organizational structure that will ensure that their manufacturing
operations meet the requirements of part 1120. The organizational
structure should clearly delineate the parts of the organization and
personnel responsible for complying with the proposed requirements. FDA
has observed that it is standard industry practice to maintain an
organizational structure, position descriptions, and employee training
programs.
    Proposed Sec.  1120.12(b) would require finished and bulk tobacco
product manufacturers to employ sufficient personnel to carry out the
requirements of proposed part 1120. Personnel must have the background,
education, training, and experience, or any combination thereof, needed
to carry out the requirements of proposed part 1120. Each manufacturer
should determine the appropriate background and necessary education for
personnel to carry out these requirements. A manufacturer may determine
that appropriate certifications and job-related trainings are necessary
for a particular job function. For example, employees responsible for
quality assurance could take classes or coursework relevant to their
role auditing the production process and evaluating the final product
for conformance to tobacco product specifications and other
requirements established in the MMR. FDA recommends that such training
be updated on a regular basis so that responsible employees are aware
of current procedures and controls to ensure that they can consistently
meet the requirements of proposed part 1120. Proposed Sec.  1120.12(b)
would also require manufacturers to maintain appropriate written
records of the background, education, training, and experience of its
personnel in the format described in proposed Sec.  1120.12(f) and
discussed in more detail below.
    Proposed Sec.  1120.12(c) would require each finished and bulk
tobacco product manufacturer to designate, in writing (on paper or
electronically), the appropriate responsibility and authority for all
personnel who perform an activity subject to proposed part 1120.
Therefore, while proposed Sec.  1120.12(a) would require manufacturers
to establish an organizational structure, this provision would require
manufacturers to specifically designate the responsibilities and
authority for those personnel who would be responsible for performing
the activities required under proposed part 1120. This provision would
help manufacturers to ensure that their tobacco products conform to
their established specifications and reduce the likelihood that
nonconforming products would be distributed to consumers.
    Proposed Sec.  1120.12(d) would require finished and bulk tobacco
product manufacturers to designate, in writing (on paper or
electronically), management with executive responsibility that has the
duty, power, and responsibility to implement the proposed requirements
under proposed part 1120. Management with executive responsibility
refers to those individual(s) who are ultimately responsible for
ensuring compliance with proposed part 1120. This responsibility would
include the allocation of resources, including facilities, equipment,
materials, controls, and personnel used for the manufacture,
preproduction design validation, packing, and storage of a tobacco
product. These employees are typically senior employees with the
authority to establish or make changes to tobacco product manufacturing
policies and ensure that they are effectively communicated throughout
the organization. Management with executive responsibility would be
required to establish and maintain required processes and procedures to
ensure compliance with requirements under proposed part 1120. Such
person(s) also would be required to ensure that TPMP requirements are
communicated, understood, implemented, and followed at all levels of
the organization. FDA believes that this proposed requirement is
generally similar to existing industry practice.
    Proposed Sec.  1120.12(e) would require finished and bulk tobacco
product manufacturers to establish and maintain training procedures.
This provision would require that training procedures identify training
needs and establish training frequency for personnel based on the work
the employee performs. Under this provision, manufacturers should
assess whether employees need periodic or refresher training. FDA is
not proposing to prescribe the extent and frequency of training or type
of training, but rather the Agency believes that manufacturers should
have the flexibility to determine how to adequately train their
personnel to perform their assigned responsibilities in accordance with
proposed part 1120. For example, some tobacco manufacturing facilities
are only open for portions of the year and staffed with seasonal
personnel. In this case, a manufacturer may opt to train its personnel
at the start of each new manufacturing season.
    Proposed Sec.  1120.12(e) would also require finished and bulk
tobacco product manufacturers to train personnel on their assigned
responsibility and on the TPMP requirements relevant to their
responsibility. Under this provision, manufacturers would not be
required to train personnel on all the requirements of the proposed
regulation, but rather on the provisions of the regulation that are
relevant to their assigned responsibility,

including their understanding of the relevant procedures and how to
maintain applicable records. Training should also cover the
consequences of improper performance so that personnel will be apprised
of nonconformities that can result if they do not adequately perform
their assigned responsibility and implement the tobacco product
manufacturing requirements relevant to their responsibility.
    Proposed Sec.  1120.12(f) establishes the format for training
records required by Sec.  1120.12(b). These training records would be
required to include the type and description of the training, the
training date, the names of the parties performing and taking the
training, and documentation supporting completion. Training records
should demonstrate which personnel were trained, identify the training
completed, and illustrate whether that personnel received the proper
training for their job functions. Documentation supporting completion
may include the results of an assessment or examination given to
personnel upon completion of the training.
    The Agency believes that the proposed organization and personnel
requirements would assure that the public health is protected by
requiring that the responsible individuals at all levels of the
organization have the knowledge, experience, and training to ensure
that the establishment manufactures and distributes tobacco products
that conform to established specifications and are not contaminated
during the manufacturing process. Deficiencies in personnel
qualification and training could increase the likelihood that a company
manufactures and distributes nonconforming tobacco products. For
example, one company found that spotting and staining of nonconforming
finished cigarettes was due to improper training, when personnel used
plasticizer instead of casing in the manufacturing process (Ref. 18).
In addition, if an employee responsible for analyzing samples in the
lab is not properly trained on the techniques for sample preparation
and extraction to measure for pH in smokeless tobacco, the results may
be unreliable and could lead to products that do not conform to the
established specifications for distribution. The pH can influence the
availability of nicotine and increase the risk to consumers beyond
those normally associated with the product (Ref. 19).
    In addition, the Agency believes that the proposed personnel
requirements would help assure that tobacco products are in compliance
with the requirements of chapter IX of the FD&C Act. In particular, the
proposed requirements would help ensure that personnel with proper
background and expertise are participating in and monitoring the
production process, thus ensuring that the tobacco product does not
become adulterated or misbranded under section 902 or section 903 of
the FD&C Act. The proposed requirements also would help ensure that new
and modified risk tobacco products (MRTPs) are manufactured consistent
with the specifications provided in their applications (i.e., SE
Report, request for SE exemption, PMTA, MRTPA) and that pre-existing
products are manufactured consistent with their original
characteristics. For example, for an SE product, qualified personnel
are needed to ensure that tobacco products are manufactured to the
specifications described in the SE report. Similarly, these proposed
personnel requirements would help ensure that tobacco products that
were commercially marketed in the United States as of February 15, 2007
(pre-existing products), continue to be manufactured consistently with
their original characteristics.
    Qualified and trained personnel are vital to a controlled
production process. Requiring manufacturers to have qualified personnel
with designated roles and who are appropriately trained would help
ensure that personnel are competent in their assigned roles. This, in
turn, would help ensure that manufacturing operations are performed
correctly and would reduce the chances of adulteration during the
manufacturing process. For example, qualified personnel with specific
responsibilities to clean tobacco product-contact surfaces would help
decrease the likelihood that products contain filthy, putrid, or
decomposed substances, or are otherwise contaminated by added poisonous
or deleterious substances that may render the product injurious to
health. This would also help ensure that products are not prepared or
held under insanitary conditions.
2. Tobacco Product Complaints
    Proposed Sec.  1120.14 sets forth the requirements for the receipt,
evaluation, investigation, and documentation of all complaints. FDA
considers a ``complaint,'' in this context, to be any communication
(including written, electronic, and oral communication) that the
tobacco product does not meet expectations, is unsatisfactory or
unacceptable, or appears to be a nonconforming product. Tobacco product
complaints may come from any source, including healthcare
professionals, consumers, the public, and businesses (e.g., retailers,
other tobacco product manufacturers).
    The proposed requirements are generally similar to complaint
handling processes that FDA has observed during establishment
inspections. For example, FDA is aware that tobacco product
manufacturers generally maintain complaint records containing
information about nonconforming tobacco products, such as incorrectly
packaged tobacco products, filters that fall off the filter rod of a
cigarette, broken or torn cigarettes, filter plug problems, and
irregular and improper burning of cigarettes. FDA is also aware of
complaint records containing information about contaminants and hazards
in finished tobacco products such as NTRMs (e.g., metal, glass, nails,
pins, wood, dirt, sand, stones, rocks, fabric, cloth, plastics),
biological materials (e.g., mold, mildew, hair, fingernails), oil or
greasy spots on cigarettes, chemicals (e.g., ammonia, cleaning agents,
kerosene), and the presence or infestation of tobacco beetles or
insects. Further, FDA is aware that manufacturers maintain reports of
complaints such as exploding e-cigarettes, excessive heating during use
and charging of ENDS, as well as cuts and lacerations, broken teeth,
vomiting, nausea, burns, allergic reactions, dizziness, numbness,
headaches, and other personal or property damage reported to tobacco
product manufacturers. These experiences and records have informed the
proposed complaint requirements.
    Given the clear importance of tobacco product complaints in
alerting manufacturers and FDA to product problems, proposed Sec.
1120.14(a) would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for the receipt,
evaluation, investigation, and documentation of all tobacco product
complaints. FDA believes it is necessary for manufacturers to establish
and maintain procedures to address all activities related to complaints
(i.e., receipt and processing; evaluation, investigation, and
documentation) in order to ensure that manufacturers properly handle
complaints.
    Proposed Sec.  1120.14(a)(1) through (3) would require that the
tobacco product complaint procedures ensure that each complaint is: (1)
processed upon receipt in a uniform and timely manner; (2) evaluated
and, if necessary, investigated, in accordance with Sec.  1120.14(b)
and (c); and (3) documented in accordance with Sec.  1120.14(e). All
complaints would need to be processed upon receipt by the

manufacturer. Even complaints that may not appear to be directly
related to illness or injury (such as failure to meet a specification,
defective packaging, mixup of products, product bearing wrong labeling/
warning, or incorrect quantity of product) may be important in
identifying a nonconforming product or other manufacturing issue. Such
complaints may indicate that the product is adulterated or misbranded
and that a corrective action, such as a recall, is needed. Moreover,
even a complaint regarding a side effect that appears to be normally
associated with tobacco use may indicate a nonconforming product or a
product design issue and, therefore, would be required to be
investigated. For example, a complaint about respiratory distress could
be determined to be attributed to a nonconforming product due to
defective solder joints from an ENDS cartomizer that results in
metallic particles in the aerosol (Ref. 2). Similarly, a complaint
about dizziness or nausea could be due to the addition of too many
ammonia compounds and other substances to reconstituted tobacco in a
cigarette, which can affect free nicotine levels.
    FDA is aware that some manufacturers have a corporate complaint
department that handles complaints for all establishments and others
have different complaint handling units for different product types and
different establishments, which could result in multiple processes for
handling complaints. Therefore, under proposed Sec.  1120.14,
manufacturers should designate in their procedures which individual(s)
are responsible for coordinating and performing all complaint handling
functions to ensure consistent handling, categorization, and
evaluation/investigation of complaints across the corporation and
establishments.
    Proposed Sec.  1120.14(b) elaborates on the evaluation requirement
found in proposed Sec.  1120.14(a)(2). Proposed Sec.  1120.14(b) would
require that personnel evaluate each complaint to determine whether it
could be related to: (1) a nonconforming tobacco product; (2) a product
design issue; or (3) any adverse experience that is required to be
reported under a regulation issued under section 909(a) of the FD&C Act
or implementing regulations.\3\
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    \3\ We note that, currently, there are no adverse events
required to be reported under section 909(a) of the FD&C Act;
however, this provision would trigger automatically should FDA issue
a regulation based on section 909(a).
---------------------------------------------------------------------------

