Southeastern Fisheries Association


Summary of HR 2699; Known as the National Uniformity for Food Act of 2003, HR 2699 was filed in

the House of Representatives by Rep. Burr, on July 10, 2003. The Grocery Manufacturers of America
worked to get the bill introduced. Their stated intention is for uniformity in warning statements on food
labels (i.e., because of California’s Prop 65) but the bill includes many additional sweepingly preemptive
features which invalidates a state’s laws if its law is not identical to the Federal FD&C Act. By adding
‘(6) to Sec. 402 Adulterated Food and adding ‘Sec. 403B Uniformity in Food Safety Warning Notification
Requirements, the bill requires any state or political subdivision’s law to be identical to its federal
counterpart in the Federal FD&C Act regarding adulterated food containing poisonous or deleterious
substances, raw agricultural commodities containing pesticides defined as unsafe, irradiated foods
unless approved, unsafe color additives and food additives, tolerances for poisonous ingredients,
conditions for emergency permit control, suspension of that permit, promulgation of rules, access for
inspection and dietary supplement labeling regulations. Any non-identical state or local law becomes
invalidated 180 days after the enactment of this bill. The bill also preempts a state’s ability to establish
a requirement because of an imminent health hazard unless the state notifies the Secretary of HHS and
the Secretary has not initiated enforcement action. The state must then petition the Secretary within
30 days for an exemption to the federal law or establishment of a new federal standard and then
initiate enforcement action itself.

The bill has the potential to be interpreted very broadly which could invalidate many state laws and
rules and therefore, the programs which get their authority to operate from these laws and rules.
There is no mention of, nor allowance for, local health departments, even those operating under homerule
provisions in their state. Under the strictest interpretation of the bill, states without identical laws
defining adulterated food and warning statements on food labels, including laws governing the rulemaking
process could lose their legal foundation for conducting the FDA Cooperative Programs (Milk
Safety, Shellfish Sanitation and Retail Food Protection) and then not be able to adopt identical federal
regulations if their rule-making process was not identical.

FDA Cooperative Programs: Milk safety, shellfish sanitation and retail food protection are
cooperative programs with states (including local city and county agencies with retail food programs)
carrying out compliance and enforcement activities and FDA providing training/standardization,
oversight and evaluation. All three programs work through a conference body (NCIMS, ISSC or CFP)
for presenting issues, arriving at consensus and developing model codes or ordinances. When
interstate transport of Grade A milk and shellfish occur, the conferences, through MOUs, also provide
for reciprocity of licensing and inspections between states. States adopt these model ordinances/codes
into law and some states rely on state revenues funds and license or permit fees to support the
operation of the program. FDA’s role in the three cooperative programs includes CFSAN’s Division of
Cooperative Programs (Milk, Shellfish, Retail Food and Lab Quality Assurance) which provide
standardization and certification services, evaluations, training and technical assistance to FDA/state
field staff and laboratories. CFSAN’s Cooperative Programs staff also work with foreign countries on
equivalency determinations, laboratory evaluations and program evaluations. OPDF and CVM also
provide input and technical assistance to the Cooperative Programs on milk, shellfish, produce and drug
residues. ORA’s Division of Federal-State Relations, Division of Human Resource Development and
Office of Regional Activities (Regional Specialists) perform training, field standardization, program
evaluation and technical assistance.

survey included milk, shellfish, retail food and feed inspections, investigations, enforcement activities
and samples analyzed. (Survey results available at http://www.afdo.org). While data from all 50
states are available, not all state agencies or all 2900+ local health departments responded to the
survey, making the final reported figures less than the actual by an unknown amount. FDA, through
cooperative partnerships and contracts, leverages limited resources at the federal, state and local levels
to protect the nation’s food supply. Relevant state and local cooperative programs’ data reported in the
AFDO Survey are listed below.

