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[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Proposed Rules]
[Pages 23914-23920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10415]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / 
Proposed Rules

[[Page 23914]]

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

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

National Organic Program; Periodic Residue Testing

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would clarify a provision of the Organic 
Foods Production Act of 1990 and the regulations issued thereunder that 
require periodic residue testing of organically produced agricultural 
products by accredited certifying agents. The proposed rule would amend 
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 
proposed rule would expand the amount of residue testing of organically 
produced agricultural products by clarifying that sampling and testing 
are required on a regular basis. The proposed rule would require 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 would help further ensure the integrity of 
products produced and handled under the NOP regulations.

DATES: Comments must be received by June 28, 2011. Pursuant to the 
Paperwork Reduction Act, comments on the information collection burden 
that would result from this action must be received by June 28, 2011.

ADDRESSES: Interested parties may submit written comments on this 
proposed rule using one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Lisa M. Brines, Agricultural Marketing Specialist, 
National Organic Program, USDA-AMS-NOP, Room 2646-So., Ag Stop 0268, 
1400 Independence Ave., SW., Washington, DC 20250-0268.
    Instructions: All submissions received must include the docket 
number AMS-NOP-10-0102; NOP-10-10, and/or Regulatory Information Number 
(RIN) 0581-AD11 for this rulemaking. You should identify the topic and 
section number of this proposed rule to which your comment refers. You 
should clearly indicate whether or not you support the action being 
proposed for any or all of the items in this proposed rule. You should 
clearly indicate the reason(s) for your position. You should also offer 
any recommended language changes that would be appropriate for your 
position. Please include relevant information and data to support your 
position (e.g. scientific, environmental, manufacturing, industry 
impact information, etc.). All comments received will be posted without 
change to http://www.regulations.gov.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov. Comments submitted 
in response to this proposed rule will also be available for viewing in 
person at USDA-AMS, National Organic Program, Room 2646--South 
Building, 1400 Independence Ave., SW., Washington, DC, from 9 a.m. to 
12 noon and from 1 p.m. to 4 p.m., Monday through Friday (except 
official Federal holidays). Persons wanting to visit the USDA South 
Building to view comments received in response to this proposed rule 
are requested to make an appointment in advance by calling (202) 720-
3252.
    Pursuant to the Paperwork Reduction Act, interested persons may 
comment on the information collection and recordkeeping requirements 
required by this proposed rule using one of the following methods:
     Mail: Comments should be sent to above address and to the 
Desk Officer for Agriculture, Office of Information and Regulatory 
Affairs, Office of Management and Budget, New Executive Office 
Building, 725 17th Street, NW., Room 725, Washington, DC 20503.
     Written comments should be identified with the docket 
number AMS-NOP-10-0102; NOP-10-10 and should reference the date and 
page number of this issue of the Federal Register and indicate that the 
comment is regarding the information collection and recordkeeping 
requirements.
     Comments are specifically invited on: (1) The accuracy of 
the Agency's burden estimate of the proposed collection of information; 
(2) ways to minimize the burden of the collection of information on 
those affected; (3) whether the proposed collection of information is 
sufficient or necessary to demonstrate compliance with the requirement 
that certifying agents report all analyses and tests performed to the 
Administrator, applicable State organic program's governing State 
official, and to health agencies in accordance with the proposed 
amendments to Sec.  205.670; and (4) ways to enhance the quality, 
utility, and clarity of the information to be collected.
    All comments on the information collection and recordkeeping 
requirements required by the proposed amendments to Sec.  205.670 will 
become a matter of public record and will be available for public 
viewing at the above referenced location.

