Preproposal statement of inquiry was filed as WSR 10-09-083.
Title of Rule and Other Identifying Information: Chapter 16-160 WAC, Registration of materials for organic food production.
Hearing Location(s): Natural Resources Building, 2nd Floor, Room 259, 1111 Washington Street, Olympia, WA 98504-2560, on August 25, 2010, at 2:30 p.m.
Date of Intended Adoption: September 8, 2010.
Submit Written Comments to: Teresa Norman, P.O. Box 42560, Olympia, WA 98504-2560, e-mail WSDARulesComments@agr.wa.gov, fax (360) 902-2092, by 5:00 p.m., August 25, 2010.
Assistance for Persons with Disabilities: Contact Julie Carlson by August 19, 2010, TTY (800) 833-6388 or (360) 902-1880.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of the rule is to update chapter 16-160 WAC pertaining to the registration of materials for use in organic food production and processing. The organic food program operates a registration program for brand name material inputs that comply with the United States Department of Agriculture national organic standards. This list is used by certified organic producers and processors to assist in ensuring the material inputs that are used will not jeopardize their certification.
In January 2010, the department sought legislative approval for changes to chapter 15.86 RCW to clarify the authority of the program to operate the brand name registration program. The resulting changes to chapter 16-160 WAC are needed to bring statute and rule into alignment. The changes to chapter 16-160 WAC includes clarifying application requirements and outlining inspection requirements and record-keeping requirements.
Reasons Supporting Proposal: The brand name material registration program continues to grow in the number of applicants seeking approval and listing on the brand name material list. Currently, the list consists of approximately six hundred products, with over two hundred companies applying. The rule will ensure that the applications are complete and that the inspection and record-keeping requirements are clear to applicants. The result will be a list of material inputs that comply with organic standards and continued compliance of certified organic operations.
Statutory Authority for Adoption: Chapter 15.86 RCW.
Statute Being Implemented: Chapter 15.86 RCW.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Washington department of agriculture, (WSDA) organic food program, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Marty Beagle, Olympia, (360) 902-1924.
No small business economic impact statement has been prepared under chapter 19.85 RCW. Fees are in statute and have not been changed as a result of this rule change. Participation in the registration program is voluntary and not required in order to sell or represent a material input as "organic" or as "allowed in organic production."
A cost-benefit analysis is not required under RCW 34.05.328. WSDA is not a listed agency under RCW 34.05.328 (5)(a)(i). RCW 34.05.328 regulates "significant legislative rules" and RCW 34.05.328 (5)(a)(i) lists the specific state agencies that are considered "significant legislative rule agencies." WSDA is not listed, therefore, we do not consider ourselves to be a "significant legislative rule agency." In addition, section 309 (for the department of agriculture), chapter 372, Law of 2006, provide that: (2) Fees and assessments approved by the department in the 2005-2007 biennium are authorized to exceed the fiscal growth factor under RCW 43.135.055.
July 19, 2010
AMENDATORY SECTION(Amending WSR 03-03-045, filed 1/10/03, effective 2/10/03)
WAC 16-160-010 ((
What is the)) Purpose of this (( rule?))
This chapter specifies the (( review)) process (( and
criteria)) for registering (( brand name)) materials (( used))
approved for use in organic (( food)) production, processing
and handling on the department's brand name materials list. This chapter is promulgated pursuant to (( RCW 15.86.060 in
which the director is authorized to adopt rules for the proper
administration of chapter 15.86 RCW and RCW 15.86.070 in which
the director is authorized to adopt rules governing the
certification of producers of organic food)) chapter 109, Laws
of 2010 to implement the brand name materials list.
[Statutory Authority: Chapter 15.86 RCW. 03-03-045, § 16-160-010, filed 1/10/03, effective 2/10/03; 99-16-054, § 16-160-010, filed 7/30/99, effective 8/30/99; 91-05-007, § 16-160-010, filed 2/7/91, effective 3/10/91.]
(1))) "Animal manure" means (( a material composed of
excreta, with or without bedding materials and/or animal drugs
and collected from poultry, ruminants or other animals except
(2) "Applicant" means the person who submits an application to register a material pursuant to the provisions of this chapter.
(3) "Brand name material" means any material that is supplied, distributed or manufactured by a person.
(4))) feces, urine, other excrement, and bedding produced by livestock that has not been composted.
"Authorized representative" means either the registrant or a person authorized by the registrant to act on the registrant's behalf and bind the registrant for purposes of this chapter and registration on the brand materials list.
