Nothing Special   »   [go: up one dir, main page]

GMO Certification Scheme

Download as pdf or txt
Download as pdf or txt
You are on page 1of 25

NSF International

Protocol P454-2019
NSF Non-GMO
Certification Program

The Public
Health and Safety
Company.TM
NSF International, an independent, not-for-profit,
nongovernmental organization, is dedicated to
being the leading global provider of public health
and safety-based risk management solutions
while serving the interests of all stakeholders.

Not for
Distribution
or Sale

This Protocol is subject to revision.


Contact NSF to confirm this revision is current.

Users of this Protocol may request clarifications and


interpretations, or propose revisions by contacting:

NSF International
789 Dixboro Road, PO Box 130140
Ann Arbor, Michigan 48113-0140
Phone: (734) 769-8010 Telex: 753215 NSF INTL
Fax: (734) 769-0109
E-mail: info@nsf.org
Web: <www.nsf.org>
NSF P454 – 2019

NSF Protocol P454

Not for
NSF Non-GMO
Certification Program

Distribution
or Sale

Protocol Developer
NSF International
Consumer Values Verified

i
Publish Date: August 20, 2015

Revisions:

Not for
Revised October 2016 Revised December 2016 Revised June 2019

Distribution
or Sale
Published by

NSF International
PO Box 130140, Ann Arbor, Michigan 48113-0140, USA

For ordering copies or for making inquiries with regard to this Protocol, please reference the Protocol title.

Copyright © 2019 NSF International

Previous editions © 2016

Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any
means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
NSF International.

Without the written permission of NSF, it is strictly prohibited to use this designation in whole or in part, to
indicate conformance with this Protocol through the marking of products or packaging, or by any other
means.

Printed in the United States of America.

ii
Objectives and Disclaimers

This NSF Protocol provides basic criteria to promote and protect non-GMO integrity. Provisions for food
safety have not been included in this Protocol as elements of a thorough food safety system go beyond the
non-GMO requirements set forth in this document. NSF International does not assume, displace, or
undertake to discharge any obligations or responsibilities of the manufacturer or any other party, including
but not limited to those responsibilities and obligations arising from the other certifications or standards
incorporated into this Protocol. Under no circumstances shall NSF International be liable for direct, indirect,
incidental, consequential, special, punitive or any other use of this Protocol. This Protocol may be revised
from time to time.

Participation in NSF Protocol Development activities by regulatory agency representatives (federal, local,
state) shall not constitute their agency’s endorsement of NSF or any of its Protocol. NSF’s Protocol
Development is driven by a process of seeking input from all interested parties and balancing stakeholder
feedback. Use of this Protocol is strictly voluntary.

Not for
Distribution
or Sale

iii
Not for
Distribution
This page is intentionally left blank.

or Sale
Contents

1 General............................................................................................................................................. 2

2 Normative references ....................................................................................................................... 2

3 Definitions ........................................................................................................................................ 3

4 NSF Non-GMO certification requirements ....................................................................................... 6

5 Additional requirements for livestock and feed .............................................................................. 11

6 Exemptions .................................................................................................................................... 14

7 Labeling .......................................................................................................................................... 15

8 Request for deviation or variance .................................................................................................. 16

Not for
Distribution
or Sale

v
Not for
Distribution
This page is intentionally left blank.

or Sale
© 2019 NSF NSF P454 – 2019

© 2019 NSF NSF P454 – 2019

NSF Non-GMO Certification Program

1 General
1.1 Purpose

The primary aim of this Protocol is to create clear production, testing, and evaluation criteria for the
determination of feed, food, dietary supplements, personal care, and household cleaning products to be
considered eligible for labeling as “non-GMO”.

1.2 Scope

Organizations, including those which grow, produce, manufacture, process, and trade in food and
beverage, dietary supplement, cosmetic, personal care, and household cleaning products are eligible to

Not for
apply for NSF Non-GMO certification. NSF reserves the right to reject applications for certification of
products deemed outside the scope of eligibility due to regulatory restrictions or other public health and
safety concerns.

Applicants must demonstrate effective implementation of procedures which control the integrity of the

Distribution
product and process by preventing deviations from NSF Non-GMO compliant formulations and procedures.
This includes, but is not limited to, supplier and raw material approval and monitoring procedures, controls
in product development and launch procedures, sanitation and segregation controls, documented operating
procedures, record keeping, testing programs designed to monitor compliance of ingredients and finished
products, and supply chain traceability.

or Sale
Applicants shall exercise due diligence to ensure compliance with all applicable regulatory requirements.
Compliance with this Protocol does not imply that all regulatory requirements have been met.

