National Organic Program; Periodic Residue Testing, 67239-67251 [2012-27378]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Rules and Regulations]
[Pages 67239-67251]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27378]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / 
Rules and Regulations

[[Page 67239]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-10-0102; NOP-10-10FR]
RIN 0581-AD10


National Organic Program; Periodic Residue Testing

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: Effective Date: This final rule is effective January 1, 2013.

FOR FURTHER INFORMATION CONTACT: Melissa R. Bailey, Ph.D., Director, 
Standards Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under section 6511 of the Organic Foods Production Act of 1990 
(OFPA), as amended, (7 U.S.C. 6501-6522), the National Organic Program 
(NOP) is authorized to implement regulations that require accredited 
certifying agents to conduct residue testing of organically produced 
agricultural products. Section 6506 of the OFPA also requires that the 
NOP include provisions for periodic residue testing by certifying 
agents of agricultural products produced or handled in accordance with 
the NOP.
    Residue testing plays an important role in organic certification by 
providing a means for monitoring compliance with the NOP and by 
discouraging the mislabeling of agricultural products. Testing of 
organically produced agricultural products is promulgated in section 
205.670 of the NOP regulations (7 CFR part 205). This section provides 
that the Secretary, State organic programs, and certifying agents may 
require preharvest or postharvest testing of any agricultural input 
used or agricultural product to be sold, labeled, or represented as 
``100 percent organic,'' ``organic,'' or ``made with organic (specified 
ingredients or food group(s))'' when there is reason to believe that 
the agricultural input or product has come into contact with a 
prohibited substance or has been produced using excluded methods.
    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).\1\ 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.
---------------------------------------------------------------------------

    \1\ U.S. Department of Agriculture, Office of Inspector General, 
Audit Report 01601-03-Hy, March 2010. Available at https://www.usda.gov/oig/webdocs/01601-03-HY.pdf.
---------------------------------------------------------------------------

    AMS conducted a review of this issue in response to the OIG audit. 
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.
    On June 23 and June 24, 2010, the NOP conducted two webinar 
trainings with certifying agents on periodic residue testing under the 
NOP. The objective of the webinar was to present an overview of 
requirements for periodic residue testing under the OFPA and the NOP. 
The NOP also solicited feedback from the certifying agents who 
participated in the webinar. Of the certifying agents accredited at 
that time, 55 individuals registered to participate in the webinar. Ten 
participants in the webinar provided written feedback to the NOP in 
response to the information provided. These comments were considered in 
the development of this final rule.
    On April 29, 2011, AMS published a proposed rule for periodic 
residue testing (76 FR 23914). The rule proposed that certifying 
agents, on an annual basis, must sample and conduct residue testing 
from a minimum of five percent of the operations that they certify. The 
proposed rule included a 60 day comment period. Comments were also 
specifically requested on the information collection burden that would 
result from the proposed action. The NOP received over 30 written 
comments in response to the proposed rule.

II. Comments on Proposed Rule

    Comments in response to the proposed rule were received from 
certified organic operations, certifying agents, consumers, trade 
associations, organic associations, and various industry groups.
    The majority of commenters supported residue testing in general, 
and offered comments regarding the role of the National Organic 
Standards Board (NOSB), sampling rates, sample selection, costs and 
costs estimates, testing methodology, data collection, and reporting 
requirements.
    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).

[[Page 67240]]

    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.

Authority To Issue Rule

    Seven commenters indicated that they did not believe that AMS has 
the authority to issue a rule on residue testing under the OFPA without 
a recommendation from the NOSB.
    The NOSB is a federal advisory committee established by the 
Secretary of Agriculture under section 6518 of the OFPA to assist in 
the development of standards for substances to be used in organic 
production and to advise the Secretary on other aspects of the 
implementation of the NOP.
    The commenters cited section 6518 of the OFPA which states ``the 
Board shall advise the Secretary concerning the testing of organically 
produced agricultural products for residues caused by unavoidable 
residual environmental contamination.''
    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.\2\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.\3\ 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.
---------------------------------------------------------------------------

    \3\ National Organic Standards Board, Final Recommendations, 
Residue Testing, 1994. Available on the NOP Web site at https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=stelprdc5058863.
---------------------------------------------------------------------------

Number of Samples

    AMS received twelve comments on the issue of the amount of sampling 
or number of samples. The proposed rule indicated that certifying 
agents would be required, on an annual basis, to sample and conduct 
residue testing from a minimum of five percent of the operations that 
they certify. The proposed rule indicated that residue testing 
conducted for causative reasons, such as complaint-driven testing, or 
testing when there was reason to suspect contamination, would not be 
counted towards the minimum percentage required.
    Based on the comments received, AMS believes that using a 
percentage of certified operations to determine sample selection offers 
the simplest implementation for certifying agents and ensures that all 
certifying agents conduct a minimal level of residue testing. Further 
discussion of the comments received is provided below.

