Thursday, September 29, 2016

Agricultural Law Weekly Review—September 29, 2016

Written by M. Sean High – Staff Attorney

The following information is an update of recent, local, state, national, and international legal developments relevant to agriculture:

Liability: Court Rules against Application of Equine Activities Immunity Act
On September 26, 2016, the United States District Court, M.D. Pennsylvania denied a motion claiming immunity protection under the Pennsylvania Equine Activities Immunity Act (EAIA) regarding an injury suffered at an equine facility due to a broken stirrup (Melendez v. Happy Trails and Riding Center, Inc., 2016 WL 5402745).  Under EAIA, to receive negligence protection, a qualifying defendant must demonstrate that their equine facility had proper signage and that the plaintiff assumed the risk of the equine activities (4 P.S. §§ 601-606).  According to the court, a “Defendant must show that [a] Plaintiff knew that the equipment he was provided with might break and voluntarily continued with the horseback ride in spite of that knowledge.” The court stated that because the equine facility failed to point to anything in the record to show that the injured party knew of the risk of equipment failure “and voluntarily disregarded it, EAIA provides no relief.”

Fertilizer Sales: Court Rules New OSHA Retail Facilities Safety Standard Must Go Through Rulemaking Process
On September 23, 2016, the United States Court of Appeals, District of Columbia Circuit ruled that the Occupational Safety & Health Administration (OSHA) violated the Occupational Safety and Health Act when the agency issued a new safety standard designed to narrow the exemption for retail facilities that deal in toxic chemicals (Agricultural Retailers Association and The Fertilizer Institute v.United States Department of Labor and Occupational Safety & Health Administration, 2016 WL 5315200).  According to the court, OSHA’s action was a modification of an existing safety standard, and as such, could only be validly accomplished by complying with the notice and comment procedures required by the Administrative Procedure Act.

GMO: APHIS Determines GE Apple Unlikely Environmentally Harmful
On September 23, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced that regarding the deregulation of the genetically engineered apple line known as Arctic® Fuji, the agency was making available: (1) the final Determination and plant pest risk similarity assessment and (2) the Finding of No Significant Impact (FONSI).  According to APHIS, Arctic® Fuji apples, which are engineered to resist enzymatic browning, “are unlikely to pose plant pest risk and are no longer to be considered regulated articles under APHIS’ Biotechnology Regulations.” As a result, APHIS stated that a determination of nonregulated status of the apple line “will have no significant environmental impacts.”

GMO: AHIS Extends Preliminary Determination of Nonregulated Status on GE Potatoes
On September 24, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) published notice in the Federal Register that the agency “has reached a preliminary decision to extend [a] determination of nonregulated status of J.R. Simplot Company's (Simplot) InnateTM Potato designated as Russet Burbank event W8 (the antecedent potato event) to Simplot's Ranger Russet variety (X17) and Atlantic variety (Y9) potatoes” (81 FR 65622).  According to APHIS, “Simplot’s X17 and Y9 potatoes have been genetically engineered for late blight resistance, low acrylamide potential, lowered reducing sugars, and reduced black spot using the same genetic constructs used to transform the antecedent potato event.” The comment period on the preliminary decision closes October 24, 2016.

Labeling: FDA Announces Industry Guidance and Comment Docket Regarding Use of Term “Healthy”
On September 28, 2016, the United States Food and Drug Administration (FDA) published notice in the Federal Register “announcing the availability of a guidance document for industry entitled “Use of the Term ‘Healthy’ in the Labeling of Human Food Products: Guidance for Industry” (81 FR66527).  According to FDA, “the guidance advises manufacturers who wish to use the implied nutrient content claim ‘healthy’ to label their food products as provided by [FDA] regulations.” Relatedly, on September 28, 2016, FDA published notice in the Federal Register that the agency has established “a docket to receive information and comments on the use of the term ‘healthy’ in the labeling of human food products” (81 FR 66562).  Comments must be received by FDA on January 26, 2017. 

