National Organic Program March 20, Cheri Courtney Director, Accreditation and International Activities Division USDA National Organic Program

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1 National Organic Program March 20, 2013 Cheri Courtney Director, Accreditation and International Activities Division USDA National Organic Program

2 Why Organic? Environmentally sound farming systems Biodiversity Animal welfare Less toxic inputs Rural development Economic opportunity

3 Organic: A Brief History Before 1990 No national organic standards, consumer mistrust 2002 USDA organic regulations fully effective 1990 Congress passes Organic Foods Production Act, creates foundation for USDA organic regulations Present Ongoing work to clarify and enforce USDA organic regulations Agricultural Marketing USDA National Service Organic Program

4 Why is Certification Important? Allows use of USDA organic seal and organic claim Empowers consumers to choose between production methods Gateway to USDA services for organic operations Verifies that products meet national organic standards Protects consumers Establishes level playing field for farmers, processors, and marketers Agricultural Marketing USDA National Service Organic Program

5 Organic Certification: Ensures products were produced without prohibited methods/substances, such as: GMOs, arsenic, synthetic fertilizers, prohibited pesticides Note: Natural substances allowed unless specifically prohibited, synthetic substances prohibited unless specifically allowed. Is scale-neutral: all operations must meet same requirements Agricultural Marketing USDA National Service Organic Program

6 What Can Be Certified? Crops Wheat, cotton, pasture Wild crops Mushrooms, kelp, berries Livestock Beef, eggs, milk Processed/multi-ingredient products Chopped carrots, bread, yogurt Agricultural Marketing USDA National Service Organic Program

7 Land Eligibility No prohibited substances on land for three years Before three year waiting period: No use of USDA organic seal No selling, labeling, representing product as organic Agricultural Marketing USDA National Service Organic Program

8 What are the Requirements? Specific requirements for each certification category (e.g. crops) Production Labeling Record-keeping Violators subject to compliance and enforcement actions: Loss of certification, financial penalties Agricultural Marketing USDA National Service Organic Program

9 Cost of Certification Depends on size/scope of operation Few hundred several thousand dollars Annual recertification costs Agricultural Marketing USDA National Service Organic Program

10 Certification A third-party certifying agent Accredited by the USDA National Organic Program Can be: State department of agriculture Domestic or foreign organization Almost 50% located around the world Agricultural Marketing USDA National Service Organic Program

11 Who Doesn t Need to Be Certified? Small organic farms and businesses Gross agricultural income from organic sales $5,000 per year or less Some brokers, distributors, and traders Retail food establishments Exempt handling operations These operations must still meet specific requirements. Agricultural Marketing USDA National Service Organic Program

12 10 Years of USDA Organic 85 accredited certifying agents Over 25,000 certified operations across 133 countries $31 billion in U.S. organic sales Tens of thousands of inspections, reviews, and certification decisions Agricultural Marketing USDA National Service Organic Program

13 Geographic-specific challenges Not applying standards uniformly Lack of data Insufficient technology Limited funding Agricultural Marketing USDA National Service Organic Program

14 United States Dept. of Agriculture Agricultural Marketing Service National Organic Program Residue Testing Final Rule 3/21/

15 Final Rule for Periodic Residue Testing Title As of January 1, 2013: Certifying agents must test products from at least 5 percent of the operations they certify each year. Program will help certifying agents identify and take enforcement action against farms and businesses using prohibited substances or methods, such as: Prohibited pesticides Antibiotics Synthetic hormones Genetic engineering 15

16 Detected Pesticide Residues on final product Three possible references if residues are detected: Pesticide Residue Pesticide Residue Pesticide Residue U.S. Environmental Protection Agency (EPA) Tolerance Level established for the tested sample Food and Drug Administration (FDA) Action Level (AL) established for the tested sample No tolerance or action level NOTE: Action levels only exist for edible crops and products. Other sample sources, such as soil or leaves, do not have established tolerance or action levels at this time. 16