Number of Samples--Changes Based on Comments

    AMS received five comments requesting that all residue testing 
conducted by a certifying agent be counted towards the five percent 
minimum requirement, including compliance testing, investigative 
testing, risk-based sampling, and random sampling. One commenter 
indicated that establishing random testing at five percent would make 
it more difficult to do other types of testing (e.g. risk-based, 
compliance testing) because of the costs involved. Several commenters 
indicated that compliance, investigative, and risk-based testing would 
yield more meaningful results than random testing.
    One comment from a certifying agent indicated that it did not 
support revising the rule to include compliance or investigative 
testing as part of the five percent requirement. Based on experience in 
taking samples for both purposes, the commenter indicated that the 
concern from certifying agents that the proposed rule would be a 
disincentive to conduct compliance or investigative testing was 
unfounded.
    The NOP accepts the majority of the commenters' suggestions to 
include all testing towards the minimum requirement. Any residue 
testing performed by a certifying agent may be counted towards the 
minimum requirement for residue testing, provided that the certifying 
agent samples and tests from a minimum of five percent of the 
operations it certifies on an annual basis.
    AMS received two comments requesting a phase-in period for the 
testing requirements. One commenter suggested testing a portion of the 
five percent minimum percentage of operations in 2012, and the full 
percentage of operations in 2013. The commenter noted that a phase-in 
would enable certification agents to plan budgets, develop office 
procedures, and train staff and inspectors. The commenter also noted 
that a phase-in would enable the NOP to assess the effectiveness of the 
testing program. AMS received one comment requesting a phase-in of 
three percent for the first two years, which could be reevaluated and 
adjusted accordingly in the future.
    AMS has considered the commenters' suggestion for a phase-in of the 
implementation and compliance date of the final rule and has issued 
this final rule with an effective date of January 1, 2013. Certifying 
agents must be fully compliant with the five percent requirement for 
the 2013 calendar year. The NOP understands that a minority of 
accredited certifying agents currently conduct residue testing on a 
regular, periodic basis. However, the NOP notes that certifying agents 
are already required, under section 205.504(b)(6) of the NOP 
regulations, to have procedures and trained staff in place for 
investigations of pesticide drift, complaints, or when reason to 
believe a product has come into contact with a prohibited substances. 
As evidence of their expertise and ability, certifying agents are also 
already required to submit a copy of the procedures to be used for 
sampling and residue testing pursuant to section 205.670 as an 
accreditation requirement.

Number of Samples--Changes Requested But Not Made

    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

[[Page 67241]]

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.
    Another commenter suggested that AMS should require sampling based 
on a percentage of products, rather than a percentage of operations.
    Two comments indicated that the five percent number was arbitrary 
and not statistically valid, but did not offer an alternative method 
for determining sampling size.
    AMS disagrees. Basing sampling 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. The five percent 
requirement satisfies AMS's intent to discourage the mislabeling of 
agricultural products and provide a means for monitoring compliance 
with the NOP.
    Under the final rule, certifying agents have the discretion to 
select operations for residue testing based on criteria such as size of 
operation, quantity of products produced, previous compliance issues, 
or other risk factors. Certifying agents are knowledgeable about the 
risk factors affecting the operations it certifies; therefore, it is 
appropriate for a certifying agent to determine what operations should 
be tested under this action.
    AMS received three comments requesting that AMS lower the minimum 
percentage of operations to be tested from five percent to three 
percent due to costs. One of the commenters stated that the costs of 
testing would be passed on indirectly to farmers and processors in the 
form of higher certification fees. Another commenter stated that 
requiring three percent, rather than five percent, would allow the 
certifying agent more latitude for doing risk-based and compliance 
sampling.
    In the final rule, AMS allows for both periodic testing and 
compliance sampling to be counted towards the minimum requirement, but 
has retained the minimum percentage of operations to be tested at five 
percent annually.
    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.
    AMS notes that lowering the percentage below five percent does not 
have an impact on the smallest quartile of certifying agents that 
certify fewer than thirty operations to the NOP per year, since they 
are required to sample a minimum of one operation under either 
scenario.
    One comment from a consumer group indicated that AMS should reserve 
the right to raise the percentage for a specific certifying agent if 
residue testing shows that a certifying agent has an unusually high 
number of positive results. AMS believes that the regulations provide 
sufficient flexibility for the NOP to address issues that may arise on 
a case-by-case basis, and therefore, no modifications are necessary to 
the regulations.
    One commenter requested that AMS review the residue testing data in 
five years to see if the percentage of operations tested could be 
reduced. AMS notes that the final rule does not prohibit AMS from 
reconsidering the percentage of operations required for compliance at a 
later date based on new information, but this would be under a separate 
rulemaking action.
    AMS received one comment from a certifying agent regarding the role 
of State organic programs under the proposed rule. AMS currently has 
one State organic program in California. The commenter requested that 
testing conducted by a State program should offset the certifying 
agents' requirement in that State. AMS disagrees. Under the OFPA, 
certifying agents are required to conduct residue testing. AMS believes 
that requiring certifying agents to test from five percent of certified 
operations on an annual basis is reasonable, and that testing conducted 
by other organizations, including State organic programs or other 
private testing programs, should not offset this requirement under the 
OFPA.