Equine: APHIS Announces Proposed Rule to Amend Horse Protection Regulations
On September 22, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) published notice in the Federal Register that the agency is extending the comment period regarding the “proposed rule to amend the horse protection regulations to provide that [APHIS] will train and license inspectors to inspect horses at horse shows, exhibitions, sales, and auctions for compliance with the Horse Protection Act” (81 FR 65307).  The revised comment period closes October 26, 2016.  Additionally, APHIS announced that the agency is “also making a clarification to the proposed regulations pertaining to specific prohibitions concerning exhibitors.”

Apples: Secretary Publishes Referendum Order on Continuation of the Pennsylvania Apple Marketing Program
On September 24, 2016, Pennsylvania Secretary of Agriculture Russell Redding published a notice in the Pennsylvania Bulletin entitled “Referendum Order on Continuation of the Pennsylvania Apple Marketing Program” (46 Pa.B. 6023).  According to the Referendum Order, “[t]he Pennsylvania Apple Marketing Program was established under the provisions of the Agricultural Commodities Marketing Act…[and] requires that the Secretary of Agriculture call a referendum of affected producers every five years to determine whether or not a majority of those voting still desire the program.” Eligible referendum voters include “[a]ll apple producers who produced, grew, or caused to be grown 500 or more apple trees for sale or marketing in the Commonwealth in calendar year 2016 and intend to produce, grow, or cause to be grown 500 or more apple trees for sale or marketing in the Commonwealth in calendar year 2017.” The referendum period runs from October 17, 2016 through October 31, 2016.

Thursday, September 22, 2016

Agricultural Law Weekly Review—September 22, 2016

Written by M. Sean High – Staff Attorney

The following information is an update of recent, local, state, national, and international legal developments relevant to agriculture:

Legal Settlement: Syngenta Agrees to Pay $1.2 M. for Selling Misbranded Pesticides
On September 16, 2016, the United States Environmental Protection Agency (EPA) issued a press release stating that the agency has reached a settlement agreement with Syngenta Crop Protection, LLC (Syngenta) for allegedly violating the Federal Insecticide, Fungicide, and Rodenticide Act through the repackaging, selling and distribution of unregistered and misbranded pesticides. As a result of the settlement agreement, Syngenta will pay $766,508 in civil penalties and spend $436,990 to implement an environmental compliance promotion Supplemental Environmental Project.

FSMA: PA Announces $6.3 M. to Implement Produce Safety Rule
On September 19, 2016, Pennsylvania Governor Tom Wolf issued a press release announcing that the Commonwealth has received a $6.3 million Federal grant to assistance Pennsylvania produce growers in meeting requirements enacted under the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA).  According to the press release, “The funding, spread across five years, gives the [Pennsylvania Department of Agriculture] resources to implement a produce safety system, develop and provide education and outreach, and to develop programs to address the specific and unique needs of the growers in Pennsylvania’s farming communities.”

GIPSA: Amendment Regarding Electronic Transactions Clears House Ag Committee
On September 14, 2016, the United States House Agriculture Committee passed H.R. 5883 which would amend the Packers & Stockyards Act (GIPSA) “to expand the definition of ‘marketing agency’ to include any person engaged in the business of buying or selling livestock in commerce through online, video, or other electronic methods on a commission or other fee basis when handling or providing a means to handle receivables or proceeds from the sale of that livestock.” Additionally, according to the Bill Summary, H.R. 5883 would also amend GIPSA “to specif[y] that funds for purchasing livestock may be transferred to the account of the seller by electronic funds transfer or any other expeditious method that the Department of Agriculture determines to be appropriate.” Subsequently, on September 20, 2016, H.R. 5883 was placed on the Union Calendar, Calendar No. 601.