2 Normative references
The following documents contain provisions that, through reference, constitute provisions of this Protocol.
At the time this Protocol was written, the editions listed below are current and valid. All documents are
subject to revision, and parties are encouraged to investigate the possibility of applying the most recent
editions of the documents indicated below. The most recent published edition of the document shall be
used for undated references.

7 CFR Part 66, National Bioengineered Food Disclosure Standard 1

21 USC - Chapter 9 – Federal Food, Drug, And Cosmetic Act 2

1 United States Department of Agriculture (USDA). 1400 Independence Ave., S.W. Washington, DC 20250.
<www.usda.gov>
2 US Food and Drug Administration (US FDA) – CFR Code of Federal Regulations Title 21.
<www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm>
© 2019 NSF NSF P454 – 2019

CAN/CGSB-32.315-2004 [Reaffirmed May 2016], Voluntary Labelling and Advertising of Foods That Are
and Are Not Products of Genetic Engineering 3

15 USC. § 2052 – Consumer Product Safety Act 4

US FDA Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been
Derived from Genetically Engineered Plants 5

Global Food Safety Initiative (GFSI) 6

ISO 22716:2007, Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing
Practices 7

Non-GMO Project Standard 8

NSF/ANSI 305, Personal Care Products Containing Organic Ingredients

USDA Food Safety and Inspection Service (FSIS) – Statements That Bioengineered or Genetically Modified
(GM) Ingredients or Animal Feed Were Not Used in Meat, Poultry, or Egg Products1

Determinations1

USDA National Organic Program1


Not for
USDA National Organic Standards Board, Materials / GMO Subcommittee Proposal: Excluded Method

Distribution
USDA Policy Memo: Consistency Between Bioengineered Disclosure and the National Organic Program,
(September 19, 2016)1

or Sale
3 Definitions
3.1 audit: An extensive physical examination of a facility, its equipment, and its testing procedures for
the purpose of observation of practices and collection of samples to determine compliance with facility
programs and structures; an evaluation of programs and systems.

3.2 certified entity: An organization contracting with NSF for certification and use of the NSF Non-GMO
Mark.

3.3 claimed ingredient: Specific ingredient(s) prominently displayed on a product’s packaging, either in
the product’s name or on the primary display panel. This does not include the nutrition or supplement facts
panel or the ingredient list. For example, Vitamin E is a claimed ingredient in the product, “Face lotion with
Vitamin E.”

3 Government of Canada, Public Services and Procurement. 11 Laurier Street, Phase III, Place du Portage Gatineau,
4 US Consumer Product Safety Commission. 4330 East West Highway, Bethesda, MD 20814. <www.cpsc.gov>
5 US FDA. 10903 New Hampshire Avenue, Silver Springs, MD 20993. <www.fda.gov>
6 Global Food Safety Initiative, c/o the Consumer Goods Forum. 22/24 rue du Gouverneur Général Eboué, 92130

Issy-les-Moulineaux, France. <www.mygfsi.com>


7 International Organization for Standardization (ISO). Case postale 56, CH-1211 Geneve 20, Switzerland.
<www.iso.org>
8 The Non-GMO Project. 1155 N State St, Ste 502, Bellingham, WA 98225. <www.nongmoproject.org>
© 2019 NSF NSF P454 – 2019

3.4 commercial availability (commercially available; commercialized): The availability to obtain a


production ingredient in an appropriate form, quality, or quantity to fulfill an essential function in a system
of production or handling.

3.5 composite sample: When several samples are taken from different locations within a lot and
combined to create a representative sample.

3.6 cosmetic product: (1) An article intended to be rubbed, poured, sprinkled, or sprayed on, introduced
into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and (2) an article, other than soap, intended for use as a
component of any such articles (Federal Food, Drug, and Cosmetic Act 21 U.S.C. 321i).

3.7 dietary ingredient: An ingredient for use or used in a dietary supplement that is a vitamin, a mineral,
an herb or other botanical, an amino acid, a dietary substance for use by humans to supplement the diet
by increasing the total dietary intake, or a concentrate, metabolite, constituent, or extract.

