VII\. Comments on Personnel

(Final Subpart B)

[A. Organization of Final Subpart B]{.underline}

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       N/A
  Subpart for Written Procedures?                    

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

  § 111.12 What Personnel Qualification Requirements § 111.12
  Apply?                                             

  § 111.13 What Supervisor Requirements Apply?       § 111.13

  § 111.14 Under This Subpart, What Records Must You N/A
  Make and Keep?                                     
  -------------------------------------------------- --------------------

[B. Highlights of Changes to the Proposed Requirements for
Personnel]{.underline}

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]{.underline}

(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]{.underline}

[for Written Procedures?]{.underline}

[(Final 111.8)]{.underline}

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?]{.underline}

([Final § 111.10]{.underline})

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?]{.underline}

([Final § 111.12]{.underline})

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". For the definition of
quality control personnel (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?]{.underline}

[(Final § 111.13)]{.underline}

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?]{.underline}

[(Final § 111.14)]{.underline}

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.

(Comment 82) Several comments respond to our question as to whether the
final rule should require documentation about consultants, including
each consultant's name, address, qualifications and a description of
services provided. Several 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.