Issue

H.R. 2749

Current Law

CFBF Reaction

Produce & Other Raw Foods

NOTE: APPLIES TO THE FARM

FDA “shall establish by regulation scientific and risk-based standards for the safe growing, harvesting, processing, packing, sorting, transporting, and holding of those types of raw agricultural commodities …”

·         “that are from a plant or a fungus; and”

·         “for which the Secretary has determined that such standards are reasonably necessary to minimize the risk of serious adverse health consequences or death to humans or animals.”

May set forth such procedures, processes, and practices as the determined to be reasonably necessary …

·         to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards,

·         including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced (including by acts of terrorism) into raw agricultural commodities that are from a plant or a fungus; and

·         to provide reasonable assurances that such commodity is not adulterated

May include, with respect to growing, harvesting, processing, packing, sorting, transporting, and storage operations, standards for safety as FDA determines to be reasonably necessary

·          May include standards addressing

o        manure use,

o        water quality,

o        employee hygiene,

o        sanitation and animal control,

o        and temperature controls,

Would “take into consideration, consistent with public health protection, the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, water shed-protection efforts, and organic production methods.”

HHS may coordinate with the USDA and may contract/coordinate with the agency or department designated by the Governor of each State to ensure compliance with this section.

Proposed Rule 18 months after the date of enactment of this Act, Final Rule not later than 3 years.

No effect on existing HACCP authorities.

NONE

Concerns:

1. H.R. 2749 creates NEW on-farm regulations for produce, tomatoes, melons, and other raw foods.
2. The bill requires FDA to implement regulations setting standards for the growing, harvesting and storage of raw agricultural products, including natural occurring hazards such as mycotoxins.
3. The bill allows FDA to issue overly broad controls that it determines to be “reasonably necessary.”
4. Components of this section are not limited to produce, but extend to any “plant or fungus.”

Requested Action: Strike “growing” and “harvesting” from the bill. FDA should not be granted authority to set farming standards. The vast majority of food safety emergencies occur at the processing level. On-farm regulation is unnecessary, burdensome, and intrusive. Expanded FDA authority would increase costs associated with such an intrusion.

Issue

H.R. 2749

Current Law

CFBF Reaction

Recall

NOTE: Secondary Impact to Farming Operations

If a company refuses to do so voluntarily, FDA would have authority to order a mandatory recall, order companies to cease distribution, and notify the supply chain where food is adulterated or misbranded in such a manner that, if consumed, “may result in illness or injury”

FDA would also be able to take possession of the food. (See Administrative Detention)

Procedures are outlined for hearings on mandatory recall orders. Hearings would be to determine if recall would be needed, but would occur after recall had been ordered.

Failure to comply with a recall order would be a prohibited act, making products deemed misbranded/adulterated.

NONE

NONE

Concern:   FDA would be able to recall a product with only a “reason to believe” that a product is adulterated or misbranded. Under this lowered standard, FDA could issue recall orders without scientific proof.  This would result in high costs to producers from unsold products and decreased demand from perceived dangers.

Requested Actions: 

1. The bill should mandate that FDA indemnify growers and facilities that sustain economic damage from erroneous FDA recalls and quarantines. This would serve as a check on unfettered regulation.
2. FDA should be required to maintain the current standard of “credible evidence.”

See the following Issues: Administrative Detention & Quarantine

Issue

H.R. 2749

Current Law

CFBF Reaction

Traceability

NOTE: APPLIES TO THE FARM

FDA shall by regulation establish a tracing system for food located in the U.S. or for importation into the U.S.

Prior to issuing regulation, FDA would need to establish one or more pilot programs.

The program should include:

·         maintain the full pedigree of the origin and previous distribution history of the food;

·         link that history with the subsequent distribution of the food;

·         establish and maintain a system for tracing the food that is interoperable with the systems established and maintained by other such persons; and

·         use a unique identifier for each facility owned or operated by such person for such purpose, as specified under section 911; and assess—

o        the costs and benefits associated with the adoption and use of such technologies;

o        the feasibility of such technologies for different sectors of the food industry; and

o        whether such technologies are compatible with the requirements of this subsection

Goal of system would be to trace food/products involved in a food safety emergency back to it’s source within 2 business days.

