November 13, 2013
Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA-2011-N-0920; Proposed Rule on Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for Human Food
Dear Division of Dockets Management,
The International Food Additives Council (IFAC) is responding to the proposed rule, “Current Good
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food”
(proposed rule), published in the January 16, 2013 Federal Register. IFAC is an international association
representing companies that produce high quality substances used worldwide as food additives and
GRAS substances. IFAC strives to promote science-based regulation worldwide, and we appreciate the
opportunity to comment on this proposed rule.
General Comments on the Proposed Rule:
IFAC strongly supports the U.S. Food and Drug Administration’s (FDA) efforts to ensure food safety
through the implementation of the FDA Food Safety Modernization Act (FSMA), including this proposed
rule. We appreciate the many opportunities FDA has provided to receive input on the development of this
rule, including comment requests and public meetings. IFAC looks forward to the successful
implementation of this and other FSMA regulations.
We note that FDA has proposed to retain the definition of “food” found in section 201(f) of the U.S. Food,
Drug and Cosmetic Act (FD&C Act). This definition considers food additives to be the same as finished
food and, thus, the manufacture of food ingredients (e.g., food additives and GRAS substances) would be
subject to the proposed requirements. IFAC does not object to the FD&C Act definition. However, as has
been stated in previous IFAC comments regarding FSMA, we reiterate that there are fundamental and
important differences between food additives and GRAS substances and finished food which should be
considered as FDA finalizes and implements this and other FSMA regulations. A paramount difference
between the two is their inherent risk profile. For finished food, including fresh produce and other foods
where there is a reasonable expectation that the product will be directly consumed, a higher potential for
risk exists. On the other hand, food additives and GRAS substances are likely to undergo further
downstream processing before ever reaching the consumer so have a lower risk profile.
Furthermore, manufacturers of food additives and GRAS substances often employ processes that are
markedly different from their finished food counterparts. Food additives and GRAS substances may be
synthesized using various chemical and biochemical processes, or may be extracted, hydrolyzed or
otherwise modified from their natural sources. These unique processing steps result in food safety
hazards that are quite different from finished food preparations. For example, unless appropriate
preventive control measures are put in place for certain ready-to-eat (RTE) products and fresh produce,
the potential for microbial contamination can be quite high. In contrast, food additives and GRAS
substances are often produced using processes that minimize microbial contamination hazards and are
almost always used in food products that undergo further downstream processing. Moreover, finished
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food products, when produced in accordance to current good manufacturing practices (cGMPs), are
expected to have appropriate preventive controls in place to ensure product safety. Thus, food additives
and GRAS substances generally present a significantly lower public health hazard compared to finished
food and should be regulated accordingly. Additionally, due to the differences in their potential
vulnerability to physical, chemical, and microbial hazards, the issues and challenges faced by
establishments that handle, process and distribute food additives and GRAS substance are very different
from finished food manufacturers.
IFAC supports a risk-based approach to food cGMP modernization where regulatory requirements are
matched to risk and food safety outcomes. A strength of the current food cGMPs, 21 CFR Part 110, is
their applicability to the broad spectrum of food manufacturing, from the manufacture of processed
products and packaging of fresh produce to production of food additives and GRAS substances. As FDA
revises the cGMPs, IFAC urges the Agency to preserve the regulatory flexibility necessary for the diverse
food industry. However, if the final cGMPs promulgated are general in nature, industry and auditors must
rely upon FDA guidance documents or their individual interpretation of the cGMP requirements to
determine appropriate application of cGMPs in a specific industry sector.
Therefore, as FDA finalizes the proposed rule and considers publication of relevant guidance and
compliance documents for food additives and GRAS substances, IFAC urges the Agency to consider and
potentially reference the enclosed IFAC Good Manufacturing Practice and Quality Assurance Guide for
Food Additives and GRAS Substances (Guide). The IFAC Guide provides a general science and riskbased approach to food additive and GRAS substance manufacturing safety and quality that we believe
should guide the implementation of preventive controls for our industry. The Guide, which was developed
over several years, addresses relevant sections of FSMA, and several food additive associations have
offered positive feedback on the Guide. .