17 Action levels and tolerance levels EPA establishes tolerance levels for registered pesticides allowed to be applied on specific crops EPA tolerances are applicable to specific crops; if there is no registered use for the crop, then the EPA sets no tolerance for the pesticide on that crop FDA sets action levels for older pesticides that are no longer EPA registered but are still persistent in environment 17

18 1. No Residue Detected No residues detected: The product may be sold as organic. The certifying agent will notify operator of test results. The certifying agent will maintain records of analysis and provide results to the public upon request. 18

19 2. Residues at or less than 0.01 ppm (trace) Residues detected at or less than 0.01 ppm (10 ppb) BQL Below Quantifiable Levels or LOD Limit of Detection The product may be sold as organic. The certifying agent will notify operator of test results Assess why the residue is present and follow up with operation as appropriate. Maintain records of analysis and provide results to the public upon request. 19

20 3. Residue samples detected at or below 5% of EPA tolerance Residues detected at or below 5% of EPA tolerance: The certifying agent will notify the operator of test results. The product may be sold as organic if residues are not a result of application of prohibited pesticides or commingling. 20

21 3. Residue samples detected at or below 5% of EPA tolerance continued Residues detected at or below 5% of EPA tolerance: The certifying agent will investigate why residues are present If residue presence is determined to be due to inadequate buffer zones or inadequate management practices to prevent commingling or contact with prohibited substances, issue an Notice of Noncompliance and require corrective actions to prevent future contamination. 21

22 3. Residue samples detected at or below 5% of EPA tolerance continued Residues detected at or below 5% of EPA tolerance: If evidence of intentional application of prohibited substances is found, the certifying agent should propose suspension or revocation of certification. The certifying agent may coordinate adverse actions with the NOP. 22

23 4. Residue samples detected greater than 5% of EPA tolerance, but not above the EPA tolerance level. Residues detected greater than 5% of EPA tolerance, but not above the EPA tolerance level: The certifying agent will immediately notify the NOP or State Organic Program, if applicable, of test results. The product may not be sold as organic. 23

24 4. Residue samples detected greater than 5% of EPA tolerance, but not above the EPA tolerance level Residues detected greater than 5% of EPA tolerance, but not above the EPA tolerance level: Investigate why residues are present Issue a Notice of Noncompliance for violation of having prohibited substances at levels greater than 5 percent of the EPA tolerance level. 24

25 4. Residue samples detected greater than 5% of EPA tolerance, but not above the EPA tolerance level Residues detected greater than 5% of EPA tolerance, but not above the EPA tolerance level: If application of prohibited substances is found, the certifying agent should propose suspension or revocation of certification. The certifying agent should coordinate adverse actions with the NOP. 25

26 5. Residue samples detected above EPA tolerance level. Residues detected above EPA tolerance level: Immediately notify the NOP, EPA, state food safety programs or foreign health agency (if outside the U.S.) The product may not be sold as organic. Investigate why residues are present and issue a Notice of Noncompliance for violation of having prohibited substances at levels greater than the EPA tolerance level. 26

27 5. Residue detected above EPA tolerance level continued Residues detected above EPA tolerance level: The certifying agent will follow adverse action procedures. The certifying agent should coordinate adverse actions with the NOP. NOP may pursue civil penalties. 27

28 6. Residue detected below FDA Action Level When there is no EPA tolerance level established for the tested residue sample, but the residue is below the FDA Action Level: The certifying agent will notify the operator of test results. The certifying agent will investigate why residues are present to determine if residues are a result of application of prohibited pesticide or were due to unavoidable residual environmental contamination. The product may be sold as organic if residues are not a result of the application of prohibited pesticides, commingling or contamination during handling. 28

29 7. Residue detected at or above the FDA Action Level When residues are detected at or above the FDA Action Level: Immediately notify the NOP, FDA, state food safety programs, and/or foreign health agency (if outside of U.S.). Investigate why residues are present. Product may not be sold as organic. Work with NOP to identify violations and take enforcement action. 29

30 8. Residue detected with no EPA tolerance or FDA Action level Residues detected above 0.01 ppm with no EPA tolerance or FDA action level: The certifying agent will immediately notify the NOP, FDA, state food safety programs, and/or foreign health agency (if outside of U.S.). Product may not be sold as organic. Investigate why residues are present and issue a Notice of Noncompliance for possible violations, if applicable. 30