Operation Selection and Conflict of Interest--Changes Requested But Not 
Made

    AMS received nine comments regarding the selection of operations 
for residue testing. Several commenters requested clarification on 
selection of operations and whether it is AMS' intent to have 
certifying agents select operations at random or use other criteria. It 
is not AMS' intent for this final rule to require certifying agents to 
select operations at random. AMS is not specifying how certifying 
agents should select operations for residue testing in order to provide 
flexibility to the certifying agency. Instead, AMS is providing 
discretion to the certifying agent to select operations. Operation 
selection for residue testing may include risk factors such as number 
of products produced, split operations, size of the operation, high-
value or high-risk crops, or other criteria deemed appropriate by the 
certifying agent.
    Three commenters indicated that certifying agents should not select 
the operations for residue testing since this may be an inherent 
conflict of interest. Commenters suggested that the NOP or other third-
party groups select the operations. AMS disagrees. Certifying agents 
are already required to implement procedures to prevent conflict of 
interests as a condition of accreditation under the NOP regulations 
(Sec.  205.501(a)(11)). AMS also conducts regular audits of certifying 
agents to ensure compliance with NOP accreditation requirements 
including preventing conflicts of interest. AMS does not have reason to 
believe that selection of operations for purposes of periodic residue 
testing would be different from any other certification work carried 
out by certifying agents with respect to conflict of interest.
    Several commenters suggested utilizing a system of statistical 
sampling methods for operation selection, such as that used by the AMS 
Pesticide Data Program. AMS disagrees. It is not AMS' intent to 
assemble data and draw conclusions based on statistical sampling 
techniques, as the sampling performed by certifying agents will vary 
considerably due to the worldwide diversity of operations which are 
certified to the NOP. Certifying agents have the discretion to sample 
from higher risk operations, which may yield results that are not 
representative of all organic operations.

Types of Samples--Changes Based on Comments

    AMS received eight comments regarding the selection of samples for 
residue testing. The commenters requested changes in the rule to 
clarify that residue sampling may be performed on samples which are not 
finished products, such as soil samples, tissue samples, or water.
    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,

[[Page 67242]]

soil, or water may be more appropriate at certain times during the 
growing season.
    AMS agrees with the commenters' suggestions and has amended the 
regulatory text accordingly to clarify that testing may be conducted 
preharvest or postharvest, and that residue testing is not limited to 
salable products only. The final rule specifies the types of materials 
for sampling that are currently listed in section 205.403(c)(3) for on-
site inspections. This may include collection and testing of soil; 
water; waste; seeds; plant tissue; and plant, animal, and processed 
products samples. AMS notes that, in the case of pesticide residue 
testing, tolerances are established by the Environmental Protection 
Agency (EPA) for specific harvested commodities. These tolerances 
enable the certifying agent to take appropriate enforcement action, if 
warranted, for the harvested commodity. If a prohibited residue is 
detected in a sample where there is not an established tolerance, such 
as soil, water, or other plant tissues, follow-up testing of the 
harvestable product may be needed for the certifying agent to determine 
the appropriate enforcement action.
    Additionally, AMS notes that certifying agents currently have the 
authority to collect samples under section 205.403(c) which states that 
``The on-site inspection of an operation must verify: (3) That 
prohibited substances have not been and are not being applied to the 
operation through means which, at the discretion of the certifying 
agent, may include the collection and testing of soil; water; waste; 
seeds; plant tissue; and plant, animal, and processed products 
samples.''

Types of Samples--Changes Requested But Not Made

    AMS received one comment requesting that processed products which 
are to be sold or labeled as ``organic'' or ``made with organic 
(specified ingredients or food group(s))'' be excluded from residue 
testing requirements. The commenter states that testing would not 
pinpoint the source of contaminants in processed, multi-ingredient 
products. In certain cases, the source of a residue detected in a 
multi-ingredient processed product may be more difficult to identify; 
however, we have retained the allowance for testing processed products 
to allow certifying agents the flexibility of sampling processed 
products when it may be useful to determine compliance with the 
regulations.

Reporting Requirements

    AMS received eight comments regarding reporting requirements. 
Several commenters requested clarification on the use of the term 
``promptly'' in reporting results to the AMS Administrator 
(Administrator). The proposed rule did not specify a reporting time 
period and retained the term ``promptly'' from the existing NOP 
requirements at section 205.670.
    Several commenters also requested a distinction between reporting 
violative versus non-violative sample results. The commenters suggested 
that violative samples (i.e., samples with residues detected) could be 
reported to the Administrator as the information was received, but 
requested that non-violative samples (i.e., where no residues are 
detected) be reported on a more infrequent basis, such as quarterly or 
annually. One commenter requested that reporting be required on at 
least an annual basis, but not more than twice annually. Two commenters 
requested that the NOP require all results to be reported and 
incorporated into a dataset that would be available to the public.
    After further consideration, AMS has amended the reporting 
requirements required under section 205.670 in order to reduce the 
reporting burden on certifying agents. This rule eliminates the 
requirement that certifying agents must submit all residue testing 
results to the Administrator or State organic program's governing State 
official. AMS does not intend to consolidate residue testing data from 
certifying agents and does not need reporting of residue testing 
results as the mechanism to ensure that certifying agents are meeting 
the requirement periodic residue testing.
    AMS intends to verify compliance of certifying agents with the 
requirements for periodic residue testing as part of the existing 
accreditation process. Accreditation requirements at section 
205.504(b)(6) require certifying agents to have administrative policies 
and procedures, including procedures to be used for sampling and 
residue testing pursuant to Sec.  205.670. Certifying agents are also 
required to submit an annual report to the Administrator on or before 
the anniversary date of the issuance of notification of accreditation 
which includes a complete and accurate update of information submitted 
pursuant to Sec. Sec.  205.503 and 205.504. In order to verify that 
certifying agents are implementing this rule in advance of regularly 
scheduled on-site audits, AMS intends to require, as authorized under 
section 205.510(a)(3), certifying agents to submit in their next annual 
report a description of the measures implemented in the previous year 
and any measures to be implemented in the coming years to meet the 
requirements in this rule for periodic residue testing. In addition, 
AMS notes that certifying agents should continue to maintain the 
complete results of laboratory analyses for residues of pesticides and 
other prohibited substances conducted during the current and three 
preceding calendar years, as required by section 205.504(b)(5)(iii).
    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.\4\ 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.
---------------------------------------------------------------------------

