united states department of agriculture...crops, wild crops, livestock and handling operations mofga...

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United States Department of Agriculture

Agricultural Marketing Service

National Organic Program

meets all the requirements prescribed in the USDA National Organic Program Regulations

7 CFR Part 205

as an Accredited Certifying Agent

for the scope of

Crops, Wild Crops, Livestock and Handling Operations

MOFGA Certification Services, LLC

38 School Street, Unity, Maine, 04988, U.S.A.

This certificate is receivable by all officers of all courts of the United States as prima facie evidence of the truth of the statements therein contained. This

certificate does not excuse failure to comply with any of the regulatory laws enforced by the U.S. Department of Agriculture .

Status of this accreditation may be verified at http://www.ams.usda.gov

Certificate No: NP7163NNA

Effective Date: June 3, 2017

Expiration Date: June 3, 2022

Jennifer Tucker, Ph.D.

Deputy Administrator

National Organic Program

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, age, disability, and

where applicable, sex, marital status, familial status, parental status, religion, sexual orientation, genetic information, political beliefs, reprisal, or because all or part of

an individual’s income is derived from any public assistance program.

http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateJ&page=NOPACAs

1400 Independence Avenue, SW. Room 2646-S, STOP 0268 Washington, DC 20250-0201

NP7163NNA CA Report MCS 101718 Page 1 of 10

NATIONAL ORGANIC PROGRAM: CORRECTIVE ACTION REPORT

AUDIT AND REVIEW PROCESS

An onsite renewal assessment of the MOFGA Certification Services, LLC organic program was

conducted on June 12-16, 2017. The National Organic Program (NOP) reviewed the auditor’s

report to assess MOFGA Certification Services, LLC’s compliance to the USDA organic

regulations. This report provides the results of NOP’s assessment.

GENERAL INFORMATION

Applicant Name MOFGA Certification Services, LLC (MCS)

Physical Address 38 School Street, Unity, Maine 04988

Mailing Address PO Box 170, Unity, Maine 04988

Contact & Title Chris Grigsby, Director

E-mail Address [email protected]

Phone Number 207-568-6030

Reviewer

Auditors

Jason Lopez, NOP Reviewer;

Patricia Heckart and Robert Yang, On-site Auditor(s).

Program USDA National Organic Program (NOP)

Review Dates

Audit Dates

NOP assessment review: April 30 – October 5, 2018

Onsite audit: June 12-15, 2017

Audit Identifier NP7163NNA

Action Required No

Audit & Review Type Renewal Assessment

Audit Objective To evaluate the conformance to the audit criteria; and to verify the

implementation and effectiveness of MCS’s certification

Audit & Determination

Criteria

7 CFR Part 205, National Organic Program as amended

Audit & Review Scope MCS’s certification services in carrying out the audit criteria during

the period: October 2012 through June 2017

An onsite renewal audit of MOFGA Certification Services LLC (MCS) was conducted on June

12-15, 2017 at the MCS office in Unity, ME.

MCS was formed by the Maine Organic Farmers and Gardeners Association (MOFGA) in 2002

in order to provide USDA organic certification services to Maine farmers and food processors. It

is a for-profit business. MCS was accredited as a certifying agent on June 3, 2002 by the USDA

National Organic Program (NOP) for crops, wild crops, livestock, and handling operations.

The MOFGA Board of Directors appoint a management committee to oversee the operation of

MCS. Members of this committee cannot have operations that are certified by MCS. An

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mailto:[email protected]


advisory committee is also formed to help develop guidance materials. Members of both

committees sign conflict of interests and confidentiality statements each year.

MCS’s list of certified operations at the time of the assessment consisted of 518 operations:

Crops (410), Livestock (131); Wild crops (63); and Handlers (182). Certification services are

provided to operations in the states of Maine, New Hampshire, Massachusetts, and Vermont.

MCS’s staff includes 31 individuals: 1 administrative; 8 technical; 5 reviewers and 17 inspectors

(5 staff, 6 part-time staff, and 6 contracted).

As part of the onsite audit activities, two witness audits and one review audit were conducted.

Witness audits of a crops/livestock inspection and handler (spice processor) inspection were

conducted. A review audit of a wild crops/processing operation was conducted.

NOP DETERMINATION

The NOP reviewed the onsite audit results to determine whether MCS corrective actions

adequately addressed previous noncompliances. The NOP also reviewed the findings identified

during the onsite audit to determine whether noncompliances should be issued to MCS.

Noncompliances from Prior Assessments

Any noncompliance labeled as “Cleared,” indicates that the corrective actions for the

noncompliance are determined to be implemented and working effectively. Any noncompliance

labeled as “Outstanding” indicates that either the auditor could not verify implementation of the

corrective actions or that records reviewed and audit observations did not demonstrate

compliance. Any noncompliance labeled as “Accepted” indicates acceptance of the corrective

actions and verification of corrective action implementation will be conducted during the next

onsite audit.

NP2155ACA.NC1 – Cleared


NP4160BJR.NC1 – Cleared




NP4160BJR.NC5 - Cleared

NP2155ACA.NC7 – Accepted. 7 CFR §205.662(a) states, “Notification: When an

inspection, review, or investigation of a certified operation by a certifying agent or a State

organic program's governing State official reveals any noncompliance with the Act or

regulations in this part, a written notification of noncompliance shall be sent to the certified

operation.”

