UNITED STATES DEPARTMENT OF AGRICULTURE 

AGRICULTURAL MARKETING SERVICE 

BEFORE THE ADMINISTRATOR 

) 

Inre: ) Administrator's Decision 

Organic Food Development ) 

and Certification Centre of China ) APL-045-19 

Nanjing, China ) 

) 

This Decision responds to an appeal (APL-045-19) of a Notice ofNoncompliance and 

Proposed Suspension of Accreditation issued to the Organic Food Development and Certification 

Centre of China (OFDC) by the U.S. Department of Agriculture (USDA), Agricultural 

Marketing Service (AMS), National Organic Program (NOP). The certifier has been deemed not 

in compliance with the Organic Foods Production Act of 1990 (Act) 1 and the U.S. Depmiment of 

Agriculture organic regulations. 2 

BACKGROUND 

The Act authorizes the Secretary to accredit agents to certify crop, livestock, wild crop, 

and handling operations pursuant to the USDA organic regulations (7 C.F.R. Part 205). 

Accreditation of certifying agents is done by the NOP, which also initiates compliance actions to 

enforce program requirements. Noncompliance procedures for certifying agents are set forth in 

§205.665 of the USDA organic regulations. Persons subject to the Act who believe that they m·e 

adversely affected by a noncompliance decision of the NOP may appeal such decision to the 

1 7 U.S.C. 6501-6522 2 7 C.F.R. Part 205 

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AMS Administrator, pursuant to §205.680 Adverse Action Appeals Process - General, and 

§205.681, Appeals ofthe USDA organic regulations. 

FINDINGS OF FACT 

1. On April 4, 2014, NOP accredited OFDC for crops, wild crops, livestock, and 

handling/processing. OFDC cmTently certifies 36 operations. 

2. On June 11-15, 2018, NOP conducted a renewal audit/accreditation assessment of 

OFDC. 

3. On March 7, 2019, NOP issued a Notice of Noncompliance and Proposed Suspension of 

Accreditation to OFDC based on the findings ofthe June 2018 audit. 

4. On April 3, 2019, OFDC filed an Appeal. 

DISCUSSION 

The NOP proposed a suspension of OFDC's accreditation, stating that OFDC is 

noncompliant with the USDA organic regulations at 7 CFR §205 as follows: 

The organic regulations at 7 CFR §205.lO0(a) state, "Except for operations exempt or 

excluded in §205.101, each production or handling operation or specified portion of a production 

or handling operation that produces or handles crops, livestock, livestock products, or other 

agricultural products that are intended to be sold, labeled, or represented as "100 percent 

organic," "organic," or "made with organic (specified ingredients or food groups(s))" must be 

certified according to the provisions of subpart E ofthis part and must meet all other applicable 

requirements of this part." 

The organic regulations at 7 CFR §205.20l(a) state, "An organic production or handling 

system plan must include: (1) A description ofpractices and procedures to be performed and 

maintained, including the frequency with which they will be performed; (2) A list of each 

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substance to be used as a production or handling input, indicating its composition, source, 

location(s) where it will be used, and documentation of commercial availability, as applicable; 

(3) A description of the monitoring practices and procedures to be perfmmed and maintained, 

including the frequency with which they will be performed, to verify that the plan is effectively 

implemented; (4) A description of the recordkeeping system implemented to comply with the 

requirements... ; (5) A description of the management practices and physical bmTiers established 

to prevent commingling of organic and nonorganic products on a split operation and to prevent 

contact of organic production and handling operations and products with prohibited substances; 

and ( 6) Additional information deemed necessm·y by the certifying agent to evaluate compliance 

with the regulations." 

The organic regulations at 7 CFR §205.403(c)(l) state, "The on-site inspection ofan 

operation must verify: The operation's compliance or capability to comply with the Act and the 

regulations in this part." 

The organic regulations at 7 CFR §205.403(e)(2) state, "A copy of the on-site inspection 

report and any test results will be sent to the inspected operation by the certifying agent." 