HPAI: FSIS Issues Directive Regarding Poultry Slaughterhouse Inspection
On September 21, 2016, the United States Department of Agriculture (USDA) Food Safety and Inspection Service released a directive regarding how “inspection program personnel (IPP) at official poultry slaughter establishments [are] to conduct enhanced inspection for domestic poultry in the event of a Highly Pathogenic Avian Influenza (HPAI) outbreak or an agro terrorism incident that involves HPAI viruses” (6020.1 Rev. 1).  According to FSIS, the new directive updates FSIS Directive 6020.1 regarding: (1) current notification procedures and enhanced inspection documentation; and (2) instructions for IPP assigned to establishments under the New Poultry Inspection System (NPIS).

FSMA: FDA Announces Effective Date for Definition of Qualified Auditor for Two Final Rules
On September 19, 2016, the United States Food and Drug Administration (FDA) published notice in the Federal Register announcing the effective date regarding the definition of a qualified auditor in the following FDA Food Safety and Modernization Act final rules: (1) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis; and (2) Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor (81FR 64060).  Accordingly, the definition for each final rule became effective September 19, 2016. 

Pesticides: EPA's Announces Draft Human Health and Ecological Risk Assessments
On September 19, 2016, the United States Environmental Protection Agency (EPA) published notice in the Federal Register announcing “the availability of EPA's draft human health and ecological risk assessments for the registration review of carfentrazone-ethyl, copper compounds, mineral acids, spinosad, and spinetoram and opens a public comment period on these documents” (81 FR 64149).  According to the published notice, “EPA's periodic review of pesticide registrations is intended to ensure that each pesticide…can perform its intended function without unreasonable adverse effects on human health or the environment.” The comment period regarding the draft human health and ecological risk assessments closes November 18, 2016.

Eggs: Final Rule Regarding Voluntary Grading of Shell Eggs
On September 16, 2016, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published notice in the Federal Register of a final rule “amend[ing] the Regulations Governing the Voluntary Grading of Shell Eggs to clarify the definition of ‘condition’ and revise the prerequisite requirement for shell eggs eligible for voluntary USDA grading and certification” (81 FR 63675).  This final rule is effective September 16, 2016.

Animal Welfare: USDA Extends Comment Period for Horse Protection Regulations
On September 16, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) issued a press release announcing that the agency is extending by 30 days the comment period on the proposed rule that would amend APHIS’ Horse Protection Act (HPA) regulations.  As a result interested stakeholders may now submit comments until October 26, 2016.  According to the press release, under the proposed rule APHIS would: (1) assume responsibility for training, screening and licensing horse inspectors; and (2) prohibit the use of all action devices, pads, and foreign substances at horse shows, exhibitions, sales, and auctions. 

Crop Insurance Update: Coverage for Pennsylvania Pears

Written by M. Sean High—Staff Attorney

On September 14, 2016, the United States Department of Agriculture (USDA) Raleigh Regional Office—Raleigh, NC issued a Risk Management Agency Fact Sheet regarding crop insurance for pears grown in Pennsylvania. 

According to USDA, crop insurance is available for all pears in a Pennsylvania county where: (1) a premium rate is provided by the actuarial documents; (2) the pears are of a variety that is adapted to the area; and (3) the pears are grown on trees that have produced at least 3 tons of pears per acre in at least 1 of the previous 4 years.

USDA states that all pears in Adams County are eligible for crop insurance, and that “pears may [also] be insurable in other [Pennsylvania] counties by written agreement if specific criteria are met.”

According to USDA, crop insurance provides pear producers protection against the following: (1) adverse weather conditions, including hail, frost, freeze, wind, drought, and excess precipitation; (2) failure of irrigation water supply, if caused by an insured peril during the insurance period; (3) fire caused by an insured peril during the insurance period; (4) insect damage and plant disease, except for insufficient or improper application of control measures; or (5) wildlife.

