June 30, 2014

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

RE: Proposed Rule – Focused Mitigation Strategies To Protect Food Against

Intentional Adulteration; Docket No. FDA–2013–N–1425

The National Grain and Feed Association (NGFA) and North American Export Grain

Association (NAEGA) submit this joint statement in response to the Food and Drug

Administration’s (FDA) proposed regulation implementing the Food Safety Modernization Act’s

(FSMA) provisions mandating domestic and foreign facilities required to register under the

federal Food, Drug and Cosmetic Act (FDCA) to address hazards that may be intentionally

introduced by acts of terrorism.

The NGFA, established in 1896, consists of more than 1,050 grain, feed, processing, exporting

and other grain-related companies that operate more than 7,000 facilities and handle more than

70 percent of all U.S. grains and oilseeds. Its membership includes grain elevators; feed and

feed ingredient manufacturers; biofuels companies; grain and oilseed processors and millers;

exporters; livestock and poultry integrators; and associated firms that provide goods and services

to the nation’s grain, feed and processing industry. The NGFA also consists of 26 affiliated State

and Regional Grain and Feed Associations. In addition, the NGFA has strategic alliances with

Pet Food Institute and North American Export Grain Association.

NAEGA, established in 1912, is comprised of private and publicly owned companies and

farmer-owned cooperatives involved in and providing services to the bulk grain and oilseed

exporting industry. NAEGA member companies ship virtually all of the bulk grains and oilseeds

exported each year from the United States. Dedicated to engaging the entire value chain,

NAEGA focuses on predictable, reliable and expanded international trade of grains, oilseeds and

their primary products. NAEGA members, stakeholders, and governments around the world are

key beneficiaries of NAEGA work to provide leadership, experience and capacity providing for

global reach and influence supportive of international trade and investment.

2

The NGFA was involved extensively during the development and consideration by Congress of

legislation that resulted in the enactment of the Food Safety Modernization Act (FSMA). As

such, it provided frequent input and specific legislative language on provisions of FSMA, and

supported the prevention-, science- and risk-based principles it embodies. The NGFA also

joined with the American Farm Bureau Federation and American Meat Institute to help lead a

broad-based group of nearly 30 agricultural producer and agribusiness organizations that

provided input during the legislative process.

NGFA and NAEGA commend FDA for the extensive public outreach it has conducted in

advance of proposed rulemaking to implement the various provisions of this ground-breaking

statute. We appreciate the time and effort FDA is expending to host public meetings, speak at

meetings hosted by public and private-sector organizations and conduct smaller group meetings

to solicit a wide range of stakeholder input. We believe such outreach is essential to

implementing this complex and far-reaching law in a manner that further enhances what already

is a safe and wholesome food and animal feed supply, without adding unnecessary regulatory

burdens and costs that would undermine the industry’s ability to provide an abundant and

affordable food supply to U.S. and world consumers.

The NGFA and NAEGA have been in the forefront of developing and promoting risk assessment

and facility security throughout the grain, feed and processing industry since shortly after Sept.

11, 2001.

NGFA has been an active participant in the Food and Agriculture Sector Coordinating Council,

the presidentially sanctioned partnership consisting of federal, state, tribal, territorial and private

sector organizations and entities that are focused on continually assessing and addressing risks of

intentional adulteration of the food and feed supply. NGFA’s president currently serves as the

Sector Coordinating Council co-chair.

In addition, NGFA and NAEGA are partnering with FDA to offer a Food Defense Awareness

Workshop that will be conducted on July 29, 2014 in Kansas City, MO. The goal of the full-

day workshop is to provide members of the grain, grain and oilseed processing, feed

manufacturing, flour milling and other industry sectors with information on food defense, the

tools and resources available from FDA (i.e., FDA’s Food Defense Plan Builder Tool and

industry), and to walk participants through a series of exercises on how to create a food defense

plan for their facilities.

Significantly, the NGFA and NAEGA also worked previously with FDA to assess and identify

mitigation strategies at grain handling facilities and animal feed mills through the Strategic

Partnership Program Agroterrorism (SPPA) – a public-private cooperative effort between the

U.S. Department of Agriculture (USDA), the Federal Bureau of Investigation and Department of

Homeland Security, in partnership with state and industry partners. The SPPA vulnerability

assessments included: 1) tours of a country grain elevator, export grain elevator and an animal

feed mill; 2) an analysis of the processes at typical facilities; and 3) identification of potential

risks and risk-mitigation strategies.

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During the SPPA exercises, the NGFA and NAEGA hosted teams of federal and state officials, as

well as industry members, to conduct CARVER+Shock1 risk assessments. Significantly, the

assessments at each facility did not identify a specific action or process step that represented a

threat of intentional adulteration that could result in widespread harm to the public. To the

contrary, each assessment only identified general threats, such as accessibility and vulnerability

that can be mitigated through broad strategies. Some examples of the “broad” proposed

mitigations as identified within the SPPA exercises to address the general threats included: 1)

limited access control to certain areas; 2) awareness and training programs; 3) increased lighting;

and 4) strategically placed cameras and electronic surveillance.