3.8 dietary supplement: A product (other than tobacco) that:

— is intended to supplement the diet and bears or contains one or more of the following dietary

Not for
ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use
by humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite,
constituent, extract, or combination of these ingredients;

— is intended for ingestion in pill, capsule, tablet, powder, gummy or liquid form; and

Distribution
— is labeled as a “dietary supplement” or has the word “dietary” deleted and replaced by the name of
the dietary ingredient(s) in the product (e.g., calcium supplement) or an appropriately descriptive term
indicating the type of dietary ingredients that are in the product (e.g., herbal supplement with vitamins).

or Sale
3.9 genetic engineering (aka bioengineering or genetic modification): Products produced from, or
comprised of, genetically modified organisms (GMOs) that have had their genome altered through genetic
engineering (aka biotechnology) which may include synthetic biology or gene editing; a result of in vitro
nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic
acid into cells or organelles; fusion of cells beyond the taxonomic family that overcome natural physiological
reproductive or recombination barriers and that are not techniques used in traditional breeding and
selection.

3.10 high risk: Seeds, crops and animals of which a genetically modified (GM) variety is available; raw
materials or ingredients derived from those originating from a facility engaged in parallel production or
parallel ownership and the supplier does not participate in verified identity preservation system; raw
materials (or ingredients derived from them) which are the product of genetic engineering as defined under
Section 3.9.

3.11 household cleaning product: A substance (i.e., liquids, powders, sprays, or granules) purchased
by consumers for the purpose of removing dirt, dust, stains, bacteria, and odors on surfaces.

3.12 intact DNA: DNA that has been untouched or unimpaired.

3.13 intervening event: A step or an activity in the manufacturing process that mitigates risk of an
identified hazard, especially when parallel processing certified and non-certified product in common
facilities or on common equipment.

3.14 livestock: Animals raised in an agricultural setting for use or consumption by humans. This
includes honey bees and animals raised for meat, seafood, eggs and dairy.
© 2019 NSF NSF P454 – 2019

3.15 lot: A specific quantity of a finished product or other material that is intended to have uniform
character and quality, within specified limits, and/or is produced according to a single manufacturing order
during the same cycle of manufacture.

3.16 lot number: A distinctive combination of letters, numbers or symbols, or any combination thereof
from which the complete history of the manufacture, processing, packaging, holding, and distribution of a
batch or lot of finished products can be identified.

3.17 management system: A framework of processes and procedures used to ensure that an
organization can fulfill all tasks required to achieve its objectives.

A group management system exists where a Certified Entity (group manager) and its internally approved
co-manufacturers / co-producers of the certified product may be certified as a group structure where:

 the main entity manages the certification compliance management system of multiple suppliers
under its control, operating an internal control system to ensure ongoing compliance;

 a legal agreement defining the responsibilities of the group manager and the members exists
between the main entity and each member of the group (example: brand owner Certified Entity seeks

Not for
certification with dairies and co-manufacturers as members; all of which are involved in certification);
and

 the legal agreement may be in the form of an agreement, purchase contract, co-op relationship, or
other.

3.18

Distribution
manufacture or manufacturing: All operations associated with the production of ingredients or
finished products including packaging, labeling, testing, and quality control of an ingredient or finished
product.

or Sale
3.19 organization: Company, corporation, firm, enterprise, municipality, authority or institution, or part
or combination thereof, whether incorporated or not, public or private, that has its own function.

3.20 personal care product: A consumable cosmetic product (as defined above) or soap product
(as defined below). Personal care products are specifically for use in such activities as cleansing, toning,
moisturizing, hydrating, exfoliating, conditioning, anointing, massaging, coloring / decorating, soothing,
deodorizing, perfuming, and styling.

3.21 processing aids: a) Are substances that are added during processing but are removed with good
manufacturing practices; b) substances added during processing but do not have a technical or functional
effect; c) are substances added for their technical or functional effect but are present at insignificant
amounts. [21 CFR 101.100 (a)(3)(ii)]

3.22 representative samples: A sample collected in such a manner that sample characteristics
represent accurately that of the population from which it was drawn.

3.23 review: A systematic evaluation to determine if programs and related activities achieve planned
expectations including the review or challenging of written programs, documentation of activities, corrective
actions, and trends to determine the correlations between documented procedures and activities and actual
execution.

3.24 risk assessment: The organization’s evaluation of its facilities, products, processes, and activities
to determine where there is any potential for GMO material to commingle with or cross-contaminate
non-GMO raw materials or products.

3.25 risk level: Refers to the likelihood and severity of the presence of GMO DNA or
cross-contamination of non-GMO compliant products with GE containing substances.
© 2019 NSF NSF P454 – 2019

3.26 sample: A quantity collected from a lot.

