Quality Archives - NaturPro Scientific

Dec

How to Meet Amazon Supplement COA (Certificate of Analysis) Requirements

by NaturPro in Quality, Uncategorized Comments: 0

Understanding Amazon’s new requirements for supplement testing can be hard, but we can help.

We are aware of the rapidly changing, uncertain requirements of Amazon for dietary supplements.

One of the key new requirements is for marketers to submit certificates of analysis, of COA for many dietary supplement products.

As of late 2020, Amazon.com is now requiring many supplement products to submit lab reports as evidence that their products are independently tested and meet label claims for active ingredients listed on the label.

There is no ‘one-size-fits-all’ solution to testing, COA’s or meeting Amazon requirements, so its important to evaluate your product testing program, and improve it so you can stay on the Amazon selling platform.

Contact us to learn more about how to ensure you are meeting Amazon requirements.

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Here is a handy checklist of some of the main requirements for information now required by Amazon for many supplement products, in order to be approved for sale on the Amazon platform:

Product name
Lot number
Manufacture date
Valid expiration date, or ‘best by’ date
Name and physical address of manufacturer or distributor
Testing Lab method is scientifically valid, and the lab reports (Lab Certificates of Analysis are complete, and issued from an ISO 17025 certified laboratory within the past 6 months
The COA contains a quantitative analytical result that supports the concentration of active ingredients stated on the supplement product label.

These are items that many sellers (and even FDA) has overlooked in the past. Considering the importance of Amazon to the supplement industry, these new requirements could determine which supplement marketers, or own-label distributors, are going to survive in the new world of stricter requirements on the Amazon website.

ABOUT US:

NaturPro Scientific are experts in label review, supplement testing and COA’s, and we can help you make sure you are compliant with Amazon’s latest requirements.

Contact us to learn more about how to ensure you are meeting Amazon’s document and testing requirements for dietary supplements.

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And for more info, check out some of our FREE articles on supplement label requirements:

Dietary Supplement Label Review

Supplement Label Review Checklist

Dietary Supplement Quality Assurance Services

How to Know the Regulatory Status of Your Ingredient

Supplement Testing Lab and Testing Method Qualification

Nov

Harvesting a quality hemp supplier from the chaff

by NaturPro in Product Development, Quality Comments: 0

The supply chain for hemp ingredients like CBD is crowded, with the whole spectrum of quality available. At the top are legitimate, transparent sources exerting extreme care, control and expertise. At the bottom, a glut of traders and speculators who are blind to product provenance and production.

Sep

Supplement & Distributor SOP’s and Procedures

by NaturPro in Quality, Uncategorized Comments: 0

If you market or sell your own label of supplement or food product that is manufactured by a third party, such as a contract manufacturer or copacker, then you are responsible for its manufacture and labeling—even if you never physically touch the product.

May

Dietary Supplement Facts and Label Review

by NaturPro in Quality, Uncategorized Comments: 26

There’s a lot of detail required for dietary supplement labels. Between supplement facts, structure-function health claims, content claims, and required formatting, it’s easy to overlook some of the FDA requirements for labeling.

Supplement Label Review for Supplement Facts, Nutrition Labeling and Claims

Dietary Supplement Facts and Label Review

As part of our Label Review services, NaturPro helps clients develop, review and suggest improvements to dietary supplement labels, to ensure compliance with FDA regulatory requirements

Our clients enjoy the following benefits:

Reliability: 100% accuracy and FDA compliance
Experience: 15+ years of experience reviewing supplement labels
Science-driven: Our reviews are based on the most current, reliable information, techniques and evidence
Perspective: We have experience on the business side of the industry, so we know what the law is, whether it’s followed, and what is likely to happen if you don’t.

Updated Pricing:

Label Review (Basic): $350-550 — review only label — for “red flags” and suggested improvements

Label Review (Complete): $550-850 – review of label for red flags and suggested improvements, and matching finished product specifications

Label and Marketing Review: $800-1500 per label – web page / sales sheet

(Volume discounts may apply for similarly labeled products — Contact for Pricing

FDA Dietary Supplement Labeling Guidelines

See our Dietary Supplement Label Review Checklist.