The organic regulations at 7 CFR §205.405(a) state, "When the certifying agent has 

reason to believe, based on a review of the information specified in §205.402 or §205.404, that 

an applicant for certification is not able to comply or is not in compliance with the requirements 

cifthis part, the certifying agent must provide a written notification ofnoncompliance to the 

applicant." Additionally, §205.406(c) states, "Ifthe certifying agent has reason to believe, based 

on the on-site inspection and a review of the information specified in §205.404, that a certified 

operation is not complying with the requirements ofthe Act and the regulations in this part, the 

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certifying agent shall provide a written notification of noncompliance to the operation in 

accordance with §205.662 ... " 

The organic regulations at 7 CFR §205.50l(a)(3) state, "A private or governmental entity 

accredited as a certifying agent under this subpart must: Carry out the provisions ofthe Act and 

the regulations in this part, including the provisions of §§205.402 through 205.406 and 

§205.670." Specifically, §205.404(b) states, "The ce1iifying agent must issue a certificate of 

organic operation ... " 

The organic regulations at 7 CFR §§205.50l(a)(5-6) state, "A private or governmental 

entity accredited as a ce1iifying agent under this subpart must: 5) Ensure that its responsibly 

connected persons, employees, and contractors with inspection, analysis, and decision-making 

responsibilities have sufficient expertise in organic production or handling techniques to 

successfully perfonn the duties assigned; 6) Conduct an annual performance evaluation of all 

persons who review applications for ce1iification, perform on-site inspections, review 

certification documents, evaluate qualifications for certification, make recommendations 

concerning certification, or make certification decisions and implement measures to con-ect any 

deficiencies in certification services." 

The organic regulations at 7 CFR §205.501 (a)(l5)(i) state, "A private or governmental 

entity accredited as a certifying agent under this subpart must: Submit to the Administrator a 

copy of: Any notice of denial of certification issued pursuant to §205.405, notification of 

noncompliance, notification of noncompliance correction, notification ofproposed suspension or 

revocation, and notification of suspension or revocation sent pursuant to §205.662 

simultaneously with its issuance ... " 

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The organic regulations at 7 CFR §205.501(a)(21) state, "A private or governmental 

entity accredited as a certifying agent under this subpart must: Comply with, implement, and 

carry out any other te1ms and conditions determined by the Administrator to be necessary." 

The organic regulations at 7 CFR §205.504(a)(4) states, "A private or governmental 

entity seeking accreditation as a certifying agent must submit the following documents and 

information to demonstrate its expertise in organic production or handling techniques; its ability 

to fully comply with and implement the organic certification program established ... and it ability 

to comply with the requirements for accreditation set forth in §205.501: A description of any 

training that the applicant has provided or intends to provide to personnel to ensure that they 

comply with and implement the requirements of the Act and the regulations in this part." 

The organic regulations at 7 CFR §205.642 state, "Fees charged by a certifying agent 

must be reasonable, and a ce1iifying agent shall charge applicants for certification and ce1iified 

production and handling operations only those fees and charges that it has filed with the 

Administrator. The certifying agent shall provide each applicant with an estimate ofthe total 

cost of certification and an estimate ofthe annual cost of updating the certification." 

NOP stated in the March 7, 2019 Notice ofNoncompliance and Proposed Suspension of 

Accreditation that the June 11-15, 2018 onsite renewal assessment ofOFDC's organic program 

revealed 13 noncompliances. The assessment covered OFDC's certification services from July 

2015 through June 2018. NOP found that 6 noncompliances remained outstanding from the 

prior audit in July 2015. Evidence showed that OFDC hadn't fully implemented the conective 

actions it previously presented to NOP for those 6 noncompliances and which NOP had 

approved to continue accreditation. NOP also found 7 new noncompliances during the June 

2018 audit. 

