Source: https://www.federalregister.gov/articles/2012/11/09/2012-27378/national-organic-program-periodic-residue-testing
Timestamp: 2016-04-29 16:01:13
Document Index: 731923759

Matched Legal Cases: ['art 205', '§ 205', '§ 6511', '§ 6506', '§ 6506', 'art 1320', 'art 205', 'art 205', '§ 205']

Publication Date: Friday, November 09, 2012
-67251 (13 pages)
Document Number AMS-NOP-10-0102
NOP-10-10FR
0581-AD10
Document Number: 2012-27378
Shorter URL: https://federalregister.gov/a/2012-27378 Related Topics
This final rule clarifies a provision of the Organic Foods Production Act of 1990 and the regulations issued thereunder that requires periodic residue testing of organically produced agricultural products by accredited certifying agents. The final rule amends the U.S. Department of Agriculture's (USDA) National Organic Program (NOP) regulations to make clear that accredited certifying agents must conduct periodic residue testing of agricultural products that are to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)).” The final rule expands the amount of residue testing of organically produced agricultural products by clarifying that sampling and testing are required on a regular basis. The final rule requires that certifying agents, on an annual basis, sample and conduct residue testing from a minimum of five percent of the operations that they certify. This action will help further ensure the integrity of products produced and handled under the NOP regulations.
National Organic Program, Periodic Pesticide Residue Testing, NOP-10-0102 3 actions from April 29th, 2011 to June 2012
76 FR 23914
F. Civil Rights Impact Analysis
Table 1—Estimated Costs per Sample Collected
Effective Date: This final rule is effective January 1, 2013.
Melissa R. Bailey, Ph.D., Director, Standards Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.
The Agricultural Marketing Service (AMS) is issuing this final rule in response to an audit of the NOP which was conducted in March 2010 by the USDA Office of Inspector General (OIG).
As part of the audit, the OIG visited four certifying agents accredited by the NOP. The audit found that none of the four certifying agents visited conducted periodic residue testing. The OIG indicated that these certifying agents noted that they considered residue testing to be required by the regulations only under certain circumstances.
II. Comments on Proposed Rule Back to Top
Four comments specifically addressed the information collection and recordkeeping requirements of this action pursuant to the Paperwork Reduction Act (44 U.S.C. 3501-3520) (PRA). AMS received one comment from a certifying agent requesting an extension of the comment period. Since the proposed rule included a 60 day comment period and because the NOP previously conducted two webinar trainings with certifying agents on periodic residue testing on June 23 and June 24, 2010, we did not agree that an extension of the comment period was warranted.
Additionally, two commenters cited a 1990 report of the U.S. Senate Committee on Agriculture, Nutrition, and Forestry, which indicates that the NOSB would be most knowledgeable on the subject of levels of acceptable residues of prohibited materials for organic food, and that the Committee intends that the NOSB shall advise the Secretary concerning appropriate residue levels and testing methods for organic products.
AMS disagrees with the commenters' claims that AMS does not have the authority to issue a rule in this area. This final rule is issued under the authority of the OFPA at section 6506(a)(6) which requires periodic residue testing by certifying agents. This rule does not amend any provisions or thresholds related to the maximum allowable pesticide residue for organic food or thresholds related to unavoidable residual environmental contamination (UREC). The existing NOP regulations regarding UREC at section 205.671 were based on a recommendation adopted by the NOSB at its meeting June 1-4, 1994 in Santa Fe, New Mexico.
UREC is defined under section 205.2 of the NOP regulations as background levels of naturally occurring or synthetic chemicals that are present in the soil or present in organically produced agricultural products that are below established tolerances. This rule does not amend this existing definition.
One commenter noted that the number of operations that would be sampled under the proposed rule was small relative to the total number of operations. The commenter noted that sampling based on the number of operations does not account for differences in sizes of the operations, and suggested that sampling be based upon size and quantity, rather than the number of operations. The commenter suggested that AMS have an unbiased group determine sampling methodology using proper scientific and statistical techniques. The commenter noted that, unless AMS uses a sound basis in choosing the number, size, and site of the samples, any conclusions drawn from the testing would be invalid.