Comments: The review of the certification files found that 2 of the 8 files showed

“continuous improvement points” were issued instead of noncompliances to operations

where issuance of noncompliance was warranted.


• One of the eight files reviewed had a certification decision letter for 2012 which listed

“continuing improvement points” rather than citing these issues as noncompliances.

• One of the eight files reviewed had a “Findings” letter which provided a copy of the

inspection report and “continuing improvement points.” These continuous

improvement points should have been issued as noncompliances, specifically the

recordkeeping issue of not having any compost records on file.

2012 Corrective Action: MOFGA’s response indicated a necessary change in interpretation

of the regulation, including discontinued use of the term “continuous improvement point.”

Training for staff was conducted October 2012 to address what is a minor non-compliance as

a condition for continued certification vs. non-compliance vs. major non-compliance.

MOFGA has provided the new NOP Penalty Matrix to all staff as a guideline for citing non-

compliance issues. MOFGA has also created a staff role for Quality Control and Quality

Assurance Manager, who will be responsible for overall program compliance and quality

checks; a copy of the job description for this position has been provided as objective

evidence. If the Penalty Matrix and staff training are effectively implemented, MOFGA’s

response demonstrates capability to comply with NOP accreditation requirements.

June 2014 NOP Verification: Three files showed that the operations had used a prohibited

sanitizer. One operation also had significant problems with outdoor access for pigs and

chickens. MOFGA addressed these issues through continuing improvement points. The

reviewers did not issue Notices of Noncompliance, but instead explained to the operations

that they could choose to use an additional sanitizer as an intervening event or change to a

different type of sanitizer.

October 2014 Corrective Action: The MCS Director and Associate Director attended the

ACA/NOP training in San Diego in February 2014 where NOP’s revised, one-page Penalty

Matrix was introduced. This training was brought back and shared with MCS staff. Non-

conformities such as the ones described here clearly fit the type of violation described in the

new one-page Penalty Matrix as ones that need to be addressed by issuing notices of non-

compliance instead of compliance inquiry or continuing improvement point letters.

MOFGA has also created a staff role for Quality Control and Quality Assurance Manager, who

will be responsible for overall program compliance and quality checks; a copy of the job

description for this position has been provided as objective evidence. If the Penalty Matrix and

staff training are effectively implemented, MOFGA’s response demonstrates capability to

comply with NOP accreditation requirements. The Director has already implemented weekly

individual meetings with specialists, to review their clients’ status and the specialists’ approaches

to the issues their clients have complying with the regulation. MOFGA is also using weekly staff

meetings to discuss, as a team learning exercise, compliance issues encountered in inspection

reports or OSP reviews, and whether or not non-compliance notices are in order. MOFGA is also

conducting sessions with small groups of specialists, to foster cross-training and consistent

interpretations of internal guidelines and NOP regulations.

Verification of Corrective Actions: The staff position for Quality Control and Quality

Assurance is vacant. Review of client files and inspection reports indicates that compliance

issues are still communicated as “continuous improvement points” and not as noncompliances.

January 2018 Corrective Actions: MCS Director is performing the duties of the Quality

Control and Quality Assurance position. In this position, the MCS Director is working to


implement a consistent application of the regulations and uniformity of the letters and notices

sent by MCS. MCS is in the process of revising its Quality Manual to include specific guidance

for specialists to determine levels of activity through the use of the penalty matrix (NOP 4002).

MCS reviewed the use of “noncompliance” terminology instead of “compliance inquires” with

MCS specialist during a June 28, 2017 meeting. MCS will include the NOP 4002 “Penalty

Matrix” into MCS’s Certification Review SOP document to be completed in the spring of 2018.

Noncompliances Identified during the Current Assessment

Any noncompliance labeled as “Accepted,” indicates that the corrective actions for the

noncompliance are accepted by the NOP and will be verified for implementation and

effectiveness during the next onsite audit.

NP7163NNA.NC1 – Accepted. 7 C.F.R. § 205.662(a)(1) & (3) states, “When an inspection …

reveals any noncompliance with the Act or regulations in this part, a written notice of

noncompliance shall be sent to the certified operation. Such notice shall provide a description of

each noncompliance; The date by which the certified operation must rebut … each

noncompliance ….” \

Comments: In all five notices of noncompliance reviewed, citations to the USDA organic

regulations were either not made, or were very general and did not cite the specific regulation.

Additionally, the operation was not made aware of the opportunity to rebut the noncompliance.

Corrective Actions: MCS revised and submitted its notice of noncompliance template to

inform operations of the option for a rebuttal response. MCS created and submitted the SOP

Letter Writing – Official Correspondence with Clients. MCS informed its certification

specialists to include full applicable citation on all notices and trained staff on the new SOP on

January 10, 2018. MCS will prevent the reoccurrence of these issues with continued training,

oversight and references to the Official Correspondence with Clients SOP are included in the

Certification/Inspection Review SOP submitted on June 30, 2018.

NP7163NNA.NC2 – Accepted. 7 C.F.R. § 205.501(a)(7) states, “A private entity accredited as a

certifying agent must have an annual program review.”