The following outlines some of the most frequently asked questions (FAQ) for dietary supplement labels:

How are dietary supplements defined?Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients:
1. A vitamin;
2. A mineral;
3. An herb or other botanical;
4. An amino acid;
5. A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
6. A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements.
What label statements are required on the containers and packages of dietary supplements?Five statements are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.
Where do I place the required label statements?You must place all required label statements either on the front label panel (the principal display panel) or on the information panel (usually the label panel immediately to the right of the principal display panel, as seen by the consumer when facing the product), unless otherwise specified by regulation (i.e., exemptions).
What label statements must I place on the principal display panel?You must place the statement of identity and the net quantity of contents statement on the principal display panel. Where packages bear alternate principal display panels, you must place this information on each alternate principal display panel.
How do I locate the principal display panel?The principal display panel of the label is the portion of the package that is most likely to be seen by the consumer at the time of display for retail purchase. Many containers are designed with two or more different surfaces that are suitable for use as the principal display panel. These are alternate principal display panels.
What label statements must I place on the information panel?You must place the “Supplement Facts” panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor on the information panel if such information does not appear on the principal display panel, except that if space is insufficient, you may use the special provisions on the “Supplement Facts” panel in 21 CFR 101.36(i)(2)(iii) and (i)(5). See questions 46 and 56 in Chapter IV for more details.
Where is the information panel?The information panel is located immediately to the right of the principal display panel as the product is displayed to the consumer. If this panel is not usable, due to package design and construction (e.g. folded flaps), the panel immediately contiguous and to the right of this part may be used for the information panel. The information panel may be any adjacent panel when the top of a container is the principal display panel.
What name and address must I list on the label of my product?You must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address.
May I place intervening material on the information panel?No. You may not place intervening material, which is defined as label information that is not required (e.g., UPC bar code), between label information that is required on the information panel.
What type size, prominence and conspicuousness am I required to use on the principal display panel and the information panel?You are required to use a print or type size that is prominent, conspicuous and easy to read. The letters must be at least one-sixteenth (1/16) inch in height based on the lower case letter “o,” and not be more than three times as high as they are wide, unless you petition for an exemption in accordance with 21 CFR 101.2(f). The lettering must contrast sufficiently (it does not need to be black and white) with the background so as to be easy to read. See Chapter IV for the type size requirements for the nutrition label.
Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?Yes. Unless excepted by law, the Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.
What is the nutrition label for a dietary supplement called?The nutrition label for a dietary supplement is called a “Supplement Facts” panel.
1. You must list dietary ingredients without RDIs or DRVs in the “Supplement Facts” panel for dietary supplements. You are not permitted to list these ingredients in the “Nutrition Facts” panel for foods.
2. You may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements. You cannot list the source of a dietary ingredient in the “Nutrition Facts” panel for foods.
3. You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the “Supplement Facts” panel.
4. You must include the part of the plant from which a dietary ingredient is derived in the “Supplement Facts” panel for dietary supplements. You are not permitted to list the part of a plant in the “Nutrition Facts” panel for foods.
5. You are not permitted to list “zero” amounts of nutrients in the “Supplement Facts” panel for dietary supplements. You are required to list “zero” amounts of nutrients in the “Nutrition Facts” panel for food.How does “Supplement Facts” differ from “nutrition facts?”The major differences between “Supplement Facts” panel and “Nutrition Facts” panel are as follows:
What information must I list in the “Supplement Facts” panel?You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement. For example, when the net quantity of contents statement is 100 tablets and the “Serving Size” is one tablet, the “Serving Per Container” also would be 100 tablets and would not need to be listed.
How must I display the “Supplement Facts” panel?The “Supplement Facts” nutrition information (referred to as a panel) must be enclosed in a box by using hairlines. The title, “Supplement Facts,” must be larger than all other print in the panel and, unless impractical, must be set full width of the panel. The title and all headings must be bolded to distinguish them from other information.
How must I present the information in the “Supplement Facts” panel?You must present all information using the following:
1. A single easy-to-read type style;
2. All black or one color type, printed on a white or neutral contrasting background, whenever practical;
3. Upper- and lowercase letters, except that you may use all uppercase lettering on small packages (i.e., packages having a total surface area available to bear labeling of less than 12 square inches);
4. At least one point leading (i.e., space between lines of text); and
5. Letters that do not touch.
What are the type size requirements for the “Supplement Facts” panel?Except as provided for small and intermediate-sized packages, you must set information other than the title, headings, and footnotes in uniform type size no smaller than 8 point. You also must use a type size larger than all other print size in the nutrition label for the title “Supplement Facts.” You may set the column headings and footnotes in type no smaller than 6 point type. See the section on “Special Labeling Provisions” for the exceptions for small and intermediate-sized packages.
For more information, visit FDA Dietary Supplement Labeling Guide

Jan

Supplement contract manufacturing recall ‘unprecedented’

by NaturPro in Quality, Uncategorized Comments: 0

Blake Ebersole, founder and president of NaturPro Scientific LLC, a consulting firm in the natural products industry, lauded FDA for its ultimate enforcement action. “Companies like this are a big drag on the industry and they’re putting out potentially unsafe products, giving responsible companies a black eye,” he said in an interview.