3.27 shared equipment: Equipment used in the manufacture of certified non-GMO products that is also
used in the manufacture of non-certified products.

3.28 soap: A cleansing and emulsifying agent, made usually by action of alkali on fat or fatty acids that
consists essentially of sodium or potassium salts of such acids.

3.29 spot sampling: Collecting a convenience sample when systematic or representative sampling is
not possible in order to supply analytical test evidence. Spot sample test results must be supported with
process verification documents and is only possible when a justification has been documented and
approved by NSF.

3.30 systematic sampling: A planned approach to sampling based on a starting position determined
at random to collect multiple samples from a heterogeneous population at a consistent frequency or location
pattern in order to form a representative composite sample.

3.31 test sample: The quantity selected from a sample or composite sample from a lot for laboratory
analysis.

4.1
Not for
4 NSF Non-GMO certification requirements
Available GM crops and animals

Distribution
The list below represents crops and animals for which a GM variety is available. Any ingredient or product
derived from one of these, will require evidence, as stated in Section 4, to show that the GM version was
not used. This list is not inclusive and will be continually evaluated and updated as needed.

or Sale
Additionally, many microorganisms used to produce ingredients via fermentation are genetically modified.
Therefore, ingredients or products produced using microorganisms will also require evidence to show the
microorganism has not been genetically modified.

 Alfalfa;
 apple (Artic™ only);
 canola;
 corn;
 cotton;
 eggplant (BARI Bt Begun only);
 papaya (ringspot virus-resistant varieties only);
 pineapple (pink flesh);
 potato (Innate®);
 salmon (Aquadvantage® only);
 soybean;
 squash (aummer only); and
 sugar beet.

4.1.1 All eligible consumer goods shall not contain more than 0.9% GM derived ingredient content
(including water and salt) by weight according to the exemptions in Section 6.2.

4.1.2 Livestock feed shall not contain any GM ingredient that is individually greater than 5% in the feed
ration formulation (including water and salt) by weight.
© 2019 NSF NSF P454 – 2019

4.1.3 Animal products and ingredients of animal origin which are an ingredient in a finished food, dietary
supplement, or other consumer good shall be derived from animals in compliance with the Protocol
requirements under Section 5.

4.1.4 Annual monitoring: all organizations shall submit to annual monitoring of their program, either by
remote desk review and/or on-site audits by NSF and agree to cooperate in the certification process through
timeliness and transparency. These on-site audits may be announced or unannounced as determined by
risk.

4.1.5 Claimed ingredients on retail packaged products must be compliant to the Protocol.

4.2 Documentation requirements

4.2.1 All applicants shall submit:

 a completed certification application; and

 a facility risk assessment(s) and procedures and records under Section 4.2;

Not for
or

 a currently valid product certification for USDA Organic (or equivalent) or Non-GMO Project
Certificate of Verification for the product(s) under review;

Distribution
or

 a currently valid USDA Organic (or equivalent) certificate for the production facility, or GFSI
benchmarked scheme certification, or third-party GMP facility registration (dietary supplements
only), and evidence of compliance to Sections 4.3, 4.7 (if applicable), and 4.10.

4.2.2



or Sale
Procedures and records may include, but are not limited to:

product integrity (Section 4.3);


storage, transportation, and packaging materials (Section 4.4);
— cleaning and sanitation (Section 4.5);
— internal quality control and compliance monitoring (Section 4.6);
— sampling and test methods (Section 4.7);
— traceability (Section 4.8);
— training (Section 4.9);
— ingredient approval and monitoring (Section 4.10);
— control and disposition plan for noncompliant product (Section 4.11); and
— product withdrawal (Section 4.12).

4.2.3 The organization shall permit NSF full access to any related audit report that would support
evidence of compliance to the NSF Non-GMO Protocol.

4.3 Product integrity

4.3.1 Documents / procedures / records detailing the product integrity protective measures shall include,
but are not limited to:

— product formulations;

— process flow chart, description of facilities and activities;


© 2019 NSF NSF P454 – 2019

— method for confirming the integrity of ingredients or final products sourced under certified non-GMO
claims;

— method for prevention of commingling and/or cross-contamination of ingredients and finished


products from receiving, through processing, packaging, storage and final distribution; and
— commingling and/or cross-contamination prevention of packaging materials; and storage
containers where risk to integrity exists.

