Showing posts with label antimicrobial. Show all posts
Showing posts with label antimicrobial. Show all posts

Thursday, September 20, 2018

Agricultural Law Weekly Review - September 20, 2018


Written by:
Jackie Schweichler - Education Programs Coordinator

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

International Trade: USDA Releases Report Addressing International Trade Program Payments
On August 31, 2018, the U.S. Department of Agriculture (USDA) released a report explaining the methodology used to calculate payment rates to agricultural producers.  In July 2018, USDA announced compensation programs for producers and farmers who have experienced losses as a result of trade complications with China.  These programs include the Market Facilitation Program (MFP) and Food Purchase and Distribution Program (FPDP).  Under MFP, the Farm Service Agency will provide payments to corn, cotton, dairy, sorghum, soybean, hog, and wheat producers.  Under FPDP, the Agricultural Marketing Service will purchase up to $1.2 billion in commodities for distribution to nutrition assistance programs.  To see how USDA calculated costs and payments, see the report Trade Damage Estimation for the Market Facilitation Program and Food Purchase and Distribution Program.

Antimicrobial Use: FDA Reveals Five Year Plan for Antimicrobial Stewardship
On September 14, 2018, the U.S. Food & Drug Administration (FDA) Center for Veterinary Medicine (CVM) released its five year plan, Supporting Antimicrobial Stewardship in Veterinary Settings.  In the initial announcement of this plan on July 31, 2018, FDA explained that overuse of antimicrobial drugs can promote development of antimicrobial-resistant bacteria.  The plan involves pre-approval review where the drug sponsor must show that the drug is safe and effective for treating animals. In addition, for drugs used in food-producing animals, CVM will evaluate the safety of any drug residue that may remain in the food. The plan also includes post-approval surveillance and monitoring, where CVM will review event reports, monitor resistance trends, and update animal drug product labeling.

WOTUS: Court Enjoins WOTUS Rule in Iowa
On September 18, 2018, the U.S. District Court for North Dakota issued a court order enjoining the Waters of the United States rule (WOTUS) in Iowa (State of North Dakota, et al, v. EPA, et al, Case No. 3:15-cv-59). The WOTUS rule has now been suspended in more than half of the fifty states.  On August 16, 2018, a federal district court in South Carolina enjoined the WOTUS rule in twenty-four states. A month later, on September 12, 2018, the U.S. District Court for the Southern District of Texas enjoined WOTUS in Texas, Louisiana, and Mississippi (State of Texas, et al. v. EPA, et al, 3:15-CV-00162).  

Food Safety: Court Allows Lawsuit to Move Forward Regarding Generally Recognized as Safe Rule
On September 12, 2108, the U.S. District Court for the Southern District of New York issued an opinion allowing a lawsuit to go forward with respect to the final rule Substances Generally Recognized as Safe (GRAS rule)  (21 CFR Parts 20, 25, 170, 184, 186, and 570).  Several food safety organizations filed suit against the U.S. Food and Drug Administration (FDA) alleging that the GRAS rule is an abuse of discretion, violates fundamental principles of separation of powers, and exceeds FDA’s authority. Under the GRAS rule, manufacturers independently determine whether a chemical additive is generally recognized as safe.  As such, FDA approval is optional and GRAS substances may be added to food without FDA review or approval.  In the most recent order, the court declared that the plaintiffs plausibly allege harm and, therefore, have standing to bring the case. (Center for Food Safety, et al, v. Department of Health and Human Services, et al., 2018 WL 4356730)  

Water Quality: USDA Announces Funding for Rural Water Infrastructure Projects
On September 17, 2018, the U.S. Department of Agriculture (USDA) announced $392 million in funding for rural water and wastewater infrastructure.  The money will be used to support 120 infrastructure projects through the Water and Waste Disposal Loan and Grant program.  State and local governmental entities and private nonprofits can apply for long-term loans or grants.  Funding may be used for infrastructure costs relating to drinking water, sewer, solid waste, stormwater, and drainage.  

