. Many private individuals and representatives of certifying agents expressed similar sentiments at the four public listening session the USDA held in March. Support for empowering certifying agents to terminate certification was driven by concern that the Secretary could not act swiftly enough to respond effectively to suspected violations. The proposed administrative appeal process would mean that, during the proceedings, suspect operations would retain certified status and suspect product would continue to be marketed as organic. Commentators on the Proposed Rules were in agreement that state and private certifying agents need the leverage of unilateral and immediate termination authority to effectively administer the NOP.

In responding to the Proposed Rules, representatives from more than a dozen private and several state certification organizations stressed their strong interest in retaining the authority to terminate certification. Some of these comments emphasized the procedural importance of having the authority: "NOFA-NJ has often had to withhold certificates, and approval of certification, in order to collect requested information." California Certified Organic Farmers expressed financial concerns: "Do the standards provide for denial of certification for operators that have not paid all account due within a reasonable time?" However, concern that non-compliant product could enter the organic market was the most commonly cited justification to delegate termination authority. Consumer confidence in the integrity of certified product has generated phenomenal market growth and the organic community is extremely sensitive to protecting its hard-earned reputation for enforcement. One comment from the Carolina Farm Stewardship Association reflects the intensity of this concern: "CFSA feels it is completely unacceptable for us to bear responsibility for the presence in the marketplace of products we determine have not been produced according to our standards." Any resolution of the conflict over the authority to terminate certification must address concerns of the organic community and the general public that non-compliant product be removed expeditiously from the organic marketplace.

Removing Suspect Product From the Market

Current System State and most private certifying agents have procedures in place to help prevent producers and handlers from marketing fraudulent organic products. The process begins when certifying agents substantiate conditions or practices which deviate significantly from the approved farm or handling plan and violate underlying standards. Certifying agents may discover violations when reviewing an application for renewal of certification, during an inspection, or as the result of a complaint. Every certifying agent has their own procedure for confirming violations and determining how to handle non-compliant products, but many similarities in practice exist. Typically, the certifying agent first notifies the operation of the suspected violation(s), requests that non-compliant product not be sold as organic, and, if warranted, takes steps to inform the operation's actual or potential customers that certification is being terminated.

The legal framework for enforcement represents a fundamental distinction between private and state certifying agents. Private certifying agents, whether non-profit or for profit, can revoke or withdraw their services under the provisions established in the contract with the operation they certify. In contrast, when state certifying agents grant certification, they are conveying a license which cannot be abrogated without due process. Protection under due process includes the right to an impartial hearing before any penalty can be imposed. While private certifying agents may establish an internal review or appeals process to allow operations to contest enforcement actions such as termination of certification, the decisions of state certifying agents do not take affect until after an administrative appeal is completed.

Whether or not certification has legally been terminated, public notification that a certifying agent has initiated termination procedures is often sufficient to interrupt the sale of suspect product. Some certifying agents expedite public notification by requiring operations to identify their intended customers in their application for certification. When the certifying agent revokes part or all of an operation's certification, it informs those customers of the decision. For state certifying agents, initiating the administrative procedures to revoke certification will often block the sale of non-compliant product. In Texas, for example, every certified processing and handling operation is notified when an action to revoke a producer's certification is initiated. Customers for that non-compliant product are generally certified operations themselves, and to accept suspect product would jeopardize their status. While states do have authority to seize or embargo mislabeled or adulterated products, this power has rarely been used to confiscate food which does not represent an immediate human health hazard.

Evaluation of Current System The current system is far from perfect. In cases where private certifying agents determine that suspect product is on the market, they can immediately "revoke" their approval, demanding that the product not be sold as "certified organic." However, private certifying agents have no means to compel an operation to cease organic sales or recall product, other than going to court to enforce the contract. In some cases, operations have thousands of labels for product (with the certifier's seal) already printed and may choose to ignore the certifying agent. Private certifying agents are liable for their actions and, in some cases, have been sued for deciding to terminate certification. In other cases, small non-profit certifying agents face large businesses with high-powered legal teams, making the odds of success slim. In many cases, resolution of legal battles occurs after all the suspect product is sold. Indeed, the most effective means private certifying agents have to expeditiously remove suspect product from the market is to obtain voluntary compliance or notify potential customers that the product is not organic.

