Showing posts with label Produce Safety Rule. Show all posts
Showing posts with label Produce Safety Rule. Show all posts

Thursday, September 21, 2017

Agricultural Law Weekly Review—September 21, 2017

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:
                 
Ag-Gag: Tenth Circuit Rules Wyoming Resource Data Collection Law Violates First Amendment
On September 7, 2017, the U.S. Court of Appeals for the 10th Circuit ruled that Wyoming’s “statutes imposing civil and criminal liability on any person who ‘[c]rosses private land to access adjacent or proximate land where he collects resource data’” violate the First Amendment.  The court stated that under the Wyoming statutes, the phrase “collects resource data” is broadly defined so as to include numerous activities on public lands that “fit comfortably in the speech creation category recognized” by case law.  Accordingly, the court asserted that while “trespassing does not enjoy First Amendment protection, the statutes at issue target the ‘creation’ of speech by imposing heightened penalties on those that collect resource data.”  As a result, the court held “that the statutes regulate protected speech under the First Amendment and…are not shielded from constitutional scrutiny merely because they touch upon access to private property.”

FSMA: FDA announces that the FSMA produce Safety Rule is Now Final
On September 17, 2017, the U.S. Food and Drug Administration (FDA) announced that the FDA Food Safety and Modernization Act (FSMA) Produce Safety rule is now final.  Initially proposed in 2013, FDA stated that “[t]he final rule is a combination of the original proposal and revisions outlined in the supplemental proposal (proposed in 2014), with additional changes as appropriate.” According to FDA, key requirement of the final rule include: (1) agricultural water; (2) biological soil amendments; (3) sprouts; (4) domesticated and wild animals; (5) worker training and health and hygiene; and (6) equipment, tools and buildings. 

FSMA: FDA Commissioner Announces Steps to Help States Implement Produce Safety Rule
On September 12, 2017, the U.S. Food and Drug (FDA) Commissioner Scott Gottlieb announced “a number of immediate next steps in a comprehensive approach to ensuring successful implementation of the Produce Safety Rule established by the FDA Food Safety Modernization Act.”  According to Commissioner Gottlieb, “the agency has recognized a need for additional efforts to educate the produce industry and state regulatory partners on the new produce safety requirements, and will continue its focus on training, guidance development, and outreach over the next year.”  As a result, Commissioner Gottlieb asserted the FDA’s intention to: (1) extend agricultural water compliance dates; (2) engage stakeholders regarding agricultural water standards; (3) recognize other methods that are appropriate for use in agricultural water testing; (4) delay inspections to assess compliance with the non-water requirements of the Produce Safety Rule for produce other than sprouts; and (5) work in partnership with farmers and the states to provide training opportunities for producers and regulators.   

Food Safety: FDA Commissioner Issues Statement Regarding Crops Affected by Recent Hurricanes
On September 14, 2017, the U.S. Food and Drug (FDA) Commissioner Scott Gottlieb issued a statement regarding crops, particularly rice, affected by Hurricanes Harvey and Irma.  Commissioner Gottlieb stated that “I want to make it clear that the FDA has not issued a ban on rice or any other food crops.”  According to the Commissioner, “[r]ice grown in normal conditions and rice that has not been exposed to contaminated floodwaters from the recent hurricanes may enter commerce.” Additionally, Commissioner Gottlieb stated that “rice and other crops that were harvested and stored safely before storms hit should not be considered impacted by these events.”

SNAP: Alaska Agrees to Pay Nearly $2.5 Million over Allegedly False SNAP Claims
On September 18, 2017, the U.S. Department of Justice (DOJ) announced that “[t]he Alaska Department of Health and Social Services (ADHSS) has agreed to pay the United States $2,489,999 to resolve allegations that it violated the False Claims Act in its administration of the Supplemental Nutrition Assistance Program.” According to the DOJ, beginning in 2009, ADHSS contracted with an outside consultant who “injected bias into ADHSS’s quality control process and resulted in ADHSS submitting inaccurate quality control data and information to USDA.” The DOJ alleged that due to the inaccurate submissions, ADHSS received “performance bonuses for fiscal years 2010, 2011, 2012, and 2013, that it should not have received.”