Jan

Dietary Supplement Recall

by NaturPro in Quality, Uncategorized Comments: 5

January 17, 2020 — Dietary Supplement Recall announced for 1,200 products from 850 supplement distributors made between January 2013 and November 2019.

FDA Supplement Recall on 1200 product from 850 companies made from 2013-2019

ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. (the “COMPANIES”) is conducting a nationwide recall of ALL lots of its dietary supplement products pursuant to a Consent Decree entered by the U.S. District Court for the Eastern District of New York. This recall applies to all dietary supplement products manufactured and sold between January 2013 – November 2019 and all lots of products are included in this recall.

These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations. Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process resulting in finished supplement products with decreased identity, purity, strength and composition.

To date, there have been no reported illnesses or injuries as a result of this situation.

The COMPANIES contract manufactured dietary supplements for other firms and did not sell products directly to consumers. Link to Press Release

Contract Manufacturing Advocacy and Recall Prevention

It’s important to recognize the differences between GMP certification and GMP verification.

If you own a supplement brand, and are not 100% sure whether your supplement contract manufacturer is meeting FDA requirements, contact us.

Jan

Contract Supplement Manufacturer Advocates

by Morgan Settle in Product Development, Quality, Uncategorized Comments: 12

Behind every successful product is a great contract supplement manufacturer.

We’ve audited and worked together with a lot of contract manufacturers.

That means we know how to get the best value, at the best quality, from supplement contract manufacturer partners.

Nov

Choosing the best independent supplement testing labs

by NaturPro in Quality, Uncategorized Comments: 0

Overall, brand marketers/manufacturers are best served if they have a lab qualification procedure in place just as they have a supplier qualification procedure, according to Blake Ebersole, president, NaturPro Scientific.

Aug

FSVP: FDA’s Requirements under FSMA for Imported Ingredients

by NaturPro in Quality Comments: 1

Importing any food or supplement products? Do you have training, procedures and records according to FDA’s FSVP guidance?

Many firms in the food and dietary supplement industry are quietly putting significant investment into meeting the Food Safety Modernization Act (FSMA). FSMA was signed by President Obama in 2011 as the first major legislation to update food safety regulations in more than 50 years. FSMA and FSVP represent the best approach to ensuring a safe global food chain.

For supplements and health foods, its more reliable to verify than it is to trust.

FDA Requires You To Do these Things:

Your FSVP includes all written procedures and records that demonstrate compliance with FSMA, especially the requirements for Supply Chain Preventive Controls (PC). If you purchase any ingredients directly from foreign sources outside the U.S., then you must have a written FSVP. And if your U.S. based supplier imports ingredients, you are responsible for verifying their FSVP is effective.
Warehouses, marketers and distributors, and supplement manufacturers are subject to “modified” FSVP requirements. Even if you don’t receive product, or open any containers, you must still verify those you designate to handle, order, process or store your product. If your name is on the label of any product or package, then you must be able to show (with written documentation) that your supplier, warehouse, processor, and customer ensures the safety of the product within 24 hours of the FDA visiting you or requesting this information by phone.
If you import, own and/or have a financial stake in the imported goods, then you are probably responsible for the goods as the designated “FSVP Importer”. For imports involving multiple U.S. parties, there must be a written agreement specifying who is responsible for what. Foreign firms who send goods to the U.S. without a designated buyer must have a U.S.-based agent to act as importer, and take responsibility for the shipment once it arrives to the U.S.
You need to have a Qualified Individual or QI to write your FSVP. No standard training is required to be a QI, but it will greatly help your QI to be trained on PCQI and/or FSVP. Because the final FSVP rule includes more than 300 mentions of the word ‘flexibility’, you still gotta know what you’re doing.
With few exceptions, importers must perform a hazard analysis on all imported products. This requires you to know how your ingredients are grown and made, where they came from, and what biological, chemical or physical hazards may be present that could make them unsafe. A hazard requiring a preventive control is defined as one that is “known or reasonably foreseeable to cause significant injury or illness”. It’s up to your QI to determine these hazards. You can agree in writing with your supplier or customer to ensure that they are responsible for a preventive control – otherwise, the responsibility probably falls on you.
The most common hazards are:
1. Undeclared allergens
2. Salmonella
3. Listeria
4. These three are the source of 88% of all product recalls!
Economically Motivated Adulteration (EMA) and radiological contamination are often overlooked as hazards, and often require PC in the FSVP guidance.
Much of the available information on hazards is provided by FDA for free. Some examples:
1. FDA Import Alerts
2. FDA Warning Letters
3. FDA Product Recalls
4. FDA Guidance on Potential Hazards for Foods and Processes
5. FDA Bad Bug Book
6. FDA Guidance on Chemical Hazards
7. FDA Reportable Food Registry
8. Product specifications that control for hazards like salmonella and allergens. These are often not publicly available, but many are found on industry databases like UL Prospector.
The easiest and most impactful thing you can do to start evaluating your foreign supplier is to request their hazard analysis!
Third party experts are the most popular way to develop FSVP programs. A couple days of staff training is not the same as experience and expertise, especially with today’s global supply. Remember that suppliers are not allowed to verify themselves – this duty is left to customers, third party auditors, or other qualified individuals sent on behalf of the customer.