Water Quality: Penn State Publishes Research on Conservation Dairy Farming
On September 13, 2018, Penn State University researchers published a study the impacts of conservation dairy farming.  The study examined a conservation dairy farming system that “produces the majority of the dairy feed and forage crops, with no-till, continuous diversified plant cover, and manure injection.”  The researchers showed that conservation dairy farming has the potential for soil fertility balance as well as decreased emissions of nitrous oxide.  The researchers also found conservation dairy farming could improve overall water quality and reduce sediment concentrations in streams.  The study, Conservation Dairy Farming Impact on Water Quality in a Karst Watershed in Northeastern US, was published in ScienceDirect.

From National Ag Law Experts:
Ag & Food Law Update, The National Agricultural Law Center (September 18, 2018)

Sharon Anglin Treat, More Than 300 State Legislators Urge Removing Corporate-Friendly ISDS Provisions from NAFTA, Institute for Agriculture & Trade Policy (September 14, 2018).

Pennsylvania Regulations 
HB 2647 referred to Environmental Resources and Energy (September 17, 2018) bill would allow construction sites on small acreage to apply for a waiver of the National Pollutant Elimination System Permit.

HB 2648 referred to Game and Fisheries (September 17, 2018) bill would remove restrictions on thermal and night vision equipment for hunting

Pennsylvania Notices
Public hearing: Milk Marketing Board to conduct hearing on September 26, 2018 (to solicit comments for changes to Milk Marketing Law)
Public hearing: Senate Agriculture and Rural Affairs meeting on invasive and native species (October 2, 2018)

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

Stay Informed:
Listen to our weekly Agricultural Law Podcast
Read our monthly Agricultural Law Brief newsletter     
Follow us on Twitter at PSU Ag & Shale Law (@AgShaleLaw) to receive daily AgLaw HotLinks
Connect with us on Facebook to view our weekly CASL Ledger detailing Center publications and activities
Visit The Ag & Food Law Blog for a comprehensive summary of daily judicial, legislative, and regulatory developments in agriculture and food

Thursday, July 5, 2018

Agricultural Law Weekly Review - July 5, 2018


Written by:
Jackie Schweichler - Education Programs Coordinator

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

Farm Bill: U.S. Senate Agrees to Latest Amendments in 2018 Farm Bill
On June 28, 2018, the U.S. Senate voted to pass its latest version of the 2018 Farm Bill with a vote of 86 to 11. Earlier, on June 21, 2018, the House of Representatives passed H.R.2, and the latest Senate action substantially amended H.R.2, including changing the name of the bill from the Agriculture and Nutrition Act of 2018 to the Agriculture Improvement Act of 2018.  Before the bill can go to a final vote, Congress must go conference to resolve legislative differences between the House and Senate versions of the bill. The 2018 Farm Bill provides updates and changes to Department of Agriculture programs including those in conservation, nutrition assistance, farm credit, rural development, crop insurance, and more.

Biofuels: EPA Releases Proposed Volume Requirements for Renewable Fuels
On June 26, 2018, the U.S. Environmental Protection Agency (EPA) released proposed volume requirements for the Renewable Fuel Standard Program. The EPA sets renewable fuel percentage standards each year for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel as applied to gasoline and diesel transportation fuel. Part of the proposed volume requirements would increase the 2019 renewable fuel blending mandate to 19.88 billion gallons, an increase of 3 percent from 2018. EPA also plans to increase advanced biofuel requirements to 4.88 billion gallons and cellulosic biofuel to 381 million gallons. EPA will hold a public hearing for the proposed rule on July 18th and will accept public comment until August 17, 2018.

