FDA considers simplifying agricultural water standards under the FSMA produce safety rule

In response to industry feedback, the FDA is considering the simplification of the microbial quality and testing requirements for agricultural water established by the Food Safety Modernization Act’s (FSMA’s) (P.L. 111-353) produce safety rule while still protecting public health.

The FSMA’s produce safety rule (80 FR 74353) establishes two sets of criteria for microbial water quality of agricultural water, both of which are based on the presence of generic E. coli, which can indicate the presence of fecal contamination:

  • No detectable generic E. coli are allowed for certain uses of agricultural water in which it is reasonably likely that potentially dangerous microbes, if present, would be transferred to produce through direct or indirect contact. Examples include water used for washing hands during and after harvest, water used on food-contact surfaces, water used to directly contact produce (including to make ice) during or after harvest, and water used for sprout irrigation. The rule establishes that such water use must be immediately discontinued and corrective actions taken before re-use for any of these purposes if generic E. coli is detected. The rule prohibits use of untreated surface water for any of these purposes.
  • The second set of numerical criteria is for agricultural water that is directly applied to growing produce (other than sprouts). The criteria are based on two values, the geometric mean (GM) and the statistical threshold (STV). The GM of samples is 126 or less colony forming unit (CFU) of generic E.coli per 100 mL of water and the STV of samples is 410 CFU or less of generic E.coli in 100 mL of water.

If the water does not meet these criteria, corrective actions are required as soon as is practicable, but no later than the following year. Farmers with agricultural water that does not initially meet the microbial criteria have additional flexibility by which they can meet the criteria and then be able to use the water on their crops. These options include, for example:

  • Allowing time for potentially dangerous microbes to die off on the field by using a certain time interval between last irrigation and harvest, but no more than four consecutive days.
  • Allowing time for potentially dangerous microbes to die off between harvest and end of storage, or to be removed during commercial activities such as washing, within appropriate limits.
  • Treating the water.

The produce safety rule bases testing frequency on the type of water source (i.e. surface or ground water).

Testing Untreated Surface Water

In testing untreated surface water that is directly applied to growing produce (other than sprouts), the FDA requires farms to do an initial survey, using a minimum of 20 samples, collected as close as is practicable to harvest over the course of two to four years. The initial survey findings are used to calculate the GM and STV (these two figures are referred to as the “microbial water quality profile”) and determine if the water meets the required microbial quality criteria.

Testing untreated ground water

For untreated ground water that is directly applied to growing produce (other than sprouts), the FDA requires farms to do an initial survey, using a minimum of four samples, collected as close as is practicable to harvest, during the growing season or over a period of one year. The initial survey findings are used to calculate the GM and STV and determine if the water meets the required microbial quality criteria.

For untreated ground water that is used for the purposes for which no detectable generic E. coli is allowed, the FDA requires farms to initially test the untreated ground water at least four times during the growing season or over a period of one year. Farms must determine whether the water can be used for that purpose based on these results.

Testing public water supplies

There is no requirement to test agricultural water that is received from public water systems or supplies that meet requirements established in the rule (provided that the farm has public water system results or certificates of compliance demonstrating that the water meets relevant requirements), or if the water is treated in compliance with the rule’s treatment requirements.

Industry feedback

The feedback that the FDA has received in response to the produce safety rule is that some of these standards, which include numerical criteria for pre-harvest microbial water quality, may be too complex to understand, translate, and implement. These factors can be important to achieving high rates of compliance.

FDA response

In response to these industry concerns, the FDA is considering how it might simplify the water standards. The FDA indicates it intends to work with stakeholders as these efforts related to the water standards proceed.

 

FDA considers establishing a new ‘Office of Patient Affairs’

The FDA announced that it is establishing a public docket to solicit public input on ongoing efforts to enhance mechanisms for patient engagement at the agency. In addition, to achieve a more transparent, accessible, and robust experience for patient communities, the FDA is considering establishing a new Office of Patient Affairs.

On November 4, 2014, the FDA established a docket (FDA-2014-N-1698) for the public to submit information related to the FDA’s implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144), Patient Participation in Medical Product Discussions under FDASIA section 1137.

Based on the comments received, the FDA identified objectives for its patient engagement activities. First, to develop a nuanced understanding of the patient experience of disease by: (1) gathering patient perspective on what is clinically meaningful; (2) assessing attitudes towards benefit-risk and tolerance of uncertainty; and (3) enhancing the science of eliciting and integrating patient input.

Second, to support patients and their advocates in understanding regulatory processes and navigating the FDA by: (1) communicating relevant FDA positions, procedures, and activities; (2) connecting patients and their advocates with the appropriate resources; and (3) resolving discrete challenges and needs.

To achieve these objectives, the FDA is considering establishing a central “Office of Patient Affairs.” The responsibilities of this central office would include:

  • offering a single, central entry point to the FDA for the patient community;
  • providing triage and navigation services for inbound inquiries from patient stakeholders;
  • hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with the FDA by patient stakeholders and the FDA’s relationships with patient communities; and
  • developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.