If you don’t have the time or expertise on staff to handle your supplier verification according to FSMA, make sure you talk to someone trained in FSVP with experience in qualifying your type of products and suppliers.

For more information on FSVP, visit the FDA page “FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals”

NaturPro Scientific LLC is a leading natural products consultancy specializing in evaluating and maximizing the value of foods and dietary supplements. Contact us for more information at https://naturproscientific.com/contact-us.

Mar

Cannabis, Hemp & CBD | SOP and Procedures

by NaturPro in Quality, Uncategorized Comments: 22

Standard Operating Procedures (SOP) for Cannabis, CBD and Hemp operations are required for every type of business — even if you are only a distributor or marketer.

Our experts have decades of experience with all types of document requirements, for all types of firms — especially SOP supporting the following:

Good Manufacturing Practices (GMP’s)
Good Agricultural and Collection Practices (GACP)
Good Distribution and Storage Practices

Need help with your SOP’s and GMP’s? Contact us!

Our goal is to help you meet Cannabis, CBD and Hemp regulatory requirements as efficiently as possible.

Cannabis & Hemp Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging, marketing, distribution, or testing business.

Cannabis SOP are required by each state where cannabis, marijuana or hemp are regulated.

Cannabis SOP and procedures are required in every state or jurisdiction.

All cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of regulations and standards from seed to shelf.

NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.

Startups who invest in solid standard operating procedures (SOP) accelerate their growth from the start.

The worst thing a start-up can do is go in blind to what their processes and procedures — their Good Manufacturing Practices — should be.

But within a patchwork of regulations, processes and procedures depend on the type of product you are making.

So what GMP guidelines should you follow?

Here’s some free advice, that’s common sense: Follow the most applicable regulatory guidelines, that are closest to your type of product.

The following types of products are generally considered dietary supplements, which are products intended to supplement the diet, but not replace food. Supplements in the U.S. are governed by 21 CFR 111, Good Manufacturing Practices (GMP) for Dietary Supplements:

Tinctures
Oils
Capsules and Softgels
Tablets
Powders
Food products with structure-function claims nutrients without recommended daily values

The following types of products are generally considered foods, governed under 21 CFR 117, that are FDA GMP’s for Food:

Protein powders
Ready to drink beverages
Snacks
Infused coffee and tea

Need help with your SOP’s and GMP’s? Contact us!

When it comes to other types of products, standards or test methods, we generally recommend to pick the most relevant standards for your type of product.

Here is a basic set of quality management SOP’s for a Food facility:

Quality Management Systems
1. Product Quality Policy/Manual
2. Recordkeeping
  1. Document Control
  2. Formula Records
  3. Batch Records
  4. Certificates of Analysis
3. Traceability & Recall
4. Risk Analysis
  1. Hazard Analysis
  2. Purchasing Criteria & Specifications
  3. Supplier Qualification
  4. Intentional Adulteration
  5. Preventive Controls
5. Product Approval & Rejection, Material Inspection
6. Complaints & CAPA (Corrective Actions)

We recommend to follow the standards and requirements set by FDA and other standards-setting organizations:

Need help with your SOP’s and GMP’s? Contact us anytime!

