The Food Safety Modernization Act (FSMA) implementation continues to be the most sweeping food safety reform in over 70 years. The Food and Drug Administration (FDA) has issued several proposed rules. The comment period has not yet ended for most of these.
FDA redrafting provisions
The comment period for two of the most significant proposals for growers - the produce safety rule and the preventive controls rule - ended on November 15, 2013, but the FDA is redrafting four of the key provisions, so growers have another chance to express their points of view on them.
In a statement from December 19, 2013, Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, said, "Everyone shares the goal of ensuring produce safety, but as we said at the beginning of the process, the new safety standards must be flexible enough to accommodate reasonably the great diversity of the produce sector, and they must be practical to implement."
He continued, "To achieve this goal, we believe that significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers. These provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms."
Taylor said the FDA plans to propose revised rule language and give the public the opportunity to provide input. He added, "There may be other revisions to the proposed rules; the scope of the revised proposals, on which we will seek further comment, will be determined after we complete our initial review of written comments." He indicated that the FDA will accept additional comments only on those sections of the proposed rules that have been revised.
As of this writing, there were 18,617 comments on the produce safety rule and 7,992 on the preventive controls rule; many of them singled out these key provisions.
The FDA plans to publish the revised language by early summer 2014. When published in the Federal Register, the comment period will be announced.
The produce safety rule (http://1.usa.gov/1c5bJ9O) proposes requirements for agricultural water, biological soil amendments, health and hygiene, domestic and wild animals, and equipment, tools and buildings, plus special requirements for sprouts. It does not cover produce that is rarely consumed raw. It exempts farms that sell $25,000 or less annually and those averaging less than $500,000 per year with a majority of sales to qualified end users in the same state or within 275 miles.
The preventive controls rule (http://1.usa.gov/1fpfgQX) establishes standards for food facilities. It requires facilities to develop a written food safety plan, including a hazard analysis for each type of food and preventive controls for processes, allergens and sanitation. Monitoring, corrective actions, verification, record-keeping and recall procedures must be part of the plan.
The compliance dates for these rules vary with the farm and facility size. As of this writing, it was not clear how the redrafting of certain provisions would change the dates. The docket number for the produce safety rule is FDA-2011-N-0921; the number for the preventive controls rule is FDA-2011-N-0920.
Hard Hat: Chaowalek Julaketpotichai/shutterstock.com.
As noted, a plethora of comments and suggestions prompted the FDA to redraft four of the rules' proposed requirements.
Both the Produce Marketing Association (PMA) and United Fresh Produce Association (United) questioned the water quality standards and testing in the produce rule. The PMA noted that more research is needed before mandated controls could be imposed. For example, the PMA contended that the body of scientific knowledge is currently inadequate to establish quantitative metrics based solely on the use of generic E. coli as an indicator organism. Furthermore, growers must be able to use updated, improved testing and sampling methodologies as new information becomes available.
United said that the proposal's specific arbitrary metrics, target organisms and testing intervals for irrigation water are not based on sound science and differ from other world regulatory standards. United also noted that because risks differ significantly across different fruits and vegetables, metrics should be addressed in companion guidance tailored to specific commodities and updated when science is better informed.
The National Sustainable Agriculture Coalition (NSAC), reflecting the concerns of sustainable and organic farmers, pointed out the expense of requiring weekly water tests regardless of risk, which would drive small farms out of business.
As proposed, the water standards apply to water that comes in contact with covered produce, which includes irrigation, frost abatement and packing operations. Laboratories must perform tests.
The PMA said that the application-to-harvest interval for treated biological soil amendments of animal origin should not be tied to a specific quantitative standard, but should correspond with the risk of crop contamination based on an individual grower's operational assessment. Further research is needed that can customize the interval based on agroecological growing conditions and practices.
The NSAC said the proposed standards would make it effectively impossible for farmers to use manure, and would create barriers to the use of compost. The nine-month harvest interval for manure in the proposed rule contradicts the federal organic standard of four months. The NSAC added that using chemicals instead of natural soil amendments is against the public interest.
