For Those Handlers Using a Quaternary Ammonium Sanitizer

You may recall in our July/August 2006 newsletter we discussed appropriate sanitation protocols for facilities handling certified organic products. In this article, we explained that a facility using quaternary ammonia (also referred to as “quat”) as a sanitizer (or any sanitizer not on the National List of Allowed Substances) needs to demonstrate to QAI that quaternary ammonia residues do not contact the organic ingredients or products. As quaternary ammonia has significant residual activity, the equipment usually needs to be thoroughly rinsed several times, and/or purged with an adequate quantity of organic product. To confirm the efficacy of the rinse or purge, an ammonium test strip needs to be used with a detection level of 0 ppm to ensure that no residues are lingering on equipment and food contact surfaces prior to organic production.

QAI is aware that the normal ammonium test strips on the market, and most often used by certified facilities, have a range of 0-400 ppm, with match points at 0-100-200-300-400 ppm. Therefore, it is very difficult for a facility to prove that all quaternary ammonia residue has been completely removed from equipment because the match point at 100 ppm will not start to turn color until there is approximately 75 ppm of quat present. This means that the test strip may indicate a “0” reading when there is still quat residue on equipment.

It appears that there are only a few ammonium tests available that test quaternary ammonia concentrations at less than 25 ppm. Among those are:

1. Ammonia Test Strips (High Sensitivity) with a range of 0-6ppm available from Hach Co, www.hach.com, 1 800 227 4224, orders@hach.com
   
2. Hydrion Lo-Range Quat Test Kit with a range of 0-100 ppm, with match point at 0-25-50-100 ppm available from Micro Essential laboratory, Inc, www.microessentiallab.com, 718 338 3618.

QAI welcomes information on other suppliers of low range/high sensitivity ammonium test strips so that we can provide contact details to certified facilities.

The Skinny on Stream of Commerce for organic products produced prior to June 9, 2007

Stream of Commerce

As the June 9th deadline steadily approaches (that is, when minor agricultural ingredients in products making an ”Organic” claim must either be sourced in organic form or must be listed on 205.606 and proven to be organically unavailable) certified processors are asking what date must organic products be produced by before the deadline in order for those products to enter the stream of commerce?

The NOP has provided verbal clarification that stream of commerce applies to organic product that is produced, packaged and labelled prior to June 9, 2007. To reiterate, organic product that is produced, packaged and labelled prior to June 9, 2007 may enter the stream of commerce and be sold as NOP Organic.

What to do with product labels after June 9, 2007?

1. For products that will continue to make an “Organic” claim: Please note that if you have changed the formulation of your product to comply with the new requirements for agricultural ingredients, QAI will allow a specified timeframe for you to use up old labels. For example, if you have replaced an non-organic ingredient with an organic ingredient, but the label still lists the non-organic ingredient, we will evaluate the number of labels that you have left in stock to use up and will allow you to exhaust these in a timely manner (e.g., 6 months).
   
2. For products that will have to make a “Made with Organic” claim: If, however, you choose to drop you product down to the "made with organic" category, your labels will need to be changed to reflect the new claim and to comply with the "made with" labelling requirements by June 9, 2007.

Please contact your Account Coordinator with any questions or concerns.

Update on NOP Requirements for Livestock Feed, Supplements, and Additives

At the recent Accredited Certifier Training held in CA, the NOP clarified that the requirement for the use of 100% organic agricultural ingredients in livestock feed also applies to agricultural ingredients in feed additives and supplements, based on 205.237 (a).

Section 205.237 (a) of the NOP states: The producer of an organic livestock operation must provide livestock with a total feed ration composed of agricultural products, including pasture and forage, that are organically produced and, if applicable, organically handled: Except, That, non-synthetic substances and synthetic substances allowed under §205.603 may be used as feed additives and supplements.

Based on this recent NOP clarification, all agricultural ingredients in livestock feed, additives and supplements must be organic.

Feed, Feed Additives, and Feed Supplements 

Effective immediately, any agricultural feed, feed additive or feed supplement that contains agricultural ingredients: e.g., soybean meal, or agricultural group listing (e.g. roughage products), must be accompanied with a label/specification sheet and an organic certificate (or other certification documentation) showing that the agricultural ingredients are certified organic.  

Please note that feed additive or supplement manufacturers do not need to be certified, but they must be able to supply current organic certification documents for any agricultural ingredients that are used in the feed additives or supplements.  Livestock producers must maintain supporting certification documentation with their feed input documents for the organic inspector to review.

