The USDA announced changes to the process for exempting prohibited substances in organic food without public comment. Under the new policy, exempted synthetic materials could be indefinitely permitted unless a two-thirds majority of the NOSB votes for their removal, rather than requiring reapproval every five years. Consumer and environmental groups decried this move as weakening the meaning of the organic label by minimizing incentives for natural alternatives and lowering consumer expectations. They intend to campaign for the USDA to reverse the changes and uphold the spirit of the organic law and standards.
Eversheds Food and Drink Seminar - Health Nutrition Labelling Presentation 3r...Eversheds Sutherland
Eversheds Food and Drink Seminar - Health Nutrition Labelling Presentation 3rd October 2013 - Katharine Vickery, Eversheds LLP.
Current Developments - What’s changed over the past 12 months?
• Nutrition and Health Claims: register of approved claims
What's changed available and informal guidance available;
• New regulation on Generic Descriptors under Article 1(4);
• Judgment on Article 13.5 claims;
• Front of Pack Labeling Scheme introduced; and
• ECJ gives second ruling on meaning of Nutrition and Health Claims Regulation.
Effective October 6, 2014, hydrocodone combination products (HCP), such as Vicodin and Lortab, have been reclassified from Schedule III to Schedule II drugs.
This workshop will explore state-level Green Chemistry initiatives and chemicals policy reform efforts, which aim to protect public health and the ecosystems in the Great Lakes basin. Participants will learn how chemicals policy is an integral aspect of Great Lakes restoration, and how green chemistry fits into this discussion.
Don't Bank on It: Farmers Face Significant Barriers to Credit
Access During Economic Downturn.
Farmers Face Delays, Denials and Bureaucratic Roadblocks in Accessing Farm Loans.
Farm credit is the backbone of American agriculture. During the recent economic downturn, America’s family farmers faced significant barriers to accessing farm credit, which endangered their economic security and the stability of rural communities and food production in America. This national survey of farm credit counselors and farm advocacy organizations demonstrates the
critical, growing and overlooked gaps in credit availability for our nation’s farmers at a time when they need it most.
A four step approach to a successful search strategy for new online retailers.
A presentation given at the Sheerluxe Conference 2009 by Stephen Pratley of Shine Marketing
Framework for Hispanic or Female Farmers' Claims ProcessRAFI-USA
Published 13 January, 2012.
DEADLINE EXTENDED: Claims must be submitted by May 1, 2013.
MORE INFORMATION: http://rafiusa.org/deadline-march-25th-usda-claims/
The United States Government has established a claims process to make available $1.33 billion or more to farmers or ranchers who allege discrimination by the U.S. Department of Agriculture (USDA) in the denial of farm loan benefits based on being female or Hispanic. The exact time period covered by this claims process are as follows: Hispanic Farmers & Ranchers: Jan. 1, 1981 to Dec. 31, 1996 -or- Oct. 13, 1998 to Oct. 13, 2000. Female Farmers & Ranchers: Jan.1, 1981 to Dec. 31, 1996 -or- Oct. 19, 1998 to Oct. 19, 2000.
Eversheds Food and Drink Seminar - Health Nutrition Labelling Presentation 3r...Eversheds Sutherland
Eversheds Food and Drink Seminar - Health Nutrition Labelling Presentation 3rd October 2013 - Katharine Vickery, Eversheds LLP.
Current Developments - What’s changed over the past 12 months?
• Nutrition and Health Claims: register of approved claims
What's changed available and informal guidance available;
• New regulation on Generic Descriptors under Article 1(4);
• Judgment on Article 13.5 claims;
• Front of Pack Labeling Scheme introduced; and
• ECJ gives second ruling on meaning of Nutrition and Health Claims Regulation.
Effective October 6, 2014, hydrocodone combination products (HCP), such as Vicodin and Lortab, have been reclassified from Schedule III to Schedule II drugs.
This workshop will explore state-level Green Chemistry initiatives and chemicals policy reform efforts, which aim to protect public health and the ecosystems in the Great Lakes basin. Participants will learn how chemicals policy is an integral aspect of Great Lakes restoration, and how green chemistry fits into this discussion.
