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Addressing Food Safety and Good Agricultural Practices through Certification:

US FARMGAP Announces Cost Effective GAP Program for Farms and Packing Operations

By Jonathan Austin

Enlightened farms and packers recognize, even without recent government interest, that food safety is the key to being a successful and responsible citizen of the agricultural community and the world at large. In response to food safety incidents in the past few years, a wave of new interest, and in some cases, new laws and regulations, has spread throughout the food and agriculture community.

Recently the Congress passed and the President signed into law, the Food Safety Modernization Act, which was intended to be a major overhaul of food safety regulations in the United States. Included in its provisions were the requirements that farms and packers have a food safety compliance plan, in addition to annual mock recalls. Only the diligent work of  Montana Senator Jon Tester ensured that there was a small farm exemption which excluded operations with less than $500,000 in sales who sale the majority of their product direct to consumers or within 275 miles of the farm and within the same state. Nonetheless, processors, packers, and growers who sale the majority of their product to distributors, processors, or national or regional retailers, will be required to comply with the Act and the FDA regulations promulgated as a result of the act.

Among the requirements of the Act are that some operations must register with the FDA under the Bioterrorism Act, operations must identify potential hazards, must implement effective preventative controls, conduct annual mock recalls, and have a written food safety plan. Most farms and packers will be affected by the Act and subsequent rule making by the FDA.

US FARMGAP, a program run by OIA North America, a USDA accredited certifying agent under the USDA National Organic Program, is one company which is trying to assist farms and packing operations comply with the regulations through a standardized food safety and Good Agricultural Practices certification program.

Farms and packing houses seeking certification are provided a standard which is based on the common potential hazards in farming and packing operations, a model compliance plan which can be tailored to the operation, an onsite inspection to ensure that preventative measures are implemented effectively, and once compliance is determined, a certificate attesting to the operation’s compliance with the requirements of the standard. Among the common potential hazards addressed by the standard are microbiologic qualities of water, use of manure on the farm, wildlife activity and animal waste contamination, and worker personal health and hygiene. Packing operations address a similar set of hazards, as well as hazards addressed through the use of sanitizers and chemicals.

The program which was piloted successfully this spring with blueberry growers in Florida is intended to take the mystery and confusion out of compliance while being extremely cost effective. The average farm pays about $500 to be certified under the program and to access the off the shelf program components. Packing operations are charged prices beginning at $750 and are able to access the same off the shelf resources created for packing operations.

OIA North America, which operates the program, is rolling the program out nationwide and hopes that farms and packers should find the program a valuable and cost effective tool to address compliance issues within their operation and communicate to regulators, customers, and the general public their commitment to food safety and best practices.  

 More information about the US FARMGAP program is available at www.oianorth.com.

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Admin - Mon Jun 20, 2011 @ 01:44PM
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Managing Environmental Contamination under the USDA National Organic Program Final Rule

Part One: Pesticide Residue Testing for Farms

By Jonathan Austin

Background

 The USDA NOP Final Rule, as contained 7 CFR 205 provides the regulations by which agricultural products may be certified and represented as organic in the United States. Generally the regulation prohibits the use of synthetic substances in the production of products to be certified and represented as organic. Additionally the regulation requires that accredited certifying agents engage in regular testing of certified organic products for the presence of prohibited substances.

 

Despite this requirement, no certifier currently engages in regular testing of certified organic products for the presence of prohibited substances--instead the testing conducted has been based upon complaints or other indications of noncompliance. While the NOP is currently attempting to develop a detailed program to be followed by certifiers in conducting residue testing, this requirement has yet to be finalized. Additionally, all draft measures which have been submitted to certifiers for comments have been based on a combination of random selection of certified products for testing and a risk based analysis for selecting products to be tested. The current thinking of the NOP does not appear to contemplate residue testing for all operations or all products.