Right to Farm Laws: North Carolina Legislature Overrides Governor Veto to Approve Changes to Right to Farm Law
On June 27, 2018, the North Carolina House voted to override the governor’s veto of SB 711 which, now passed, will provide protections to farmers against nuisance lawsuits. The governor vetoed the bill on June 25th and the Senate voted to override the veto on June 26th. SB 711 adds language to the North Carolina Farm Act of 2018 to shield farmers who are operating in good faith from nuisance lawsuits that are filed after the operation has been established. The changes to the law include a requirement that counties must have land records that provide notice where a tract of land is located within half a mile from a poultry, swine, or dairy operation. The law prohibits any nuisance action from being filed against an agricultural operation unless the plaintiff’s property is directly affected, the affected property is within a one-half mile of the operation, AND the action is filed within one year of the establishment of the operation or within one year of the operation undergoing a fundamental change.

Antimicrobial Use: FDA Releases Guidance on Antimicrobial Animal Drug Sale Rule
On June 28, 2018, the U.S. Food & Drug Administration (FDA) released a new guidance document regarding antimicrobial animal drug sales for small business entities. The guidance document, Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide, is intended to help small businesses understand and comply with “reporting regulations for antimicrobial animal drug sales and distribution information.” The guidance document was prepared following the 2016 publication of the final rule, Antimicrobial Animal Drug Sales and Distribution. The rule requires that sponsors of approved antimicrobial animal drug products must submit an annual report on the amount that is sold or distributed for use.

Right to Farm Laws: Court Awards $25 Million in Second Nuisance Lawsuit Against Hog Operation
On June 29, 2018, the U.S. District Court for the Eastern District of North Carolina awarded $25 million to plaintiffs in a nuisance lawsuit filed against Smithfield Foods, according to NewsObserver (McGowan v. Murphy-Brown, LLC, No. 7:14-CV-182-BR). The plaintiffs are neighboring landowners who complained of flies, stench, rumbling trucks and other problems associated with living next to a hog farm. This is the second in a series of recent lawsuits filed against Smithfield Foods, the world’s largest pork processor and hog producer. In April, a jury awarded $50 million in damages to ten neighbors of another Smithfield hog operation (McKiver et al v. Murphy-Brown, LLC, 7:2014cv00180). The damages award in the first case has since been reduced to $3.25 million due to North Carolina’s statutory cap on punitive damages.

From National Ag Law Experts:
Institute for Agriculture & Trade Policy, Uprooted Episode 38: Chatting with the IATP Board (June 27, 2018)
Tiffany Dowell Lashmet, James v. Young: Are Landowners Liable for Horse Riding Injury to Child?, Texas Agriculture Law (July 2, 2018)

Pennsylvania Notices
Environmental Quality Board Meeting Cancellation, the Board meeting for July 17th is cancelled; the next regular meeting will be August 21, 2018 (June 30, 2018)

Pennsylvania Legislation
HB 2121 Commonwealth Budget 2018-2019 (signed by Governor, June 22, 2018)

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

Stay Informed:
Listen to our weekly Agricultural Law Podcast
Read our monthly Agricultural Law Brief newsletter     
Follow us on Twitter at PSU Ag & Shale Law (@AgShaleLaw) to receive daily AgLaw HotLinks
Connect with us on Facebook to view our weekly CASL Ledger detailing Center publications and activities
Visit The Ag & Food Law Blog for a comprehensive summary of daily judicial, legislative, and regulatory developments in agriculture and food

Thursday, September 28, 2017

Agricultural Law Weekly Review—September 28, 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:

GMOs: Syngenta Settles with Corn Farmers over Loss of Chinese Market
On September 26, 2017, Syngenta announced that a settlement had been reached with U.S. corn farmers “to resolve litigation concerning the launch of Syngenta’s Agrisure Viptera and Agrisure Duracade corn traits.” The litigation stemmed from allegations that Syngenta had introduced new genetic traits (commercially advertised as Viptera and Duracade) into the U.S. corn market before the genetically modified varieties had been approved by all major export markets.  Eventually, the traits were detected in U.S. corn imports to China and resulted in U.S. corn farmers being denied access to the Chinese market.  Though Syngenta did not disclose the financial terms of the settlement, Bloomberg News reported  that the total amount exceeded $1.4 billion.