Don't Bank on It: Farmers Face Significant Barriers to Credit
Access During Economic Downturn.
Farmers Face Delays, Denials and Bureaucratic Roadblocks in Accessing Farm Loans.
Farm credit is the backbone of American agriculture. During the recent economic downturn, America’s family farmers faced significant barriers to accessing farm credit, which endangered their economic security and the stability of rural communities and food production in America. This national survey of farm credit counselors and farm advocacy organizations demonstrates the
critical, growing and overlooked gaps in credit availability for our nation’s farmers at a time when they need it most.
A four step approach to a successful search strategy for new online retailers.
A presentation given at the Sheerluxe Conference 2009 by Stephen Pratley of Shine Marketing
Framework for Hispanic or Female Farmers' Claims ProcessRAFI-USA
Published 13 January, 2012.
DEADLINE EXTENDED: Claims must be submitted by May 1, 2013.
MORE INFORMATION: http://rafiusa.org/deadline-march-25th-usda-claims/
The United States Government has established a claims process to make available $1.33 billion or more to farmers or ranchers who allege discrimination by the U.S. Department of Agriculture (USDA) in the denial of farm loan benefits based on being female or Hispanic. The exact time period covered by this claims process are as follows: Hispanic Farmers & Ranchers: Jan. 1, 1981 to Dec. 31, 1996 -or- Oct. 13, 1998 to Oct. 13, 2000. Female Farmers & Ranchers: Jan.1, 1981 to Dec. 31, 1996 -or- Oct. 19, 1998 to Oct. 19, 2000.
Amnesty International USA Engagement Media Overview—Kyra StoddartBig Duck
Presentation on Amnesty International USA's approach to online engagement, presented by Kyra Stoddart to Farra's Online Engagement class at the New School.
Unconventional Gas and Hydraulic Fracturingfnfnlands
This presentation was made by Hydrogeologist Gilles Wendling at Keepers of the Water VI in Fort Nelson, BC. This event was hosted by Fort Nelson First Nation.
Presented by Rural Advancement Foundation International (RAFI-USA) Research & Policy Associate James Robinson. May 21, 2013.
For more information about forced pooling and landowner rights visit: http://rafiusa.org/issues/landowner-rights-and-fracking/
Disaster Programs and the Changing Face of Agriculture in North CarolinaRAFI-USA
Written by Scott Marlow, Executive Director, RAFI-USA.
Published August 2007.
After each disaster, farm families across North Carolina sit down at their kitchen tables to figure out how to recover their losses and go forward. For an increasing number of families, the best and sometimes only option is to leave farming.
Disaster preparedness and response is a constant aspect of North Carolina agriculture. North Carolina experienced 28 agricultural disaster or emergency declarations between 1980 and 2004, including droughts, floods, killing frosts, and Hurricanes Floyd, Fran, Hugo, Ophelia, Isabel, Bertha, Irene, Ivan, Frances, Dennis and Bonnie. Yet today federal disaster relief programs protect less farm income and fewer farm assets in North Carolina than they did in 1980. If Hurricane Floyd were to happen today, by all likelihood, North Carolina farmers would receive less, not more, assistance from the federal government.
More information online at http://rafiusa.org/programs/farmsustainability/disaster-programs/report/
The Agricultural Justice Project - Social Stewardship Standards in Organic & ...RAFI-USA
Updated April 2008. The Agricultural Justice Project - Social Stewardship Standards in Organic and Sustainable Agriculture. Full Standards Document. The Agricultural Justice Project (AJP) is a multi-organizational initiative formed for the purpose of developing, piloting, and promoting a market-based food label for social justice and economic equity.
International Conference on Organic Agriculture and Food Security (2007)RAFI-USA
Contains Issues Paper: Organic Agriculture and Access to Food by Michael Sligh and Carolyn Christman. This paper was presented by RAFI staff at the May 2007 United Nations Food and Agriculture Organization’s International Conference on Organic Agriculture and Food Security. 3-5 May 2007. Food and Agriculture Organization of the United Nations (FAO), Italy.