    Complaint information may need to be incorporated into the risk
management process in proposed Sec.  1120.42 to inform the
manufacturer's risk assessment and risk treatment. For example, a
manufacturer that previously determined in its risk assessment that a
dissolvable tobacco product is unlikely to cause a safety hazard to
users would be required to reassess its risks, pursuant to proposed
Sec.  1120.42(a)(1)(iii), if it receives complaints alleging choking
adverse experiences that could change the previous risk assessment.
    Proposed Sec.  1120.14(c)(1) states that if the evaluation
determines that the complaint could be related to the circumstances
identified in proposed Sec.  1120.14(b)(1) through (3), an
investigation must be performed (unless it is subject to the exception
as provided in proposed Sec.  1120.14(d). For example, if a complaint
evaluation indicates that an ENDS product explosion could be related to
an issue with the product's design, the tobacco product manufacturer
would be required to perform an investigation under Sec.  1120.14(c).
Records of previously received complaints may be relevant to this
evaluation. The evaluation phase would not be required to include an
analysis regarding the veracity of the complaint.
    Accordingly, this proposed section would require that all
complaints be processed and evaluated. However, only certain complaints
would need to be investigated (i.e., complaints that could be related
to a nonconforming product, a product design issue, or reportable
adverse experience). For example, a complaint regarding the price of
the product or the size offerings distributed by the manufacturer (for
example, customer complaints that the manufacturer should offer a
larger package size) would need to be processed and evaluated but would
not need to be investigated under the proposed rule. However,
complaints regarding an exploding battery, metal or rocks found in the
tobacco, or nicotine poisoning of the user (or nonuser) would need to
be investigated.
    As stated in proposed Sec.  1120.14(c)(2), the complaint
investigation would be required to identify the scope and cause of the
issue and the risk of illness or injury it poses. If a manufacturer's
investigation shows that the scope and cause of the issue cannot be
determined without the involvement of another entity, such as a
specification developer, contract manufacturer, or other entity or
establishment that performs a manufacturing operation for the product,
then the manufacturer should work together with the other entity to
determine the scope and cause of the issue. This would include the
timely reporting to other entities of all relevant information related
to the complaint.
    For example, if complaints are reported to a contract manufacturer
and, after investigation, are determined to pertain to a possible
product design issue, the contract manufacturer should report these
complaints to the specification developer for further investigation.
The specification developer has the specific knowledge of the design
and development information of the finished tobacco product and would
be required to conduct an investigation of the product complaints and
implement CAPA, as needed pursuant to proposed Sec.  1120.16, including
potential redesign of the product. The contract manufacturer, in turn,
should continue to work with the specification developer to ensure that
the complaint is resolved in accordance with the proposed requirements
in this section. Similarly, if a finished tobacco product manufacturer
that only packages or labels bulk tobacco products receives complaints
of nonconforming products that may be related to the design or
manufacture of the incoming bulk tobacco product, it should report
these complaints to the bulk manufacturer who must then also conduct an
investigation into the scope and cause of the issue, the risk of
illness or injury posed by the issue, and whether any followup action
is necessary, and implement CAPA, as needed pursuant to proposed Sec.
1120.16. The finished tobacco product manufacturer should follow up
with the bulk manufacturer as needed to ensure that the product
complaints have been resolved in accordance with these proposed
requirements. This would include the finished tobacco product
manufacturer documenting the evaluation, investigation, and any
associated followup action regarding the complaint, including any
information provided by the bulk manufacturer.
    A complaint investigation also must determine whether any followup
action is necessary, including whether a CAPA is necessary under
proposed Sec.  1120.16. Followup action could include, for example,
updating a procedure, requiring refresher training, making a
manufacturing process change, or other action to correct and prevent a
nonconforming product or design problem; initiating a recall; reporting
an adverse experience under a section 909(a) regulation; or beginning
to monitor the issue to see if there is a trend that might require
further action. This proposed requirement is necessary to ensure that
finished and bulk tobacco product manufacturers adequately

investigate complaints that could relate to nonconforming tobacco
products, issues related to product design, and reportable adverse
experiences to protect consumers, correct the issue, and prevent the
same or similar problems from occurring in the future.
    A complaint investigation may lead the tobacco product manufacturer
to initiate a corrective action, such as a recall or a change to the
manufacturing process. For example, in one case, FDA received a
consumer complaint that an ENDS product created thick and searing smoke
that caused an unexpected health problem, specifically, sore, raw, and
swollen throat that persisted for several days (Ref. 20). If, during
the investigation, the manufacturer determined that the user's health
problem was due to excess voltage causing the atomizer coil to burn,
these proposed requirements would ensure that manufacturers investigate
the scope of such an issue, the risk of illness or injury it poses, and
whether any followup action, such as a CAPA, is necessary. A tobacco
product manufacturer may initiate a CAPA under proposed Sec.  1120.16,
to implement a design change to control the maximum voltage output to
prevent coil overheating. While some tobacco product manufacturers may
initiate such actions on their own, FDA believes that these
requirements are needed to ensure that all manufacturers take these
steps to assure the public health is protected.
    Complaints could also identify a reasonably foreseeable risk not
previously known to the manufacturer, including risks that may occur
with normal use and reasonably foreseeable misuse of the tobacco
product, which could relate to a design issue. FDA acknowledges that a
manufacturer cannot possibly foresee every single potential misuse
during the design of a tobacco product, but should the manufacturer
become aware through a complaint of information about risks posed by
the product due to misuse, the corrective and preventive action
requirements under proposed Sec.  1120.16 and the risk management
requirements under proposed Sec.  1120.42 would be triggered, which
would include reassessing and treating the risk pursuant to proposed
Sec.  1120.42(a)(1)(iii). For example, an ENDS manufacturer may receive
complaints of respiratory distress for an ENDS product and determine in
its investigation that users are modifying the heating element to
increase voltage in order to produce greater clouds of vapor, resulting
in higher aerosol temperatures than designed that generate harmful
constituents such as formaldehyde, acetaldehyde, and acrolein (Ref.
21). Knowing that information, the manufacturer would reassess and
treat the risk and initiate appropriate corrective action, which may
include implementing design changes to prevent a user from
disassembling and modifying the heating element.
    When conducting investigations, tobacco product manufacturers
should also review available records related to the complaint (e.g.,
acceptance records, nonconforming product records, or CAPA records).
For example, a tobacco product manufacturer may receive complaints
about an ENDS overheating. Even if the product is not returned, the
manufacturer may review other complaint files and determine that
complaints related to other ENDS models have been received. An
investigation and review of acceptance records (see proposed Sec.
1120.64) may reveal an increase in the number of heating element
components being rejected from a particular supplier. As a result of
the investigation, the tobacco product manufacturer may initiate a CAPA
to increase monitoring of the supplier and require additional testing
to ensure that received components meet established specifications.
    Proposed Sec.  1120.14(d) provides an exception to the requirement
to conduct an investigation under Sec.  1120.14(c). This paragraph
would provide that a tobacco product manufacturer is not required to
complete an investigation if it has already conducted an investigation
of a similar complaint and the tobacco product manufacturer determines
and documents that the previous investigation results apply and another
investigation is not necessary. FDA interprets a similar complaint to
be one related to the same type of nonconformity or issue and likely to
have the same cause or source. Therefore, a tobacco product
manufacturer would not need to conduct an investigation if its
documentation includes a reference to a previous investigation and a
statement explaining why the complaints were sufficiently similar such
that the previous investigation results apply and another investigation
is not necessary. This analysis would be based on the particular facts
and circumstances at issue. For example, a tobacco product manufacturer
may determine and document that it need not investigate a complaint of
an ENDS overheating, because it had previously investigated a complaint
and found that a particular component caused the overheating and the
production record shows that the product at issue used the same
component from the same supplier, before the problem was corrected.
    Proposed Sec.  1120.14(e) would require a manufacturer of finished
or bulk tobacco products to maintain complaint records containing the
information required by Sec.  1120.14(e)(1) through (14). Complaints
requiring investigation that may result in a risk of illness, injury,
or death not normally associated with tobacco product use must be
clearly identified or separated. Additional discussion of the meaning
of ``not normally associated'' can be found in section II.A.2. This
proposed requirement would enable tobacco product manufacturers to
recognize these types of complaints and prioritize appropriate followup
action.
    Proposed Sec.  1120.14(e)(1) through (14) states that the complaint
record must include the following information, if available: the name
of the product, including brand and sub-brand; a description of the
product; manufacturing code; date the complaint was received; format of
complaint (i.e., oral or written); name, address, and phone number of
complainant; nature and details of the complaint, including how the
product was used; identification of individual(s) receiving complaint;
record of evaluation by the manufacturer, including the name of the
individual(s) performing the evaluation; if no investigation is
undertaken, the name of the individual(s) responsible for that decision
and the rationale for the decision; investigation date(s); record of
investigational activities performed and personnel who performed the
activities; results of investigation; and any follow up action taken,
including any reply to the complainant or any corrective and preventive
action taken. Some of this information would be obtained during the
evaluation stage while other information would be obtained during the
investigation stage, if an investigation is required. The complaint
record would also include activities performed by other entities that
assist in the investigation. For example, if a manufacturer reports a
complaint to another entity, such as a specification developer, or
contract manufacturer, because the manufacturer's investigation shows
that the scope and cause of the issue cannot be determined without the
involvement the other entity, then the manufacturer should include in
the complaint record information regarding the investigation performed
by the other entity, if available.
    The information in proposed Sec.  1120.14(e) is basic information
that is

essential to any complaint investigation and necessary to ensure a
thorough complaint investigation and facilitate an appropriate
followup. The manufacturer should make a reasonable effort to obtain
the information listed in proposed Sec.  1120.14(e)(1) through (14).
For example, should some of the basic information in proposed Sec.
1120.14(e)(1) through (14) be missing with respect to a particular
complaint, a single unsuccessful attempt to reach the complainant would
not be considered by FDA to be a reasonable effort to obtain
information related to the complaint. If the information described in
proposed Sec.  1120.14(e)(1) through (14) cannot be obtained, this
provision would require the manufacturer to document the attempts to
obtain this information and explain why the information was not
included, as described in proposed Sec.  1120.14(f).
    FDA believes that these proposed requirements would assure that the
public health is protected by requiring tobacco product manufacturers
to systematically handle the receipt, evaluation, investigation, and
documentation of all complaints to determine if there is a problem with
the tobacco product, a related tobacco product, or the manufacturing
process, and take appropriate action. If a tobacco product manufacturer
does not have a written complaint procedure, the manufacturer may not
properly evaluate and if necessary, investigate the received complaint
and may fail to identify a nonconforming tobacco product, a product
design issue, or a reportable adverse experience. For example, if a
customer reports to a manufacturer that there are metal objects in a
can of smokeless tobacco (e.g., Ref. 3), and the complaint procedures
do not describe how to perform an investigation, the manufacturer may
not conduct an adequate investigation and take an appropriate followup
action, including a corrective and preventive action that would prevent
consumer illness or injury from such contaminants.
    Complaints from users and nonusers are an invaluable source of
information for tobacco product manufacturers. The evaluation and
investigation of complaints can help a tobacco product manufacturer
identify problems with a tobacco product's design, established
specifications, or production process. For example, if a manufacturer
is receiving complaints alleging explosions of ENDS, this proposed rule
would require the manufacturer to investigate the scope and cause of
the issue to determine if, for example, it is due to a design problem
or manufacturing problem. The investigation may determine that the
problem is due to use of a non-Original Equipment Manufacturer battery
charger that does not meet the manufacturer's established
specification. The U.S. Fire Administration has found that nearly 25
percent of e-cigarette fires occurred when the battery was being
charged (Ref. 22). Many e-cigarettes are charged using an ordinary
universal serial bus (USB) port charging connection that allows users
to connect the e-cigarette to power adapters that are not provided by
the original manufacturer of the device. Because the voltage and
current provided by USB ports can vary significantly between
manufacturers, use of a USB port or power adapter not supplied by the
original manufacturer may subject the battery to a higher current than
is safe, leading to thermal runaway that results in an explosion and/or
fire. As a result of this complaint information, the manufacturer may
initiate a CAPA pursuant to proposed Sec.  1120.16 (and further
discussed in section IV.B.3) to redesign the battery to have a
proprietary connection that could only be connected to a charging unit
designed to be compatible or redesign the battery management system to
detect an incompatible power adapter and prevent the battery from
charging. New information on increased likelihood of occurrence or
severity of harm obtained from tobacco product complaints should be
incorporated into the manufacturer's ongoing risk management activities
(i.e., review of new information that could change the original risk
assessment and risk treatment) under proposed Sec.  1120.42.
    In addition, FDA believes that the proposed tobacco product
complaint requirements would help assure that tobacco products are in
compliance with the requirements of chapter IX of the FD&C Act.
Consumer complaints about adverse experiences or product problems may
indicate nonconforming tobacco products that are not being manufactured
to established specifications. Therefore, these proposed complaint
requirements would help tobacco product manufacturers to ensure that
new tobacco products and MRTPs are manufactured consistent with the
specifications provided in their applications (i.e., SE Report, request
for SE exemption, PMTA, MRTPA) and that pre-existing products are
manufactured consistent with their original characteristics. For
example, if numerous complaints are received about a product, the
manufacturer may investigate and learn that the product does not have
the same characteristics it had as of the pre-existing date.
    Complaints can also indicate that distributed tobacco products are
adulterated or misbranded under section 902 or 903 of the FD&C Act. For
example, complaints could indicate that products have been ``prepared,
packed, or held under insanitary conditions'' (section 902(2) of the
FD&C Act). In addition, as noted previously, complaints can uncover
cross-contamination in a production process that resulted in an adverse
experience to the user, necessitating a change in the manufacturing
process to prevent the further production of cross-contaminated
products. The proposed requirements in this rule that would require
manufacturers to process, evaluate, investigate, and document
complaints would help them to address and prevent recurrence of such
adulteration.
    These proposed complaint requirements also may help ensure that the
packaging, labeling, or labels of finished and bulk tobacco products
comply with applicable statutory and regulatory requirements. For
example, a complaint may note that tobacco products are missing labels
with required warning statements causing the products to be misbranded
under section 903 of the FD&C Act. The investigation may determine that
adequate acceptance activities are not being performed during the
packaging and labeling operations. This provision would enable the
manufacturer to ensure that required warning statements are applied to
prevent misbranded products from being commercially marketed.
3. Corrective and Preventive Actions
    Proposed Sec.  1120.16 sets forth the requirements for CAPA. CAPA,
for purposes of proposed Sec.  1120.16, is a systematic assessment of
nonconforming tobacco products and design problems to determine the
cause and implement appropriate changes to the product specifications,
relevant manufacturing methods and production process procedures, and/
or packaging, labeling, and labels to correct and prevent the cause of
the nonconformity or design problem. CAPA also helps prevent the
distribution of identified nonconforming product and helps identify
design problems. These proposed requirements are generally similar to
the industry recommendations and to practices of tobacco product
manufacturing establishments that follow ISO 9001-2015 (Ref. 11).
Tobacco product manufacturers have utilized CAPA in