Pesticides: EPA Intends to Permit Use of Dicamba in 2018
On September 20, 2017, Reuters reported that the U.S. Environmental Protection Agency (EPA) intends “to allow farmers to spray the controversial weed-killer dicamba next year, but with additional rules for its use.” According to the report, Reuben Baris, the acting chief of the herbicide branch of the EPA Office of Pesticide Programs, recently told state regulators that “the agency had not yet determined what steps it would take to mitigate problems associated with dicamba.” Reuters stated that “[t]he herbicide, which fights weeds resistant to another herbicide called glyphosate, was linked to widespread crop damage this summer.” Accordingly, some farmers have alleged that “the chemical caused damage by drifting away from where it was sprayed to fields of soybeans and other plants that could not tolerate it.”

Labor: Michigan Dairy Pleads Guilty to Hiring Undocumented Immigrants
On September 20, 2017, M Live reported that Michigan dairy farmer Denis Burke has pleaded guilty to federal charges of hiring undocumented immigrants. The report stated that “[b]etween February 2008 and May 2013, [Burke and his wife] hired and harbored more than 100 undocumented immigrants to work on their [two Michigan] farms.” According to the report, under the terms of the guilty plea, Burke faces a prison sentence of between 33 and 41 months and must pay a fine of $187,500.

SNAP: USDA Extends D-SNAP to Floridians Affected by Hurricane Irma
On September 22, 2017, the U.S. Department of Agriculture (USDA) announced that “Floridians struggling with the after effects of Hurricane Irma could be eligible for help buying food through USDA’s Disaster Supplemental Nutrition Assistance Program (D-SNAP).” According to Agriculture Secretary Sonny Perdue, “households who may not normally be eligible under regular SNAP rules may qualify for D-SNAP -- if their income is under the disaster limits and they have qualifying disaster-related expenses.” The announcement stated that “D-SNAP eligible households in the affected areas will receive two months of benefits, equivalent to the maximum amount of benefits normally issued to a SNAP household of their size.”

Antimicrobial: FDA Announces Public Meeting for National Antimicrobial Resistance Monitoring System
On September 21, 2017, the U.S. Food and Drug Administration (FDA) published notice in the Federal Register announcing a public meeting entitled 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System (82 FR 44189).  According to the notice, “[t]he purpose of the public meeting is to discuss the current status of the National Antimicrobial Resistance Monitoring System (NARMS) and directions for the future.”  The announced meeting is scheduled to be held in Washington, DC on October 24 and 25, 2017.

Spotted Lanternfly: PDA Expands Spotted Lanternfly Quarantine
On September 22, 2017, the Pennsylvania Department of Agriculture (PDA) announced that the Commonwealth’s Spotted Lanternfly quarantine had been expanded to include 26 municipalities in Berks, Bucks, Chester, Lehigh, Montgomery and Northampton counties.  According to PDA, “[t]he quarantine was already in effect in other areas of the six counties.” PDA stated that the Spotted Lanternfly, which can be particularly destructive to the apple, grape and hardwood industries, “had not been found in the United States prior to its initial detection in Berks County in the fall of 2014.”
                 
Pennsylvania Legislation
Agricultural and Rural Affairs Committee (Senate)
  • Joint public hearing to discuss the Spotted Lanternfly (Hearing Room #1, North Office, October 18, 2017) 

Agricultural and Rural Affairs Committee (House)
  • Public hearing on HB 1463 - legislation which will increase dog license fees and authorize a Statewide online license registry (Room 205, Ryan Office, September 27, 2017)
  • Joint informational meeting on Spotted Lanternfly (Hearing Room #1, North Office, October 18, 2017) 

Environmental Resources and Energy (House)
  • HB 1818 Legislation providing for labeling, signage, and restrictions on sales and use of seeds/plants treated with neonicotinoid pesticides (Referred to committee September 25, 2017) 

Pennsylvania Actions and Notices
Department of Agriculture
Environmental Hearing Board
State Conservation Commission

AgLaw HotLinks:

Listen to our new Agricultural Law Podcast by clicking here!