GMOs: European Court Finds Italy’s GMO ban unlawful
On September 13, 2017, Reuters reported that the European Court of Justice has determined that Italy wrongfully banned the cultivation of the genetically modified (GMO) maize MON 810.  Though previously approved by the European Union in 1998, Italy nonetheless decided to ban MON 810 after two Italian studies questioned the products safety.  According to the European Court of Justice, however, “unless there is significant evidence that GMOs are a serious risk to human or animal health or the environment, then member states cannot adopt emergency measures to prohibit their use.”

Food Safety: USDA Requires HACCP Reviews in Hurricane Affected Areas
On September 19, 2017, the USDA Food Safety and Inspection Service (FSIS) issued notice that establishments affected by recent hurricanes must reassess their Hazard Analysis Critical Control Point plans and take appropriate actions.  The notice stated that “[r]eview of FSIS data and published research indicates the potential for an increase in Salmonella incidence in regulated food products following flood events.” According to the notice, inspection program personnel must also “verify whether the establishment’s Sanitation SOPs and any cleaning and related monitoring are adequate to address any additional sanitation problems related to the hurricanes.”

FSMA: FDA Offers Training for Carriers covered by the Sanitary Transportation of Human and Animal Food Rule
On September 20, 2017, the U.S. Food and Drug Administration (FDA) announced that the “FDA is offering a one-hour training module, free of charge, to help carriers meet the requirements of FDA’s Sanitary Transportation of Human and Animal Food Rule.” According to the FDA, under the Sanitary Transportation Rule, covered rail and motor vehicle carriers must “provide food safety training to their personnel engaged in transportation operations.” The FDA stated that while the offered “course is designed to provide basic food safety training to transportation operations personnel…[it] does not describe specific operating procedures and practices.”  Instead the training is only “intended to complement industry best practices.”

Pennsylvania Actions and Notices
Milk Marketing Board


AgLaw HotLinks:


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Thursday, May 25, 2017

Agricultural Law Weekly Review—May 25, 2017

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:

Menu Labeling: New York City Announces Upcoming Enforcement of New Menu Labeling Rules
On May 18, 2017, New York City Mayor Bill de Blasio “announced that all New York City chain food retailers offering prepared foods, or ‘restaurant-type foods,’ will be required to post calorie counts on menu boards.” Additionally, the announcement stated that “chain restaurants and retailers will be required to have full nutritional information – not just calories – for standard menu items available on site, and they will have to post a statement about the daily recommended caloric intake of 2,000 calories.” Accordingly, on August 21, 2017, the New York City Departments of Health and Consumer Affairs “will begin issuing notices of violation subject to fines for not following the updated rule.”

Drones: Court Rules against Registration of “Model” Aircrafts
On May 18, 2017, Air & Space reported that the Court of Appeals for the District of Columbia has determined “that the FAA’s registration system for small unmanned aircraft was illegal as applied to ‘model’ aircraft.” According to the report, the court determined that the registration program violated the FAA Modernization and Reform Act of 2012 which states in Section 336 that FAA “may not promulgate any rule or regulation regarding a model aircraft.” The report stated, however, that “[t]he ruling did not affect any aircraft operated for commercial operations under Section 333 or Part 107, so drones of any size operating for business…still have to register.”

International Trade: President Sends Congress Notice of NAFTA Renegotiation
On May 18, 2017, The New York Times reported that “[t]he Trump administration gave Congress official notice…that it plans to renegotiate Nafta.” According to the report, “[i]n a brief letter to lawmakers, Robert Lighthizer, the newly confirmed United States trade representative, said the administration aimed to support economic growth and better-paying jobs through unspecified improvements to Nafta that would modernize the 23-year-old agreement.” According to the report, President Trump “had threatened to withdraw completely from the agreement, only to relent in late April when the leaders of Canada and Mexico, the other parties to the deal, called and asked him to renegotiate instead.”