4.4 Storage / transport / packaging materials

4.4.1 Documents / procedures / records detailing the storage / transport / packaging materials used and
how they ensure non-GMO integrity shall include, but are not limited to:

 where there is high risk of cross-contamination by GM ingredients via shared use


equipment / containers or environmental conditions, there are controls in place to prevent
cross-contamination. For example, storage areas for these materials and containers are protected from
environmental contamination by GM dust, etc.;

— methods exist to prevent commingling in direct contact transport containers (i.e., milk, tankers /

Not for
bulk storage areas [silos, tanks]) from GM sources; and

— label integrity must be maintained throughout the production cycle so as to prevent mislabeling of
GM products as non-GMO.

Distribution
4.5 Cleaning and sanitation

4.5.1 Documents / procedures / records detailing the cleaning and sanitation efforts in place to ensure
non-GMO integrity shall include, but are not limited to:

or Sale
— cleaning and sanitation method(s) and procedure(s) used to prevent commingling and
cross-contamination by waste from noncompliant animals or of noncompliant ingredients or products;

— monitoring methods to demonstrate efficacy of sanitation procedures; and

— methods for evaluating the efficacy of intervening event for nondedicated lines.

4.6 Internal quality control and compliance monitoring

4.6.1 The organization shall have in place appropriate procedures to ensure non-GMO integrity of
ingredients and finished products which may include, but is not limited to:

— process control monitoring methods including frequencies, and storage and handling procedures;

— internal auditing program and documented risk assessment; and

— supplier agreements to ensure identity preservation procedures are observed to maintain


non-GMO status.

4.7 Sampling and test methods

4.7.1 Sampling and testing, as described under Sections 4.7.2 through 4.7.10, is only required when:

 an ingredient is derived from a source where available GM versions exist, per Section 4.1;

 sampling and testing can be performed at the point where intact DNA (i.e., a raw material prior to
processing) is present and a *valid test method exists and;
© 2019 NSF NSF P454 – 2019

 the ingredient is not certified organic or certified under another non-GMO identity preservation
system.

*NOTE: — For gene-edited crops for which a valid test method does not exist, a signed affidavit from the
ingredient supplier is required.

4.7.2 Valid sampling and testing plans shall be submitted to NSF for review. Sampling plans for bulk
agricultural commodities shall be designed to attain minimum 90% confidence level that a contaminated lot
would be detected.

4.7.3 Sampling methods shall be supported by valid statistical sampling reference sources and/or
recognized industry or regulatory sampling criteria.

4.7.4 Acceptable analytical testing methods shall include:

— valid qualitative strip / lateral flow immunoassay tests;

— valid quantitative strip / lateral flow immunoassay tests;

Not for
— PCR; or

— a scientifically valid method which has been shown to be fit for purpose for the particular sample
matrix being tested.

Distribution
NOTE – Qualitative or quantitative strip / lateral flow immunoassay tests are only applicable for
monitoring seed / grain.

4.7.5 All testing shall be conducted by an appropriately trained and qualified individual according to the
test method employed.

or Sale
4.7.6 Outside laboratories used for GM testing shall be ISO 17025 accredited for the relevant method of
testing or approved by NSF through validation of methods or evaluation of validation study results supplied
by the laboratory.

4.7.7 Testing is required for GM events associated with the source of the ingredient for each lot used to
produce NSF Non-GMO certified product.

4.7.8 Test reports shall indicate the presence of intact DNA and specify a lot number, or other
designation, that can be linked to the finished product.

4.7.9 If GM DNA is detected due to an inadvertent or unintentional presence, it shall be no more than
0.9% for all GM events combined. GM DNA detected in a single ingredient exclusively used in animal feed
shall be no more than 5% for all GM events combined.

4.7.10 In the event of confirmed positive test result(s) (exceeding the applicable allowable threshold as
noted above), the organization shall investigate the cause and control non-conforming ingredients or
finished product. Records and corrective actions taken shall be documented and submitted to NSF to
review.

4.8 Traceability

4.8.1 Traceability documents / procedures / records, in order to ensure non-GMO integrity, shall include
but are not limited to:

4.8.1.1 Demonstrated ability to trace materials from receiving through sale via linked lot / production
numbers on process paperwork; and
© 2019 NSF NSF P454 – 2019

4.8.1.2 Original records of receiving and production for the materials and products when specified by
NSF and for the period defined by NSF for reconciliation review. The records may be evaluated by NSF
during the initial evaluation and/or during the on-site audit.

