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.

Proposed Rules Federal Register

23914 

Vol. 76, No. 83 

Friday, April 29, 2011 

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. 

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 § 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 § 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 


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Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Proposed Rules 23915 

1Audit Report 01601–03–Hy, March 2010. 

§ 205.670(b) of the NOP regulations. 

This section provides that the Secretary, 

State organic programs, and certifying 

agents may require pre-harvest 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 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. 

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 

§ 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 § 205.504(b)(6), to have 

procedures in place for sampling and 

residue testing pursuant to § 205.670. 

Certifying agents should already be 

conducting sampling and laboratory 

testing in instances where 

contamination is suspected under 

§ 205.403(c)(3) and § 205.670(b). 

II. Overview of Proposed Amendments 

Requirement for Periodic Residue 

Testing 

This proposed rule would amend 

§ 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 § 205.670 to reflect the scope of 

products currently listed under 

§ 205.670(a) and (b). The amended title 

would read as follows: § 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 × 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 × 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 § 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
23916 Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Proposed Rules 

2NOP Policy Memo 11–6. 

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 § 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 

§ 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 

§ 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 

§ 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. 

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 § 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 § 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 §§ 205.670 

and 205.671. 

Technical Correction 

The proposed rule would amend 

§ 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. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Proposed Rules 23917 

3NOP Policy Memo 11–6. 

4U.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/. 

5U.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. 

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. 

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. 

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 nonsignificant 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 

§ 2115(b) of the OFPA (7 U.S.C. 

6514(b)). States are also preempted 

under §§ 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 § 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 § 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. 

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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
23918 Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Proposed Rules 

7Organic Trade Association’s 2010 Organic 

Industry Survey, http://www.ota.com. 

8As reported by certifying agents during the 2010 

certification year and available at http:// 

apps.ams.usda.gov/nop/. 

to 24 percent each year. In 2009, organic 

food sales grew 5.1%.7

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 § 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. 

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 § 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 § 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 

§ 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 § 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 § 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 § 205.670(f). 

The PRA also requires AMS to 

measure the recordkeeping burden. 

While certifying agents are already 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Proposed Rules 23919 

9U.S. Department of Labor, Bureau of Labor 

Statistics, Occupational Employment and Wages, 

May 2009. 

10U.S. Department of Agriculture, Agricultural 

Marketing Service, Pesticide Data Program Annual 

Summary, Calendar Year 2008. http:// 

www.ams.usda.gov/pdp. 

required to maintain records under 

§ 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 § 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 § 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. 

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 § 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. 

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 

§ 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, 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
23920 Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Proposed Rules 

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: 

§ 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 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2011–0318; Directorate 

Identifier 2010–CE–033–AD] 

RIN 2120–AA64 

Airworthiness Directives; Burl A. 

Rogers (Type Certificate Previously 

Held by William Brad Mitchell and 

Aeronca, Inc.) Models 15AC and 

S15AC Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM); Extension of the comment 

period. 

SUMMARY: This document extends the 

period for public comment on the 

above-referenced NPRM. The proposed 

AD would require repetitive inspections 

of the upper and lower main wing spar 

cap angles for cracks and/or corrosion 

and installing inspection access panels. 

The proposed AD would also require 

replacing the wing spar cap angles if 

moderate or severe corrosion is found 

and applying corrosion inhibitor. The 

proposed AD was prompted by reports 

of intergranular exfoliation and 

corrosion of the upper and/or lower 

wing main spar cap angles found on the 

affected airplanes. We are proposing 

this AD to detect and correct cracks, 

intergranular exfoliation and corrosion 

in the wing main spar cap angles, which 

could result in reduced strength of the 

wing spar and the load carrying capacity 

of the wing. This could lead to wing 

failure and consequent loss of control. 

This extension of the comment period is 

necessary to assure that all interested 

persons have ample opportunity to 

present their views on the proposed 

requirements of the NPRM. 

DATES: We must receive comments on 

this proposed AD by July 3, 2011. The 

comment due date is being extended 

from May 19, 2011. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 


emcdonald on DSK2BSOYB1PROD with PROPOSALS