In response to the SPPA assessments, the NGFA and NAEGA in 2008 revised their facility

security guide, originally created in 2001, designed to assist grain elevators, feed manufacturers

and grain processors in conducting facility risk assessments, as well as in developing and

implementing facility security plans. The revisions reflected lessons learned from the facility

vulnerability assessments that were conducted in conjunction with the SPPA. In fact, each of the

reports emanating from the SPPA exercises for the grain handling and feed manufacturing sectors

listed the NGFA-NAEGA facility security guidance document as a tool to use as part of a

potential mitigation strategy.

Significantly, the NGFA-NAEGA facility security guide provides basic concepts that can be used

as a starting point upon which to build facility-specific risk-assessment and security plans. Thus,

it is a foundation upon which individual companies can build their own tailored plans specific to

their facility operations and personnel; agricultural commodities handled; geographic

surroundings; potential threats; and other conditions. The guide also provides a sample template

for developing a facility-specific security plan.

It is from this perspective that the NGFA and NAEGA strongly support provisions of the

proposed rule that would exempt the manufacturing, processing, packing and holding of animal

feed and pet food from FDA’s proposed regulation. Further, our joint statement provides a

detailed explanation as to why the agency’s proposed definition of “holding” should be revised

by appropriately including activities that grain handling facilities traditionally perform to safely

and effectively store food so as to provide such facilities with a clear exemption from FDA’s

proposed regulation. In addition, this statement explains how liquid storage and handling at

grain-handling facilities represent an extremely low risk of intentional adulteration of human

food, and why such an activity should be encompassed within FDA’s definition of “holding.”

NGFA and NAEGA also highlight why the low risk of intentional adulteration to human food at

grain handling facilities, as substantiated by the SPPA reports and underpinned by existing

USDA facility security requirements, provide ample justification for FDA to not mandate the

implementation of focused mitigation strategies at such facilities. We conclude by providing

comments on certain aspects of FDA’s proposed regulation.

1 C (Critically)-A (Accessibility) – R (Recuperability) – V (Vulnerability) – E (Effect) – R (Recognizability) +

SHOCK (health, economic and psychological impacts) methodology.

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Proposed Exemption for Animal Feed and Pet Food

As noted previously, FDA is proposing this regulation under the FDCA, as amended by FSMA.

Under sections 103 and 106 of FSMA, FDA is proposing the requirements applicable to a facility

required to register under section 415 of the FDCA.

Section 103 of FSMA establishes requirements applicable to a facility required to register under

section 415 of the FDCA. Section 418(a) of the FDCA is a general provision that requires a

facility to evaluate the hazards that could affect food manufactured, processed, packed or held by

the facility; identify and implement preventive controls; monitor the performance of those

controls; and maintain records of the monitoring. In addition to the general requirements in

section 418(a) of the FDCA, sections 418(b) to (i) of the Act contain more specific requirements

applicable to facilities, including several provisions explicitly directed at intentional adulteration.

Section 106 of FSMA – Protection Against Intentional Adulteration – amends the FDCA to

create a new section 420, which mandates that FDA issue regulations to protect against the

intentional adulteration of food. Section 420(b)(1) of FDCA requires that such regulations are to

specify how a person is to assess whether the person is required to implement mitigation

strategies or measures intended to protect against the intentional adulteration of food. Section

420(b)(2) requires that the regulations specify appropriate science-based mitigation strategies or

measures to prepare and protect the food supply chain at specific vulnerable points, as

appropriate. Section 420(c) provides that such regulations are to apply only to food for which

there is a high risk of intentional adulteration and for which such intentional adulteration could

cause serious adverse health consequences or death to humans or animals. Section 420(c)(1)

provides that such foods are to include those for which FDA has identified clear vulnerabilities.

FDA is proposing all of the provisions under section 420 of the FDCA.

Section 418(m) of the FDCA authorizes FDA to exempt or modify the requirements for

compliance with section 418 for facilities that engage solely in the production of animal feed and

pet food. Further, section 420(c) of the FDCA requires that regulations that FDA issues under

this section apply only to food for which there is a high risk of intentional contamination.

Accordingly, FDA proposes at §121.5(f) to exempt from the requirements of the regulation the

manufacturing, processing, packing and holding of food for animals other than man. In

proposing the exemption, FDA states that the agency is not aware of contaminants that could be

incorporated into animal feed at levels that would not produce noticeable clinical signs and/or

mortality in animals and carry over to result in significant human morbidity or mortality among

consumers that subsequently eat the meat, eggs or milk derived from such animals. Further,

FDA states that while incorporation of a contaminant into animal feed or pet food could result in

significant animal morbidity and mortality, the risk posed with regard to targeting by terrorist

organizations appears to be significantly lower than those involving human morbidity and

mortality. As such, the agency tentatively has concluded that animal feed and pet food

(regardless of whether it is produced at a facility solely engaged in the production of animal feed

or pet food or at a facility engaged in the production of both animal and human food) does not

involve significant vulnerabilities that require focused mitigation strategies.