AMS has considered the comment that this action may indirectly increase costs to certified operations if certifying agents increase their certification fees to recover costs from increased residue testing. This action implements periodic residue testing in a way that should minimize the direct costs to certifying agents and any indirect costs to certified operations while still meeting the objectives of implementing periodic residue testing as required by OFPA. Additional details on the costs, benefits, and alternatives considered are discussed in the section titled Executive Order 12866 and Executive Order 13563.
Commenters noted that preharvest sampling may be more meaningful when sampling is risk-based or for investigative testing (e.g., when use of a prohibited substance is suspected). In addition, commenters suggested that preharvest testing of tissue samples, soil, or water may be more appropriate at certain times during the growing season.
The final rule also clarifies the reporting requirements when test results indicate that a specific agricultural product contains pesticide residues or environmental contaminates that exceed the Food and Drug Administration's (FDA) or EPA's regulatory tolerances. Under section 6506 of the OFPA, certifying agents, to the extent that they are aware of a violation of applicable laws relating to food safety, are required to report such violation to the appropriate health agencies. This is promulgated in section 205.670(e), amended by this final rule at 205.670(g), of the NOP regulations, which requires reporting to the Federal health agency whose regulatory tolerance or action level has been exceeded. The NOP issued a policy memo on reporting health and safety violations to stakeholders and interested parties.
This final rule clarifies the reporting requirements at 205.670(g), but does not change the responsibility for reporting by certifying agents when residues are found in excess of federal regulatory tolerances established by EPA or FDA. The final rule indicates that certain residue testing results that are in violation of EPA or FDA requirements must be reported to the appropriate State health agency or foreign equivalent. This change in the regulations is intended to recognize the role of State agencies, or their foreign equivalents, in responding to residues in violation of tolerance requirements.
One comment from a certifying agent that operates outside of the United States indicated that reporting test results that exceed federal regulatory tolerances is under the operator's responsibility. The commenter indicated that, as a certifying agent, it would check to make sure reporting was done correctly by the operation, and that the certifying agent would inform the NOP. AMS disagrees. Under the OFPA (7 U.S.C. 6506), certifying agents, to the extent that they are aware of a violation of applicable laws relating to food safety, are required to report such violation to the appropriate health agencies. This requirement is promulgated at section 205.670 of the regulations. This final rule clarifies the reporting requirements, but does not change the responsibility for reporting by certifying agents.
In addition to the reporting requirements outlined in the final rule, the NOP published, on June 13, 2011 in the Federal Register (76 FR 34180), the availability of draft guidance entitled, NOP 5028—Responding to Results from Pesticide Residue Testing, that outlines the actions to be taken by accredited certifying agents if test results from residue analysis show evidence of prohibited substance(s) in or on the product. The notice included a 60-day comment period, which closed on August 12, 2011. After review of the comments received, the NOP intends to publish final guidance on this issue in the NOP Handbook, as described under Related Documents. Under section 205.671, when residue testing detects prohibited substances that are greater than five percent of the EPA'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. This final rule does not change this existing requirement. The draft guidance document provides information to certifying agents on how to respond to results that indicate residues of prohibited substances and how to report results that are in violation of FDA or EPA's regulatory tolerances as required by section 205.670(g).
The commenter also requested written clarification as to how unavoidable pesticide residue contamination of wild crops would be addressed under the regulation in the absence of EPA-established tolerances for most plant species. A clarification is included in the draft guidance NOP 5028—Responding to Results from Pesticide Residue Testing, as described below under Related Documents.
Several commenters requested a more thorough analysis of the costs of implementing periodic residue testing. A more detailed analysis of the costs associated with this action is provided under the section titled Executive Order 12866 and Executive Order 13563. AMS notes that a minority of certifying agents currently conduct periodic residue testing at or above the minimum levels established by this final rule and there would be no additional costs associated with this action for those certifying agents. The majority of certifying agents, however, would need to allocate additional resources for the costs associated with periodic residue testing. AMS received one comment from a certifying agent operating outside of the United States which indicates that it currently tests 20-25% of its certified operations, which is above the minimum level specified in this final rule.