Farmers are at the root of high quality product, so here’s some free SOP’s for farmers, followed by a sample guidance proposed for cannabis, hemp and CBD agricultural materials (i.e. “Farm SOP’s”)

CANNABIS, HEMP AND CBD FARM SOP LIST

Cultivation or Processing
1. Management
2. Applicable Regulations
3. Operations
4. Training & Safety
5. Hygiene
6. Sanitation & Cleaning
7. Farm or Facility
8. Equipment
9. Seeds and Propagation Materials
10. Agricultural Inputs
11. Pre-harvest practices
12. Harvesting
13. Post-harvest practices
14. Drying & Milling
15. Sampling
16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
17. Waste Management

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A BASIC EXAMPLE for FARM OPERATIONS

The following information is a partial excerpt from draft from U.S. Hemp Roundtable guidance for CBD products, which NaturPro was fortunate to contribute to.

CBD SOP’s and Cannabis Procedures

U.S. Hemp Guidance Program PHASE 2

1 GROWER
1.1 GENERAL TERMS & DEFINITIONS

The following Definitions and Interpretations apply to such terms when used in this U.S. Hemp Guidance Program.

Adulteration refers to a food that may be considered adulterated if it contains “any poisonous or deleterious substance which may render it injurious to health…..or if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is”.

Batch means a specific quantity of industrial hemp that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified period of time according to a single manufacturing record.

Batch number, or lot number means any distinctive group of letters, or numbers, or any combination of them, from which the complete history of the processing, packaging, labeling, and/or storage of a batch or lot of industrial hemp product can be determined.

Biomass means the amount of living matter in a given habitat, expressed either as the weight of organisms per unit area or as the volume of organisms per unit volume of habitat.

Component means any substance intended for use in the manufacture of industrial hemp, including those that may not appear in the finished batch of the industrial hemp.

Growth Medium means the solid, liquid or semi-solid substance used to support the growth of the plant.

Hemp refers to cannabis varieties and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis.

Industrial Hemp is Hemp
Ingredient means any substance that is used in the manufacture of hemp and that is intended to

be present in the finished batch of the hemp product.

In-process material means any material that is compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any way for use in the manufacture of the hemp product.

Lot means a batch, or a specific identified portion of a batch, or, in the case of a hemp product produced by continuous process, a specific identified amount produced in a specified unit of time or

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U.S. Hemp Guidance Program PHASE 2

quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

Microorganisms means yeasts, molds, bacteria, viruses, toxins, and other similar microscopic organisms which may or may not have a health or sanitary concern.

Pest means any objectionable insect or other animal including but not limited to birds, rodents, flies, mites, and larvae.

Physical plant or facility means all or any part of a building or facility used for or in connection with manufacturing, processing packaging, labeling, or storage of industrial hemp products or ingredients.

Processor means making a transformative change to the hemp plant or product following harvest.

Product complaint means any communication that contains any allegation, written, electronic, or oral, expressing concern, which may or may not have be related to the quality of an industrial hemp product.

Quality means that the hemp product meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.

Quality Management Systems means a planned and systematic operation or procedure for ensuring the quality of a hemp product.

Quality Management Systems personnel means any person, persons, or group, within or outside the organization, designated to be responsible for quality control operations.

Representative sample means a sample with an adequate number of units that are intended to ensure that the sample accurately portrays the material being sampled.

Reserve sample means a representative sample of product that is held for a designated period of time.

Sanitize means to adequately treat cleaned equipment, containers, utensils, etc.by a process that is effective in destroying of microorganisms of public health concerns.

U.S. Hemp Guidance Program PHASE 2

1.2 REGISTRATION/APPLICATION/NOTIFICATION

Prior to the Industrial Hemp Grower planting any seed, a license or agreement with the State must be obtained. The following information is required to make the application before a license will be issued: (Each State may have different regulations – refer to application – See Kentucky Hemp Policy Guide as an example)

1.2.1 Registration/Application Guidance

Name of the person or corporation to whom the license or authorization is to be issued
Address of the farm or place including county and township or legal description
The number of acres
Global Positioning System coordinates
Intended purpos of industrial hemp
In the case of a plant breeder, the variety of industrial hemp that may be cultivated; and

o Any conditions that are necessary to minimize security, public health or safety hazards related to the licensed or authorized activities.

o Specify if the hemp is for food or non-food purposes

1.2.2 Notification of Changes to the licensor by the licensee

Every licensee shall notify the State of any changes to the information provided on the application, within 15 days after the change, including:

Corporate name or ownership, or officers, and the replacement of an officer, or director
Any change to the address of the licensee
The replacement of an individual referred to a licensee
Any change in the mailing address of the licensee
Any change in the ownership of the land used to cultivate industrial hemp
Any change to the approved cultivar being sown or, in the case of a plant breeder, to thevariety of industrial hemp being sown;
Any genetic modification.