The sales closing date for Pennsylvania pear crop insurance coverage is November 20, 2016 with the insurance coverage period beginning of November 21, 2016 and lasting until the earliest occurrence of one of the following events: (1) total destruction of the crop; (2) harvest of the crop; (3) final adjustment of a claim; (4) abandonment of the crop; (5) September 15 for all types of summer and fall pears; or (6) October 15 for all types of winter pears.

Thursday, September 15, 2016

Agricultural Law Weekly Review—September 15, 2016

Written by M. Sean High – Staff Attorney

The following information is an update of recent, local, state, national, and international legal developments relevant to agriculture:

Labor: California Governor Signs Bill Removing Agricultural Worker Overtime Exemption
On September 12, 2016, California Governor Edmund G. (“Jerry”) Brown signed into law legislation removing California’s agricultural worker overtime exemption (AB 1066).  Prior to the enactment of AB 1066, California agricultural workers only received overtime pay if they worked more than 10 hours a day or 60 hours per week.  Now, however, agricultural workers must receive overtime pay if they work in excess of 8 hours a day or 40 hours per week.  The new law will phase in the new overtime requirements for agricultural worker over the course of 4 years, though agricultural producers with 25 or fewer employees will be given an additional 3 years to phase in the overtime requirements.

Trade: U.S. Brings WTO Action against China for Rice, Wheat, and Corn Support  
On September 13, 2016, the United States Department of Agriculture (USDA) issued a press release stating that “the Obama Administration has launched a new trade enforcement action against the People's Republic of China at the World Trade Organization (WTO) concerning excessive government support provided for Chinese production of rice, wheat, and corn.” According to USDA, China’s excessive government support violates WTO rules, have caused an inflation of prices above market levels, and have denied American rice, wheat, and corn farmers the ability to compete on a level playing field.

Litigation: Court Rules EPA’s Release of CAFO Information Violated FOIA
On September 9, 2016, the United States Court of Appeals for the Eighth Circuit ruled that the Environmental Protection Agency (EPA) violated the Freedom of Information Act (FOIA) when EPA released personal information pertaining to owners of concentrated feeding operations (American Farm Bureau Federation v. U.S. Environmental Protection Agency, Case No. 15-1234).  The court remanded the case back to the district court to consider American Farm Bureau Federation’s request for injunctive relief. 

FSMA: States to Receive $21.8 Million to Farmers Comply with Produce Rule
On September 9, 2016, the United States Food and Drug Administration (FDA) issued a press release announcing that the agency was “awarding…$21.8 million to support 42 states in the implementation of the FDA Food Safety Modernization Act (FSMA) produce safety rule.” According to FDA, the state “[a]pplicants were classified into five tiers of funding eligibility based on the estimated number of farms growing covered produce within their jurisdiction.” FDA stated that the funding is available for five years, subject to the availability of funding from Congress.

Quarantine: PDA Establishes Quarantine for Spotted Lanternfly
On September 10, 2016, the Pennsylvania Department of Agriculture published notice in the Pennsylvania Bulletin of an Addendum to the Order of Quarantine regarding the Spotted Lanternfly (46 Pa.B. 5814).  According to PDA, “[a] quarantine is hereby established with respect to Lyons Borough, Alsace Township, Exeter Township, St. Lawrence Borough, Berks County and Upper Macungie Township, Lehigh County and West Pottsgrove, Montgomery County.” PDA stated that “[t]his is in addition to, and does not replace, any townships and areas already subject to the Spotted Lanternfly Quarantine Order published at 44 Pa.B. 6947 issued Saturday, November 1, 2014, and any previous Addendums to that Quarantine Order.”

Crop Insurance Update: Understanding the Actual Production History Yield Exclusion


Written by M. Sean High—Staff Attorney

Under the 2014 Farm Bill, the United States Department of Agriculture (USDA) Risk Management Agency (RMA) offers crop insurance policy holders the potential to exclude certain bad production years when calculating yields used to establish crop insurance coverage.  Known as the Actual Production History (APH) Yield Exclusion (YE), this provision allows for the exclusion of certain years when the average per planted acreage yield for a specific county is at least 50% below the simple average for the previous 10 consecutive crop years.