Medical Treatments

1. Feed Supplements used for Acute Conditions (Medical Nutritional Supplements):If you are making the argument that a feed supplement, which contains non-organic agricultural ingredients, is being used as a medical treatment, the label must clearly denote that the product is to be used for an acute medical treatment on a short-term basis.  Examples would be a calcium product with agricultural ingredients used for Ketosis (milk fever) or a feed supplement product containing high levels of electrolytes and nutrients for a calf that has scoured due to shipping stress. Additionally, you will be asked by QAI to submit a procedure outlining the acute condition and time frame for which the product will be used. You will also need to keep a journal detailing the acute condition and length of use so that the inspector can verify that the supplement has been used for medical purposes only.
   
2. Homeopathic tinctures and herbal preparation products: Livestock producers, especially dairy producers, traditionally use homeopathic tinctures or herbal products as health treatments.  Again if these products contain non-organic agricultural ingredients, they may be allowed for use if it can be justified that they are used as a medical treatment only. If the herbal product has a health claim and is used on a limited basis, then non-organic sources of the herbs or tinctures will be accepted.  Nevertheless, Organic herb preparations and tinctures are becoming more and more commercially available, so QAI’s approval for non-organic herbal preparations will be given on a temporary basis, and a time-line for sourcing and using organically sourced herbal products must be provided.

Carriers in Vitamins/Minerals: The NOP has made it very clear that carriers for feed additives must be organic if from agricultural ingredients. As such, if there are agricultural ingredient carriers listed in the ingredient statement of the FDA/AAFCO allowed vitamins and minerals pre-packs, the carriers must be from organic sources.

Going Forward

QAI realizes that this is a change to previous NOP interpretation with regards to supplements and feed additives. We will be contacting all livestock clients, including dairy and egg producers, individually to discuss the issue in greater detail.

Please note that any livestock feed additive or supplement with non-organic agricultural ingredients fed to organic livestock that has been purchased after the date of this notification will be cited as a major non-compliance due to use of a prohibited substance. Invoices, or other purchase documentation, must be kept on file and made available to the QAI inspector to demonstrate the date of purchase and the quantities purchased. Suspension of certification may result from the continual use of feed, supplements, or additives containing non-organic agricultural ingredients.

Please contact your Account Coordinator if you have any questions.

Producers and the Audit Trail

Producers of organic crops will usually be the first to admit that the paperwork side of certification is the most cumbersome. Most producers would rather be out in the field than in an office filing documents, making phone calls and doing the books. Of course, record keeping and the audit trail in one of the most necessary requirements of organic certification, because it is one of the main ways an inspector can verify that the operation complies with the organic requirements. Since the organic inspector is usually only on site for several hours out of an entire year, they rely on accurate, clear and detailed records that describe how the organic product was produced, including inputs and equipment used, how it was harvested, stored, and sold the other 364 days of the year.

The National Organic Program (NOP) Regulation requires in section205.103 thata certified operation must maintain records concerning the production, harvesting, and handling of organic agricultural products. “Such records must:

(1) Be adapted to the particular business that the certified operation is conducting;

(2) Fully disclose all activities and transactions of the certified operation in sufficient detail as to be readily understood and audited;

(3) Be maintained for not less than 5 years beyond their creation; and

(4) Be sufficient to demonstrate compliance with the Act and the regulations in this part.

(c) The certified operation must make such records available for inspection and copying during normal business hours by authorized representatives of the Secretary, the applicable State program's governing State official, and the certifying agent.”

The NOP does not prescribe the exact records that shall be maintained by the certified operation but it does stress that the records that are kept must allow for the clear auditing of all organic activities and transactions. In other words, all harvested and sold organic crop must be traceable back to the field(s) of origin; all inputs, including seed, used to produce the crop must be traced back to the supporting documents that confirm that the inputs are in compliance with the NOP; all equipment used must be verified to be clean from conventional debris; and all product grown in the buffers must be verified to have been sold as non-organic. One of the inspector’s roles is to test the producer’s tracking systems to reveal deficiencies and communicate those deficiencies to the producer and the certifier.

Some Specifics

While the audit trail maintained by producers should be unique to each individual operation and designed to be as simple as possible, there are several important details that should be a part of the records maintained.

