FDA Registration Renewal

Onset Worldwide has renewed it’s FDA registration; if you need a statement, please email Sara.

Please remember to also renew! Here are instructions:

The 2018 Biennial Registration Renewal Period begins Monday, October 1, 2018.

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. ง 350d] requires food facilities required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. 

 

  • If you register your food facility before October 1, 2018, you must renew your registration before December 31, 2018 and provide us with any updated information, if applicable.
  • If you update your food facility registration before October 1, 2018, you must renew your registration before December 31, 2018 and provide us with any updated information, if applicable.

 

  • As a reminder, if you are the new owner of a registered food facility, the previous owner is required to cancel the food facility’s registration within 60 calendar days of the change of ownership and you must re-register the facility reflecting the new ownership (see 21 CFR 1.234 and 1.235).

The owner, operator, or agent in charge of the facility, or a person authorized by one of them, can submit a facility’s registration renewal electronically at http://www.access.fda.gov/. Please note that you must first create or have an existing FURLS account to access the module and submit your renewal.

Microduction® Press Release

Check out our press release in Quality Assurance Magazine, Supermarket News, and Nutraceuticals World! 

http://www.qualityassurancemag.com/article/onset-worldwide-introduces-microduction-validated-5-log-kill-step-system/ 

https://www.supermarketnews.com/sponsored-content/validated-5-log-kill-step-system-set-change-food-industry-microduction

https://www.nutraceuticalsworld.com/contents/view_breaking-news/2018-08-28/validated-5-log-kill-step-system-hopes-to-change-food-industry/

Pesticide Tolerance Levels – Update

You can search each pesticide on the EPA website. Here are instructions: https://www.epa.gov/pesticide-tolerances/how-search-tolerances-pesticide-ingredients-code-federal-regulations
 

For Organic pesticide levels, USDA organic regulation allows for pesticide/herbicide residue due to cross contamination up to 5% of the EPA tolerance for each pesticide on the specific product. 

 
Some testing results will indicate pesticide residues for which EPA has not established a tolerance, and the FDA has not established an action level. Therefore, the USDA Organic limit defaults is 0.01 parts per million (ppm); however (and this is contradicting) the FDA level defaults to 0.00.
 
“FDA considers samples that contain pesticide residues for which no tolerances have been established by EPA to be in violation of the Federal Food, Drug, and Cosmetic Act. FDA uses this information to develop compliance activities, such as conducting targeted testing or implementing Import Alerts to flag future shipments for closer scrutiny.”
 
Another caveat, chia seeds may not be considered “oilseeds” with regards to pesticide tolerances established by the EPA. I’ve been in contact with the EPA to establish with commodity grouping chia falls under. This is their reply as of June 2018: “The good news is that we are going to add chia seed to the cereal grain group, which is currently crop group 15 in 40 CFR 180.41. The bad news is that it will be a few years before that is implemented through rulemaking to revise 40 CFR 180.41. The crop group expert is currently working on all of the changes to the cereal grain group, which has to go through an internal approval process. Then it has to be included in a proposed regulation and a final regulation. We are currently working on Phases 5 and 6 of the crop group rule changes; the cereal grain group is likely to be in Phase 7.”
 
For oilseeds, glyphosate tolerances on conventional is 40 ppm, and therefore, for organic, the tolerance is 2 ppm. Diquat isn’t listed for oilseeds, and therefore the tolerance is 0 ppm. Other pesticides/herbicides can be searched using the link above. 
 
More information >
 
 
In summary, things are confusing, the government agencies are contradicting (according to what I’ve researched), and there is still gray area with regards to ‘chia seeds’ specifically. 
 
-Sara Morrison

Stay updated with documents and changes

If you’d like to be proactively updated with updates and renewals of Onset Worldwide’s certifications, or changes to our products or processes, please email us to be added to this mailing list or sign up below. 

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Milling Flax and Chia!

