Document ID: FDA-1996-N-0028-0052
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-08-01T04:00Z

VII.  Comments on Personnel

(Final Subpart B)

	A.  Organization of Final Subpart B

     Proposed subpart B contained three provisions regarding personnel. 
Table 3 lists the sections in final subpart B and identifies the
proposed sections that form the basis of the final rule.  

Table 3.- Derivation of Sections in Final Subpart B

Final Rule	

2003 CGMP Proposal

§ 111.8 What Are the Requirements Under This Subpart for Written
Procedures?	

N/A

§ 111.10 What Requirements Apply for Preventing Microbial
Contamination From Sick or Infected Personnel and for Hygienic
practices?	

§ 111.10

§ 111.12 What Personnel Qualification Requirements Apply?	

§ 111.12

§ 111.13 What Supervisor Requirements Apply?	

§ 111.13

§ 111.14 Under This Subpart, What Records Must You Make and Keep?	

N/A

 	

	B.  Highlights of Changes to the Proposed Requirements for Personnel

1. Revisions

•     The final provisions in subpart B include revisions that clarify
that the final rule applies only to persons who manufacture, package,
label or hold dietary supplements unless subject to an exclusion in §
111.1. 

•	The final provisions also include revisions that clarify the
applicability of the rule to persons who perform labeling operations for
dietary supplements.

2.  Changes After Considering Comments

	The final rule

●    Requires you to establish and follow written procedures to
fulfill the requirements of subpart B; 

●    Provides flexibility regarding the requirement to exclude
personnel who might be a source of microbial contamination (e.g., due to
illness or open lesions) so that such personnel must be excluded only
from operations where such contamination may occur; 

●	Clarifies that the qualification of personnel and supervisors may be
done through education, training, or experience; 

●	Sets forth a new requirement that you identify qualified personnel
to perform quality control operations and requires that such personnel
have distinct and separate responsibilities related to performing
quality control operations from those responsibilities that the person
otherwise has when not performing quality control operations; and 

●	Sets forth a new requirement to make and keep records that document
training of personnel. 

	

C. General Comments on Proposed Subpart B

	(Comment 67) Some comments assert one or more proposed requirements are
unconstitutionally vague under the Fifth Amendment and arbitrary and
capricious under section 706(2)(B) of the Administrative Procedure Act
(APA) and therefore should be deleted.  The comments focus on:

●    Proposed § 111.12(a) which would require “qualified
employees;” and

●	Proposed § 111.13(a) which would require “qualified personnel to
supervise.”

     In general, these comments say the proposal’s failure to define
the term “qualified” means that persons who are subject to the rule
could not discern the meaning of the term.  These comments also say the
proposal imposes no limits on enforcement officers as to what would
satisfy the requirements and, thus would represent an exercise of
unbridled discretion and disparate decisionmaking.  These comments argue
proposed § 111.12(b) which would require employees to have “the
training and experience to perform the person’s duties” and proposed
§ 111.13(b) which would require supervisors to be “qualified by
training and experience to supervise” would suffice.

      (Response)  We are not deleting § 111.12(a) and 111.13(a) as
requested by these comments.  As discussed in section V, we disagree the
terms in question are unconstitutionally vague, need to be defined, or
may result in discriminatory enforcement.  There has been sufficient
common usage of these terms in the food industry to enable
manufacturers, and those who enforce the requirements, to comprehend and
apply such terms “with a reasonable degree of certainty” to their
particular operations (See Boyce Motor Lines v. United States 342 U.S.
at 340).  Further, agencies are permitted to use qualifying terms to
enable them to address a wide variety of conditions at companies. For
these reasons, we have retained the use of the terms in the final rule. 
The provisions at issue also give firms the flexibility to determine how
to comply with the regulations.  We also explain in section V that the
final rule does not violate the APA.

D.  What Are the Requirements Under This Subpart 

for Written Procedures? 

(Final 111.8)

     We received many comments that recommended written procedures for
various provisions.  We address the need for written procedures
generally in section IV.  We also respond to individual comments on
specific provisions in the same section.  Final § 111.8 requires you
to establish and follow written procedures to fulfill the requirements
of subpart B.  In addition, to ensure that we can evaluate firms’
compliance with their written procedures, final § 111.14 requires that
a person who manufactures, packages, labels, or holds dietary
supplements make and keep records of such procedures.  Such records
would be available to us under subpart P.