According to RMA, the agency conducts a review of the crop insurance actuarial documents to identify years that will be eligible for APH YE.  RMA states that the agency primarily uses RMA data to identify eligible years, but “[i]f RMA data is not sufficient for any given crop year, National Agriculture Statistics Service data is used, if available and appropriate, and then, in a limited number of situations, the applicable county transitional yield may be used, as appropriate, to complete a 10-year consecutive period.” Information regarding eligible APH YE years can be found at: http://prodwebnlb.rma.usda.gov/apps/MapViewer/index.html.

According to RMA, to be permitted to exclude bad production years when calculating yields used to establish crop insurance coverage, an agricultural producer “must choose the Actual Production History Yield Exclusion Option by the sales closing date for [their] insurance policy.” Importantly, RMA states that this option is continuous, and once chosen, “will automatically exclude all eligible crop years from your actual production history database, unless you specifically opt out of the exclusion for a specific crop year because you wish to retain your yield for an eligible crop year in your actual production history database.” Consequently, if the policy holder decides to end this coverage, they must request a cancellation of the option by the sales closing date.

Finally, RMA states that the exclusion of bad production years may result in “an increased approved yield, a higher insurance guarantee and greater indemnity payment could occur due to the yield exclusion.” Because of this potential benefit, the policy holder claiming the exclusion will have their policy premium adjusted to reflect the higher effective coverage level.  

Tuesday, September 13, 2016

Crop Insurance Update: Understanding the Risk Management Agency

Written by M. Sean High—Staff Attorney

Established in 1996, the United States Department of Agriculture’s (USDA) Risk Management Agency (RMA) provides assistance to America’s farmers through the promotion, support, and regulation of risk management tools designed to “strengthen the economic stability of agricultural producers and rural communities.” According to RMA, the work of the Agency consists of three main program areas: (1) promoting and supporting crop insurance services; (2) developing, testing, and reviewing crop insurance products; and (3) assessing and investigating crop insurance compliance.

Significantly, RMA manages the Federal Crop Insurance Corporation (FCIC) which administers the Federal crop insurance program.  According to RMA, “FCIC promotes the economic stability of agriculture through a sound system of crop insurance and providing the means for the research and experience helpful in devising and establishing such insurance.”

A wholly owned government corporation, FCIC is governed by a nine member Board of Directors consisting of three members from USDA and six members from the private sector.  The three FCIC Board members from USDA are: (1) the Under Secretary of Farm and Foreign Agricultural Services; (2) USDA’s Chief Economist; and (3) the current manager of FCIC (in a nonvoting role).  The six FCIC Board members from the private sector are: (1) four farmers, one of whom grows a specialty crop; (2) an individual involved in insurance; and (3) an individual knowledgeable about reinsurance or regulation.

Subject to the general supervision of the Secretary of Agriculture, “[t]he FCIC Board approves any new policy, insurance plan, or major modification to an existing plan or other materials under procedures established by the Board.”

According to RMA, under the Federal crop insurance program, “Approved Insurance Providers (AIP) sell and service Federal crop insurance policies in every state and in Puerto Rico through a public-private partnership with RMA…[and] RMA backs the AIPs who share the risks associated with catastrophic losses due to major weather events.” To locate an AIP or RMA insurance agent, an agricultural producer can contact any USDA service center or visit RMA’s Agent Locator webpage at: http://www.rma.usda.gov/tools/agent.html.  

Monday, September 12, 2016

FSMA Update: Final Rule for Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules

Written by Errin McCaulley – Research Assistant

On August 24, 2016 the Food and Drug Administration (FDA) announced a final rule in the Federal Register titled The Food and Drug Administration Food Safety Modernization Act: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules (81 Fed. Reg. 57,784). Generally, this final rule first extends compliance dates for certain provisions throughout four preceding final rules while, second, providing clarification for stakeholders with regard to specific provisions that FDA has received extensive correspondence on from stakeholders through FDA’s Technical Assistance Network (TAN).