Will enforcement improve under the scheme recommended by the Wallace Institute? Somewhat. The OFPA does not include a ready mechanism to remove misrepresented product from the marketplace. An analysis of USDA and FDA food labeling and safety programs indicates that, absent an imminent threat to human health, the federal government has limited authority to recall agricultural products or prohibit their sale. Just like under the existing private system, voluntary recall and public notification is often the best means of achieving expeditious removal of mislabeled product. However, partnership with the Federal government brings the benefit of a national USDA communication network that will significantly bolster the efforts of private certifying agents to notify the public of problem products. Furthermore, in cases where alleged offenders refuse to comply with certifying agent requests and enforcement becomes a legal battle, private certifying agents will be empowered through the financial support and legal expertise of the USDA.

Revoking Certification from Suspect Operations

Current System State and most private certifying agents have procedures to withdraw certification from operations that violate standards and fall out of compliance with their farm or handling plans. As discussed in our comments on removing suspect product, state and private certifying agents follow separate administrative procedures for determining when an operation is non-compliant. Private certifying agents have the flexibility to impose an immediate order to terminate certification on all or part of an operation. The certifying agent is responsible for investigating the alleged violation and determining if the facts constitute sufficient grounds for termination. If termination is warranted, the certifying agent notifies the operation of its decision. Private certifying agents typically have review procedures to allow operations to appeal termination, but the decision remains in effect unless, and until, it is overturned. State certifying agents must follow due process requirements and provide an opportunity for the offending operation to challenge the decision to terminate. States which operate their own certification programs, such as Washington and Texas, file Notices of Intent with an operation to initiate termination proceedings. The Notice triggers a hearing before a state administrative law judge in which both parties present their case. The results of the private certifying agent's review process or the administrative law judge's decision are appealable in civil court.

The decision to revoke certification is often conditional and may be reversed once an operation has come back into compliance. For example, an inspector may discover that a new practice which is not approved has been added to a certified handling operation. This would result in the de-certification of all product that was handled using the non-approved practice. The operation could regain its certification by eliminating the practice and bringing back the inspector to verify compliance with the original handling plan. The nature of the violation can, however, result in a longer suspension of certification. A producer who was found to apply a prohibited material to a field would have to abide by the certifier's provisions for not using such materials (three years in the OFPA) before the site again became eligible for certification. It is common for part of an operation, such as a distinct field or particular batch or shipment of a commodity, to lose certification without the remainder being affected. In exercising their enforcement authority, certifying agents may use graduated penalties, meaning larger fines or longer suspensions, to differentiate minor violations from more serious or repeated ones.

Certifying agents may revoke certification when operations fall out of compliance with standards, have not been adequately forthcoming with documentation, or do not pay their fees. Revocation of certification can protect the certifying agent's reputation and reduce its liability by formally abrogating the relationship with an operation which is believed to be out of compliance. Certifying agents may also publicize the revocation to let the organic community and consumers in general know that the operation is no longer certified.

Evaluation of Current System Current practices do provide certifying agents with considerable leverage for insuring that operations remain in and document compliance. Revocation has limited effectiveness at capturing non-compliant product which has already gone to market, but may damage the operation's credibility and inhibit its future sales. However, there are concerns that the proliferation of private certifying agents has created the opportunity for "certification shopping" where operations seek out the least restrictive conditions. Though rarely exercised, private certifying agents have enjoyed the authority to withdraw their organization's certification when they believe sufficiently grave violations of standards have occurred. Simply having the capacity to terminate certification provides certifying agents powerful leverage to foster cooperation and compliance from producers.