the past to take appropriate actions to correct and prevent identified
causes of nonconformities and design problems (e.g., Refs. 23-27). FDA
believes that all tobacco product manufacturers should implement CAPA
procedures.
    Proposed Sec.  1120.16(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for
implementing CAPAs. Specifically, proposed Sec.  1120.16(a)(1) would
require such manufacturers to review and analyze processes, process
control records, complaints, production records, returned products,
reprocessed products, reworked products, and other sources of data to
identify existing and potential causes of nonconforming tobacco product
and design problems. These sources would help manufacturers identify
possible causes of nonconformities and design problems and may also
help manufacturers identify previously undetected problems.
    Under the proposed rule, FDA expects that manufacturers would
periodically examine manufacturing processes to look for causes of
nonconforming tobacco products or design problems, and take steps to
prevent their occurrence. For example, under proposed Sec.
1120.16(a)(1) (and the proposed production processes and controls
provision discussed further below (see Sec.  1120.66)), a finished or
bulk e-liquid manufacturer would periodically review the mixing process
for an e-liquid to determine if it has been trending towards the upper
control limit for the nicotine concentration. Such an issue would
require a corrective action to maintain the mixing operation within the
control limits so as not to produce nonconforming product. Further,
records associated with other tobacco products manufactured using the
same equipment or production process, including records of tobacco
complaints, acceptance activities, nonconforming product, and returned
products could help determine if a repeated nonconformity is associated
with a manufacturing method or procedure.
    Appropriate statistical methodology must be employed where
necessary to detect recurring problems. Statistical techniques (e.g.,
Ref. 28) are useful to identify trends of nonconforming product or
processes and records that indicate systemic problems that contribute
to nonconformities. Appropriate statistical tools, such as trend
analysis, can be used to review tobacco product complaints, process
controls, nonconforming product, acceptance activities, and production
records. It may be necessary to employ statistical techniques such as
trend analysis to identify recurring problems across multiple batches
and identify potential causes of nonconforming product or design
problems, which is an important part of preventive action.
    Proposed Sec.  1120.16(a)(2) would require finished and bulk
tobacco product manufacturers to investigate the cause of design
problems or nonconformities relating to the tobacco product or the
manufacturing process. For example, if a validated cigarette-making
process has a normal 2 percent rejection rate and that rate rises to 10
percent, this provision (along with proposed Sec.  1120.74(b)) would
require the manufacturer to perform an investigation into the
nonconformance of the process. In this example, we would expect the
investigation to include an assessment of production batches
manufactured before and after the suspect batch, including records of
monitoring of the process control parameters required by proposed Sec.
1120.66(a)(2) and continued process verification results required by
proposed Sec.  1120.66(b)(3) to determine if other batches have been
affected and whether there are process deviations that require
revalidation of the manufacturing process pursuant to proposed Sec.
1120.66(a)(3).
    If a manufacturer's investigation shows that the cause of the
design problem or nonconformity cannot be determined without the
involvement of another entity, such as a specification developer,
contract manufacturer, or other entity that performs a manufacturing
operation for the product, then the manufacturer should work together
with the other entity to determine the cause of the design problem or
nonconformity. This would include the timely reporting to other
entities of all relevant information related to the design problem or
nonconformity. For example, if a contract manufacturer investigates the
cause of a nonconformity in accordance with proposed Sec. Sec.
1120.16(a)(2) and 1120.74(b) and determines that it does not pertain to
its contract manufacturing process, the contract manufacturer should
report the information to the specification developer for
investigation. The specification developer has knowledge of, and
controls the design and development information of, the finished
tobacco product and may be in the best position to investigate whether
the nonconformity relates to a design problem, and to implement CAPA
for issues related to product design. Similarly, if a finished tobacco
product manufacturer who repackages or relabels tobacco products
performs a CAPA investigation and determines that the cause of a
nonconformity does not relate to its repackaging or relabeling process,
it should report the nonconformity to the other manufacturer(s), who
then can conduct an adequate investigation, determine the cause of the
nonconformity, and implement appropriate CAPA, for example changes to
process controls.
    Proposed Sec.  1120.16(a)(3) would require finished and bulk
tobacco product manufacturers to identify and take actions needed to
correct and prevent the recurrence of design problems and
nonconformities and other related problems found in the investigation.
Correction and prevention of inadequate procedures and practices should
result in fewer tobacco product nonconformities. To comply with this
provision, for example, a manufacturer could decide to revise and
update inadequate procedures, identify and correct improper personnel
training, or require refresher training on a procedure to address
employees' failure to follow such procedure. When identifying such
actions, manufacturers should take into account the risk of illness or
injury posed by the design problem or nonconformance. The degree of
corrective and preventive action taken to eliminate or minimize design
problems or nonconformities should be appropriate to the magnitude of
the problem and commensurate with the associated risks. For example, to
address a more serious problem such as a design problem resulting in a
fire or explosion, the manufacturer may need to take a more significant
corrective and preventive action, such as a product redesign. When
performing the CAPA in such a scenario, the manufacturer may need to
incorporate its risk management process (see proposed Sec.
1120.42(a)(1)) to assess and treat the risk.
    Proposed Sec.  1120.16(a)(4) would require finished and bulk
tobacco product manufacturers to verify or validate CAPAs to ensure
that the actions are effective and do not adversely affect the product.
Verification, as defined in proposed Sec.  1120.3, would refer to
confirmation by examination and objective evidence that specified
requirements have been fulfilled. Examples of verification activities
would include measuring a dimension such as the length or circumference
of a cigarette or cigar to confirm it meets a specified requirement,
conducting a laboratory analysis of a pH level to confirm it is within
a specified range, and performing a visual comparison of a hand-rolled
cigar against a standard or

approved model to confirm the proper shape and dimensions of that
finished cigar. Validation, as defined in proposed Sec.  1120.3, would
refer to confirmation by examination and objective evidence that the
particular requirements can be consistently fulfilled. An example of a
validation activity would be the validation of the smokeless tobacco
fermentation process, which would be used to demonstrate that when key
parameters (e.g., temperature, pH, oven volatiles, and number of turns)
are met, conforming product will be produced in that batch. The
relevant parameters would be monitored to confirm that the batch was
produced within the validated ranges for the fermentation process.
    Verification and validation could also include the collection and
analysis of data, such as from acceptance activities and nonconforming
products, to confirm that a CAPA has effectively addressed the problem.
Moreover, if a tobacco product manufacturer determines that a process
change is required because the existing process cannot be maintained,
proposed Sec.  1120.16(a)(4) would require the manufacturer to verify
or validate that this CAPA does not adversely affect the tobacco
product by, for example, modifying an established specification.
Verification and validation activities provide an opportunity to
demonstrate through examination and objective evidence that the
proposed corrective and preventive action is effective and does not
introduce new or increased risks associated with the product,
production process, packing, and storage. For example, if a
manufacturer receives complaints about the presence of mold in finished
tobacco product, it may decide to initiate a CAPA to address this issue
by changing the packaging to control the moisture content of the
tobacco product. The manufacturer must verify or validate the newly
redesigned packaging, for example, by confirming that the new packaging
material's moisture barrier meets specified requirements or conducting
shelf life testing, respectively.
    Proposed Sec.  1120.16(a)(5) would require finished and bulk
tobacco product manufacturers to implement and document changes to
tobacco product specifications, manufacturing methods and production
process procedures, and packaging, labeling, and labels needed to
correct and prevent identified causes of the design problem or the
nonconformity. A tobacco product manufacturer could comply with this
provision in many different ways. For example, a tobacco product
manufacturer that receives consumer complaints regarding respiratory
distress, may redesign an ENDS cartomizer to minimize metal and
silicate particles in the aerosol (Ref. 2). Similarly, a cigarette
manufacturer may determine that calibration procedures need to be
revised to correct the improper application of casings applied to cut
filler and prevent the recurrence of nonconforming product (Ref. 29).
Another example is a manufacturer that may change solvents used on
packaging (e.g., benzene, toluene, methyl ethyl ketone, methyl
cellosolve, cellosolve) that are found to contaminate cigarettes (Ref.
30).
    Proposed Sec.  1120.16(a)(6) would require that information related
to the design problem or nonconformity and the CAPA taken be
disseminated to management with executive responsibility, those
responsible for acceptance activities of a tobacco product, and
personnel responsible for identifying training needs in accordance with
proposed Sec.  1120.12(e). This requirement would help ensure that
designated individuals who are responsible for implementing TPMP
requirements are notified about design problems, nonconformities, and
CAPAs and can adjust procedures accordingly.
    Proposed Sec.  1120.16(b) would require that finished and bulk
tobacco product manufacturers maintain records of all activities
conducted under this section and that these records include the date
and time, the individual performing the activity, any information that
demonstrates the requirement was met, and any data or calculations
necessary to reconstruct the results. For purposes of this proposed
part 1120, FDA interprets ``reconstruct,'' in this context, to mean the
ability to re-create the results by analyzing all data, including
source and metadata data, and records, including calculations. Although
FDA is not proposing to prescribe a particular format to document CAPA
activities, this provision would require tobacco product manufacturers
to document all of the actions taken to address the requirements under
this section (e.g., Refs. 24-26).
    The proposed Sec.  1120.16 requirements would help assure that the
public health is protected by requiring tobacco product manufacturers
to perform a systematic assessment of nonconforming products and design
problems to determine and address the cause. For example, nonconforming
product can result from inadequate or nonexistent tobacco product or
process specifications; failures of or problems with purchasing
controls; inadequate process controls; improper facilities or
equipment; inadequate training; and inadequate manufacturing methods
and procedures.
    The proposed requirements would help ensure that nonconformities
and design problems are thoroughly investigated and effective CAPA are
taken to eliminate or minimize them and potential harms to the
consumer. For example, under this proposed section, an ENDS
manufacturer that receives complaints about respiratory distress and
metallic aftertaste from use of an ENDS product may initiate a CAPA
investigation. The manufacturer may determine that the cartomizer
aerosol contains traces of tin, copper, nickel, and silver metals
attributed to poor solder joints from the cartomizer supplier (Ref. 2),
and take a CAPA to change suppliers, use different cartomizer
materials, and implement solder joint reliability testing as an
acceptance activity (see Sec.  1120.64). While individual tobacco
product manufacturers may have used CAPA in the past, these proposed
requirements would ensure that all finished and bulk manufacturers take
these actions to prevent harms that could occur as a result of design
problems and nonconforming products.
    CAPA can also help minimize or prevent contamination of finished or
bulk tobacco product. For example, due to increased consumer complaints
of plastic or Styrofoam material in finished tobacco products, a
manufacturer may initiate a CAPA to implement an optical sorter to
prevent the introduction of non-ferrous NTRMs into finished and bulk
tobacco products.
    The proposed CAPA requirements would also help assure that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act by establishing procedures for the manufacturer to follow in
taking appropriate action on nonconforming and contaminated tobacco
products both prior to, and after the manufacturer starts, marketing
the products. For example, a CAPA to prevent the introduction of non-
ferrous NTRMs into finished or bulk tobacco products, as discussed
above, would help ensure that the product is not adulterated under
section 902(a)(1) of the FD&C Act. Moreover, these provisions would
help ensure that appropriate measures are taken to address new or MRTPs
that do not conform to the specifications provided by the manufacturer
to FDA in the relevant tobacco product applications (i.e., SE Report,
SE exemption request, PMTA, MRTPA) and that pre-existing tobacco
products are manufactured consistent with their original
characteristics.