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The NGFA and NAEGA strongly agree with FDA’s assessment and ensuing proposal to exempt

from its regulation the manufacturing, processing, packing and holding of animal feed and pet

food. As clearly demonstrated by the NGFA- and NAEGA-sponsored SPPA events at a

commercial animal feed mill, the activities performed during the production, distribution and use

of animal feed and pet food are not conducive to terrorist acts intended to cause widespread

public harm. As such, we believe that such products are an extremely low risk of intentional

contamination, and therefore should not be subject to FDA’s regulation.

Therefore, the NGFA strongly urges FDA to incorporate its proposed exemption for animal feed

and pet food into its final regulation. Such an exemption would represent an appropriate risk-

based approach that is consistent with the statutory authority and limits provided by FSMA

within section 418(m) and section 420(c). In addition, the exemption would alleviate the need

for animal feed and pet food facilities to expend limited resources implementing focused

mitigation strategies that would not serve to negate intentional attacks on the food supply that

could cause widespread harm to the public.

Proposed Exemption for Holding of Food

As amended by the FSMA, Section 418(m) of the FDCA provides, in relevant part, that FDA

may by regulation “exempt or modify the requirements for compliance [under section 418 –

hazard analysis and risk-based preventive controls] with respect to facilities that are solely

engaged in…the storage of raw agricultural commodities (other than fruits and vegetables)

intended for further distribution or processing.”

The NGFA strongly believes this authority that would apply to raw agricultural commodities,

other than fruits and vegetables, intended for further distribution or processing represents a sound

risk-based approach, and clearly reflects the view of Congress that both industry and FDA

should focus their limited resources on segments of the food production and distribution system

where the greatest benefits to product safety can be achieved. This same risk-based approach is

embraced by food safety experts who widely recognize that the use of hazard analysis and

critical control point (HACCP) principles (like those that would be required under Section 418)

is most appropriately and effectively applied during food processing activities. It is at this step

of the food supply chain that effective controls are most readily available to eliminate or

minimize significant hazards so as to ensure product safety.

Accordingly, FDA’s proposed §121.5(b) would exempt from the agency’s regulation the holding

of food, except the holding of food in liquid storage tanks. This provision would exempt, for

example, storage of whole grains, shell eggs, fruits and vegetables, and packaged foods

(including packaged milk and orange juice). But it would not exempt, for example, storage of

milk or liquid orange juice in bulk storage tanks.

FDA states that based upon its analysis of the vulnerability assessments conducted using the

CARVER+Shock methodology, the agency identified four key activity types (bulk liquid

receiving and loading; liquid storage and handling; secondary ingredient handling; and mixing

and similar activities) as production processes that require focused mitigation strategies to

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protect against intentional adulteration. As such, FDA states that with the exception of the

holding of food in liquid storage tanks, which is not included in the proposed exemption, the

agency is not aware of activities performed during the holding of food that fit within any of these

four key activity types. Accordingly, FDA proposes to exempt from the requirements of its

proposed regulation the holding of food, except the holding of food in liquid storage tanks.

However, as FDA is aware, the NGFA and NAEGA strongly believe that the agency’s proposed

definition of holding should be revised to appropriately include activities that facilities

traditionally perform to safely and effectively store food.

FDA’s proposed definition for “holding” states: “Holding means storage of food. Holding

facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid

storage tanks. For farms and farm mixed-type facilities, holding also includes activities

traditionally performed by farms for the safe or effective storage of raw agricultural commodities

grown or raised on the same farm or another farm under the same ownership, but does not

include activities that transform a raw agricultural commodity, as defined in section 201(r) of the

Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg) of the

Federal Food, Drug, and Cosmetic Act.”

As such, facilities, such as grain elevators, that engage in activities customarily performed for the

safe or effective storage of raw agricultural commodities – such as drying, screening,

conditioning and blending – would not be exempt from the proposed intentional adulteration

requirements because such activities fall outside of FDA’s proposed definition for “holding.”

From an operational standpoint, essentially all grain elevators engage in activities to safely and

effectively store raw agricultural commodities beyond what is provided for within the proposed

definition of “holding.” Such activities are inherent to safely store such commodities.

Therefore, essentially all grain elevators and other facilities that are engaged in the storage of

raw agricultural commodities would be subject to the proposed requirements.

The NGFA and NAEGA strongly believe that FDA’s proposed definition for “holding” that

would apply to facilities storing raw agricultural commodities does not reflect the regulatory

flexibility intended within the statutory language of FSMA. Nor does it appropriately recognize

the minimal level of food safety risk associated with the operations at such facilities. Further, the

NGFA and NAEGA believe that subjecting such facilities to intentional adulteration

requirements simply because activities inherently are performed to safely and effectively store

raw agricultural commodities does not constitute sound food safety policy.

In addition, FDA has constructed its proposed definition of “holding” to differentiate between

“facilities” and “farms and farm mixed-type facilities.” For farms and farm mixed-type

facilities, holding would include activities traditionally performed by farms for the safe or

effective storage of raw agricultural commodities grown or raised on the same farm or another

farm under the same ownership, but does not include activities that transform a raw agricultural

commodity. In contrast, the proposed definition for holding for facilities would not include

activities traditionally performed for the safe or effective storage of raw agricultural

commodities, even though those activities do not transform or alter the state of a raw agricultural

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commodity. The NGFA believes that this proposed regulatory distinction between two types of

operations that perform identical activities lacks sound reasoning and is not justified when a risk-

based approach to food safety is applied.