Regarding mixed-use facilities, the PMA said the FDA must align the requirements of the produce safety and preventive controls rules. The PMA cited the example of an on-farm packinghouse, which would be regulated under the produce rule. But if it accepts fruit from a neighbor's farm, it would fall under the preventive controls rule as well. Many in the industry said that proposal is not workable. Since food facilities are required to register and be included in the preventive controls rule, the PMA pointed to the dual, divergent standards for operations with similar risks.
United said that the mixed-type facility definition that compels operations to comply with both rules is overly complicated and not risk-based. Furthermore, it would have severe economic consequences without enhancing public safety.
The NSAC pointed out that the rule fails to clarify that community supported agriculture (CSA) operations are not facilities, so CSAs and other direct-sale businesses would be subject to excessive regulations.
With respect to the withdrawal of exemptions, the NSAC said the proposed rules do not require the FDA to have proof of a problem, and there is no defined way to recover the exemption status once the FDA revokes it.
Other comments include opposition to the qualified exemptions relating to the size of operations, which commenters pointed out is not risk-based. The Fresh Produce Association of the Americas (FPAA) opposes them as well. The PMA said that contamination can occur in any operation that employs unsafe processes and practices. Both the PMA and United questioned the exclusion of produce that the FDA stated is rarely consumed raw. As an example, kale, currently in demand as a raw ingredient in smoothies, is not covered produce in the proposed rule and therefore exempt.
Martha Noble, retired senior policy associate, and Sarah Hackney, grassroots director for the National Sustainable Agriculture Coalition, interact with the audience at an educational program on FSMA for one of their member organizations.
Photos by Bob Ferguson unless otherwise noted.
Many comments suggested that the FDA include associations, commodity boards and other knowledgeable bodies among entities that can request a variance. Alternatives to the requirements that provide the same level of public safety should be available for more of the rules, rather than merely the water and soil amendment requirements.
Comments are accessible at http://www.regulations.gov in the respective rule dockets.
Two proposed rules strengthen the oversight of foods imported for U.S. consumers. Under the proposed rule on Foreign Supplier Verification Pro-grams (FSVP, http://1.usa.gov/1fnDgxZ), importers would be required to verify that imported food has been produced so as to provide the same level of public health protection as that required of domestic food producers. Importers must follow an FSVP, with modified requirements applying to small importers, importing dietary supplements, and importing food from suppliers complying with standards recognized by the FDA as equivalent to those of the U.S.
The requirements include a compliance status review, performance of a hazard analysis and verification activities, and corrective actions. Importers must have a Dun & Bradstreet Data Universal Numbering System number. They must reassess their FSVP within three years and maintain records. Two options for on-site auditing of the foreign supplier are provided, depending on the type of hazard.
The proposed rule on Accreditation of Third-Party Auditors (http://1.usa.gov/MrFVQ5) sets eligibility requirements for recognition as an accreditation body. It can be a foreign government/agency or a private third party. It must meet standards for legal authority, competency and capacity, impartiality/objectivity, quality assurance and records procedures. The bodies must monitor performance, assess and correct any problems, protect against conflicts of interest, maintain records and submit reports to the FDA.
A third-party auditor can be a foreign government, foreign cooperative or other third party. Auditors must meet the same standards as the accreditation bodies.
The FDA intends to implement the accreditation rule as soon as possible after publication of the final rule and after issuing draft model accreditation standards. The compliance date for the FSVP rule would in general be 18 months after publication of the final rule, and would also depend on the compliance dates of the produce safety and preventive controls rules.
The comment period for both of the import rules ended January 27, 2014. However, the FPAA has requested another draft proposal, because these rules interact with the produce safety and preventive controls rules. The docket number for the FSVP proposed rule is FDA-2011-N-0143; the docket number for the accreditation proposed rule is FDA-2011-N-0146.
The proposed rule on Sanitary Trans-portation of Human and Animal Food (http://1.usa.gov/1hPufFE) establishes re- quirements to ensure that food does not become contaminated. These include vehicles and transportation equipment with appropriate design and maintenance, measures such as temperature controls and separation of food and nonfood items, procedures regarding prior cargoes and cleaning, personnel training, written records on the above measures, and procedures for waivers that would not be detrimental to public health.