    \4\ NOP Policy Memo 11-6, Reporting Health & Safety Violations, 
revised October 31, 2011. Available at https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088951.
---------------------------------------------------------------------------

    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

[[Page 67243]]

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).

Wild Crops--Changes Requested But Not Made

    AMS received one comment from a certified operation regarding the 
testing of wild crops. The commenter requested an exemption from the 
requirement for periodic residue testing for wild crops on the basis 
that EPA tolerances are not established for most herbs in commerce. The 
commenter suggests that the absence of established tolerances places 
wild crops at disproportionate risk of enforcement actions as a result 
of the detection of trace amounts of unavoidable contamination (e.g., 
drift) of unknown origin. AMS disagrees. One of the purposes of 
periodic residue testing is to provide a means for monitoring 
compliance with the NOP by discouraging the mislabeling of agricultural 
products. AMS has determined that all crops should be included within 
the scope of periodic residue testing to serve as a deterrent for 
mislabeling (e.g., to deter substitution of conventionally produced 
herbs for organic wild-crop harvested herbs).
    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.

International Trade

    AMS received one comment from an organic industry group in Canada 
which opposed the proposed rule. The commenter stated that the United 
States and Canada are currently signatories to an equivalency 
determination for organic products, and that the imposition of a costly 
measure on the United States' side, without a corresponding rule in 
Canada, could lead the identification of this regulatory change as a 
critical variance which would impede trade. Residue testing is required 
under the European Union's (EU) organic standards and, in 2011, Canada 
and the EU signed an organic equivalency determination that does not 
include any critical variances related to residue testing. In addition, 
certifying agents accredited under the NOP must already conduct 
sampling and laboratory testing in instances where contamination is 
suspected under sections 205.403(c)(3) and 205.670(b). AMS does not 
anticipate that this requirement for periodic residue testing will 
impact the United States' equivalency determination with Canada.

Costs and Cost Estimates--Changes Requested But Not Made

    AMS received eighteen comments regarding estimates of the costs of 
testing. In the proposed rule, AMS had estimated the cost at $500 per 
sample, and estimated that the costs may represent approximately 1% of 
a certifying agent's operating budget.
    Several commenters stated their belief that residue testing at the 
certifying agent's own expense was a disincentive to residue testing, 
and that the OFPA did not directly address who must pay for testing. A 
comment from a certifying agent who certifies operations to the organic 
standards of the EU, the Japanese Agricultural Standard (JAS), and the 
NOP, indicated that the regulations of the EU and JAS do not oblige the 
certifying agent to pay for pesticide analyses; instead, the cost is 
directly passed on to the operator. The commenter suggested that the 
NOP adopt this same approach and indicated that it encourages 
certifying agents to take the amount of samples which is necessary, and 
not just what is required by the regulations. Another commenter 
expressed support for this model. Section 205.670(b) currently provides 
that preharvest and postharvest testing is conducted at a certifying 
agent's expense. Similar to that provision, it is reasonable that 
periodic residue testing also be conducted at the certifying agent's 
expense, and therefore no changes are made to the final rule based on 
these comments.
    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 comment from a laboratory indicated that AMS' estimated $500 
cost for analysis was high by a factor of two or more, and that it may 
be able to perform this analysis for certifying agents at $250 per 
sample or less. The commenter's estimate appears to be limited to the 
direct laboratory costs of residue analysis, and does not include the 
additional related costs that AMS has included in the estimated costs 
per sample.
    Several commenters indicated that the costs may disproportionally 
affect smaller certifying agents, since they would not be able to 
receive quantity discounts. Some laboratories may offer discounts to 
its higher-volume clients, including certifying agents. However, AMS 
also notes that lowering the percentage below five percent does not 
have an impact on the smallest quartile of certifying agents that 
certify fewer than thirty operations per year, since they are required 
to sample a minimum of one operation annually.
    One commenter suggested an alternative funding mechanism, such as 
having pesticide manufacturers and producers of genetically modified 
seed

[[Page 67244]]

pay for the costs of testing. AMS does not have the statutory authority 
to institute this type of third-party funding model.