1. Traceability of seeds used for organic crop production: It is important that, if applicable, the lot number and variety name of the seed being planted should be recorded on planting / activity records.  All seeds should have a lot number.  This lot number is generally included on the invoice / bill of lading that is provided to the producer at sale.  It is also generally included on the seed package.
   
   Recording the lot number of the seed is important because every lot is handled differently (e.g., treated or not treated).  While we can assume that the formula for a crop input does not change from one lot to another, we cannot assume that the management of the seed, especially with regard to treatment methods, is the same from one lot to another. This is especially important when certifying operations that have organic and non-organic production of the same crop and are buying a treated seed and a non-treated seed for the same crop variety.
   
   In addition, it is critical to include the crop variety or the lot number on the non-GMO and seed treatment declarations provided by the seed company suppliers for the seeds that they are selling.  For the same reasons stated above, this information is necessary for verifying that the statement being provided is actually for the seed being purchased and planted.
   
2. Verification of inputs for fertility, pest, weed, disease management: It is important that the complete commercial name and manufacturer name of the inputs that you use in field production are recorded on the documentation that you present for your audit trail (purchase receipt, Annual Input Record (AIR), input/activity record, NOP compliance documentation).  Additionally, if you are going to use the OMRI or WSDA Listings to justify the use of inputs in field production, you should provide QAI with information on the purchase receipt, AIR and input/activity record that allows for the verification of such claims.
   
   Often we find that the names of the inputs and the names of the manufacturers (the links to the OMRI or WSDA List) are not complete and consistent on each of these 3 documents in the audit trail. It is therefore difficult to verify that they are the same input and that they are in fact OMRI or WSDA Listed.
   
   Section 205.201(a)(2) of the NOP Rule requires that producers submit to their certifier “a list of each substance to be used as a production input, indicating its composition, source, location(s) where it will be used”. This information needs to be submitted prior to the inspection so that the certifier is able to determine if the operation is able to comply with the organic regulation. QAI is now asking producer clients to submit OMRI/WSDA certificates and labels for ALL inputs up front at application/application renewal review stage, when applicable. We also ask the inspector to obtain these documents at inspection if we have not received them at the application review stage.  If the labels are not submitted to QAI up front, and also are not submitted to the inspector, we will be notifying you that field may not be certified / certifiable. 

In summary, clear, accurate and detailed records are essential for organic certification. Such records, including the audit trail that enables product traceability, facilitates the verification of label claims to aid in the prevention of fraud where analytical testing cannot be used to prove authenticity. There is no simple test that can prove that a grain, vegetable or piece of fruit is “organic”. However cumbersome records may be, maintaining a healthy audit trail is like the best insurance policy and keeps non-compliances, long drawn-out inspections, and questions regarding the integrity of the organic production system at bay.

The EU market place is bustling with organic activity.  You’ve received EU certification for product intended for Europe.  You’ve received the elusive Import Authorization from the European member state, which will be importing your organic product.  Now there’s more paperwork?! 

It goes by several names: European Community Certificate, ECC, and Certificate of Inspection.  Its full name is European Community Certificate of Inspection for Import of Products from Organic Production. An ECC must be issued for every shipment into the European Community, but its not as bad as it sounds and we’re here to help.  Here are the step-by-step instructions for completion and submission to QAI of the Certificate of Inspection for Import of Products from Organic Production (ECC):

Box #1 Issuing body or authority (name and address):
Quality Assurance International (QAI)
9191 Towne Centre Drive Suite 510
San Diego, California 92122 USA

Box #2 Council Regulation  (EEC) No 2092/91 and Commission Regulation (EC) 1788/2001:
All QAI clients will check box 11.6

Box #3 Serial number of the certificate of inspection:
Leave this box blank.  QAI will assign and stamp the serial number.

Box #4 Reference no.  authorization under Article 11(6):
Please contact your importer to receive this number.  Before product can enter the EU, importers must receive a license from their Ministry allowing them to import goods from the exporter (QAI client) in the third country (US/Canada).  When an import authorization is approved, the importer will receive an authorization number from their ministry.  If your importer does not have an authorization number, you will have to submit an application for import authorization.  Please contact Ann Marie Hourigan at QAI for assistance with this.

Box #5 Exporter (name and address):
Enter the name and address of your QAI certified company.