Will enforcement improve under the scheme recommended by the Wallace Institute? Somewhat. Backing certifying agents with Federal enforcement enhances their leverage to obtain compliance. From the perspective of alleged violators, the separation of the prosecutorial from the judgement function protects important due process rights. However, the ultimate success of the recommended system hinges on the ability of USDA to act in a timely manner. Even with the assurance of annual certification, significant quantities of suspect product could enter the market during the time lag between annual certification approvals.

MODELS OF PUBLIC - PRIVATE ENFORCEMENT PARTNERSHIPS

While organic standards constitute a unique set of rules for the USDA to enforce, the Department has a long history of administering food labeling and safety regulations. The Food and Drug Administration (FDA) also has developed procedures to insure that certain food products are accurately represented to consumers and in compliance with federal codes. While the model which the Secretary has proposed to enforce the NOP may appear unfamiliar and unproven to some in the organic community, it closely resembles other federal regulatory programs. While no USDA or FDA enforcement program is flawless, they have proved to be effective, efficient, and responsive to the needs of producers and consumers. We are incorporating into our comments a review of three food labeling and safety enforcement programs to help illustrate the benefits of having a federal enforcement partner under the NOP. The programs we reviewed protect the right to due process of the regulated operations, promote a high level of compliance, and impose significant penalties when violations are confirmed. The Wallace Institute believes that elements of these federally administered programs represent viable precedents for enforcement of the NOP.

Perishable Agricultural Commodities Act (PACA)

The USDA's authority under the PACA to regulate label claims is similar to the powers it has under the OFPA to insure that certified products are in compliance with organic standards. The PACA is a statute from 1930 which regulates business practices and financial dealings between approximately 16,000 federal licensees engaged in interstate commerce in fresh or frozen agricultural commodities (licensees include retailers and brokers handling in excess of $230,000 of fruit and vegetable sales annually, as well as certain growers, truckers and restaurants). The PACA regulates bad faith business practices, such as defaulting on debt or engaging in bribery, but also covers the mislabeling or misrepresentation of product. Under the PACA, the USDA can impose penalties including the revocation of license, public censure, and civil fines only after a violation of standards has been proven.

The PACA enforcement process begins when the USDA receives a written allegation of a violation. The allegation can be anonymous and does not need to be expansive. Once the USDA receives an allegation, it is bound to conduct its investigation and any subsequent prosecution in accordance with the Rules of Practice established in the Code of Federal Regulations. The Rules of Practice protect the rights, including the guarantee of due process, of all parties under investigation. After gathering evidence through a field investigation, the USDA Trade Practices Division determines if punitive measures are warranted. In some cases, a private letter of admonition is deemed sufficient. For more serious allegations, the Department can initiate proceedings alleging PACA violations before an Administrative Law Judge (ALJ). While ALJs are USDA employees, they are independent of the Secretary's authority and authorized to adjudicate complaints between the Department and its licensees. Because the Department typically brings only the worst cases before an ALJ, conviction rates are high and negotiated consent agreements common. Rulings of an ALJ are appealable at two levels: initially, to the Judicial Officer within the Department and, ultimately, through the Court of Appeals in the district where the alleged violations occurred.

The punitive measures authorized under the PACA are similar to those in the OFPA: imposition of civil penalties and the loss of authorization (the license) required to operate a federally regulated business. A PACA license can be suspended for an interval of thirty to ninety days or revoked for up to three years. While civil penalties under PACA can reach several hundreds of thousands of dollars, license revocation is the greater punishment. Without a PACA license, operators are deprived of their livelihood and may have difficulty re-establishing their reputation should they eventually return to the business.

While not designed to regulate production standards, the Perishable Agricultural Commodities Act (PACA) illustrates how measures other than mandatory product recall can facilitate compliance. The mere threat of proceedings and publicity surrounding investigation, backed by real enforcement program, can be sufficient to get product pulled from the market. Nearly seventy years of experience with PACA indicates that the risk of swift and severe punishment is a more effective enforcement mechanism than the recall or seizure of suspect commodities. This is especially pertinent for trade in perishable products which may move through the marketplace and reach consumers before an alleged violation can be appropriately reviewed and adjudicated. USDA staff believe that the negative publicity associated with being charged under PACA is, by itself, a powerful incentive to keep licensees from committing violations.

