From the FDA docket on preventive food safety controls for fresh produce comes highlights of comments submitted by the Northwest Horticultural Council.

We thank the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (FDA) for the opportunity to share information on the tree fruit industry of the Pacific Northwest and to comment on the development by FDA of possible food safety standards for fresh produce at the farm and packinghouse. Also, our thoughts on cooperative efforts to ensure compliance with such standards, if developed, are being provided.
The NHC:

Role of the good agricultural practice guidelines entitled “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables”:

The “Guide” has become the foundation document for the food safety plans followed by our growers and packers. We find it sound, useful in practice, pragmatic, and understandable. The “Guide” should be retained by FDA as the lead document for those growing and packing fresh fruits and vegetable crops that are not deemed to be of any heightened food safety concern. An actual risk profile indicating the clear public need for the imposition of stricter standards should be required before they are imposed on a specific produce crop.

Standards for domestic and foreign growers and packers:
No federal regulatory food safety standard should be imposed by FDA on American produce growers and packers unless clearly necessary to protect the public health. When such a risk finding—based on a valid scientific assessment—is made, then both domestic and imported foreign product should be subject to the same standard.
However, in terms of fresh fruits and vegetables grown in foreign lands, any risk prevention standard or system would be extremely difficult for FDA to supervise or enforce given the overall
size of the global fresh produce market; its scattered production areas; multitude and diversity of growers; and, the lack of overseas resources at FDA. We would be skeptical about achieving the successful implementation of any required FDA food safety standard for imported produce, especially if grown in Asia, Africa or parts of the less developed world.
Two additional factors tied to this subject this should be considered by FDA: (1) the economic cost to domestic industry of implementing a given food safety measure and the competitive disadvantage that results if that same standard is not implemented and resulting costs absorbed by foreign competitors, and (2) the real risk that governments in current foreign markets for U.S. produce will demand their own on-site inspections and adherence to local food safety rules for produce grown in the United States but shipped abroad. This would result in higher costs and possible export market closures.

On the latter point, certain Washington state orchards that were the source of fresh fruit exported to Mexico received a regulatory oversight visit by three officials of Mexico’s SENASICA during the period June 27 to July 6, 2010. It was the first official food safety visit to individual orchards in our industry and, we believe, prompted by increased U.S. government activities related to food safety within Mexico.

While it is too early to evaluate the practical results of this particular visit, it is clear to our industry that greater and more effective official communication and coordination in terms of new fresh produce safety policies needs to occur between our country and the governments of our major trading partners.

Commercially important foreign inspection issues such as those related to reasonable notification of the time and method of inspection; language to be used (e.g., Spanish or English?); technical food safety standards to be applied; the possibility of the acceptance of equivalency with various existing food safety standards; and clarity on the range of possible penalties for exporting firms that may be in some level of violation need thoughtful and respectful bilateral negotiations.

For its part FDA needs to recognize the need to actively engage its fellow federal agencies, such as the United States Department of Agriculture’s Foreign Agricultural Service and the Office of the United States Trade Representative, in coordinating its mission of ensuring the safety of imported foods while taking into account the reasonable concerns of other countries. Clear lines of responsibility for the handling of the technical trade issues related to produce safety are needed within our own government.

Finally, FDA should identify and then provide an appropriate level of assistance to domestic produce growers faced with responding to on-site food safety inspection demands of foreign governments.

Identification and prioritization of risk factors:

Consideration of risk factors for growing and packing methods should be commodity specific and initially done at the industry level using the best available science as a base and following national guidelines as set by FDA.
Each industry will know best the diversity of growing and harvesting methods, climate conditions, transportation, commercial packing processes, and other factors so intertwined with possible food safety risk.

Where crops are very similar in nature, such as apples, pears, and cherries, they should be considered as one crop grouping, or industry, for purposes of the evaluation of risk factors.

Care should be taken by FDA not to broaden food safety mandates beyond the actual demonstrated need. For example, a regulation developed to address a situation involving a vegetable connected to a public food safety incident should not automatically be extended to tree fruits. Different risk factors may be in play and/or tree fruit growers may have better management of their risks based on existing good practices.

