ASTM D8250-19

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D8250 − 19
Standard Practice for
Applying a Hazard Analysis Critical Control Points (HACCP)
System for Cannabis Consumable Products
This standard is issued under the fixed designation D8250; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Terminology
3.1 Definitions:
1.1 This practice addresses the principles to follow when
3.1.1 cannabis consumable products—cannabis products
implementing and managing a Hazard Analysis Critical Con-
that are directly consumed by people or animals either through
trol Point (HACCP) system for cannabis consumable products.
ingestion or inhalation.
This practice is not intended for cannabis industrial products
(e.g., hemp products).
3.1.2 Codex Alimentarius—collection of internationally rec-
ognized standards, codes of practice, guidelines, and other
1.2 Units—The values stated in SI units are to be regarded
recommendations relating to foods, food production, and food
as standard. No other units of measurement are included in this
safety.
standard.
3.1.3 control—management of a condition to ensure that the
1.3 This standard does not purport to address all of the
compliance to a criterion is being met.
safety concerns, if any, associated with its use. It is the
3.1.4 control point—step in which a biological, chemical
responsibility of the user of this standard to establish appro-
(including radiological), and physical hazard can be controlled.
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use. 3.1.5 correction—immediate action taken to correct a non-
conformance.
1.4 This international standard was developed in accor-
dance with internationally recognized principles on standard-
3.1.6 corrective action—action taken to correct a non-
ization established in the Decision on Principles for the
conformance; it requires that the root cause is identified to
Development of International Standards, Guides and Recom-
ensure that the non-conformance does not re-occur.
mendations issued by the World Trade Organization Technical
3.1.7 critical control point (CCP)—step at which control
Barriers to Trade (TBT) Committee.
can be applied and is essential to prevent or eliminate a food
safety hazard or reduce it to an acceptable level.
2. Referenced Documents
3.1.8 critical limit—maximum and/or minimum value to
2.1 ASTM Standards:
which a biological, chemical, or physical parameter shall be
E2590 Guide for Conducting Hazard Analysis-Critical Con- controlled at a CCP to prevent, eliminate, or reduce to an
trol Point (HACCP) Evaluations
acceptable level the occurrence of a food safety hazard.
3.1.9 deviation—failure to meet a critical limit.
2.2 Other Documents:
HACCP Principles and Applications Guidelines
3.1.10 hazard analysis critical control point (HACCP)—a
General Principles of Food Hygiene
systematic approach to the identification, evaluation, and
control of hazards that may be present in cannabis consumable
products.
This practice is under the jurisdiction of ASTM Committee D37 on Cannabis 3.1.11 HACCP team—a multidisciplinary group of people
and is the direct responsibility of Subcommittee D37.02 on Quality Management
that work at the site and are responsible for developing,
Systems.
implementing, and maintaining a HACCP system.
Current edition approved March 1, 2019. Published March 2019. DOI: 10.1520/
D8250-19.
3.1.12 hazard—biological, chemical (including
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
radiological), or physical agent that can cause harm to the
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
consumer when it is not controlled.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3.1.13 hazard analysis—the process of collecting and evalu-
National Advisory Committee on Microbiological Criteria for Foods, August
ating information about the hazards associated with the canna-
14, 1997 (www.fda.gov).
bis consumable product to determine its significance and
Codex Alimentarius, Food and Agriculture Organization (FAO) CA/RCP
1-1969, Rev 4. 2003. whether it needs to be addressed in the HACCP system.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D8250 − 19
3.1.14 monitoring—to conduct a series of pre-planned ob- control, or minimize hazards (biological, chemical, or physi-
servations and/or measurements to assess whether the CCP is cal) to an acceptable level. A HACCP system can prevent
under control and to generate records that will be used for consumer harm when implemented and followed correctly.
verification purposes.