Comments: MCS did not conduct annual program reviews in 2014 or 2015. There is no written

procedure for conducting an annual program review.

Corrective Actions: MCS developed and submitted an SOP and written policy for conducting

an annual program review on June 30, 2018. The procedure states that MCS will complete its

annual program review by the end of each calendar year. MCS completed its 2017 annual

program review on December 13, 2017, and submitted the report, findings, and corrections with

its Annual Report to the NOP on June 3, 2018.

NP7163NNA.NC3 – Accepted. 7 C.F.R. § 205.403(d) states, “The inspector must conduct an

exit interview …. The inspector must also address the need for additional information as well as

any issues of concern.”

Comments: During the exit interviews of the two annual inspections witnessed, the inspector

relayed findings to the operator, but did not clearly inform the operator whether the findings

were a request for additional information or issues of concern.


Corrective Actions: MCS has revised and submitted its Inspector Manual and Exit Interview

form. The MCS Inspector Manual clearly states inspectors are to review the accuracy and

completeness of observations, confirm any OSP changes, review issues of concern, and review

additional information requests. The Exit Interview form has two distinct sections for the

inspector to capture issues of concern and information requests. MCS will review the changes to

the Inspector Manual and Exit Interview form during their February 2018 inspector training.

MCS will monitor the implementation of the policy changes on the inspector witness audit form.

NP7163NNA.NC4 – Accepted. 7 C.F.R. § 205.501(a)(21) states, “A private or governmental

entity accredited as a certifying agent under this subpart must comply with, implement, and carry

out any other terms and conditions determined by the Administrator to be necessary,”

Specifically, NOP 2609 Instruction Unannounced Inspections requires certifying agents to

conduct unannounced inspections of 5 percent of their total certified operations per year as a tool

in ensuring compliance with the regulations.

Comments: MCS did not conduct unannounced inspections of 5% of its clients in 2015. Fifteen

(15) unannounced inspections were conducted for 454 certified operations.

Corrective Actions: On June 30, 2018, MCS submitted its procedure for conducting

unannounced inspections. The MCS director has communicated the required unannounced

inspection threshold to staff. The MCS director will oversee completion of the required

unannounced inspections via direct involvement with inspection coordination.

NP7163NNA.NC5 – Accepted. 7 C.F.R. § 205.403(c)(2) states, “The onsite inspection of an

operation must verify: That the information, including the organic production and handling

system plan, provided … accurately reflects the practices used or to be used by the certified

operation ….”

Comments: During the annual onsite inspection of a handling operation, it was observed that

the inspector did not fully verify whether the operation’s handling system plan accurately

reflected the practices used by the operation. Example of sections in the operation’s Organic

Handling Plan that were observed to not have been fully verified include list of products

requested for certification; organic product profiles, including product composition; and pest

management log.

Corrective Actions: MCS has revised and submitted its Inspector Manual on June 30, 2018.

The revisions emphasize the inspector’s role and specifically list all areas of the OSP’s that must

be verified. MCS’s instruction for onsite verification of products was revised for operations with

more than 30 products. In these cases, MCS staff specialists will select 10% or 30 products and

labels, whichever is greater, to be verified by the inspector onsite. The sample of products will

be a full representation of the operation’s production. Training for this process change was done

on January 10, 2018 for MCS Staff Specialists and on February 16, 2018 for inspectors.

NP7163NNA.NC6 – Accepted. 7 C.F.R. § 205.501(a)(15)(i) states, “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 of proposed suspension or revocation, and

notification of suspension or revocation sent pursuant to § 205.662 simultaneously with its

issuance.


Comments: MCS provides copies of written notices of denials, noncompliances and adverse

actions to the Administrator on a quarterly basis.

Corrective Actions: On October 4, 2017, MCS implemented changes to its database to

simultaneously send notices of noncompliance, noncompliance resolutions, and any adverse

action notices to the certified operation and the NOP Adverse Actions email address. MCS

Certification Specialists have implemented this process. This process has been added as a

prerequisite in MCS’s Review Inspection Reports and Determine Compliance Procedure

submitted on June 30, 2018.

NP7163NNA.NC7 – Accepted. 7 C.F.R. § 205.642 states, “Fees charged by a certifying agent

must be reasonable, and a certifying agent shall charge applicants for certification and certified

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

Administrator.”

Comments: MCS changed its fee schedule for 2017. MCS did not file the fee schedule with the

Administrator prior to charging its clients according to the new fee schedule.

Corrective Actions: MCS has submitted 2017 fee schedules for renewing and initial applicants.

There have been no changes to the fee schedules for 2018. The MCS Director has added this

provision to the MCS annual work plan and will submit any changes to MCS fee schedules to the

NOP.

NP7163NNA.NC8 – Rebuttal Accepted.


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

carry out any other terms and conditions determined by the Administrator to be necessary.”

Comments: MCS does not require its certified operations exporting product to the EU under the

US – EU Equivalency Arrangement to include MCS’ assigned certifier code on product labeling.

Corrective Actions: MCS has updated and submitted the relevant section of its Practice Manual

(provided to clients) for 2018 and the table in the Export and Transaction Certificates Manual to

indicate the MCS certifier code (US-ORG-027) is to be used on all retail products going to the

EU. MCS’s will review and update this document as a part of its Annual Document and

Guidance Update process or as notified through official written USDA-NOP announcements.