C. Buildings, Facilities, and Equipment

1. Personnel Practices
    Proposed Sec.  1120.32 would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
cleanliness, personal practices, and apparel of personnel. Under this
proposed requirement, the procedures must include requirements to
ensure that contact between the personnel and the tobacco product
manufacturer or the environment would not result in contamination of
the tobacco product. These proposed requirements are generally similar
to personnel practices that FDA has observed during establishment
inspections. Personnel can contaminate tobacco products by
unintentionally transferring bacteria, viruses, or disease through the
handling of tobacco products, and contamination (e.g., physical or
microbial) may occur at any time during the manufacturing process.
Therefore, this proposed rule would require each tobacco product
manufacturer to set up appropriate, consistent, and effective measures
to prevent personnel from contaminating tobacco products. Examples of
such measures for ``cleanliness, personal practices, and apparel'' can
include outer garment requirements, personal cleanliness, restrictions
on jewelry and other loose items, adequate hand washing before handling
a tobacco product, use of gloves, head coverings, or other protective
equipment, and daily checks on these practices.
    This proposed requirement would help ensure that the public health
is protected by helping to prevent tobacco products from becoming
contaminated, which can adversely affect public health over and above
the risk normally associated with the use of the product. The proposed
requirements also would help assure that tobacco products are in
compliance with the requirements of chapter IX of the FD&C Act. These
measures would prevent a likely source of contamination and
nonconformity and help ensure that products are not manufactured under
insanitary conditions. Therefore, the requirements would help ensure
that products are not adulterated under section 902 of the FD&C Act.
2. Buildings, Facilities, and Grounds
    Proposed Sec.  1120.34(a) would require finished and bulk tobacco
product manufacturers to ensure that any buildings and facilities used
in or for the manufacture, packaging, or storage of a tobacco product
are of suitable construction, design, and location to facilitate
cleaning and sanitation, maintenance, and proper operations. These
proposed requirements are generally similar to the controls for
buildings, facilities, and grounds in the industry recommendations, and
to practices that FDA has observed during establishment inspections.
    The construction, design, and location of the physical plant
provide the infrastructure that enables a tobacco product manufacturer
to conduct its manufacturing operations. Therefore, this proposed rule
would require that each building and facility be maintained in an
appropriate condition to prevent tobacco product contamination. The
term ``suitable,'' as used in this provision, would mean that the
construction, design, and location of facilities would enable proper
cleaning and sanitizing, maintenance, and operation. Examples of
buildings and facilities that are inadequately constructed, designed or
located would include facilities that are constructed of particle board
that have exposed wood chips or flakes that could become a physical
hazard, facilities that are constructed of porous material and cannot
be adequately cleaned and sanitized, and buildings and facilities whose
equipment is so tightly placed that it prevents adequate cleaning and
maintenance of the building or facility. For the buildings and
facilities to facilitate ``proper operations'', they should be
constructed, designed, and located in a manner to facilitate the
logical flow of manufacturing activities from receipt and storage of
incoming materials, processing, packaging, and warehousing. FDA is not
proposing to require specific activities to satisfy this requirement;
rather the proposed rule is intended to provide flexibility for
manufacturers to determine what is appropriate based on the specific
manufacturing activities performed at the establishment.
    Proposed Sec.  1120.34(a)(1) would require that buildings and
facilities have adequate lighting. FDA would consider this requirement
satisfied if lighting conditions enable the tobacco product
manufacturer to perform necessary manufacturing operations, including
cleaning, sanitation, and maintenance. Among other things, this
requirement is necessary to identify insanitary conditions that may not
be visible with inadequate lighting. For example, tobacco product
manufacturers may utilize visual inspection to remove NTRMs from the
production area and inadequate lighting may make it difficult for
personnel to identify and remove these materials. Manufacturers should
also take measures to make sure that lighting is not a source of
contamination. For example, lighting should not attract pests that can
contaminate or otherwise render the tobacco products adulterated or
misbranded under section 902 or 903 of the FD&C Act. Manufacturers
should cover lighting fixtures or use shatter-proof bulbs to prevent
tobacco products from becoming contaminated with glass shards if the
light bulbs shatter.
    Proposed Sec.  1120.34(a)(2) would require that buildings and
facilities have adequate heating, ventilation, and cooling (HVAC). HVAC
equipment and systems are used to maintain the environmental conditions
of buildings and facilities. For example, a manufacturer may establish
temperature, relative humidity, and air flow conditions necessary for
storage, handling, or processing (such as mixing, cutting, or blending)
of tobacco product. Use of fans and other air-blowing equipment can
maintain air ventilation to minimize odors and vapors (including steam
and noxious fumes) in areas where they may contaminate product or
otherwise render product adulterated. This requirement would help
ensure that the HVAC equipment is designed and maintained to prevent
contamination of tobacco products. For example, manufacturers should
prevent conditions such as damaged or exposed HVAC duct insulation
hanging over processing equipment or leakage of hydraulic fluid from an
HVAC system on tobacco products that may contaminate tobacco products
(e.g., Ref. 31). While some tobacco product manufacturers may already
take such actions to control environmental conditions, these proposed
requirements would ensure that all manufacturers take these actions to
prevent contamination that could occur due to an inadequate HVAC
system.
    Proposed Sec.  1120.34(a)(3) would require finished and bulk
tobacco product manufacturers to utilize adequate plumbing (including
control of drainage, backflow, sewage, and waste) to avoid being a
source of contamination or creating insanitary conditions. For example,
water pipes should be designed so condensation does not fall on the
tobacco product or tobacco product-contact surfaces, which can cause
contamination. In addition, floors cleaned with water (or water-soluble
products) should be designed with floor drains to facilitate adequate
drainage. Water by-products, sewage, and waste can be a source of
contamination if they touch a tobacco product-contact surface or become
a part of the tobacco product. Improper control of drainage, sewage,
and waste also can result in pooling and create insanitary conditions
or attract

pests that may contaminate tobacco products with filth. Filthy
conditions from improper control of drainage, sewage, and waste can be
transferred throughout the facility on shoes and equipment.
    Proposed Sec.  1120.34(a)(4) would require that buildings and
facilities have adequate waste collection, storage, and disposal.
Adequate waste collection, storage, and disposal includes not creating
malodors that contaminate tobacco products or result in an attraction,
harborage, or breeding places for animals and pests. Trash bins should
have lids and be periodically emptied to help reduce the potential for
insanitary conditions from microbial contamination and pests.
    Proposed Sec.  1120.34(a)(5) would require finished and bulk
tobacco product manufacturers to provide adequate readily accessible
handwashing and toilet facilities. The facilities must provide for
water at suitable temperatures and appropriate cleaning and sanitation
materials. FDA considers adequate hand-washing and toilet facilities to
have hand-cleaning and sanitizing preparation areas, towel service or
suitable drying stations, water control valves, appropriate signs,
shelving or hooks on which to rest garments while using the toilet, and
trash bins that are properly constructed and maintained. Handwashing
and sanitizing, when used with water at suitable temperatures and with
appropriate cleaning and sanitation materials, are an important means
of preventing tobacco product contamination by personnel.
    Proposed Sec.  1120.34(b) would require finished and bulk tobacco
product manufacturers to maintain the facility grounds in a condition
to prevent contamination. The grounds consist of the actual physical
property where the buildings and facilities are located. Inadequately
maintained grounds can, for example, present a pest harborage area that
can be a source of contamination.
    Proposed Sec.  1120.34(c) would require finished and bulk tobacco
product manufacturers to ensure that water used in the manufacturing
process, including water that is or may become part of the tobacco
product (e.g., water used as an ingredient or water used on a tobacco
product-contact surface) is potable, will not contaminate the tobacco
product, is maintained under positive pressure (e.g., to prevent back
siphonage that can draw water from a contaminated source into the water
supply system due to leaks or gaps in the mains, cross-connections, or
valves), and is supplied from sources that comply with all applicable
Federal, State, and local requirements. Water is commonly used in the
manufacture of tobacco products, and water that is untreated may be
contaminated with Escherichia coli (E. coli) and coliform bacteria. All
piping systems, hydrants, taps, faucets, hoses, buckets, and other
equipment used for the delivery of water that is used as an ingredient
or for use on tobacco product-contact surfaces, should be designed,
constructed, maintained, and operated in such a manner as to prevent
contamination of the water.
    Under this proposal, the manufacturer's water supply should come
from a source for which adequate controls exist for testing, treatment,
and removal of contaminants (e.g., microbes and heavy metals).
    Therefore, proposed Sec.  1120.34(c) would require that the water
be supplied from sources that comply with all applicable Federal,
State, and local requirements. For example, state governments have
water departments that administer the public water system and have
specific requirements to ensure that the water is safe for consumption
and use.
    Proposed Sec.  1120.34(d) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
cleaning and sanitation of buildings, facilities, and grounds,
including procedures for the use of any cleaning compounds, sanitizing
agents, pesticide chemicals, rodenticides, insecticides, fungicides,
fumigating agents, and other toxic materials. An establishment's poor
cleaning and sanitation practices can increase the likelihood of
tobacco product contamination. A tobacco product manufacturer should
take into account the construction, design, and location of the
buildings and facilities as well as the manufacturing operations, when
establishing cleaning and sanitation procedures.
    Specifically, proposed Sec.  1120.34(d)(1) would require that
manufacturers' cleaning and sanitation procedures detail the cleaning
schedules, equipment, and materials to be used in the cleaning and
sanitization, as appropriate, of the buildings, facilities, and
grounds.
    Proposed Sec.  1120.34(d)(2) would require that these procedures
include measures to ensure that materials used for cleaning and
sanitation are identified, held, used, and stored in a manner to
protect against contamination of tobacco products and tobacco product-
contact surfaces. For example, FDA has observed on inspections that
cleaning and sanitation materials are sometimes stored in unmarked
containers in the manufacturing area (e.g., Ref. 32) and, consequently,
may be inadvertently used or mixed with tobacco product ingredients,
additives, or materials. This proposed provision would help prevent
this potential source of contamination. To help ensure that the use of
cleaning and sanitation materials are used in a manner that protects
against contamination, manufacturers should ensure that such materials
are appropriate for their intended purpose and nontoxic where possible.
    Proposed Sec.  1120.34(d)(3) also would require that the use of
cleaning and sanitation materials comply with all applicable Federal,
State, and local requirements related to their application, use, or
storage. For example, hazardous cleaning and sanitation chemicals must
be handled, used, and stored in a manner consistent with the
information contained in their safety data sheets in accordance with
the hazard communication standard at 29 CFR 1910.1200(g).
    Proposed Sec.  1120.34(e) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for
monitoring, controlling, and minimizing the presence of animals and
pests in the buildings, facilities, and grounds to protect against
contamination of tobacco products. This proposed requirement would be
limited to manufacturing activities and not extend to agricultural
activities including growing, cultivation, or curing of raw tobacco (21
U.S.C. 387). FDA acknowledges that tobacco is an agricultural crop and,
therefore, there is the likelihood that there will be a certain level
of animals and pests (such as tobacco beetles) in the tobacco. However,
it is important that manufacturers take appropriate action to control
these animals and pests, which can cause contamination (e.g., Refs. 33-
35). FDA is proposing that these procedures include requirements for
establishing threshold criteria for animals and pests. This provision
is intended to provide manufacturers with flexibility to quantitatively
establish acceptable levels of animals or pests, such as insects, that
may be present and the levels that would necessitate action to control
and minimize infestation in order to avoid contamination. Manufacturers
may employ pest control or fumigation to minimize the presence of
animals or pests (e.g., Ref. 36). This approach is recognized in the
Cooperation Centre for Scientific Research Relative to Tobacco's
(CORESTA's) Good Agricultural Practices Guidelines (Ref. 37).