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Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

U.S. Hemp Guidance Program PHASE 2

1.3 PERSONNEL

Qualified employees who grow, manufacture, package, or label industrial hemp shall be qualified to do so, and those responsible for quality control or performing any quality control operations, must have the education, training, or experience to perform the assigned functions.

Supervisors shall be qualified by education, training, or experience to supervise.
Contamination Prevention and Hygienic measures shall be taken to exclude from any operations

any person who might be a source of microbial contamination.

Such measures shall include the following:

Exclude personnel from working in any operations that may have an illness, infection, open lesion, or any other abnormal source of contamination.
Instructing employees to notify their supervisor if there is a possibility that they have a health condition described above.
Wearing outer garments in a manner that protects against the contamination.
Maintaining adequate personal cleanliness.
Washing hands thoroughly, and sanitizing if necessary, in a hand-washing facility.
Removing or covering all unsecured jewelry and other objects that might fall into components, industrial hemp, equipment, or packaging.
Using gloves when appropriate.
Wearing, where appropriate, hair nets, caps, beard covers, shoes, PPE etc.Personnel and employee safety measures shall include the following:

Appropriate and Adequate First Aid Equipment
Adequate bathrooms and changing rooms
Appropriate OSHA warnings, labels, and training
Appropriate training and personal protective equipment for pesticide application

U.S. Hemp Guidance Program PHASE 2

1.3.1 U.S. HEMP GUIDANCE – GROWER – PERSONNEL CHECKLIST
√ ifApplicable		YES	NO	NOTES
	Are the supervisors qualified for their responsibilities by training, education or experience?
	Do the employees performing the growing, processing, packaging and labeling tasks, have the proper training necessary to perform the tasks?
	Are contamination and hygienic measures in place to exclude personnel who might be a source of contamination?
	Are personnel excluded from operations if they have, an illness, infection, open lesion, or any other abnormal source of contamination?
	Do employees notify their supervisor if there is a possible health condition as described above?
	Do personnel wear outer garments in a manner that protects against the contamination?
	Do operating personnel maintain adequate personal cleanliness?
	Are hand washing facilities available and used?
	Do operating personnel remove or cover unsecured jewelry etc. to prevent them from falling into hemp products or causing harm?
	Are gloves used when appropriate?
	Are caps, shoes and head covering used when appropriate?
	Is the appropriate Personal Protective Equipment (PPE) used as needed?
	Are there adequate and appropriate first aid equipment available?
	Is there adequate bathrooms and changing rooms?
	Are the OSHA warnings and signs visible?
	Has there been adequate training?
	If applicable is the PPE and trains available for the pesticide applicators?

Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

U.S. Hemp Guidance Program PHASE 2

1.3.2 U.S. HEMP GUIDANCE – GROWER – BEST MANAGEMENT PRACTICES CHECKLIST

NOTES

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	YES	NO
Are you using the best soil available?
Have you Soil tested for macro and micro nutrients?
Have you used the appropriate Growth Medium for intended purposes?
Has the licensee determined the concentration of THC in the hemp?
Is seed planted listed on the license?
Is the entire hemp plant used as licensed?
Do you properly use pre- plant weed control?
Do you have a Germination Certificate from the seed supplier
Did you use the proper Certified Seed suitable for location?
Did you use the proper seed treatment?
Do you have a site history?
Do you have a water quality report or history?
Did you use fertilizer to target desired yield per acre according to soil test?
Did you use animal manure for fertilizer or biomass purposes?
Did you plant by optimum seeding date?
Did you plant at the optimum rate of seeds per acre?
Have samples of the industrial hemp been collected in accordance with the Guidance Procedures?
Has the equipment used to sow, harvest and transport the hemp been thoroughly cleaned to prevent contamination?
Are you prepared to harvest when the plant is ready?
Have you complied with the drying procedures
Do you have sufficient and proper storage facilities or adequate transportation equipment available?
Is the biomass sold to a licensed person or entity according the Guidance Procedures?
Is the biomass packaged, labeled, and transported according to the Transportation Guidance Procedures?
Has any loss or theft been reported according to the license requirements?
Are the records being kept according to the Guidance Procedures for Record Retention?