Inspections (2001) – Total 1,916,191
Dairy Plants 7,562     Retail Food Service 1,178,348
Dairy Farms 159,483     Institutional Food Service 51,290
Subtotal 167,045     Retail Food Stores 516,033
                                            Subtotal 1,745,671

BSE Feed Inspections 3,475
Shellfish Firm Inspection 4,784

Special Investigations (2001) – Total 86,716
Foodborne Illness Outbreaks 3,075     Farm Pesticide Residues 472
Tracebacks (Not Recalls) 154     Chemical Residues 7,855
Consumer Complaints 46,019     Disasters &/or Emergency Response 2,816
Shellfish Growing Area Class. 20,870     Food Related Animal Health Matters 204

Enforcement Activities (2001) – Total 129,090
Embargo/Seizure 13,910     Criminal Prosecutions 4,048
Stop Sale 31,546     Warning Letters 36,346
Health Advisories 90     Informal Hearings 1,102
Monetary Penalties 9,878     Other 28,537
License/Permit Revocation 74

Number of Samples Analyzed (2001) – Total 328,065
Food Chemistry 59,991
Microbiology 252,307
Pesticide Residue 15,767
Public Health Impact if State Laws Are Preempted:

General:

Four major states have already determined that this bill will invalidate many of their food safety laws and regulations, leaving wide gaps in the nation’s food safety chain. FDA does not have the staff, authority or budget to step in to provide the same oversight. Large segments of our consuming population will not be protected by any government oversight.

An aging population, new and emerging pathogens, large amounts of imported foods, increasing concern about the security of the food supply and safety of our consumers indicate a need for increased food, milk and shellfish safety, not decreased oversight.

Public confidence in the government’s ability to ensure a safe milk, shellfish and food supply will be eroded.

A significant portion of BSE feed inspections and dairy, seafood and food
manufacturing/processing plant inspections are contracted to state agencies and would not be done if the state’s laws and rules were invalidated because they were not identical to the federal  counterpart.

State and local compliance and enforcement procedures will not be able to remove adulterated and contaminated products from commercial sale thereby endangering the consumer.

There would be no meaningful role for state and local agencies as timely responders to terrorist threats and imminent health hazards when notification and petitioning to the Secretary is required beforehand.

Milk Safety:

The loss of any or all state Grade A milk programs would result in no routine regulatory
oversight of milk production and processing facilities including regulatory inspections,
pasteurization system efficiency testing, sampling and laboratory analysis of raw and processed
products to meet product safety, nutritional and labeling standards.

No reciprocity between states for inspections, sampling, etc. currently under NCIMS would be
possible to facilitate interstate commerce.

Special investigations (recalls, natural disasters, tamperings, foodborne illness outbreaks or
terrorist threats) involving Grade A dairy products would be limited to what FDA could do with
limited staff and less authority, in some cases.

No regulatory monitoring or oversight for animal drug residues in milk could result in increased
antibiotic resistance in human pathogens and allergic reactions to β-lactam antibiotics.

Lack of pesticide residue testing, well water testing and other analyses could result in
adulterated dairy products going to market.

Populations targeted to increase consumption of nutritious dairy products (infants, children,
pregnant women) may in fact consume unsafe food without regulatory oversight.

Without authority to conduct the Grade A milk program, there is a risk of losing the
manufactured milk program as well (unless USDA proposed rules to cover Grade A milk as well).

Shellfish Sanitation:

The loss of any or all state shellfish programs would result in less safe shellfish harvests,
sanitary surveys and classification and decreased or no patrols in shellfish growing areas,
enforcement of illegal harvesting in polluted waters, water quality monitoring, laboratory
analyses including product identification, tagging operations for tracebacks, processing plant
inspections or inspection of shellfish packers and shippers.

If some states have no shellfish inspection program, no reciprocity under the NSSP for states to
facilitate interstate commerce.

Illnesses from typhoid fever, hepatitis A, norovirus, Vibrio vulnificus and Paralytic Shellfish
Poisoning would likely result with decreased oversight of shellfish growing, processing and
distribution. The majority of illnesses associated with shellfish result from problems associated
with the harvest of shellfish.

Salmonella typhi was recently isolated from U.S. shellfish and one recent outbreak of hepatitis A
in a Chinese port city with no shellfish safety program resulted in over 250,000 illnesses.

Retail Food Protection:

The loss of any or all of the 3000 state and local retail food programs would result in no food
service, institutional food service or retail food store inspection, foodborne illness outbreak or
other special investigations, food sampling surveillance, emergency response and state
standardization of local trainers/inspectors.

