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July 9, 2004

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

> **Re: Docket No. 2004N-0133**
>
> **Electronic Record; Electronic Signatures**

The National Grain and Feed Association submits this statement in
response to the Food and Drug Administration's notice requesting public
comments on various topics concerning its regulations on electronic
records and electronic signatures in Part 11 (21 CFR part 11).

Established in 1896, the NGFA consists of 1,000 grain, feed, processing,
exporting and other grain-related companies that operate about 5,000
facilities that handle more than two-thirds of all U.S. grains and
oilseeds. With more than 350 member companies operating commercial feed
mills and 30 integrated livestock and poultry feed manufacturing
operations, the NGFA is the nation's largest trade association
representing feed manufacturer interests. The NGFA also consists of 35
affiliated state and regional grain and feed associations, as well as
two international affiliated associations.

The NGFA commends FDA for undertaking a wholesale reexamination of its
existing regulations, which throughout this document we will refer to as
"Part 11," under which the agency considers electronic records and
signatures equivalent to paper records and handwritten signatures.

For purposes of this rulemaking, the NGFA's statement conveys the
perspective and views of medicated feed manufacturers required to
maintain records under FDA's predicate rules governing current good
manufacturing practices (CGMPs) *\[21 CFR Part 225\]*.

At the outset, the NGFA reiterates its previous statement[^1] that the
existing Part 11 regulations originally promulgated on March 20, 1997
were written at the request of -- and with input provided by -- the
human pharmaceutical manufacturing industry. It is our understanding
that FDA's Center for Veterinary Medicine (CVM) initially considered
Part 11's potential application to the animal drug manufacturing sector,
but did not consider the impact on the animal feed manufacturing
industry. To our knowledge, the animal feed and human food industries
were neither notified nor engaged by their respective FDA Centers
seeking input into the development of the rulemaking. Nor did the food
processing and medicated animal feed manufacturing industries comment
during the initial rulemaking. Indeed, it was not until several years
later that the potential application of Part 11 to the medicated animal
feed manufacturing sector was recognized.

It was then that representatives of the NGFA and the American Feed
Industry Association met on Feb. 13, 2001 with officials from FDA/CVM to
express concerns over how Part 11 might be applied to medicated feed
manufacturers that utilize computerized records to comply with FDA's
CGMPs. During this meeting, FDA officials indicated that FDA/CVM in
October 2000 had reviewed its interpretation regarding the application
of Part 11 on the medicated feed industry. Further, it is our
understanding that CVM did so at the direction of FDA's Office of
Regulatory Affairs, which subsequent to publication of the final rule
had determined that the Part 11 regulations applied to all industries
regulated by FDA, rather than just the pharmaceutical industry.

Thus, the existing Part 11 regulations are written in a way that makes
them most appropriate for the pharmaceutical manufacturing sector.
Specifically, these rules were developed primarily for the development
and submission of data in support of human and animal drug approvals.
Indeed, the general section of the Code of Federal Regulations *\[21 CFR
Part 11\]* under which these regulations were developed is
**[not]{.underline}** specific to medicated animal feed manufacturing.

The NGFA previously supported FDA's withdrawal of its Compliance Policy
Guide 7153.17 *\["Enforcement Policy: 21 CFR Part 11; Electronic
Records; Electronic Signatures\]*, as well as previously issued Part
11-related draft guidance documents concerning electronic records and
electronic signatures, validation, glossary of terms, time stamps and
maintenance of electronic records, because they no longer represented
the agency's overall approach to Part 11. Likewise, we commended the
agency for issuing new draft guidance that stated that FDA will take a
risk-based approach to Part 11 and exercise enforcement discretion
during the reexamination period with respect to certain provisions
*\[computer validation, audit trail, legacy systems, record-copying and
record-retention.\]*

The NGFA believes strongly that as FDA considers revisions to its Part
11 regulations, it needs to recognize the different and widely divergent
types of industries and products affected. For instance, for medicated
feed manufacturers, the types of records and signatures developed and
maintained for compliance with the medicated feed CGMPs pertain to the
following:

-   Master production records (e.g., medicated feed formulas, labels,
    and manufacturing procedures related to the production of medicated
    feeds).

-   Production records (e.g., production history, including micro and
    macro batching, pelleting, packaging or bulk load out, feed
    formulation, labeling and sequencing/flushing of medicated feeds).