MCS Certification Specialists were trained at the MCS Staff Specialist Meeting on January 10,

2018 and Inspectors were trained at MCS annual inspector training held on February 16, 2018.




Comments: MCS does not require labeling on products exported by its certified operations to

Canada under the US – Canada Equivalency Arrangement to be in both English and French.



indicate that retail labels on products going to Canada must be in both English and French.

MCS’s will review and update this document as a part of its Annual Document and Guidance


Update process or as notified through official written USDA-NOP announcements. MCS

Certification Specialists were trained at the MCS Staff Specialist Meeting on January 10, 2018

and Inspectors were trained at MCS annual inspector training held on February 16, 2018.




Comments: A review of TM-11 export certificates issued by MCS for products exported to

Japan under the U.S. – Japan Equivalency Arrangement indicated that MCS did not include in

the Remarks section the statement, “Certified in compliance with the terms of the US-Japan

Organic Equivalency Arrangement.”



state that the TM-11 must contain the statement “Certified in compliance with the terms of the

US-Japan Organic Equivalency Arrangement.” MCS’s will review and update this document as

a part of its Annual Document and Guidance Update process or as notified through official

written USDA-NOP announcements. MCS Certification Specialists were trained at the MCS

Staff Specialist Meeting on January 10, 2018 and Inspectors were trained at MCS annual

inspector training held on February 16, 2018.




Comments: A review of the MCS Export Transaction Certificates Database – MCS' electronic

control log for recording/tracking the disposition of each export certificate – revealed a missing

record for a TM-11 export certificate issued for product exported to Japan. An interview with

certification staff indicated that the missing record was the result of a technical issue with the

database, which may lead to additional missing records in the future.

Corrective Actions: MCS uploaded the missing record to the “MCS Export Transaction

Certificates” database and relocated the database to the MCS “cloud”. The relocation of the

database and new process for TM-11 generation has eliminated the possibility of missing records

and allows the database to be constantly backed up and current. MCS has developed and

submitted an SOP, training, and guidance for creating and processing transaction certificates.

MSC staff who generate TM-11 transaction certificates have been trained on the new process.




Comments: MCS does not verify who is applying the JAS Seal on products exported to Japan

under the US – Japan Equivalency Arrangement.



state that the JAS logo is required on exported product and must be applied by either a Japanese

Agricultural Standards (JAS) certified importer or a USDA certified operation that has a JAS


labeling contract with a JAS certified importer. MCS’s will review and update this document as

a part of its Annual Document and Guidance Update process or as notified through official

written USDA-NOP announcements. MCS Certification Specialists were trained at the MCS

Staff Specialist Meeting on January 10, 2018 and Inspectors were trained at MCS annual

inspector training held on February 16, 2018.


entity accredited as a certifying agent under this subpart must: Carry out the provisions of the

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

§ 205.670.” Specifically, 7 C.F.R. § 205.201(a)(6) states, “An organic production or handling

system plan must include: Additional information deemed necessary by the certifying agent to

evaluate compliance with the regulations.”

Comments: MCS’ Wild Crops organic system plan form does not ask the operator to provide

the following information required by NOP 5022 Wild Crop Harvesting:

• A description of the monitoring system that will be used to ensure that the crop is

harvested in a sustainable manner that does not damage the environment, including soil

and water quality;

• Training provided to ensure that all collectors harvest crops in accordance with the OSP

and in a manner that does not damage the environment

Corrective Actions: MCS has revised and submitted its Wild Crop Supplement and Sea

Vegetable Supplement. The supplement revisions request operations to describe the methods

and monitoring procedures used to prevent negative impact to the harvest area. Additionally,

operations are asked to list harvester training and methods used to ensure harvests occur in a

manner that does not damage the environment. MSC Certification Specialists were updated on

the changes made to the Wild Crop and Sea Vegetable Supplement Forms the January 10, 2018

meeting. Producers will receive a letter with their renewal updates informing them of the

changes.





system plan must include: Additional information deemed necessary by the certifying agent to

evaluate compliance with the regulations.”

Comments: MCS’ organic system plan templates do not require operations to provide

information regarding the export of product(s) or use of organic product(s) imported under an

international trade arrangement, including how the operation meets the labeling requirements of

the applicable arrangement.

Corrective Actions: MCS added import and export questions to the Certification Application

and Organic Handling Plan and list the import documents to be maintained. The MCS

International Export Supplement lists the requirements of each organic international

arrangement. MCS has submitted the revised forms. MSC Certification Specialists were trained

on changes made to the Certification Application, the Organic Handling Plan Forms, and the new

International Export Supplement on January 10, 2018. MCS Inspectors were trained to

recognize and ask for Export/Import documentation in February 16, 2018.






system plan must include: A list of each substance to be used as a production or handling input,

indicating its composition ….”

Comments: MCS does not require its operations to provide information needed to determine

whether salt (sodium chloride) used in products requested for certification contains any

ancillary ingredients that must be reviewed for compliance with the USDA organic regulations.