"Compost" means ((
a material produced from a controlled
process in which organic materials are digested aerobically or
anaerobically by microbial action)) the product of a managed
process through which microorganisms break down plant and
animal materials into more available forms suitable for
application to the soil.
(5))) "Crop production aid" means any substance,
material, structure, or device(( ,)) that is used to aid a
producer of an agricultural product except for fertilizers and
(6))) "Department" means the department of agriculture
of the state of Washington.
(7))) "Director" means the director of the department
of agriculture or (( his or her duly authorized
representative)) the director's designee.
(8) "Distribute" means to offer for sale, hold for
sale, sell, barter, deliver, or supply materials in this
(9))) "Fertilizer" means ((
any)) a single or blended
substance containing one or more recognized plant nutrients
which is used primarily for its plant nutrient content and
which is designed for use or claimed to have value in
promoting plant growth.
(10))) "Label" means (( the)) a display of written,
printed, or graphic (( matter)) material on(( , or attached to,
the material or its)) the immediate container of an
agricultural product or any such material affixed to any
agricultural product or affixed to a bulk container containing
an agricultural product, except for package liners or a
display of written, printed, or graphic material which
contains only information about the weight of the product.
(11))) "Labeling" includes all written, printed, or
graphic (( matter, upon or accompanying a material, or
advertisement, brochures, posters, television, and radio
announcements used in promoting the distribution or sale of
the)) material accompanying an agricultural product at any
time or written, printed, or graphical material about the
agricultural product displayed at retail stores about the
(12))) "Livestock production aid" means any substance,
material, structure, or device(( ,)) that is used to aid a
producer in the production of livestock (( (e.g.,)) such as
parasiticides, medicines, feed additives(( ))).
(13) "Material" means any substance or mixture of
substances that is intended to be used in agricultural
production, processing or handling.
(14))) "Manufacturer" means a person that compounds, produces, granulates, mixes, blends, repackages, or otherwise alters the composition of materials.
"Material" means any substance or mixture of substances that is intended to be used in agricultural production, processing, or handling.
"National Organic Program" means the program administered by the United States Department of Agriculture pursuant to 7 C.F.R. Part 205, which implements the federal Organic Food Production Act of 1990 (7 U.S.C. Sec. 6501 et seq.).
"Organic waste-derived material" means grass clippings,
leaves, weeds, bark, plantings, prunings, and other vegetative
wastes, uncontaminated wood waste from logging and milling
operations, food wastes, food processing wastes, and materials
derived from these wastes through composting. "Organic
waste-derived material" does not include products that include
biosolids as defined in chapter ((
70.95)) 70.95J RCW.
(15))) "Person" means any (( individual, partnership,
association, corporation, or organized group of persons
whether or not incorporated)) natural person, firm,
partnership, exchange, association, trustee, receiver,
corporation, and any member, officer, or employee thereof or
assignee for the benefit of creditors.
(16))) "Pesticide" means, but is not limited to:
(a) Any substance or mixture of substances intended to
prevent, destroy, control, repel, or mitigate any insect,
rodent, nematode, mollusk, fungus, weed, and any other form of
plant or animal life or virus ((
()), except virus on or in
living man or other animal(( ))), which is normally considered
to be a pest or which the director may declare to be a pest;
(b) Any substance or mixture of substances intended to be used as a plant regulator, defoliant, or desiccant; and
(c) Any substance or mixture of substances intended to be
used as a spray adjuvant((
(d) Any other substances intended for such use as may be named by the director by regulation)).
(17))) "Post-harvest material" means any substance,
material, structure, or device(( ,)) that is used in the
post-harvest handling of agricultural products.
(18))) "Processing aid" means (( any material used in
processing that does not become an ingredient in the food
product (e.g., enzymes, boiler water additives, pressing aids,
and filtering aids))) a substance that is added to a food:
(a) During processing, but is removed in some manner from the food before it is packaged in its finished form;
(b) During processing, is converted into constituents normally present in the food, and does not significantly increase the amount of the constituents naturally found in the food; and
(c) For its technical or functional effect in the processing but is present in the finished food at insignificant levels and does not have any technical or functional effect in that food.
(19) "Registered material" means any material that has
applied for registration under this chapter, has met the
criteria for approval and has been issued written approval by
(20))) "Registrant" means the person registering ((
a material (( pursuant to)) on the brand name materials list
under the provisions of this chapter.
(21))) "Soil amendment" means any substance that is
intended to improve the physical characteristics of the soil,
except for fertilizers and pesticides.