Specific Comments on Sections of the Proposed Rule:
Exemptions
IFAC supports the proposed exemption for the manufacturing, processing, packing, or holding of dietary
supplements that are subject to the cGMP requirements of Part 111 (21 CFR Part 111). IFAC believes
these cGMPs are adequate and already functioning to protect public health.
We have some concerns, however, with the proposed exemption for “very small businesses.” We
recognize that Section 418(n)(1)(B) of the FD&C Act requires the regulations to define the term “very
small business,” and that a very small business is deemed a “qualified facility” that would be subject to
certain exemptions. However, even a very small business has the potential to cause a significant food
safety incident. While an incident resulting from a very small business may have less impact than that of
a larger production facility with broader distribution networks, local food related public health incidents
have the potential to cause significant harm to affected individuals, disrupt commerce and reduce
consumer confidence in the entire food supply. Thus, IFAC urges the FDA to consider these factors
when finalizing any exemptions for very small businesses from these important proposed requirements.
Economically Motivated Adulteration
FDA states that the proposed rule is not intended to address hazards that may be intentionally
introduced, including by acts of terrorism, and the Agency will address such hazards in separate
rulemaking in the future. However, on Page 3659, FDA states “that some kinds of intentional adulterants
could be viewed as reasonably likely to occur, e.g., in foods concerning which there is a widely
recognized risk of economically motivated adulteration in certain circumstances.” IFAC urges FDA to
consider the difficulties associated with a manufacturer anticipating whether any adulteration is
“reasonably likely to occur,” given the vast number of possible economically motivated adulteration (EMA)
scenarios. Except in situations where there has already been a high-profile instance of EMA (e.g., use of
melamine in milk products in China), it is not clear how a food company would know that EMA is a hazard
reasonably likely to occur in its product. Additionally, we believe food safety plans should not be required
to address adulterants that may be intentionally introduced for economic reasons.
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We also note that on April 6, 2009, FDA published a notice in the Federal Register (74 FR 15497)
announcing a public meeting to raise awareness of EMA and to gather information on how the food
industry, stakeholders and regulators could better anticipate and prevent EMA. FDA also solicited
answers to a number of questions related to EMA. IFAC recommends that FDA review the comments
submitted to this docket and provided at the public meeting as it pursues possible rulemaking regarding
EMA.
Preventive Controls and Critical Control Points
On page 3672, FDA states “We propose to require that the owner, operator, or agent in charge of a
facility identify and implement preventive controls (including at critical control points, if any) to provide
assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented
and that the food manufactured, processed, packed or held by such facility will not be adulterated under
section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.” IFAC fully supports
FDA’s intention to implement risk based food safety systems that are based on preventive controls.
However, we believe FDA should carefully review the statute to ensure that the preventive control system
specified in the final rule fits FSMA’s statutory directives. For example, we have concerns that the
proposed rule relies too heavily on prescriptive components of the Seafood and Juice Hazard Analysis
and Critical Control Point (HACCP) model. FSMA SEC. 103, “HAZARD ANALYSIS AND RISK-BASED
PREVENTIVE CONTROLS,” states that a facility should “identify and evaluate known or reasonably
foreseeable hazards that may be associated with the facility.” FSMA does not specify that the facility
should consider hazards “reasonably likely to occur,” a term used in HACCP systems that could lead to all
preventive controls being treated as critical control points (CCPs). If the Agency intends to include the
term “reasonably likely to occur” in the final rule, IFAC encourages FDA to provide guidance to help
industry determine types hazards that would be considered “reasonably likely to occur.” Without such
guidance, any imaginable hazard may be viewed as reasonably likely to occur and could lead to every
preventive control being treated as a CCP.
Along the same lines, we encourage FDA to recognize that companies will implement a range of
preventive controls, not just at CCPs, to adequately control known or reasonably foreseeable hazards.
Not all preventive controls should be considered CCPs. For example, as outlined in the Codex HACCP
Guidelines, the selection and management of controls requires consideration of two elements: severity
and probability. By considering both severity and probability (e.g. likelihood), facilities are able to
successfully evaluate the significance of potential hazards on a case-by-case basis, determine the
appropriate control measures, and decide how such measures need to be managed. FDA should ensure
CCPs receive the most rigorous management, oversight and verification, but should not view all
preventive controls as CCPs. Requiring facilities to treat every preventive control as a CCP will reduce
focus on the most critical points and tax limited resources that could be better focused on the true CCPs.