Corrective Actions: MCS has revised and submitted its Multi-Ingredient Product Profile, to

request clients to provide documentation of ancillary ingredients in salt. MCS’s

Processor/Handler Inspection Report, Narrative Inspection Report and Narrative Inspection

Report Instructions have also been revised to remind MCS inspectors. MCS Certification

Specialists were trained at the MCS Staff Specialist Meeting on January 10, 2018 and Inspectors

were trained at MCS annual inspector training held on February 16, 2018.

NP7163NNA.NC17 – Accepted. 7 C.F.R. § 205.403(a)(1) states, “A certifying agent must

conduct an initial on-site inspection of each production unit, facility, and site that produces or

handles organic products and that is included in an operation for which certification is

requested.”

Comments:

• The review of a wild crops (seaweed) certification file revealed that MCS did not conduct

an initial on-site inspection of each production site for which certification was requested

prior to certifying the site.

• The review of a handling certification file revealed that MCS did not conduct an initial

onsite inspection of a new facility its certified operator had moved to before allowing the

operation to sell product produced at the new facility.

Corrective Actions: MCS has made the following revisions to its inspection and review

procedures:

• MCS will conduct site visits of all production areas for initial applicants as well as

existing certified operations wishing to add harvest territory to their OSP, per NOP

205.403(a). MCS will communicate this change to all existing kelp producers and any

future applicants in the coming months ahead of the inspection season. MCS’ onsite

inspection process will include the use of Google Earth and State of Maine GIS overlays

from the Department of Environmental Protection to first verify through mapping the

harvest area locations. This mapping will allow MCS to note the overboard discharges,

wastewater outflows, and sewage pump-outs, which can present potential contamination

concerns. It also allows MCS to note active harbors, fish pens and other buffer

requirements. These printed maps with overlays will be included in the inspector file for

onsite verification.

• MCS has revised its certification letter to remind operations they must inform the

certifier of any changes to the Organic Handling Plan prior to implementing the

change. Additionally, MCS has revised its Practice and Quality Manuals to indicate


that operations should immediately notify the certifier of any changes to the OSP.

MCS has distributed the revised manual to its certified operations and made it

available on MCS’s website.

• MCS has developed a draft SOP that states the requirements of 7 C.F.R. §

205.403(a)(1) under the NOP’s Crop, Wild Crop, Livestock and Handling scopes.

This SOP will be completed by December 2018. MCS Certification Specialists were

trained on the requirements of during the January 10, 2018 Certification Specialist

meeting.




Specifically, NOP 3012 Interim Instruction Material Review includes the responsibilities and

options available for an accredited certifier to determine whether materials may be used in

organic production or handling under the USDA organic regulations:

Comments: For commercial compost products, MCS accepts the materials review decisions of

MOFGA Ag Services. MCS’ policy to accept MOFGA Ag Services’ review decisions does not

comply with NOP 3012.

Corrective Actions: MCS has taken over all aspects of Commercial Compost Review and re-

reviews within our Materials Review team. MCS develop and submitted a Compost Review

SOP. Initial training occurred on January 10, 2018 at the MCS Certification Specialist meeting

and will continue as needed moving forward.

1400 Independence Avenue, SW. Room 2646-S, STOP 0268 Washington, DC 20250-0201

NP4160BJR CA MOFGA 111314 Page 1 of 7

NATIONAL ORGANIC PROGRAM: CORRECTIVE ACTION REPORT

AUDIT AND REVIEW PROCESS

The U.S. Department of Agriculture, Agricultural Marketing Service, National Organic Program

(NOP) conducted a mid-term accreditation assessment of MOFGA Certification Services, LLC

(MOFGA) from June 9-12, 2014 in Unity, Maine. The NOP reviewed the auditor’s report on

Jun 26, 2014 to determine MOFGA’s capability to operate as a USDA accredited certifier.

GENERAL INFORMATION

Applicant Name MOFGA Certification Services, LLC

Physical Address 210 Crosby Brook Rd., Unity, ME 04988

Mailing Address 210 Crosby Brook Rd., Unity, ME 04988

Contact & Title Mary Yurlina, Certification Director

E-mail Address [email protected]

Phone Number 207-568-4142

Reviewer(s) &

Auditor(s) Janna Howley, NOP Reviewer; Betsy Rakola Onsite Auditor(s).

Program USDA National Organic Program (NOP)

Review & Audit Date(s) Review of Corrective Actions Date: October 21, 2014;

Audit Date: June 26, 2014

Audit Identifier NP4160BJR

Action Required None

Audit & Review Type Mid-Term Assessment

Audit Objective To evaluate the conformance to the audit criteria; and to verify the

implementation and effectiveness of MOFGA’s certification system.

Audit & Determination

Criteria

7 CFR Part 205, National Organic Program as amended

Audit & Review Scope MOFGA’s certification services in carrying out the audit criteria during

the period: June 2012 – June 2014

MOFGA Certification Services, LLC (MOFGA) was formed by the Maine Organic Farmers and

Gardeners Association in 2002 in order to provide USDA-accredited organic certification

services to Maine farmers and food processors. MOFGA was accredited as a certifying agent on

June 3, 2002 to the USDA National Organic Program (NOP) for crops, wild crops, livestock, and

handling operations.

The MOFGA organic program currently includes 435 operations certified to the NOP, consisting

of 345 crops, 51 wild crop, 113 livestock (of which several also have crops), and 114 handlers.

