FDA on the close of GAPs comment period

I asked Sebastian Cianci of FDA about the Dec. 31 close of the comment period on revisions to fruit and vegetable GAPs guidelines. Here is his response:

On Sept. 2, 2008, FDA posted a request for comments on the Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables. This document is available through www.regulations.gov (http://tinyurl.com/7nte52). Under Good Guidance Practices, comments on guidance may be submitted at any time. However, FDA requested comments by December 31, 2008 to ensure receipt in time for consideration. FDA received 22 unique comments from 21 organizations and individuals. All comments are currently under review, as possible improvements to the Guide are considered.

Dec. 31 deadline - GAP comments roll in

It is the last day the FDA is accepting comments on revisions to Good Agricultural Practices, and naturally the docket is overloaded with last day submissions. Check out the federal docket here.

So far, comments from PMA, United Fresh, California Citrus Quality Council, Association of Food and Drug Officials, Scott Horsfall, Chris Schlect, Russell Land, Florida Department of Agriculture and Consumer Services, the National Potato Council and James Gibbons.

Here is a link to a file I put together analyzing responses from various group about question #1 from the FDA, regarding ranking of risks in the revised GAPs/GMPs document.

GAPs - A threat to small and midsize farms

Here is a comment submitted for the rulemaking related to GAPs for fruits and vegetables. As the comment indicates, there is concern about the impact of GAPs going forward relative to the sustainability of small and mid-size farms...

There is not doubt that food safety is of paramount importance to Compass Group.

At the same time, I am concerned that the proposed GAP standards are not scale neutral and may undermined the future for small and midsize family farms, especially who have adopted environmentally sound production practices. As they stand, the standards encourage adverse environmental impacts (e.g. farmers tearing out buffer strips to reduce wildlife habitat and adding toxic agents to waterways to reduce the number of frogs that might jump into their fields). They also have the potential to further concentrate production in the hands of a diminishing number of very large players, thereby amplifying the scope and magnitude of the problem when food safety problems occur.

As a major buyer we are committed to grow our Buy Local purchasing initiative that would include the support of regional family farms where we do business. Our first preference is be to partner with farms who have adopted environmentally sound production practices. I would like to see a regulatory framework that actually achieves real food safety without creating barriers for small and mid-size growers and without undoing years of sustainable practices.

Marc Zammit, Vice President Corporate Sustainability Initiatives, Compass Group

United Fresh: Extend GAPs comment period

The United Fresh Produce Association has asked the FDA to lengthen its comment period on revisions to Good Agricultural Practices. From www.regulations.gov:


November 25, 2008
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
Re: Docket No. FDA–2008–N–0455
Dear Sir or Madam:
The United Fresh Produce Association appreciates the opportunity to respond to FDA’s request for comments on potential revisions to the 1998 Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (GAPs).
The 1998 GAPs guidance has served the fresh produce industry well. In the decade since its publication by FDA, it has formed the basis of dozens of food safety educational and auditing programs. Its effectiveness is also apparent in the safety of the vast majority of fresh produce commodities that have never been linked to a foodborne illness. While we agree that the guidance can be updated to incorporate learnings from the 10 years since it was written, any changes should not be considered lightly. FDA has asked important questions in the Federal Register notice, and the answers to those questions must be considered across the diversity of commodities, growing regions and growing practices that make up “fresh produce”.
United Fresh Produce Association has been actively soliciting input from our member companies and allied associations. However, the industry is still dealing with the impact of the Salmonella Saintpaul outbreak linked to fresh produce this summer, as well as the harvest season that much of the U.S. fresh produce industry experiences this time of year.
Therefore, we respectfully request that FDA extend the comment period for 90 days (until March 31, 2009), so that the industry can provide the carefully considered answers and data that FDA has asked for.
United Fresh Produce Association is the pre-eminent trade association for the produce industry in managing critical public policy issues; shaping legislative and regulatory action; providing scientific and technical leadership in food safety, quality assurance, nutrition and health; and developing educational programs and business opportunities for members to better meet consumer needs for increased consumption of fresh produce.
Founded in 1904, United Fresh represents the interests of member companies from small family businesses to the largest international corporations throughout the global fresh produce supply chain, including growers, shippers, fresh-cut processors, wholesalers, distributors, retailers, foodservice operators, industry suppliers and allied associations.
Sincerely,
David E. Gombas, Ph.D.
Senior Vice President Food Safety and Technolology
United Fresh Produce Association

Outbreaks associated with produce 1996-2007

Publishing supporting documentation to rulemaking relating to revision of the 1998 good agricultural practices for fresh produce, the FDA added to the docket the history of produce related outbreaks that have documented since 1996. Find it here in the Fresh Produce Discussion Group. This lists all outbreaks, not just those related to leafy greens that food safety lawyer Bill Marler shared earlier.