IFAC also notes that it is common practice to consider the contributions of prerequisite programs (i.e.,
sanitation and other programs required to comply with cGMP regulations) when identifying and evaluating
reasonably foreseeable hazards. We urge FDA to acknowledge the importance of considering
prerequisite programs when finalizing this rule. We believe this will further a strong food safety system
that aligns with the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS)
precedent. Given the important contributions of perquisite programs in controlling hazards, IFAC would
not object to onsite FDA access to records pertaining to prerequisite programs.
Qualified Individual
On page 3673, FDA proposes minimum requirements for a “qualified individual” who would be required to
“do or oversee the preparation of the food safety plan, validation of preventive controls, review of records
for implementation and effectiveness of preventive controls and the appropriateness of corrective
actions.” IFAC fully supports FDA’s proposal to require a qualified individual “to successfully complete
training with a standardized curriculum or be otherwise qualified through job experience to develop and
apply a food safety system.” IFAC urges FDA to ensure that job experience qualifications be retained in
the final rule. Relevant job experience can provide an individual with knowledge equivalent to that
provided through completion of a standardized curriculum. IFAC sees no benefit to public health or safety
to require an experienced, qualified individual to complete additional training for the sake of an arbitrary
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training requirement. Such a requirement would only burden the individual and hamper productivity with
no meaningful benefit.
Definitions of “manufacturing/processing,” “packing,” and “holding”
On page 3692, FDA states “we tentatively conclude there is no meaningful distinction between
‘manufacturing/ processing,’ ‘packing,’ and ‘holding’ as defined in our proposed revisions to §§ 1.227 and
1.328 and those terms as they have been used in current part 110.” IFAC believes there are differences
in these activities and therefore their definitions should be different. While we do not object to the
consistent use of these terms throughout proposed part 117 in reference to activities taking place in food
facilities, establishments, or plants, we believe there are significant distinctions in these terms that need
to be considered when finalizing requirements listed in proposed part 117.
Testing
As a general comment, IFAC strongly supports FDA’s position that testing should be considered a
verification measure, and not a preventive control. In some cases, testing will allow businesses to verify
their preventive controls are functioning properly, but testing is not an effective or practical preventive
control. Furthermore, we believe testing requirements should be flexible enough to allow producers to
institute testing methods and practices that fit the unique circumstances of their facilities and products.
IFAC also encourages FDA to issue for public review and comment proposed regulatory language on
testing prior to publishing any testing requirements as part of a final rule. By not issuing a specific
proposal for consideration and comment by industry, the Agency has made it extremely difficult, if not
impossible, for industry to provide specific comments on testing. Although FDA discusses testing in the
appendix to the proposed rule and released regulatory language that was removed prior to publication of
the proposed rule, the appendix and regulatory language did not provide a clear understanding of the
scope of the testing requirement, and therefore stakeholders have not had sufficient opportunity to
comment. If the Agency does not issue proposed language on testing requirements, we encourage FDA
to issue any testing requirements in the form of an interim final rule in order to allow further opportunity for
public comment.
With regard to product testing, on page 3763, FDA states that the Agency “believes that the role and
need for these measures varies depending on the type of products and activities of a facility. FDA further
believes that the manufacturer could consider a number of factors to establish a product testing program.”
In general, IFAC supports this position. We would note, however, that raw material testing should be
based on supplier and raw material qualifications and risk assessments. We do not support mandated
product testing for every lot of raw material received except as an identification test similar to that done
with pharmaceuticals. We are concerned that the bulleted list provided on page 3764 is too prescriptive.
Some of the steps listed should be incorporated into risk assessments, but we do not support mandating
all of the listed activities take place. Furthermore, microbiological testing may be impractical for most food
additives and GRAS substances. This is evidenced by the fact that most compendial monographs for
food additives and GRAS substances lack microbial contamination information and, as noted previously,
utilize processes and raw materials that minimize microbial contamination risks.
Lastly, we generally oppose any mandates that would require finished product testing for all products.
While IFAC acknowledges finished product testing may be useful or necessary in some limited cases, it
should only be required under specified circumstances such as when there has been a history of food
safety issues with a particular food product or the food product is likely to be consumed without being
subjected to a kill step. Finished product testing should not be required for food additives and GRAS
substances as these products are likely to undergo further downstream processing before being
consumed and present a significantly lower microbiological hazard compared with many other foods.