-   Distribution records.

-   Records associated with the receipt, use and inventory of animal
    drugs in medicated feeds.

    In addition, each of the aforementioned records requires signatures
    or initials of responsible persons completing and/or reviewing these
    records.

    **[Specifically, the NGFA believes that a literal interpretation of
    existing Part 11 compliance requirements as applied to the
    manufacturers of human and animal drugs is inappropriate for those
    complying with the aforementioned medicated feed
    CGMPs]{.underline}.** Further, we believe that "lumping" the
    medicated animal feed manufacturing sector in with the
    pharmaceutical and other industry sectors would contravene the
    agency's stated intent of developing a risk-based approach to Part
    11, and would result in precisely the kind of adverse consequences
    that FDA states in the notice that it wants to avoid, namely:

-   unnecessarily restrict the use of electronic technology in a way
    that is inconsistent with FDA's stated intent;

-   significantly increase capital outlays and compliance costs; and/or

-   discourage innovation and technological advances without providing a
    significant public health benefit to man or animals.

Further, in the case of medicated animal feed manufacturers, applying
Part 11 indiscriminately could cause certain manufacturers to reduce
their use of medications in rations in an effort to exempt themselves
from Part 11's requirements. In effect, the cost of undertaking the
required modifications to computer systems may exceed benefits
associated with manufacturing medicated feeds. This could have a
negative affect on both animal welfare and food safety.

In the remainder of this statement, the NGFA provides responses to each
of the questions posed by FDA. But we want to make clear here that our
"bottom-line" view is that FDA needs to fundamentally change its
approach if it is to truly implement a risk-based Part 11. Specifically,
the NGFA believes that FDA should determine whether and how to apply
Part 11 based upon the affected industry sector and the applicable
predicate FDA rules with which each sector is required to comply. **[In
that regard, the NGFA strongly recommends that FDA determine through its
current Animal Feed Safety System (AFSS) initiative whether and how to
apply Part 11 to the medicated feed manufacturing
industry]{.underline}**. The AFSS *\[Docket No. 2003N-0312\]*, launched
by FDA/CVM September 2003, is intended to be a comprehensive, risk-based
approach to animal feed safety.

The following are the NGFA's responses to each of the questions posed by
FDA in its April 8, 2004 notice:

A.  **Part 11 Subpart A -- General Provisions.**

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1.  ***FDA Question:** In the part 11 guidance document, we clarified
    that only certain records would fall within the scope of part 11.
    For example, we stated that under the narrow interpretation of its
    scope, part 11 would apply where records are required to be
    maintained under predicate rules or submitted to FDA, and when
    persons choose to use records in electronic format in place of paper
    format. On the other hand, when persons use computers to generate
    paper printouts of electronic records, those paper records meet all
    the requirements of the applicable predicate rules, and persons rely
    on the paper records to perform their regulated activities, FDA
    would generally not consider persons to be \`\`using electronic
    records in lieu of paper records\'\' under Sec. 11.2(a) and (b). In
    these instances, the use of computer systems in the generation of
    paper records would not trigger part 11. We are interested in
    comments on FDA\'s interpretation of the narrow scope of part 11 as
    discussed in the part 11 guidance and whether part 11 should be
    revised to implement the narrow interpretation described in the
    guidance."*\
    \
    **NGFA Response:** Our concerns over the application of Part 11 to
    the medicated feed manufacturing sector would **[not]{.underline}**
    be mollified by FDA clarifying that it does not apply to situations
    in which persons use computers to generate paper printouts of
    electronic records, and those records meet all of the requirements
    of the applicable predicate rules and persons rely on those paper
    records to perform their regulated activities. The previously cited
    records (master production records, production records, distribution
    records and animal drug receipt, use and inventory records) required
    to be maintained under the medicated feed CGMPs \[21 CFR Part 225\]
    are FDA-predicate rules. Granted, some small, single-facility
    commercial medicated feed mills continue to generate these records
    by hand or to print out and rely upon paper copies of computer
    records (and thus would not be subject to Part 11 based upon FDA's
    guidance). But most medicated feed manufacturers -- particularly
    larger firms -- use electronic programs in the development, storage
    and use of these records because doing so improves the accuracy and
    integrity of the records themselves, while reducing business costs
    attributable to fewer man-hours and fewer human errors. FDA's
    suggested clarification would provide no regulatory or economic
    relief to these firms. Instead, it would defeat the purpose of
    maintaining electronic records and signatures for these purposes, or
    impose substantial additional financial costs that could not be
    passed on to customers given the highly competitive nature of the
    industry. Further, as FDA/CVM is aware, the medicated feed CGMPs are
    not enforced uniformly across the industry. Thus, regulation for
    compliance with Part 11 also would be focused on a relatively few
    medicated feed manufacturers, creating additional disparities in
    costs incurred by those subjected to such oversight.