All operations are located in the United States. The vast majority are located in the State of

Maine, with between 5-10 operations located in Vermont, Massachusetts, and New Hampshire.

http://agnis/AMS Logo/AMS Final Color Text on Right 11-19-09.jpg

mailto:[email protected]


All activities are conducted out of MOFGA’s office in Unity, ME.

NOP DETERMINATION:

NOP reviewed the onsite audit results to determine whether MOFGA’s corrective actions

adequately addressed previous noncompliances. NOP also reviewed any corrective actions

submitted as a result of noncompliances issued from Findings identified during the onsite audit.

Non-compliances from Prior Assessments Any noncompliance labeled as “Cleared,” indicates that the corrective actions for the

noncompliance are determined to be implemented and working effectively. Any noncompliance

labeled as “Outstanding” indicates that either the auditor could not verify implementation of the

corrective actions or that records reviewed and audit observations did not demonstrate

compliance.





AIA13354BJR.NC1 – Cleared

AIA4087MMK.NC1 – Cleared

AIA4087MMK.NC2 – Cleared

NP2155ACA.NC1 – Accepted – 7 CFR §205.402 (a)(1) & (2) states, “Upon acceptance of an

application for certification, a certifying agent must: Review the application to ensure

completeness pursuant to §205.401; Determine by a review of the application materials whether

the applicant appears to comply or may be able to comply with the applicable requirements of

subpart C of this part.”

Comments: The review of the certification files found that 3 of the 8 files demonstrated that

applications and updates reviewed by the initial reviewer did not have enough information to

conduct a complete review of the file. The files moved forward for inspection without being

complete and it was requested that the inspector obtain OSP details during the on-site audit.

Some examples of missing information included: product labels, commingling descriptions, last

date of prohibited material applications, etc. With the information missing, the ACA was not

able to determine compliance or capability to comply.

2012 Corrective Action: MOFGA provided some explanation to the history and culture of

MOFGA certification. In an historical aspect, inspectors provided this type of service – helping

the farmer with his/her OSP; obtaining information about the OSP for the certifier – for years.

Once the NOP was established and prohibited this practice, MOFGA has been continually

working with the farmers and the parent organization that maintains an expectation that MOFGA

certification services, especially inspectors, be able to help the farmers in any/every way.

MOFGA understands this is a non-compliant component of their program. MOFGA held a

training session with staff in Oct 2012 to discuss NOP requirements, including complete OSPs

before inspection is scheduled. MOFGA intends to enlist their parent company, a non-profit

cooperative extension, for assistance in consulting with the farmers and helping them in the ways

the inspectors cannot. MOFGA is also going to print an article in their member newsletter


detailing the USDA audit and why this “change” to their system is so important. Finally,

MOFGA has created a staff role for a QC/QA Manager; one of the main duties will be to check

review documents generated by multiple staff to ensure continuity and compliance with NOP,

and MOFGA policies and procedures.

June 2014 NOP Verification: One of the six files reviewed was incomplete, since it did not

have any information on the handler’s recordkeeping for organic certificates, tracking of

ingredients, or their lot numbers. In addition, the inspector on the slaughterhouse witness audit

did not have the most updated copy of the operation’s labels.

October 2014 Corrective Action: MOFGA updated their procedure document,

“Administration of Organic Crop System Plan Renewals on Paper” to include a step by step

process for Specialists to follow to ensure that a consistent system is in place to process OSPs

and receive final approval from Executive Director. All mail, email and phone calls with

clients are tracked in MOFGA’s FileMaker database. MOFGA also created a “Farm Review

Checklist 2014” for Specialists to ensure that OSPs, and inspector files, are complete prior to

inspections. MOFGA provided NOP copies of these two new documents.

NP2155ACA.NC6 – Accepted - 7 CFR §205.501 (a)(11)(iv) states, “A private or

governmental entity accredited as a certifying agent under this subpart must: Prevent conflicts

of interest by: not giving advice or providing consultancy services, to certification applicants

or certified operations, for overcoming identified barriers to certification.”

Comments: The review of the certification files found that 2 of the 8 files showed use of

commanding language in the inspection report that appear to instruct the client on how to

address or fix issues of concern, rather than documenting observations to the certifier and

indicating how the observations yield, or could yield, a potential non-compliance.

One of the eight files reviewed instructed the operation to do “XYZ” rather than

documenting the observation of what was lacking in the system and how that yielded an

issue of concern or noncompliance.

One of the eight files reviewed had a certification decision letter for 2012 which

stated “continuing improvement points” and included a citation to wild crop

regulation 205.207, then cited “MCS tapping guidelines.” The ACA cannot cite

findings to their own guidelines or rules unless the rules are in the NOP regulation.

2012 Corrective Action: MOFGA’s response indicates a need to train staff on inspector roles

and language vs. reviewer roles and language; this training was conducted in October 2012.

MOFGA also indicated that language appropriate for inspection reports and not using

consulting or commanding language was a topic of discussion at the December 2012 inspector

training. Further, the creation of the QC/QA Manager position, responsible for overall

program compliance through quality control, would provide an additional layer of verification

that policies and procedures are being properly followed throughout the certification year.