Public comment: GAP guidance

Comments aren't due until Dec. 31, but the first opinions are arriving in the federal docket about the notice announcing possible FDA revisions to Good Agricultural Practices. This comment is from an anonymous student.


The FDA has created three guidance documents for the best practices of handling fresh produce, too much latitude has been given in the area of irrigation water testing and safety. In the guidance document, Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, the FDA identifies the sources in which water supplies can be contaminated, but does not require or insist on regular basic testing of fecal coliform, caused by poor sewage or animal contamination which is the most common cause of microbial contamination. Under the Clean Water Act, specific testing for fecal coliform has been mandated to ensure the safety of clean drinking water. However, the same contaminates have been directly linked to microbial foodborne illnesses outbreaks within the Untied States directly tied to contaminated irrigation water supplies. There needs to be a review of the exclusion within 21CFR 110.19 that specifically excludes agricultural handlers to eliminate the storage of fresh produce in unsanitary conditions. Contaminated irrigation water being the unsanitary conditions presented and not regulated. The Clean Water Act is too specific and should not be implemented on agriculture water supplies some of the basic testing of fecal coliform should be addressed and mandated to ensure the safety of fresh produce at its source, the farm or harvesting location.

On FDA GAPs revisions - the questions

The planned update and revisions to FDA's Good Agricultural Practices guidance bring to mind several questions as the industry prepares to engage again with the agency.

Here are the questions that FDA has asked in their notice of rule making:

FDA Question#1:. Should any future GAPs/GMPs Guide rank or prioritize among potential issues according to relative risk or importance? If yes, please offer suggestions of how that information could be presented in a way that does not detract from the broad scope of the current guidance.


TK: Tom Stenzel of United and Hank Giclas of Western Growers note that the response to this question will be important, for the agency may create interventions or guidance on the basis of industry responses. Whereas the current guidance may be considered "generic" in some respects, the agency may want more specifics:

Hank Giclas said this to me about the FDA update:

"I would anticipate - especially given the fact that FDA is looking at third party accreditation and looking at the breadth and scope of how GAPs are implemented ... and from a leadership perspective, they are calling for authority to issue mandatory GAPs, I would anticipate there will be a move to make the guidelines more specific in many areas."


Tom Stenzel said this about this question:

"Is there a way to rank the relative risk. That's a good question. That (risk question ) targets toward regulatory action or some kind of intervention takes place if there is consensus."



FDA Question #2 : How should the GAPs/GMPs Guide be organized to enhance its usefulness?


FDA Question #3: While the GAPs/GMPs Guide has been generally accepted and widely adopted, we know that there are entities in the fresh produce industry that are not aware of it. What measures can be taken,and by whom, to expand awareness by the fresh produce industry of the GAPs/GMPs guide?

Tom Stenzel says:

"To me that i is just a clear signal that if we can't say 100% of the industry is complying with basic GAPs, does it it call for mandatory regulation?. There are some hooks in their questions. So we will have to be careful and scientific in how we respond to those."


FDA Question #4: How should the GAPs/GMPs Guide be modified to motivate all operations to implement? Please include information on economic impact.


TK: A leading question...making them mandatory, perhaps?



FDA Question #5: Can the GAPs/GMPs Guide be applied equally to, and implemented by, domestic and foreign growers and packers? if not, should the GAPs/GMPs Guide be revised to incorporate additional options or special considerations (e.g., utilizing draft animals for agricultural tasks) for application and implementation?

TK: For example, can the Amish use horse-drawn wagons at harvest and be in compliance?


FDA Question: #6: Is there a need for additional guidance to assist an operator in determining which provisions of the current Good Manufacturing Practice regulations (e.g. post harvest water quality, disease control, cleanliness and supervision) could be implemented voluntarily for operations that currently are excluded under Sec. 110.19? If so, which ones?


TK: End of the exclusion for GMP compliance for whole produce packers?


FDA Question #7 Should the GAPs/GMPs Guide recommend that growers and other relevant operations develop a written food safety plan, written SOPs, and/or written SSOPs? If so, please describe the types of information or recommendations that you believe would be helpful.