Accordingly, the NGFA and NAEGA strongly urge FDA to modify its proposed definition for

“holding” to read as follows [new language boldfaced and underscored]:

“Holding means storage of food. Holding facilities include warehouses, cold storage

facilities, storage silos, grain elevators, and liquid storage tanks. For facilities, holding also

includes activities performed for the safe or effective storage of raw agricultural

commodities other than fruits and vegetables intended for further distribution or

processing, but does not include activities that transform a raw agricultural commodity,

as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a

processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic

Act. For farms and farm mixed-type facilities, holding also includes activities traditionally

performed by farms for the safe or effective storage of raw agricultural commodities grown

or raised on the same farm or another farm under the same ownership, but does not include

activities that transform a raw agricultural commodity, as defined in section 201(r) of the

Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg) of

the Federal Food, Drug, and Cosmetic Act.”

In addition, as FDA is aware, facilities such as grain elevators that hold raw agricultural

commodities, other than fruits and vegetables, may combine or “blend” different lots of the

commodity when preparing the commodity for further distribution so as to meet desired quality

specifications contracted for by the customer. The NGFA and NAEGA strongly believe that this

“blending” activity does not constitute manufacturing or processing, since such activity in no

way transforms the raw agricultural commodity into a processed food. In addition, the resulting

lot of raw agricultural commodity still is intended for further distribution or processing. As such,

the NGFA and NAEGA believe that such blending activities performed on raw agricultural

commodities rightfully should be encompassed within those activities recognized by FDA within

its “holding” definition.

To further clarify that blending and other activities traditionally performed by facilities to safely

and effectively hold and distribute raw agricultural commodities, other than fruits and

vegetables, for further distribution or processing are not considered manufacturing or processing,

we recommend that FDA’s manufacturing/processing definition be modified as follows:

“Manufacturing/processing means making food from one or more ingredients, or

synthesizing, preparing, treating, modifying, or manipulating food, including food crops

or ingredients. Examples of manufacturing/processing activities are cutting, peeling,

trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling,

pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting

juice, distilling, labeling, or packaging. For facilities, manufacturing/processing does

not include activities performed for the safe or effective storage and distribution of

raw agricultural commodities other than fruits and vegetables intended for further

distribution or processing that do not transform a raw agricultural commodity, as

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defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a

processed food as defined in section 201(gg) of the Federal Food, Drug, and

Cosmetic Act. For farms and farm mixed-type facilities, manufacturing/processing does

not include activities that are part of harvesting, packing, or holding.”

Use of Liquid Dust Suppressants at Grain Handling Facilities

With its proposed rule, FDA has identified four key activity types that the agency believes are

most vulnerable to intentional adulteration. These four key activity types are:

Bulk liquid receiving and loading, which refers to any processing step where a liquid

ingredient is being received and unloaded at a facility, or a liquid intermediate or finished

product is being loaded into an outbound shipping transport vehicle and for which there is

an opportunity for a contaminant to be intentionally introduced into the food.

Liquid storage and handling, which is defined as a step in which a liquid is contained in

bulk storage tanks or in holding, surge or metering tanks where a contaminant can be

intentionally introduced and, if it is, it is likely that the contaminant will be distributed

into the food. This key activity type refers to any processing step where a liquid

ingredient or intermediate or finished liquid product is stored in either bulk storage tanks

or smaller secondary, non-bulk holding tanks or surge tanks and for which there is an

opportunity for a contaminant to be intentionally introduced into the food.

Secondary ingredient handling, which is defined as the staging, preparation, addition or

rework step where a contaminant can be intentionally introduced into a relatively small

amount of ingredient or rework and, if it is, it is likely that the contaminant will be

distributed into a larger volume of food.

Mixing and similar activities, which are defined as a step, such as mixing, blending,

homogenizing, coating, glazing or grinding, where a contaminant can be introduced

intentionally and, if it is, it is likely that the contaminant will be distributed into the food.

Under FDA’s proposal, facilities would be required to review their production system to

determine if they have any of these key activity types or complete their own vulnerability

assessment. Once that is completed, they would need to identify actionable process steps, which

are points, steps or procedures in a food process that will require focused mitigation strategies to

reduce the risk of intentional adulteration. Facilities also would be required to complete and

implement a written food defense plan that would establish specific measures to be used to

protect against the intentional adulteration of food.

Related to FDA’s proposed key activity types, grain handling facilities may use mineral oil as an

effective means to control dust during the handling of grain. Such mineral oil is stored in liquid

storage tanks and metered onto grain. As the agency is aware, FDA’s regulations allow the

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application of mineral oil on grain2 for dust control at an application rate not to exceed 0.02

percent by weight (200 parts per million). However, laboratory testing and industry experience

have shown that mineral oil applied at a rate of 60 to 200 parts per million by weight of grain,

equating to 0.5 to 1.7 gallons of oil per thousand bushels of grain, can provide effective dust

control.3

Because of the low application rate of the liquid and nature of the food involved in the activity,

the NGFA and NAEGA believe that even if a mineral oil storage tank was intentionally

compromised, the amount of potential contaminant dispersed onto grain would be minimal and,

therefore, not pose a significant risk to public health. In addition, the application of mineral oil

on whole grain occurs at the initial phase of food processing prior to distribution and further

processing, not on a final consumer product. Therefore, the grain likely will be subject to

multiple processing steps that could mitigate any potential contaminant before it is incorporated

into human food that would be consumed.