Also, regarding citing “MCS Guidelines” for maple operators, MOFGA stated that it would

only use the NOP regulations for non-compliance citations. If effectively implemented,

MOFGA’s response demonstrates capability to comply with NOP accreditation requirements.


June 2014 NOP Verification: MOFGA showed significant improvement in this area. The

MOFGA Certification Services, LLC parent company, Maine Organic Farmers and

Gardeners, includes an “Agricultural Services” division which provides consulting services to

organic farmers, and the certification staff regularly make referrals to these consultants in

response to questions from operations. MOFGA also showed documentation of its 2012

inspector training session, which specifically discussed refraining from the use of

“commanding language.” However, the 2014 initial review letter for a dairy operation

suggested to the operator how he could change his protocols in order to bring his temporary

confinement procedures into compliance. Therefore, the documentation showed that

MOFGA provided advice to the operation on how to overcome barriers to certification, rather

than citing the practice as either a minor issue or a noncompliance.

October 2014 Corrective Action: MOFGA sent a notice to its staff to explain that the

specific language in the 2014 initial review letter for the dairy operation was considered

consulting. MOFGA regularly conducts reviews of its staff and inspectors’ work and the staff

conducts peer-reviews of each other’s work. These reviews will include a review of

documents for consulting language.

NP2155ACA.NC7 – Accepted - 7 CFR §205.662(a) states, “Notification: When an

inspection, review, or investigation of a certified operation by a certifying agent or a State

organic program's governing State official reveals any noncompliance with the Act or

regulations in this part, a written notification of noncompliance shall be sent to the certified

operation.”

Comments: The review of the certification files found that 2 of the 8 files showed

“continuous improvement points” were issued instead of noncompliances to operations

where issuance of noncompliance was warranted.

One of the eight files reviewed had a certification decision letter for 2012 which listed

“continuing improvement points” rather than citing these issues as noncompliances.

One of the eight files reviewed had a “Findings” letter which provided a copy of the

inspection report and “continuing improvement points.” These continuous

improvement points should have been issued as noncompliances, specifically the

recordkeeping issue of not having any compost records on file.

2012 Corrective Action: MOFGA’s response indicated a necessary change in interpretation

of the regulation, including discontinued use of the term “continuous improvement point.”

Training for staff was conducted October 2012 to address what is a minor non-compliance as

a condition for continued certification vs. non-compliance vs. major non-compliance.

MOFGA has provided the new NOP Penalty Matrix to all staff as a guideline for citing non-

compliance issues. MOFGA has also created a staff role for Quality Control and Quality

Assurance Manager, who will be responsible for overall program compliance and quality

checks; a copy of the job description for this position has been provided as objective

evidence. If the Penalty Matrix and staff training are effectively implemented, MOFGA’s

response demonstrates capability to comply with NOP accreditation requirements.

June 2014 NOP Verification: Three files showed that the operations had used a prohibited

sanitizer. One operation also had significant problems with outdoor access for pigs and


chickens. MOFGA addressed these issues through continuing improvement points. The

reviewers did not issue Notices of Noncompliance, but instead explained to the operations

that they could choose to use an additional sanitizer as an intervening event or change to a

different type of sanitizer.

October 2014 Corrective Action: The MCS Director and Associate Director attended the

ACA/NOP training in San Diego in February 2014 where NOP’s revised, one-page Penalty

Matrix was introduced. This training was brought back and shared with MCS staff. Non-

conformities such as the ones described here clearly fit the type of violation described in the

new one-page Penalty Matrix as ones that need to be addressed by issuing notices of non-

compliance instead of compliance inquiry or continuing improvement point letters.

MOFGA has also created a staff role for Quality Control and Quality Assurance Manager, who

will be responsible for overall program compliance and quality checks; a copy of the job

description for this position has been provided as objective evidence. If the Penalty Matrix and

staff training are effectively implemented, MOFGA’s response demonstrates capability to

comply with NOP accreditation requirements. The Director has already implemented weekly

individual meetings with specialists, to review their clients’ status and the specialists’ approaches

to the issues their clients have complying with the regulation. MOFGA is also using weekly staff

meetings to discuss, as a team learning exercise, compliance issues encountered in inspection

reports or OSP reviews, and whether or not non-compliance notices are in order. MOFGA is also

conducting sessions with small groups of specialists, to foster cross-training and consistent

interpretations of internal guidelines and NOP regulations.

Non-compliances Identified during the Current Assessment Any noncompliance labeled as “Accepted,” indicates that the corrective actions for the

noncompliance are accepted by the NOP and will be verified for implementation and

effectiveness during the next onsite audit.

NP4160BJR.NC1 - Accepted – 7 CFR §205.404(b)(2) states, “The certifying agent must issue a

certificate of organic operation which specifies the:… effective date of certification.”

Comments: Not all certificates contained the additional information and statements as

recommended by NOP 2603. The certificates do not include the next anniversary date or the

issue date. In addition, the certificate addenda contain an “effective through” date, which could

be misinterpreted as an expiration date (however, this date appears on the organic product

verification, not on the certificate itself). Although certificates reference the USDA NOP

standards, they do not specifically reference 7 CFR 205.