Meat, Egg and Poultry Product Inspection Acts

The USDA's Food Safety and Inspection Service (FSIS) enforces federal regulations on meat, poultry, and egg products. Under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, the FSIS is authorized to inspect licensed facilities to insure that products are "safe, wholesome and accurately labeled." The FSIS's mission is more analogous to enforcement of organic standards because the regulations it enforces pertain to labeling and food quality issues, not the business practices which PACA addresses. FSIS's jurisdiction extends beyond the licensed processing facilities it inspects to include product already on the market. When information indicates that previously inspected and approved product no longer complies with standards, the FSIS can intervene to keep it from reaching consumers. Despite the urgency of removing a potentially fatal food product from the market, however, the FSIS almost always uses a voluntary manufacturer's recall to do so.

The FSIS has the authority and the responsibility to determine what measures, including recall, are necessary to protect consumers from non-compliant product. When making such determinations, the FSIS places the risk from the product in one of three categories: Class I - there is reasonable probability that use of the product will cause serious adverse health consequences; Class II - there is a remote probability of such consequences; and, Class III - the likelihood is negligible. Product recalls are used only in Class I and II situations; cases which do not pose a significant risk to human health are handled through press releases. When a recall is necessary, the FSIS requests that the manufacturer take voluntary action beginning with a public announcement. While the Service does have statutory authority to detain and seize suspect product still under the producer's control, it is not a practical mechanism for re-capturing product already on the market. The re-capture rate for suspect product which has already reached the market has been consistently low. Instead of focusing on product seizure, the FSIS has prioritized notifying the public that an unsafe or mislabeled product has reached market. Confirmed violations can also result in increased inspections of the non-compliant operation to insure a return to satisfactory performance.

Federal Food, Drug, and Cosmetic Act

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the Food and Drug Administration (FDA) is authorized to regulate health and safety issues related to pesticide residues and filthy, decomposed or contaminated commodities. Despite the obvious risk to human health of non-compliant foods, however, the FDA, like the USDA, has limited ability to seize or recall suspect product. To do so, the FDA must have a United States Attorney file a case in federal court and use the U.S. Marshall Service to implement the judge's decision. Typically, perishable commodities already on the market would be sold before such actions could be taken. The FDA does have cooperative relationships with state agencies (such as Departments of Agriculture or Public Health) to seize or embargo suspect product but rarely is this authority used. Regulated operations are so concerned about damage to their reputation (plus the liability) if contaminated or falsely labeled product reaches the market, that they recall voluntarily a commodity which the FDA identifies as suspect. The FDA can also promote compliance by initiating administrative law proceedings which can result in fines against alleged violators of the FFDCA for trading in adulterated or misbranded product.

Over the long term, these types of public/private partnerships for enforcement of food labeling and safety regulations have created an environment which encourages voluntary compliance and severely punishes flagrant violations. Because the federal license is required to stay in business, operations have tremendous incentive to cooperate with regulatory authorities and demonstrate their compliance. If caught, a rogue operation which intentionally violates the conditions under which it is licensed can expect, after its day in court, to be put out of business. No more can be expected of a federal regulatory program than to allow those who wish to comply to do so while establishing administrative proceedings consistent with due process to penalize those who do not.