    This paragraph also would require that the procedures include a
requirement that any pesticide, including rodenticides, insecticides,
or fungicides used in the buildings, facilities, and grounds be
registered in accordance with the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.) and used in accordance with its
label, as applicable and used in a manner that protects against
contamination. Pesticides, such as rodenticides, insecticides, or
fungicides are useful to manufacturers to monitor, control, and
minimize animals and pests effectively. The tobacco product
manufacturer should follow all applicable pesticide labels, identify
proper compounds to be used, use the correct concentration, and apply
it as directed to avoid contamination (e.g., Refs. 38-40). Use of
inappropriate pest control chemicals or use in an inappropriate manner
can contaminate tobacco products (e.g., Refs. 39-41).
    Proposed Sec.  1120.34(f) would require finished and bulk tobacco
product manufacturers to maintain records of cleaning and sanitation
and animal and pest control activities required under this section.
These records would be required to include the date and time, the
individual performing the activity, the type of activity performed, any
information demonstrating the requirement was met, and any data or
calculations necessary to reconstruct the results. We believe these
records are necessary for tobacco product manufacturers to ensure that
the required activities have been conducted and for FDA to verify that
the activities have been adequately performed.
    The proposed requirements for buildings, facilities, and grounds
would help assure that the public health is protected by helping to
prevent tobacco product contamination by, among other things, toxic
cleaning compounds, inadequate maintenance, or cross-contamination from
inadequate cleaning (e.g., Refs. 42-44). Insanitary conditions can
create the potential for growth of microorganisms that may render
tobacco products injurious to health beyond what is normally associated
with tobacco products (e.g., Refs. 45 and 46).
    These proposed requirements also would help assure that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act by helping to ensure that tobacco products are not ``prepared,
packed, or held under insanitary conditions'' that may contaminate
tobacco products and render them adulterated under section 902 of the
FD&C Act. As discussed above, inadequate or inappropriate maintenance,
cleaning and sanitizing procedures, or animal and pest control may
result in conditions that can adulterate tobacco products.
3. Equipment
    Proposed Sec.  1120.36(a) would require finished and bulk tobacco
product manufacturers to ensure all equipment is appropriately designed
and constructed, and is suitable for its intended purpose. These
proposed requirements are generally similar to the equipment controls
in the industry recommendations and to controls that FDA has observed
during establishment inspections. The term ``equipment'' means any
machinery, tool, instrument, utensil, or other similar or related
article, used in the manufacture, preproduction design validation,
packing, or storage of a tobacco product. Equipment that is
appropriately designed, constructed, and suitable for its intended
purpose is designed and constructed in a manner that facilitates its
function, use, maintenance, and cleaning. For example, under this
proposal, a tobacco cutter would be required to be designed and
constructed to enable use, cleaning, and maintenance (e.g., inspection
and replacement of its cutting blade). It would also be required to be
suitable for its intended purpose to cut tobacco to particular
specifications (e.g., different cut sizes).
    Proposed Sec.  1120.36(b) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures, including
the methods and schedules, for the routine cleaning and maintenance of
equipment, to ensure proper performance of equipment and prevent
contamination. This provision is intended to give each tobacco product
manufacturer the flexibility to determine the appropriate methods and
frequency of cleaning and maintenance of equipment based on their
manufacturing practices. For example, a manufacturer may require that
cutting equipment be cleaned after each batch of tobacco is produced,
using approved sanitizing agents that will not contaminate the tobacco
product. The manufacturer also could schedule maintenance involving
disassembling, inspection, and replacement of the cutting blade to be
performed every 6 months. Proposed Sec.  1120.36(b) would also require
that the procedures provide for any change-over of tobacco product and
account for changes, limitations, or adjustment to the equipment. For
example, if a manufacturer uses the same equipment to manufacture
flavored and nonflavored tobacco products,\4\ the cleaning and
maintenance procedures must address the change-over activities to
prevent mixups or cross-contamination (e.g., Refs. 47 and 48).
---------------------------------------------------------------------------

    \4\ FDA recently issued proposed tobacco product standards that
would prohibit menthol as a characterizing flavor in cigarettes, 87
FR 26454 (May 4, 2022), and characterizing flavors (other than
tobacco) in all cigars and their components and parts, 87 FR 26396
(May 4, 2022).
---------------------------------------------------------------------------

    Proposed Sec.  1120.36(c) would require finished and bulk tobacco
product manufacturers to identify (electronically, by signage, or other
method of identification), if applicable, all processing lines and
major equipment to be used during manufacturing to prevent mixups and
contamination. The intent of this identification requirement is to
prevent mixups (e.g., flavored vs. nonflavored, regular vs.
mentholated) and distribution of nonconforming product. FDA is also
proposing that related information (i.e., which major equipment and
processing line was used in the manufacture of a batch of finished or
bulk tobacco product) be maintained in the production record, pursuant
to proposed Sec.  1120.70(b)(3) to establish traceability and assist
with, for example, nonconforming tobacco product investigations.
    FDA recognizes that it is impractical to identify every piece of
equipment used during manufacturing. Thus, the Agency proposes to
require identification of major equipment only. Major equipment
includes blending silos, conditioning cylinders, makers, filling
machines, assembly equipment (for cartridge production), and packers.
For example, if a manufacturer has multiple blending silos to hold
different blends, conditioning cylinders at different stages that add
different moisture levels, dedicated makers for different cigarette
lengths/circumferences, filling machines for dry vs. moist snuff, and
packers for soft vs. hard packs, this provision would require all such
equipment to be appropriately identified. Examples of equipment that
would not need to be identified under this proposed provision include a
portable hand-held mixer, optical detectors (to remove foreign matter),
metal detectors, string doffers (to remove string), and moisture
meters/detectors. In addition, manufacturers would be required to
identify all processing lines. For example, if there are dedicated
maker and packer lines for regular and mentholated products, these
processing lines would be required to bear appropriate identification
to prevent mixups and contamination. If a

manufacturer does not have multiple or dedicated processing lines or
major equipment that could lead to product mixup, it should document
this as a justification for not implementing these proposed
identification requirements.
    Manufacturers may also choose to include in the identification of
the processing line or major equipment the identification of the
product being processed. FDA has observed that some manufacturers place
designated, color coded, indicator to identify the flavor of the
product (for example, pink for cherry flavor) being manufactured with
that equipment. This requirement is intended to work in conjunction
with the requirements for identification and acceptance status
established in proposed Sec.  1120.64. Identifying the product as well
as major manufacturing equipment, will help minimize or eliminate
mixups during the manufacturing process.
    Proposed Sec.  1120.36(d) sets out additional requirements for
testing, monitoring, and measuring equipment. Testing, monitoring, and
measuring equipment is used in all stages of manufacturing. Examples of
testing, monitoring, and measuring equipment include pH meters,
moisture meters, and weight or measurement scales that are used to
verify established tobacco product specifications.
    Proposed Sec.  1120.36(d)(1) would require finished and bulk
tobacco product manufacturers to establish and maintain procedures for
all testing, monitoring, and measuring equipment to ensure such
equipment is capable of producing accurate and reliable results. For
example, if a manufacturer uses a pH meter, this proposal would require
procedures for the use of such a meter to address how its reference and
pH electrodes are to be maintained in order to produce accurate
results; otherwise, it could result in unstable and off-scale readings
(Ref. 49). In addition, if an ingredient specification is measured by
weight in grams, the scale would need to be sensitive enough to
accurately and reliably provide these measurements to ensure the
correct amount of the ingredient is added to the tobacco product.
    Proposed Sec.  1120.36(d)(2) would require that all testing,
monitoring, and measuring equipment be identified and disabled,
removed, replaced, or repaired when it is no longer suitable for its
intended purpose or when it is no longer capable of producing accurate
and reliable results. Defective equipment is not suitable for use in
the manufacturing process and can result in nonconforming or
contaminated tobacco product.
    Proposed Sec.  1120.36(d)(3) would require finished and bulk
tobacco product manufacturers to establish and maintain procedures for
the routine calibration of testing, monitoring and measuring equipment.
Calibration provides assurance that equipment is properly performing
and providing accurate and reliable measurements. Under this proposal,
the procedures must describe an appropriate reference standard and
include specific directions and acceptance criteria for the limits of
accuracy and precision. Testing, monitoring, and measuring equipment
must be calibrated before first use; thereafter, at a frequency
determined by the equipment manufacturer or at intervals necessary to
ensure accurate and reliable results; and after repair or maintenance.
The appropriate frequency of calibration would likely depend on the
particular equipment, the equipment manufacturer's recommendation, the
activity the equipment is used for, and the individual calibration
process. Calibration should be performed at suitable intervals in
accordance with an established procedure containing specific
directions, schedules, and limits for accuracy and precision based on
the type of instrument being used and other factors such as operating
environment and wear and tear.
    Proposed Sec.  1120.36(e) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. Records would be required to include the date and
time, the individual performing the activity, the type of activity
performed, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results.
    The proposed equipment requirements would assure that the public
health is protected, by helping to prevent the use of malfunctioning
equipment that can produce nonconforming product. For example, if a
tobacco cutter is not designed, constructed, or maintained properly, it
can result in tobacco strips that do not conform to established
specifications for cut size. The size of the cuttings of tobacco is a
physical design specification that can influence the release of
nicotine in a tobacco product (Ref. 6). Maintenance of equipment is
also necessary to prevent contamination of tobacco product. For
example, a finished tobacco product manufacturer previously recalled
tobacco products due to heavy oil spots from a cutter head oil leak
(Ref. 50). While some manufacturers may already have controls similar
to the proposed requirements in place, FDA believes it is important
that all manufacturers comply with these requirements to help protect
against the manufacturing and distributing of contaminated or otherwise
nonconforming product. The proposed identification requirement would
help assure that the public health is protected by preventing mixups
and contamination of tobacco products that could have an adverse impact
on public health.
    The proposed equipment requirements also would help assure that
tobacco products are in compliance with the requirements of chapter IX
of the FD&C Act. For example, the equipment requirements would help
ensure that tobacco products meet applicable statutory requirements
under sections 905, 907, 910, and 911 of the FD&C Act. Equipment that
functions properly and produces accurate and reliable results is
necessary to ensure that new tobacco products and MRTPs are
manufactured consistent with the specifications described in their
applications (i.e., SE Report, request for SE exemption, PMTA, MRTPA);
that the specifications for pre-existing tobacco products continue to
be consistent with their original characteristics; and that tobacco
products subject to tobacco product standards are manufactured in
accordance with those standards.
    For example, consider a cigarette product marketed pursuant to an
SE Report. If laboratory equipment used in the cigarette manufacturing
provides a check on the nicotine content in the manufactured products,
improperly functioning equipment may allow higher nicotine content in
the manufactured products. Such products would not conform to the
specifications described in the SE Report. Because FDA authorizes the
marketing of tobacco products based on the specifications described in
the relevant marketing application, nonconforming products, such as the
cigarette in this example, would be on the market without FDA
authorization in violation of chapter IX of the FD&C Act.
    In addition, a bulk manufacturer that does not properly maintain or
calibrate its testing, monitoring, and measuring equipment can produce
nonconforming bulk tobacco products. For example, cutting equipment
that has not been properly maintained can result in bulk cigarette
tobacco, RYO, or pipe tobacco products with an incorrect cut size.
Similarly, filling equipment that has not been properly calibrated can
produce bulk e-liquids with nicotine concentration that exceeds the
labeled concentration.

