Agricultural Law Weekly Review—July 7, 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:

GMO Labeling: Senate Votes to Limit Debate on Labeling Legislation

On July 6, 2016, the United States Senate voted 65-32 for cloture on legislation establishing a “National Bioengineered Food Disclosure Standard” (S.Amdt.4935 to S.764).  By obtaining the 60 votes necessary for cloture, debate on the proposed legislation will be limited to no more than 30 hours.  If enacted, the proposed legislation would create a national labeling standard for foods containing genetically modified organisms (GMO) and preempt state GMO labeling laws.

Antitrust: Court Approves Settlement of Class Action against Egg Producers

On June 30, 2016, the United States District Court for the Eastern District of Pennsylvania approved five separate settlement agreements reached in a consolidated class action suit, brought against five different national egg producers, for allegedly manipulating the supply and domestic price of eggs (In re: Processed  Egg Products Antitrust Litigation, 2016 WL 3584632).  The combined amount of the five separate settlement agreements totaled $8.425 million.

Food Safety: FDA to Extend Comment Period Regarding Raw Manure and Produce

On June 30, 2016, the United States Food and Drug Administration (FDA) published notice in the Federal Register that the agency was “extending the comment period for the notice entitled ‘Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments’ that appeared in the Federal Register of March 4, 2016” (81 FR 42715).  FDA stated that the extension is “due to maintenance on the Federal eRulemaking portal in early July 2016.” As a result, FDA will now accept submitted comments, either written or electronic, by July 19, 2016.

Pesticides: EPA Extends Comment Period for Ecological Risk Assessments of 3 Herbicides

On July 6, 2016, the United States Environmental Protection Agency (EPA) published notice in the Federal Register extending the “comment period for the draft ecological risk assessments of atrazine, simazine, and propazine…60 days, from August 5, 2016, to October 4, 2016.” (81 FR 44018).  According to EPA, the “comment period is being extended in response to a number of extension requests from various stakeholders citing difficulty commenting during the growing season, and the length, quantity, and complexity of the Risk Assessments.”

Worker Safety: OSHA to Increase Civil Penalties for Violations

On June 30, 2016, the United States Department of Labor (DOL) announced that DOL was adjusting civil penalties for the department’s Occupational Safety and Health Administration (OSHA).  According to DOL, “OSHA's maximum penalties, which were last adjusted in 1990, will increase by 78%...[and] [g]oing forward, the agency will continue to adjust its penalties for inflation each year based on the Consumer Price Index.” DOL stated, “[t]he new penalties will take effect after August 1, 2016…[and] [a]ny citations issued by OSHA after that date will be subject to the new penalties if the related violations occurred after November 2, 2015.”

Farm Inspection: Court Orders Government Access to “Private Membership Association” Facilities and Records

On July 6, 2016, the United States District Court for the Eastern District of Pennsylvania held that the United States Department of Agriculture and its Food Safety and Inspection Service (FSIS) can enforce “an April 4, 2016 FSIS administrative subpoena requiring…access to Miller’s Organic Farm’s facilities and records related to the farm’s meat and poultry products” (United State of America v. Miller’s Organic Farm and, Amos Miller, Civil Action No. 16-cv.2732)  According to the court, prior to the ruling, Miller’s Organic Farm, and its owner Amos Miller, had “refused to comply with the subpoena, on grounds that it infringed their First Amendment right to freedom of association, because Miller’s Organic Farm is a ‘Private Membership Association.’” The court stated that “Defendant Amos Miller,” who represented himself in court, “failed to show cause why Miller’s Organic Farm and he should not produce the summoned information and grant the summoned access.”      

Agricultural Law Weekly Review—March 10, 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:

FSMA: FDA Seeks Public Input Regarding Use of Raw Manure and Produce Safety

On March 4, 2016, the United States Food and Drug Administration (FDA) published notice in the Federal Register that the Agency was requesting public comments, scientific data, and information regarding the use of raw manure and produce safety.  According to FDA, the Agency will use the requested submissions for the development of a “risk assessment” that will be used “to determine how much consumer health is put at risk by the use of raw manure as fertilizer in growing crops covered by the Produce Safety rule, and what can be done to help prevent people from getting sick.” The submission deadline for comments, scientific data, and information regarding raw manure and produce safety is May 3, 2016.

HPAI: APHIS Releases Findings Regarding January Outbreak in Indiana

On March 4, 2016, the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (AHIS) issued a report regarding the January Highly Pathogenic Avian Influenza (HPAI) outbreak among commercial turkeys in Indiana.  Entitled Epidemiologic and Other Analyses of Indiana HPAI/LPAI-Affected Poultry Flocks: March 4, 2016 Report, the report stated that while “genetic analysis determined that all H7N8 HPAI viruses detected from this event are of North American wild bird lineage…sampling and testing of wildlife near infected premises…[did not contain] evidence of existing virus.” According to the report, the outbreak may have been due to unusually warm and wet weather conditions and the failure of the turkey producers to eliminate high risk activities previously associated with HPAI outbreaks in 2015.