The hydraulic fracturing "fast track bill," Senate Bill 76, Domestic Energy Jobs Act. General Assembly of North Carolina, Session 2013
SENATE BILL 76 (Edition 7)
To check for newer or updated versions or recent action on this bill follow this link: http://www.ncleg.net/gascripts/BillLookUp/BillLookUp.pl?Session=2013&BillID=S76
Finance Committee Substitute Adopted 2/14/13
Seventh Edition Engrossed 6/7/13
Short Title: Domestic Energy Jobs Act
AN ACT TO (1) RECONSTITUTE THE MINING COMMISSION AS THE MINING AND ENERGY COMMISSION, (2) REQUIRE THE MINING AND ENERGY COMMISSION AND OTHER REGULATORY AGENCIES TO DEVELOP A MODERN REGULATORY PROGRAM FOR THE MANAGEMENT OF OIL AND GAS EXPLORATION AND DEVELOPMENT ACTIVITIES IN THE STATE, INCLUDING THE USE OF HORIZONTAL DRILLING AND HYDRAULIC FRACTURING FOR THAT PURPOSE, (3) AUTHORIZE HORIZONTAL DRILLING AND HYDRAULIC FRACTURING, BUT PROHIBIT THE ISSUANCE OF PERMITS FOR THESE ACTIVITIES PENDING SUBSEQUENT LEGISLATIVE ACTION, (4) ENHANCE LANDOWNER AND PUBLIC PROTECTIONS RELATED TO HORIZONTAL DRILLING AND HYDRAULIC FRACTURING, AND (5) ESTABLISH THE JOINT LEGISLATIVE COMMISSION ON ENERGY POLICY.
2009 NOAP Summit Discussion Paper: Towards a National Organic Action PlanRAFI-USA
February 25 & 26, 2009.
LaCrosse, WI
This National Organic Action Plan Summit Discussion Paper represents nearly five years of dialogue meetings among a wide cross section of organic movement and industry with the express purpose of encouraging the development of a National Organic Action Plan that reflects the passions, concerns, hopes, and visions of this diverse and thriving community.
Amnesty International USA Engagement Media Overview—Kyra StoddartBig Duck
Presentation on Amnesty International USA's approach to online engagement, presented by Kyra Stoddart to Farra's Online Engagement class at the New School.
Unconventional Gas and Hydraulic Fracturingfnfnlands
This presentation was made by Hydrogeologist Gilles Wendling at Keepers of the Water VI in Fort Nelson, BC. This event was hosted by Fort Nelson First Nation.
Presented by Rural Advancement Foundation International (RAFI-USA) Research & Policy Associate James Robinson. May 21, 2013.
For more information about forced pooling and landowner rights visit: http://rafiusa.org/issues/landowner-rights-and-fracking/
Disaster Programs and the Changing Face of Agriculture in North CarolinaRAFI-USA
Written by Scott Marlow, Executive Director, RAFI-USA.
Published August 2007.
After each disaster, farm families across North Carolina sit down at their kitchen tables to figure out how to recover their losses and go forward. For an increasing number of families, the best and sometimes only option is to leave farming.
Disaster preparedness and response is a constant aspect of North Carolina agriculture. North Carolina experienced 28 agricultural disaster or emergency declarations between 1980 and 2004, including droughts, floods, killing frosts, and Hurricanes Floyd, Fran, Hugo, Ophelia, Isabel, Bertha, Irene, Ivan, Frances, Dennis and Bonnie. Yet today federal disaster relief programs protect less farm income and fewer farm assets in North Carolina than they did in 1980. If Hurricane Floyd were to happen today, by all likelihood, North Carolina farmers would receive less, not more, assistance from the federal government.
More information online at http://rafiusa.org/programs/farmsustainability/disaster-programs/report/
The Agricultural Justice Project - Social Stewardship Standards in Organic & ...RAFI-USA
Updated April 2008. The Agricultural Justice Project - Social Stewardship Standards in Organic and Sustainable Agriculture. Full Standards Document. The Agricultural Justice Project (AJP) is a multi-organizational initiative formed for the purpose of developing, piloting, and promoting a market-based food label for social justice and economic equity.