Written Assurances Compliance Date Extensions

FDA has extended compliance dates for the written assurances provisions of the following rules: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls For Human Food (PCHF), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food For Animals (PCAF), Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule). Written assurances, for example, are required under PCHF when a producing facility identifies a hazard yet relies on a PCHF-covered customer receiving the food product with the identified hazard to take steps to ensure the hazard “will be significantly minimized or prevented.” 21 C.F.R. § 117.136(a)(2). In doing so, the facility must annually obtain assurances from this customer which stipulate “the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the identified hazard.” 21 C.F.R. § 117.136(a)(2)(ii).

PCHF’s original compliance date for “small businesses” (those with fewer than 500 full-time equivalent employees) was September 18, 2017 and is now September 18, 2019. All other businesses subject to PCHF (neither small nor very small as defined in the rule) had an original compliance date of September 19, 2016 and must now comply by September 19, 2018.

PCAF’s original compliance date for small businesses (those with fewer than 500 full-time equivalent employees) was September 17, 2018 and is now September 17, 2020. All other businesses subject to PCAF (neither small nor very small as defined in the rule) had an original compliance date of September 18, 2017 and must now comply by September 18, 2019.

FSVP’s compliance dates have been extended by 30 months. FSVP’s original compliance dates were the later of either May 30, 2017 or 6 months after the importer’s supplier was required to comply with PCHF, the Preventive Controls (PCs) or Current Good Manufacturing Practices (CGMPs) of PCAF, or the Produce Safety rule. With the extension in this final rule, the earliest a business subject to FSVP would have to comply with the written assurances provision of FSVP is May 28, 2019. Note that the extension of compliance dates for written assurances for FSVP are not impacted by the earlier mentioned extensions for written assurances under PCHF, PCAF, or the Produce Safety rule extension described below. This means an importer subject to FSVP must comply with the written assurances provisions of FSVP 30 months after the original compliance dates for the rules the supplier must comply with (e.g., PCHF).

The written assurances for the Produce Safety rule are being extended with regard to the exemption available in 21 C.F.R. § 112.2(b). This exemption allows operations to be exempted from compliance when “produce receives commercial processing that adequately reduces the presence of microorganisms of public health significance.” 21 C.F.R. § 112.2(b)(1). In order to qualify, operations must make disclosures and obtain written assurances from customers. The extension is split into two categories: sprout operations and all other operations covered by the Produce Safety rule. First, for sprout operations the compliance dates for written assurances are as follows: sprout operations that are “very small business” (average sales of over $25,000 but no more than $250,000 during previous three years adjusted for inflation using 2011 as the base year) were originally required to comply by January 28, 2019 and now must comply by January 26, 2021; sprout operations that are “small business” (average sales between $250,000 and $500,000 during previous three years adjusted for inflation using 2011 as the base year) were originally required to comply by January 26, 2018 and now must comply by January 27, 2020; all other sprout operations (those exceeding $500,000 in average annual sales during previous three years adjusted for inflation using 2011 as the base year) were required to comply by January 26, 2017 and now must comply by January 28, 2019. Second, for all other covered produce operations excluding sprouts, the compliance dates are as follows: very small businesses (as defined in this paragraph) originally were required to comply by January 27, 2020 and now must comply by January 26, 2022; small businesses (as defined in this paragraph) originally were required to comply by January 28, 2019 and now must comply by January 26, 2021; all other businesses (as defined in this paragraph) were originally required to comply by January 26, 2018 and now must comply by January 27, 2020.