Environmental Monitoring
IFAC believes environmental monitoring programs should be science and risk based. On page 3738,
FDA states the procedures, practices, and processes described in the definition of preventive controls
may include an “environmental monitoring program to verify the effectiveness of pathogen controls in
processes where a food is exposed to a potential contaminant in the environment (section 418(o)(3)(C) of
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the FD&C Act).” Later in the document, on page 3744, FDA requests comment on “an environmental
monitoring program,” as well as other activities that preventive controls may include.
IFAC agrees that microbial contamination is of potential concern, and we believe companies should
monitor for pathogens when producing certain at risk products. As discussed above with regard to
product testing, however, FDA should not include environmental monitoring requirements in the final rule.
Although FDA discusses environmental monitoring in an appendix to the proposed rule and released
regulatory language that was removed from the proposed rule, the appendix and regulatory language did
not provide a clear understanding of the scope of environmental testing, and stakeholders therefore have
not had sufficient opportunity to comment.
While environmental testing can be an effective way to verify that sanitation and other preventive controls
are working effectively, environmental pathogen testing may be impractical in certain situations, for
example in chemical plants that also produce food additives. In these plants, equipment may be located
outside or in the chemical plant environment. IFAC strongly believes that there should be different
requirements for microbiological testing, particularly environmental pathogen testing, for food additive
facilities compared with finished food processing facilities.
Furthermore, we note that FDA’s proposed CGMP revisions already include provisions to address
biological hazards including environmental pathogens. Some of the requirements detailed in the
proposed § 117.80, “Processes and controls” include:
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Proposed § 117.80(a)(5), “Chemical, microbial or extraneous-material testing procedures must be
used where necessary to identify sanitation failures or possible cross-contact and food
contamination.”
Proposed § 117.80(b)(2), “Raw materials and ingredients must either not contain levels of
microorganisms that may render the food injurious to the health of humans, or they must be
pasteurized or otherwise treated during manufacturing operations so that they no longer contain
levels that would cause the product to be adulterated.”
Proposed § 117.80(c)(2), “All food manufacturing, processing, packing, and holding must be
conducted under such conditions and controls as are necessary to minimize the potential for the
growth of microorganisms or for the contamination of food.”
Additionally, proposed § 117.135(d)(3), “Sanitation controls,” details the requirements for sanitation
controls and states, in part, the following:
“Where necessary to significantly minimize or prevent hazards that are reasonably likely to occur
(including any environmental pathogen that is reasonably likely to occur in a ready-to-eat food that is
exposed to the environment prior to packaging, any microorganism of public health significance that is
reasonably likely to occur in a ready-to-eat food due to employee handling, and any food allergen hazard)
sanitation controls must include…”
IFAC believes that the abovementioned proposals adequately address biological contaminants, including
environmental pathogens. These proposals provide processors the flexibility to implement appropriate
control measures, including environmental testing, without the FDA developing specific regulations
prescribing what those measures should entail.
If FDA opts to require mandatory environmental monitoring, we urge the Agency to develop clear
guidance regarding when environmental testing is required and for which microorganisms of public health
significance, including environmental pathogens, should be tested. Otherwise, the specifics of
environmental monitoring, including the frequency and locations of sampling, should be left to the
discretion of each individual facility. Because food additives generally undergo additional processing,
their microbiological risk is typically much lower than finished food products. Therefore, if environmental
monitoring is required in the final rule, IFAC urges FDA to provide unique requirements for microbiological
testing, particularly environmental pathogen testing, for food additive facilities. Similarly, any facility that
manufactures a product that does not support the survival or growth of environmental pathogens should
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not be subject to mandatory environmental testing requirements as there is not a reasonable likelihood
that such organisms would pose a risk in the finished food.
Potential Revisions to Establish Requirements for Education and Training
IFAC agrees that training is necessary; however, because of the inherent differences in establishment
size, product types, etc., individual facilities need flexibility to develop suitable programs appropriate to
their specific situation. We believe the manufacturer should establish and maintain procedures for
identifying training needs and providing the necessary training to personnel performing activities affecting
food additive safety. Appropriate records of training should be maintained. Training should address the
particular operations that the employee performs and the cGMPs as related to the employee’s function.