2.  ***FDA:** "We are interested in comments on whether revisions to
    definitions in part 11 would help clarify a narrow approach and
    suggestions for any such revisions."\
    *\
    **NGFA Response:** Revisions to definitions in Part 11 would help
    narrow their applicability. But as explained in our response to
    question 1, such action would not go far enough for the medicated
    feed manufacturing sector. As noted in the preface to this
    statement, the NGFA strongly believes that the predicate rule
    requirements for medicated feed CGMPs established under 21 CFR Part
    225 should be exempt from Part 11 requirements, and that the records
    should be evaluated for compliance with Part 225 requirements on a
    case-by-case basis. Under current medicated feed mill inspections,
    such records are reviewed on a routine basis. To our knowledge,
    neither the industry nor FDA have experienced adverse food or feed
    safety issues attributable to problems involving the accuracy or
    integrity of electronic records or electronic signatures in
    compliance with Part 225.

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1.  ***FDA:** In the part 11 guidance, we announced that we did not
    intend to take enforcement action to enforce compliance with the
    validation, audit trail, record retention, and record copying
    requirements of part 11 in the manner described in the part 11
    guidance. We emphasized that records must still be maintained or
    submitted in accordance with the underlying predicate rules, and the
    agency could take regulatory action for noncompliance with such
    predicate rules. We are interested in comments on the need for
    clarification in part 11 regarding which records are required by
    predicate rules and are therefore required to be part 11 compliant?\
    *

> **NGFA:** We believe that the revised guidance published in August
> 2003 is clear and unambiguous. Part 11 should be amended to reflect
> comparable language.

**B. Part 11 Subpart B -- Electronic Records.**

1.  ***FDA:** As mentioned previously, the part 11 guidance identified
    four areas where we do not intend to take enforcement action under
    the circumstances described in the part 11 guidance, including the
    validation, audit trail, record retention, and record copying
    requirements of part 11. The part 11 guidance further recommends
    that decisions on whether or not to implement part 11 requirements
    on validation, audit trail, record retention, and record copying
    should be based on a justified and documented risk assessment and a
    determination of the potential of the system to affect product
    quality and safety, and record integrity. We are interested in
    comments on whether there are other areas of part 11 that should
    incorporate the concept of a risk-based approach, detailed in the
    part 11 guidance (e.g., those that require operational system and
    device checks).\
    *

    **NGFA:** As expressed previously, the NGFA believes that records
    related to the medicated feed CGMPs contained in 21 CFR Part 225
    should be excluded from Part 11 requirements and instead be
    addressed as part of FDA/CVM's Animal Feed Safety System initiative
    that is developing a comprehensive, risk-based approach to feed
    safety hazards. The NGFA believes that FDA should determine whether
    and how to apply Part 11 based upon the affected industry sector and
    the applicable predicate FDA rules with which each sector is
    required to comply.

2.  ***FDA:** Is additional clarity needed regarding how predicate rule
    requirements related to subpart B can be fulfilled?"*\
    \
    **NGFA:** As stated previously, the NGFA believes that FDA should
    determine whether and how to apply Part 11 based upon the affected
    industry sector and the applicable predicate FDA rules with which
    each sector is required to comply. Such clarity can be provided
    through that sector-specific process.

3.  ***FDA:** Under the current part 11, the controls that apply to
    electronic records that are maintained also apply to electronic
    records that are submitted to FDA. Should the requirements for
    electronic records be separate from electronic records maintained to
    satisfy predicate rule requirements?*\
    \
    **NGFA:** The NGFA believes that Part 11 requirements applicable to
    electronic records maintained for submission to FDA **[should be
    distinct from, and treated differently than]{.underline}**, those
    records maintained for compliance with medicated feed CGMPs \[Part
    225\] predicate rules.