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, August 17, 2017

Agricultural Law Weekly Review—August 17, 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:

FSMA: FDA Releases Guidance on Sanitary Transportation of Human and Animal Food Rule
On August 14, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of guidance material entitled: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule: Guidance for Industry.  According to FDA, “this guidance provides clarification on the scope of the waiver for food establishments that provide food directly to consumers from the requirements of the Sanitary Transportation of Human and Animal Food Rule (the food establishment waiver).”  FDA stated that the guidance is “in response to questions the Agency has received since publication of the final rule.”

Farmland Preservation: Pennsylvania Announces 33 Newly Preserved Farms
On August 11, 2017, the Pennsylvania Department of Agriculture (PDA) announced that the “Pennsylvania’s Agricultural Land Preservation Board [has] added 2,999 acres on 33 farms in 12 counties to the more than half a million acres and 5,100 Pennsylvania farms permanently preserved for agricultural production.”  According to PDA, the 33 newly persevered farms are located in Berks, Blair, Bucks, Centre, Chester, Lancaster, Lehigh, Northampton, Perry, Snyder, Union and York counties.  PDA stated that since the Pennsylvania Agricultural Conservation Easement Purchase Program “began in 1988, federal, state, county and local governments have invested nearly $1.4 billion to preserve 539,180 acres on 5,169 farms in 59 counties for future agricultural production.”

Livestock Mandatory Reporting/COOL: USDA Strengthens Enforcement Rules for Livestock Mandatory Reporting and COOL Programs
On August 8, 2017, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced that the agency has “issued a final rule allowing USDA to take action as needed, including levying civil penalties, against violators of the Livestock Mandatory Reporting (LMR) and the Country of Origin Labeling (COOL) regulations.” USDA-AMS stated that “[t]he action extends the current rules of practice under the Agricultural Marketing Act of 1946, as amended, to include LMR and COOL violations.” Accordingly, the new rules “allow up to $10,000 in fines per violation for violating the LMR regulations…[and] fines for a retailer or person engaged in the business of supplying a covered commodity that willfully violates COOL regulations.”

Antimicrobial: FDA Proposes New Method to Determine Antimicrobials in Food Animals
On August 15, 2017, the U.S. Food and Drug Administration (FDA) published notice in the Federal Register of the “availability for public comment of a proposed method for applying a food animal biomass denominator to annual data on antimicrobials sold and distributed for use in food animals in the United States” (82 FR 38695).  According to FDA, “[a]nimal drug sponsors are required to report annually to FDA the amount of antimicrobials sold or distributed for use in food-producing animals and provide species-specific estimates of the percentage of their drug product sales for use in any of the four major food-producing species (cattle, swine, chickens, and turkeys) identified on the approved product label.” FDA is proposing a “method for using a biomass denominator to adjust these sales data.” FDA stated that “[t]he proposed method will provide estimates of annual antimicrobial drug sales adjusted for the size of the animal population (the animal biomass of each such species) potentially being treated with those drugs.”

Dairy: FDA Announces Guidance for Ultrafiltered Milk  
On August 14, 2017, the U.S. Food and Drug Administration (FDA) published notice in the Federal Register of the availability of a guidance for industry entitled: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry (82 FR 37815).  According to FDA, “[t]he guidance advises manufacturers who wish to use ultrafiltered milk (UF milk) or ultrafiltered nonfat milk (UF nonfat milk) in the production of standardized cheeses and related cheese products that, pending completion of a rulemaking regarding the use of UF milk in the production of these products, [FDA] intend[s] to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products." Additionally, FDA stated that the agency “also intend[s] to exercise enforcement discretion regarding the declaration of ingredients in the labeling of standardized cheeses and related cheese products when fluid UF milk and fluid UF nonfat milk are used as ingredients.”