6. Practice
3.1.15 pre-requisite programs (PRP)—procedures, includ-
6.1 The application of the HACCP principles shall be done
ing good manufacturing practices (GMPs), that address opera-
in the sequential steps outlined as follows:
tional conditions that provides the foundation for the HACCP
6.1.1 Preliminary Step 1: Assemble the HACCP Team—The
system.
HACCP team shall consist of individuals that have specific
3.1.16 preventive actions—actions taken to prevent non-
knowledge and expertise about the product and the operations.
conformances.
This can be accomplished by having a multidisciplinary team
3.1.17 severity—the seriousness of the effect(s) of the haz-
that includes all areas of the operation, such as engineering,
ard. production,qualityassurance,maintenance,andsanitation.Itis
theteam’sresponsibilitytodevelop,implement,andreviewthe
3.1.18 step—a point, procedure, operation, or stage in the
HACCP system. The individuals on the HACCP team shall
operation from primary production to final consumption.
work on the site where the cannabis consumable products are
3.1.19 validation—collection and evaluation of scientific
manufactured. The team may need assistance from external
and technical information to determine if the HACCP system,
resources, such as consultants, trade association experts, and
when properly implemented, will control the hazard.
regulatory authorities, that have knowledge of biological,
3.1.20 verification—those activities, other than monitoring,
chemical (including radiological), and physical hazards that
that determine that the HACCPsystem is valid and is operating
may be associated with the processes and the products.
as written.
However, caution shall be exercised when using external
resources. External resources shall never replace the expertise
4. Summary of Practice
of the site’s HACCP team. The team shall be fully involved
4.1 Sites that are engaged in the production of cannabis
during the development of the HACCP system as relying on
consumable products shall implement pre-pequisite programs
the technical experts alone may lead to a system that is
(PRPs), including good manufacturing practices (GMPs), prior
erroneous, incomplete, and lacking local personnel support.
to the application of a HACCP system. These PRPs shall
The HACCP team is responsible for ensuring that record
promote good hygiene and operational control practices as
review is done within seven working days and that re-analysis
outlined in the Codex Alimentarius and/or the regulations of
of the HACCP system is completed once a year, when new
the country where the cannabis consumable product is being
products are developed, when significant changes occur in
manufactured. These PRPs shall be well-established,
product, equipment or process step, or if there are new
operational, and verified to ensure successful development and
regulatory requirements. Records of the HACCP team
implementation of the HACCP system. Pre-Requisite Pro-
members, function within the team, and experience shall be
grams (PRPs) shall include operational and sanitary controls
part of the records included in the HACCP system (refer to
that ensure the hygienic and safe processing of cannabis
Appendix X1 for an example of a HACCP team). Records of
consumable products. For all types of businesses that manu-
training and competency for the members of the HACCP team
facture cannabis consumable products, management awareness
shall also be included.
and commitment are necessary for the implementation of a
6.1.2 Preliminary Step 2: Describe the Product—A full
HACCPsystem.Training is essential as the effectiveness of the
description of the cannabis consumable product shall be
system depends greatly on management and employees having
developed by the HACCP team. The product description shall
the appropriate knowledge and skills to competently complete
include information that is relevant to the food safety of the
their functions within the operations. The PRPs and HACCP
cannabis consumable product, such as composition (e.g.,
system shall be site specific and, therefore, shall address the
ingredients), chemical composition relevant to the cannabis
processesandhazardsassociatedwiththesiteand/oroperation.
consuming product safety (e.g., water activity, pH, etc.),
The HACCP system shall be reviewed (1) at a minimum
packaging (type and size), shelf life, storage conditions, and
annually, (2) when new cannabis consumable products are
distribution methods. Each product manufactured shall have its
developed, (3) when any modification is made to the cannabis
own description.
consumable product, equipment or process step, or (4) when
6.1.3 Preliminary Step 3: Identify Intended Use—Describe
new regulatory requirements are established. The five prelimi-
theintendeduseoftheproduct.Theintendeduseshallbebased
nary steps and the seven principles outlined in the Codex
on the expected use of the product by the end consumer.