4.  ***FDA:*** *The controls for electronic records in subpart B
    distinguish between open systems (an environment where system access
    is not controlled by persons who are responsible for the content of
    electronic records that are on the system) and closed systems (an
    environment where system access is controlled by persons who are
    responsible for the content of electronic records that are on the
    system). Should part 11 continue to differentiate between open
    systems and closed systems?"*

> **NGFA:** Were medicated feed manufacturers interpreted to have "open"
> systems, such requirements under Part 11 would far exceed what is
> required to comply with CGMP records. Further, we believe the costs
> would be prohibitive, amounting to millions of dollars across the
> industry. In addition, our members have checked with vendors of
> computer software and report that many are unaware of the potential
> applicability of Part 11 rules. Those vendors that are aware of Part
> 11 have not taken steps yet to bring their products into compliance,
> and we believe this process would take an estimated five years or
> longer, depending upon the demand crunch imposed on such vendors.\
> \
> Most importantly, the NGFA has major concerns that even if such a
> conversion were implemented to make medicated feed mill computer
> systems Part 11-compliant, there would be no demonstrable resulting
> benefit in terms of improvements to feed safety or public health.
> FDA's current focus on food safety systems is far better use of time
> and resources for protecting public health than applying Part 11
> requirements to medicated feed records.

**Comments Pertinent to Individual Controls in Subpart B:**

1.  ***FDA:** The part 11 guidance identified validation as one of the
    four areas where we intend to exercise enforcement discretion in the
    manner described in the guidance. Should we retain the validation
    provision under Sec. 11.10(b) required to ensure that a system meets
    predicate rule requirements for validation?*\
    \
    **NGFA:** FDA/CVM has used regulatory discretion in the enforcement
    of validation provisions on software and hardware used for
    compliance with Part 225. This discretion has been based upon lack
    of need, and a sound compliance record by the industry. Indeed if
    the agency were to enforce the validation provisions, feed
    manufacturers likely would find it necessary to revert to
    paper-reliant systems, thereby losing much of the efficiency and
    improved accuracy currently derived from using electronic systems.
    While legacy systems can be excluded from validation requirements,
    they continue to be enhanced and updated, making them subject to
    Part 11 requirements. For these reasons, the NGFA believes FDA/CVM
    should continue to be permitted to exercise enforcement discretion
    over the application of Part 11 requirements to medicated feed CGMP
    requirements promulgated under Part 225.

2.  **FDA:** The part 11 guidance identified record retention and record
    copying requirements as areas where we plan to exercise enforcement
    discretion in the manner described in the part 11 guidance. Are
    there any related predicate rule requirements that you believe are
    necessary to preserve the content and meaning of records with
    respect to record copying and record retention? What requirements
    would preserve record security and integrity and ensure that records
    are suitable for inspection, review, and copying by the agency?\
    \
    **NGFA:** For the reasons previously cited, we believe that all
    medicated feed CGMP records promulgated under 21 CFR Part 225 should
    be subject to enforcement discretion by FDA/CVM concerning Part 11
    compliance. Electronic Part 225 records are more accurate and
    improve feed safety compliance in many ways. The ultimate
    beneficiaries are feed customers, who receive a higher-integrity
    product at a lower cost than otherwise would be the case. Compliance
    with Part 11 will move many users of electronic records and
    procedures back to paper recordkeeping systems kept by hand. This
    would not be in the public interest. Conversely, as noted
    previously, applying Part 11 indiscriminately could cause some other
    manufacturers to reduce their use of medications in rations in an
    effort to exempt themselves from Part 11's requirements. In effect,
    the cost of undertaking the required modifications to computer
    systems may exceed benefits associated with manufacturing medicated
    feeds. This could have a negative affect on both animal welfare and
    food safety.

3.  ***FDA:** Should audit trail requirements include safeguards
    designed and implemented to deter, prevent, and document
    unauthorized record creation, modification, and deletion?*\
    \
    **NGFA:** Our members estimate audit-trail requirements would
    increase costs substantially on an initial investment, and on an
    ongoing basis. Several member companies have examined this issue
    very carefully, and do not find any added value from this additional
    investment in human resource time and computer programming costs
    spent solely for FDA-compliance purposes. Such investment of human
    and capital resources could detract from feed and food safety
    measures that are much more important to public health.