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

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Organic Foods Production Act (OFPA) of 1990 (7 U.S.C. 
6511), the National Organic Program (NOP) is authorized to implement 
regulations that require accredited certifying agents to conduct 
residue testing of organically produced agricultural products. The OFPA 
(7 U.S.C. 6506) 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

[[Page 23915]]

Sec.  205.670(b) of the NOP regulations. This section provides that the 
Secretary, State organic programs, and certifying agents may require 
pre-harvest or post-harvest 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 proposed rule would clarify the requirement for residue testing 
under the NOP by requiring residue testing by certifying agents on a 
regularly occurring basis, in addition to residue testing when there is 
reason to suspect contamination with a prohibited substance.
    The Agricultural Marketing Service (AMS) is issuing this proposed 
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 periodic residue testing 
to be required by the regulations only under certain circumstances.
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    \1\ Audit Report 01601-03-Hy, March 2010.
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    In response, the AMS conducted a legal review of this issue. The 
AMS has concluded that, under 7 U.S.C. 6506 of the OFPA, accredited 
certifying agents are required to conduct residue testing of organic 
products on a regular and random basis, as well as when there is reason 
to believe contamination has occurred.
    Accordingly, the AMS has issued this proposed rule, which would 
amend Sec.  205.670 of the NOP regulations to clarify that certifying 
agents conduct periodic 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 
OFPA requires periodic residue testing by certifying agents of organic 
products to determine if the products contain any pesticide, other 
nonorganic residue, or natural toxicants (7 U.S.C. 6506). This action 
will clarify the amount and frequency of testing and will ensure 
consistency across all certifying agents in their inspection and 
testing of agricultural products certified to the NOP regulations. The 
proposed rule specifies that certifying agents would be required, on an 
annual basis, to randomly sample and test agricultural products from a 
minimum of five percent of the operations they certify.
    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 agencies 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 proposed rule.
    While the proposed action would expand the amount of testing of 
organically produced agricultural products to include a requirement 
that is regular and random in scope, certifying agents are already 
required, under Sec.  205.504(b)(6), to have procedures in place for 
sampling and residue testing pursuant to Sec.  205.670. Certifying 
agents should already be conducting sampling and laboratory testing in 
instances where contamination is suspected under Sec.  205.403(c)(3) 
and Sec.  205.670(b).

II. Overview of Proposed Amendments

Requirement for Periodic Residue Testing

    This proposed rule would amend Sec.  205.670 of the NOP regulations 
to require accredited certifying agents to conduct random, periodic 
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 proposed rule would amend the title of Sec.  205.670 to reflect 
the scope of products currently listed under Sec.  205.670(a) and (b). 
The amended title would read as follows: Sec.  205.670 Inspection and 
testing of agricultural product to be sold, labeled, or represented as 
``100 percent organic,'' ``organic,'' or ``made with organic (specified 
ingredients or food group(s)).''

Number of Samples

    The proposed rule would require that all certifying agents conduct 
a minimum level of periodic residue testing. Under the proposed rule, 
the minimum number of operations to be sampled for periodic residue 
testing would be at least five percent of the operations that the 
certifying agency certifies on an annual basis, rounded to the nearest 
whole number. Certifying agents that certify fewer than 30 operations 
on an annual basis would be required to sample from at least one 
operation annually. For example, a certifying agency that certifies 29 
operations would be required to sample a minimum of 1 operation 
annually (i.e., 0.05 x 29 = 1.45, which rounds to 1 operation). A 
certifying agency that certifies 30 operations would be required to 
sample a minimum of 2 operations annually (i.e., 0.05 x 30 = 1.50, 
which rounds to 2 operations). The minimum number of samples required 
would be calculated based on the overall number of certified 
operations. Certifying agents may collect more than one sample per 
operation for residue testing; however, a minimum of five percent of 
all its certified operations must be sampled annually, regardless of 
the number of samples collected per operation.
    The proposed five percent minimum for periodic residue testing 
would be in addition to any testing that certifying agents conduct when 
there is reason to believe that the agricultural product has come into 
contact with a prohibited substance. Testing of products when there is 
reason to believe a violation has occurred, e.g. complaint-driven 
testing, would not be considered to be random, periodic testing, and 
must continue to be conducted in addition to the proposed five percent 
requirement for periodic residue testing.
    The NOP understands that a minority of accredited certifying agents 
currently conduct residue testing on a regular, periodic basis. Any 
additional costs for residue testing under this proposed rule will need 
to be provided by the applicable certifying agent and are considered a 
cost of doing business. The additional costs of residue testing will be 
borne by the applicable certifying agent, as previously discussed in 
the preamble to the December 21, 2000 final rule (65 FR 80548).