(22))) "Spray adjuvant" means (( any wetting agent,
spreading agent, deposit builder, adhesive, emulsifying agent,
deflocculating agent, water modifier, or similar agent with or
without toxic properties of its own intended to be used with
any other pesticide as an aid to its application or to its
effect, and which is in a package or container separate from
that of the pesticide with which it is to be used)) any
product intended to be used with a pesticide as an aid to the
application or to the effect of the pesticide and that is in a
package or container separate from the pesticide. Spray
adjuvant includes, but is not limited to, wetting agents,
spreading agents, deposit builders, adhesives, emulsifying
agents, deflocculating agents, and water modifiers or similar
agent with or without toxic properties of its own intended to
be used with any other pesticide as an aid to its application
or to its effect. Spray adjuvant does not include products
that are only intended to mark the location where a pesticide
"USDA" means the United States Department of Agriculture.
[Statutory Authority: Chapter 15.86 RCW. 03-03-045, § 16-160-020, filed 1/10/03, effective 2/10/03; 99-16-054, § 16-160-020, filed 7/30/99, effective 8/30/99; 91-05-007, § 16-160-020, filed 2/7/91, effective 3/10/91.]
(2) Registration of a material on the brand name materials list under this chapter does not guarantee acceptance for use in organic production, processing, or handling by organic certifying agents other than the department. The department is not liable for any losses or damage that occurs as a result of use of a material registered on the brand name materials list.
(2) Manufacturers may submit applications to the department at:
Washington State Department of Agriculture
Organic Food Program
P.O. Box 42560
Olympia, WA 98504-2560.
These forms may also be found on the department's web site at: http://agr.wa.gov/foodanimal/organic
(3) Applications for registration will not be approved unless the applicant demonstrates that the material meets the requirements and standards of the National Organic Program and is approved for use in organic production, processing, or handling in accordance with the National Organic Program. Specifically, the material may not be a material prohibited for the use in the production or handling of organic products by 7 C.F.R. Section 205.105, and may not be otherwise prohibited for use in organic production and handling by the National Organic Program.
(4) All registrations expire on October 31st of the registration year.
(5) Requests for expedited review must be submitted on a form provided by the department. If approved, expedited review is billed as provided under WAC 16-160-200.
(a) Material registrant agreement in which the registrant agrees to comply with chapter 16-160 WAC.
(b) The name and address of the registrant.
(c) Manufacturer information:
(i) Name and address of the manufacturer;
(ii) Contact information, including the name and phone number of the authorized representative of the registrant; and
(iii) List of all material manufactured at the same facility as the registered material.
(d) The brand name that the material is sold under.
(e) A copy of the label or bill of lading accompanying the material and a statement of all claims made for it, including directions and precautions for use.
(f) The complete formula or any alternate formulations for the material, including active and inert ingredients:
(i) Supplier of each ingredient;
(ii) Percentage of ingredient in the final formula; and
(iii) Purpose of each ingredient in the formula.
(g) Ingredient information for each ingredient listed in the formula (including alternate formulas) sufficient to demonstrate compliance with the standards of the National Organic Program:
(i) Manufacturing process; and
(ii) Formulation, including active and inert ingredients.
(h) A description of the manufacturing process for the material, including all substances used for the extraction and synthesis process, if appropriate. If the manufacturing facility manufactures materials other than the material listed in the application, the application must include a plan to prevent the contamination or commingling of materials allowed or prohibited in organic agriculture.
(i) A flow chart, indicating movement of material from incoming ingredient to outgoing final material. The flow chart may include, but is not limited to:
(i) Storage facilities;
(ii) Equipment location; and
(iii) Shipping facilities.
(j) The intended use of the material.
(k) The required fee for registration.
(l) Signature by authorized representative.
(m) The department may request additional information related to the items above as necessary to demonstrate that the material meets the standards of the National Organic Program.
(2) Applications for fertilizers and pesticides must submit verification of a valid registration from the WSDA pesticide management division.
(3) In addition to the information required in this section, a registrant who is packaging or distributing a material manufactured by another person or manufacturer or are otherwise not responsible for the processing or production of the final product must submit a statement from the manufacturer of the material granting the department access to the manufacturing facility and authorizing inspections in accordance with WAC 16-160-180.
(a) Material registrant agreement in which the registrant agrees to comply with chapter 16-160 WAC;
(b) Name(s) of the material(s) seeking renewal;
(c) Name and address of the manufacturing facility(ies) for each registered material;
(d) Notification of changes to the original application;
(e) Signature of authorized representative; and
(f) The required fee for renewal. Renewal applications postmarked after October 31st must include the appropriate late fee as listed under WAC 16-160-200.