It is also important to recognize that there should be a process in place that serves to identify new risk factors that may emerge over time. Similarly, there should be a process to remove or reduce a risk factor that time shows not as important as first thought or where later effective procedures are developed to remove the threat.
Environmental assessment of hazards and possible pathways of contamination:

?Tree fruit crops, such as apples, pears, and cherries, have a very low food safety risk profile.
? Orchard floors should be kept clear of commercial flocks or herds of grazing animals, such as cattle or sheep.
? Fruit that has fallen to the ground should not be picked up for human consumption.
?Water can be a hazard if coming from any nearby livestock feeding facility or other such contaminated source.
?Traditional harvest equipment is not a contamination worry in orchards. Our fruit is hand-harvested, not by machine. Ancillary harvest equipment such as ladders and picking bags pose no real food safety issue.

Mechanical equipment, such as tractors and bin-loaders, that routinely go into an orchard at harvest require no prior special pre-cleaning before entering an orchard. It must be remembered that harvest occurs in an open environment and is conducted, at times, under adverse weather conditions, with muddy ground not unusual.

?Water in flumes should be clean and monitored.
? Workers who touch fruit need to use and have access to appropriate cleaning facilities.
? Packing line equipment needs regular cleaning.
?Animals need to be actively excluded from buildings where food is stored or handled for processing.

The impact of scale of growing operations on the nature and degree of possible food safety hazards:
We think that if a food safety standard is deemed necessary by the federal government to protect the public health, it should apply to any size of commercial operation—big or small.

Methods to tailor preventive controls to particular hazards and conditions affecting an operation:
While careful consideration should be given by FDA to identifying environmental hazards and possible pathways of contamination specific to each crop, the existing USDA GAP guidance program (based on FDA recommendations)—or the simple adherence by growers to those same voluntary FDA recommendations—has worked for our tree fruit industry, as there simply have been no significant food safety incidents reported involving fresh whole apples, pears, or cherries.

For example, in terms of water:
? Microbial testing of irrigation water may be valid and necessary for crops grown at ground level, while unnecessary for tree fruits.
?Rules should recognize special conditions, like flooding.
?Water from an open irrigation canal, which may run for over a hundred miles, is dynamic and a test at one point in time does not scientifically reflect the overall condition of the water.
?There is no evidence of a public health incident being tied to water used for irrigating the trees of an orchard.

Any FDA rule on testing irrigation water should, therefore, be tailored to exclude tree fruits.
Historical lessons derived by FDA from food borne illness outbreaks of high risk commodities should not be extended to tree fruits.

Possible approaches to tailoring preventive controls to the scale of an operation so that the controls achieve an appropriate level of food safety protection and are feasible for a wide range of large and small operations:

We think the best approach is for FDA to give commercial produce growers and packers helpful general food safety guidance, based on the most current science, while reserving specific regulatory requirements to the narrowest range of actions compatible with achieving reasonable levels of ultimate consumer safety. This targeted approach, based on a risk analysis of individual produce items or crop groupings, will lessen red tape for producers while ensuring that real and significant food safety risks are attended to by industry and government. It will also serve to avoid any artificial distinction between small and large producers in terms of food safety protection.

There is no zero risk. Economics do have to be considered even in food safety.

Coordination of produce food safety practices and sustainable and/or organic production methods:
We do not see any reason why either sustainable or organic production should have any different food safety rules than those employing conventional agricultural production techniques.

If a federal standard is deemed necessary by FDA to protect the public health it should be applied uniformly.
If organic or sustainable agriculture standards are in conflict with any true food safety requirement, then the organic or sustainable agricultural standards should themselves be adjusted to accommodate the serious public health need.

Another point: in the tree fruit part of production agriculture, it is not unusual for a grower to have certain acreage in organic production and other acreage in conventional. It would not make sense to have one orchard be subject to two different FDA food safety mandates.

Coordination of produce food safety practices and environmental and/or conservation goals and practices:
Conservation and environmental practices do not have a direct effect on food safety. While social issues should not be allowed to muddy the science, government does have an obligation to take into account other priorities of our society when assessing the overall value of certain of its food safety regulations. We are not proposing that other priorities or goals be grafted on to food safety regulations: we would strongly oppose this as improper for FDA. We do say that sometimes a secondary food safety point should be trumped by a greater need in another public policy area, such as wildlife preservation.

Our growers take pride in growing premium fruit along the great rivers and aside the towering mountain ranges of the Pacific Northwest. Not only is it not necessary in terms of food safety, it is a violation of the spirit of this landscape to destroy the habitat of wild animals, or wantonly kill animals not posing a significant threat of harm to our fruit.

Federal food safety standards actually requiring such things as the fencing of orchards, mandating clear-cut buffer zones, or prohibiting a grower from having a farm dog’s steady companionship would be abhorrent—in the absence of any clear scientific showing of actual health risk to the ultimate consumers of our harvested tree fruits.