 

The Significance of Positive Pesticide Residue Test Results

If the USDA does implement a requirement that certifiers conduct residue testing, there is some question of how positive results will be addressed. At its most basic, a positive test result is likely to lead to an investigation by the certifier and/or the USDA NOP as to the cause of the contamination. The outcome for the certified operation will hinge on three factors, the amount of contamination, the cause of the contamination, and whether or not the operation’s willful violation of the regulations led to the contamination.

 

If it is found that the contamination is the result of a willful or knowing application of a prohibited substance to the crop, then the most likely result is that the operation’s certification will be revoked. Additionally, the operation and its responsibly connected persons may face criminal and civil sanctions. Recently the owner of a certified organic operation was charged and convicted in federal court of willfully marketing non-organic products as organic and was sentenced to prison. Even civil sanctions can be severe—up to $11,000 per violation of the USDA NOP Final Rule.

If it is found that the contamination was inadvertent, having resulted from an unknown and unintentional application, the most likely results range from excluding the product from sale as organic to suspension or revocation of the operator’s certification.

If the contamination occurred as a result of unavoidable residual environmental contamination much hinges on the level of contamination present.  The USDA has established, under 205.271, Exclusion from Organic Sale, of the USDA NOP Final Rule, that “(w)hen residue testing detects prohibited substances at levels that are greater than 5 percent of the Environmental Protection Agency's tolerance for the specific residue detected or unavoidable residual environmental contamination, the agricultural product must not be sold, labeled, or represented as organically produced. The Administrator, the applicable State organic program's governing State official, or the certifying agent may conduct an investigation of the certified operation to determine the cause of the prohibited substance.” 

Unavoidable Residual Environmental Contamination

The Preamble to the NOP Final Rule also contemplates the establishment of levels of Unavoidable Residual Environmental Contamination (UREC), above which the product would be excluded from organic sale. However, the USDA has not acted on this intention and the current rule only mentions tolerances established by the Environmental Protection Agency (EPA). Although not stated in the rule, the Preamble appears to contemplate that action levels set by the FDA would function also function as thresholds for acceptable UREC levels.  

The Preamble also contemplates the USDA NOP being able to suspend certification of an operation when the residues in product which exceed the 5% EPA tolerance, regardless of the cause. (“These levels will represent limits at which USDA may take compliance action to suspend the use of a contaminated area for organic agricultural production.”)

The USDA NOP Final Rule and the Preamble, when taken together, lead to a number of questions about addressing residue testing and UREC detectable in products which are certified or are considered for certification.

The NOP has put forward some suggested guidelines on residue testing and the interpretation of such tests and the effects of detection of residues, but it is not clear if these will be implemented as currently worded. The NOP is taking comments on the proposed guidelines and these comments may alter the final outcome.

 

Conclusions and Discussion

The operator of an organic farm, or an entity looking to assess the acceptability of a specific site for organic production should take note of the USDA’s approach to unavoidable residual contamination and the current trajectory of moving towards more comprehensive testing of organic products for pesticide residues. Obviously, any operator who is certified or is seeking certification must avoid the use of any prohibited substance, including prohibited pesticides. A failure to follow the dictates of the NOP Final Rule can have severe civil and criminal penalties. However, merely steering away from prohibited practices probably does not constitute a best practice, and operators must strive to set the bar higher.

 

As we have reviewed in this article, residual environmental contamination is an issue which operators must care about and be proactive in the management of growing operations and site selection of growing operations. A failure to include the potential for environmental contamination in the analysis conducted for new growing sites and management practices implemented on the farm can lead crops being excluded from organic sale, and revocation or suspension of organic certification. However, even for the most proactive of growers considering these issues, the issue of unavoidable residual environmental contamination leads to many difficult questions.  For instance, while an operator is required to consider environmental contamination in their organic farm plan, do the USDA NOP regulations require an operation to conduct soil or residue testing? Do the USDA NOP regulations require the disclosure of such test results to the USDA or the certifier? Are the EPA tolerance levels the only levels which must be taken into account in such testing? What if a residue is detected but the EPA has set no tolerance level for that pesticide and the FDA has set no action level? Finally, are genetically modified organisms (GMOs) handled differently than pesticide residues under the USDA NOP regulations?