4. Environmental Controls
    Proposed Sec.  1120.38(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to
adequately control environmental conditions where appropriate. In
addition, under the proposed requirement, environmental control systems
would have to be maintained and monitored to verify that environmental
controls, including necessary equipment, are adequate and functioning
properly. Environmental control systems include associated equipment
(e.g., HVAC equipment, humidifier, air filters) that manages the
facility's environmental conditions (e.g., temperature, humidity,
ventilation, filtration). These proposed requirements, which are
intended to ensure that the tobacco product meets its specifications
and is not adversely affected by environmental conditions, complement
those in proposed Sec.  1120.34, which are intended, in part, to ensure
that buildings and facilities have adequate controls to prevent
contamination. These proposed requirements are generally similar to the
practices of manufacturing establishments that follow ISO 9001-2015
(Ref. 11).
    The appropriate environmental control procedures needed to comply
with this proposed requirement can vary by product, manufacturing
process, and other factors. For example, if a tobacco product
manufacturer uses a sterilization process for a moist snuff product to
achieve a product stability specification, it should establish
environmental controls for temperature, moisture, and time (Ref. 51).
If a tobacco product manufacturer determines that specific conditions
are necessary to minimize mold growth, it would need to establish
appropriate environmental controls, such as controlling the relative
humidity (Ref. 52). In addition, if an ENDS manufacturer determines
that airborne particulates can contaminate e-liquids, appropriate
environmental controls, such as use of air filters or precautions
against potential sources of airborne contaminants, should be taken
(e.g., Ref. 10).
    Proposed Sec.  1120.38(a) also would require that environmental
control systems be maintained and monitored to verify that
environmental controls, including necessary equipment, are adequate and
functioning properly. Monitoring of these systems can be performed by
recording data, using alarms to determine if the environmental controls
deviate from the operating range or fail, or other means to ensure that
environmental controls are operating as intended.
    Proposed Sec.  1120.38(b) would require finished and bulk tobacco
product manufacturers to maintain records regarding environmental
controls, including maintenance and monitoring. Records would be
required to include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results. We believe these records are necessary to
ensure that the required activities have been conducted and for FDA to
verify that the activities have been adequately performed.
    The proposed environmental controls requirements would help assure
that the public health is protected by maintaining proper environmental
conditions to protect products from contamination and to ensure they
meet specifications. For example, improper humidity and temperature
during storage of tobacco can result in spoilage and the growth of mold
(Ref. 53). Studies have shown that mold can grow on reconstituted
tobacco at certain humidity and temperature conditions (Ref. 54). FDA
is aware that some tobacco product manufacturers have a microbiological
monitoring plan and perform environmental monitoring of water and air
in accordance with that plan and assess the effectiveness of their
sanitation procedures (Ref. 55). As an example of how environmental
controls can also be important to ensure that products meet
specifications, if a smokeless tobacco product uses a heat treatment
process (Ref. 56) or a cigar uses a fermentation process (Ref. 57) to
achieve a pH specification, the tobacco product would not conform to
its established specification if the manufacturer does not establish
and maintain environmental controls for the temperature, moisture, and
time. As explained in more detail in the discussion of proposed Sec.
1120.74 (see section II.E below), a specification such as pH can affect
the speed and amount of nicotine that is delivered to a user (Refs. 6
and 19). Moisture and pH also can be associated with concentrations of
nicotine in smokeless tobacco (Refs. 58 and 59). While some
manufacturers may already have similar controls in place, this proposed
rule would help ensure that all manufacturers establish such controls
to help protect against the manufacturing and distributing of
contaminated or otherwise nonconforming product.
    In addition, the proposed environmental controls would help assure
that tobacco products are in compliance with the requirements of
chapter IX of the FD&C Act. As discussed, specific controlled
environmental conditions may be necessary to manufacture a tobacco
product that conforms to established specifications, including
specifications described in any relevant tobacco product applications
(i.e., SE Report, request for SE exemption, PMTA, MRTPA), and to ensure
that the specifications for pre-existing tobacco products continue to
be consistent with their original characteristics.

D. Design and Development Controls

1. Design and Development Activities
    Proposed Sec.  1120.42 addresses risks associated with design and
development activities by requiring finished and bulk tobacco product
manufacturers to establish and maintain procedures to control the
design and development of each finished and bulk tobacco product and
its package, including the control of risks associated with the
product, production process, packing, and storage. Procedures to
control the design and development of finished and bulk tobacco
products would need to address risk management as well as design
verification and validation. The proposed requirements incorporate
principles similar to those found in, for example, ISO 9001; the QSR
for medical devices; current good manufacturing practice, hazard
analysis, and risk-based preventive controls for human food; and HACCP
regulations.
    Proposed Sec.  1120.42(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to control
the design and development of each product and its package, including
the control of risks associated with the product, production process,
packing, and storage. While FDA is aware that some tobacco product
manufacturers already engage in a wide variety of activities to control
the design and development of tobacco products, including chemistry,
toxicology, and nonclinical testing; clinical assessment and
investigations; and consumer and market research (e.g., Ref. 55), the
Agency believes that these requirements are needed to ensure that all
manufacturers address risks associated with design and development
activities. A manufacturer's procedures may vary based on the type of
tobacco product and may be specific to one or multiple products.
Therefore, FDA is proposing a flexible framework to allow manufacturers
to implement procedures that best suit their specific design and
development approach.

    Design activities can be performed by different parts of a tobacco
product manufacturer's organization, (e.g., manufacturing, marketing,
purchasing, and regulatory affairs). Procedures to control the design
and development of a tobacco product should establish the roles that
any groups have in process and describe the information that they
should receive and transmit, including any approvals that may be
necessary.
    Under proposed Sec.  1120.42(a), design and development controls
must control for risks associated with each finished and bulk tobacco
product and its package, production process, packing, and storage.
Specifically, proposed Sec.  1120.42(a)(1) would require that the
design and development procedures include a risk management process.
For purposes of this rule, a risk management process is a preventive
means to identify and control for potential risks throughout the
product lifecycle (i.e., during design, manufacturing, distribution,
and use of products). Risk management is an established practice used
by manufacturers in many industries, including in the manufacture of
FDA-regulated products such as foods, drugs, biologics, and medical
devices. General risk management standards such as ISO 31000:2018--Risk
Management--Principles and Guidelines (Ref. 12) can be used by
manufacturers to provide guidance in establishing and maintaining a
risk management system. In some industries, industry-specific risk
management standards have been developed (e.g., Refs. 60 and 61),
whereas other industries use a more broadly developed framework (e.g.,
Ref. 62). While FDA is not proposing to require compliance with a
particular risk management framework or standard, FDA recommends that
finished and bulk tobacco product manufacturers use an established risk
management framework such as a standard or guideline.
    The proposed provision would give manufacturers flexibility in
devising their risk management process and the type of risk assessment
technique(s) employed; however, at a minimum, proposed Sec.
1120.42(a)(1) would require that the risk management process include
the following steps: risk assessment (including risk identification,
risk analysis, and risk evaluation), risk treatment, and reassessment.
A tobacco product manufacturer can perform their risk management
process for categories, types, or families of products that share
similar specifications and design characteristics. During inspections,
the Agency has observed that some tobacco product manufacturers
currently use a risk management framework (including, e.g., HACCP
plans) that is consistent with these proposed requirements (Ref. 63).
    Under proposed Sec.  1120.42(a)(1)(i), each finished and bulk
manufacturer must perform a risk assessment that includes risk
identification, risk analysis, and risk evaluation. Manufacturers can
utilize various risk assessment techniques to help ensure compliance
with this section, such as preliminary hazard analysis, Delphi,
scenario analysis, fault tree analysis, cause-and-effect analysis,
failure mode and effect analysis, hazard and operability studies, and
hazard analysis and critical control points (Ref. 62). Risk assessment
for risks associated with the tobacco product would need to be
performed for each tobacco product manufactured, packed, or stored,
taking into account the individual attributes of each product, its
package, and manufacturing process. For example, a manufacturer
performing a risk assessment for e-liquids would need to consider
potential risks associated with access of e-liquid by children or
leakage of e-liquid from cartridges during and after use, which can
cause acute nicotine toxicity to users and nonusers.
    The first step of risk assessment that would be required under
proposed Sec.  1120.42(a)(1)(i) is risk identification. At this step,
manufacturers would be required to identify all known or reasonably
foreseeable risks associated with the tobacco product and its package,
as well as its production process, packing, and storage (see Refs. 12
and 62). In identifying all known or reasonably foreseeable risks
associated with the tobacco product, a manufacturer would be required
to identify known or reasonably foreseeable risks that may occur
naturally or be introduced, intentionally or unintentionally, in the
growing, harvesting, curing, leaf processing, and warehousing of
tobacco leaf, and during primary production, manufacturing, packing, or
storage of finished or bulk tobacco products. These risks may include
biological, chemical, or physical hazards in a tobacco product, such as
harmful bacteria, pesticides, and NTRMs. Risk identification would also
need to take into account risks associated with product design. An
example of a risk associated with product design is a dissolvable
tobacco product whose size and shape resembles candy, resulting in
potential misuse by and harm to children.
    ``Known'' risks refer to those risks that a tobacco product
manufacturer knows about through, for example, its manufacturing and
distribution experience, records, and reports (such as complaints,
returned products, nonconforming product, and CAPA). ``Reasonably
foreseeable'' risks are those risks that a reasonably prudent tobacco
product manufacturer would become aware of through scientific
literature, publications, or public information, such as an industry
standard or FDA guidance document. To identify risks, the manufacturer
should evaluate relevant information, such as complaint file
investigations, published literature, articles, and reports. For
example, in identifying reasonably foreseeable risks associated with an
ENDS product with a lithium battery, a manufacturer should take into
consideration, among other things, available information regarding
design features of lithium ion batteries that could cause overheating,
fires, and explosions (e.g., Refs. 64-69).
    Proposed Sec.  1120.42(a)(1)(i) would also require that risk
identification include risks that may occur with normal use (i.e.,
labeled and customary uses) and with reasonably foreseeable misuse
(i.e., any use not intended by the manufacturer, including user error)
of a tobacco product. Risks that may occur with normal use and with
reasonably foreseeable misuse are discussed in greater detail below.
    The concept of ``reasonably foreseeable misuse'' is well-
established and utilized in risk management. For example, the American
National Standards Institute (ANSI)/Advancement of Medical
Instrumentation (AAMI)/International Electrotechnical Commission (IEC)
62304:2006 regarding medical device software, states that manufacturers
must identify potential causes of hazardous situations, including
reasonably foreseeable misuse (Ref. 70). Since misuse of a product can
be a source of harm, FDA believes it is appropriate to consider
reasonably foreseeable misuse when completing risk management
activities for tobacco products. An example of a risk related to
reasonably foreseeable misuse would include a child accessing an e-
liquid container that does not have a secure container closure system
and ingesting the product, which could lead to serious injury or death
due to nicotine toxicity.
    Proposed Sec.  1120.42(a)(1)(i) would require each finished and
bulk tobacco product manufacturer to identify all known or reasonably
foreseeable risks associated with the tobacco product and its package,
as well as its production process, packing, and storage. Risks
associated with a tobacco product under proposed Sec.  1120.42(a)(1)(i)
would include risks associated with finished or bulk tobacco product
specifications,