Coordination of produce food safety practices and Federal, State, local and tribal governmental statutes and regulations:
Through the U.S. Constitution’s Commerce Clause, our country benefits from a vital asset—a national market place. Consumers expect safe food from whatever the source. A patchwork of different food safety requirements for the growing and packing of fresh produce is unneeded and would be decidedly unhelpful.
If a food safety measure is required by the FDA for a certain produce crop, this federal measure should preempt any state, local or tribal rule or regulation attempting to cover that same ground.

Having said the above, we are open to the question whether once a standard has been set by FDA, implementation or enforcement work might be done in cooperation with sister federal agencies, such as USDA, or state governments.

Microbial testing:

Microbial testing for human pathogens should not be required by FDA of our growers and packers since to our knowledge, commercially handled whole fresh tree fruits have never been implicated in any significant food safety incident related to human pathogens.

Regulations for testing processed food should not be applied to fresh produce at packinghouses since, with whole fresh apples, pears, and cherries; there is no multiple product mixing/blending, whereby contaminated ingredients might possibly be introduced into the process. And, choosing several pieces of fruit from a packinghouse sorting line to test will never provide adequate assurance that there is no contamination present.

Meanwhile, any mandatory microbial testing would invariably lead to false positives and negatives, directly resulting in unnecessary product destruction and severe economic loss.

If some scientifically-proven system of microbial testing should be developed and ever required by FDA to be used to verify the effectiveness of preventative control measures, it will need to be determined—before general implementation—if such testing is warranted for all types of produce and for all stages of each individual crop’s growing and handling. What might be reasonable for a crop raised at ground level, or in the soil itself, probably would not be reasonable for one grown high off the ground on the limb of a tree.

It should also be pointed out that adding significant costs (for example, those related to sampling, record keeping, and laboratory test fees) and operational complexities, especially at the orchard level, will invariably lead to greater economic pressure on small scale producers leading to more industry consolidation, i.e., fewer but larger orchards.

The potential enormous collective costs to our growers and packers of any FDA required regular microbial testing program at orchards and packinghouses are not justified when weighed against such testing’s probable ineffectiveness in protecting the health of the ultimate consumer.

Post-harvest operations and the role of the current good manufacturing practices in 21 CFR part 110:

Most tree fruit packinghouses have established HACCP plans appropriate for their operations. As indicated in 21 CFR 110.5 close attention is paid to ensure that finished products are moved and packed under conditions that would minimize potential contamination and not render it injurious to health. Though many of the regulations associated with 21CFR 110 are more applicable to processed food, fresh tree fruit packinghouses are cognizant of good manufacturing requirements and employees are trained with food safety in mind.
Records and other documentation that would by useful to industry and regulators in ensuring the safety of produce:

As a practical matter, a commercially workable product traceability system is in place in our tree fruit industry, which requires systematic record keeping by firms.

Aside from this, we do note that the current legal liability system in our country serves to discourage any grower or packinghouse from keeping additional detailed records related to food safety as such records are subject to an intrusive judicial subpoena power at the sweeping command of any private litigator.

It should also be stated that most growers are involved in farming because they want to avoid being clerks, accountants or bureaucrats. Forcing detailed and time consuming food safety record keeping tasks on these people will lead to no good outcome. Only the bare minimum of necessary record keeping requirements should be imposed by the federal government.

EPA and state regulations already require that growers maintain records concerning type of pesticide application; application rates and times; and environmental conditions, such as wind speed. The remote potential of pesticide contamination related to food safety is already adequately and effectively regulated.

Strategies to enhance compliance:

The best strategy for compliance is to have an easily understood regulatory system that is focused on actual and significant food safety dangers. It should be flexible to change, given advances in scientific knowledge.

Voluntary compliance should be the goal. Growers and packers will accept and adopt procedures that are clearly shown to lead to better consumer health. It is in their self-interest to do so. However, they will resist doing things that are viewed as just window-dressing and not related to better consumer health. Our growers will not be convinced of the need to wash their tractors before going into a muddy orchard at harvest.

Education is the means to achieve voluntary compliance. Information presented on the Internet, by food safety officials at grower association meetings, and by county extension agents would all be useful. Federal funds will be necessary to promote this type of broad educational effort over the breadth of the United States and, for produce imports, in supplier countries.

Fines and criminal penalties should be reserved for the most egregious cases. The coercive arm of the state should be sparingly put to use.

Submitted by Christian Schlect, President, Northwest Horticultural Council
July 16, 2010