4.  ***FDA:** Section 11.10(k) requires appropriate controls over
    systems documentation. In light of how technology has developed
    since part 11 became effective, should part 11 be modified to
    incorporate concepts, such as configuration and document management,
    for all of a system's software and hardware?*\
    \
    **NGFA:** We believe that the additional control over system
    documentation, in the case of Part 225 compliance, would not have a
    feed safety benefit. These additional controls would result in more
    reliance upon paper records kept by hand rather than automating such
    functions, which has been shown in the medicated feed industry to
    improve product safety and reduce product cost.

**C. Part 11 Subpart C -- Electronic Signatures**

> ***FDA:** Within the context of subpart C, we would like interested
> parties to address the following: Section 11.10(d) requires that
> system access be limited to authorized individuals, but it does not
> address the handling of security breaches where an unauthorized
> individual accesses the system. Should part 11 address investigations
> and follow-up when these security breaches occur?*\
> \
> **NGFA:** We do not believe that Part 11 should be required for
> electronic signatures on medicated feed CGMP Part 225 records, and
> therefore this question is not applicable.

D.  **Additional Questions**

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1.  ***FDA:** What are the economic ramifications of modifying part 11
    based on the issues raised in this document?"*\
    \
    **NGFA:** In most cases, modifying Part 11 as outlined in this
    notice would result in the medicated feed industry needing to
    upgrade computer and software systems. In many cases, entirely new
    computer systems and software would be required, despite the fact
    that existing systems are operating flawlessly and FDA/CVM has not
    raised this matter as a feed safety concern. Considering the diverse
    nature of the medicated feed industry, tremendous economic
    consequences would result. The NGFA believes the ultimate loser
    would be feed customers and the public, as the result most likely
    would be a return to paper-reliant systems that are not as accurate,
    nor as efficient, as today's electronic systems. As explained
    previously, the NGFA believes CVM is in the best position to address
    any pertinent Part 11-related requirements for medicated feed CGMPs
    as part of its AFSS initiative.

2.  ***FDA:** Is there a need to clarify in part 11 which records are
    required by predicate rules where those records are not specifically
    identified in predicate rules? If so, how could this distinction be
    made?*\
    \
    **NGFA:** As they pertain to the medicated feed sector, the NGFA
    believes that predicate rules are clear and need no further
    identification.

3.  ***FDA:*** *In what ways can part 11 discourage innovation?*\
    \
    **NGFA:** Part 11 will discourage innovation among the medicated
    feed industry when it comes to part 225 compliance by:

-   causing many medicated feed manufacturers to revert to hand-kept
    paper records to avoid the costs and complexities resulting from
    FDA's application of Part 11 requirements for electronic records and
    signatures. Given the fiercely competitive nature and the
    overcapacity that exists in the medicated feed industry, any
    additional costs likely would be borne by the feed manufacturer,
    particularly since a significant percentage of the industry
    currently relies on manual records. In effect, the cost of
    compliance with Part 11 requirements would offset the economic
    advantages of utilizing electronic records.

-   triggering compliance with other rules, such as validation
    requirements, resulting in no added value but only compliance costs.
    To be successful, compliance costs also must bring value, especially
    in terms of added animal feed and human food safety. In this case,
    these additional Part 11 rules bring no such commensurate benefit.

1.  *FDA: What potential changes to part 11 would encourage innovation
    and technical advances consistent with the agency's need to
    safeguard public health?*\
    \
    **NGFA:** In the case of Part 225 compliance, our previous
    recommendations of vesting the application of Part 11 with FDA/CVM
    and having FDA/CVM consider the medicated feed CGMPs under its AFSS
    initiative would more than adequately protect human and animal
    health. At the same time, it would allow FDA to meet its objective
    of encouraging, not retarding, technological innovation and enabling
    the industry and the public health to benefit from the accuracies
    and efficiencies gained by utilizing electronic records and
    signatures. The net result is more efficient medicated feed
    manufacturing operations, and improved product safety and
    affordability for feed purchasers and consumers of meat, milk and
    egg products.