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The Noncompliance Report from the June 2018 audit, dated October 17, 2018, describes 

all the noncompliances which occurred in the areas of OFDC inspection and certification 

services. These included OFDC personnel not properly reviewing and considering certification 

applications; deficiencies in the conducting of inspections; inadequate process for certification 

decisions; and improper issuance of and/or the failure to issue adverse action notices to 

operations. The June 2018 audit also revealed that OFDC 's personnel continue to lack the 

knowledge necessary to implement an organic certification program. Therefore, NOP 

recommended a suspension of OFDC's accreditation for 1 year. 

OFDC stated in its Appeal that it is awarn there are defects in some of its procedures and 

operations and that it hasn't fully met all the requirements for accreditation. However, OFDC 

contends it hasn't "seriously violated" any ofthe organic regulations or NOP procedures and 

policies. OFDC states it is making efforts to understand the standards and requirements of 

accreditation and is trying to resolve its noncompliances. OFDC stated it is "actively working" 

on resolving 8 ofthe 13 noncompliances cited in the March 7, 2019 Notice ofNoncompliance 

and Proposed Suspension and plans on having all noncompliances resolved within 3 months (this 

would be July 2019, as the Appeal was filed April 3, 2019). OFDC also states it sent staff to the 

Biofach conference in Germany to meet with NOP staff, and had planned on attending the NOP 

training in Greenville, South Carolina on January 29, 2019, which was not held. OFDC.states it 

will have in-depth training for personnel in the next few months. OFDC submitted a "Training 

Plan for Noncompliance CmTective Action to NOP 2019" addressing the noted noncompliances 

and stating that training in the deficient areas would be conducted in the "near future." 

OFDC also submitted several new or revised documents with its Appeal which are titled: 

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Organic Certification Manual; Certification Staff Management Procedure; Guidance of 

Unannounced Inspection; Procedure of Staff Capability Assessment; Organic Contract Review 

Fmm Attaclnnent; and Revised Certificate Template. The documents were drafted or revised 

April 1, 2019, and cover such topics as the hiring, training and evaluation of personnel; the 

duties of each position; the issuance of adverse action notices; and certification procedures 

including reviewing applications, conducting inspections, verifying information in Organic 

System Plans (OSP), conducting exit interviews, and providing inspection report copies to 

operations. The materials also cover OFDC's fees and residue testing. 

However, the AMS review of this case finds voluminous evidence which substantiates 

OFDC's history of noncompliance with the Act and the organic regulations dating back to its 

application for accreditation. The noncompliances described in the Notice of Proposed 

Suspension ofAccreditation are numerous and recmTent. OFDC has acknowledged defects in its 

procedures and operations, and that it hasn't met all the requirements for accreditation. OFDC 

failed to implement corrective actions for numerous noncompliances, despite previously having 

submitted corrective action plans to resolve the noncompliances and obtaining NOP's approval 

ofthe corrective actions. Further, in addition to not correcting previously noted noncompliances, 

the June 11-15, 2018 on-site renewal assessment revealed more noncompliances. 

Specifically, the 2018 on-site assessment found that OFDC inspectors did not conduct 

inspections in accordance with the USDA organic regulations. OFDC inspectors didn't provide 

operations with a copy ofthe inspection repmt after unannounced inspections, and only provided 

a copy oftest results when requested. Further, inspectors (1) couldn't consistently determine or 

weren't aware of labeling requirement differences for retail products versus nonretail containers; 

(2) didn't verify that OSPs accurately reflected practices of operations; (3) couldn't conduct 

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adequate traceability verifications; ( 4) didn't know to conduct exit interviews after inspections 

have concluded; (5) didn't review records such as sales invoices, shipping documents, and input 

material purchase invoices; (6) didn't review actual transactional documents and relied instead 

on logs generated by the operations; and (7) didn't reference the specific NOP organic 

regulations when identifying concerns to operations. Inspectors also addressed issues of concern 

which were not based on requirements in USDA organic regulations and inspectors issued 

Notices ofNoncompliance, although they don't have the authority to do so. Additionally, OFDC 

improperly refers to China Food Safety Standards for pesticide tolerance levels instead ofthe 

Environmental Protection Agency tolerance levels and Food and Drng Administration action 

levels when pesticides are found. OFDC doesn't have a procedure for addressing pesticide 

residue test tesults. 