One commenter suggested an alternative funding mechanism, such as having pesticide manufacturers and producers of genetically modified seed pay for the costs of testing. AMS does not have the statutory authority to institute this type of third-party funding model.
AMS does not intend to integrate results into a single dataset, as was requested by some commenters. To minimize the reporting burden for certifying agents, this final rule does not require that certifying agents submit copies of test results to the Administrator; however, certifying agents continue to be required to report certain test results that are found in excess of federal regulatory tolerances or action levels for pesticide residues or environmental contaminants to the appropriate health agency under the section 205.670(g). This final rule does not require reporting of testing data to the Administrator since this action is not intended as a data collection mechanism to draw conclusions about residues in organic products in general. AMS will verify compliance of certifying agents with this rule under the existing requirements for accreditation as discussed in the response to comments on Reporting Requirements.
On February 2, 2011, the NOP published NOP 2611-1, Prohibited Pesticides for NOP Residue Testing, on the NOP Web site in the NOP Handbook. This document provides a list of target pesticides to certifying agents that conduct pesticide residue testing of organically produced agricultural products. This document is available at the NOP Web site at http://www.ams.usda.gov/nop and is discussed below under Related Documents. AMS has not included a specific list of pesticide residues that could be tested for in the regulations. This is intended to allow flexibility in revising the list of target pesticide residues as new pesticides enter the market. In addition, this flexibility allows the NOP to respond more quickly to observed trends in detection of residues on specific commodities.
The final rule maintains the current requirement under section 205.670 that chemical analysis must be made in accordance with the methods described in the most current edition of the Official Methods of Analysis of the AOAC International
or other current applicable validated methodology for determining the presence of contaminants in agricultural products. On February 2, 2011, the NOP provided instructions on laboratory selection criteria for pesticide residue testing to certifying agents. These instructions are further described below under Related Documents and are available on the NOP Web site at http://www.ams.usda.gov/nop. AMS anticipates that these instructions will change over time in response to advances in testing methodology, analytical instrumentation, and residue detection techniques.
AMS received several comments regarding ISO 17025 accreditation of laboratories. This accreditation is mentioned in NOP 2611, Laboratory Selection Criteria for Pesticide Residue Testing, which is further discussed under Related Documents and is available on the NOP Web site at http://www.ams.usda.gov/nop. No comments requested the incorporation of ISO 17025 accreditation into the regulatory text. The comments are under consideration for future revision of the instruction documents and are not impacted by this rulemaking action.
AMS received four comments specifically on the issue of information collection burden. Two comments indicated that they were unclear whether the estimated time is accurate and that more data and analysis was needed. One commenter suggested that the NOSB should hear from the various stakeholders in public forums before AMS considers the accuracy of the estimate. One commenter indicated that the estimate of 1.74 hours appears to be low, especially when foreign operations and imported products are considered, but did not offer an alternative estimate for the number of hours or data to support a different estimate.
AMS received one comment that indicated that the proposed rule did not identify what would be done with the information collected. A response is provided above under the section, Purpose of Testing—Changes Requested But Not Made.
AMS received four comments on instruction documents that the NOP has published in the NOP Handbook regarding residue testing. The instruction documents are discussed under Related Documents. These comments are beyond the scope of this rulemaking; however, they are under consideration for future revision of the instruction documents through a separate action.
A proposed rule was published in the Federal Register on April 29, 2011 (76 FR 23914). Additional documents related to this final rule include the Organic Foods Production Act (OFPA), as amended (7 U.S.C. 6501-6522) and its implementing regulations (7 CFR part 205). The March 2010 USDA Office of Inspector General audit report of the National Organic Program is available as Audit Report 01601-03-Hy.