Corrective Action: Certificates and product verifications have been updated to contain the

required information. MOFGA attached copy of updated certificates. Certificates are now a

standard layout and produced by their database, which prints out the Certificate and the Product

Verification.

NP4160BJR.NC2 - Accepted - 7 CFR §205.403(b)(2) “All on-site inspections must be

conducted when an authorized representative of the operation who is knowledgeable about the

operation is present and at a time when land, facilities, and activities that demonstrate the


operation's compliance with or capability to comply with the applicable provisions of subpart C

of this part can be observed, except that this requirement does not apply to unannounced on-site

inspections.”

Comments: MOFGA does not conduct all inspections during a time when the activities that

demonstrate the operation’s compliance can be observed. One file review showed that all

vegetables had been harvested prior to the inspector’s visit, and another showed that an

inspection of a ruminant livestock operation was conducted after the grazing season had

concluded. MOFGA stated that if an annual update inspection for a producer was late in the

season one year, they try to schedule them earlier for the next year. MOFGA also stated that

initial applicants are always inspected during the production season.

Corrective Action: MOFGA will reduce the occurrence of “late season” inspections by hiring

more staff inspectors. Since the audit in June 2014, MOFGA trained a new dairy/livestock

inspector. This inspector has been trained by staff and is now performing inspections. The

inspector’s resume and signed Conflict of Interest statement were provided to the NOP.

Additionally, the Executive Director gave additional assignments to three contract inspectors in

August and September. MOFGA is also considering managing three part-time professional staff

members so they work full time schedules during summer months and reduced hours in the

winter. This will allow them to perform more inspections during the summer. MOFGA

continues to also pursue a 2015 budget that will allow them to afford additional staff resources.

NP4160BJR.NC3 - Accepted - 7 CFR §205.501(a)(4) states, “A private or governmental entity

accredited as a certifying agent under this subpart must: use a sufficient number of adequately

trained personnel, including inspectors and certification review personnel, to comply with and

implement the organic certification program established under the Act and the regulations in

subpart E of this part.”

Comments: MOFGA stated that not all contract inspectors attend annual inspector training. If

an inspector does not attend the training, there is no mechanism for providing them with the

training information or requiring additional training in order to ensure that they maintain the

necessary expertise on organic regulations.

Corrective Action: MOFGA will use a web-based meeting format like GoToMeeting or

Readytalk for their next training this fall. This will eliminate the travel issue, which has been the

chief factor for not being able to attend trainings. Inspectors will continue to assign homework or

a self-test, but MOFGA will now keep their completed work on file to be used as verification of

training. MOFGA has set up a Google Group for email announcements and discussions amongst

staff and inspectors. This is intended to facilitate fast information dissemination and clarification.

Inspectors who do not participate will not be called upon to inspect. MOFGA has 100%

participation in the Google Group. The Director posted a message to the group explaining that

inspectors need to participate in training if they are to receive inspection work.

NP4160BJR.NC4 - Accepted - 7 CFR §205.501(a)(6) states, “A private or governmental entity

accredited as a certifying agent under this subpart must: conduct an annual performance

evaluation of all persons who review applications for certification, perform on-site inspections,

review certification documents, evaluate qualifications for certification, make recommendations


concerning certification, or make certification decisions and implement measures to correct any

deficiencies in certification services.”

Comments: The Certification Director’s inspections are not evaluated. The Management

Committee evaluates her overall performance, but her certification functions (such as

inspections) are not evaluated.

Corrective Action: On October 7, 2014, the MOFGA Management Committee came to the

decision that the Director will no longer do inspections, but instead delegate this activity. A

greater separation of levels and duties within the staff structure is desired; removing this job task

from the Director's work plan will enhance the integrity of the program. It will also effectively

resolve this non-compliance. The decision was effective immediately. An internal MOFGA

policy was developed that clearly stated that the Director will not be part of the inspection

process, and the Director’s job description has been updated to reflect this change. The

Director’s two remaining 2014 scheduled inspections have been given to other inspectors.

NP4160BJR.NC5 - Accepted – 7 CFR §205.501(a)(18) states, “A private or governmental

entity accredited as a certifying agent under this subpart must: provide the inspector, prior to

each on-site inspection, with previous on-site inspection reports and notify the inspector of its

decision regarding certification of the production or handling operation site inspected by the

inspector and of any requirements for the correction of minor noncompliances.”

Comments: During the handler witness inspection, the inspector did not have the most updated

labels. MOFGA had the operation’s most recent labels in the certification file, but it did not

provide copies of these labels to the inspector prior to the witness inspection.

Corrective Action: MOFGA has an established label review process; they used this process for

a few years, but had not recently. They are conducting a focused label review training in

November. MOFGA provided a copy of the updated SOP for Inspection Folders. MOFGA

explained that it is printing labels that are placed on the outside of each inspection folder.

MOFGA staff assembling the inspector folders check off each item once it is enclosed in the

inspector folder. The label has a specific checkbox for the presence of labels. Unchecked boxes

indicate that the folder may be incomplete and not ready to be sent to the inspector. Those

folders will be flagged for inquiry. The labels will be renewed annually. MOFGA will continue

to put copies of all labels in the inspection file as part of the review process. MOFGA provided

NOP a copy of their revised procedure document, “Protocol: Client and Inspection Files.”

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