Other noncompliances identified in the Noncompliance Report of October 17, 2018 

include deficiencies in OFDC's template OSPs, which do not comply with the USDA organic 

regulations because they are incomplete and lack the detail needed for certification staff to 

effectively review and determine the compliance of operations. OFDC's certification staff also 

do not request sufficient documentation to review inputs according to NOP policies and 

procedures to determine whether the material may be used in organic production or handling; 

incon-ectly identify ce1tification anniversary dates; and issue improperly worded organic 

ce1tificates. Overall, OFDC's certification personnel conducting certification reviews and 

making certification decisions don't demonstrate an adequate understanding ofthe USDA 

organic regulations and policies. This has resulted in notices of noncompliance not being issued 

when inspection reports identified issues of concerns; improperly granting certification to 

operations; improperly issuing adverse action notices to operations and not following procedures 

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for obtaining the operations' corrective actions; and not submitting Notices ofDenial of 

Certification to the AMS Administrator after issuance. OFDC's fee schedule doesn't provide 

information on the potential refund of fees, and the schedule wasn't approved by NOP. 

OFDC was also found deficient in the evaluation and training of its personnel. OFDC 

doesn't conduct annual field evaluations, including witness inspections, of its inspectors; and 

didn't provide NOP with a description of the training it intends to provide to its certification 

personnel to ensure they comply with and implement the NOP regulations. This has resulted in 

practices that are not consistent with the USDA organic regulations and NOP policies. 

OFDC's noncompliance with the organic regulations date predates its accreditation by 

NOP. The Pre-Decisional Onsite Audit Report ofthe July 13-19, 2013 assessment revealed 

noncompliances in OFDC's planned certification services. OFDC's Combined Notice of 

Noncompliance and Denial of Certification template lacked information on an operation's right 

to reapply for certification, file an appeal, or request mediation. OFDC hadn't established 

procedures for selecting qualified mediators or procedures for notifying operations receiving 

adverse action notices on the right to appeal if mediation is unsuccessful. Additionally, OFDC 

was uncertain on who processes appeals to its adverse action notices, and the charging of fees for 

annual residue testing samples. NOP issued a Notice of Noncompliance to OFDC on January 2, 

2014 for these noncompliances and OFDC submitted a response addressing the 4 

noncompliances. NOP detailed OFDC's corrective actions in the Pre-Decisional Audit Rep01t of 

March 11, 2014 and granted accreditation to OFDC on April 4, 2014. OFDC subsequently 

signed the Terms ofAccreditation document on April 17, 2014 which required OFDC to resolve 

· any deficiencies identified during desk audits and onsite evaluations by the date set by NOP, and 

to comply with the Act and NOP regulations, directives, and guidance. OFDC also agreed to 

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conduct an annual performance evaluation of all personnel who review certification applications; 

perform onsite inspections; review certification documents; evaluate qualifications for 

certification; make recommendations concerning certification or make certification decisions; 

and implement measures to coJTect any deficiencies in these areas. 

However, the Onsite Assessment ofJuly 14-17, 2015 revealed new noncompliances. 

The Corrective Action Report for the July 2015 assessment states that the 4 noncompliances 

previously noted during the July 2013 Pre-Decisional Onsite Audit Repmi and in the January 2, 

2014 Notice ofNoncompliance were cmTected or cleared; however, 15 new noncompliances 

were found. The new noncompliances appeared in the areas of ce1tification services; training; 

and maintaining personnel with the knowledge and expe1iise to administer the NOP organic 

ce1iification program. NOP issued a Notice ofNoncompliance on May 19, 2016 regarding the 

July 2015 onsite assessment, and asked OFDC to submit proposed coJTective actions for all the 

noncompliances within 30 days of the notice's date. NOP instructed OFDc' to indicate how the 

noncompliances will be coJTected and how OFDC's management system will be modified to 

prevent future noncompliances. (A description ofthe corrective actions and NOP's acceptance is 

detailed in the CoJTective Action Repmi for the July 2015 assessment.) NOP issued a Notice of 