Immigration Enforcement: ICE Arrests in 2017 Increase by Nearly 40 Percent
On May 17, 2017, Reuters reported that “U.S. arrests of suspected illegal immigrants rose by nearly 40 percent in the first 100 days of Donald Trump's presidency, following executive orders that broadened the scope of who could be targeted for immigration violations.” The report stated that according to the acting director of Immigration and Customs Enforcement (ICE) Thomas Homan, “arrests by his agency jumped to 41,318 between January 22 of this year and the end of April, up from 30,028 arrests in roughly the same period last year.” According to the report, “[o]f those arrested almost two-thirds had criminal convictions.” The report stated, however, that there “was also a significant jump - of more than 150 percent - in the number of immigrants not convicted of further crimes arrested by ICE: 10,800 since the beginning of the year compared to 4,200 non-criminal arrests in the same period in 2016.”

Food Safety: SCOTUS Rejects Appeal of DeCoster Sentencing
On May 23, 2017, The Des Moines Register reported that the U.S. Supreme Court declined to hear the appeals of Austin "Jack" DeCoster and his son, Peter DeCoster whose Iowa-based egg production company caused a significant salmonella outbreak in 2010.  According to the report, in 2015, the father and son were each sentenced to three months in prison because “they knew or should have known about the risks posed by the presence of salmonella in and around millions of egg-laying hens.” The sentencing judge, however, “allowed the DeCosters to stay free while they appealed the sentences, which they argued were unconstitutional and unreasonably harsh.” The report stated that according to the U.S. Supreme Court, the DeCosters cannot further appeal their sentences.

Industrial Hemp/Cannabis: Washington State Governor Signs Organic Marijuana and Industrial Hemp Legislation
On May 17, 2017, Reuters reported that Washington Governor Jay Inslee has “signed a bill that paves the way for the state to create what is believed to be the first system in the United States to certify marijuana as organic.” According to the report, the new legislation "creates a voluntary program for the certification and regulation of organic marijuana products" which is “to be administered by the Washington agriculture department.” Additionally, the report stated that “[w]hile it is legal for adults to smoke marijuana in Washington, it is not legal to grow industrial hemp.”  As a result, the new legislation will now provide “for the study of a method to allow hemp to be grown and used for industrial purposes.”

Industrial Hemp/Cannabis: South Carolina Legalizes Industrial Hemp
On May 20, 2017, The State reported that South Carolina has passed legislation legalizing the growing of industrial hemp.  According to the report, “Soon, perhaps this summer, the S.C. Department of Agriculture and the State Law Enforcement Division will issue 20 licenses to grow crops on up to 20 acres as a pilot program.” The report stated that to receive a license, a grower must: (1) pass a State Law Enforcement Division background check; (2) work with an in-state research university to develop and market the products; and (3) have a contracted buyer for the hemp.

Industrial Hemp/Cannabis: First Medical Marijuana Cultivation License Awarded in Maryland
On May 18, 2017, Marijuana Business Daily reported that “[t]he Maryland Medical Cannabis Commission gave final approval to the first company to win a cultivation license under the state’s MMJ program.” According to the report, “[t]he announcement…comes nine months after the state revealed 15 preliminary license winners, underscoring the slow rollout of Maryland’s medical cannabis program.” The report stated that the other 14 preliminary license “winners are still undergoing background checks, completing facility buildouts, and obtaining local zoning approval, according to a news release from the commission.” 