The NOP has also published three instruction documents related to residue testing as part of the NOP Handbook: (1) Sampling Procedures for Residue Testing (NOP 2610), (2) Laboratory Selection Criteria for Pesticide Residue Testing (NOP 2611), and (3) Prohibited Pesticides for NOP Residue Testing (NOP 2611-1). The goal of the NOP Handbook is to provide those who own, manage, or certify organic operations with guidance, instructions, and policy memos that can assist them in complying with the NOP regulations. The most recent edition of the NOP Handbook is available for viewing and downloading through the NOP Web site at http://www.ams.usda.gov/nop.
On June 13, 2011, the NOP published draft guidance, NOP 5028—Responding to Results from Pesticide Residue Testing, that outlines the actions to be taken by accredited certifying agents if test results from residue analysis show evidence of prohibited substance(s) in or on the product. A notice on the availability of draft guidance was published in the Federal Register (76 FR 34180) with a 60 day comment period. The comment period closed on August 12, 2011, and comments are under review by the NOP. After review of the comments received, the NOP intends to publish the final guidance in the NOP Handbook.
Members of the public who wish to request that the agency issue, reconsider, modify, or rescind a guidance or instruction document may do so by sending an email to NOP.Guidance@ams.usda.gov or by mailing a letter to Standards Division, National Organic Program, U.S. Department of Agriculture, Room 2646-So. (Stop 0268), 1400 Independence Ave. SW., Washington, DC 20250-0268.
OFPA authorizes AMS to administer the NOP. Under the NOP, AMS oversees national standards for the production and handling of organically produced agricultural products.
Section 6506 of the OFPA requires periodic residue testing by certifying agents of agricultural products that have been produced on certified organic farms and handled through certified organic handling operations to determine whether such products contain any pesticide or other nonorganic residue or natural toxicants. This section also requires certifying agents to report violations of applicable laws relating to other federal tolerance requirements (e.g., pesticide residues in excess of FDA action levels or EPA tolerances) to the appropriate health agencies. Additional information on reporting health and safety violations has been previously provided by the NOP to stakeholders and interested parties.
This information is available on the NOP Web site at http://www.ams.usda.gov/nop.
AMS is issuing this final rule in response to an audit of the NOP which was conducted in March 2010 by the USDA's OIG.
As part of the audit, the OIG visited four certifying agents accredited by the NOP. The OIG indicated that these certifying agents noted that they considered residue testing to be required by the regulations only under certain circumstances.
In addition, proposals for testing at a reduced sampling rate, and testing scaled to the size of operation or to the number of certified organic products were suggested by commenters and are discussed under the above section, Number of Samples—Changes Requested But Not Made. AMS believes that calculating the samples based on a percentage of operations reduces the burden on the certifying agents by providing a clear and simple formula for how to comply with the regulations. AMS has not specified how certifying agents must select operations for residue testing to provide flexibility and discretion to the certifying agent in how to most efficiency and effectively implement the minimum testing required under the rule. Operation selection for residue testing may include risk factors such as number of products produced, split operations, size of the operation, split operations (i.e., operations that produce or handle both organic and nonorganic agricultural products), previous non-compliances, high-value or high-risk crops, or other criteria deemed appropriate by the certifying agent.
The first alternative of maintaining the status quo was not considered feasible due to a finding identified in an audit report issued by USDA's OIG in March 2010.
In response to the OIG audit, AMS conducted a review of the residue testing requirements in OFPA and the NOP regulations. AMS concluded that, under section 6506 of the OFPA, accredited certifying agents are required to conduct residue testing of organic products on a regular and reoccurring basis, as well as when there is reason to believe contamination has occurred, and that the regulations be revised as provided for in this rulemaking.
The second alternative distinguishes between periodic residue testing and risk-based testing for purposes of calculating the percentage of operations to be tested annually. This alternative was discussed in the proposed rule published April 29, 2011 (76 FR 23914). The proposed rule indicated that certifying agents would need to sample a minimum of five percent of their certified operations annually, and that such testing would be in addition to any testing conducted when there was reason to believe that the agricultural product had come into contact with a prohibited substance (e.g., investigative or complaint-driven testing). This alternative would result in higher costs to the certifying agent, since costs associated with other types of testing would be in addition to costs for periodic testing. After consideration of the comments received, AMS believes that the final rule offers more flexibility by allowing both complaint-driven and periodic residue testing to count toward the sample minimum. This final rule should also minimize the burden on certifying agents by removing the need to distinguish between different types of testing.
