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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.
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
NP7163NNA CA Report MCS 101718 Page 2 of 10
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
NP2155ACA.NC6 – Cleared
NP4160BJR.NC1 – Cleared
NP4160BJR.NC2 – Cleared
NP4160BJR.NC3 – Cleared
NP4160BJR.NC4 – 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.
NP7163NNA CA Report MCS 101718 Page 3 of 10
• 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
NP7163NNA CA Report MCS 101718 Page 4 of 10
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.
NP7163NNA CA Report MCS 101718 Page 5 of 10
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.
NP7163NNA CA Report MCS 101718 Page 6 of 10
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.
NP7163NNA.NC9 – 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.”
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.
NP7163NNA.NC10 – 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.”
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.
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 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
NP7163NNA CA Report MCS 101718 Page 7 of 10
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.
NP7163NNA.NC11 – 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.”
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.”
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
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.
NP7163NNA.NC12 – 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.”
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.
NP7163NNA.NC13 – 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.”
Comments: MCS does not verify who is applying the JAS Seal on products exported to Japan
under the US – Japan Equivalency Arrangement.
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
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
NP7163NNA CA Report MCS 101718 Page 8 of 10
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.
NP7163NNA.NC14 – Accepted. 7 C.F.R. § 205.501(a)(3) states, “A private or governmental
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.
NP7163NNA.NC15 – Accepted. 7 C.F.R. § 205.501(a)(3) states, “A private or governmental
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’ 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.
NP7163NNA CA Report MCS 101718 Page 9 of 10
NP7163NNA.NC16 – Accepted. 7 C.F.R. § 205.501(a)(3) states, “A private or governmental
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)(2) states, “An organic production or handling
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
NP7163NNA CA Report MCS 101718 Page 10 of 10
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.
NP7163NNA.NC18 – 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 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.
NP4160BJR CA MOFGA 111314 Page 2 of 7
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.
NP2155ACA.NC2 – Cleared
NP2155ACA.NC3 – Cleared
NP2155ACA.NC4 – Cleared
NP2155ACA.NC5 – Cleared
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
NP4160BJR CA MOFGA 111314 Page 3 of 7
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 non- compliance.
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.
NP4160BJR CA MOFGA 111314 Page 4 of 7
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
NP4160BJR CA MOFGA 111314 Page 5 of 7
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
NP4160BJR CA MOFGA 111314 Page 6 of 7
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
NP4160BJR CA MOFGA 111314 Page 7 of 7
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.”