Additionally, we believe that qualified individuals should conduct cGMP training with sufficient frequency
to ensure that employees remain familiar with applicable cGMP principles.
IFAC believes cGMP training should include adequate personal hygiene training for personnel who
handle materials so that they understand the precautions necessary to prevent contamination. The
training programs should ensure personnel understand that deviations from procedures may have an
impact on product quality and safety.
However, we note that relevant hygiene training for a food additive facility would be different from training
needed in a RTE food facility because different hygienic practices are used. Therefore, IFAC reiterates
our position that FDA must maintain enough flexibility in any training requirements to ensure training is
tailored to the specific products or product categories produced by a facility.
Proposed § 117.135(d)(3)—Sanitation Controls
IFAC recognizes that maintenance of clean and sanitary conditions is critical to food additive and GRAS
substance quality and safety. However food additives and GRAS substances are produced in
manufacturing environments and under conditions that may vary from finished foods. Thus, conditions
that may be considered appropriate for maintaining sanitary operations at one establishment may not be
suitable for another.
On pages 3741-3742, FDA lists a number of proposed sanitation controls that are designed to minimize
or prevent hazards that are reasonably likely to occur. It is not clear to IFAC whether the proposed
requirements would be applicable to all food facilities or only to facilities that make RTE products. IFAC
reiterates that sanitation practices for chemical plants, that also produce food additives, are distinctly
different from plants that only produce finished food products.
For instance, at chemical facilities that also produce food additives and GRAS substances, it is standard
practice to clean equipment, but this cleaning may not always “sanitize” the equipment or use running
water or disinfectant solvents to flush equipment. For example, dry flushing will ensure that the
equipment is clean and the equipment will not pose a risk of contamination, but the flushing operation
may not actually disinfect the equipment. Additionally, sanitation practices and procedures for food
additives and GRAS substances produced at chemical type establishments where operators are required
to wear safety gloves and/or protective outer clothing for personal protection against chemical and
environmental hazards and where there is little to no direct handling of the product by production
personnel during the production cycle would not be suitable for exclusive food additive and GRAS
substance manufacturing establishments where the production process involves more direct handling by
production personnel or where the products are more sensitive to contamination.
Therefore, while IFAC supports maintaining documented procedures that define the scope, cleaning or
sanitation objectives, management responsibility, monitoring, corrective action, and record keeping
associated with the cleaning or sanitation procedures, IFAC also believes that firms which manufacture
food additives and GRAS substances should have the flexibility to use a risk-based approach for
identifying and implementing appropriate sanitation practices and procedures necessary to protect
against contamination of their products. We do not support prescriptive sanitation practices that are
unlikely to be suitable to the range of facilities currently producing food, food additives and GRAS
substances in the global food industry.
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Proposed § 117.135(d)(2)—Food Allergen Controls
Food allergen management and control measures should be risk-based. This would enable individual
establishments to evaluate their specific situation and put in place appropriate programs and control
measures to ensure compliance with the Food Allergen Consumers Labeling and Protection Act
(FACLPA).
IFAC supports the need for a thorough risk assessment of all potential allergens associated with the
production of a food or food additive/GRAS substance. However, some food additives and GRAS
substances are manufactured in chemical type establishments that do not use or handle any of the eight
major food allergens identified in FALCPA. This creates a situation where the risk of cross contact with
allergens would be minimal and food safety resources could be better prioritized on risks that are more
likely to occur. Therefore, we believe allergen controls should not be mandated for facilities where an
allergen risk assessment shows no risk associated with food allergens. IFAC further believes that the
plant site food safety plan should provide for review and validation of all allergen risk mitigation strategies
and be based on an allergen risk assessment. If an allergen risk assessment shows no risk of allergen
cross contamination in the final product then such controls would provide no additional public health
benefit.
In contrast, other establishments may handle or produce food additives and GRAS substances containing
one or more of the eight major food allergens on shared equipment. At such facilities, the need for a food
allergen management program and effective use of preventive control measures is critical for ensuring
food safety. Still, other establishments may use and/or handle one or more of the eight major food
allergens, but have dedicated production lines and closed systems where the opportunity for crosscontact between products is minimal.