NONE: Within Federal Food, Drug, and Cosmetic Act

Bioterrorism Act requires trace of “one step forward/one step back.” Bioterrorism act currently excludes farms and farm facilities.

Concerns:

1. H.R. 2749 would increase record keeping costs for producers.
2. The proposal far exceeds the current requirement that facilities maintain records to identify the immediate previous source of the products or ingredients.
3. All collected records must be secure, confidential, and private.

Requested Action:  FDA should exempt a food, facility or farm if it is determined that such a tracing system is infeasible or impractical in instances where the costs greatly outweigh the benefits.

Issue

H.R. 2749

Current Law

CFBF Reaction

Inspections

Record Keeping, & Access to Records

NOTE: APPLIES TO THE FARM

If food is adulterated, misbranded, or otherwise in violation of this act (including records), FDA could inspect records and facilities.

If there is a reasonable belief that an article of food presents a threat of serious adverse health consequences or death to humans or animals, FDA may require each person who

• manufactures, processes, packs, transports, distributes, receives, holds, or imports articles of food similar in nature to the emergency to submit records in a Food Safety Emergency after written notification.***

FDA inspects if it has a reasonable belief that a food is adulterated and presents a threat of serious adverse health consequences or death.

FDA is authorized to enact regulations requiring records of immediate previous sources and subsequent recipients of articles of food and their packaging. (while authorized, FDA has not yet done so, according to research)

FDA can inspect records relating to the interstate transport of foods.

Concerns:

1. Expanding the scope of inspections to include farms increases intrusion and removes current farm exemptions (See explanation below).
2. While FDA does not currently have the resources to meet this proposal, we are concerned about implications if/when FDA is granted the resources.

Concerns:

1. Currently FDA is required to have a “reasonable belief” that a product is adulterated and presents a threat of serious adverse health consequences. H.R. 2749 decreases that standard.
2. If a food is adulterated, misbranded, or in violation of the act, inspectors could visit any farm producing that item.

1. FDA should only have access to those records that directly bear upon product safety.
2. FDA should have “credible evidence” prior to accessing records.

Explanation

Currently the Food, Drug, and Cosmetic act only applies inspection and record keeping activities to “any factory, warehouse, or establishment where food, drugs, devises, or cosmetics are manufactured, produced, packed, or held” for interstate commerce. Currently farms and restaurants are specifically excluded. 

HR 2749 would remove the farm exemption, therefore allowing FDA on-farm inspections.

***Records inspection could extend outside of the scope of the supply chain directly linked to a food safety emergency to investigate if the emergency is broader than known.

Issue

H.R. 2749

Current Law

CFBF Reaction

Reportable Food Registry

NOTE: APPLIES TO THE FARM

The bill would mandate who needs to report when they reasonably believes a food is adulterated or misbranded in a manner that “may result in illness or injury to humans or animals” and notify FDA of their concern.

Includes:

• Those who register as a facility that manufactures, processes, packages, or holds food
• Person who owns, operates, an agent of, or someone otherwise responsible for food on a farm
• A person who owns or operates a restaurant or other retail food establishment.
• Importers who are required to register under the act.

Reportable Food Registry applies to the person submitting the registration for a registered food facility and when there is a reasonable probability that an article of food will cause serious adverse health consequences or death.

Concern: This could expand the liability of the farmer and farm employees.

Issue

H.R. 2749

Current Law

CFBF Reaction

Detention of Products

NOTE: APPLIES TO THE FARM

FDA would be provided with administrative detention authority when the agency “has reason to believe” that a food “is adulterated or misbranded.”

FDA would be required to issue an interim final rule implementing this provision.

Detention may be at any level of the supply chain from retail outlets to agricultural producers.

FDA may order the administrative detention of an article of food if an officer (FDA) or qualified employee (FDA) has “credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death.”

Concern: The bill lowers FDA’s standard to only have a “reason to believe” that a product is adulterated or misbranded.

Requested Actions:

1. The bill should mandate that FDA indemnify growers and facilities that sustain economic damage from erroneous FDA recalls and quarantines. 
2. FDA should maintain the current standard of having “credible evidence” prior to detaining products.