Animal Welfare: Pennsylvania Captive Deer Herd Tests Positive for Chronic Wasting Disease
On August 11, 2017, the Pennsylvania Department of Agriculture (PDA) “announced that 27 deer from a Bedford County deer farm have tested positive for Chronic Wasting Disease.”  According to PDA, “[t]o prevent further spread of the disease, officials from the U.S. Department of Agriculture Veterinary Services, USDA Wildlife Services and the Pennsylvania Department of Agriculture depopulated, or euthanized, the herd [of 215 deer] on June 20, 2017.” Subsequently, “[t]he National Veterinary Services Laboratory in Ames, Iowa conducted the testing and reported results to the department and USDA on August 7, 2017.”  PDA stated that “[a]ccording to the Centers for Disease Control and Prevention, there is no strong evidence that humans or livestock can contract Chronic Wasting Disease.”

Pennsylvania Legislation
Agriculture and Rural Affairs Committee (Senate)


Agriculture and Rural Affairs Committee (House)


Pennsylvania Actions and Notices
Department of Agriculture


AgLaw HotLinks:


Listen to our new Agricultural Law Podcast by clicking here!

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.

Monday, June 15, 2015

FDA Publishes Final Rule on Veterinary Feed Directive

On June 3, 2015, the Food and Drug Administration (FDA) published the final rule for the Veterinary Feed Directive (VFD). The VFD places the use of antimicrobial drugs in or on the feed of food-producing animals (VFD drugs) under veterinary oversight. The rule is part of a broader effort on the part of the FDA to eliminate antimicrobial drug use in a productive capacity, such as promoting animal growth.

The final rule outlines the authorization process of VFD drug use and provides veterinarians with a national framework regarding the authorization of drug use for specific animal health purposes.  VFD drugs can be issued only in the context of a veterinarian-client-patient-relationship (VCPR). The rule provides the key elements that constitute the relationship.

The final rule also requires that veterinarians follow the state-defined requirements for a VCPR. The FDA will defer to the state’s judgment regarding conduct standards for veterinarians so long as the state meets the federal VCPR. In the event that a state fails to meet the standard, the FDA will require veterinarians to adhere to the federal standard.

The FDA will begin enforcement of the VFD final rule in December of 2016 to allow adequate time for industry to adjust to the new regulations. The full text of the final rule can be found here. For the outline of the FDA’s “current thinking” on industry compliance for the final rule, see the draft guidance available here.

Written by Tyler R. Etter- Research Assistant
June 15, 2015

Friday, May 29, 2015

Farm Foundation Launches Effort to Reduce Antimicrobial-Drug Use


On May 14, 2015, Farm Foundation, a nonprofit organization that attempts to promote dialogue between the various farm sectors, conducted the first of a series of forums designed to educate livestock producers, veterinarians, and government regulators regarding the phasing-out of antimicrobial-drug use in food producing animals.

According to the United States Food and Drug Administration (FDA), the growing resistance to antimicrobial-drugs represents a “global threat.” Significantly, FDA states that “[a]ntimicrobial use in animals can contribute to the emergence of antimicrobial resistance in bacteria that may be transferred to humans, thereby reducing the effectiveness of antimicrobial drugs for treating human disease.”

To combat the dangers associated with antimicrobial-drug use in animals, FDA has issued a series of guidelines on the judicious use and the phasing out of these drugs. 

Though FDA’s guidelines are voluntary, its recommendations are often difficult for interested livestock producers and veterinarians to fully understand.  Through its forum series, Farm Foundation seeks to provide these individuals with the tools necessary to achieve the recommended FDA guidelines.  Furthermore, Farm Foundations hopes to help government regulators better understand the challenges producers and veterinarians face when attempting to implement the suggested guidelines.
Written by M. Sean High - Staff Attorney
May 29, 2015