Thus, establishments should have the flexibility to design food allergen management and control
programs based on risk. Such programs should be designed and implemented by qualified individuals
after careful review and evaluation of the specific situation at the production site. As appropriate, the food
allergen management plan should include elements such as training of processing and supervisory
personnel, segregation of food allergens during storage and handling, cleaning procedures to adequately
remove food allergens from food contact surfaces, prevention of cross-contact during processing, product
label review and label usage and control, record keeping, and a supplier control program for ingredients
and labels. Firms that institute food allergen management and control programs and follow rigorous
handling practices will minimize the potential of allergen cross-contact. In plants that implement these
control measures, it is not necessary to mandate allergen controls in non-production areas. Allergen
controls should be focused on hazards associated with the production space of the plant and be risk
based.
We also support the establishment of allergen thresholds as a necessary metric to measure compliance
with allergen controls and as a tool firms can use to determine the risk posed by trace amounts of food
allergens that may be detected by increasingly sensitive detection techniques. These thresholds will
further allow food safety resources to be allocated based on risk.
Proposed § 117.135(e)—Applicability of Monitoring, Corrective Actions, and Verification
On page 3745, FDA requests comments on “whether to include a requirement for a mock recall as
verification activity in the final rule.” IFAC supports the need for mock recalls and encourages FDA to
include such a requirement in the final rule.
Proposed Requirements for Validation
IFAC urges FDA to base validation requirements on risk. On pages 3752-3756, FDA describes activities
that would be required to validate that preventive controls are adequate to control hazards. FDA should
ensure that any required validation activities provide flexibility for food additive production which may run
intermittently at plants that also produce industrial, cosmetic, and excipient grade products. In these
plants, food grade ingredients may only be produced a few times per year. In such cases, facilities will
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carry out calibration checks and secondary verifications, but in some cases validation data may be
limited.
Proposed § 117.150(b)—Verification of Monitoring
On page 3765, FDA describes some of the activities that the proposed § 117.150(b) would require to
verify monitoring is taking place. IFAC is concerned that FDA is proposing to include a second
verification step or activity, which would bring food cGMPs to the same level as pharmaceutical or
excipient standards. In particular, we feel that the metal detector example provided is impractical. A
quality control officer is not likely to go out onto the plant floor every shift to verify the operators metal
detector readings. Instead, the operator would document the metal detector readings and they would be
captured as part of the batch record review. IFAC does not support a second verification step or activity
because of the precedent it sets. Food, food additive and GRAS substance manufacturing is distinct from
pharmaceutical and/or excipient manufacturing and should be regulated differently.
Recordkeeping Requirements
IFAC supports FDA’s conclusion that food or food additive/GRAS substance manufacturers should
establish procedures for the identification, collection, indexing, filing, storage, maintenance and
availability of records. Records should be maintained to demonstrate preventive controls have been
implemented, are functioning and are being monitored. Records should be legible and, where
appropriate, identifiable with the product involved. Records should also be housed where they are
created to ensure they can be reviewed in the appropriate context.
Entries in records should be clear, indelible, made directly after performing the activity (in the order
performed), and signed or initialed and dated by the person making the entry. Corrections to entries
should be signed and dated, leaving the original entry legible. Records should be available for each
batch of food additives or GRAS substances produced and should include complete information relating
to the production and control of each batch. For continuous processes, the batch and its records should
be defined (for example, based on time or a defined quantity).
However, there are certain aspects of the recordkeeping requirements listed in the proposed rule that
raise some concerns. On page 3757, FDA states “proposed § 117.150(d)(2)(i) would require review of
the monitoring and corrective action records within a week after the records are made.” IFAC is
concerned that, for some continuous processes and for certain products, it may take more than a week
after production to assemble all records. Furthermore, if microbiological testing is required in the final
rule, records associated with such testing will take more than a week to assemble. IFAC notes that
proposed § 117.150(d)(2)(ii) would require “review of the records related to calibration within a
reasonable time after the records are made.” We therefore urge the Agency to revise proposed §
117.150(d)(2)(i) to replace “a week” with a “reasonable time after the records are made” to ensure that
records review will not take place until all available and relevant data is assembled.
