[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Rules and Regulations]
[Pages 67239-67251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27378]
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Rules and Regulations
Federal Register
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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.
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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.
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\1\ U.S. Department of Agriculture, Office of Inspector General,
Audit Report 01601-03-Hy, March 2010. Available at http://www.usda.gov/oig/webdocs/01601-03-HY.pdf.
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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\
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\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.
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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.
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\3\ National Organic Standards Board, Final Recommendations,
Residue Testing, 1994. Available on the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=stelprdc5058863.
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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.
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\4\ NOP Policy Memo 11-6, Reporting Health & Safety Violations,
revised October 31, 2011. Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088951.
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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 http://www.ams.usda.gov/nop and is discussed below under
Related Documents. AMS has not included a specific list of pesticide
residues that could be tested for in the regulations. This is intended
to allow flexibility in revising the list of target pesticide residues
as new pesticides enter the market. In addition, this flexibility
allows the NOP to respond more quickly to observed trends in detection
of residues on specific commodities.
The 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
http://www.ams.usda.gov/nop. AMS anticipates that these instructions
will change over time in response to advances in testing methodology,
analytical instrumentation, and residue detection techniques.
---------------------------------------------------------------------------
\5\ http://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 http://www.ams.usda.gov/nop. No comments requested the incorporation
of ISO 17025 accreditation into the regulatory text. The comments are
under consideration for future revision of the instruction documents
and are not impacted by this rulemaking action.
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 http://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 http://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 [email protected] 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 http://www.ams.usda.gov/nop.
---------------------------------------------------------------------------
\7\ NOP Policy Memo 11-6, Reporting Health & Safety Violations,
revised October 31, 2011. Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088951.
---------------------------------------------------------------------------
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 http://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 http://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. http://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. http://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: http://www.ams.usda.gov/nop. AMS
believes that most of these entities would be considered small entities
under the criteria established by the SBA.
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\12\ U.S. Department of Agriculture, Economic Research Service.
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
\13\ U.S. Department of Agriculture, Economic Research Service,
2009. Data Sets: Procurement and Contracting by Organic Handlers:
Documentation. http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
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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.
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\14\ As reported by certifying agents during the 2010
certification year and available at http://apps.ams.usda.gov/nop/.
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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\
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\15\ Dimitri, C.; Oberholtzer, L. 2009. Marketing U.S. Organic
Foods: Recent Trends from Farms to Consumers, Economic Information
Bulletin No. 58, U.S. Department of Agriculture, Economic Research
Service, http://www.ers.usda.gov/Publications/EIB58.
\16\ Organic Trade Association's 2011 Organic Industry Survey,
http://www.ota.com.
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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: http://www.ams.usda.gov/nop. AMS
believes that most accredited certifying agents would be considered
small entities under the criteria established by the SBA. Approximately
30,118 operations worldwide were certified to the NOP standard in 2011;
certified operations may be indirectly impacted by this action as
additional operations will be subject to residue testing by certifying
agents.
For certifying agents who are not currently conducting residue
testing at the minimum levels specified in the final rule, this action
will increase costs. AMS has estimated costs at $492 per sample. At an
estimated cost of $492 per sample and a sampling rate of 5% of
certified operations, certifying agents would need to budget an
estimated $25 per certified operation for testing costs. The total
costs of residue testing are estimated at approximately $492 to $51,106
per certifying agent per year based on the average cost of $492 per
sample and the range in the number of operations certified by different
certifying agents. Additional costs may be required to follow up on
results if prohibited substances are detected. The portion of the total
estimated costs would be considered new or additional costs as a result
of this action is not known, as a minority of certifying agents are
already conducting residue testing of organic products and have
budgeted for these costs under their existing fee structures. If these
costs have not been previously budgeted for by the certifying agent, it
will need to account for these costs as part of their cost of business.
To reduce additional inspector costs associated with sample
collection, AMS has not specified which operations must be sampled
annually or when the samples must be collected. This is intended to
provide flexibility to the certifying agent implement a schedule for
sample collection in the most efficient manner.
The final rule will increase costs for certifying agents who are
not currently performing residue testing at the minimal levels
specified in this rule. Some certifying agents may increase their
certification fees for its clients to pay for additional costs
associated with residue testing. At an estimated cost of $492 per
sample and a sampling rate of 5% of certified operations, certifying
agents would need to budget approximately $25 per operation for testing
costs.
This final rule clarifies a provision of OFPA and the regulations
issued thereunder that requires periodic residue testing of organically
produced agricultural products by accredited certifying agents. The
final rule expands the amount of residue testing of organically
produced agricultural products by clarifying that sampling and testing
are required on a regular basis. The final rule requires that
certifying agents, on an annual basis, sample and conduct residue
testing from a minimum of five percent of the operations that they
certify.
AMS believes that the benefits of residue testing in protecting
organic integrity and ensuring compliance with the regulations outweigh
the estimated costs.
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