We are regularly milling flax and chia seeds at our NJ facility. We can toll process or supply the seed. Our process has proprietary developments to nitro-mill® the whole seeds. This modified atmosphere milling preserves the nutrients and extend the shelf life. The system is complete with rare earth magnets and an in-line metal detector. 

Email us for a quote or quality documents today! 

Pesticide Tolerance when no limit is established

“FDA considers samples that contain pesticide residues for which no tolerances have been established by EPA to be in violation of the Federal Food, Drug, and Cosmetic Act. FDA uses this information to develop compliance activities, such as conducting targeted testing or implementing Import Alerts to flag future shipments for closer scrutiny. “

You can check pesticide tolerance levels using the instructions on our previous post. 

More information >

Pesticide Tolerances on Your Foods

You can search each pesticide tolerance level on the EPA website. Click here for instructions. 

For Organic pesticide levels, USDA organic regulation allows for pesticide/herbicide residue due to cross contamination up to 5% of the EPA tolerance for each pesticide on the specific product. 

Some testing results will indicate pesticide residues for which EPA has not established a tolerance, and the FDA has not established an action level. Therefore, the USDA Organic limit defaults is 0.01 parts per million (ppm). More info

Microduction® Launching January 2018!

Microduction®: a total safety solution. 

The reduction of microbiological counts on food ingredients. A proprietary system developed by Onset Worldwide.

Benefits of Microduction®:

  • Organic certified process
  • No heat
  • No residual
  • Validated 5 log reduction
  • Zero yield loss caused by treatment
  • Cost effective
  • Use of seal
  • Raw

Beneficiaries:

  • Producers
  • Retailers
  • Retail brands
  • Manufacturers
  • Co-packers
  • Bakeries
  • Resellers
  • Processors

Onset Worldwide – CTPAT Certified Member

As of September 2017, Onset Worldwide is a certified member of the Customs-Trade Partnership Against Terrorism (C-TPAT), a supply chain security program established by U.S. Customs and Border Protection (CBP).  Membership in C-TPAT requires that our company and its business partners commit to minimizing the risk of unauthorized and/or dangerous goods entering the U.S. in one of our shipments. 

This commitment requires, among other things, that we ask our business partners to analyze their physical security and internal control procedures, and certify that they have taken the necessary steps to protect their part of the supply chain, as we have done ourselves. 

CTPAT Partners enjoy a variety of benefits, including taking an active role in working closer with the U.S. Government in its war against terrorism. As they do this, Partners are able to better identify their own security vulnerabilities and take corrective actions to mitigate risks. Some of the benefits of the program include:

  • Reduced number of CBP examinations
  • Front of the line inspections
  • Shorter wait times at the border
  • Assignment of a Supply Chain Security Specialist to the company
  • Importer eligibility to participate in the Importer Self-Assessment Program (ISA)
  • And more.

For more information on the program, please review the CTPAT webpages: https://www.cbp.gov/border-security/ports-entry/cargo-security/ctpat

Toll Processing Services

Our New Jersey production facility is fully operational! We can clean, mill, re-package, and private label allergen-free seeds and grains. 

Raw material is cleaned in our state-of-the-art Siftex® cleaning system, where we remove foreign material (overs and unders) that could degrade the end product.

We have proprietary developments to Nitro-Mill® whole seeds and grains into flours. This modified atmosphere milling preserves the nutrients and extends the shelf life.

This modified atmosphere packing preserves the nutrients and extends the shelf life organically. Our packaging equipment can accommodate 8 oz through supersack packaging; retail, foodservice, and bulk.

Check out more details here: https://onsetworldwide.com//toll-processing/

Contact us today for pricing! 

Organic Chia Oil & Organic Defatted Chia Flour – In Stock!

We currently have organic chia oil, packed in 20 Liter jugs, in stock! We also have organic defatted chia flour in stock. This is a finer mesh than milled chia, and the oil has been pressed out of it for a higher protein content.