IFAC also requests that FDA exempt preventive controls records from public disclosure under the
Freedom of Information Act. FDA regulations currently exempt HACCP records from public disclosure
unless they have been previously disclosed to the public or relate to a product or ingredient that has been
abandoned. The USDA FSIS exempts many meat and poultry HACCP records (e.g., records of critical
control points and critical limits, process flow charts, specific processing details) from public disclosure.
We do not see why preventive controls records should receive less protection. Aside from the fact that
such records may contain trade secrets and confidential information, they may also contain information
that can be used by individuals who wish to defeat a facility’s food safety plan.
Supplier Approval and Verification
IFAC strongly supports FDA’s intention to specify requirements and qualifications for accredited auditors
through another FSMA proposed rule. We note that there are currently many auditors who do not have
adequate training, particularly with respect to food additives and GRAS substances. We also agree that
specifying requirements as FDA proposes will minimize this problem. As noted by the Agency, preventive
controls are the foundation of many food safety third-party auditing schemes and certifications, such as
those recognized by the Global Food Safety Initiative (GFSI). As the food industry is embracing GFSI
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standards, and the number of companies becoming certified to a GFSI standard is increasing, there
should be recognition and harmonization by FDA of GFSI-benchmarked standards such as Safe Quality
Food certification.
However, IFAC notes that food additive and GRAS substance manufacturers often face unique
challenges when qualifying foreign suppliers and raw materials as many third-party auditing schemes
designed for finished food products may not fit the needs of food additive and GRAS substance
manufactures, including the GFSI standards. In some cases, it may be necessary for such manufacturers
to conduct different types of risk assessment and/or supplier audits to ensure the material is safe for the
intended use. This is one of the reasons why IFAC included section 6.4.3, “Supplier Qualification and
Periodic Verification,” in the IFAC Guide mentioned previously in these comments. IFAC urges FDA to
consult this section of the Guide when issuing guidance or drafting regulations pertaining to supplier
verification for food additive and GRAS substance manufacturers.
IFAC supports the use of accredited third-party food safety audits. Third-party audits can be an important
component of the food safety system. Food additive plants frequently make cosmetic ingredients and/or
excipients and expend significant resources managing the volume of audits now required by FDA and
other global regulations. The ability to use qualified third-party auditors provides the flexibility that
companies need to manage the volume of audits now required while ensuring the highest level of
compliance within the supply chain.
Furthermore, IFAC believes supplier verification is an important component of any preventive control
based system and supports codifying domestic supplier verification requirements in the preventive
controls final rule. We generally support FDA’s proposal to use a preventive approach, where a facility
receiving raw materials or ingredients from a supplier must verify that the supplier has implemented
preventive controls to significantly minimize or prevent hazards that the receiving facility has identified as
reasonably likely to occur in that raw material or other ingredient unless the receiving facility will itself
control the identified hazard.
We strongly believe that the frequency of supplier verification activities should be based on risk
assessment with inputs or hazards deemed highest risk receiving the most frequent verification activities.
We do not see any benefit to health or safety from prescriptive requirements that specify verification
activities must be conducted at a specific frequency or for every hazard identified with every raw material
or input. Such a requirement would force companies to expend limited resources conducting repetitive
verification activities when multiple inputs are sourced from the same supplier. Rather than requiring
verification activities for every hazard identified with each input, we urge FDA to allow companies to focus
verification activities on inputs or hazards that pose the greatest risk and provide a method for companies
to conduct verification activities for multiple, lower risk hazards or inputs sourced from a single supplier.
We also urge FDA to provide modified supplier verification requirements when inputs are sourced from a
supplier under the same corporate ownership as the receiving facility.
Submission of a Facility Profile to FDA
On page 3768, FDA describes some of the potential benefits and drawbacks of requiring facilities to
submit a food safety plan or facility profile to FDA. IFAC has some general concerns about submission of
such information and believes submission will not necessarily improve food safety.
First, we are concerned that, if submission of a facility profile is required, companies would have to
resubmit the profile anytime the company changes or updates an aspect of the profile. This creates a
significant burden and cost that is unlikely to result in any benefit to food safety. We also note that the
data elements of a facility profile listed in the proposed rule are extensive and could include information
that may be confidential or sensitive in nature (e.g., a facility’s preventive controls). Some of the
information (e.g., the hazards identified as reasonably likely to occur, preventive controls, facility
operations schedule) could also be used to defeat a facility’s food safety plan, yet the proposed rule does
not explain how FDA would protect such information from public disclosure. Furthermore, we believe that
maintaining such a facility profile would be similar to maintaining a Drug Master File, and we again
question the precedent that this would set.