Box #6 Inspection body or authority (name and address):
Quality Assurance International (QAI)
9191 Towne Centre Drive Suite 510
San Diego, California 92122 USA

Box #7 Producer or preparer of the product (name and address):
If your company physically handles and exports the product, enter your company information.  If another operation physically handles and ships the product enter the name and address of that entity.  

Box #9 Country of Destination:
Enter the EU member state at which the consignment will arrive.

Box #10 First consignee in the Community (name and address):
Enter the name and address of the entity in Europe that will receive the consignment.

Box #11 Name and address of the importer:
Enter the name and address of the entity that has purchased the consignment. This may be the same entity as is named in Box #10.

Box #12 Marks and numbers. Container No (s). Number and kind. Trade name of the product:
Enter any identifying marks, numbers, descriptions, etc. that may be applicable for the consignment.  Please be sure that such identifying marks are listed on the corresponding invoice and/or bill of lading.

Box #13 CN Codes:
Enter the Combined Nomenclature Codes for the products concerned.  If you do not know the CN code for your product, please visit the following website:  http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_286/l_28620051028en00010886.pdf

Box #14 Declared quantity:
Enter the amount and unit of measurement for the consignment.  Please be sure that the quantities listed match the quantities on the corresponding invoice and/or bill of lading.

Box #15:
This will be completed by QAI upon review and approval.

Important Notes:

An original certificate, stamped and signed by QAI, must accompany each and every consignment, which is shipped to the European Union. Without an approved ECC / Certificate of Inspection, the port authorities will not allow the product to be released.   

Please complete the certificate entirely in capital letters or entirely in typescript.

Please be sure to include a Cover Sheet and a corresponding bill of lading and/or invoice.  Without these documents the ECC will not be processed.  All of the information listed on the ECC must correspond with the information on the bill of lading and/or invoice. 

QAI processes ECCs within 24 – 48 hours.  However, issues do arise.  If for some reason QAI cannot approve your ECC and your product has arrived at the European port, the product may be kept in port and duties may be incurred.  Please submit ECCs with ample time before the product is due to arrive in port. 

ECCs will NOT be approved while a client has major noncompliance issues.
ECCs will NOT be approved after EU certification has expired. 

Are you staying current with NOP and Certification Updates?

QAI frequently sends broadcast emails to our clients regarding changes to NOP and certification policy. Here is a brief recap of just a few of the hot topics for 2007. If you would like more details, please visit our website under News/Client Notifications or call you account coordinator at QAI.

Group Management/Grower Group Policy Changes are likely to impact organic Sugar, Coffee, Spices, and More

Mark Bradley, NOP Associate Deputy Administrator, announced at the recent Certifying Agent trainings (held January 23, 2007; EcoFarm Conference, California; and February 15, 2007, BioFach, Germany) that the current NOP interpretation of 205.403(a), “all production units, facility, and sites must be 100% site-inspected on an annual basis,” includes all sites within a Group Management Operation. This is contrary to current national and international certification schemes for these types of operations.

The NOP’s recent position is expected to have a large impact on group management participants as well as handlers and consumers who purchase their products (e.g., sugar, coffee, tea, spices). If you are concerned by this recent clarification, please contact the Organic Trade Association (OTA), specifically, Tom Hutcheson, OTA's Regulatory & Policy Manager, at thutcheson@ota.com.

BREAKING NEWS!! On May 2, 2007, the following notification was circulated to all accredited certifiers from Barbara Robinson of the NOP:

After speaking with the Chair of the NOSB, Andrea Caroe, about grower groups, we have come to the following determination in the National Organic Program, effective immediately:

1. NOP will do rulemaking to address the concerns that we have in the Program, but
    
2. NOP will also collaborate with the Board about this - this will be a topic on the fall meeting agenda for the NOSB.
    
3. In the interim, we have the 2002 NOSB recommendation on grower group certification (PDF). We will re-publish this on the website under "Today's News." ACAs are reminded that as long as they use the NOSB recommendation for interim guidance, no enforcement action will be taken by the Program related to grower group certification. The NOSB recommendation is quite detailed in scope.

As discussed, there may be some areas of the NOP regulations which might be amended, or suggested for amendment, which would require public input through notice and comment rulemaking. NOP will consult with the Board on these areas, prior to drafting rulemaking, but certainly during the rulemaking period.

QAI will continue to keep you posted on relevant changes to the Group Management Program.