The Office of Patient Affairs would be directly accountable to the medical product Centers. A regular evaluation of this central office and of FDA’s overall patient engagement efforts are also proposed.

 

 

Fish advice issued for women and parents of young children

Fish and shellfish provide protein, are low in saturated fat, are rich in many micronutrients, and provide certain omega-3 fatty acids. However, as a result of natural processes and human activity, fish also contain mercury in the form of methylmercury. Methylmercury can adversely affect the central nervous system, particularly the developing brain of the fetus. As a result, women who are pregnant or may become pregnant, as well as breastfeeding mothers and parents of young children, need information to make informed choices when it comes to fish that are healthy and safe to eat.

In June 2014, the FDA and the U.S. Environmental Protection Agency (EPA) jointly released a draft update to a March 2004 document entitled “What You Need to Know About Mercury in Fish and Shellfish.” The agencies have now announced revised fish advice that contains advice and supplemental questions and answers for those who want to understand the advice in greater detail. The fish advice contains a reference chart that sorts 62 types of fish into three categories:

  • Best Choices (36 types of fish)
  • Good Choices (19 types of fish)
  • Choices to avoid (7 types of fish: King mackerel, Marlin, Orange roughy, Shark, Swordfish, Tilefish (Gulf of Mexico), and Tuna (bigeye))

The reference chart suggests that women of childbearing age (16-49 years old), especially pregnant and breastfeeding women, and parents and caregivers of young children should observe the following guidelines:

  • Eat two to three servings of fish a week from the Best Choices list or one serving from the Good Choices list.
  • Eat a variety of fish.
  • Serve one to two servings of fish a week to children, starting at age two.
  • If you eat fish caught by family or friends, check for fish advisories. If there is no advisory, eat only one serving and no other fish that week.

The recommended serving size for an adult is four ounces. For children age four to seven, the recommended serving size is two ounces.

How were fish categorized?

The agencies note that they took a cautious and highly protective approach in determining which fish belonged in each category. They calculated how many servings the average pregnant woman could eat in a week using information on mercury content of each fish type from FDA’s database for commercial fish and other sources. If she could eat that fish at least three times a week, then they listed it in the “Best Choices” category. If she could eat that fish only once a week, or twice but not three times a week, then they listed it in the “Good Choices” category. If she could not eat a serving of that fish once a week, then they listed the fish in the “Choices to Avoid” category.

Why are some fish in more than one category?

The agencies explain why tuna and tilefish appear in multiple categories on the chart. Tuna comes in different types (or species), such as albacore, bigeye, and yellowfin. And because some types of tuna that are bigger or live longer tend to have higher mercury levels, they are in different categories. For example, canned light tuna is in the Best Choices category. Albacore (or white) tuna and yellowfin tuna are in the Good Choices category, and bigeye tuna is in the Choices to Avoid. In addition, fish of the same species that are caught in different geographic locations can vary in mercury content. For example, tilefish are in two categories because tilefish in the Gulf of Mexico have higher mercury levels than those in the Atlantic Ocean. As such, Gulf of Mexico tilefish is in the Choices to Avoid and Atlantic Ocean tilefish is in the Good Choices.

If some species of fish are not on the reference chart, such as mussels, that means the agencies did not have enough reliable mercury data to include it.

 

The Empire State woos pharma, biotech industries

The 21st Century Cures Act (Cures Act) was passed by the House on November 30, 2016 and the Senate on December 7, 2016. The President signed it into law on December 13, 2016.  The Cures Act contains three primary titles that makes good on the promise of its name through FDA reforms by accelerating drug and device development and delivery. The Cures Act also creates new administrative positions related to mental health and substance abuse and provides state funding to combat opioid addiction. The President applauded Congress’ approval of the bill, commenting, “I think it indicates the power of this issue and how deeply it touches every family across America.”

In a similar vein, New York Governor Andrew Cuomo and New York City Mayor Bill de Blasio recently unveiled two initiatives that would commit $1.15 billion in funding and tax incentives for education, business development, and job creation in the life sciences sector. Of the total amount,  New York City will be investing $500 million in biotech and life sciences over the next decade via a program called LifeSci NYC, the largest piece is composed of $300 million in tax credits that will be made available to companies building lab space in the city, in order to defray the high costs of construction in the city. The state’s contributions include $250 million in tax incentives for new and existing life science companies, $200 million in state capital grants to support investment in wet-lab and innovation space, and $100 million in investment capital for early stage life science initiatives with an additional match of at least $100 million for operating support from private sector partnerships.

Citing the lack of affordable and appropriate lab space as a barrier to industry, especially in the New York City real estate market, the state and city initiatives will provide more than 3.2 million square feet of innovation space and 1,100 acres of developable land available tax-free at 45 colleges and universities statewide. The availability of grants, land and space would offer an incentive for life science industry to access labs, infrastructure, and other equipment for product development.