Purpose of Testing--Changes Requested But Not Made

    AMS received several comments requesting clarification on the 
purpose of residue testing.
    AMS is publishing this final rule to implement the requirements of 
the OFPA for periodic residue testing by certifying agents. Residue 
testing plays an important role in organic certification by providing a 
means for monitoring compliance with the NOP regulations and by 
discouraging the mislabeling of agricultural products.
    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.
    The NOP also notes that this final rule does not amend the existing 
requirement that results of all analyses and tests performed under 
section 205.670 be made available for public access, unless the testing 
is part of an ongoing compliance investigation. The public may access 
sampling results obtained by certifying agents under the existing 
regulations.

Types of Residues--Changes Requested But Not Made

    AMS received four comments regarding types of residues that would 
be considered acceptable targets for testing under the rule.
    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 https://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 NOP does not intend for certifying agents to test every sample 
for all residues on the list of target pesticides. Instead, the list is 
provided as a reference for a number of pesticides which are prohibited 
under the NOP regulations, and that may be detected by a laboratory 
that conducts multi-residue analysis of agricultural products.
    AMS received one comment that indicated that this list would serve 
as a ``cheat sheet'' for operations seeking to willfully violate the 
NOP regulations. AMS disagrees. The document provides a list of 
pesticide residues most commonly found on conventional commodities, 
based on data obtained from the AMS Pesticide Data Program. This list 
is intended to instruct certifying agents and laboratories on which 
residues would be the most useful targets for multi-residue analysis of 
agricultural products. The regulations and guidance documents do not 
prohibit a certifying agent from testing for other residues if the 
presence of a specific pesticide is suspected.
    Four commenters requested clarification on testing for genetically 
modified organisms (GMOs). AMS does not intend for the testing 
conducted under section 205.670 to be limited to pesticides residues. 
Under the existing provisions at section 205.670, certifying agents 
have the flexibility to test for a range of prohibited materials and 
excluded methods, including, but not limited to, pesticides, hormones, 
antibiotics, and GMOs. AMS notes that, under section 205.671, 
thresholds for unavoidable residual environmental contamination are 
established only for pesticides residues.

Testing Methodology

    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 \5\ 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 
https://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.
---------------------------------------------------------------------------

    \5\ https://www.aoac.org/.
---------------------------------------------------------------------------

    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 https://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.

Information Collection Burden

    The proposed rule requested comments on the information collection 
and recordkeeping requirements required by the proposed amendments to 
section 205.670. Comments were specifically invited on (1) whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information will have practical utility; (2) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    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

[[Page 67245]]

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.
    Two comments indicated that submission of report copies, or 
laboratory summaries of test results, should be sufficient to 
demonstrate compliance with the requirement. In order to reduce the 
information collection burden on certifying agents, AMS has removed the 
requirement that test results be reported to the Administrator. AMS has 
retained the requirement that test results that indicate a specific 
agricultural product contains pesticide residues or environmental 
contaminants that exceed the Food and Drug Administration's or the 
Environmental Protection Agency's regulatory tolerances be reported to 
the appropriate health agency.
    AMS intends to verify compliance of certifying agents with the 
requirements for periodic residue testing as part of the existing 
accreditation process, rather than by requiring submission of residue 
testing results. Accreditation requirements at section 205.504(b)(6) 
require certifying agents to have administrative policies and 
procedures, including procedures to be used for sampling and residue 
testing pursuant to Sec.  205.670. Certifying agents are also required 
to submit an annual report to the Administrator on or before the 
anniversary date of the issuance of notification of accreditation which 
includes a complete and accurate update of information submitted 
pursuant to Sec. Sec.  205.503 and 205.504. In order to verify that 
certifying agents are implementing this rule in advance of regularly 
scheduled on-site audit of certifying agents, AMS intends to require, 
as authorized under section 205.510(a)(3), certifying agents to submit 
in their next annual report a description of the measures implemented 
in the previous year and any measures to be implemented in the coming 
years to meet the requirements in this rule for periodic residue 
testing.
    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.
    One comment suggested that existing testing programs, such as the 
AMS Pesticide Data Program, should be used to the extent possible. The 
commenter also suggested that AMS should partner with the FDA and 
various State agencies that currently conduct residue testing programs. 
AMS notes that testing conducted by other third-parties does not 
eliminate the requirement under OFPA for residue testing by certifying 
agents. AMS believes that requiring certifying agents to conduct 
residue testing from a minimum of five percent of the operations they 
certify is a reasonable number which ensures that all certifying 
agents, regardless of the number of operations they certify, are 
responsible for some level of regular testing at reasonable cost.
    One comment indicated that certifying agents would prefer to submit 
test results on a quarterly basis. In this final rule, AMS has removed 
the requirement for reporting results of residue testing, with the 
exception of results that exceed certain federal regulatory 
requirements established by EPA or FDA. AMS notes that certifying 
agents should maintain the complete results of laboratory analyses for 
residues of pesticides and other prohibited substances conducted during 
the current and three preceding calendar years, as required by section 
205.504(b)(5)(iii).

Comments on Instruction Documents

    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.