Industrial Hemp/Cannabis: Colorado Law Protects Hemp Farmers Who Use Federal Water
On May 22, 2017, The Journal reported that Colorado Governor John Hickenlooper has “sign[ed] a bill protecting hemp farmers who use water stored in federal reservoirs.” According to the report, “Colorado legalized growing hemp in 2014, but it is still banned at the federal level, creating complications when water from a federal project is used to water it.” As a result, Colorado law makers passed SB 117, entitled Recognize Industrial Hemp Agricultural Product for Agricultural Water Right, which permits Colorado water right holders the right to use the water “on hemp if the person is registered by the state to grow hemp for commercial, or research purposes.”

Food Safety: FDA Announces Updated Produce Safety Network page
On May 23, 2017, the U.S. Food & Drug Administration (FDA) issued an update to the agency’s Produce Safety Network page.  Accordingly, the updated page, entitled Building the Produce Safety Network, now includes a directory of regional network representatives.

Pennsylvania Legislation
House of Representatives
·         HB 790: An Act regulating controlled plants and noxious weeds (Passed by House – May 22, 2017)
Agricultural and Rural Affairs Committee (House)
·         HB 944: Amending the Public School Code to further provide agricultural education and providing for Commission for Agricultural Education Excellence (Referred to committee – May 19, 2017)

AgLaw HotLinks:
·         Got Milk? Too much of it, say U.S. dairy farmer - MarketWatch
·         Chicken chain commits to GAP welfare standards - Meatingplace
·         US appeals court sidesteps key ruling with MMJ business owner - Marijuana Business Daily
·         H-2A Guest Worker Visa Set Another Record - Brownfield Ag News
·         CDC: Raw Milk, Cheese Cause Almost All Dairy Foodborne Illness - Food Safety Magazine
·         USDA Secretary Sonny Perdue Defends Elimination of Rural Development Mission Area - National Sustainable Agriculture Coalition blog
·         Canadian lawmakers derail GMO labeling bill - Food Chemical News

Follow us on Twitter at PSU Ag & Shale Law (@AgShaleLaw) to receive AgLaw HotLinks

Connect with us on Facebook! Every week we will post the CASL Ledger which details all our publications and activities from the week.

Stay informed with our monthly Agricultural Law Brief located here.


For a comprehensive summary of daily judicial, legislative, and regulatory developments in agriculture and food, visit The Ag & Food Law Blog.

Thursday, January 19, 2017

Agricultural Law in the Spotlight—FSMA Regulatory Update

Written by Errin McCaulley – Research Assistant

On January 19, 2017 the Food and Drug Administration (FDA) announced the issuance of draft guidance titled Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations (FDA-2017-D-0175). Specifically, FDA has published this draft guidance to aid sprout operations comply with Subpart M (21 C.F.R. §§ 112.141-112.150) of the Produce Safety Rule. Interested parties wishing to comment upon this draft guidance may do so through https://www.regulations.gov/. Alternatively, written comments should be submitted to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should include reference to docket number FDA-2017-D-0175.

Scope of Draft Guidance

Generally, Subpart M applies to operations engaged in the “growing, harvesting, packing and holding of all sprouts,” as those terms are defined in the Rule, not otherwise exempted from coverage. Subpart M does not, however, apply to sprouts that are grown in soil or non-soil substrates which are harvested above the soil or substrate line without roots. This draft guidance does not cover all other applicable requirements for sprout operations under the Produce Safety Rule, such as Subpart F (relating to biological soil amendments), but does include reference to key provisions which are supplemented by Subpart M. For example, Subpart M includes sprout-specific building, tools, and equipment standards (21 C.F.R. § 112.143(a)-(b)) that apply in addition to Subpart L’s buildings, tools, and equipment standards (21 C.F.R. § 112.122). The majority of this draft guidance is devoted to the various testing requirements under Subpart M relating to E. coli, Salmonella, Listeria, and L. monocytogenes. Lastly, this draft guidance includes advice regarding voluntary compliance with Subpart M for sprout operations that are otherwise exempted from coverage under the Produce Safety Rule.

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.