§ 205.101 - Exemptions from certification.

§ 205.101 Exemptions and exclusions from certification.

Cross Reference

Link to an amendment published at 88 FR 3621, Jan. 19, 2023.

The following operations in paragraphs (a)

Exemptions.

through (

1) A production or handling operation that sells agricultural products as “organic” but whose gross agricultural income from organic sales totals $5,000 or less annually is

h) of this section are exempt from certification under subpart E of this part and from submitting an organic system plan for acceptance or approval under § 205.201 but must comply with the applicable organic production and handling requirements of subpart C of this part

and

(2) A handling operation that is a retail food establishment or portion of a retail food establishment that handles organically produced agricultural products but does not process them is exempt from the requirements in this part.

(3) A handling operation or portion of a handling operation

, the applicable labeling requirements of

§ 205.310. The products from such operations shall not be used as ingredients identified as organic in processed products produced by another handling operation.

subpart D of this part, and any requirements described in paragraphs (a) through (i) of this section.

(a) A production or handling operation that sells agricultural products as “organic” but whose gross agricultural income from organic sales totals $5,000 or less annually.

(b) A retail establishment that does not process organically produced agricultural products.

(c) A retail establishment that processes, at the point of final sale, agricultural products certified under this part as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)).”

(d) A handling operation that only handles agricultural products that contain less than 70 percent organic ingredients

by total weight of the finished product (excluding water and salt) is exempt from the requirements in this part, except:

(i) The provisions for prevention of contact of organic products with prohibited substances set forth in § 205.272 with respect to any organically produced ingredients used in an agricultural product;

(ii) The labeling provisions of §§ 205.305 and 205.310; and

(iii) The recordkeeping provisions in paragraph (c) of this section.

(4) A handling operation or portion of a handling operation

(as described in § 205.301(d)) or that only identifies organic ingredients on the information panel

is exempt from the requirements in this part, except:

(i) The provisions for prevention of contact of organic products with prohibited substances set forth in § 205.272 with respect to any organically produced ingredients used in an agricultural product;

(ii) The labeling provisions of §§ 205.305 and 205.310; and

(iii) The recordkeeping provisions in paragraph (c) of this section.

(b) Exclusions.

(1) A handling operation or portion of a handling operation is excluded from the requirements of this part, except for the requirements for the prevention of commingling and contact with prohibited substances as set forth in § 205.272 with respect to any organically produced products, if such operation or portion of the operation only sells organic agricultural products labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” that:

(i) Are packaged or otherwise enclosed in a container

.

(e) An operation that only receives, stores, and/or prepares for shipment, but does not otherwise handle, organic agricultural products that:

(1) Are enclosed in sealed, tamper-evident packages or containers prior to being received or acquired by the operation; and

(2) Remain in the same sealed, tamper-evident packages or containers and are not otherwise handled while in the control of the operation.

(f) An operation that only buys, sells, receives, stores, and/or prepares for shipment, but does not otherwise handle, organic agricultural products already labeled for retail sale that:

(1) Are enclosed in sealed, tamper-evident packages or containers that are labeled for retail sale prior to being received or acquired by the operation; and

(

ii

2) Remain in the same

package or container

sealed, tamper-evident packages or containers that are labeled for retail sale and are not otherwise

processed

handled while in the control of the

handling

operation.

(

2

g) A

handling operation that is a retail food establishment or portion of a retail food establishment that processes, on the premises of the retail food establishment, raw and ready-to-eat food from agricultural products that were previously labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” is excluded from the requirements in this part, except:

(i) The requirements for the prevention of contact with prohibited substances as set forth in § 205.272; and

(ii) The labeling provisions of § 205.310.

(c) Records to be maintained

Customs broker (per 19 CFR 111.1) that only conducts customs business but does not otherwise handle organic agricultural products.

(h) An operation that only arranges for the shipping, storing, transport, or movement of organic agricultural products but does not otherwise handle organic products.

(i) Recordkeeping by exempt operations.

(1)

Any handling operation exempt from certification pursuant to paragraph

Exempt operations described in paragraphs (a) and (

3

c)

or

through (

a

f)

(4)

of this section must

maintain records sufficient to

make available to representatives of the Secretary, upon request, records that:

(i)

Prove

Demonstrate that

ingredients

agricultural products identified as organic were organically produced and handled; and

(ii) Verify quantities

produced from such ingredients.

of organic agricultural products received and shipped or sold

(2)

Records

All records described in this section must be maintained for no less than 3 years beyond their creation, and the operations must allow representatives of the Secretary and the applicable State organic programs' governing State official access to these records for inspection and copying during normal business hours to determine compliance with the applicable regulations set forth in this part.

[88 FR 3621, Jan. 19, 2023]