III. Related Documents

    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.\6\
---------------------------------------------------------------------------

    \6\ U.S. Department of Agriculture, Office of Inspector General, 
Audit Report 01601-03-Hy, March 2010. Available at https://www.usda.gov/oig/webdocs/01601-03-HY.pdf.
---------------------------------------------------------------------------

    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 https://www.ams.usda.gov/nop.
    The three instruction documents are meant to inform certifying 
agents about best practices for conducting residue testing of 
organically produced agricultural products. NOP 2610, Sampling 
Procedures for Residue Testing, contains recommended procedures for 
product sampling, including documentation, recommended sample sizes, 
shipping conditions to the laboratory, and chain of custody 
requirements. NOP 2611, Laboratory Selection Criteria for Pesticide 
Residue Testing, contains instructions for certifying agents in 
selecting a qualified laboratory for pesticide residue testing, 
including accreditation, quality assurance, proficiency testing, and 
reporting guidelines. NOP 2611-1, Prohibited Pesticides for NOP Residue 
Testing, is a list of pesticide residues that certifying agents can 
provide to laboratories which conduct pesticide residue testing of 
agricultural products. The three instruction documents were effective 
immediately upon their issuance and publication on February 2, 2011.
    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.

IV. Statutory and Regulatory Authority

    OFPA authorizes AMS to administer the NOP. Under the NOP, AMS 
oversees national standards for the production

[[Page 67246]]

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.\7\ This information is available 
on the NOP Web site at https://www.ams.usda.gov/nop.
---------------------------------------------------------------------------

    \7\ NOP Policy Memo 11-6, Reporting Health & Safety Violations, 
revised October 31, 2011. Available at https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088951.
---------------------------------------------------------------------------

    Section 6511 of the OFPA requires the Secretary, the applicable 
governing State official, and the certifying agent to utilize a system 
of residue testing to test products sold or labeled as organically 
produced.
    Section 6511 of the OFPA also allows the Secretary, the applicable 
governing State official, or the certifying agent to require preharvest 
tissue testing of any crop grown on soil suspected of harboring 
contaminants.

A. Executive Order 12866 and Executive Order 13563

    Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This action has been determined not significant for 
purposes of Executive Order 12866, and therefore, has not been reviewed 
by the Office of Management and Budget.
Need for the Rule
    NOP is authorized to implement regulations that require accredited 
certifying agents to conduct residue testing of organically produced 
agricultural products (7 U.S.C. 6511). In addition, section 6506 of 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. This final rule ensures that all 
certifying agents conduct a minimal level of residue testing.
    Residue testing plays an important role in organic certification by 
providing a means for monitoring compliance with the NOP and by 
discouraging the mislabeling of agricultural products. Testing of 
organically produced agricultural products is promulgated in section 
205.670 of the NOP regulations. This section provides that the 
Secretary, State organic programs, and certifying agents may require 
preharvest or postharvest testing of any agricultural input used or 
agricultural product to be sold, labeled, or represented as ``100 
percent organic,'' ``organic,'' or ``made with organic (specified 
ingredients or food group(s))'' when there is reason to believe that 
the agricultural input or product has come into contact with a 
prohibited substance or has been produced using excluded methods.
    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.\8\ 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.
---------------------------------------------------------------------------

    \8\ U.S. Department of Agriculture, Office of Inspector General, 
Audit Report 01601-03-Hy, March 2010. Available at https://www.usda.gov/oig/webdocs/01601-03-HY.pdf.
---------------------------------------------------------------------------

    AMS conducted a review of this issue in response to the OIG audit. 
AMS concluded that, under 7 U.S.C. 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.
Regulatory Objective
    The primary objective of this rule is to align the NOP regulations 
with the requirement for residue testing of organic products under 
OFPA. This final rule ensures that all certifying agents conduct a 
minimum level of residue testing.
Alternatives Considered
    Alternatives to this final rule that were considered include (1) 
maintaining the status quo; (2) distinguishing periodic residue testing 
from risk-based testing for purposes of calculating the percentage of 
operations to be tested annually; (3) requiring testing at an alternate 
level of 25% of the operations certified by a certifying agent; and (4) 
testing all certified operations annually.
    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.\9\ 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.
---------------------------------------------------------------------------

    \9\ U.S. Department of Agriculture, Office of Inspector General, 
Audit Report 01601-03-Hy, March 2010. Available at https://www.usda.gov/oig/webdocs/01601-03-HY.pdf.
---------------------------------------------------------------------------

    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

[[Page 67247]]