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Grower Signature___________________________ Date _________________ Printed Name___________________ Farm location or identifier__________________

U.S. Hemp Guidance Program PHASE 2

1.3.3 U.S. HEMP GUIDANCE – GROWER – FACILITY & BIOSECURITY AWARENESS CHECKLISTA.

√ ifApplicable

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Facility Security (physical security of buildings and grounds)
Is the facility using:	YES	NO	NOTES
Security lighting
Perimeter fencing
Controlled gate access
Off-hours security guard
Electronic motion detectors
Door alarms
Video cameras
Adequate indoor lighting
Alarms linked to an off-site security system
Door hardware is of industrial design
Guards are installed on exterior ladders
Exit doors and gate are electronically/mechanically secured
Entry and discharge points of exterior tanks are padlocked when not in use
All vehicles parked outside are locked
Empty/loaded containers are parked inside
Law enforcement patrol over company premises on regular but unpredictable basis
Employees reporting any suspicious behaviors
Restricted access to computer process control and data systems
Safeguard of data systems using data security program
Backup of all data and processes at an off-site place

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√ ifApplicable

Visitor Policy

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Is the facility using:

YES

NOTES

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Company representative for visitor to check in with

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Signs informing visitors where to report

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Specific area for visitor parking

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Records of visitors (include name, company, arrival and departure, and purpose of visit)

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Visitor badges/identification cards

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Company representative to escort visitor all the time

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Restricted access to key manufacturing areas

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√ ifApplicable

Distribution

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Is the facility implementing the following:

YES

NOTES

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Bulk containers are inspected prior to loading for foreign and/or suspicious material

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U.S. Hemp Guidance Program PHASE 2

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Verify that all customer pick-up drivers are representatives of the customer
The product stream is inspected visually
Container access points are secured after loading
Seal numbers are documented on the shipping papers
Shipping documents are used to identify the contents of each compartment
Shipping log is maintained
Bio-sanitation program is implemented
Procedures exist to disinfect vehicles and drivers

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√ if Applicable

√ ifApplicable

Housekeeping

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Is the facility implementing the following:

YES

NOTES

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Written housekeeping program for all areas of the facility

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Written pesticide and rodenticide program

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Emergency Response

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Is the facility implementing the following:

YES

NOTES

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Employees are adequately trained to respond to a crisis as calmly and safely as possible

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Current inventory of all hazardous and flammable products

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A plan to provided MSDS to emergency response teams etc.

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A list of emergency contacts is posted

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An action plan to deal with suspicious devices or substances

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Evacuation plan in case of fire and explosions is published

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Establish and maintain an up-to-date employee roster and visitor log to facilitate personnel head count at any time

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Disaster Preparedness Plan

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A weapons security program

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Conduct evacuation and respond drill periodically

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Post a site plan depicting escape routes, fire-fighting and rescue equipment

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Signature: _____________________________
Printed Name: __________________________ Company: ________________________________

Date: ________________________________ Facility Location: ________________________________8

U.S. Hemp Guidance Program PHASE 2

1.4 SAMPLING AND HANDLING HEMP FOR THC & CBD1.4.1 Definitions

delta-9-THC means delta-9-tetrahydrocannabinol concentration.
Authority having jurisdiction usually means the state, but it could be FDA, USDA,

county or city.

Certified seed means seed for which a certificate or any other instrument has been issued, by an agency authorized under the laws of a state, territory, or possession to certify seed and which has standards and procedures approved by the United States Secretary of Agriculture to ensure the genetic purity and identity of the seed certified.

Plot means a contiguous area in a field, greenhouse, or indoor growing structure containing the same variety or strain of hemp throughout the area.

ppm means parts per million.ppb means parts per billion.

Post-Harvest Sample means a sample taken from the harvested hemp materialfrom a particular plot’s harvest. The entire plot’s harvest must be in the same form(e.g., intact-plant, flowers, ground materials, etc.), homogenous, and not mixed with non-hemp materials or hemp materials from another plot.

Pre-Harvest Sample means a composite, representative portion from plants in a hemp plot collected in accordance with the procedures as defined by the state providing authority.

Processing means converting an agricultural commodity into a marketable form.Prohibited Variety means a variety or strain of cannabis excluded from the state

providing authority.

Sample means a sufficient amount of material that is representative of the population from which it is taken. A sample may be a particular plant part, including inflorescence (flower), leaf, stalk or seed, or it may be a processed product (oil, extract, powder. Samples must be dried to a sufficiently low moisture content so as not to harbor growth of microorganisms.