All of these are good questions, some of which lack clear answers. In our next article in this series we will address these questions and where clear answers are lacking give some suggestions on best practices.

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The USDA NOP has issued a new Q&A regarding the Canadian Equivalency Agreement whereby USDA NOP certified operations can ( with some restrictions and requirements) export and sale NOP certified product in Canada. Please follow the following link to read it: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5077525&acct=nopgeninfo

Tags: USDA, NOP, Organic, Canada
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National Organic Program Publishes Amendments to the National List of Allowed and Prohibited Substances (Crops and Processing)
AMS No. 239-10

 
Soo Kim (202) 720-7476
Soo.kim@ams.usda.gov

 
WASHINGTON, Dec. 13, 2010—The National Organic Program (NOP) today published a final rule amending the National List of Allowed and Prohibited Substances for crops and processing.

 
The rule, effective tomorrow December 14, 2010, enacts six recommendations submitted to the Secretary of Agriculture by the National Organic Standards Board (NOSB) from November 30, 2007, and May 22, 2008:

 
• Adds aqueous potassium silicate, along with any restrictive annotations, for use as an insecticide and for plant disease control in organic crop production. Potassium silicate is manufactured by fusing naturally occurring compounds (silica sand and potassium carbonate) and can be used for agricultural crops, nuts, fruits, vines, turf and ornamentals. The substance can reduce crop damage from mites, whiteflies and other insects, powdery mildew, botrytis, and root diseases.

 
• Adds sodium carbonate peroxyhydrate, along with any restrictive annotations, for use as an algaecide in organic crop production. Sodium carbonate peroxyhydrate is manufactured via a dry, wet or spray process from sodium carbonate and hydrogen peroxide. Sodium carbonate peroxyhydrate can be used in aquaculture, rice/wild rice fields and paddies, and commercial greenhouses, nurseries and garden centers.

 
• Adds gellan gum, along with any restrictive annotations, as a nonsynthetic allowed for use in organic handling. Gellan gum functions as a thickening agent to produce texture in a range of products such as bakery fillings, puddings, and sauces. It is a water soluble, off-white powder that forms gels in the presence of positively charged ions, and its thickness can be manipulated for specific functions by the addition of potassium, magnesium, calcium, and/or sodium salts.

 
• Adds fortified cooking wine – Marsala, and cooking wine – sherry, along with any restrictive annotations, for use in organic handling as a nonorganic agricultural ingredient only when not commercially available in organic form. Both fortified cooking wines are ingredients that impart a unique flavor to a variety of foods such as soups and entrees. Marsala is produced by adding yeast to the juice of crushed and press grapes. Sherry is produced by adding spirits after fermentation. Both wines become non-beverage, cooking wines with the addition of salt.

 
• Adds tragacanth gum, along with any restrictive annotations, for use in organic handling as a nonorganic agricultural ingredient only when not commercially available in organic form. Tragacanth gum provides texture, viscosity, and emulsion stability in foods such as salad dressings and sauces. It is harvested from the stems and branches of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (Fam. Leguminosae) in the desert and arid areas of the Middle East. The dried gum is cleaned, mechanically cut, dissolved in water and filtered before it is used in food processing.

 
The rule also removes glycerine oleate (glycerol monooleate) as a synthetic inert ingredient allowed in organic crop production since its exemption to be used expired on Dec. 31, 2006. Removal of this substance does not have a new regulatory effect.

 
The National List identifies synthetic substances that may be used (7 CFR 205.601 and 205.603) and nonsynthetic (natural) substances that may not be used (§§205.602 and 205.604) in organic production. It also specifies nonagricultural (nonorganic) substances that may be used in processed organic products (§205.605) and nonorganically produced agricultural products that may be used in processed organic products (§205.606). Since established, the National List has been amended thirteen times.