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.
    The third alternative of requiring certifying agents to test 25% of 
the operations they certify annually was also considered. This target 
is based a statistically based sample size based upon the rate of 
detection of residues in organic products sampled through the AMS 
Pesticide Data Program (PDP). The costs associated with this 
alternative and that would be imposed on certifying agents are 
estimated at $3.70 million annually, based on an estimated $492 in 
costs to the certifying agent per operation tested across 7,530 
certified operations (25% of 30,118). The costs associated with testing 
25% of operations are significantly higher than the costs of sampling 
5% of operations under the final rule. AMS determined that using a 
statistically based sample size is not necessary to achieve the 
regulatory objective of this action and would impose unnecessary 
additional direct costs to certifying agents.
    The fourth alternative of sampling all operations annually was also 
considered as an alternative to the five percent minimum requirement. 
The costs associated with this alternative are estimated at $14.82 
million annually, based on an estimated $492 in costs per operation for 
30,118 certified operations. The objectives for periodic residue 
testing can be met by sampling a subset of operations annually, and 
therefore, the additional costs that would be required to test all 
operations are unnecessary.
Baseline
    AMS is aware that a minority of accredited certifying agents are 
currently conducting periodic residue testing at or above the minimum 
levels established by this final rule. In 2011, the NOP received 
pesticide residue results from 13 accredited certifying agents. Seven 
of the certifying agents that reported results to the NOP were based in 
the United States and six were based internationally. The NOP also 
understands that there may be additional certifying agents that are 
currently conducting residue testing that do not report results to the 
NOP, or that submit results only when a prohibited residue is detected.
    The number of results reported to the NOP in 2011 represents a 
sampling rate of less than 1% of certified operations. The majority of 
results reported to the NOP in 2011 were received from certifying 
agents which are headquartered outside of the United States, where 
periodic residue testing is a requirement under international organic 
standards (e.g., the EU). AMS received one comment on the proposed rule 
from a certifying agent operating outside of the United States which 
indicates that it currently tests 20-25% of its certified operations.
    AMS received one comment from a certifying agent that indicated 
that it has a history of sampling and testing products for more than 20 
years. This commenter supported the five percent testing requirement as 
outlined in the proposed rule and did not support revising the rule to 
include compliance or investigative testing as part of the five 
percent. AMS also received one comment from a certifying agent that had 
increased their testing program for residues within the last two years 
and requested that the proposed rule be revised to allow sampling from 
sources other than the agricultural product (e.g. samples of soil, 
water, seeds) to be counted towards the minimum testing requirement. 
Under this final rule, sampling from a range of sources as indicated in 
sections 205.670(b) and (c) may be counted towards the minimum testing 
requirement.
Benefits to the Final Rule
    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 
rule ensures consistency of the regulations with OFPA by ensuring that 
all certifying agents are conducting residue testing of organic 
products on a regular reoccurring basis. Residue testing plays an 
important role in organic certification by providing a means for 
monitoring compliance with the NOP and by discouraging the mislabeling 
of agricultural products. This action further ensures the integrity of 
products produced and handled under the NOP regulations.
Costs of the Final Rule
    This final rule increases the amount of residue testing currently 
conducted by most accredited certifying agents. Direct costs to the 
certifying agents include the cost of sample analysis (i.e., laboratory 
costs), sample packaging and shipping costs, and the staff costs 
associated with sample collection by an inspector, review and 
maintenance of sample results, and reporting costs. In addition, some 
certifying agents indicated that the proposed action would also 
increase their training costs for review staff and field inspectors. 
AMS is unable to ascertain how certification fees may shift in response 
to this action because of the diversity of fee structures used by 
certifying agents.
    The total direct cost of this action is estimated to be $741,000 
annually. This estimate is based on a sampling rate of five percent of 
certified operations. There were an estimated 30,118 operations 
certified under the NOP in 2011. The five percent sampling requirement 
would result in sample collection from approximately 1,506 operations 
per year. AMS has estimated the total costs to the certifying agent at 
$492 per sample as detailed in Table 1.
    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.\10\ 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.
---------------------------------------------------------------------------

    \10\ Mean Hourly Wage for Agricultural Inspector, U.S. 
Department of Labor, Bureau of Labor Statistics, Occupational 
Employment and Wages, May 2010. https://bls.gov/oes/current/oes452011.htm.
---------------------------------------------------------------------------

    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

[[Page 67248]]

Bureau of Labor Statistics.\11\ 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.
---------------------------------------------------------------------------

    \11\ U.S. Department of Labor, Bureau of Labor Statistics, 
Occupational Employment and Wages, May 2009. https://www.bls.gov/oes/2009/may/oes132011.htm.
---------------------------------------------------------------------------

    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 Sec.  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
------------------------------------------------------------------------
                                 Estimated cost
              Item                 per sample       Basis for estimate
------------------------------------------------------------------------
Sample collection (inspector             $20.36  1 hour @ $20.36 per
 time).                                           hour.
Sample shipping boxes and                 40.00  AMS Pesticide Data
 supplies.                                        Program.
Shipping costs.................           25.00  Estimate for in-state
                                                  shipping of 5 pound
                                                  sample.
Laboratory costs for multi-              390.00  AMS Pesticide Data
 residue analysis.                                Program.
Review of Sample Results--Labor           16.21  0.5 hour @ $32.42 per
 Costs.                                           hour.
                                ----------------------------------------
    Total costs per sample.....          491.57
------------------------------------------------------------------------

B. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
in order to avoid unduly burdening the court system. This final rule is 
not intended to have a retroactive effect.
    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.