Seed source means the origin of the seed or propagules as determined by the state providing authority.

U.S. Hemp Guidance Program PHASE 2

1.4.2 Sampling Timeline and Grower Responsibilities
1. The grower shall refer to the jurisdiction having authority to determine a timeline.
2. During the sampling, the grower or an authorized representative shall be present at the growing site.
3. Floral materials harvested for phytocannabinoid extraction shall not be moved beyond the processor, nor commingled, nor extracted, until test results are complete
1.4.3 Pre-Harvest Sampling Procedure
1. Adequate personal protective equipment shall be used.
2. Proper equipment shall be used to prevent cross contamination.
3. The material selected for Pre-Harvest Sampling will be determined by the grower. Cuttings will be collected to make one representative sample.
4. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
  1. Clip the top 12 inches of hemp plant’s primary stem, including female floralmaterial.
  2. Take cuttings from at least five (5) hemp plants within the plot.
  3. Place the complete sample in a paper bag.
  4. Seal the bag by folding over the top once and staple the bag shut.
  5. A separate sample must be taken from each non-contiguous plot of a given variety.
  6. A separate sample must be taken for each variety.
  7. Samples shall be secured in a paper bag (to allow for air-drying during transport).
  8. Label the sample container with a sample ID.
1.4.4 Handling Procedures of Pre-Harvest Samples
1. Samples will be taken for drying and storage.
2. Samples should be arranged in a single layer for drying.
3. Drying oven will be used when possible.
4. Samples in the oven will be left in the labeled sample bag.
5. If selected for testing, the entire sample will be sent to a testing lab for analysis.
1.4.5 Post-Harvest Sampling Procedures for Floral Material
1. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
2. Adequate personal protective equipment shall be used.
3. Proper equipment shall be used to prevent cross contamination
4. The plot selected for sampling shall be designated by the Pre-Harvest Sampleresults. The material selected for Post-Harvest Sampling from this plot will be

U.S. Hemp Guidance Program PHASE 2

determined by the grower. All Post-Harvest Samples of floral material shall be taken from the designated harvested plot materials in the form (intact-plant, flowers, ground materials, etc.) in which the material will be sent to the processor

e. Grower must inventory the entire harvest to determine the form in which it exists and follow the protocol as appropriate in part a), b), or c) below.

If, upon inventory, the grower determines that the entire harvest is not in a homogenous form (intact-plant, flowers, ground materials, etc.), it must be determined to take additional samples or other course of action or take the pre-harvest results.
For intact-plant post-harvest samples:
1. Ensure that the entire harvest is accounted for and in the sameform (i.e., intact-plants).
2. Clip the top 12 inches) of hemp plant, primary stem, includingfemale floral material.
3. Take cuttings from at least five (5) non-adjacent hemp plantswithin the harvest’s storage/drying area.
4. Place the complete sample in a paper bag.
5. Seal the paper bag by folding over top once and stapling to keep closed.
6. Complete sampling procedures in part (d) –(f).
For ground plant or ground floral material Post-Harvest Samples:
1. Ensure that the entire harvest is accounted for and in the sameform (i.e., all harvested material whether whole plant or floral material only must be ground with no intact plants or whole flowers remaining from that harvest).
2. Sample material from bag or container.
3. Sample from a minimum of four locations within the containers from a given harvest.
4. Place the complete sample in a plastic sample container.
5. Seal the plastic sample container.
6. Complete sampling procedures in part (d) –(f).
For Post-Harvest Samples in other forms (e.g., trimmed floral material, or floral material and stems, etc.):
1. Ensure that the entire harvest is accounted for and in the same form (i.e., all harvested material must be uniform).
2. Randomly collect at least one cup of material by volume.
3. Place the complete sample in a paper bag or plastic containerand seal the container, as appropriate.
4. Complete sampling procedures in part (d) –(f).
A separate sample must be taken for each plot designated for Post-Harvest Sampling.
Samples shall be labeled and prepared for transport to the lab.
Label the sample container with a sample ID.

U.S. Hemp Guidance Program PHASE 2

1.4.6 Handling Procedures of Post-Harvest Samples

The entire sample will be sent to the testing lab for analysis.
Industrial hemp crops generated from Certified seed will incur pre-harvest testing of at least five percent (5%) of growing plots per variety, per seed source.
Industrial hemp crops from planting materials other than Certified seed will incur pre- harvest testing of at least fifty percent (50%) of growing plots per variety, per seed source.
100% of post-harvest samples will be tested.