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FDA responsive to industry concerns on FSMA

February 5, 2018 10:52 am0 commentsViews: 8

Despite early January media reports of an E. coli outbreak in Canada and the U.S. possibly linked to romaine lettuce, food safety news was not all bad.

U.S. authorities had not yet linked the outbreak to romaine lettuce as of Jan. 8. Media reports said 58 people in the U.S. and Canada were sickened by E. coli and two died — one in California and one in Canada.

The smaller headlines held better tidings for the fresh produce industry.

Speaking to confusion over whether fruit and vegetable packinghouses for fresh produce should be covered by the produce safety rule or the preventive controls rule, the Food and Drug Administration on Jan. 4 said it will not enforce selected food safety regulations during what it calls it “enforcement discretion period.”

The agency said the enforcement discretion period would remain in place until it resolves issues with the provisions.

The provisions the agency does not intend to enforce relate to aspects of the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food, FDA Commissioner Scott Gottlieb said in a statement.

One of the key regulations that the FDA is delaying enforcement on is for facilities that would be farms except for certain factors and activities.

In the food safety regulations, some packinghouses fall under the preventive controls rule, while others would be covered by the produce safety rule.

Industry food safety experts have argued for consistency in the regulations.

Enforcement discretion is appreciated by the industry because the FDA has not yet resolved the farm/facility issue to clarify which rule operations fall under, said Jennifer McEntire, vice president of food safety and technology for the United Fresh Produce Association.

A look at ag water

The ag water provision has been troubling for produce industry interests, and in September, the FDA pushed back the start of produce safety inspections by one year and extended the deadline for water testing compliance by two years.

At the time, FDA commissioner Gottlieb said the moves were designed to make sure the produce safety rule is successful at the farm level.

For produce farm inspections, the FDA said large farming operations will still be expected to meet all produce safety requirements set by the rule for produce other than sprouts, except those related to agricultural water, by the original Jan. 26 compliance date.

However, inspections to assess compliance with the non-water requirements of the produce safety rule for produce other than sprouts won’t start until 2019.

The FDA and state partners will use the year to give more education, training and outreach to growers on the new requirements, according to a news release.

For agricultural water compliance dates, the FDA issued a proposed rule that would extend the compliance dates for the agricultural water requirements by an additional two to four years for produce other than sprouts.

The extension will allow the FDA to “take another look” at the water standards to ensure that they are feasible for farmers in all regions of the country and still protect public health, the FDA said.

Gottlieb said at the time the agency plans to talk with farmers, state regulatory partners and others about how water is used in agriculture.

Toward that end, the Produce Safety Alliance is hosting an agricultural water summit on Feb. 27-28 in Covington, Ky. FDA officials will be in attendance at the meeting. P

The new agricultural water compliance date the FDA is proposing for the largest farms is January 2022, the release said.

Small farms and very small farms would have until January 2023 and January 2024, the FDA said.

The agency said it does not intend to take action to enforce the agricultural water requirements for produce other than sprouts while the rulemaking to extend the compliance dates is underway.

The FDA also announced eight additional water testing methods that can be used for meeting the requirements of the produce safety rule.

The agency said it intends to add other methods to the list as they are identified.

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