Instead of characterizing mineral oil addition to grain as a key activity type that would subject a

grain elevator to FDA’s regulation, the NGFA and NAEGA believe such activity rightfully

should be included among those encompassed by FDA’s definition for “holding.” As expressed

previously, the NGFA and NAEGA strongly urge FDA to modify its proposed definition for

“holding” so that it includes activities performed for the safe or effective storage of raw

agricultural commodities, other than fruits and vegetables, intended for further distribution or

processing, but does not include activities that transform a raw agricultural commodity into a

processed food. Since mineral oil is added to raw grains and oilseeds for safe and effective

storage, and does not transform the raw agricultural commodity into a processed food, we

believe the application of liquid dust suppressants to grain is an activity that should be included

within FDA’s definition for “holding.”

In addition, pertaining to the risk of intentional adulteration of human food at grain elevators, we

believe the NGFA and NAEGA-sponsored SPPA events at a country elevator and export grain

elevator clearly demonstrated that the activities performed by grain handling facilities are not

conducive to terrorist acts intended to cause widespread public harm. As such, we believe that

such products are at a low risk of intentional contamination, and therefore should not be subject

to FDA’s regulation.

Accordingly, the NGFA and NAEGA strongly believe that grain handling facilities should not be

required to implement focused mitigation strategies based upon the storage and handling of

liquid dust suppressants, which are applied to grains and oilseeds for their safe and effective

storage. To encompass grain handling facilities within the regulation for such an activity would

not represent a risk-based approach and would not enhance protection of the food supply from

acts of intentional adulteration.

2 See, for example, “Emission Factors for Grain Elevators, Final Report;” Midwest Research Institute, Kansas City,

MO; January 3, 1997, page A-1. 3 Letter from Thomas C. O’Connor, National Grain and Feed Association, to Dallas Safriet, U.S. Environmental

Protection Agency, Research Triangle Park, NC, June 30, 1997.

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Existing Facility Security Requirements for Grain Handling Facilities

The U.S. Department of Agriculture since Sept. 1, 2004 has required that grain elevators entering

into a Uniform Grain and Rice Storage Agreement (UGRSA) contract with the Commodity

Credit Corp. (CCC) conduct a facility vulnerability assessment and implement a facility security

plan. UGRSA contracts are required for grain elevators that store or handle CCC-owned grain, or

that offer marketing assistance loans to producers under the U.S. farm programs.

Among other things, the UGRSA contract – which addresses the warehouse operator’s

contractual responsibilities – specifically requires facilities to implement a security plan that

“includes measures to protect grain handled and stored” under the contract. The facility

vulnerability assessment most warehouse operators are required to conduct addresses four major

components: 1) the general security of the physical structures and grounds of the grain storage

facility; 2) the warehouse’s shipping and receiving procedures to ensure grain is “not subject to

tampering”; 3) actions to be taken in the event of a “national emergency”; and 4) emergency

contact information for local security authorities.

Currently, USGRSA warehouses comprise 8.9 billion bushels of the 10.4 billion bushels of total

U.S. commercial grain storage capacity. Thus, more than 85 percent of U.S. commercial grain

storage capacity is comprised by facilities that are subject to the UGRSA requirements to

conduct facility vulnerability assessments and implement facility security plans. Such facilities

are subject to grain warehouse inspections by USDA and state regulatory agencies that include

compliance with these UGRSA requirements. Accordingly, the NGFA and NAEGA strongly

believe that establishing new FDA requirements for grain handling facilities that already have

risk-mitigation and facility security policies in place to address intentional adulteration hazards

would be duplicative, burdensome and unnecessary to protect the human food supply.

NGFA/NAEGA Comments on Selected Proposed Requirements

The NGFA and NAEGA offer the following comments on other specific requirements proposed

by FDA in this rulemaking:

Scope of Requirements to Implement Focused Mitigation Strategies:

As previously expressed, FDA’s proposal would require facilities to review their production

system to determine if they have any of the FDA-identified key activity types or complete their

own vulnerability assessment. Once that review is completed, facilities would need to identify

“actionable process steps” for key activity types or other identified vulnerabilities. FDA

proposes to define an “actionable process step” as “a point, step or procedure in a food process at

which food defense measures can be applied and are essential to prevent or eliminate a

significant vulnerability or reduce such vulnerability to an acceptable level.” Facilities also

would be required to complete and implement a written food defense plan that would establish

specific measures to be used to protect against the intentional adulteration of food. Further, such

specific measures would be subject to detailed requirements associated with monitoring,

corrective actions, verification and recordkeeping.