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We also note that the facility profile information would likely be submitted electronically through FDA’s egateway. Many companies have found the gateway to be very difficult to use. In some cases, companies
have even had to employ third-parties to ensure currently required information is accurately submitted
through the e-gateway. We are concerned that expanded use of the e-gateway would place an undue
burden on companies, and we question whether FDA has the necessary resources to review the tens of
thousands of food facility profiles likely to be submitted under such a requirement.
Finally, IFAC opposes any requirement for remote access to company’s manufacturing and related
records. FDA’s access to company records must be conducted on-site in the course of an authorized
inspection so that FDA is able to understand the full context in which the records were created. Remote
access to records creates the real possibility that records would be reviewed outside of the context in
which they were created and potentially misinterpreted. Furthermore, reviewing records offsite precludes
FDA’s ability to ask for clarification if questions arise. When records are reviewed on-site, plant staff
familiar with recordkeeping practices and the context in which the records are created can aid FDA in
their review.
Proposed § 117.305—General Requirements Applying to Records
On page 3781, FDA states “proposed § 117.305(a) also would require that electronic records be kept in
accordance with part 11 (21 CFR part 11)…The proposed requirement clarifies and acknowledges that
records required by proposed part 117 may be retained electronically, provided that they comply with part
11.” IFAC is concerned that requiring records to be maintained in a manner that complies with Part 11
could be extremely burdensome for facilities that have developed and invested in implementing best
practices for electronic record keeping. These facilities have the necessary safeguards in place to ensure
electronic records cannot be altered without producing evidence of such alteration, and should have the
flexibility to continue using their record keeping systems without being forced to comply with the
requirements in Part 11.
Furthermore, IFAC recognizes the importance of ensuring that electronic records are kept accurately, but
we do not see any benefit to food safety that would come from requiring companies that already have
these assurance systems in place to comply with the requirements in Part 11. Because of the burden
compliance with Part 11 would place on some companies, we urge FDA to allow records to be maintained
electronically so long as the facility has adequate mechanisms in place to ensure these records cannot be
altered without record.
Exemption for R&D Facilities, Test Kitchens, and Pilot Plants
IFAC requests that the final rule includes an exemption for R&D facilities, test kitchens, and pilot plants.
The food manufactured, processed, packed, and held at such facilities is not distributed to the public and
therefore poses a minimal public health risk. Since these facilities are constantly changing the foods they
produce and the processing methods they use, it is extremely difficult for them to adhere to a food safety
plan along the lines required by the proposed rule. If FDA believes it does not have statutory authority to
exempt such facilities, we request that FDA announce that it intends to exercise enforcement discretion
with respect to such facilities.
Comment Summary
As FDA finalizes this propose rule, IFAC urges the Agency to preserve the regulatory flexibility necessary
for the diverse food industry. CGMPs must address the manufacture of a wide range of products in
establishments of varying sizes and processing technologies. Risk-based regulations will give regulated
establishments maximum flexibility to adapt preventive controls to their unique situation and allow them to
identify practices and procedures that enhance food safety and public health without becoming overly
burdensome.
We hope the Agency will consult IFAC’s Good Manufacturing Practice and Quality Assurance Guide for
Food Additives and GRAS Substances as it finalizes the proposed rule and considers guidance document
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for specific industries. IFAC’s Guide provides a science and risk-based approach that should guide the
adoption of preventive controls for food additives
IFAC supports the risk-based approach FDA has proposed and looks forward to continuing to work with
the Agency to implement meaningful preventive controls that will minimize food risks and help instill
greater consumer confidence in the food supply. Please let us know if any questions arise as you review
these comments and the enclosed Guide.
We appreciate the opportunity to comment on this foundational proposed rule. Please contact me with
any questions.
Sincerely,
Haley C. Stevens, Ph.D.
Executive Director
Enclosed:
IFAC Good Manufacturing Practice and Quality Assurance Guide for Food Additives and
GRAS Substances