Issue

H.R. 2749

Current Law

CFBF Reaction

Quarantine

NOTE: APPLIES TO THE FARM

Permits the FDA to quarantine any geographic location where food is located or from which food originated when there is credible evidence or information that a product presents an imminent threat of serious adverse health effects to humans or animals.

NONE

Concerns:

1. The quarantine authority is broad and far exceeds the authority currently granted to USDA.
2. Unlike USDA, FDA is not required or able to provide any indemnification, whether a quarantine is justified or erroneous.

Requested Action: The bill should mandate that FDA indemnify growers and facilities that sustain economic damage from erroneous FDA recalls and quarantines.

Explanation

If FDA had the quarantine authority and had chosen to utilize it in 2008 – when it erroneously suspected, based on what it believed at the time was “credible information” that tomatoes were a source of salmonella contamination – entire regions of the country could have been quarantined, further decimating a sector of agriculture that already had suffered severe economic damage.

Issue

H.R. 2749

Current Law

CFBF Reaction

Civil & Criminal Fines

NOTE: APPLIES TO ANYONE

Any person who knowingly violates the act with respect to food that is misbranded or adulterated shall be imprisoned for not more than 10 years, fined, or both.

ANY violation of this act shall be subject to a civil penalty for

• Individuals: $20,000/violation not to exceed $50,000/proceeding.
• Any other person (businesses or groups): $250,000/violation not to exceed $1,000,000/proceeding.

Any action that KNOWINGLY VIOLATES this act shall be subject to a civil penalty for

• Individuals: $50,000/violation not to exceed $100,000/proceeding.
• Any other person (businesses or groups): $500,000/violation not to exceed $7,500,000/proceeding.

Each day of violation is considered a separate violation.

Farmers are NOT subject to this penalty.

In the one situation where persons who introduce adulterated food due the presence of pesticides into interstate commerce are liable to civil penalties of $50,000 for an individual, $250,000 for any other person, not to exceed $500,000 in a single proceeding.

If FDA assesses a civil penalty, it may not use its criminal authorities or seizure/injunction authorities.

Violations of the prohibited acts section result in one year imprisonment, a fine of $1000, or both. Repeated violations or violations with the intent to defraud or mislead result in up to 3 years imprisonment or a fine of $10,000, or both.

Concerns:

1. With other changes proposed to H.R. 2749 (including produce standards, record keeping, and inspections), this section would have an adverse affect. 
2. Fines seem excessive to individual violators, considering fees extend to ANY violation of the act, regardless of knowing violation.
3. HR 2749 would likely have an inequitable impact on small businesses and small farms.

Requested Action:  The financial impact of a food safety incident on the producer is incentive enough to put the safest food on the market.  Mounds of additional regulation could result in fines that do little to improve the safety of our food.

Issue

H.R. 2749

Current Law

CFBF Reaction

List of Contaminants

FDA would be required to review and evaluate a list of “food-borne contaminants that have the greatest adverse impact on public health.”

Would issue, through guidance or regulation, science-based performance standards to minimize such hazards.

The standards would be applicable to products and product classes and would not be specific to an individual facility.

Listing is data driven.

NONE

Concern: New regulations would add to the overall costs of certain products deemed high risk by FDA.

Issue

H.R. 2749

Current Law

CFBF Reaction

Facility Registration

NOTE: Under this section farms and farming operations do not fall under the definition of facility

The term facility (for this section) includes “any factory, warehouse, or establishment … that manufactures, processes packs, or holds foods. Such term does not include farms …”

Food facilities, both domestic and foreign, and importers would be required to register with FDA annually.

The information required as part of registration would be expanded. 24 hour emergency contact person required.  Registered facilities would also need to conduct a Hazard Analysis and prepare a Food Safety Plan.

Each registered facility and importer would have a unique registration number.

FDA would have the authority to suspend a facility’s registration for any violation of the act that could result in serious adverse health consequences or death, or if the facility “delays, limits, or denies” an inspection; must be preceded by opportunity for an informal hearing; process for reinstatement and appeals.

