June 30, 2014
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane Room 1061
Rockville, MD 20852Federal Docket: FDA-2013-N-1425, RIN 0910-AG63
Dear Sir or Madam:
Pennsylvania Farm Bureau (PFB) is pleased to offer its comments on the proposed rule, “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.”
PFB is a general farm organization, made up of more than 58,000 members, providing legislative support, information, and services to Pennsylvania's farmers and rural families since 1950. Our organization includes 54 local organizations (county Farm Bureaus) that actively operate in 64 of Pennsylvania’s 67 counties. PFB is the state affiliate of the American Farm Bureau Federation (AFBF), an organization representing more than six million member families throughout the United States.
In addition to the comments we are offering today, we want to affirm our support of any comments to be filed by AFBF on this topic, and would request that such comments be treated as part of the comments contained herein. PFB’s comments on the proposed rule are organized in two parts, with the first focusing on the rule’s potential effects on the dairy industry and the second identifying areas of general concern with the rule.
Comments Related to the Potential Inclusion of Dairy Farms in the Final Rule
First of all, while dairy farms are not covered in the proposed rule, the preamble discusses potentially covering dairy farms in the final rule and requests comments on mitigation strategies. Any issue potentially impacting the dairy industry is of critical importance to Pennsylvania. Dairy farmers play a major role in Pennsylvania agriculture and the state’s economy, generating nearly $2 billion in revenue per year from the sale of milk. Pennsylvania’s dairy farmers rank fifth nationally in the production of milk and rank second in the number of dairy farms with more than 7,000. Dairy farms support the economies of local communities, because on average they spend about 85% of their income locally, helping to support jobs and businesses in those areas.
The risk posed by intentional adulteration on dairy farms should be addressed. However, addressing that risk through the FSMA rulemaking process is not the most effective way of doing so. PFB believes that any new standards for dairy farms should go through the National Conference on Interstate Milk Shipments (NCIMS) process and be implemented through the Pasteurized Milk Ordinance (PMO), rather than by adding requirements for such farms under FSMA.
However, if FDA intends to cover dairy farms in the final rule, any provisions related to such farms should be drafted as separate from other requirements to prevent intentional food adulteration, and should cover dairy requirements in their entirety. Any additional regulation of dairy products should then be subject to a full comment period, as adding a new industry into the final rule would be a significant change which the dairy industry must have the opportunity to review and provide input in response. 2
If dairy farms are included in the final rule, a number of uncertainties would need to be addressed. In its comments, the Pennsylvania Department of Agriculture (PDA) is expected to touch upon several of those uncertainties, including:
• The criteria used to determine which dairy farms would be covered.
• The safety standard that would be applied to dairy farms.
• The probability that dairy processors could be subject to both the preventive controls rule for human food and the intentional adulteration rule.
• The means by which FDA would propose to create an establishment inventory of impacted dairy farms, given that dairy farms are not required to be registered under Section 415 of the federal Food, Drug & Cosmetic (FD&C) Act.
• The inspection frequency that would apply to dairy farms under the intentional adulteration rule (given that those inspection frequency provisions apply only to registered facilities).
• The entity that would be responsible for enforcement.
• The method by which the cost of this rule would be analyzed, including whether or not a new Regulatory Impact Analysis would be conducted.
Given the concerns enumerated above, PFB acknowledges FDA’s recognition that dairy operations are not traditionally facilities as defined in this rule, and that farms typically are not subject to the type of controls epitomized by the Hazard Analysis and Critical Control Point (HACCP) standards. We support the FDA requiring the use of current good manufacturing practices standards to promote food safety, rather than implementing HACCP controls. Dairy producers are already subject to numerous, frequent tests of their product.
General Comments on the Proposed Rule
PFB agrees with the statutory exemption applying to farms, excluding those that produce milk, from this rule. While ensuring food safety is in the interest of all affected parties, PFB believes the highest risk for large-scale public harm does not occur at the farm level. PFB also agrees that those farms covered under the proposed produce rule should be exempt from the proposed intentional adulteration rule, and that an exemption should be provided for on-farm manufacturing, processing, packing, or holding identified as having low-risk production practices when conducted by a small or very small business if such activities are the only activities conducted by the business subject to the proposed preventative controls rule.
Definitions of “Farm” and “Mixed-Type Facility”
PFB notes that under the new Section 420 of the FD&C Act, farms, except those that produce milk, are specifically exempt from the intentional adulteration rule. However, the definition of “farm” and farming activities proposed by FDA is too limited. Section 1.227(b)(3) defines farm as “a facility in one general physical location devoted to the growing and harvesting of crops…Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting...” The definition ignores that farm activities can also include culling, conveying, sorting, waxing, storing, labeling, packing, packaging and shipping of raw, intact produce, and storing can include crop maintenance activities like fumigation, pest control, sprout inhibition and atmosphere control for ripening or ripening inhibition. In short, any normal handling, holding or packing activity performed on raw, intact produce that results in no significant change in the produce shape or structure and creates no significant change in the hazard analysis for the product should be considered consistent with the “farm” definition, and operations that perform only such activities should be covered under the produce safety rules and thus exempt to this proposed rule pursuant to Section 420.
PFB also opposes the concept of a “farm mixed-type facility.” FDA continues to define a “farm mixed-type facility” as an “establishment that grows or harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment be registered as a food facility” (78 Fed. Reg. 78032). The intentional adulteration rule does not apply to farms or those covered under the produce safety rules. However, as proposed, the intentional adulteration rule and the additional regulations proposed in preventive control rules apply to the “non-farm” activities. This leaves farmers with the extremely confusing obligation to determine whether any of their activities are exempt, and what activities trigger the preventive control rules or subject them to this intentional adulteration rule. The distinctions proposed are not readily understandable, and FDA provides no evidence that such divisions promote public safety.
Exemptions Based on Size of Operation
PFB believes that food safety and food danger is size-neutral and all covered producers should meet necessary standards. However, FDA should consider that the financial ability of growers to implement practices and systems to reduce or limit liability should not overburden smaller growers with unnecessary practices that would drive them out of business. PFB believes that food safety regulations should be tailored to the size, type and capacity of the farm.
Records and other documentation should not increase production costs for diversified farm-based operations, most of whom operate as small businesses. PFB members currently maintain a wide variety of records, yet most farms (like many small businesses) do not have the technical or financial resources available to make their record-keeping systems interoperable with government or others in the food chain.
According to USDA’s National Agricultural Statistics Service (NASS), 70 percent of farms have access to a computer, 68 percent own or lease a computer and 40 percent of U.S. farms used a computer for farm business in 2013. NASS also concludes that two-thirds of U.S. farms have Internet access, but some farms still rely on dial-up access. Therefore, if recordkeeping is determined necessary, there must be acceptable, basic alternatives to an electronic format.
Finally, the privacy and confidentiality of individual businesses must be considered in the development of new regulations. Any recordkeeping requirements must be accompanied by assurance that information accessed by federal government authorities in regards to food safety protocols will remain confidential.
PFB is committed to improving food safety in a targeted, scientific, and risk-based manner, and its members look forward to continuing our working partnership with FDA to promote food safety.
Director, Regulatory Affairs