E.  What Requirements Apply for Preventing Microbial Contamination From
Sick or Infected Personnel and for Hygienic Practices?

(Final § 111.10)

	The title of this provision has been changed from proposed § 111.10
to clarify that the requirements are related to the  prevention of
microbial contamination due to the health condition of personnel and not
other sources. 

1.  Final § 111.10(a)  

     Final § 111.10(a) requires you to take measures to exclude from
any operations any person who might be a source of microbial
contamination, due to a health condition, where such contamination may
occur, of any material including components, dietary supplements, and
contact surfaces used in the manufacture, packaging, labeling, or
holding of a dietary supplement.  This provision is similar to proposed
§ 110.10.  We added “due to a health condition” for clarity.

     (Comment 68)  Several comments suggest that employees who are sick
should be allowed to work in areas where they will not come into contact
with components, dietary supplements, or contact surfaces, and that the
requirements of proposed § 111.10 are too strict.  These comments say
proposed § 111.10(a) is too broad in stating that such persons be
excluded “from working in any operation.”  These comments explain
that such persons may be suitable for performing other tasks, such as
warehouse functions or administrative work.  These comments would revise
§ 111.10(a) so that it is acceptable for such persons to work so long
as they will not be a vessel for microbial contamination. 

     Other comments agree with proposed § 111.10(a), and state that
employees who are sick should be excluded from the plant, even from
areas where products are not processed.  These comments state excluding
such personnel should be mandatory as the microbes from an open sore,
wound, or other source of contamination could contaminate the
surrounding air, personnel, etc.  For example, if the production area is
a closed loop air handling system, then contamination could spread to
the other areas through the common air handling units/ducts.

     (Response)  We agree that some tasks may be suitable for a person
who might be a source of microbial contamination.  Certain warehouse
functions or administrative tasks may be appropriate for such a person
to do, provided that these functions or tasks do not expose components,
dietary supplements, or contact surfaces to microbial contamination from
the person, and provided that the person would not infect others who
would then expose components, dietary supplements, or contact surfaces
to microbial contamination. 

	A requirement to exclude employees from being present at work would
limit potential microbial contamination, which is the basis of the point
made by some comments that employees who are sick should be excluded
from the plant.  However, the comments do not persuade us to deny firms
the flexibility to determine whether it would be appropriate for an
employee who may be a source of microbial contamination to work in some
areas of the physical plant that are sufficiently separated from areas
where product contamination could occur.  When considering whether an
employee may be permitted to work and whether he/she represents a
potential source of microbial contamination, one should look beyond the
obvious potential sources of contamination, and consider possibilities
such as the forms of indirect contamination discussed by the comments. 
Therefore, we are revising § 111.10(a) to require you to take measures
to exclude “from any operations any person who might be a source of
microbial contamination, due to a health condition, where such
contamination may occur, of any material including components, dietary
supplements, and contact surfaces used in the manufacture, packaging,
labeling, or holding of a dietary supplement.”  

	As one measure to reduce potential microbial contamination, final
§ 111.10(a)(1) requires you to exclude, from working in any operations
that may result in contamination, any person who, by medical
examination, the person’s acknowledgement, or supervisory observation,
is shown to have, or appears to have an illness, infection, open lesion,
or any other abnormal source of microbial contamination, that may result
in microbial contamination of components, dietary supplements, or
contact surfaces, until the health condition no longer exists.  Final
§ 111.10(a)(1) is similar to proposed § 111.10(a)(1).  We have added
that the person can acknowledge that he or she may be a source of
microbial contamination.  We are moving and modifying the prepositional
phrase concerning “working in any operation.”  We also have added
the word “infection” to clarify the sources of potential abnormal
contamination.

	(Comment 69)  Several comments suggest employees who may be the source
of microbial contamination should be permitted to work in areas of the
plant where they pose no risk of contamination, and therefore should not
be excluded unless they pose such a risk.  