including product risks attributable to components or parts,
ingredients, additives and materials; product design; and issues
addressed in a tobacco product standard under section 907 of the FD&C
Act. For example, use of an improper charger on a rechargeable e-
cigarette may result in a battery fire or explosion due to differences
in specifications. Similarly, use of e-liquid flavors containing
diacetyl may cause acute-onset bronchiolitis obliterans, a severe and
irreversible obstructive lung disease (Ref. 71).
    Risk identification would also need to be performed for known or
reasonably foreseeable risks associated with the tobacco product
package. Risks associated with a tobacco product package would include
substances that may render the contents injurious to health and cause
the tobacco product to become adulterated under section 902(3) of the
FD&C Act or a package design which can cause or expose users and
nonusers to harm. For example, an e-liquid manufacturer would need to
consider potential risks of leakage of e-liquid from cartridges, which
can cause product malfunction (Ref. 72) or skin irritation (Ref. 73),
as well as risks to nonusers such as children who can access the e-
liquid and experience acute nicotine toxicity (Refs. 74-76).
    Risk identification would also need to be performed for all known
or reasonably foreseeable risks associated with the production process,
packing, and storage. Risks associated with the production process,
packing, and storage would include substances and conditions that can
contaminate and/or render the tobacco product injurious to health and
thereby cause the tobacco product to become adulterated under section
902(1) and (2) of the FD&C Act, including but not limited to,
biological, chemical, and physical hazards described below. Risk
identification should take into account the type of tobacco product
being manufactured, the manufacturing processes, and the facility where
the product is manufactured, packed, or stored. Risks identified in one
facility may not be significant in another facility, even if it
manufactures the same or a similar product, due to differences in
equipment, process controls, and/or maintenance programs. Additionally,
risks associated with a facility's tobacco products may differ based on
the type of tobacco product manufactured, packed, or stored.
    Risk identification should take into account biological, chemical,
and physical hazards. For example, biological hazards such as bacteria,
mold, yeast, microbes, and other biological organisms can grow on
tobacco and tobacco products as a result of environmental conditions in
their warehousing, packing, and storage. These hazards vary widely in
their prevalence, mode of action, infectious dose, growth and survival
specifications, and resistance to heating, chemical agents, and other
processes or treatments. The Agency has observed on inspection that a
cigarette manufacturer identified potential mold on incoming ``tobacco
with yellow spots'' during visual inspection that was determined by
microbiological analysis to be Aspergillus flavus (the major producer
of aflatoxin, which is associated with an increased risk of liver
cancer) (Ref. 77). In addition, microbes that can be found on tobacco
and tobacco products include bacteria, bacterial spores, fungi (yeast
and mold), fungal spores, cell wall components (certain glucans and
flagellum), and diverse microbial toxins that include exotoxins and
endotoxins (Ref. 78). Examples of bacterial-derived toxins include
endotoxins (lipopolysaccharide, LPS; inflammatory factor) and mold-
derived mycotoxins (Ref. 78).
    Similarly, risk identification should include chemical hazards.
Chemical hazards, including pesticide residues, can be naturally
occurring or intentionally, unintentionally, or incidentally added to
tobacco, tobacco products, or tobacco-product contacting surfaces. For
example, pesticide chemical residues have been found on commercially
available cigarettes. In 2003, the European Commission's Joint Research
Centre investigated the content of organochlorine pesticides in a
selection of commercially available cigarette brands and found that
they contained pesticide chemical residues (Ref. 79). Organochlorine
pesticides act on the nervous system to prevent the normal flow of
nerve impulses to muscles that control both voluntary movement, such as
walking, and involuntary movement, such as breathing and heartbeat
(Ref. 80). These classes of pesticides are also associated with a range
of adverse health effects that could result in immediate and life-
threatening effects, such as respiratory failure, or conditions that do
not appear immediately, such as cancer (Ref. 80).
    When identifying chemical hazards, tobacco product manufacturers
should assess the chemicals that are used in the manufacturing
establishment for cleaning, sanitation, and pest control purposes that
may be associated with the manufacturing, packing, and storage of
tobacco products, including rodenticides, insecticides, fungicides, and
fumigating agents. For example, FDA is aware of situations where
packaging solvents, cleaning solutions, hydraulic oil leakage, and
machine grease may have caused contamination (Refs. 50 and 81).
    Risk identification should also take into account any physical
hazards that may be associated with the tobacco product. These hazards
include animals, animal parts and excrement, insects and insect
excrement, such as tobacco beetles and insect parts; rocks, stones, and
sand; plastic string, plastic sheet, foam, and rubber; metal, glass,
hessian/burlap, wood products, cloth, and cotton strings; and other
forms of NTRMs that may be introduced on the farm, during harvesting,
and during the manufacturing process. The facility and equipment also
can be a source of physical hazards (e.g., metal fragments such as nuts
and bolts from equipment used in manufacturing and processing, glass
pieces from overhead light bulbs, or debris from overhead equipment).
FDA is aware that glass shards have been found in smokeless tobacco
products (Ref. 81). If glass is present in chewing tobacco, it may
lacerate the gums or lips of the user of the tobacco product. FDA
believes it is critical to identify NTRMs that may be introduced
throughout the supply chain (Ref. 37).
    FDA is proposing that the risk management process require
identification of all known and reasonably foreseeable risks associated
with the tobacco product, including risks that cause illness, injury,
or death normally associated with the use of tobacco products.
Identifying risks normally associated with the use of the tobacco
product is necessary to perform an adequate risk analysis and
evaluation. Some symptoms or health effects of risks not normally
associated with the use of the tobacco product can be similar to the
symptoms or health effects of risks normally associated with the use of
the tobacco product, and therefore this requirement would help ensure
that risks that may appear to be normally associated with the use of
tobacco products, but are not, are included in the risk analysis and
evaluation. In addition, identifying symptoms or health effects of
risks normally associated with the use of the tobacco product and their
likelihood and consequence of occurrence will help inform the
investigation of user reports and complaints about such symptoms or
health effects, because they may also point to risks not normally
associated with the use of the tobacco product. For example, an
increase of reported frequency or severity of respiratory distress from
use of an ENDS product may help a

manufacturer detect a previously unidentified risk of metallic
particles in the cartomizer aerosol due to defective solder joints from
the cartomizer (Ref. 2). Similarly, increased complaints of pneumonia,
exacerbation of asthma, bronchitis, chronic obstructive pulmonary
disease, eosinophilic pneumonitis, and laryngitis may be associated
with chemical contamination of a tobacco product (Ref. 82).
    After risk identification, the next step of risk assessment is risk
analysis. Risk analysis is an analysis of the nature and level of the
risk for each identified known or reasonably foreseeable risk that
takes into account the likelihood of occurrence of the risk and the
consequences of occurrence of the risk (i.e., severity of the potential
harm). When considering the likelihood of occurrence of the risk, the
manufacturer should consider the frequency that such risk may occur in
the type of product, the production process, and the particular
manufacturing establishment. When considering the consequences of the
occurrence of the risk, the manufacturer should consider the health
effects of the risk, including the severity, immediacy, or near-term
onset of any potential injury or illness, and long-term effects from
chronic or cumulative exposure, on both users and nonusers.
    For example, FDA is aware that some manufacturers have identified
styrene (Styrofoam) as a risk that requires risk control. Styrene is a
chemical hazard that can be introduced in tobacco products as an NTRM
such as via food containers that contaminate tobacco products during
manufacturing or via a packaging coating that can be transferred to the
tobacco product (Ref. 83). Styrene can enter into the body of consumers
by inhalation or ingestion. Styrene consumption can affect the nervous
system, resulting in changes in color vision, tiredness, feeling drunk,
slowed reaction times, concentration problems, and balance problems
(Ref. 84). The International Agency for Research on Cancer (IARC) has
determined that styrene is a possible carcinogen (Ref. 85). Under the
proposed rule, a manufacturer performing a risk analysis for styrene
would consider the likelihood of styrene being introduced into the
tobacco product and reaching consumers. It would also consider the
health effects of styrene exposure on users and nonusers. For example,
storage conditions such as temperature and duration can affect
microbial growth and nitrite formation, which can influence tobacco-
specific N-nitrosamines (TSNA) content in processed and packaged
smokeless tobacco products. (See Ref. 16, Ref. 181-182). Under the
proposed rule, a manufacturer should perform a risk analysis of the
tobacco product using the expected storage period and conditions and
determine the likelihood of changes to TSNA content that may result in
an increased risk to public health as the product sits in storage.
    Following risk analysis, the last step of risk assessment is risk
evaluation. The proposed risk evaluation requirement would require an
evaluation of each identified risk. Risk evaluation is a determination
of the significance of the risk and the type of risk treatment needed
(e.g., avoiding the risk, mitigating the risk, or choosing to retain
the risk), including the priority of the risk treatment. A
comprehensive risk evaluation demonstrates that the manufacturer has
considered all relevant information about the tobacco products being
manufactured, packed, or stored and determined the significance of the
identified risks and what type of risk treatment is needed.
    In this context, determining the significance of the risk means
evaluating whether the risk and its magnitude are acceptable,
tolerable, or unacceptable. In determining the significance of the
risk, manufacturers should develop criteria against which the risk and
its magnitude can be evaluated. For example, a manufacturer may
determine that, based on its risk criteria, a risk of nonusers
ingesting e-liquids resulting in toxic nicotine exposure is not
tolerable and must be controlled. The manufacturer may similarly
determine that, based on its risk criteria, a nicotine concentration
that is a certain percentage higher than the established specification
is not tolerable and must be controlled through additional
manufacturing controls such as acceptance testing. Determining the
significance of a risk would inform the manufacturer's decision
regarding what type of risk treatment is appropriate and the priority
of that risk treatment. FDA is aware that during the evaluation stage
of a risk assessment, manufacturers across industries sort risks into
categories based on established risk criteria to determine whether risk
control/mitigation is required, should be considered, or is not
necessary (Ref. 12).
    Proposed Sec.  1120.42(a)(1)(ii) would require that each finished
and bulk manufacturer treat all identified risks, including risks
addressed in applicable tobacco product standards. Risk treatment can
include implementing controls to avoid or remove the risk, or making an
informed decision to retain the identified risk (Ref. 12). The proposed
risk treatment requirements would require the manufacturer to
significantly minimize or prevent risks identified in proposed Sec.
1120.42(a)(1)(i) that are reasonably likely to occur and that may cause
serious illness, injury, or death not normally associated with the use
of the tobacco product, or that the manufacturer determines constitute
an unacceptable level of risk. Additionally, risks addressed in any
applicable tobacco product standards would be required to be treated in
a manner that ensures the tobacco product will conform to the
specifications and requirements established in the tobacco product
standard. FDA requests comment on whether these are the appropriate
risks for which risk prevention or mitigation should be required.
    FDA's application of risk management concepts acknowledges that the
use and consumption of tobacco products entails some degree of risk
inherent to tobacco use. Therefore, the risk mitigation and prevention
requirements in the proposed rule focus on reducing or eliminating
those risks associated with the tobacco product, its design and
packaging, and its associated production process, packing, and storage
that are reasonably likely to occur and may cause an illness, injury,
or death not normally associated with the use of tobacco products.
These requirements are also intended to address issues that the
manufacturer determines constitute an unacceptable level of risk. This
proposed provision would, therefore, require tobacco product
manufacturers to, at a minimum, undertake risk treatment to
significantly minimize or prevent such risks. Additionally, any risks
identified in an applicable tobacco product standard would need to be
treated in a manner that ensures the tobacco product will conform to
the tobacco product standard.
    For example, a manufacturer may determine that NTRMs such as glass,
metal, rocks, and stones are introduced on the farm, during harvesting,
or during the manufacturing process, and that, as a result, hard or
sharp NTRMs are reasonably likely to occur in a tobacco product. The
manufacturer may also determine that, when these hard or sharp NTRMs
are present in a tobacco product, they may cause traumatic injury,
including laceration and perforation of tissues of the mouth, tongue,
throat, stomach, and intestine as well as damage to the teeth and gums.
Based on this information, the manufacturer would be required to
significantly minimize or prevent the risk under Sec.
1120.42(a)(1)(ii) of the proposed rule.