(2) Registrants who package or distribute a material manufactured by another person or manufacturer or are otherwise not responsible for the processing or production of the final product must annually submit a statement from the manufacturer of the material granting the department access to the manufacturing facility and authorizing inspections in accordance with WAC 16-160-180.
(3) Full disclosure of the complete formula of the material, including active and inert ingredients, is required every five years.
(2) By applying for registration on the brand name materials list, the registrant expressly grants the department or other organic certifying agent or inspection agent approved by the National Organic Program the right to enter the registrant's premises during normal business hours or at other reasonable times to:
(a) Inspect the portion of the premises where the materials, inputs or ingredients are stored, produced, manufactured, packaged or labeled;
(b) Inspect records related to the sales, storage, production, manufacture, packaging or labeling of the material, inputs or ingredients; and
(c) Obtain samples of materials, inputs or ingredients.
(3) Inspections may be conducted as a condition of ongoing compliance, after receiving an initial or a renewal application, notification of a change to an application, upon receipt of a complaint, or as required by the National Organic Program. Inspections may be announced or unannounced.
(4) Registrants who package or distribute a material manufactured by another person or manufacturer or are otherwise not responsible for the processing or production of the final product must annually submit a statement from the manufacturer of the material granting the department access to the manufacturing facility and authorizing inspections. The signed consent must be on a form provided by the department.
(5) Should the registrant or manufacturer refuse to allow inspection of the premises or records or fail to provide samples, the registration on the brand name materials list is canceled as provided under WAC 16-160-220. The department shall deny applications for registration where the registrant refuses to allow the inspection of the premises or records, fails to provide samples as provided in this section, or fails to provide the department with the consent described in subsection (4) of this section.
(6) Inspections must be documented on a form approved by the department. Inspections conducted by an inspection body other than the department will be accepted when a review determines that the inspection document is sufficient to demonstrate compliance with the standards of the National Organic Program.
(a) Records pertaining to incoming raw materials:
(i) Invoices/bills of lading;
(ii) Transportation documentation;
(iii) Material safety data sheets;
(iv) Storage documentation.
(b) Production records:
(i) Material formulations;
(ii) Dates of production;
(iii) Amount of ingredients used in each batch;
(iv) Amount of final materials;
(v) Sampling and/or laboratory analyses;
(vi) Lot identification and tracking;
(vii) Other records maintained during manufacturing.
(c) Finished material records:
(i) Packaging documentation;
(ii) Sales documentation;
• Purchase orders;
• Shipping documents;
(iii) Storage documentation.
(2) Records shall be maintained for six years.
(1) Initial material registration:
(a) The application fee for initial registration of a pesticide, spray adjuvant, processing aid, livestock production aid or post-harvest material is five hundred dollars per material.
(b) The application fee for initial registration of a fertilizer, soil amendment, organic waste derived material, compost, animal manure or crop production aid is four hundred dollars per material.
(2) Renewal registration: The application fee for renewing a registration for a pesticide, spray adjuvant, processing aid, livestock production aid or post-harvest material is three hundred dollars per material. The application fee for renewing a registration for a fertilizer, soil amendment, organic waste derived material, compost, animal manure or crop production aid is two hundred dollars per material.
(3) Late fees: Renewal applications postmarked after October 31st must include a late fee in addition to the renewal fee. Renewal applications received after February 2nd will not be accepted.
|If your application is postmarked after October 31st but before:||Then the late fee is:|
(5) Samples: Chemical analysis of samples, if required for registration or renewal, or obtained during an inspection, will be charged to the applicant at a rate established by the department of agriculture or at the cost for analyses performed by another laboratory.
(6) Expedited evaluation fees: Requests for expedited reviews may be submitted and, if approved, are billed at the rate of forty dollars per hour.
(2) Application or registrations will be revoked, canceled, or denied if a material fails to meet the standards for approval or is no longer approved for use in organic production, processing, or handling by the National Organic Program.
The following sections of the Washington Administrative Code are repealed:
|WAC 16-160-030||Do I need to register my brand name material with the organic food program?|
|WAC 16-160-035||Brand name materials list.|
|WAC 16-160-040||How do I apply for registration?|
|WAC 16-160-050||When do registrations expire?|
|WAC 16-160-060||What criteria are used to determine if a brand name material is approved?|
|WAC 16-160-070||Application fees.|
|WAC 16-160-090||Denial or revocation of a registration.|
|WAC 16-160-100||Labeling of registered brand name materials and use of organic logo.|
|WAC 16-160-110||Organic material registration logo.|