International Conference on Organic Agriculture and Food Security (2007)RAFI-USA
Contains Issues Paper: Organic Agriculture and Access to Food by Michael Sligh and Carolyn Christman. This paper was presented by RAFI staff at the May 2007 United Nations Food and Agriculture Organization’s International Conference on Organic Agriculture and Food Security. 3-5 May 2007. Food and Agriculture Organization of the United Nations (FAO), Italy.
The hydraulic fracturing "fast track bill," Senate Bill 76, Domestic Energy Jobs Act. General Assembly of North Carolina, Session 2013
SENATE BILL 76 (Edition 7)
To check for newer or updated versions or recent action on this bill follow this link: http://www.ncleg.net/gascripts/BillLookUp/BillLookUp.pl?Session=2013&BillID=S76
Finance Committee Substitute Adopted 2/14/13
Seventh Edition Engrossed 6/7/13
Short Title: Domestic Energy Jobs Act
AN ACT TO (1) RECONSTITUTE THE MINING COMMISSION AS THE MINING AND ENERGY COMMISSION, (2) REQUIRE THE MINING AND ENERGY COMMISSION AND OTHER REGULATORY AGENCIES TO DEVELOP A MODERN REGULATORY PROGRAM FOR THE MANAGEMENT OF OIL AND GAS EXPLORATION AND DEVELOPMENT ACTIVITIES IN THE STATE, INCLUDING THE USE OF HORIZONTAL DRILLING AND HYDRAULIC FRACTURING FOR THAT PURPOSE, (3) AUTHORIZE HORIZONTAL DRILLING AND HYDRAULIC FRACTURING, BUT PROHIBIT THE ISSUANCE OF PERMITS FOR THESE ACTIVITIES PENDING SUBSEQUENT LEGISLATIVE ACTION, (4) ENHANCE LANDOWNER AND PUBLIC PROTECTIONS RELATED TO HORIZONTAL DRILLING AND HYDRAULIC FRACTURING, AND (5) ESTABLISH THE JOINT LEGISLATIVE COMMISSION ON ENERGY POLICY.
2009 NOAP Summit Discussion Paper: Towards a National Organic Action PlanRAFI-USA
February 25 & 26, 2009.
LaCrosse, WI
This National Organic Action Plan Summit Discussion Paper represents nearly five years of dialogue meetings among a wide cross section of organic movement and industry with the express purpose of encouraging the development of a National Organic Action Plan that reflects the passions, concerns, hopes, and visions of this diverse and thriving community.
In order to promote the uptake of biosimilars across the U.S., stakeholders must be informed about the basic science of these important medicines. Created out of the Biosimilars Forum's Biosimilars Roundtable (formerly the Biosimilars Forum Stakeholder Workshop group), this two page document incorporates feedback from nearly 40 stakeholder groups, from patient advocacy organizations to physician and payer groups, and presents the basic knowledge that all stakeholders need to know about the safety and efficacy of biosimilars, including answers to common myths about them.
Dialogue with Canada’s leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
A biologic drug (biologics) is a product that is produced from living organisms or contain components of living organisms.
Biologic drugs are used for treatment of numerous diseases and conditions, and are the most advanced therapies available. Some biologic drugs are used for the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, and other autoimmune diseases.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
Presentation to the San Diego Regulatory Affairs Network (SDRAN) RAC Review course; August 2011; covering:
♦ Basics
♦ New Dietary Ingredients
♦ Claims Allowed
♦ GMPs and Other Regulatory Requirements
♦ Adverse Events
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Differences between Verification, Calibration and Validation
Dr. Deepak
December 8, 2017
7 Comments
Data Scrutiny is important before reporting
Data Scrutiny is important before reporting
You have perhaps come across these terms in laboratory documents and wondered that they convey the same meaning so where is the need for different terminology.
A little insight will help you understand the fine differences between them. Giving their concise definitions may suffice to gain a basic understanding but to help you get a clearer understanding I have attempted to offer clarity on the terms in context of routine activities in analytical laboratories as I believe that giving real life examples rather than recalling definitions serves the purpose better and makes you remember what is being conveyed longer.
Along with their definitions, I have also pointed out the difference between calibration and validation, and also the difference between calibration and verification. So you will be able to use these terms appropriately.