    Risk treatment measures will vary based on the type of product and
the risks identified as well as the manufacturing facility. Risk
treatment can include manufacturing controls, redesigning the tobacco
product, clarifying user instructions, or ordering a component or part
from a different supplier. Risk treatment also may include personnel
requirements (e.g., health, cleanliness, personal practices, and
apparel of personnel), cleaning and sanitation controls, animal and
pest controls, maintenance of equipment, environmental controls,
purchasing controls (e.g., Good Agricultural Practices, supplier
guarantee, testing raw tobacco for pesticide chemical residues (Ref.
86)), acceptance activities (e.g., visual inspection, tests, and other
verification activities), and process controls (e.g., metal detectors,
x-rays, optical sorters). For example, FDA has noted on inspections
that certain manufacturers have implemented manufacturing policies that
include a requirement to use pens that do not have caps, are color-
coded, and contain ferrous material to prevent physical hazards from
being introduced in the tobacco product during the production process
and enable the hazard to be readily identified by metal detectors and
magnets if necessary (Ref. 87).
    Where risk treatment measures required by proposed Sec.
1120.42(a)(1)(ii) are implemented to significantly minimize or prevent
a risk associated with the production process, packing, and storage
that is reasonably likely to occur and may cause serious illness,
injury, or death not normally associated with the use of the tobacco
product and package, or that the manufacturer determines constitutes an
unacceptable level of risk, the manufacturer should incorporate these
measures in the relevant procedure(s) under proposed part 1120. For
example, the manufacturer may need to incorporate the risk treatment
measures into its procedures for personnel practices under proposed
Sec.  1120.32, buildings, facilities, and grounds under proposed Sec.
1120.34, environmental controls under proposed Sec.  1120.38,
purchasing controls under Sec.  1120.62, acceptance activities under
proposed Sec.  1120.64, and production processes and controls under
proposed Sec.  1120.66. Manufacturers also would be required to
validate or verify their production process in accordance with proposed
Sec.  1120.66.
    A manufacturer may determine that a risk is unacceptable if it
occurs infrequently but the consequences are severe. Likewise, a risk
may be unacceptable if the risk occurs frequently, even if it is not
associated with serious illness or injury. For example, if a cigarette
manufacturer uses a new filter supplier that uses methyl isothiocyanate
(which can cause throat irritation) in its filter processing, it may
determine that this is an unacceptable level of risk if it occurs
frequently, even though the severity of the risk is moderate or low.
    Although testing alone is rarely considered an effective risk
treatment, testing can be useful to verify that control measures are
effectively minimizing or preventing risks. For example, microbial
testing of raw materials may verify that suppliers have controlled for
biological hazards. Environment testing also may verify whether
sanitation or environmental controls have addressed the potential for
environmental pathogens to contaminate tobacco products. For example,
during acceptance moisture testing, a manufacturer may determine a
finished product has excessive moisture content during the packing
process that has resulted in spoilage of cigarettes due to growth of
Aspergillus restrictus and Aspergillus glaucus mold, a biological
hazard (Ref. 88).
    Where a manufacturer has identified a risk associated with consumer
misuse of a product, the manufacturer may need to redesign the product
in order to comply with this proposed provision. If there is a
potential for misuse that causes harm and such misuse could be
prevented, the manufacturer should address it. For example, a tobacco
product manufacturer may determine that a package redesign could reduce
choking hazards associated with dissolvable tobacco products or toxic
exposure to e-liquids (e.g., Refs. 89 and 90). Similarly, an ENDS
manufacturer could redesign a battery charger connection if the
manufacturer identifies the risk that users are misusing the USB
charging connection port and using a nonstandard USB power source that
does not match the manufacturer's specifications. Depending on the
manufacturer's assessment of the risk, a redesign may not always be
necessary. However, if new information suggests that risk treatment
short of redesign has not been effective, the proposed rule would
require the manufacturer to reassess their risk treatment activities
pursuant to proposed Sec.  1120.42(a)(1)(iii) and consider additional
mitigation.
    Proposed Sec.  1120.42(a)(1)(iii) would require each finished and
bulk tobacco product manufacturer to reassess the risks whenever the
manufacturer becomes aware of new information that could change the
risk assessment and risk treatment, including information about
previously unidentified risks or the adequacy of risk treatment
measures.
    The risk management process FDA is proposing is an ongoing process
whereby manufacturers update their risk assessment as new information
is learned. The purpose of the reassessment requirement is to determine
if existing risk assessment and risk treatment need to be updated in
light of new information that bears on the effectiveness of the risk
management process. New information can inform the scientific
understanding of a previously assessed risk or identify a new risk. A
finished or bulk tobacco product manufacturer may become aware of new
information in a variety of ways, including user and nonuser reports of
adverse experiences, records and reports (such as complaints, returned
products, nonconforming product, and CAPA), and through scientific
literature, publications, or public information, such as an industry
standard or FDA document.
    Proposed Sec.  1120.42(a)(1)(iii) would specifically require
finished and bulk tobacco product manufacturers to reassess risks
whenever the manufacturer becomes aware of new information that
indicates a previously unidentified risk. For example, an ENDS
manufacturer may become aware that the ENDS product's power settings
can result in carbonyl generation which can increase cancer potency
(Refs. 91 and 92). Under these circumstances, the ENDS manufacturer
would have to undertake the risk assessment and risk treatment steps
for the newly identified risk.
    Additionally, this provision would also require the manufacturer to
reassess the risks when it becomes aware of new information that
indicates that a previously identified risk they did not believe was
reasonably likely to occur is, in fact, reasonably likely to occur. For
example, a tobacco product manufacturer may have previously identified
metal fragments in chewing tobacco as a risk that was not reasonably
likely to occur. If the manufacturer begins to receive consumer
complaints about metal fragments being found in its chewing tobacco,
this new information would necessitate a reassessment of the risk to
determine whether the initial risk analysis and evaluation must be
updated and new risk treatment measures must be implemented.
    In addition, this provision would also require manufacturers to
reassess risks when they become aware of new information that indicates
the existing risk treatment measures are ineffective.

For example, if consumer complaints report that finished tobacco
products continue to have NTRM after risk treatment measures have been
implemented, the tobacco product manufacturer would need to reassess
the risk and modify the treatment measures as necessary.
    FDA recognizes that batteries and other components may be a source
of risk. Therefore, FDA is proposing that finished and bulk tobacco
product manufacturers, which are responsible for component selection
and design (e.g., an ENDS manufacturer responsible for the selection of
the battery and the manner in which it operates in the ENDS product),
would need to do a risk assessment of the risks associated with the
finished or bulk tobacco product, including risks attributable to such
components. For example, an ENDS manufacturer should perform a risk
assessment of the battery design (such as an internal or a commercially
available off-the-shelf external battery), safety rating, and suppliers
to consider potential risks associated with use of the battery with
their ENDS product that may occur during normal use (e.g., charging)
and during reasonably foreseeable misuse (e.g., customer replacement
with a non-OEM battery).
    FDA is aware that not all tobacco product manufacturers design the
tobacco products they manufacture. Under this proposed rule, contract
manufacturers who are not responsible for product design would not be
required to assess the design risks associated with the products'
specifications. For example, if a contract manufacturer does not engage
in design activities but only manufactures a tobacco product for
another party based on specifications provided by that party, the
contract manufacturer would not be responsible for assessing the design
risks associated with the product's specifications.
    For finished and bulk tobacco products first commercially marketed
or modified after the effective date of this rule, proposed Sec.
1120.42(a)(2) would require finished and bulk tobacco product
manufacturers to perform design verification to confirm that the
tobacco product and its packaging meet specifications and design
validation to assess the performance of the tobacco product. These
activities would be informed by the risk management process in proposed
Sec.  1120.42(a)(1). Process verification and process validation would
be separate requirements and are found in proposed Sec.  1120.66.
Design verification confirms that the product and packaging meet their
specifications. Design verification activities can include testing and
studies, and reviewing design documents before their release as
specifications in the MMR. For example, an ENDS manufacturer may
establish that the specification for a battery is a power of 4 volts,
temperature range of 200 [deg]C to 300 [deg]C, it must be charged in
less than 90 minutes, and that it can be recharged 1,000 times. Under
the proposed rule, the manufacturer would be required to perform
battery testing to verify that the battery performance meets those
specifications.
    Design validation is a process to assess the product performance to
confirm that it consistently performs or functions as intended. For
example, a manufacturer could perform testing of child resistant
packaging to validate the effectiveness of the package design in
preventing children from accessing the tobacco product while allowing
adult users to open the package.
    For finished and bulk tobacco products first commercially marketed
or modified after the effective date of this rule, proposed Sec.
1120.42(a)(3) would require that the product and packaging design be
approved by a designated, authorized individual. The review and
approval would be required to ensure that the product and packaging
specifications are supported by the product design verification and
validation activities and that appropriate risk treatment measures have
been implemented.
    For finished and bulk tobacco products first commercially marketed
or modified after the effective date of this rule, proposed Sec.
1120.42(a)(4) would require finished and bulk tobacco product
manufacturers to transfer the approved product and packaging
specifications to the MMR. Proposed Sec.  1120.42(a)(5) would require
finished and bulk tobacco product manufacturers, where appropriate, to
utilize the processes under proposed Sec.  1120.42(a)(2) through (4)
for design changes before the changes are implemented.
    Proposed Sec.  1120.42(b) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. These records would be required to include the date
and time, individual performing the activity, type of activity
performed, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results.
Manufacturers would have flexibility to determine the format in which
these records are maintained. For example, these records may be
maintained in a single record or single file of records, or as part of
a product- or product-type-specific index system that references and
includes the location of all the required information. The results of
the design and development activities would produce the information
documented in the MMR, including specifications, manufacturing methods
and procedures, and packaging and labeling (see proposed Sec.
1120.44(a)).
    The proposed requirements for design verification and validation,
design approval, and design transfer under Sec.  1120.42(a)(2) through
(4) would not apply to existing tobacco products already commercially
marketed before the effective date of this rule, including, for
example, pre-existing tobacco products commercially marketed in the
United States as of February 15, 2007. Finished and bulk tobacco
product manufacturers would not be required to perform retroactive
design verification to confirm that such tobacco products and their
packages meet specifications, or retroactive design validation to
assess their performance. Similarly, finished and bulk tobacco product
manufacturers would not be required to perform retroactive design
approval and design transfer for such products under proposed Sec.
1120.42(b)(3) and (4). However, the proposed Sec.  1120.42(a)(2)-(4)
requirements would apply to finished and bulk tobacco products first
commercially marketed after the effective date of the rule, and to any
finished and bulk tobacco products that are modified after the
effective date of the rule, including changes made in order to comply
with a tobacco product standard. When changes are made to finished or
bulk tobacco products commercially marketed before the effective date
of any final TPMP rule, the proposed requirements of Sec.
1120.42(a)(2) must be followed to confirm that the tobacco product and
its package, as modified, meet specifications and that the tobacco
product will perform as intended.
    The proposed design and development activities requirements would
help assure that the public health is protected by helping to prevent
illness, injury, or death not normally associated with the use of the
tobacco product, including to users and nonusers. The proposed
provisions would require finished and bulk tobacco product
manufacturers to perform an assessment of the known and reasonably
foreseeable risks associated with the tobacco product, its package, and
its production process, packing, and storage that may occur with normal
use of the tobacco product or with any reasonably foreseeable misuse of
the product, including user error. For

example, ENDS can overheat, resulting in fires and explosions (e.g.,
Refs. 64, 93 and 94). Under these proposed requirements, an ENDS
manufacturer would be required to assess the risk the battery poses in
the design of its finished tobacco product, as lithium batteries can
contribute to ``thermal runaway'' and cause a battery fire or explosion