     (Response)  We agree with the comments and are revising
§ 111.10(a)(1) accordingly.  Therefore, you may allow persons with
certain health conditions to work in areas of a plant where they pose no
risk of contamination even though they must be excluded from other areas
where they would pose such a risk. 

     Final § 111.10(a)(2) requires you to instruct your employees to
notify their supervisor(s) if they have, or if there is a reasonable
possibility that they have, a health condition discussed in paragraph
(a)(1) of this section that could contaminate any components, dietary
supplements, or any contact surface.  

     We did not receive comments specific to proposed § 111.10(a)(2).  

2.	Final § 111.10(b)

	Final § 111.10(b) requires, if you work in an operation during which
adulteration of the component, dietary supplement, or contact surface
may occur, you to use hygienic practices to the extent necessary to
protect against contamination of components, dietary supplements, or
contact surfaces.  Final § 111.10(b) lists nine hygienic practices,
such as wearing outer garments in a manner that protects against
contamination, washing hands thoroughly, and wearing, where appropriate,
hair nets, caps, beard covers, or other effective hair restraints. 

    We did not receive any comments concerning proposed § 111.10(b)(1)
(wearing outer garments in a manner that protects against
contamination), § 111.10(b)(2) (maintaining adequate personal
cleanliness), § 111.10(b)(3) (washing hands thoroughly), §
111.10(b)(4) (removing all unsecured jewelry and other objects that
might fall into components, dietary supplements, equipment, or packaging
and removing hand jewelry that cannot be adequately sanitized), §
111.10(b)(6) (wearing, where appropriate, hair nets, caps, beard covers,
and other effective hair restraints), § 111.10(b)(7) (not storing
clothing or other personal belongings where components, dietary
supplements, or contact surfaces are exposed or where contact surfaces
are washed), and § 111.10(b)(9) (taking any other precautions necessary
to protect against contamination).  

     Proposed § 111.10(b)(5) would require the hygienic practices that
you use to include maintaining gloves used in handling components,
dietary ingredients, or dietary supplements in an intact, clean, and
sanitary condition and ensuring that gloves  be of an impermeable
material. 

     (Comment 70) One comment asks us to clarify the requirements for
the use of gloves in proposed § 111.10(b)(5).  The comment say there
are situations in which gloves are ineffective or cumbersome.  The
comment provides as an example, if a person is packaging a bulk material
in fiber packs with metal ring lids, bulky gloves can interfere with the
finer work such as attaching security tabs, and thin, flexible gloves
can be easily damaged by the sharp edges of the metal rings on the lid. 

     (Response) Final § 111.10(b)(5) requires you to maintain gloves
in an intact, clean, and sanitary condition; it does not require you to
use gloves in any specific situation.  Although there is no requirement
for wearing gloves while performing specific operations, you must wear
gloves when they are necessary to protect against contamination of any
components, dietary supplements, or contact surfaces.

	(Comment 71) Proposed § 111.10(b)(8) would require that the hygienic
practices that you use to the extent necessary to protect against
contamination to include not eating food, chewing gum, drinking
beverages, or using tobacco products in areas where components, dietary
ingredients, dietary supplements, or any contact surfaces are exposed,
or where contact surfaces are washed.

	One comment would substitute the word “processed” for the word
“exposed” in proposed § 111.10(b)(8).  The comment says, although
areas where components, dietary supplements and contact surfaces are
exposed pose the greatest risk, adulteration is also possible where
these items are held (i.e., stored in containers and thus not exposed). 
Furthermore, the comment explains the use of the word “processed,”
rather than “exposed,” would cover all areas intended to be covered
by CGMPs and would alleviate the need to specify that the requirement
applies to areas where contact surfaces are washed. 

     (Response) We decline to revise the rule as suggested by the
comment.  We believe the word “exposed” covers all areas intended to
be covered by the requirement, including areas where contact surfaces
are washed.  We consider an area where contact surfaces are washed to
“expose” the contact surface.  To avoid any confusion, we are
modifying § 111.10(b)(8) to say “. . . any contact surfaces are
exposed, or where contact surfaces are washed.”  As written, the
requirement to not eat, chew gum, drink, or use tobacco products in
areas where components, dietary supplements, and contact surfaces are
exposed gives firms appropriate flexibility to determine areas where
employees may or may not, eat, chew gum, drink, or use tobacco products.