Sample collection costs (inspector costs) are estimated at $20.36 per sample. This estimate is based on an estimated 1.0 labor hour per sample at $20.36 per hour. The hourly rate is estimated based on the mean hourly wage for agricultural inspectors as published by the Bureau of Labor Statistics.
This classification was selected as an occupation with similar duties and responsibilities to that of an organic inspector. Such duties and responsibilities include inspection of agricultural commodities, processing equipment, and facilities, to ensure compliance with regulations and laws governing health, quality, and safety.
Sample shipping boxes and supplies are estimated at $40 per sample, based on a costs associated with a pilot project for pesticide residue sampling conducted by the NOP in conjunction with the AMS Pesticide Data Program. Shipping costs are estimated at $25 per sample. AMS notes that these costs are an average and may vary depending on the sample type and shipping distance to laboratory.
Labor costs associated with review of sample results are estimated at $16.21 per sample. This estimate is based on an estimated 0.5 labor hour per sample at $32.42 per hour. The hourly rate is estimated based on the mean hourly wage for auditors as published by the Bureau of Labor Statistics.
This classification was selected as an occupation with similar duties and responsibilities to that of a certifying agent. Such duties and responsibilities include conducting reviews of operations against accepted standards and evaluating audit or inspection findings for compliance.
If certifying agents receive sample results which are in excess of EPA or FDA regulatory tolerances, the certifying agent must promptly report such data to the Federal health agency (i.e., EPA or FDA) whose regulatory tolerance or action level has been exceeded. Test results that exceed federal regulatory tolerances must also be reported to the appropriate State health agency or foreign equivalent. This requirement is clarified in this final rule under § 205.670(g); however, this is not a new requirement under this action and additional costs not expected from this clarification. AMS expects that the majority of tested organic products will not have detectable residues of prohibited pesticide substances, based on historical data from the AMS Pesticide Data Program.
AMS believes that this rate of testing provides the benefits at reasonable cost to certifying agents. AMS recognizes that a minority of certifying agents conduct residue testing on a regular basis, and that certifying agents not currently conducting testing will need to account for these costs as a cost of doing business.
In consideration of training costs, the NOP notes that, while this action expands the amount of testing of organically produced agricultural products to include a requirement that is regular and periodic in scope, certifying agents are already required, under section 205.504(b)(6), to have procedures in place for sampling and residue testing pursuant to section 205.670. Certifying agents must already be conducting sampling and laboratory testing in instances where contamination is suspected under section 205.403(c)(3) and section 205.670(b). Therefore, AMS does not believe that additional training costs are imposed by this final rule.
Table 1—Estimated Costs per Sample Collected Back to Top
Sample collection (inspector time)
1 hour @ $20.36 per hour.
Sample shipping boxes and supplies
AMS Pesticide Data Program.
Estimate for in-state shipping of 5 pound sample.
Laboratory costs for multi-residue analysis
Review of Sample Results—Labor Costs
0.5 hour @ $32.42 per hour.
Total costs per sample
States and local jurisdictions are preempted under the OFPA from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in section 6514(b) of the OFPA. States are also preempted under sections 6503 through 6507 of the OFPA from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA.
Pursuant to section 6507 of the OFPA, a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must: (a) Further the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary.
Pursuant to section 6519 of the OFPA, this final rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-392), nor the authority of the Administrator of the EPA under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136-136(y)).
Section 6520 of the OFPA provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. The OFPA also provides that the U.S. district court for the district in which a person is located has jurisdiction to review the Secretary's decision.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small business will not be unduly or disproportionately burdened. Section 605 of RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.
Pursuant to the requirements set force in the RFA, AMS performed an economic impact analysis on small entities in the final rule published in the Federal Register on December 21, 2000 (65 FR 80548). AMS has also considered the economic impact of this final rule on small entities. AMS certifies that this rule would not have a significant economic impact on a substantial number of small entities.