Testing Methodology

    The proposed rule maintains the current requirement under Sec.  
205.670(c) that chemical analysis must be made in accordance with the 
methods described in the most current edition of the Official Methods 
of Analysis of the AOAC International or other current applicable 
validated methodology for determining the presence of contaminants in 
agricultural products. On February 2, 2011, the NOP provided 
instructions on laboratory selection criteria for pesticide residue 
testing to certifying agents. These instructions are

[[Page 23916]]

further described below under Related Documents and are available on 
the NOP Web site at http://www.ams.usda.gov/nop. The AMS anticipates 
that these instructions will change over time in response to advances 
in testing methodology, analytical instrumentation, and residue 
detection techniques.

Analytes for Pesticide Residue Testing

    On February 2, 2011, the NOP published a list of target pesticides 
that are suggested for certifying agents that conduct pesticide residue 
testing of organically produced agricultural products. This list is 
available at the NOP Web site at http://www.ams.usda.gov/nop and is 
discussed below under Related Documents. The AMS does not intend to 
amend the NOP regulations to include a specific list of pesticide 
residues to allow flexibility in revising the list of target pesticide 
residues as new pesticides enter the market. In addition, this 
flexibility will allow the NOP to respond more quickly to observed 
trends in detection of residues on specific commodities.

Reporting Requirements

    The proposed rule would maintain the current reporting requirements 
for submitting results of all analyses and tests performed under Sec.  
205.670. Certifying agents would continue to be required to submit 
results promptly to the Administrator; except, that, where a State 
organic program exists, all results shall be provided to the State 
organic program's governing State official. Required reporting would 
include copies of original laboratory results, including analyses where 
residues are not detected or are not in violation of the NOP standards. 
Submission of copies of original test results, rather than requiring 
that results be provided in a specific format, is intended to minimize 
the reporting burden on certifying agents.
    The proposed rule would amend Sec.  205.670 to clarify 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 or 
Environmental Protection Agency's regulatory tolerances. Under the OFPA 
(7 U.S.C. 6506), certifying agents, to the extent that they are aware 
of a violation of applicable laws relating to food safety, are required 
to report such violation to the appropriate health agencies. This is 
promulgated in Sec.  205.670(e) of the NOP regulations, which requires 
reporting to the Federal health agency whose regulatory tolerance or 
action level has been exceeded. The NOP has previously provided 
additional information on reporting health and safety violations to 
stakeholders and interested parties and is available on the NOP Web 
site at http://www.ams.usda.gov/nop. \2\ The proposed rule would amend 
Sec.  205.670(e) to clarify that these results must also be reported to 
the appropriate State health agency or foreign equivalent. This change 
is proposed to acknowledge the role of State agencies, or their foreign 
equivalents, in responding to residues in violation of food safety 
requirements.
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    \2\ NOP Policy Memo 11-6.
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    The proposed rule would not change the requirement that certifying 
agents provide copies of test results, including results when residues 
are not detected, to certified operations in accordance with Sec.  
205.403(e)(2).
    In addition to the reporting requirements outlined in the proposed 
rule, the NOP plans to publish a guidance document that will outline 
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. This document will be published in the NOP Program 
Handbook, as described under Related Documents. Under Sec.  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 proposed rule would not change this 
requirement. The guidance document will provide information to 
certifying agents on how to respond to results that indicate residues 
of prohibited substances and report results to the Administrator, or 
State organic program, under Sec. Sec.  205.670 and 205.671.