FDA Question #8: Records can be divided into the following two broad groups: 1) records to facilitate traceback, and 2) non-tracebook or operational records. Does the GAPs/GMPs Guide provide sufficient recommendations regarding record keeping? If not, please describe what would be most helpful and why.


TK: Traceability rears its head again.


FDA Question #9 The recent produce safety initiatives concerning leafy greens and tomatoes highlighted the importance of performing environmental assessments before planting, throughout production and prior to harvest. Would it be useful to enhance coverage of thee concepts in the GAPs/GMPs guide?

TK: Can science based numbers be established for environmental assessments?
.
FDA Question # 10. Several newer produce safety programs, such as the California Leafy Green Products Handler Marketing Agreement (Ref. 8), incorporate recommendations (or requirements) for microbial testing. Does the information on microbial testing in the GAPs/GMPs Guide provide sufficient information?

FDA Question # 11. Some comments submitted in connection with the 2007 public hearings expressed concerns that field management activities intended to minimize microbial hazards, such as removing vegetation to reduce animal harborage near the production field, could have a negative, albeit unintended, impact on the environment and water sheds, among other areas. What data support these concerns? Could/should the GAPs/GMPs Guide do more to identify, address, and possibly mitigate unintended environmental consequences of food safety measures?

FDA Question # 12. Are there existing regulatory requirements at the Federal, State, or local level that act as a disincentive (or as an incentive) for growers or other operators to implement agricultural or manufacturing practices that should be taken into consideration when updating this guidance to reduce the risk of microbial contamination of fresh produce? If yes, please identify and explain.

What's old is new again

The FDA's notice about its intent to update 10-year old Good Agricultural Practices is found here. There is a lot to cover in that document so I may take it by sections. Meanwhile, let's reflect on what Packer legend Larry Waterfield wrote in the paper 11 years ago when the first round of GAPs was being readied. Deja vu all over again...





From November 1997.....

Ideas cover broad range FDA proposals could lead to more control over produce industry.
By Larry Waterfield
Washington, D.C., Editor
ARLINGTON, Va. -- The federal government's forthcoming voluntary guidelines for the produce industry will touch every aspect from the field to the receiver and could mean more stringent controls on imported produce and even so-called ``traceback'' mechanisms.
The aim of federal agencies, led by the Food & Drug Administration, is to have draft proposals ready by Dec. 1, with proposed guidelines prepared by late January and final guidelines in place by June.
FDA officials plan to put guidelines in place in 1998 for high-risk fruits and vegetables, which have yet to be named.
At a meeting Nov. 17, which involved federal agencies, a government panel on microbes in food and produce industry representatives, the agency officials pointed out that the guidelines, which are being referred to as ``the Guide,'' will be voluntary. But several industry officials said receivers and retailers are likely to latch onto the guidelines and require suppliers to follow the government guidance.
The next move in the process will be a series of seven public meetings across the country to get input from the produce industry. One meeting will deal with international produce safety issues. Those meetings begin Dec. 1 in Grand Rapids, Mich.
Those attending the Nov. 17 meeting got a preview of what may be in the proposed guidelines. They will deal with water quality, irrigation water, the use of manure in production, field sanitation, packinghouse sanitation, storage, cooling, refrigeration, handling, bins and packaging, packing lines, worker sanitation and transportation. The guidelines will be in the form of Good Agricultural Practices and Good Manufacturing Practices, referred to as ``GAPs and GMPs.''
The agencies are considering calling for anyone who handles produce from the field through the distribution system to wear disposable gloves. Guidelines may call on producers to make special efforts to divert deer and other wildlife from fields and orchards.
Companies may be asked to implement personal hygiene training programs for workers at all levels.
Methods to trace produce back to its source are likely to be a part of the guidelines as a way to limit any outbreaks of foodborne illnesses.
``These proposals represent our current thinking,'' said Thomas Gardine, director of the FDA's division of imports and a key official implementing the President's Produce Safety Initiative.
At the industry-government meeting the scope of the initiative began to emerge. Several Cabinet departments, 12 federal agencies and thousands of inspectors and government workers will be involved at the federal and state levels. The USDA will involve about 6,000 of its Extension Service personnel, plus researchers. A representative of the National Association of State Departments of Agriculture said the states have several thousand employees who are ready to take part.
On imported produce, officials are calling for more border surveillance and screening. The bill, the Safety of Imported Food Act of 1997, gives the FDA the authority to make sure foreign food safety systems match those in the United States, and it gives the agency power to block imports if inspectors are denied access to foreign facilities.
``There is no evidence that imported fruits and vegetables are more likely to be contaminated than domestic produce,'' said Lee Frankel, president of the Fresh Produce Association of the Americas, Nogales, Ariz., which represents importers of Mexican produce.
He warned that U.S. safety inititatives must treat imported produce fairly and equally and that the rules or guidelines must be in accord with international trade agreements under the World Trade Organization and must not interfere with U.S. trade obligations.
He cautioned officials not to make ``prejudicial statements'' that imply that foreign produce is not safe to eat when traveling in those countries and that indicate the imports may not be safe.
He said ``these officials show lack of knowledge and understanding of the farming, harvesting, packing and shipping processes.''
He said he is concerned that the ``guidance'' will focus on imports and will allow U.S. inspectors to block imports but will not treat U.S. produce the same under ``voluntary'' guidelines.
He urged the officials to hold a fact-finding meeting in Mexico or on the border and to come to Mexico to see practices.
Stacey Zawel, director of science and regulatory affairs at the United Fresh Fruit and Vegetable Association, Alexandria, Va., urged the government to recognize that produce is unlike other food industries and is made up of many diverse industries.
She pointed out that there are many gaps in the knowledge about microbial contamination of produce. She said the Industrywide Guidance, developed by 20 produce groups, focuses on the most critical microbial issues.
``A failure to bring focus to the microbiological food safety issues will squander scarce resources and dilute the effectiveness of our efforts,'' she said.
Fred Shank, director of the FDA's Center for Food Safety and Applied Nutrition, said there are funds available under the President's Initiative to carry out research into microbial contamination of produce.
Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, which she said represents more than a million U.S. and Canadian consumers, called for mandatory HACCP rules for the produce industry.
``CSPI urges the Clinton administration to mandate HACCP systems for the produce industry rather than guidelines,'' she said. ``Guidelines will not address the problems of the domestic industry, and they will be unenforceable internationally.''
She said the goal must be to ``identify and eliminate the sources of contamination for fruits and vegetables.''