4.9 Training

4.9.1 Documents / procedures / records of proper training on ensuring non-GMO integrity shall include
but are not limited to:

4.9.1.1 Employees shall receive initial and annual refresher training;

4.9.1.2 Purpose and requirements of the program as applicable to job responsibilities;

4.9.1.3 Policies and procedures related to compliance with the program requirements as applicable to
the job responsibilities; and

4.9.1.4 Work instructions related to specific tasks required to maintain compliance.

4.9.2 Employee training shall be in accordance with the organization’s documented policies and

Not for
procedures for maintaining compliance.

4.9.3 All employee training records shall be maintained at the production facility for a period of five (5)
years and available for review during on-site audits.

Distribution
4.10 Ingredient approval and monitoring

4.10.1 Documents from ingredient suppliers shall include, but are not limited to:

 supplier product specification sheets that include full disclosure of any sub-ingredients or additives

or Sale
and include source information (i.e., vegetable oil from corn);

and when applicable:

 sworn statement / affidavit of non-GMO status, when approved by NSF; or

 evidence that the crop source was grown in a country where GM cultivation is prohibited, or

 in-house genetic modification detection testing on incoming agricultural ingredient material lots,
according to Section 4.7, or

 Non-GMO Project Certificate of Verification, or

 National Organic Program Certificate or recognized equivalent certificate; or

 certification to NSF/ANSI 305 – Personal Care Products Containing Organic Ingredients or


COSMOS - Cosmetics Organic and Natural Standard (applicable to personal care products only); or

 certification to other programs such as identity preservation that require a system designed to avoid
GMOs from crop to finished product and is deemed valid by NSF.

4.10.2 Ingredients on the National List of Substances Allowed in Certified Organic Products
(7 CFR 205.605 and 205.606) are allowed at up to 5% of the formula by weight (including water and salt)
as is permitted in the organic regulation, unless they are claimed ingredients or present on the supplement
facts panel of a dietary supplement product, with the exception of riboflavin. An affidavit of non-GMO status
may be required.
© 2019 NSF NSF P454 – 2019

4.10.3 For ingredients used, individually or combined, at no more than 0.9% and approved under the
exemption allowance per Section 6.2, one of the following is required:

 records to verify that the ingredient or final product has been subjected to a refinement process
validated to make any modified genetic material in the food undetectable; or

 certificate of analysis or other records of testing appropriate to the specific ingredient or finished
product that confirm the absence of modified genetic material.
Feed is excluded from this requirement.

4.11 Control and disposition plan for noncompliant product.

4.11.1 Upon notification of a quality control failure, the certified entity shall review their policies and
procedures and conduct a root cause analysis to determine the cause of the failure and implement
corrective action to prevent reoccurrence.

4.11.2 NSF shall review both the root cause analysis and corrective action to determine if additional
testing or audits are necessary, or if suspension of certification is warranted until NSF is confident that
effective control is reestablished.

4.11.3

Not for
Documents / procedures / records of the control and disposition plan for nonconforming product
in order to ensure non-GMO integrity shall include, but are not limited to:

— record of the details of the cause of the nonconformance (i.e., which area of the compliance

Distribution
management system or control measure failed; segregation, sanitation, incoming raw material
compliance, etc.) and how it was detected; and

— record of volume of noncompliant product and evidence of destruction or diversion to conventional


sale, if permitted by law, provided any claims or logos relating to NSF Non-GMO certification are

or Sale
removed or completely obscured.

4.12 Product withdrawal

4.12.1 Documents / procedures / records of withdrawing product from the marketplace in order to ensure
non-GMO integrity shall include policies and procedures that define the retest and withdrawal / recall of a
product(s) should it become necessary, and these documents shall be included with the facility’s policies
and procedures.

4.12.2 Certified organizations shall notify NSF of any product withdrawal or recall of an NSF Non-GMO
certified product.

5 Additional requirements for livestock and feed


In addition to the certification requirements listed under Section 4, the requirements listed below are
applicable to livestock and livestock feed.

5.1 Livestock

5.1.1 All participating animals shall not be a product of GM reproductive techniques or administered GM
growth promoters / hormones.

5.1.2 The following documentation shall be maintained:

— feed records, including the suppliers, lot numbers and receiving date of feed provided to animals;
— veterinary activity records, where applicable; and
© 2019 NSF NSF P454 – 2019

— livestock transport activities and the feed provided during transport, if applicable.