Let’s first explore what these terms mean:
Verification
In simple terms verification means confirming the authenticity of activities or data before communication to concerned parties. It is important that the results communicated by you are free from errors. Essentially verification comprises of multiple checks on supplies, samples and data before forwarding the results of your testing activities. Majority of the checks can be carried out by you but it is advised that independent assistance be taken for rechecking the data before submission.
Self Checks
The Correct sample was taken up for analysis.
The Sample description, analysis instructions were verified before start of analysis.
The Equipment and glassware used were calibrated.
Recommended grades of chemicals from reliable sources were used.
Weight readings were correctly recorded and entered in calculations.
Recommended environmental conditions were maintained throughout the analysis.
Independent checks
It is strongly recommended that independent rechecking be carried out by a set of trained individuals before the analysis results are consolidated for report generation.
The Sample is analyzed as per the customer’s requirements. As an example in pharmaceutical analysis the tests are conducted in compliance with USP, BP, IP, etc.
If sample information such as name, batch number, date of manufacture, date of expiry, sample source, etc are entered correctly or not in reports.
Entered data matches with the data in the w
Calibration of laboratory instrum
Come to the Table Guidebook: Second EditionRAFI-USA
The second edition of the Come to the Table Guidebook is a 40-page publication released in 2015 by RAFI, the NC Council of Churches and Resourceful Communities. It includes snapshots of community groups that have pioneered innovative food access work, the current status of hunger and agriculture in North Carolina and nationally, along with new resources and stories from faith leaders and from the field.
RAFI's #UnSelfie Template for #GivingTuesdayRAFI-USA
Join thousands of individuals and organizations across the globe on December 2, 2014 to celebrate #GivingTuesday, an international day of giving back. Celebrate generosity by giving your time, talent, money or voice - and start by sharing your very own #unselfie.
Creating an #unselfie to support RAFI in four easy steps:
1) Print out the #unselfie template or grab a piece of paper.
2) Write down how and why you are giving back this #GivingTuesday.
3) Take a moment to snap a selfie - but instead of showing your smile, feature a handwritten message about why you are giving back by supporting RAFI.
4) Post your photo to Twitter, Instagram, Facebook or Pinterest - and be sure to tag @rafiusa so we can celebrate together!
Are you ready to vote in your FSA county committee election but not sure how? This document will show you how to properly fill out an FSA county committee ballot.
Note: FSA ballots are mailed to farmers prior to an election. The back of the mailing has a large print of the USDA logo.
Source: RAFI's Farmer Leadership Network
For more information visit: http://rafiusa.org/farmer-leadership-network/
Proceedings of the 2014 Summit on Seeds & Breeds for 21st Century AgricultureRAFI-USA
To address both the growing crisis in seed biodiversity and our global capacity to develop diverse seed and breed varieties, RAFI and the Coalition for Seeds and Breeds for 21st Century Agriculture organized the 2014 Summit on Seeds and Breeds for 21st Century Agriculture.
The event, which was held in Washington, DC in March of 2014 brought together plant breeders, experts on the seed industry, farmers, activists and academics representing ten universities, twelve civil society organizations and four seed collections to discuss the state of our global seed supply and develop recommendations for reinvigorating public breeding research and increasing seed availability in the country.
The Proceedings of the 2014 Summit on Seeds & Breeds for 21st Century Agriculture provide a compilation of the summit keynote papers, response papers, presentations and findings, as well as a summary of recommendations collaboratively developed by summit participants during discussion.
The publication includes the summit keynote papers authored by well-known plant breeders and researchers in the plant breeding field including:
• William Tracy, a sweet corn breeder with the University of Wisconsin;
• Major Goodman, a corn breeder and professor of crop science at North Carolina State University;
• Tommy Carter, a research geneticist and professor of crop science at North Carolina State University;
• David Ellis, the head of the Genebank Unit at the International Potato Center in Peru;
• Kathy Jo Wetter, Research Director of ETC Group’s Action Group on Erosion, Technology & Concentration;
• Michael Mazourek, a vegetable breeder and professor of plant breeding at Cornell University; and
• Charles Brummer, Senior V.P. Director of Forage Improvement at the Samuel Roberts Noble Foundation.