31 Resources U.S. EPA Pesticide Tolerances ances.htm European Organic Certifiers Council task force residues Guidance document for the certification decision making process es/as_eocc_pesticide_guidelines_version_sept 2012.pdf 31

32 Resources US EPA Index to Pesticide Chemical Names, Part 180 Tolerance Information FDA Guidance for Industry: Action Levels for Poisonous or Deleterious Substance in Human Food and Animal Feed nformation/guidancedocuments/chemicalcontaminantsa ndpesticides/ucm htm 32

33 Examples 0.05 ppm chlordane on winter squash No EPA tolerance level FDA Action Level = 0.1 ppm Investigate and take appropriate action If chlordane was not applied, the product may be sold as organic 0.2 ppm DDE on tomatoes No EPA tolerance level FDA Action level = 0.05 ppm Product cannot be sold as organic Notify FDA and NOP, coordinate investigation 33

34 Examples 0.2 ppm Metalachlor on buckwheat EPA tolerance 0.1 ppm Exceeds EPA tolerance May not be sold as organic Notify EPA if field sample, FDA if non-field sample Notify NOP, investigate and take appropriate action 1 ppm Chlorpropham on potatoes EPA tolerance = 30 ppm Less than 5% EPA tolerance level Investigation indicates operation knowingly used CIPC (chlorpropham) for sprout inhibition Appropriate adverse action combined NONC/NOPR 34

35 Sampling results: actions For all sample results: Notify applicant or certified operation of test results. Maintain records of analysis and provide results to the public upon request. Maintain sample collection information and sample results for review during NOP accreditation audits. When residues are found, investigate why residues are present and take enforcement action as appropriate. 35

36 Reporting test results to authorities In the U.S., report test results that indicate violations of EPA and FDA regulations as follows: Notify the EPA if the violation of the EPA regulation can be traced back to a prohibited application of a pesticide in a field in the U.S. A prohibited application occurred if a pesticide was applied but was not permitted to be applied to a particular crop (i.e. there is no EPA tolerance) or a pesticide was applied at levels that were too high for a particular crop (i.e. above the tolerance). Submit notice of such EPA violations to 36

37 Reporting test results to authorities Notify the FDA of violations of the EPA tolerance levels or FDA action levels when : The product that was tested is in the stream of commerce, and The location and time of violation that may have occurred in a field cannot be determined. Report notice of such violations to the FDA district office where the violation was discovered. To find Information on district offices, go to: 37

38 Responding to detected residues other than pesticide residues Antibiotics, hormones, medications, GMOs Investigate to determine source of residues and take appropriate adverse action. Use of prohibited substance or method: Knowingly, willful, reason to know = Proposed Revocation Inadvertent, Error = Proposed Suspension Inadequate measures to prevent contamination or commingling: Notice of Noncompliance: require corrective actions to mitigate future contamination.

39 Responding to detected sample residues other than pesticide residues Example: GMO residues The NOP regulations prohibit the use of genetically modified organisms, prohibit commingling or contamination during processing and handling, and require preventative practices to avoid contact with genetically modified organisms (GMOs). Organic agricultural products should have minimal, if any, GMO presence. However, no tolerance level has been established for the presence of GMO material.

40 Responding to detected sample residues other than pesticide residues GMO residues, continued If investigation determines that the residue levels indicate use of excluded methods, then take adverse actions to suspend or revoke certification. If investigation determines that the residue levels are due to inadequate measures to avoid contact with excluded methods from adjoining land use or commingling, then issue NONC. Corrective actions must include measures to mitigate contamination.

41 Final Rule for Periodic Residue Testing Review: Test Results- Provide copy to operator and make available to public Investigate positive results to determine source Take appropriate action: adverse actions and notification of authorities 41

42 Thank You Organic Integrity from Farm to Table, Consumers Trust the Organic Label Agricultural Marketing USDA National Service Organic Program