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As such, the NGFA and NAEGA believe these core aspects of FDA’s proposed regulation

essentially would require that preventive controls for FDA-identified key activity types or other

identified vulnerabilities be implemented and managed in a manner similar to a “critical control

point” that has been established within a formal HACCP plan.

The NGFA and NAEGA strongly believe such an outcome is not consistent with the statutory

authority provided to FDA under FSMA to promulgate an intentional adulteration regulation.

Clearly, the statutory language within FSMA does not mandate that covered facilities address all

vulnerabilities that may be present with its operation in the same demanding and burdensome

manner that would be required of a critical control point within a formal HACCP plan.

Instead, the NGFA and NAEGA believe that FDA’s intentional adulteration regulation should

closely follow the FSMA statutory language to provide for implementation of “science-based

mitigation strategies or measures to prepare and protect the food supply chain at specific

vulnerable points, as appropriate.” [Emphasis added.] As such, we believe that the level of

rigor used to manage the range of necessary controls should be commensurate with the nature of

the vulnerability and the type of controls being used, with only those controls that are critical to

ensuring food defense receiving the most rigorous management oversight.

In the context of mitigating the potential for acts of intentional adulteration, it is very common

during vulnerability assessments to consider the contributions of broad mitigation strategies in

deciding whether a particular threat warrants additional and more focused preventive controls

that would be subject to enhanced management oversight. The NGFA and NAEGA strongly

believe that FDA within its regulation needs to acknowledge the protection provided by the use

of broad mitigation strategies, so as to avoid the unnecessary and untenable outcome of each

preventive control being subject to the burdensome requirements of monitoring, corrective

actions, verification and recordkeeping.

In particular, the NGFA and NAEGA are very concerned that FDA’s proposal essentially

predetermines that a facility engaged in one or more of the FDA-identified key activity types

must implement focused mitigation strategies regardless of the other controls that the facility

may have implemented and demonstrated to be effective. In addition, we are concerned that

FDA’s use of key activity types to trigger requirements under the regulation does not sufficiently

direct the proposed requirements to “apply only to food for which there is a high risk of

intentional contamination.” Indeed, FDA’s proposed regulation would apply to essentially all

human food facilities, since essentially all human food facilities engage in one of more of FDA’s

key activity types. The NGFA and NAEGA do not believe such outcomes adhere to the

statutory language of FSMA.

As such, the NGFA and NAEGA strongly urge FDA within its regulation to provide flexibility

for management oversight of vulnerabilities that is tailored to each facility’s operation and

commensurate with the nature of the vulnerability that may be present. As such, FDA’s

regulation addressing intentional adulteration should be science- and risk-based, non-

prescriptive, and provide sufficient flexibility to allow facilities to adopt practices that are

practical and effective for their specific, individual operations.

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Vulnerability Assessments and Qualified Individuals:

Proposed § 121.130(b) would provide that a facility covered by its rule could conduct, or have

conducted, their own vulnerability assessment of the food operations at a facility, rather than

assessing their food operation against the FDA-identified key activity types. FDA proposes that

such a vulnerability assessment be performed by an individual(s) qualified by experience and/or

training using appropriate methods. Further, FDA does not propose to specify the particular

training or experience requirements of the individual(s) qualified to conduct such vulnerability

assessments, or the particular methods that must be used to conduct these assessments. Instead,

FDA states that facilities conducting their own vulnerability assessment would be required to

employ appropriate methods and use a qualified individual(s) to conduct a robust and

scientifically sound vulnerability assessment of the facility’s food operation.

The NGFA and NAEGA agree that it would be appropriate to allow facilities to conduct their

own vulnerability assessments using scientifically sound methods. In addition, we agree that it

would be appropriate to deem the individual conducting the assessment to be qualified by

training and/or experience. Providing the option for a qualified individual to conduct a

vulnerability assessment within a facility, rather than assessing their food operation against the

FDA-identified key activity types, would give facilities the needed flexibility to assess potential

vulnerabilities in accordance with individual operations and types of food. In addition, we

believe that FDA should articulate clearly that such vulnerability assessments properly consider

the contributions made by broad and effective mitigation strategies that a facility already has

implemented.

Economically Motivated Adulteration:

FDA states within its proposed rule, for a variety of reasons, that the vulnerability assessment-

type approach being proposed by the agency to address intentional adulteration is not well suited

to address the potential for economically motivated adulteration of food. As such, FDA states

that it tentatively has concluded that economically motivated adulteration would be best

addressed in other FSMA-related rulemakings.

The NGFA and NAEGA generally agree with FDA’s tentative conclusion, and will respond to

FDA’s proposed approach for addressing the potential for economically motivated adulteration

once it is issued by the agency. However, the NGFA and NAEGA believe it is advisable for

FDA to finalize its regulations for unintentional adulteration of food, animal feed and pet food

and food defense, and provide adequate time for industry to come into compliance with

requirements prior to addressing the issue of economically motivated adulteration. We believe

that such an approach would provide both FDA and industry necessary time to gain valuable

experience in applying food-defense principles that would assist in identifying what gaps, if any,

need to be further addressed pertaining to the potential for economically motivated adulteration.