F.  What Personnel Qualification Requirements Apply? 

(Final § 111.12)

      Final § 111.12(a) requires you to have qualified employees who
manufacture, package, label, or hold dietary supplements.  Final §
111.12(a) is similar to proposed § 111.12(a), except that the final
rule includes an editorial change to clarify that the requirement is to
have the qualified employees do the work rather than merely to have
qualified employees.  

     (Comment 72)  The 2003 CGMP Proposal invited comment on whether
there is a minimum number of employees needed to manufacture dietary
supplements (68 FR 12157 at 12183).  Several comments state the final
rule should not include such a minimum number because firms should be
able to decide for themselves how many qualified personnel they need.

     (Response)  The final rule does not stipulate a minimum number of
employees.  However, there should be enough employees to manufacture,
package, label, and hold dietary supplements to ensure compliance with
the final rule.  In general, current good manufacturing practice
suggests the need for a minimum of two persons: one to perform the work,
and a second to check the work performed to ensure that a manufacturing
deviation or an unanticipated occurrence is not overlooked.  

      (Comment 73)  Some comments about the proposed definition of
“quality control unit” say the quality control function need not be
performed by a distinct or separate unit.  These comments say the
quality control function is best performed by a person or persons
qualified by training, education, or experience in the different
processing areas.

     (Response)  As discussed, we have revised the proposed definition
and substituted the term “personnel” for “unit”.  Ffor the
definition of quality control personnelunit (see section VI), we agree
the quality control functions do not need to be performed by a distinct
or separate unit or person and that a person who is qualified by
training, education, or experience can serve a quality control function.
 Therefore, we are adding a new § 111.12(b) to clarify that you must
identify who is responsible for quality control operations.  Under final
§ 111.12(b) each person identified must be qualified to perform such
operations, and must have distinct and separate responsibilities related
to performing such operations from those responsibilities that the
person otherwise has when not performing such operations. The quality
control personnel can have dual functions within the facility but should
separately perform the different responsibilities.

	Final § 111.12(c) requires that each person engaged in manufacturing,
packaging, labeling, or holding, or in performing any quality control
operations, have the education, training, or experience to perform the
person’s assigned functions.  Final § 111.12(c) includes a revision
associated with final § 111.12(b) by including persons who perform
quality control operations as persons who also need to have the
education, training, or experience for the assigned functions. 

    (Comment 74)  Several comments state we should revise the rule to
allow for any combination of “training or experience.”  These
comments explain it is not always possible for an employee to have both
“training and experience.”  These comments would revise proposed
§ 111.12(b) to read, “each person engaged in the manufacture of a
dietary product should have the proper education, training, and
experience (or any combination thereof) needed to perform the assigned
functions.  Training should be in the particular operations(s) that the
employee performs as they relate to the employee’s functions.” 
Another comment asks for guidance as to what type of education,
training, or experience is required for an employee to be considered
qualified.

     (Response) We agree with the point made by the comments.  We
acknowledge that some positions will require an appropriate educational
background in addition to any on-the-job training. In the preamble to
the 2003 CGMP Proposal (68 FR 12157 at 12183) we noted “training”
may be considered a form of “education” and elected to require that
employees be qualified by “training and experience” rather than
“education, training, and experience.”   The 2003 CGMP Proposal used
the conjunction “and” because we considered “experience” to be
different from training, in that “experience” is knowledge that a
person gains over time e.g., as he or she becomes increasingly familiar
with a particular action or piece of equipment.

     These comments persuade us that the rule would be clearer if we
added “education” to the list of attributes that are used to qualify
an employee.  We also agree there are some employees who could be
qualified based solely on their education or experience and other
employees who would become qualified through, for example, on the job
training before they are left on their own to perform their assigned
duties.  Rather than revise the rule to list all three attributes and
then explain that an employee can be qualified by any combination of the
attributes, we have changed the conjunction from “and” to “or.” 
Additionally, on our own initiative, we have replaced “person’s
duties” with “person’s assigned functions.”  This change
reinforces the principle that the employee’s training relates to the
functions that he or she is assigned to perform.