Continued Accreditation on November 23, 2016 stating that corrective actions submitted in 

response to the 15 noncompliances from the July 2015 onsite assessment and prior 

noncompliances are accepted. NOP stated that the corrective actions would be verified during 

the next on-site assessment. However, as.noted above, the June I 1-15, 2018 onsite assessment 

revealed that 6 noncompliances from the July 2015 assessment remained outstanding as OFDC 

failed to properly and adequately implement the corrective actions. Fmiher, the June 2018 onsite 

assessment revealed 7 new noncompliances. 

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CONCLUSION 

The evidence substantiates that OFDC has violated the organic regulations at 7 CFR 

§205.l00(a); 7 CFR §205.201(a); 7 CFR §403(c)(l); 7 CFR §205.403(e)(2); 7 CFR §205.405(a); 

7 CFR §205.406(c); 7 CFR §205.501(a)(3); 7 CFR §§205.501(a)(5-6); 7 CFR 

§205.501(a)(15)(i); 7 CFR §205.50l(a)(21); 7 CFR §205.504(a)(4); and 7 CFR §205.642. An 

accredited ce1tifying agent must demonstrate the ability to fully comply with the requirements 

for accreditation set forth in the organic regulations. Specifically, an accredited certifying agent 

is required pursuant to 7 CFR 205.501, General requirements for accreditation, to "use a 

sufficient number of adequately trained personnel, including inspectors and certification review 

personnel. .. ( and) ensure that its responsibly connected persons, employees, and contractors with 

inspection, analysis, and decision-making responsibilities have sufficient expertise in organic 

production or handling techniques to successfully perfonn the duties assigned." Further, a 

ce1tifying agent must "ensure that its responsibly connected persons, employees, and contractors 

with inspection, analysis, and decision-making responsibilities have sufficient expertise in 

organic production or handling teclmiques to successfully perform the duties assigned." 

OFDC has a history of noncompliance with the organic regulations regarding its 

certification services and oversight ofits certification personnel. Despite being given 

opp01tunities to permanently resolve the noncompliances and submitting corrective actions 

which appear adequate, OFDC hasn't consistently implemented the corrective actions. While 

some noncompliances are resolved, others are not, and new noncompliances were subsequently 

found. OFDC doesn't contend that the noncompliance findings were in enor and acknowledges 

there are 'defects' in its procedures and operations and that it hasn't fully met the requirements 

for accreditation. 

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In its appeal, OFDC submitted new or revised manuals/procedures regarding various 

aspects ofits ce1tification services; however, there is no evidence that these new or revised 

procedures have been implemented. Fmther, the procedures were only allegedly adopted 

effective April 1, 2019, and therefore, have not been reviewed by NOP's Accreditation and 

International Activities Division. OFDC is attempting to resolve noncompliances through the 

appeals process. However, these effmts are belated. Further, it is concerning that after 5 years of 

accreditation, OFDC states it is still making efforts to "understand the standards and 

requirements of accreditation," and NOP has found numerous noncompliances related to critical 

accreditation activities. 

DECISION 

The appeal is denied and OFDC's accreditation is to be suspended for 1 year. Attached 

to this fo1mal Administrator's Decision is a Request for Hearing form. OFDC has thi1ty days to 

request an administrative hearing before an Administrative Law Judge. If OFDC does not request 

a hearing in that period, this Decision will be implemented and the suspension ofOFDC's 

accreditation will become final. 

In accordance with the organic regulations at 7 C.F.R. §205.665, OFDC may apply for 

reinstatement ofits accreditation after the 1 year suspension has been served, in accordance with 

§205.502 ofthe organic regulations. 

Done at Washington, D.C., on this z.,y f', 

day of -Sun... ,2019. 

Bruce Summers 

Administrator 

Agricultural Marketing Service 

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