5.1.3 Method for segregation of noncompliant live animals and withholding from program production
where applicable. This includes, but is not limited to: segregation of feed storage, rotation of
controlled / uncontrolled groups in living areas, cleaning procedures, record keeping, etc.

5.1.4 All livestock, feed, and products of animal origin collected at the livestock facility shall be
transported and handled during transport, in a manner which does not compromise the NSF Non-GMO
compliant status.

5.1.5 Feed materials purchased shall be monitored for compliance and acquired only from
NSF Non-GMO certified or equivalent compliant source. Equivalent compliance may be determined by
review of records maintained by the purchaser or feed supplier.

5.1.6 All livestock shall be raised in compliance with the Lifecycle Management Schedule requirements
in Table 5.1.

Not for
Distribution
or Sale
© 2019 NSF NSF P454 – 2019

Table 5.1
Lifecycle Management Schedule

Source Non-GMO feeding requirement


Beef cow, goat, sheep, swine,
etc., (mammals raised for directly after weaning, upon feeding of solid food
meat)
Calf (raised for meat) 7 days of age

Shellfish 30 days post hatching when fed high risk grain


for salmon and char – from 180 days post hatchery; for all other
Fish
species from 90 days post hatchery
Poultry / broilers for meat
at grain consumption (From first feeding within 72 hours age)
production
egg layers at grain consumption (From first feeding within 72 hours age)
Production dairy cow, goat,

Not for
30 days prior to first certified milk production and continuously
etc., (mammals raised for
thereafter1,2
dairy)
continuously fed non-GMO feed during periods of nonproduction if
Dry dairy cow, goat, etc., (not
the intent is to return the animal to non-GMO certified product
milking)
production

Distribution
supplemental feed materials supplied by the apiary manager must be
Honey bees from a non-GMO source3. GM crops deemed by NSF to be attractive
to bees are not permitted on land within the 1.8-mile forage zone.
1 Whenproduct is sold as conventional (not labeled as certified non-GMO) the animal shall be continuously fed non-
GMO feed if the animal’s future production is intended to be labeled as non-GMO.

or Sale
2 Spent NSF Non-GMO certified dairy cows may only be represented as Certified when sold for meat if the animal

was raised in compliance with the feeding requirements for beef cows.
3 Processors must demonstrate they have specified to the producers that bees not be fed GMO sources of
supplemental feed. Sworn statements from the apiary manager (hive owner) regarding the compliance of
supplemental feed sources provided to the bees are accepted, and are subject to verification by NSF.
Processors collecting honey from producers in regions consisting of native (non-GMO) agriculture can submit an
affidavit regarding the commercial agriculture in the collection region. Those processors / producers in regions with
risk of GM agriculture must provide forage zone maps and provide a summary of the industrial and agricultural
activity occurring in the forage zone.
The operation may submit justification for the allowable presence of attractive GM crops in the forage zone; for
example, due to blooming times not coinciding with the presence of foraging bees or the presence of highly attractive
compliant and accessible forage crops in the forage zone and evidence that the bees do not visit the less attractive
GM crop.
© 2019 NSF NSF P454 – 2019

5.2 Feed sample compliance

5.2.1 Feed is not required to be certified but must be demonstrated to be compliant with these
requirements by the certified operation using the feed.

5.2.2 The feed compliance calculations shall be determined on a total diet / ration basis, including
moisture content of feed formulations and forage materials, but not including free-choice water consumed
by the animal.

5.2.3 Annual rolling average of lot testing results for GM content per commodity shall not exceed 5% GM
content.

5.2.4 If a single lot test result exceeds 5% GM content, the Certified Operation remains in compliance
with the Protocol. However, the Certified Operation shall take steps to notify the supplier, conduct a
corrective action investigation, and possibly reject future shipments and disqualify the supplier if there is a
pattern of noncompliance. If the certified operation fails to improve control over the feed materials supplied
they are at risk for suspension of certification.

5.3 Testing of planting seed

Not for
5.3.1 Seed used for production of high moisture crops, specifically silage (e.g., corn, alfalfa) and for
alfalfa in general, when a supplier can demonstrate via seed tag, invoice and letter from seed company that
planting seed GM content is less than 5%, no further testing is required.

Distribution
5.3.2 Additionally, the supplier shall provide evidence of a system designed to avoid GM contamination.

5.3.3 Alternatively, evidence of seed supplier certification to the NSF Non-GMO Protocol or other
applicable third-party certification or regulation deemed equivalent by NSF shall be sufficient to show
compliance.