Raw Milk: West Virginia Legalizes Herd Share Distribution Agreements

On March 4, 2016, West Virginia Governor Earl Ray Tomblin signed into law legislation permitting shared animal ownership agreements for the purpose of consuming raw milk (S.B. 387).  According to the legislation, a responsible party may now acquire a percentage ownership in a milk producing animal and receive a share of the animal’s raw milk production.  Nevertheless, the legislation states that this percentage ownership does not allow for any further distribution of the raw milk production received and that “[t]he sale or resale of milk obtained from a herd share is strictly prohibited.” 

Crop Insurance: Pennsylvania Deadline Nears for Spring Planted Crops

Tuesday March 15, 2016, is the final day for Pennsylvania farmers to either apply for crop insurance on most insurable spring planted crops or make changes to their present crop insurance policies regarding spring planted crops.  According to the United States Department of Agriculture's Risk Management Agency, farmers that meet the March 15, 2016 deadline have the ability to obtain coverage “for cabbage, corn, forage seeding, fresh market sweet corn, fresh market tomatoes, grain sorghum, green peas, potatoes, processing beans, processing sweet corn, processing tomatoes, soybeans, spring barley, spring oats, and tobacco in Pennsylvania.” Further information regarding crop insurance is available at http://www.rma.usda.gov/.  

Conservation: USDA Announces Availability of $20 Million for Conservation Projects

On March 7, 2016, the United States Department of Agriculture issued a press release stating the availability of $20 million for conservation projects through the Department’s Conservation Innovation Grants (CIG) program.  According to the press release, CIG “is designed to focus on innovative conservation projects that promote science-based solutions to benefit both producers and the environment.” The press release stated that qualifying “[p]rojects may include on-farm pilot projects and field demonstrations, and are funded to accelerate the transfer and adoption of promising technologies to landowners in order to address critical natural resource concerns.” 

Clean and Green: Agricultural and Rural Affairs Committee Considers Amending Use Values

On March 8, 2016, the Pennsylvania State Senate Agricultural and Rural Affairs committee announced that on Tuesday March 15, 2016, it will hold a meeting to consider House Bill 806 (HB 806).  According to the House Co-Sponsorship Memoranda issued by Representative Martin Causer, the purpose of the proposed legislation is to amend the Pennsylvania Farmland and Forest Land Assessment Act of 1974 (commonly known as Clean and Green) “to prohibit the application of use values that result in assessments higher than fair market value.” The committee meeting considering HB 806 will be held at 8:45am in the State Capitol, Room 8E-A, East Wing.

FSMA Update: Farmers Now Required to Retain Records to Prove “Qualified Exemption” Status

Written by M. Sean High – Staff Attorney

On January 26, 2016, the federal Food Safety Modernization Act (FSMA) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption became effective [21 CFR 112].  As a result, beginning on January 26, 2016, all farmers that seek to claim qualified exemption status under FSMA must maintain records that support the claim.

Under FSMA, the federal government has established rules to regulate produce safety.  Nevertheless, FSMA has provided an exemption for small produce growers that can meet (and verify) certain requirements. 

According to FSMA, a produce grower is entitled to receive a qualified exemption if: (1) during the previous three years, the average annual sales of all foods (not just produce) was less than $500,000, and (2) the majority of the food sold was sold directly to qualified end-users [21 CFR 112.5(a)].

To define the term food, FSMA uses the definition found in Section 201(f) of the federal Food, Drug, and Cosmetic Act which states: “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article [21 U.S.C. 321(f)].” Additionally, FSMA defines the term food to also include “seeds and beans used to grow sprouts” [21 CFR 112.3(c)].

FSMA defines qualified end-users as consumers, restaurants, or retail food establishments (such as grocery stores) that are: (1) located in the same state (or Indian reservation), and (2) not more than 275 miles from the farm claiming the end-user for purposes of qualified exemption statues [21 CFR 112.3(c)].

Importantly, farmers are now required to establish and keep records (such as sales receipts) that demonstrate that a farm has met all of the qualified exemption requirements [21 CFR 112.7].  The compliance date for maintaining records to support eligibility for the qualified exemption began January 26, 2016 (the effective date of the rule).

Finally, FSMA requires that a farm seeking a qualified exemption must “including a written record reflecting that you have performed an annual review and verification of your farm's continued eligibility for the qualified exemption" [21 CFR 112.7].  According to the final rule for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, however, farmers do not need to complete this written requirement until the farm’s general compliance date [80 FR 74353].

FDA Issues New Food Safety Rules

Written by Katharine Richter

On November 13, 2015, the United States Food and Drug Administration (FDA) finalized new rules updating the bipartisan Food Safety Modernization Act (FSMA).  The new rules will “establish enforceable safety standards for produces farms and make importers accountable for verifying that imported food meets U.S. safety standards.”  A rule was also established that created third-party certification bodies which will perform food safety audits in foreign food facilities.

The three rules released are “referred to as the Produce Safety rule, the Foreign Supplier Verification Programs rule, and the Accredited Third-Party Certification rule.”  The stream of recent foodborne illnesses that have occurred over the last few years highlighted to the FDA the need for updates to food safety rules.