Technical Correction

    The proposed rule would amend Sec.  205.670(e) by changing 
``tolerences'' to ``tolerances'' to correct the spelling of this term.

III. Related Documents

    Documents related to this proposed rule include the Organic Foods 
Production Act (OFPA), as amended (7 U.S.C. 6501 et seq.) and its 
implementing regulations (7 CFR part 205). The March 2010 USDA Office 
of Inspector General audit report of the National Organic Program is 
available as Audit Report 01601-03-Hy.
    The NOP has also published three instruction documents related to 
residue testing as part of the NOP Program Handbook: (1) Sampling 
Procedures for Residue Testing (NOP 2610), (2) Laboratory Selection 
Criteria for Pesticide Residue Testing (NOP 2611), and (3) NOP Target 
Pesticide List (NOP 2611-1). The goal of the NOP Program 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 
Program 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, NOP Target Pesticide List, is a list 
of pesticide residues that certifying agencies 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.
    Members of the public who wish to request that the agency issue, 
reconsider, modify, or rescind a guidance or instruction document, or 
to complain that the agency is not following the procedures in the 
Office of Management and Budget's Bulletin on Good Guidance Practices 
published January 25, 2007 (72 FR 3432), or is improperly treating a 
guidance document as a binding requirement, may do so by sending an 
email to NOP.Guidance@ams.usda.gov or by mailing a letter to Standards 
Division, National Organic Program, U.S. Department of Agriculture, 
Room 2646-So. (Stop 0268), 1400 Independence Ave SW., Washington, DC 
20250-0268.

[[Page 23917]]

IV. Statutory and Regulatory Authority

    The Organic Foods Production Act of 1990 (OFPA), as amended (7 
U.S.C. 6501 et seq.), authorizes the Agricultural Marketing Service 
(AMS) to administer to the NOP. Under the NOP, AMS oversees national 
standards for the production and handling of organically produced 
agricultural products.
    Section 2107(a)(6) of the OFPA (7 U.S.C. 2107) 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 food safety (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.\3\ This information is available on the NOP Web 
site at http://www.ams.usda.gov/nop.
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    \3\ NOP Policy Memo 11-6.
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    Section 2112(a) of the OFPA (7 U.S.C. 6511) 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 2112(b) of the OFPA (7 U.S.C. 6511) 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

    This action has been determined non-significant for purposes of 
Executive Order 12866, and therefore, has not been reviewed by the 
Office of Management and Budget.

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 proposed 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 Sec.  
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
Sec. Sec.  2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507) 
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 Sec.  2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), 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 Sec.  2120(f) of the OFPA (7 U.S.C. 6519(f)), this 
proposed rule would not alter the authority of the Secretary under the 
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry 
Products Inspections Act (21 U.S.C. 451 et seq.), or the Egg Products 
Inspection Act (21 U.S.C. 1031 et seq.), 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 et seq.), nor the authority of the Administrator of the EPA under 
the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et 
seq.).
    Section 2121 of the OFPA (7 U.S.C. 6520) 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. Regulatory Flexibility Analysis (5 U.S.C. et seq.)

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) 
requires agencies to consider the economic impact of each rule on small 
entities and evaluate alternatives that would accomplish the objectives 
of the rule without unduly burdening small entities or erecting 
barriers that would restrict their ability to compete in the market. 
The purpose is to fit regulatory actions to the scale of businesses 
subject to the action. 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 forth in the RFA, the 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). The AMS has also considered the economic impact of this action 
on small entities. The AMS has determined that the impact on entities 
affected by this proposed rule would not be significant.
    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.\4\ ERS, based upon the list of certified operations maintained by 
the NOP, estimated the number of certified handling operations was 
3,225 in 2007.\5\ AMS believes that most of these entities would be 
considered small entities under the criteria established by the SBA.
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    \4\ 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/.
    \5\ 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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    The U.S. sales of organic food and beverages have grown from $3.6 
billion in 1997 to nearly $21.1 billion in 2008.\6\ The organic 
industry is viewed as the fastest growing sector of agriculture, 
representing over 3% of overall food sales in 2009. Between 1990 and 
2008, organic food sales have historically demonstrated a growth rate 
between 15