The experience of federal food labeling and safety enforcement programs indicates that regulated industries cooperate because they value their license to operate so highly. In a recent example, the Hudson Foods Company voluntarily recalled twenty-five million pounds of hamburger because the USDA issued a notice that it was potentially tainted. We suspect that no federal action could have been as swift and effective at removing suspect product from the shelf. Hudson Foods was willing to take an enormous financial loss in order to protect its reputation and not jeopardize its license should USDA initiate administrative proceedings against the company. An earlier experience involving the FFDCA illustrates the potential for operations to benefit from sharing enforcement responsibilities with federal partners. In the early 1980's, public confidence in the Tylenol line of pain relievers was seriously undermined when an extortionist tampered with some product already on the shelf by contaminating it with cyanide. Once the public became aware of the danger, sales of Tylenol plummeted. The manufacturer was unable to convince consumers that the product recall and package protection measures it implemented were sufficient to insure their safety. Only after the FDA reviewed the situation under the FFDCA and publically declared that Tylenol was in compliance with federal safety standards did sales begin to return to normal. Consumer confidence in the FDA's declaration that Tylenol was safe is believed to have saved the Tylenol product line. Organic producers and handlers will gain the trust of a broader audience than they have traditionally reached when the USDA gains a direct role in certification. The broader recognition which a USDA seal will enjoy compared to existing private or state seals may prove valuable should a widely publicized case of fraud or misrepresentation damage public confidence in organic certification.

An Example of the Capabilities and Limitations of Enforcement

One high profile example of misrepresentation of product as organic illustrates the difficulty of removing suspect commodities once violations have been confirmed. In 1996, the Minnesota Department of Agriculture received information that Glacial Ridge Foods, a distributer doing business in the state, was falsely labeling and selling conventional grains and edible beans as organic. The Dairy and Foods Inspection Division seized records from Glacial Ridge Foods and determined that the company was selling substantially more product as organic than it had bought. Glacial Ridge Foods had concealed the deception from its private certifying agent by manipulating the invoices provided during inspection. The Department of Agriculture used its authority (as the FDA surrogate for implementing the FFDCA) to detain adulterated and misbranded food and embargoed approximately 53,000 pounds of products in the Glacial Ridge Foods warehouse. Further investigation revealed that one million or more pounds of commodities may have been fraudulently sold as organic over an eighteen month period.

Once it realized the magnitude of the misrepresentation, the Department of Agriculture dropped its misdemeanor mislabeling investigation and referred the case to the Attorney General's Office for criminal prosecution under the state's broad theft by swindle statute. The Attorney General's office brought felony charges which led to two principals from Glacial Ridge Foods pleading guilty and receiving fines and jail sentences. The two employees also agreed to court supervision of their work activities for a period of twenty years should they re-enter the wholesale grain business. Following the investigation and sentencing, Glacial Ridge Foods went out of business. Despite the severity of punishment, however, the state had minimal success at removing non-compliant product from the organic market. Only product still in the company's possession could be kept off the organic market. Absent a verifiable risk to human health, the misrepresented product which had already been sold was not recalled.

Conclusion

As the organic movement evolves from an amalgamation of state and private programs into a national, unified network, we believe it is appropriate and necessary that authority to terminate certification becomes a federal responsibility. The Wallace Institute supports the Secretary's assertion that organic certification, once awarded, represents a federal license which can only be removed through the administrative procedures established by USDA.

We understand that the transfer of authority to terminate certification constitutes a significant change from the way that state and private certifying agents have operated in the past. We are confident that the success of state certification programs, including those in Texas and Washington, which closely resemble the model recommended in our comments, indicate that such a model can be fair, workable and responsive to the needs of the entire community. Many people who prefer that accredited certifiers retain the authority to terminate certification believe that the USDA administrative procedures will be too slow, or vulnerable to political manipulation, to be effective. Having reviewed several other federal food labeling and safety enforcement programs in preparing these comments, we do not find that concern to be justified. In those examples, producers and handlers have come to accept that federal oversight is a necessary, and indeed valuable, condition for retaining public confidence. The voluntary recall mechanism found in these enforcement programs works because operations which violate standards do not want non-compliant product to enter the market. The legal liability and loss of reputation associated with sub-standard product is too great for operations to defy federal requests to recall product. An enforcement program as envisioned in this paper will engender a high degree of public confidence that organic standards are being maintained while insuring that the cost of deliberate, repeated or excessive non-compliance will be prohibitive.


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