The Produce Safety rule “establishes science-based standards for growing, harvesting, packing, and holding produce” which are designed to minimize risk of illness when consuming contaminated produce.  The Foreign Supplier Verification Programs rule requires food importers in the U.S. that have received imported foreign foods, that these foods are meeting U.S. safety standards and meet the same standards of food safety as domestic farms.  The importers are required to conduct various verification activities.  The Accredited Third-Party Certification creates a program where “third-party certification bodies…conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.”

EPA Prepares to Ban Chlorpyrifos

Written by Tyler R. Etter

On October 30, 2015, the Environmental Protection Agency (EPA) opened for commenting a proposal to revoke all tolerances for the insecticide chlorpyrifos. The proposal is being issued pursuant to a court order from August of 2015.

Originally, the EPA planned to issue the proposed rule by April of 2016, but the 9^th Circuit ordered the Agency to deny the petition issued for a safety evaluation, issue a proposal, or issue a final rule by October 31, 2015. Due to the Agency being unable to make a safety finding, and questions in scientific assessment still being open, the EPA has issued the proposal.

The proposal will seek to revoke all food residue tolerances for chlorpyrifos. Under current analysis, there does not appear to be a risk from exposure to chlorpyrifos from food. However, the Agency cannot make a conclusion about the aggregate exposure between food residue and exposure from drinking water in affected watersheds.

The comment period is open until January 5, 2016. The EPA expects to release a final rule by December of 2016. The proposed rule can be read and commented on here.

USDA Plan to Help Small Farmers with Certification

Written by Stephen Kenney


On September 15, 2015, Agricultural Marketing Service (AMS) Administrator Anne Alonzo spoke about the expansion of a pilot program that was designed to help small and mid-sized growers and cooperatives meet the Good Agricultural Practices (GAP) certification.  The certification verifies that a farm follows the food safety practices and recommendations from the Food and Drug Administration.  The safety practices focus on producing, packing, handling, and storing fruits and vegetables in a safe manner that minimizes risks of microbial food safety hazards.  Produce purchasers are increasingly requiring that suppliers attain GAP certification.

The pilot program was referred to as the GroupGAP program.  Small and mid-size farmers can often find it difficult to attain the GAP certification because the audit process can be expensive.  The program enabled growers, food hubs, and cooperatives to work together to attain certification and share the cost of the audits.

In July 2015 Michigan State released a study on how the food safety pilot program fared in Michigan.  The study found that GAP certification could meet the certification needs of small farms.  It was also found that the program could be affordable.  The audit costs were $492 per-farm.  The study estimated that individual farm savings through GroupGAP certification versus individual GAP certification was about $700. 

AMS will share details of the future program at the October 23rd-25th Produce Marketing Association (PMA) Fresh Summit meeting in Atlanta.

Raw Milk Update: FDA Releases Risk Assessment of Cheese Produced from Raw Milk

On July 31, 2015, the Food and Drug Administration, in conjunction with Health Canada, released a risk assessment for soft-ripened cheeses produced from raw milk. The assessment was focused on the risk of contracting listeriosis by consuming the products.

Listeriosis is caused by Listeria monocytogenes, a pathogen that is frequently found in agricultural and food processing environments. Listeriosis generally affects the digestive tract, but can also spread to other parts of the body, known as “invasive listeriosis”. Those most at-risk for the disease are the elderly, pregnant women, children, and individuals with compromised immune systems.

In the risk assessment, the risk of contracting listeriosis was conducted on a per-serving basis of a Camembert-like soft-ripened cheese, with a comparison between the use of pasteurized and non-pasteurized milks in the production of the cheese. The assessment also focused on different production methods, such as the aging period and intervention techniques to reduce the risk of contracting listeriosis. The current standard is a 60-day aging period, but the FDA is considering the benefits of a performance standard in its place.

The risk assessment had already received criticism during the draft phase in 2013. Both U.S. and French cheese associations have called the assessment flawed, and are concerned that the assessment will cast doubt on all cheeses produced from raw milk, including hard cheese.

The FDA is currently requesting additional comments and data as a response to the assessment. The full risk assessment can be read here.

Written by Tyler R. Etter- Research Assistant
August 3, 2015

FDA Extends Comment Period for FSMA Regulations

On August 8, 2013, the U.S. Food and Drug Administration issued Federal Register notices that the comment periods for the “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” proposed rule and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” proposed rule are extended until November 15, 2013.

The Preventive Controls for Human Foods proposed rule contains provisions requiring hazard analysis and risk based preventive controls as well as revisions to the Current Good Manufacturing Practice requirements found in 21 CFR part 110.

The Produce Safety proposed rule sets science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. Please see our previous blog post on the Produce Safety proposed rule for more information.

Please visit the FDA’s website and the Federal Register concerning the two proposed rules for further information.

Written by Sarah Doyle - Research Assistant
The Agricultural Law Resource and Reference Center
@PSUAgLawCenter
August 9, 2013