[[Page 23918]]

to 24 percent each year. In 2009, organic food sales grew 5.1%.\7\
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    \6\ Dimitri, C., and L. Oberholtzer. 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.
    \7\ Organic Trade Association's 2010 Organic Industry Survey, 
http://www.ota.com.
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    The USDA has 94 accredited certifying agents (ACAs) who provide 
certification services to producers and handlers under the NOP. A 
complete list of names and addresses of ACAs may be found on the AMS 
NOP Web site at: http://www.ams.usda.gov/nop. The AMS believes that 
most of those accredited certifying agents would be considered small 
entities under the criteria established by the SBA. Certifying agents 
reported approximately twenty-seven thousand certified operations 
worldwide in 2010.
    The AMS is proposing a minimum testing requirement of five percent 
of certified operations. 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 Sec.  205.670(b) of the current NOP regulations, certifying 
agents are responsible for expenses associated with preharvest and 
postharvest testing; this requirement would also apply to the 
requirements for periodic residue testing in this proposed 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. 3%, 5%, and 10% 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 for 2009) 
would be required to collect a minimum of 105 samples. Smaller 
certifying agents (those certifying fewer than 30 operations) would be 
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.\8\ Over half of all certifying agents 
certified fewer than 200 operations in 2010 and would be required to 
sample 10 or fewer operations annually under this proposal for periodic 
residue testing.
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    \8\ 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 sample 
analysis would range from approximately $500 to $53,000 per certifying 
agent per year based on the average cost of $500 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 AMS is proposing a five percent level in this proposed rule 
because this level is expected to be, in most cases, no more than one 
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 would be consistent with the amount of residue 
sampling already being conducted by some certifying agents.
    The AMS considered two additional alternatives to the 5% 
proportional requirement: (1) A requirement for certifying agents to 
sample 25% of all certified operations (a statistically based sample 
size based upon the rate of detection of residues in organic products 
sampled through the USDA AMS Pesticide Data Program (PDP)), and (2) a 
requirement for certifying agents to sample all 27,000 certified 
operations. The AMS determined that both alternatives are impractical 
due to the costs and the uneven burden that could be placed upon 
smaller certifying agents in either scenario.
    The proposed rule is necessary to clarify a requirement of OFPA 
that certifying agents conduct periodic residue testing of organic 
products. The proposed rule would increase the amount of residue 
testing that certifying agencies must conduct when compared to the 
current regulations. The costs of testing will be borne by the 
applicable certifying agent and is considered a cost of doing business.