     We will consider whether it would be useful to provide guidance on
what type of education, training, or experience would be sufficient for
an employee to be properly qualified.  We believe that such education,
training, or experience may vary by job function and that it would be
difficult to provide generic guidance that would be sufficient for all
specific job tasks.  We decline to suggest that training should be
limited, as the comments suggest, to the particular operation(s) that
the employee performs as they relate to the person’s functions.  These
CGMP requirements apply to many types of manufacturing operations of
various size and complexity, so the training may vary depending on the
circumstances and may include more than the employee’s assigned
functions. 

     (Comment 75)  One comment states we should provide training
materials such as texts, videos, internet training, or seminars, to help
companies properly train their employees.

     (Response) We have no plans at this time to provide companies with
training materials for their employees.  We expect that most companies
already have trained or will train their employees and that where
additional training is needed to comply with these regulations,
companies will develop the training materials that are appropriate for
the functions their employees perform.  We may consider providing
guidance in the future if circumstances warrant such guidance.

G.  What Supervisor Requirements Apply?

(Final § 111.13)

     Final § 111.13(a) requires you to assign qualified personnel to
supervise the manufacturing, packaging, labeling, or holding of dietary
supplements.  Final § 111.13(a) derives from proposed § 111.13(a). 

	We did not receive comments specific to proposed § 111.13(a).  

	Final § 111.13(b) requires each supervisor you use to be qualified by
education, training, or experience to supervise.  Final 111.13(b)
derives from proposed § 111.13(b) which would require you and your
supervisors to be qualified by training and experience to supervise.  

     (Comment 76) Several comments ask us to revise the rule so that
supervisors may be qualified by any combination of training or
experience.  These comments would revise proposed § 111.13(b) to read,
“supervisors must be qualified by education, training, and experience
(or any combination thereof) to supervise the manufacturing, packaging,
or holding of dietary ingredients and dietary supplements in compliance
with this rule.”  One comment, however, would make an exception for
quality control and sanitation supervisors, stating we should require
these supervisors to have both training and experience.

     (Response) Consistent with the change we made to proposed §
111.12(c), we are revising proposed § 111.13(b) to require the
supervisors you use to be qualified by “education, training, or
experience.” We acknowledge that some supervisory personnel may need a
different range of education, training, or experience than others, and
expect firms to determine the appropriate balance of education, training
and experience. 

    (Comment 77) Several comments say our use of the phrase “you and
the supervisors you use” in proposed § 111.13(b) was unclear. 
According to these comments, the term “you” as defined in the
proposal, is quite expansive and could be read so broadly as to require
the Chief Executive Officer (CEO) of a company be “qualified” to
supervise.

     (Response)  We agree that the phrase “you and the supervisors you
use” could be clearer.  Therefore, we are revising proposed
§ 111.13(b) to say that “each supervisor whom you use” must be
qualified to supervise.  Section 111.13(b) applies to any person who
supervises the manufacturing, packaging, labeling, or holding of dietary
supplements, even if that person also is an executive such as the CEO. 
Thus, final § 111.13(b) states, “Each supervisor whom you use must
be qualified by education, training, or experience to supervise.”

     (Comment 78)  Several comments say the term “to supervise” is
ambiguous and would revise the rule to clarify what a supervisor must be
qualified to supervise: the manufacture, packaging, or holding of
dietary ingredients and dietary supplements.  Another comment would
revise proposed § 111.13(b) to clarify what type of training and
experience are required so that firms would have more guidance as to
what is expected to confirm that personnel are qualified.

     (Response)  We decline to revise the rule as suggested by the
comments.  We disagree that the term “to supervise,” which is
commonly used in the industry, is ambiguous.  These CGMP requirements
apply to many types of manufacturing operations of various size and
complexity, and the training must be suited to the circumstances. 

H.  Under this Subpart, What Records Must You Make and Keep?

(Final § 111.14) 

     As discussed in this section, the final rule contains a new §
111.8 requiring you to establish and follow written procedures to
fulfill the requirements of subpart B.  Those written procedures are
records.  Therefore, we are adding a new § 111.14(a) requiring you to
make and keep records in accordance with subpart P.  Final §
111.14(b)(1) requires you to make and keep a record of the written
procedures for fulfilling the requirements of subpart B. 