2.  ***FDA:** What risk-based approaches would help to ensure that
    electronic records have the appropriate levels of integrity and
    authenticity elements and that electronic signatures are legally
    binding and authentic?*\
    \
    **NGFA:** We believe strongly that existing government-based
    inspections and enforcement conducted by FDA/CVM and State
    Departments of Agriculture, through state-federal partnerships,
    provide a risk-based approach for ensuring the integrity and
    authenticity elements of records maintained for medicated feed CGMP
    Part 225 compliance. The NGFA strongly supports FDA/CVM's inclusion
    of Part 225 regulations and compliance as part of its AFSS
    initiative, which is the best means of ensuring feed safety.

3.  ***FDA:** The part 11 guidance announced that the agency would
    exercise enforcement discretion (during our reexamination of
    part 11) with respect to all part 11 requirements for systems that
    otherwise were operational prior to Aug. 20, 1997 (legacy systems),
    the effective date of part 11. What are stakeholder concerns in
    regards to modifications made to legacy systems in use as of August
    1997? Can the use of risk mitigation and appropriate controls
    eliminate concerns regarding legacy systems?*\
    \
    **NGFA:** As noted previously, the NGFA's concern is that
    modifications to legacy systems will cause such systems to be
    subject to full compliance with Part 11. We believe we have
    articulated our concerns relative to the problems and issues
    associated with Part 11 requirements. Most medicated feed
    manufacturing companies that use electronic systems have both legacy
    and newer systems placed into operation since the Aug. 20, 1997
    effective date of the Part 11 regulations. This means many
    multi-facility companies have a combination of systems that have
    been programmed to work together in their medicated feed CGMP Part
    225 compliance efforts. Part 225 records created from such systems
    have been evaluated as adequate for part 225 compliance needs by FDA
    and state inspectors, and have not been found to present food or
    feed safety concerns. Several NGFA-member companies have examined
    closely their internal computer systems used to comply with Part
    225, and have evaluated them against the requirements of Part 11. We
    believe the costs for such upgrades will result in a reduction in
    their use, and a return to paper systems that resulted in human
    errors that electronic systems have helped to eliminate.

4.  ***FDA:** Should Part 11 address record conversion?*\
    \
    **NGFA:** In the case of Part 225 compliance, Part 11 should not
    address record conversion.

5.  ***FDA:*** *Are there provisions of part 11 that should be
    augmented, modified, or deleted as a result of new technologies that
    have become available since part 11 was issued?"*\
    \
    **NGFA:** We believe Part 225 requirements should not be within the
    jurisdiction of Part 11, and therefore have no comment. However,
    regulations must be flexible to adapt to technology and market
    needs. The NGFA again reiterates its belief that any consideration
    of technology impacts should, in the case of the predicate
    requirements of Part 225, be considered by FDA/CVM within its AFSS
    initiative -- and **[not]{.underline}** be a function of Part 11.

**Conclusion**

In summary, the NGFA fully supports FDA's efforts to improve feed safety
to protect human and animal health. The NGFA also has publicly supported
FDA/CVM's AFSS initiative, and believe it is the prudent, risk-based way
to address any Part 11 issues that could affect feed or food safety.

Further, government-based inspections conducted by FDA/CVM and states
are adequately overseeing medicated feed manufacturing establishments
subject to Part 225 CGMPs. For these reasons, we do not believe Part 225
should be subject to Part 11 requirements applied to the pharmaceutical
industry. Doing otherwise would trigger a multitude of additional costs,
and compliance complexities that would far exceed any commensurate feed
safety benefits.

When initially developed, Part 11 did not consider Part 225 compliance
issues nor the impact such rules would have on the regulated medicated
feed manufacturer. And FDA should not attempt to foist its burdensome,
costly and stifling requirements upon this vital industry sector now.

Sincerely yours,

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Joe Garber, Chairman Randall C. Gordon

Feed Legislative/Regulatory Affairs Committee Vice President

National Grain and Feed Association National Grain and Feed Association

[^1]: NGFA Statement submitted to FDA Dockets Management Branch on
    Docket Nos. 03-D-0060, 99D-1458, 00D-1538, 00D-1543, 00D-1542, and
    00D-1539; "Draft Guidance for Industry on Part 11, Electronic
    Records, Electronic Signatures -- Scope and Application." April 28,
    2003.