GAP Mental Modeling

Luis of the Fresh Produce Industry Discussion Group caught (Do you think you know GAPs or you only fooling yourself?) a recent notice in the Federal Register that's worth comment. It sounds as if the FDA is seeking to understand how growers comprehend Good Agricultural Practices. Or more precisely, why they don't; "There is evidence that growers have not fully implemented GAPs to reduce production risk, despite intensive GAPs training programs." From the Federal Register notice:


Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed study entitled ``Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices.''
Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices.

The proposed information collection will help FDA protect the public from foodborne illness by increasing the agency's understanding of how farmers and growers use Good Agricultural Practices (GAPs) to address common risk factors in their operations and thereby minimize food safety hazards potentially associated with fresh produce. Fresh fruits and vegetables are those that are likely to be sold to consumers in an unprocessed or minimally processed (i.e., raw) form and that are reasonably likely to be consumed raw. Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393 (b)(2)), FDA is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the Nation's food supply. Under Title 42 of the Public Health Service Act (1944), FDA has authority to act to protect the public health.
In 1998, FDA issued a guidance document entitled ``Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' available at http://www.cfsan.fda.gov/~dms/prodguid.html. The guidance addresses microbial food safety hazards and good agricultural and good management practices common to the growing, harvesting, washing, sorting, packing, and transporting of most fruits and vegetables sold to consumers in an unprocessed or minimally processed (raw) form.
There is evidence that growers have not fully implemented the GAPs to reduce production risks, despite intensive GAPS training programs. FDA is planning to conduct a study to determine growers' decision- making processes with regard to understanding and implementing GAPs on the farm, to more fully understand the barriers and constraints associated with GAPs implementation.
The project will use ``mental modeling,'' a qualitative research method wherein the decision-making processes of a group of respondents (described below) concerning the implementation of GAPs on the farm are modeled and compared to a model based on expert knowledge and experience in the implementation of GAPs. The information will be collected via a telephone interview concerning the factors that influence the perceptions and motivations related to the implementation of GAPs. A comparison between expert and consumer models based on the collected information may identify ``consequential knowledge gaps'' that can be redressed through information campaigns designed by FDA.
Description of respondents:
Respondents will be farmers or growers, GAPs trainers, and retail buyer and/or grower association representatives.
The study will involve approximately 60 respondents, including 24 farmers or growers of fruits and vegetables, 24 GAPs trainers, and 12 retail buyer or grower association representatives. FDA will also conduct a pretest using 9 respondents.