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Written Focused Mitigation Strategies:

FDA proposes under §121.135(a) to require that a covered facility identify and implement

focused mitigation strategies at each actionable process step to provide assurances that the

significant vulnerability at each step will be minimized significantly or prevented, and the food

manufactured, processed, packed or held by such facility will not be adulterated. Since the

focused mitigation strategy needs to be tailored to the significant vulnerability applicable to the

specific actionable process step, FDA does not propose to specify the particular focused

mitigation strategies that would be appropriate. Instead, FDA states that it expects that the

facility will identify and implement the focused mitigation strategy that is suitable and effective.

The NGFA and NAEGA agree with FDA’s proposed approach in allowing facilities to identify

and implement focused mitigation strategies that are appropriate and effective for their individual

operations. We believe that such flexibility is in accordance with FSMA’s statutory language

and necessary to ensure the success of the mitigation strategy.

Monitoring Requirements:

Proposed §121.140(a) and §121.140(b) would require that the focused mitigation strategies be

subject to written monitoring requirements. FDA does not propose to specify what specific

monitoring activities would be required, nor the monitoring frequency. Instead, FDA proposes

that monitory activities are to provide assurances that focused mitigation strategies are applied

consistently.

In response, the NGFA and NAEGA strongly believe that FDA should not mandate specific

activities that facilities must complete when monitoring focused mitigation strategies to ensure

they are being consistently applied. As such, the NGFA and NAEGA agree with FDA’s

proposal that would provide facilities with the ability to establish and implement appropriate

monitoring activities that reflect the nature of their operations.

Verification Activities:

Proposed §121.150(a) and §121.150(b) would require that the facility verify that monitoring of

focused mitigation strategies is being conducted and that appropriate corrective actions are being

taken. FDA does not propose specific procedures to verify such activities. Instead, the agency’s

proposal provides that facilities are to establish and implement verification activities appropriate

for their operation. In addition, FDA does not propose that the adequacy of the focused

mitigation strategies needs to be validated.

The NGFA and NAEGA agree that FDA should not mandate specific activities to verify the

monitoring of focused mitigation strategies and appropriateness of corrective actions taken. We

believe FDA’s regulations should provide facilities with the flexibility to establish and

implement verification activities that are effective for their individual operations.

The NGFA and NAEGA also agree that FDA should not require that facilities validate the

adequacy of focused mitigation strategies. We believe that establishing a requirement to validate

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focused mitigation strategies would exceed the mandate of FSMA, which provides for flexibility

in the use and verification of controls. Further, we believe that focused mitigation strategies for

food often are not conducive to scientific validation.

Implementation and Effectiveness of Focused Mitigation Strategies:

FDA proposes in §121.150(d)(2) to require that any additional focused mitigation strategies

subsequently identified by a facility be implemented before the change at the facility is operative

or, when necessary, during the first six weeks of production.

In response, the NGFA and NAEGA believe that prescribing a specific time frame for such

activity is arbitrary and does not provide sufficient flexibility to facilities to always complete

effective implementation of focused mitigation strategies. Instead, we strongly recommend that

FDA allow facilities to complete implementation within a reasonable time.

Training of Personnel:

Proposed §121.160(a) would require that personnel and supervisors assigned to actionable process

steps receive appropriate training in food defense awareness and their respective responsibilities in

implementing focused mitigation strategies. FDA states that it tentatively has concluded that

completion of FDA’s training course on Food Defense Awareness for the Front-line Employee,

which takes about 20 minutes to complete, would be sufficient to satisfy this element of the

proposed training requirement. In addition, FDA proposes that training must contain specifics about

the actionable process steps where employees are working and their roles in the proper

implementation of the focused mitigation strategy(ies) applied at those actionable process steps.

In response, the NGFA and NAEGA recommend that FDA’s final regulations provide covered

facilities the flexibility to provide food defense training in a manner that is appropriate and effective

for their own operations. We do not believe FDA should prescribe specific training materials or

establish required training intervals. Instead, each facility should be allowed to design an

appropriate training program and demonstrate its adequacy through the performance of its food

defense plan. In addition, we believe that training on food defense should be necessary only for

personnel responsible for actionable process steps that are part of the facility’s written food defense

plan. We believe that expanding the training requirement to all employees at the facility will not

advance food defense. To the contrary, expanding the training requirement to non-germane

employees runs the risk of creating a more generalized approach that may, in fact, diminish the

ability of the facility to effectively train personnel who have significant roles in assuring required

activities.

Record Requirements – Part 11:

FDA proposes at §121.301 to establish requirements associated with specified records that are to

be created and maintained in accordance with the food defense plan. Significantly, proposed

§121.305(a) also would require that electronic records be kept in accordance with part 11 (21

CFR part 11). Part 11 provides criteria for acceptance by FDA, under certain circumstances, of

electronic records, electronic signatures and handwritten signatures executed to electronic

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records as equivalent to paper records and handwritten signatures executed on paper. However,

FDA also requests comment on whether there are any circumstances that would warrant not

applying Part 11 requirements within the regulation.