According to Economic Research Service (ERS) data, based on information from USDA accredited certifying agents, the number of certified U.S. organic crop and livestock operations totaled nearly 13,000 and certified organic acreage exceeded 4.8 million acres in 2008.
ERS, based upon the list of certified operations maintained by the NOP, estimated the number of certified handling operations was 3,225 in 2007.
AMS estimates that there were 30,118 operations certified to the NOP in 2011. USDA has 93 accredited certifying agents that provide certification services to producers and handlers under the NOP. A complete list of names and addresses of certifying agents may be found on the AMS NOP Web site at: http://www.ams.usda.gov/nop. AMS believes that most of these entities would be considered small entities under the criteria established by the SBA.
This final rule will affect all certifying agents by requiring that each agent conduct residue testing from a minimum of five percent of the operations they certify on an annual basis. This level was chosen to ensure that all certifying agents, regardless of the number of operations they certify, are responsible for some level of regular residue testing at reasonable cost. Under section 205.670, certifying agents have been responsible for expenses associated with preharvest and postharvest testing; this requirement also applies to expenses for periodic residue testing in this final rule. To estimate the annual costs associated with instituting periodic residue testing, the NOP conducted a preliminary assessment of costs at different minimum testing requirements (i.e., 5%, 25%, and 100% of certified operations).
Under this new action with a five percent minimum testing requirement, the two certifying agents with the largest number of certified operations (approximately 2,100 operations each in 2009) are required to collect a minimum of 105 samples. Smaller certifying agents (those certifying fewer than 30 operations) are required to collect and test at least 1 sample on an annual basis. In 2010, approximately one-third of accredited certifying agents certified fewer than 30 operations to the NOP.
Over half of all certifying agents certified fewer than 200 operations in 2010 and are required to sample 10 or fewer operations annually under this final rule.
At a five percent minimum testing requirement, the costs of sampling are estimated from approximately $492 to 51,106 per certifying agent per year based on the average cost of $492 per sample and the range in the number of operations certified by different certifying agents. Additional costs may be required to follow up on results if prohibited substances are detected. AMS expects that the majority of results will be for samples with no prohibited residues detected, based on historical data from the AMS Pesticide Data Program.
AMS is establishing a five percent testing level in this final rule because this level is expected to be, in most cases, no more than two percent of a given certifying agent's operating budget, a level that can be considered a reasonable cost to the organic industry given the benefits of residue testing in discouraging the mislabeling of agricultural products. Furthermore, the number of samples required at a five percent level is consistent with the amount of residue sampling already being conducted by some certifying agents. As a percentage of a certifying agent's total operating costs, this estimate was revised upward from one percent to two percent, based on public comment received in response to the proposed rule. Comments included a summary of data from an association representing certifying agents, and included data from 25 certifying agents. The range of costs was reported at between 1% and 11% of a certifying agent's overall operating budget, with one certifying agent reporting that the cost of one sample would account for 11% of their total operating costs for the year and one certifying agent reporting that the cost for three samples would account for 1% of their total operating costs. The majority of these certifying agents estimated the costs associated with this action to account for no more than 2% of their operating budget annually.
These are discussed in detail above under Alternatives Considered. AMS determined that the alternatives of a statistically based sample size (i.e., 25% of operations annually) or testing all operations annually were not practical due to the costs and the uneven burden that could be placed upon smaller certifying agents in either scenario.
Between 1990 and 2008, organic food sales have historically demonstrated a growth rate between 15 to 24 percent each year. In 2010, organic food sales grew 7.7%.
The NOP is authorized under OFPA to implement regulations that require accredited certifying agents to conduct residue testing of organically produced agricultural products (7 U.S.C. § 6511). In addition, the OFPA requires that the NOP include provisions for periodic residue testing by certifying agents of agricultural products produced or handled in accordance with the NOP (7 U.S.C. § 6506). This final rule ensures that all certifying agents conduct a minimal level of residue testing.