Extension of Compliance Dates for PCHF and PCAF

FDA has extended the compliance dates for facilities that are solely engaged in packing and/or holding activities on produce raw agricultural commodities (RACs) to the extent that these facilities are subject to PCHF. Under the Produce Safety rule, activities such as these occurring on a farm (as defined in 21 C.F.R. § 1.227) were covered by the Produce Safety rule. After receiving extensive stakeholder input, FDA has announced that these off-farm facilities, such as packinghouses, although subject to PCHF, may “still be able” to rely upon the Produce Safety rule when drafting their food safety plans and preventive control management components. These facilities, however, must still comply with PCHF. For eligible very small businesses as defined in PCHF, the original compliance date was September 17, 2017 and is now January 27, 2020. Eligible small businesses (less than 500 full-time equivalent employees) had an original compliance date of September 18, 2017 and must now comply by January 28, 2019. All other eligible businesses (neither small nor very small) had an original compliance date of September 19, 2016 and must now comply by January 26, 2018.

FDA has made a similar extension of compliance dates for facilities that are solely engaged in packing and/or holding activities on produce RACs and are subject to PCAF. Specifically, FDA noted that this extension is directed at facilities covered by PCHF or the Produce Safety rule but also produce human food by-products (such as culls) that are used in animal food. These facilities, under PCAF, must comply with either the CGMPs of PCHF or the applicable packing and holding requirements of the Produce Safety rule. For these types of facilities, FDA has extended the compliance dates for PCAF. PCAF’s original compliance dates were staggered with compliance with PCAF CGMPs occurring first, then compliance with PCAF PCs. Eligible very small businesses as defined in PCAF (note there is a difference in definition of very small business under PCAF as compared to PCHF) had an original compliance date for CGMPs of September 17, 2018 and PCs of September 17, 2019; respectively the new compliance dates are January 27, 2020 and January 26, 2021. Eligible small businesses (fewer than 500 full-time equivalent employees) had an original compliance date for CGMPs of September 18, 2017 and PCs of September 17, 2018; respectively the new compliance dates are January 28, 2019 and January 27, 2020. All other eligible facilities had an original compliance date for CGMPs of September 19, 2016 and PCs of September 18, 2017; respectively the new compliances dates are January 26, 2018 and January 28, 2019. These extensions only apply to facilities described above and do not apply to facilities that manufacture/process produce RACs or nut hulls in addition to their packing and/or holding activities.

Extension of Compliance Dates for Facilities that Would Qualify as Secondary Activities Farms Except for Ownership

FDA has extended compliance dates for both PCHF and PCAF for facilities that, despite their ownership, would qualify as secondary activities farms. These facilities, in order to qualify for the extension, must meet all the qualifications of a secondary activities farm (defined under “farm” in 21 C.F.R. § 1.227) except for the ownerships requirements. Furthermore, FDA is requiring that facilities, to qualify for the extension, must (1) not be located on a primary production farm; (2) be devoted to harvesting, packing, and/or holding of RACs; and (3) be under common ownership with the primary production farm(s) that “grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the operation.” 81 Fed. Reg. 57,784, 57,791 (Aug. 24, 2016). Under this extension of PCHF and PCAF, the new compliance dates will coincide with the compliance dates established for similarly sized operations under the Produce Safety rule. Under PCHF, the new compliance dates are as follows: eligible very small businesses (as defined in PCHF) had an original compliance date of September 17, 2018 and must now comply by January 27, 2020; eligible small businesses had an original compliance date of September 18, 2017 and must now comply by January 28, 2019; all other eligible operations (neither small nor very small) had an original compliance date of September 19, 2016 and must now comply by January 26, 2018. Under PCAF, the compliance dates are staggered with CGMPs first and PCs after. Eligible very small businesses (as defined in PCAF) had an original compliance date for CGMPs of September 17, 2018 and PCs of September 17, 2019; respectively the new compliance dates are January 27, 2020 and January 26, 2021. Eligible small businesses had an original compliance date for CGMPs of September 18, 2017 and PCs of September 17, 2018; respectively the new compliances dates are January 28, 2019 and January 27, 2020. All other eligible operations (neither small nor very small) had an original compliance date for CGMPs of September 19, 2016 and PCs of September 18, 2016; respectively the new compliance dates are January 26, 2018 and January 28, 2019.