Learn more: http://rafiusa.org/publications/seeds/
The Final Report released by the North Carolina Mining and Energy Commission (MEC) in response to public comments on the draft fracking rules. A few of the proposed changes strengthen the rule set, especially those requiring Surface Use Agreements for any proposed drilling unit application. Unfortunately, some of the most inadequate rules, such as setbacks for high occupancy building, remain unchanged.
Executive Summary from Proceedings of 2014 Summit on Seeds & Breeds for 21st ...RAFI-USA
A compilation of 2014 Seed Summit keynote papers, response papers, presentations, findings, and a summary of recommendations to address the seed crisis.
The 2013 Annual Report from the Rural Advancement Foundation International-USA.
For more information contact:
RAFI-USA
PO Box 640
Pittsboro, NC 27312
www.rafiusa.org
Managing Specialty Crop Risk in North Carolina 2013RAFI-USA
Addressing risk is critical to the survival of family farms. Specialty crops in particular face a greater challenge. Over the past year, RAFI worked with specialty crop farmers across North Carolina to research and write Managing Specialty Crop Risk in North Carolina.
1. CONTACTS: Urvashi Rangan, Ph.D. 914.378.2211 Patty Lovera 202.744.0525
Consumers Union Food & Water Watch
Terry Shistar, Ph.D. 816.487.0022 Lisa Bunin, Ph.D. 831.425.7121
Beyond Pesticides Center for Food Safety
JOINT STATEMENT OF CONSUMERS UNION, FOOD AND
WATER WATCH, BEYOND PESTICIDES AND
CENTER FOR FOOD SAFETY
U.S. Department of Agriculture Guts
National Organic Law; Circumvents Public Process
Decision makes it easier to continue use of artificial
ingredients and substances, undermining integrity of organic label
In a move decried by consumer and environmental groups as severely weakening the
meaning of the organic label, the U.S. Department of Agriculture announced this week that the
agency had changed the process for exempting otherwise prohibited substances (such as
synthetics) in food that carries the “organic” or “made with organic” label. No public comment
period was provided for the changes to this policy, which had been in place since 2005.
Under the federal organic law1
and prior to Friday’s announcement, there was a
controlled process for allowing the use of substances not normally permitted in organic
production because of extenuating circumstances. These exemptions were supposed to be made
for a five-year period, in order to encourage the development of natural (or organic) alternatives.
The exemptions were required by law to expire, known as “sunset,” unless they were reinstated
by a two-thirds “decisive” majority vote of the National Organic Standards Board (NOSB) and
include a public review. This is no longer the case.
The USDA’s recent decision now puts the burden of identifying exempted materials for
removal largely onto environmentalists and consumers. Under the new policy, an exempt
material could be permitted indefinitely unless a two-thirds majority of the NOSB votes to
remove an exempted (synthetic) substance from the list. The new policy allows USDA to relist
1 1 The Organic Foods Production Act 7 USC 6517 (e) Sunset Provision – No exemption or prohibition contained
in the National List shall be valid unless the National Organic Standards Board has reviewed such exemption or
prohibition as provided in this section within 5 years of such exemption or prohibition being adopted or
reviewed and the Secretary has renewed such exemption or prohibition.
2. exemptions for synthetic materials without the recommendation of the independent board and
outside of public view, as required by current law.
“The USDA’s decision minimizes all incentives for creating organic, natural alternative
ingredients and lowers the standard for what consumers can expect behind the organic label.
Allowing the USDA to automatically relist materials without the recommendation of the NOSB
erodes the Board’s legal authority over materials decisions, a key to consumer trust in the organic
label. The fact that the agency made this decision without any public input only adds to the
violation felt by watchdog groups and consumers alike,” the groups said.
“Potentially allowing an indefinite listing of non-natural ingredients and requiring a
super-majority vote to retire a substance after five years undermines the spirit of the law for how
materials head into “sunset” or retirement. It is unfair to producers trying to produce a truly
organic product and it is unfair to consumers trying to make meaningful purchasing decisions.
Simply put, this lowers the bar for much of the organic market. We believe the USDA must
reverse course and we intend to mount a fierce campaign to hold the agency accountable to the
millions of Americans who expect more from the government—and the organic label.”