However, AMS has concluded that, under 7 U.S.C. § 6506 of the OFPA, accredited certifying agents are required to conduct residue testing of organic products on a regular and reoccurring basis, as well as when there is reason to believe contamination has occurred.
The final rule is necessary to clarify a requirement of OFPA that certifying agents conduct periodic residue testing of organic products. The final rule will increase the amount of residue testing that certifying agents must conduct when compared to the current regulations. This final rule ensures that certifying agents are conducting a minimal level of residue testing on a regular and reoccurring basis.
The cost of testing is to be borne by the applicable certifying agent and is considered a cost of doing business.
The population that is directly impacted by this final rule is accredited certifying agents. The USDA has 93 certifying agents who provide certification services to producers and handlers under the NOP. A complete list of names and addresses of certifying agents may be found on the AMS NOP Web site at: http://www.ams.usda.gov/nop. AMS believes that most accredited certifying agents would be considered small entities under the criteria established by the SBA. Approximately 30,118 operations worldwide were certified to the NOP standard in 2011; certified operations may be indirectly impacted by this action as additional operations will be subject to residue testing by certifying agents.
For certifying agents who are not currently conducting residue testing at the minimum levels specified in the final rule, this action will increase costs. AMS has estimated costs at $492 per sample. At an estimated cost of $492 per sample and a sampling rate of 5% of certified operations, certifying agents would need to budget an estimated $25 per certified operation for testing costs. The total costs of residue testing are estimated at approximately $492 to $51,106 per certifying agent per year based on the average cost of $492 per sample and the range in the number of operations certified by different certifying agents. Additional costs may be required to follow up on results if prohibited substances are detected. The portion of the total estimated costs would be considered new or additional costs as a result of this action is not known, as a minority of certifying agents are already conducting residue testing of organic products and have budgeted for these costs under their existing fee structures. If these costs have not been previously budgeted for by the certifying agent, it will need to account for these costs as part of their cost of business.
To reduce additional inspector costs associated with sample collection, AMS has not specified which operations must be sampled annually or when the samples must be collected. This is intended to provide flexibility to the certifying agent implement a schedule for sample collection in the most efficient manner.
The final rule will increase costs for certifying agents who are not currently performing residue testing at the minimal levels specified in this rule. Some certifying agents may increase their certification fees for its clients to pay for additional costs associated with residue testing. At an estimated cost of $492 per sample and a sampling rate of 5% of certified operations, certifying agents would need to budget approximately $25 per operation for testing costs.
This final rule clarifies a provision of OFPA and the regulations issued thereunder that requires periodic residue testing of organically produced agricultural products by accredited certifying agents. The final rule expands the amount of residue testing of organically produced agricultural products by clarifying that sampling and testing are required on a regular basis. The final rule requires that certifying agents, on an annual basis, sample and conduct residue testing from a minimum of five percent of the operations that they certify.
AMS believes that the benefits of residue testing in protecting organic integrity and ensuring compliance with the regulations outweigh the estimated costs.
In accordance with Office of Management and Budget (OMB) regulations (5 CFR part 1320) that implement the Paperwork Reduction Act (44 U.S.C. 3501-3520) (PRA), the information collection requirements associated with the NOP have been previously approved by OMB and assigned OMB control number 0581-0191. A new information collection package was submitted to OMB at the proposed rule stage for approval of 776 hours in total burden hours to cover this new collection and recordkeeping burden of the amendments to section 205.670 of this final rule. Between the proposed rule and this final rule, there is a reduction of 350 hours based on comments received. Upon OMB's approval of this new information collection, the NOP intends to merge this collection into currently approved OMB Control Number 0581-0191.
AMS has reviewed this rule in accordance with the Department Regulation 4300-4, Civil Rights Impact Analysis (CRIA), to address any major civil rights impacts the rule might have on minorities, women, and persons with disabilities. After a careful review of the rule's intent and provisions, AMS has determined that this rule has no potential for affecting certified operations or certifying agents in protected groups differently than the general population of certified operations and certifying agents. This rulemaking was initiated to clarify a regulatory requirement and enable consistent implementation and enforcement.