 
The NOSB evaluates substances petitioned for inclusion or deletion from the National List through the petition process implemented under §205.607 of the NOP regulations. The Secretary can amend the National List based on recommendations by the NOSB under the authority of the Organic Foods Production Act of 1990.

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POLICY MEMORANDUM

From: OIA North America

To: All OIA North America File Reviewers and Inspectors  

Date: October 12, 2010

SUBJECT: Summary of Organic System Plan Changes for Inspectors Conducting Interim Inspections

 

I. BACKGROUND

Currently, OIA North America provides each inspector a copy of the file of the operation to be inspected, as well as a copy of the previous year’s inspection report (where applicable) for each inspection assigned to an inspector. In cases where the inspection is an interim or additional inspection it is also necessary to provide the inspector with a summary of all changes to the Organic System Plan which have been implemented since the original certification was granted. In many cases operators make changes to inputs and ingredient suppliers, as well as adding additional products for certification after receiving initial certification. While these changes are included in the annual renewal application submitted by the operation, in interim inspections this information will take the form of communications via email and documents submitted by the operation directly to OIA North America. For the inspector to be able to fully assess the operator’s compliance during an onsite inspection, it is imperative that the inspector be provided with these changes to the previously approved organic system plan. This memorandum establishes a policy and practice to ensure that such changes are communicated to inspectors on a consistent basis.

 

 

II. Appropriate Regulatory Provisions from the USDA NOP Final Rule.

NOP s. 205.403(c)(2), Verification of Information, states: “The on-site inspection of an operation must verify: That the information, including the organic production or handling system plan  . . . accurately reflects the practices used or to be used by the applicant for certification or by the certified operaton.”

 

III. Policy on organic system plan changes and interim  inspections

In order to ensure compliance with the NOP regulations and to ensure operation of a quality program, OIA North America hereby creates the following policies addressing Organic System Plan changes by operations, and communication of changes to inspectors for interim or additional inspections:

1. Changes to Organic System Plan by Certified Operations: Certified operations may update or change any aspect of their organic production or handling plan at any time by providing the request in writing and requesting approval of the change from OIA North America. OIA North America may request additional information or the completion of specific forms in order to conduct the review of the requested change(s). OIA North America will review the requested change and documentation provided and will make a decision to approve or disapprove the change within a reasonable time. A failure to inform OIA North America of a change to the approved Organic System Plan will result in OIA North America issuing a Notice of Noncompliance. A change that cannot be approved under the USDA NOP regulations, which is implemented by an operator without informing OIA North America, may result in suspension or revocation of certification.

2. Written Communications of Changes to Organic System Plan Incorporated into Organic System Plan: The organic production or handling plan is more than just the formal application originally submitted to OIA North America for approval. It also consists of all written communications of requested changes and approvals to the plan. All written communications related to changes in the Organic System Plan are incorporated into the Organic System Plan once approved by OIA North America and become a permanent part of the operator’s file. Such written communications, which may take the form of email communications, supersede the relevant portion of the originally submitted application and plan once approved by OIA North America. Where there is a contradiction between the original application and subsequent written communication of changes approved by OIA North America, the subsequent written communications control.

3. Inspectors to Be Provided with Organic System Plan Changes Summary for Interim Inspections:For any additional or interim inspection conducted outside of the initial onsite inspection and the annual renewal inspection, OIA North America shall provide the inspector, along with any other documentation necessary for the inspection, a memorandum outlining any changes to the original application and plan submitted by the operator, including changes to: products certified, inputs approved for use by the operator, ingredient suppliers or formulas, and any other material changes to the original Organic System Plan. Inspectors are expected to be familiar with the memorandum of changes and to supplement the original plan and application as described in the memorandum and to inspect against the summarized changes in addition to all other aspects of the Organic System Plan.  

 

Please contact OIA North America if you have any questions about this policy.

Sincerely,

Jonathan Austin

OIA North America

 

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