The goal of the transportation proposed rule is prevention of practices that could create food safety risks. With some exceptions, the rule applies to shippers, receivers and carriers who transport U.S. food by motor or rail vehicle, and also to exporters outside the U.S. who ship food to the U.S. in an international freight container by an oceangoing vessel or in an airfreight container. In general, it does not apply to operations with less than $500,000 in annual sales, transshipped food or food imported for future export, shelf-stable food, compressed food gases, live animals or transportation of raw agricultural commodities by a farm. The PMA's FSMA page (http://www.pma.com/fsma) has explanatory information important to farms.
Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, comments at a hearing on FSMA.
Compliance with the transportation rule is one or two years from final rule publication, depending on the business size. This rule was issued January 31, 2014; the comment period ends May 31, 2014. The docket number is FDA-2013-N-0013.
The proposed rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (http://1.usa.gov/1eCDwzh) requires domestic and foreign facilities to address vulnerable processes to prevent acts intended to cause public harm. This rule requires large food businesses to have a written food defense that addresses significant vulnerabilities. The key facilities the FDA has identified as the most vulnerable include bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing and similar activities.
The exemptions to this rule include those who hold food, except those holding in liquid storage tanks; packing and labeling operations in which the container contacting the food remains intact; activities falling within the definition of "farm"; manufacturers, processors, packers or holders of animal food; alcoholic beverages under certain conditions; and businesses with less than $10 million in annual sales, although documentation may be requested.
The written plan must include actionable process steps, focused mitigation strategies, monitoring, corrective actions, and verification of the monitoring and any corrective actions.
The compliance dates vary from one to three years, according to the business size, after the publication of the final rule. The comment period ends March 31, 2014. The docket number is FDA-2013-N-1425.
Issued on February 4, 2014, the Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of FSMA (http://1.usa.gov/1hgZTZO) requires the FDA to designate high-risk foods for which additional record-keeping requirements are appropriate. This is so such foods can be traced rapidly during a foodborne illness outbreak. The FDA is requesting comments to develop a risk score. The draft outlines various factors used to evaluate food risk. The factors include known safety risks, the potential risk for microbiological or chemical contamination that would support the growth of pathogenic microorganisms, the point in the manufacturing process where contamination is most likely to occur, the likelihood of reducing the contamination, the likelihood that consumption will result in foodborne illness, and the likely or known severity of such an illness.
The pilot project for improving product tracing has been submitted to the FDA by the Institute of Food Technologists. The FDA will develop record-keeping requirements for the high-risk foods.
The comment period ends April 7, 2014. In this particular instance, scientific data and information may be submitted as well as comments, electronically or by mail at the addresses below. The docket number is FDA-2014-N-0053.
How to comment
Comments may be submitted electronically at http://www.regulations.gov. Written comments may be faxed to 301-827-6870, or mailed/hand-delivered to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The appropriate docket number must be on all comments.
New timelines for final regulations
The FDA had been under a court order, which was under appeal, to issue final FSMA rules by June 30, 2015. However, a settlement agreement, announced February 20, 2014, with the Center for Food Safety (CFS) and the Center for Environmental Health has allowed later deadlines.
According to the CFS release, the agreement requires the FDA to issue the regulations with these deadlines: preventive controls rule, August 30, 2015; imported food rules, October 31, 2015; produce safety rule, October 31, 2015; sanitary transportation rule, March 31, 2016; and intentional adulteration of food rule, May 31, 2016.
In its announcement about the agreement, CFS said, "It also removes the upcoming March 2014 deadline for public comment periods, allowing more robust public participation throughout the rulemaking process." The release did not specifically mention the FDA's approach to high-risk foods.
As of this writing, the FDA had not announced any changes to the aforementioned comment deadlines.
The FDA website, http://www.fda.gov/fsma, is continually updated. A subscription service is also available on the site. In addition, major trade associations and organizations such as the NSAC, the PMA and United, plus those that represent commodity groups, keep their members and the public informed with news releases, publications and websites.
The author is a writer/researcher specializing in agriculture.