Protected individuals have the same opportunity to participate in the NOP as non-protected individuals. The NOP regulations prohibit discrimination by certifying agents. Specifically, section 205.501(d) of the current regulations for accreditation of certifying agents provides that “No private or governmental entity accredited as a certifying agent under this subpart shall exclude from participation in or deny the benefits of the NOP to any person due to discrimination because of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, or marital or family status.” Section 205.501(a)(2) requires “certifying agents to demonstrate the ability to fully comply with the requirements for accreditation set forth in this subpart” including the prohibition on discrimination. The granting of accreditation to certifying agents under section 205.506 requires the review of information submitted by the certifying agent and an on-site review of the certifying agent's operation. Further, if certification is denied, section 205.405(d) requires that the certifying agent notify the applicant of their right to file an appeal to the AMS Administrator in accordance with section 205.681. These regulations provide protections against discrimination, thereby permitting all handlers, regardless of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, or marital or family status, who voluntarily choose to adhere to the final rule and qualify, to be certified as meeting NOP requirements by an accredited certifying agent. This final rule in no way changes any of these protections against discrimination.
For the reasons set forth in the preamble, 7 CFR part 205 is amended as follows:
1.The authority citation for 7 CFR part 205 continues to read as follows: Authority:
2.Section 205.670 is revised to read as follows: § 205.670 Inspection and testing of agricultural products to be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)).”
[FR Doc. 2012-27378 Filed 11-8-12; 8:45 am]
1. U.S. Department of Agriculture, Office of Inspector General, Audit Report 01601-03-Hy, March 2010. Available at http://www.usda.gov/oig/webdocs/01601-03-HY.pdf.
2. U.S. Senate, Committee on Agriculture, Nutrition, and Forestry. Food, Agriculture, Conservation, and Trade Act of 1990, S. Rpt. 101-357 to accompany S. 2830, July 6, 1990.
3. National Organic Standards Board, Final Recommendations, Residue Testing, 1994. Available on the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=stelprdc5058863.
4. NOP Policy Memo 11-6, Reporting Health & Safety Violations, revised October 31, 2011. Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088951.
5. http://www.aoac.org/.
6. U.S. Department of Agriculture, Office of Inspector General, Audit Report 01601-03-Hy, March 2010. Available at http://www.usda.gov/oig/webdocs/01601-03-HY.pdf.
7. NOP Policy Memo 11-6, Reporting Health & Safety Violations, revised October 31, 2011. Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088951.
8. U.S. Department of Agriculture, Office of Inspector General, Audit Report 01601-03-Hy, March 2010. Available at http://www.usda.gov/oig/webdocs/01601-03-HY.pdf.
9. U.S. Department of Agriculture, Office of Inspector General, Audit Report 01601-03-Hy, March 2010. Available at http://www.usda.gov/oig/webdocs/01601-03-HY.pdf.
10. Mean Hourly Wage for Agricultural Inspector, U.S. Department of Labor, Bureau of Labor Statistics, Occupational Employment and Wages, May 2010. http://bls.gov/oes/current/oes452011.htm.
11. U.S. Department of Labor, Bureau of Labor Statistics, Occupational Employment and Wages, May 2009. http://www.bls.gov/oes/2009/may/oes132011.htm.
12. U.S. Department of Agriculture, Economic Research Service. 2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
13. U.S. Department of Agriculture, Economic Research Service, 2009. Data Sets: Procurement and Contracting by Organic Handlers: Documentation. http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
14. As reported by certifying agents during the 2010 certification year and available at http://apps.ams.usda.gov/nop/.
15. Dimitri, C.; Oberholtzer, L. 2009. Marketing U.S. Organic Foods: Recent Trends from Farms to Consumers, Economic Information Bulletin No. 58, U.S. Department of Agriculture, Economic Research Service, http://www.ers.usda.gov/Publications/EIB58.
16. Organic Trade Association's 2011 Organic Industry Survey, http://www.ota.com.