Highly susceptible populations in institutional facilities would be at increased risk of foodborne
illness with less regulatory oversight of their facilities.

Food service, retail food store and institutional food service establishments are associated with
more than 50% of the identified foodborne outbreaks. Eliminating regulatory oversight
programs for this part of the food chain would cause a huge increase in risk for consumers and
cases of foodborne illness.

Some unique behaviors and unique challenges directly related to foodborne outbreaks that occur
at the retail and food service level (300-400% annual staff turnover, lack of education, language
and cultural barriers, etc.) would not be overcome with Agency inspection at the manufacturing
or processing level.

Sixty seven percent (67%) of the foodborne outbreaks whose cause is known are caused by
viruses such as norovirus and hepatitis A virus, mostly because of risky behaviors by food
employees (lack of or poor hand washing habits; bare hand contact with ready-to-eat foods; ill
employees working with food; etc.).

FDA Legal Base for Cooperative Programs:

While the Public Health Service Act, in 42 U.S.C. 301 (a), gives FDA authority to cooperate with
and assist the states in the shellfish, Grade A milk and retail food programs, the three respective
model ordinances/codes (PMO, NSSP and Food Code) have not been made part of the Code of
Federal Regulations and would therefore, have to, at least, go through the rule-making process
to be enforceable by FDA. This would likely take many years before a final rule could be
published that gave FDA authority to conduct the program as the states had done.

In the meantime, FDA would be limited to enforcement of contaminated/adulterated and
misbranded foods as defined in the Federal FD&C Act in sections 402 and 403, with limited
seizure authority and limited staff.

Potential Impact on the Respective Industries:

Inspection results would no longer be available concerning all shellfish harvest areas, facilities,
products, etc. inspected by the states which provide valuable information to operators about risk
factors that cause foodborne illness.

Consultative services such as plan reviews, equipment reviews, voluntary HACCP reviews, risk
control plans, etc. would not be available to the industry.

Inspection and consultation services by knowledgeable individuals familiar with milk, shellfish
and food safety requirements will only be available through commercial firms at a much higher
cost than regulatory agency fees, such as license/permit fees or inspection fees.

Potential Impact on FDA Infrastructure:

If FDA were to assume the regulatory responsibilities of the 3 cooperative milk, shellfish and
retail food programs at the same level provided by the state agencies prior to preemption, a
vastly expanded infrastructure would be required.

Increased staffing needs to replace all state programs would include field investigators,
supervisory/management staff, administrative support staff and laboratory technicians.

Retail Food program estimates – 5,000 FTEs

Laboratory analyses of milk, shellfish and retail food samples could be accomplished in
expanded FDA lab facilities or contracts with private laboratories or remaining state labs. The
increased capacity would have to replace the following state laboratories responsible for
analyzing more than 328,000 samples annually. Surge capacity in case of outbreaks, disasters
or a terrorist threat must be considered.

Inspection equipment, surveillance sampling and transportation equipment, pasteurizer checks
and other technical aids to routine and special investigations would be required, as well as
computers, printers and other office supplies.

Training for new FDA staff could be accomplished in part through on-line training modules but
would require either experienced field staff or a lengthy field orientation.

Budgetary Resources Necessary to Replace Preempted State Programs:

Budgetary resources necessary to hire approximately 6,850 new staff (under the worst
case scenario where all state/local programs were preempted) could approach $513
million annually including benefits.

The purchase of boats necessary to carry out harvest water sampling, sanitary surveys
and patrols would cost an estimated $10 - 33 million depending on initial cost and
annual maintenance and upkeep.

Motor pool expenses and purchase or leasing a fleet of cars for transportation of
investigators and samples would cost approximately $4.5 – 5 million per year.

Initial expenses for inspection and office equipment could total as high as $50 million.

Buildings and laboratory space would be difficult to estimate without further information.

Submitted by:
Shirley Bohm, Retail Food Protection Team
CDR Peter Pirillo, Shellfish Safety Team
CAPT Richard Eubanks, Milk Safety Team
March 26, 2004