Alimentarius shall be applied when developing the HACCP
Cannabis consumable products may be intended for
system. The preliminary steps and the seven principles are
recreational, medicinal, or nutritional use, etc. In addition,
outlined in Section 6.
cannabis consumable products may be intended to be con-
sumed by ingestion or inhalation. In specific cases, vulnerable
5. Significance and Use
groups of the population (e.g., immunocompromised individu-
5.1 This practice provides general guidelines for the devel- als) may need to be considered. Appendix X2 shows an
opmentandimplementationofaHACCPsystemforoperations example of documenting the product description and its
that manufacture cannabis consumable products to prevent, intended use.
D8250 − 19
6.1.4 Preliminary Step 4: Develop a Flow Diagram—Aflow and process. The suggested table for the process hazard
diagram is a sequence of steps followed to manufacture the analysis includes the CCP decision tree questions (refer to
cannabisconsumableproduct.Thepurposeoftheflowdiagram Appendix X5).
is to provide a clear overview of the steps that are followed on
6.1.7 Principle 2: Determine Critical Control Points
site in order to manufacture the cannabis consumable product.
(CCPs)—Acritical control point is a step in which control can
The same flow diagram can be used for different cannabis
be applied. It is essential to prevent, eliminate, or reduce the
consumable products, if they follow the same process. The
hazard to an acceptable level. Only significant hazards shall be
steps preceding and following the operational steps shall be
considered when determining the CCPs. A decision tree is a
taken into consideration when developing the flow diagram.
tool that can be used to determine the steps of the process that
provide essential control of the hazard (refer to Appendix X5).
6.1.5 Preliminary Step 5: Verify the Flow Diagram—The
However, the decision tree shall not substitute the knowledge
flow diagram shall be verified by the HACCP team during the
initial development and yearly after implementation of the of experts. Critical control points are located at any step of the
HACCP system. HACCP flow chart(s) shall also be verified process where the hazard shall be prevented, eliminated, or
reduced to an acceptable level. Facilities manufacturing the
when changes to process(es) or equipment(s) are made. The
same or similar products may have different critical control
verification shall take place at the manufacturing site during all
times of operation to ensure the accuracy of the flow diagram. points due to ingredient and/or processing differences. If the
This verification is not done at the desk, but rather, by walking hazard analysis does not lead to the identification of critical
control points, the process stops at the hazard analysis.
through the facility and following the sequence of steps
outlined in the diagram. Modifications to the flow diagram
6.1.8 Principle 3: Establish Critical Limits (CLs)—Critical
shall be made if discrepancies are found during the verification
limits establish the minimum and/or maximum value at which
process. The verifier(s) shall sign and date the flow diagram
thehazardisprevented,eliminated,orreducedtoanacceptable
upon completion of its verification.
level. Critical limits distinguish between safe and unsafe
conditions at a given CCP and shall not be confused with
6.1.6 Principle 1: Conduct a Hazard Analysis—The
operational limits, which are established for different purposes.
HACCP team shall conduct a hazard analysis once the five
preliminary steps are completed. The purpose of conducting a Critical limits shall be validated (have scientific basis) prior to
implementation.
hazard analysis is to identify significant hazards that most
likely can cause harm to the consumer of the cannabis
6.1.9 Principle 4: Establish Monitoring Procedures—
consumable product. All potential hazards (i.e., biological,
Monitoring procedures are a series of pre-planned activities of
chemical (including radiological), and physical) shall be con-
observations that shall be done for each critical limit at each
sidered for each step of the process when conducting a hazard
identified CCPto ensure that the hazard is under control.When
analysis. In addition, a hazard analysis shall be conducted for
designing monitoring procedures, it is important to assign the
all ingredients that are used to manufacture the final cannabis responsibility to key individuals responsible for the CCP. It is
consumable product (e.g., cannabis flower, extracted oil, etc.), also important to establish the frequency at which the moni-
packaging, and auxiliary materials used on sit
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