C. Executive Order 13175

    This final rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

D. Regulatory Flexibility Act

    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

[[Page 67249]]

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.
    Small agricultural service firms, which include producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    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.\12\ ERS, based upon the list of certified operations maintained 
by the NOP, estimated the number of certified handling operations was 
3,225 in 2007.\13\ 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: https://www.ams.usda.gov/nop. AMS 
believes that most of these entities would be considered small entities 
under the criteria established by the SBA.
---------------------------------------------------------------------------

    \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. https://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. https://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
---------------------------------------------------------------------------

    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.\14\ 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.
---------------------------------------------------------------------------

    \14\ As reported by certifying agents during the 2010 
certification year and available at https://apps.ams.usda.gov/nop/.
---------------------------------------------------------------------------

    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.
    Alternatives to this final rule that were considered include (1) 
maintaining the status quo; (2) distinguishing periodic residue testing 
from risk-based testing for purposes of calculating the percentage of 
operations to be tested annually; (3) requiring testing at an alternate 
level of 25% of the operations certified by a certifying agent; and (4) 
testing all certified operations 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.
    The U.S. sales of organic food and beverages have grown from $3.6 
billion in 1997 to nearly $21.1 billion in 2008.\15\ 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%.\16\
---------------------------------------------------------------------------

    \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, https://www.ers.usda.gov/Publications/EIB58.
    \16\ Organic Trade Association's 2011 Organic Industry Survey, 
https://www.ota.com.
---------------------------------------------------------------------------

    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. Sec.  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

[[Page 67250]]

U.S.C. Sec.  6506). This final rule ensures that all certifying agents 
conduct a minimal level of residue testing.
    Residue testing plays an important role in organic certification by 
providing a means for monitoring compliance with the NOP and by 
discouraging the mislabeling of agricultural products. Testing of 
organically produced agricultural products is promulgated in section 
205.670 of the NOP regulations. This section provides that the 
Secretary, State organic programs, and certifying agents may require 
preharvest or postharvest testing of any agricultural input used or 
agricultural product to be sold, labeled, or represented as ``100 
percent organic,'' ``organic,'' or ``made with organic (specified 
ingredients or food group(s))'' when there is reason to believe that 
the agricultural input or product has come into contact with a 
prohibited substance or has been produced using excluded methods.
    However, AMS has concluded that, under 7 U.S.C. Sec.  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: https://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.

E. Paperwork Reduction Act

    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 is committed to complying with the E-Government Act to promote 
the use of the Internet and other information technologies to provide 
increased opportunities for citizen access to Government information 
and services, and for other purposes.

F. Civil Rights Impact Analysis

    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

[[Page 67251]]

``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.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Animals, 
Archives and records, Imports, Labeling, Organically produced products, 
Plants, Reporting and recordkeeping requirements, Seals and insignia, 
Soil conservation.

    For the reasons set forth in the preamble, 7 CFR part 205 is 
amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

    Authority: 7 U.S.C. 6501-6522.


0
2. Section 205.670 is revised to read as follows:


Sec.  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)).''

    (a) All 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))'' must be made 
accessible by certified organic production or handling operations for 
examination by the Administrator, the applicable State organic 
program's governing State official, or the certifying agent.
    (b) The Administrator, applicable State organic program's governing 
State official, or the certifying agent may require preharvest or 
postharvest testing of any agricultural input used or agricultural 
product to be sold, labeled, or represented as ``100 percent organic,'' 
``organic,'' or ``made with organic (specified ingredients or food 
group(s))'' when there is reason to believe that the agricultural input 
or product has come into contact with a prohibited substance or has 
been produced using excluded methods. Samples may include the 
collection and testing of soil; water; waste; seeds; plant tissue; and 
plant, animal, and processed products samples. Such tests must be 
conducted by the applicable State organic program's governing State 
official or the certifying agent at the official's or certifying 
agent's own expense.
    (c) A certifying agent must conduct periodic residue testing of 
agricultural products to be sold, labeled, or represented as ``100 
percent organic,'' ``organic,'' or ``made with organic (specified 
ingredients or food group(s)).'' Samples may include the collection and 
testing of soil; water; waste; seeds; plant tissue; and plant, animal, 
and processed products samples. Such tests must be conducted by the 
certifying agent at the certifying agent's own expense.
    (d) A certifying agent must, on an annual basis, sample and test 
from a minimum of five percent of the operations it certifies, rounded 
to the nearest whole number. A certifying agent that certifies fewer 
than thirty operations on an annual basis must sample and test from at 
least one operation annually. Tests conducted under paragraphs (b) and 
(c) of this section will apply to the minimum percentage of operations.
    (e) Sample collection pursuant to paragraphs (b) and (c) of this 
section must be performed by an inspector representing the 
Administrator, applicable State organic program's governing State 
official, or certifying agent. Sample integrity must be maintained 
throughout the chain of custody, and residue testing must be performed 
in an accredited laboratory. 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.
    (f) Results of all analyses and tests performed under this section 
will be available for public access, unless the testing is part of an 
ongoing compliance investigation.
    (g) If test results indicate a specific agricultural product 
contains pesticide residues or environmental contaminants that exceed 
the Food and Drug Administration's or the Environmental Protection 
Agency's regulatory tolerances, the certifying agent must promptly 
report such data to the Federal health agency 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.

    Dated: November 5, 2012.
David R. Shipman,
Administrator, Agricultural Marketing Service.
[FR Doc. 2012-27378 Filed 11-8-12; 8:45 am]
BILLING CODE 3410-02-P