Processing Defoamer No Longer Approved

OMRI (Organic Materials Review Institute) recently removed the product, Foam Blast® RKA produced by Emerald Performance Materials LLC, from its approved products list and reassigned the product to the status of Prohibited for use in the processing of organic products. QAI is requiring certified clients discontinue the use of Foam Blast® RKA.

Producer Fertilizer No Longer Approved

Please be advised that the liquid fertilizer product, Biolizer XN produced by California Liquid Fertilizer, has recently been removed from the approved products list published by OMRI (Organic Materials Research Institute) and is no longer approved for use in organic production. QAI is requiring producers to discontinue the use of Biolizer XN.

Need a Change of Color?

The NOSB voted to sunset colors, which means that, as of October 22, 2007, colors will not be renewed as an approved non-agricultural substance on the National List.

Certified clients will be required to reformulate products by October if an approved replacement for their color ingredient is not sourced. In addition to sourcing organic color ingredients, clients have the option to petition for their specific nonorganic color to be added to the National List.

Several colors have already been petitioned to the National List, 205.606. For information on the NOP Petition process, please visit the NOP website. www.ams.usda.gov/nop/Petition/PetitionHome.html

Flavors and the FDA

In late February, the USDA issued a guidance document regarding flavors.

As long as flavors meet the definition of a natural flavor, according to the FDA in 21 CFR Part 101.22(a)(3), and they are from nonsynthetic sources and are not produced using synthetic solvents, carrier systems, artificial preservatives, GMO’s or irradiation, they may be used.

The FDA definition of natural flavor is as follows: “The term natural flavor or natural flavoring means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in §§ 182.10, 182.20, 182.40, and 182.50 and part 184 of this chapter, and the substances listed in § 172.510 of this chapter.” FDA 21 CFR Part 101.22(a)(3)

May 5 - 8th All Things Organic, McCormick Place, Chicago, IL - Please stop by and see us at Booth #435.

This time we turn the spotlight on Natalie Velazquez - aka “Natalie V” – QAI Account Coordinator extraordinaire by day and Starbuck’s aficionado anytime!

Back Story:

I was born and raised in California; ranging from the city of Los Angeles to the hot desert of Lancaster and finally settling on the beaches of sunny San Diego. I spent a few years working towards my Associates Degree while working full-time in the corporate aviation industry. I am currently working on my Bachelor’s degree in Communications at Cal State San Marcos and plan to graduate in 2008.

I began working for QAI in August of 2005 as an Administrative Assistant and less than a year later, I transferred over to the Account Coordinator department. I have enjoyed every moment since the change. Every day brings a new challenge and a growing desire to learn as much about the organic industry as I can.

I pride myself in having half of my roots embedded in the Latin culture, which is known to boast a welcoming personality as well as an outgoing flair for life. This aspect has led me to become one of the bilingual Account Coordinators here at QAI. It is a pleasure to be able to put my Spanish speaking skills to good use. Es un placer tener la oportunidad de ayudar a los clientes localizados en diferentes regiones de México.

Real Time:

I truly enjoy coming to work everyday and undertaking new projects as well as building strong relationships with my clients. It is a blessing to be able to work with such amazing co-workers who help to create a fun and positive atmosphere. The varying personalities at the “Q” help make coming to work that much more enjoyable. The ongoing education I gain from working in the organic industry has greatly affected my personal life as well as professional. Outside of work and school I enjoy spending time with my close friends and family. I fill what little spare time I have with working out, reading and enjoying a good movie. I try to lead each day with a smile accompanied by a positive attitude.

Fun Facts:

Favorite color: Blue

Favorite beverage: Boba Tea and just about anything on the Starbucks menu.

Favorite TV show: Grey's Anatomy

Favorite food: Gourmet bread and cheese are my weaknesses, but who can forget about CHOCOLATE!

In my DVD player right now: Little Miss Sunshine and fitness DVDs

What's in my CD player now: Country music mix

Favorite place: Hawaii…pretty much anything near the ocean.

Places I'd love to visit someday: Paris, Italy, France

Favorite book: Anything by Nicholas Sparks

Favorite animal: Domestic = dogs, Wild = gorillas/monkeys

To contact QAI:

If you have questions, concerns, or need general information, go to the QAI web site to learn how to contact us or to send us an email. For questions pertaining to QAI’s Quality News contact Joshua Rollins, Sales Coordinator.

QAI, Inc. is an NSF International Company. Visit the NSF web site to learn more about NSF International, The Public Health and Safety Company™.