     The preamble to the 2003 CGMP Proposal invited comment on whether
we should require documentation and records regarding each employee’s
training (68 FR 12157 at 12183).  After considering comments and for the
reasons discussed below, § 111.14(b)(2) requires you to make and keep
documentation of training, including the date of training, the type of
training, and the person(s) trained. 

     We also invited comment on whether the final rule should contain
requirements for documentation about consultants that you use (68 FR
12157 at 12183).  We specifically suggested any such requirement include
the consultant’s name, address, qualifications and a description of
services provided.  After considering the comments and for the reasons
discussed below, the final rule does not include any requirements to
make and keep records regarding consultants.

     (Comment 79)  Several comments state employee training records are
critical and should be required under the final rule.  The comments
explain that these records should show the content of the training, the
date of the training, and the signature of the employee trained.  These
comments assert that a formal (written) GMP training program is
necessary to track which employees have been trained in the CGMP
requirements.  These comments add, without a written and documented
training program, it is likely that some employees may not receive
sufficient training, or in some cases, any CGMP training at all.  These
comments say successful quality control programs are inextricably
connected to appropriate training programs, and written documentation of
employee training is an important safeguard to ensuring safe and
accurately labeled dietary supplements.  These comments also state it is
already an industry standard to document training.  

	Other comments question our ability to evaluate whether a firm’s
employees have been adequately trained without written documentation of
the training.

     (Response) As discussed more fully in subpart E in section X, the
final rule focuses on ensuring the quality of the dietary supplement at
every stage of the production and process control system.  Such a system
begins with the proper training.  We agree that documentation of
employee training is necessary to track which employees have been
trained in which operations.  Therefore, final § 111.14(b)(2) requires
you to keep documentation of training, including the date of the
training, the type of training, and the person(s) trained. 

      (Comment 80)  One comment says we should not require manufacturers
to document and keep records regarding each employee’s training.  The
comment says the rule should focus on end results and not on process.

     (Response) We disagree with the comment.  As we have explained in
this section, each person engaged in an activity covered by these CGMP
regulations must have the education, training, or experience to perform
the person’s assigned functions.  Some employees will be considered
qualified based in part on training taken as company employees.  To show
that such training is appropriate to the employee’s functions and has
in fact occurred, the training must be properly documented.  This
documentation is an important aspect of ensuring adequate training and,
therefore, helping to ensure the result of having qualified employees
who perform their functions properly.  

	(Comment 81) Several comments state the documentation of the training
program should include the title of the person doing the training, an
evaluation of the employee’s understanding of the training, and
recommendations for the frequency of refresher training.  One comment
describes a specific method for training and for tracking training.  The
comments state an evaluation of the employee’s understanding of the
training would ensure that employees who receive training understand
what they have been taught.

     (Response) We decline to require specific additional documentation
of employee training.  We believe a firm should have some flexibility in
how it wants to document training.

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ఀveral comments say that documenting this information is useful and
could be done on a voluntary basis, but that such information is not
necessary to ensure safe and accurately labeled supplements and, thus,
should not be required.  One comment notes that recommendations from
consultants may or may not be used, and that a company should not have
to explain at a later date why such decisions were made.  Another
comment asserts that we and the company may have different opinions on
whether a consultant is qualified and that the consultant’s
qualification is not our concern if a product is not adulterated.  One
comment says documenting the name and services of the GMP consultants
should be required to facilitate contact in case of need.

     (Response) The proposal noted documentation of the name, address,
qualifications, and services rendered for each consultant may help you
know whom to contact and if questions arise concerning the advice that
the consultant has given.  Thus, our intent in suggesting such
documentation was to help you rather than to make the information
available for us to determine whether we agreed with you that a
particular individual was qualified to be a consultant.  However, the
comments persuade us that such information is not necessary to help
ensure dietary supplement quality.  Therefore, the final rule does not
require documentation regarding consultants.

   

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Final Subpart B Revisions 9-28-05, 6-26-06

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