The NGFA and NAEGA strongly urge FDA not to apply Part 11 to electronic records that a

facility would be required to maintain under the proposed regulation. As with the Bioterrorism

Act and other cases, such a requirement is disproportionate to the regulatory need, and would

create a tremendous burden and impose excessive costs on the industry. Electronic

recordkeeping systems are used widely throughout all sectors of the food industry to document

and store business-related information. FDA’s proposal would require that numerous and

extensive documents and records be established and maintained. The most efficient and cost-

effective manner in which to establish and maintain such documents and records is with existing

electronic systems in use at facilities. The vast majority of such systems used by industry do not

meet the very stringent provisions detailed in Part 11. As such, facilities would be required to

recreate and redesign their current electronic systems at an enormous cost, or scrap the use of

existing systems and create and maintain records in a paper format. Both of these options

represent an overwhelming expense and burden that is not necessary to ensure compliance with

regulatory requirements or protect against the intentional adulteration of food.

As an alternative, the NGFA and NAEGA recommend that FDA partner with key stakeholders to

develop guidance that describes the kinds of practical principles, protocols and systems that may

be used to ensure the integrity of electronic records without imposing specific technical

requirements that are unnecessary and inappropriate.

Record Retention:

FDA proposes at §121.315 that required records be retained for two years, and that this two-year

time period run either from the date the record was prepared, for day-to-day operational records;

or from the date at which use of the record is discontinued (e.g., the written food defense plan).

FDA proposes to permit use of offsite storage for records after six months following the date that

the record was made if such records can be retrieved and provided onsite within 24 hours of

request for official review. FDA also proposes that the food defense plan would be required to

remain onsite.

The NGFA and NAEGA believe that FDA’s record- retention and location requirements should

specify the agency’s expectations for record availability and allow companies the flexibility to

use appropriate systems for meeting those expectations. At many companies, important records,

such as food defense plans, are retained at corporate headquarters or other central locations – not

at individual facilities. Requiring all records to be kept at individual facilities would be

duplicative and unnecessary so long as they can be produced promptly for official review.

Further, the NGFA and NAEGA believe that the six-month onsite record-retention requirement

is an arbitrary time frame. Instead, we believe FDA should establish a workable requirement

that provides for the efficient storage and retrieval of records in a manner whereby facilities may

make required records available promptly upon request.

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Public Disclosure:

Proposed §121.325 would establish that all records required by the regulation be protected from

public disclosure to the extent allowable under 21 CFR part 20, the Freedom of Information Act.

FDA also states that its general policies, procedures, and practices relating to the protection of

confidential or otherwise-protected information received from third parties would apply to

information received under this rule.

Concerning this issue, the NGFA and NAEGA believe that written food defense plans and

associated records required by regulation fall within the bounds of trade secret or commercial

confidential information and, therefore, should be protected from public disclosure. Such plans

and records will be process- and facility-specific. Therefore, they will contain such information

as facility and equipment design, and processing and monitoring parameters based on product

formulas. Moreover, each facility will have expended considerable time and money to develop

its written food defense plan. Therefore, the NGFA and NAEGA believe that written food safety

plans and associated records rightfully will meet the definition of trade secret or commercial

confidential information.

In addition, the NGFA and NAEGA believe it is in the best interest of public health to protect

written food defense plans and associated records so as to promote the most effective

implementation of its regulation. We believe that FDA reasonably can expect facilities to tailor

written food defense plans in a more comprehensive manner if there is not a concern of public

disclosure.

Finally, we believe disclosure of such plans could provide a “road map” to terrorists or troubled

insiders, to the detriment of public health.

Therefore, the NGFA and NAEGA urge FDA within its final rule to clarify that written food

defense plans and associated records are not subject to public disclosure because they represent

trade secret or confidential commercial information.

Conclusion

The NGFA and NAEGA reiterate their strong support for FDA’s proposed exemption of animal

feed and pet food from the regulation. We believe the proposed exemption represents an

appropriate risk-based approach that is consistent with the authority and limits provided by

FSMA within section 418(m) and section 420(c). In addition, the exemption would alleviate the

need for animal feed and pet food facilities to expend limited resources implementing focused

mitigation strategies that would not serve to negate intentional attacks on the food supply that

have the potential to cause widespread harm to the public.

As previously expressed, the NGFA and NAEGA also strongly urge FDA to clearly exempt

grain handling facilities from its proposed regulation by modifying the definition of “holding”

and “manufacturing,” and by giving appropriate consideration to the fact that food stored at such

facilities is at a very low risk of intentional adulteration, based upon previous assessments in

which FDA participated. We also urge FDA not to subject grain-handling facilities to the

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requirement to implement focused mitigation strategies based upon the storage and handling of

liquid dust suppressants, which are applied to raw grains and oilseeds for their safe and effective

storage. To encompass grain handling facilities within the regulation for such an activity would

not represent a risk-based approach and would not enhance protection of the food supply from

acts of intentional adulteration.

The NGFA and NAEGA appreciate FDA’s consideration of the recommendations expressed in

this joint statement, and look forward to being fully engaged and constructive participants in

future discussions and rulemakings with the agency.

Sincerely,

Randall C. Gordon Gary C. Martin

President President and Chief Executive Officer

National Grain and Feed Association North American Export Grain Association