D. 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 is being submitted to OMB for approval of 776 hours 
in total burden hours to cover this new collection and recordkeeping 
burden of the amendments proposed to Sec.  205.670 in this proposed 
rule. Upon OMB's approval of this new information collection, the NOP 
intends to merge this collection into currently approved OMB Control 
Number 0581-0191. In accordance with 5 CFR Part 1320, we have included 
below a description of the collection and recordkeeping requirements 
and an estimate of the annual burden on certifying agents who would be 
required to maintain information under this proposed rule. Authority 
for this action is the Organic Foods Production Act of 1990 (7 U.S.C. 
6501 et seq.), as amended.
    Title: National Organic Program; Periodic Residue Testing.
    OMB Control Number: 0581-NEW.
    Expiration Date of Approval: 3 years from OMB date of approval.
    Type of Request: New collection.
    Abstract: The information collection and recordkeeping necessitated 
by amendments to Sec.  205.670 are essential to ensure that certifying 
agents conduct periodic residue testing of agricultural products 
produced or handled as required by OFPA (7 U.S.C. 6506). Based on 
available information, AMS estimates that there are 94 certifying 
agents, both foreign and domestic, who will be subject to the 
amendments at Sec.  205.670. The proposed rule would expand the amount 
of residue testing of organically produced agricultural products by 
clarifying that sampling and testing are required on a regular, random 
basis. As a result of this action and per Sec.  205.670(e)(1), 
certifying agents would be required to report more test results to the 
AMS Administrator or, if applicable, State organic program's governing 
State official. To meet this requirement, certifying agents would need 
to submit a copy of each test result to the Administrator or State 
organic program upon receiving these results from an accredited 
laboratory. Allowing the submission of copies of test results, rather 
than requiring that results are provided in a specific format to the 
Administrator or State organic program, should minimize the reporting 
burden on certifying agents. The frequency of this reporting would be 
dependent upon when, during the course of a year, the certifying agent 
conducts their testing (i.e. certifying agents may choose to complete 
their testing and reporting all in the same month or may choose to 
spread their testing and reporting throughout the year). The expansion 
of testing may also lead, under certain circumstances, to an increase 
in the reporting to a Federal health agency, State health agency, or 
foreign equivalent as required by Sec.  205.670(f) of the proposed 
amendment. The frequency of this reporting would vary with the number 
of times that test results exceed a regulatory tolerance as specified 
at Sec.  205.670(f).
    The PRA also requires AMS to measure the recordkeeping burden. 
While certifying agents are already

[[Page 23919]]

required to maintain records under Sec.  205.510(b) of the NOP 
regulations as part of accreditation, this action would increase the 
volume of records that certifying agents would need to maintain. 
Maintaining copies of laboratory results would be necessary for 
certifying agents to demonstrate compliance with the proposed 
requirement at Sec.  205.670(c). This requirement would specify that 
certifying agents must annually conduct residue testing of agricultural 
products from at least five percent of the operations they certify. 
Certifying agents would also need to document correspondence that 
demonstrates their reporting to a Federal health agency, State health 
agency, or foreign equivalent, for results with residues that exceed 
the regulatory tolerance as specified at Sec.  205.670(f) as proposed.
    This information collection is used by the certifying agent; 
certified operation; authorized representatives of USDA, including AMS 
and NOP staff; applicable State organic program; and Federal health 
agencies, State health agencies, or foreign equivalent. Certifying 
agents and USDA are the primary users of the information.

Information Collection Burden

    Estimate of Burden: Public reporting burden for the collection of 
information per sample analysis submitted to the Administrator or State 
organic program is estimated to be 15 minutes. The estimated reporting 
burden is based upon feedback provided to the NOP by domestic and 
foreign certifying agents. To meet the requirement to annually test for 
residues from at least five percent of the operations they certify, 
certifying agents would, on average, need to conduct and report results 
on fifteen samples on an annual basis. This estimate is based upon AMS 
data that the 94 certifying agents provide certification services to 
approximately 27,000 operations. AMS estimates the annual collection 
cost per certifying agent to be $121.58. This estimate is based on an 
estimated 3.75 labor hours per year (reporting 15 samples per year at 
0.25 hour per sample) at $32.42 per hour for a total salary component 
of $121.58 per year. The hourly rate is estimated based on the mean 
hourly wage for auditors as published by the Bureau of Labor 
Statistics.\9\ 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.
---------------------------------------------------------------------------

    \9\ U.S. Department of Labor, Bureau of Labor Statistics, 
Occupational Employment and Wages, May 2009.
---------------------------------------------------------------------------