Facilities Not Registered would be considered outside of compliance and products classified as adulterated & misbranded.

Each facility would be assessed a $500 fee (per location) up to $175,000 for owners of multiple facilities.

Requires initial registration of food facilities, both domestic and foreign; requires that registration be updated within 60 days of any change to any of the required information previously submitted; no required re-registration at designated interval

Concerns:

1. H.R. 2749 would allow FDA to suspend facility registrations for violations “that could result in serious adverse health consequences or death to humans or animals.” This opens the door for FDA to shut down a business based on little or no scientific consensus. 
2. H.R. 2749 requires FDA to impose fees to fund the agency’s mission, with no basis to justify the fees and no constraints on FDA expenditures. The facility is not lonely paying the fees but is also paying for the costs associated with regulatory compliance.

Issue

H.R. 2749

Current Law

CFBF Reaction

Hazard Analysis

NOTE: Under this section farms and farming operations do not fall under the definition of facility

The term facility (for this section) includes “any factory, warehouse, or establishment … that manufactures, processes packs, or holds foods. Such term does not include farms …”

Each registered facility would be required to conduct a hazard evaluation to identify known or reasonably foreseeable hazards,” including “biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, and unapproved food and color additives,” “hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced by acts of terrorism” as well as hazards for which performance standards have been established, and implement preventive controls (including at critical control points, if any) to minimize or prevent the identified hazards.

Preventive controls expressly include the

following controls:

• Sanitation
• Training
• Environmental controls
• Allergen controls
• Recall contingency plan
• Supplier verification activities

FDA could establish preventive controls

for specific product types.

Each facility would be required to monitor the controls; establish corrective actions; maintain records of monitoring, instances of nonconformance, and corrective actions taken; and verify that the plan is working.

The results of the hazard evaluation and identification of preventive controls would be required to be written into a Food Safety Plan and made available to FDA during an inspection.

This plan would include the following:

·         the hazard analysis;

·         the preventive controls;

·         validation that such controls are effective;

·         monitoring, inc. sampling & testing plans;

·         extensive recordkeeping, including evidence of corrective actions, sampling and testing, monitoring and verification records, and validation records;

·         recall procedures;

·         traceback procedures;

·         supply chain management procedures; &

·         procedures to implement the performance standards.

The plan would need to be reanalyzed if there is a reasonable potential for a new hazard or a significant increase in a previously identified hazard, or at least every 2 years, or at FDA’s direction.

There would be no limitation on the agency to revise, issue, enforce product or category specific regulations such as existing HACCP programs.

Failure to comply with this section would

be a prohibited act.

NONE

Concerns:

1. What effect would hazard analysis have with on-farm production practices? While the analysis is not directly applied to farms, this provision could feasibly extend to the farm in applying preventative controls.
2. The bill would authorize FDA to authorize “cookie cutter,” facility specific preventative controls and the procedure would be accomplished through “guidance documents” rather than traditional notice and comment rulemaking procedures. 

Issue

H.R. 2749

Current Law

CFBF Reaction

COOL

NOTE: Secondary Impact to Farming Operations

Products would be considered misbranded:

• In the case of a processed food, if the labeling of the food fails to identify the country in which the final processing of the food occurs.
• In the case of nonprocessed food, if the labeling of the food fails to identify the country of origin of the food.

Would be required “Not later than 180 days after the date of the enactment of this Act”

NONE (Under FFDCA)

Customs Law

Nearly every item imported into the U.S. must indicate to the ultimate purchaser its country of origin, except agricultural products, including produce, nuts, meat, and fish, that are offered for sale to the ultimate purchaser in their natural state (not processed) and in bulk (not in retail packages).

Agricultural Marketing Act

Requires retailers to notify their consumers of the country of origin of certain covered commodities: fruits and vegetables, peanuts, fish and shellfish, and beef, lamb, and pork. Covered commodities that are ingredients in “processed food items” are exempt.

Concern: The bill requires all non-processed products to be identified by country of origin. While Farm Bureau supports COOL, the labeling function is not intended as a food safety tool.

Requested Action: This section as written should be removed from the bill due to the extreme potential costs, especially as it affects ingredients from numerous sources.