Extension of Compliance Dates for Coloring of RACs

FDA has extended compliance dates for PCHF for facilities that color RACs. Coloring of RACs falls outside the “farm” definition of 21 C.F.R. § 1.227, therefore coloring triggers the applicability of PCHF as FDA considers coloring to be manufacturing or processing. The compliance date extension is only applicable to operations that, despite coloring RACs, would fall within the “farm” definition of 21 C.F.R. § 1.227. Eligible very small businesses (as defined in PCHF) had an original compliance date of September 17, 2018 and now must comply by January 27, 2020. Eligible small businesses had an original compliance date of September 18, 2017 and must now comply by January 28, 2019. All other eligible operations (neither small nor very small) had an original compliance date of September 19, 2016 and must now comply by January 26, 2018.

Extension of Compliance Dates for Facilities Solely Engaged in Ginning Cotton

FDA has extended compliance dates for PCAF for facilities that solely engage in ginning cotton in the production of animal food. Ginning cotton falls under the “farm” definition when conducted on a farm, but when conducted off of a farm it is either a packing activity or a manufacturing or processing activity. These facilities, under PCAF, are exempt from CGMP requirements of PCAF, yet must still comply with the preventive controls provisions of PCAF. Under the extension, eligible very small businesses (as defined in PCAF) had an original compliance date of September 17, 2019 and must now comply by January 26, 2021. Eligible small businesses had an original compliance date of September 17, 2018 and must now comply by January 27, 2020. All other eligible operations (neither small nor very small) had an original compliance date of September 18, 2017 and must now comply by January 28, 2019.

Extension of Compliance Dates for FSVP When Importing Food Contact Substances

FDA has extended the compliance date for FSVP for operations that import “food contact substances” which fall within the definition of “food” under § 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) codified at 21 U.S.C. § 321(f). A food contact substance is “any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.” 81 Fed. Reg. 57,784, 57,793 (Aug. 24, 2016). Importers had an original compliance date of May 30, 2017 and must now comply by May 28, 2019.

Extension of Compliance Dates for PCHF CGMPs for Facilities that Produce Grade “A” Milk

FDA has extended compliance dates for the CGMPs provisions of PCHF for facilities which produce grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO). In the PCHF final rule, PMO-regulated facilities were given an extended compliance date of September 17, 2018 for the preventive control provisions of PCHF. In this most recent final rule, FDA has extended the compliance date for CGMPs to September 17, 2018 as well.

Clarification of Compliance Dates for Water Testing under Produce Safety Rule

FDA has provided several clarifications regarding the water testing requirements of the Produce Safety rule. Specifically, untreated surface water under the Produce Safety rule was not granted a 2-year extended compliance period at the time of the rule’s issuance on November 27, 2015. FDA has clarified that this was necessary to ensure that farms were able to develop their “microbial water quality profile” (MWQP) within the allotted timeframe of the Produce Safety rule. The water testing requirements of the Produce Safety rule currently require very small farms (as defined in the Produce Safety rule) to begin testing to develop an MWQP no later than 4 years after the issuance of the final rule; small farms (as defined in the Produce Safety rule) must begin no later than 3 years after issuance; and all other farms (neither very small or small) must begin testing no later than 2 years after issuance. These compliance dates are still in effect. FDA has clarified that the timing requirements for beginning testing for each respective class-size of farm does not mean the farms have only that amount of time to complete an MWQP. The farms have discretion over the number of samples included in their initial survey and the time period over which these sample are taken, provided that (1) the time period of collection must be at least 2 years and no more than 4 years and the MWQP must be made up of at least 20 samples.