    Public reporting burden for information that requires submission to 
a Federal health agency, state agency, or foreign equivalent is 
estimated to be a one hour per response. Certifying agents would need 
to report on results that show residues that exceed regulatory 
tolerances per proposed Sec.  205.670(f). Based upon the USDA AMS 
Pesticide Data Program data from calendar year 2008, results from 
residue testing of conventional commodities showed regulatory 
tolerances exceeded in approximately 4.2% of samples.\10\ While it is 
expected that organic products would have a lower incidence of samples 
with residues that exceed regulatory tolerance, the 4.2% estimate 
provides an upper limit for how often certifying agents might have to 
report residue testing results to Federal health agencies, appropriate 
State health agency, or their foreign equivalent. As a result, each 
certifying agent, on average, would be expected to report less than one 
response to a Federal health agency, State health agency, or foreign 
equivalent. AMS estimates the annual collection cost per certifying 
agent to be $19.45. This estimate is based on an estimated 0.6 labor 
hours per year (reporting fewer than one result per year, on average, 
at one hour per submission) at $32.42 per hour for a total salary 
component of $19.45 per year.
---------------------------------------------------------------------------

    \10\ U.S. Department of Agriculture, Agricultural Marketing 
Service, Pesticide Data Program Annual Summary, Calendar Year 2008. 
http://www.ams.usda.gov/pdp.
---------------------------------------------------------------------------

    Respondents: Certifying agents.
    Estimated Number of Respondents: 94.
    Estimated Number of Responses per Respondent: 15.6.
    Estimated Total Annual Burden on Respondents: 409 hours.
    Total Cost: $13,257.

Recordkeeping Burden

    Estimate of Burden: Public recordkeeping burden is estimated to be 
an annual total of 3.9 hours per respondent at $32.42 per hour for a 
total salary component cost of $126.44. This accounts for both the 
recordkeeping associated with maintaining copies of test results and 
documenting any correspondence with a Federal health agency, state 
health agency, or foreign equivalent.
    Respondents: Certifying agents.
    Estimated Number of Respondents: 94.
    Estimated Number of Responses per Respondent: 15.6.
    Estimated Total Annual Burden on Respondents: 367 hours.
    Total Cost: $11,898.
    Comments: AMS is inviting comments from all interested parties 
concerning the information collection and recordkeeping required as a 
result of the amendments proposed to Sec.  205.670 in this proposed 
rule. Comments are 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.
    Comments that specifically pertain to the information collection 
and recordkeeping requirements of this action should be sent to Lisa M. 
Brines, Agricultural Marketing Specialist, Standards Division, National 
Organic Program, USDA-AMS-NOP, Room 2646-So., Ag Stop 0268, 1400 
Independence Ave., SW., Washington, DC 20250-0268 and to the Desk 
Officer for Agriculture, Office of Information and Regulatory Affairs, 
Office of Management and Budget, New Executive Office Building, 725 
17th Street, NW., Room 725, Washington, DC 20503. Comments on the 
information collection and recordkeeping requirements should reference 
the date and page number of this issue of the Federal Register. All 
responses to this notice will be summarized and included in the request 
for OMB approval. All comments will become a matter of public record.
    The comment period for the information collection and recordkeeping 
requirements contained in this proposed rule is 60 days.
    The 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.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Animals,

[[Page 23920]]

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, subpart 
G is proposed to be amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

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

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

    2. Section 205.670 is revised to read as follows:

Sec.  205.670  Inspection and testing of agricultural product 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. 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)).'' Such tests must be conducted by the 
certifying agent at the certifying agent's own expense. 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.
    (d) 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.
    (e) Results of all analyses and tests performed under this section:
    (1) Must be promptly provided to the Administrator; Except, That, 
where a State organic program exists, all test results and analyses 
shall be provided to the State organic program's governing State 
official by the applicable certifying party that requested testing; and
    (2) Will be available for public access, unless the testing is part 
of an ongoing compliance investigation.
    (f) 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: April 25, 2011.
David R. Shipman,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2011-10415 Filed 4-28-11; 8:45 am]
BILLING CODE 3410-02-P
```