5.4

or Sale
Sampling procedures for feed or grain

5.4.1 Samples shall be collected, where possible, according to a probability-based sample collection
method resulting in a test sample which is representative of the lot.

5.4.2 Where probability-based sampling is not possible, a spot sample (see definitions) may be collected
and a compliant test result shall be supported by traceability and segregation records demonstrating the
origin of the lot traced back to compliant grain / seed. A justification shall be documented and approved by
NSF.

5.4.3 If a lot of accepted feed is implicated in a GM content noncompliance at a later stage in the supply
chain, the NSF Certified Operation which supplied the suspected noncompliant lot shall be required to
investigate the lot and verify its compliance via test results. In this case, any product or animal impacted at
the later stage in the supply chain shall not be considered noncompliant, unless some willful violation was
found otherwise affecting the compliance of the product or animal.

6 Exemptions
The following lists includes exemptions allowed under this Protocol.

6.1 The following are exempt:

— ingredients not derived from a biological source (i.e., minerals, petrochemicals);

— processing aids (per definition);


© 2019 NSF NSF P454 – 2019

— ingredients derived from non-GM microorganisms;

— fermentation feedstock except in fermented foods or beverages (vinegar, beer, wine, liquor,
vegetables, etc.);

— enzymes, except when they are a claimed ingredient in a dietary supplement, personal care, or
cleaning product;

— seeds, crops, and ingredients derived from crops not available in GM form;

— carbonated water; and

— mushroom substrates.

6.2 The following are exempt individually or combined at no more than 0.9% of the formula by weight
(including water and salt):

 ingredients derived from microorganisms that are nonviable / inactivated in the final product;
 animal derived ingredients; and

Not for
 ingredients where GM DNA is not present in the final product.

6.3 Livestock feed exemptions:

Any ingredient that is individually no more than 5% in a livestock feed ration formulation (including water

Distribution
and salt).

7 Labeling

or Sale
7.1 Use of the Mark and statement is voluntary. Use of the Mark may be accompanied by the NSF
consumer information webpage URL. For meat, poultry and egg products sold in the US, the URL shall be
included per USDA Food Safety and Inspection Service (FSIS) requirements. Marks and statements must
be in compliance with terms and conditions of use and the NSF style guide. Contact NSF for information.

7.2 Any product that bears a claim regarding “NSF Non-GMO certification” on its labeling and fails to
comply with the program requirements will be deemed to be noncompliant.

7.3 NSF Certified Non-GMO certified operations may display other third-party logos or claims respecting
GMO or non-GMO (or equivalent) status as permitted by law and may include descriptions of their control
program on the non-Primary Display Panel, provided it does not contradict NSF Non-GMO program
requirements.

7.4 If an operation wishes to request a variance regarding the labeling and marketing requirements, the
operation shall submit the variance request using a form supplied by NSF. NSF will consider requests but
is not obligated to grant the variance and will not be obligated to return any portion of fees paid if the
applicant chooses to discontinue certification as a result of NSF’s decision.

7.4.1 NSF shall not be responsible for any costs incurred by applicants related to the printed labels which
are the subject of rejected variance requests or other product noncompliance. It is the applicant’s
© 2019 NSF NSF P454 – 2019

responsibility to ensure it has received written confirmation of label compliance by NSF prior to printing
participating product labels.

7.5 The content claim “Made with Non-GMO X” accompanied by a statement “X ingredient adheres to
NSF Non-GMO requirements” may be permitted when:

— the claimed ingredient is compliant to the Protocol; and

— 70% or more of the formula is compliant to the Protocol; and

— the ingredient claimed as non-GMO is available in GM form; and

— neither the NSF Non-GMO mark nor the full certification statement are displayed on the product
label.

8 Request for deviation or variance


8.1 Any request for deviation or variance to NSF Non-GMO Certification Program requirements shall be

Not for
submitted using a form supplied by NSF.

8.2 NSF shall consider the request but is not obligated to grant the request and will not be obligated to
return any portion of fees paid if the applicant chooses to discontinue certification as a result of NSF’s
decision.

Distribution
8.3 NSF shall not be responsible for any costs incurred by applicants related to nonconforming product
which is the subject of rejected request or other product noncompliance.

8.4 To apply for a deviation or variance, the client must complete the Request for Deviation / Variance –

or Sale
NSF Non-GMO Certification Program form and submit to NSF. Fees will apply as per the fee schedule for
NSF Certified Non-GMO services.
Not for
Distribution
This page is intentionally left blank.

or Sale

You might also like