is ubiquitous in the environment and, given the amount of time the sampled coffee was out of
Descamex’ control, it could have been contaminated. Descamex also noted that one of the NOP
samples labeled “Blank” was, in fact, not a field blank sample measuring possible environmental
contamination, but a product sample, and therefore, the lab results are unreliable.

In response to this third point, AMS finds that the USDA laboratory testing of organic
coffee decaffeinated by Descamex was valid. In October 2014, NOP staff visited the [I

i: collected samples of Descamex decaffeinated coffee

product. Staff took the samples from bulk shipments sent from the Descamex production
facilities in Veracruz, Mexico mO)) OVCME) sampled decaffeinated organic
coffee from intact bags shipped from Descamex to No) VE) and collected documents
demonstrating the chain of custody for the sampled bags of coffee. There is no evidence that the
bags were opened and contaminated while in shipment between Descamex (GG
Further, NOP staff collected samples in a way that avoided cross-contamination.

Maintaining proper chain of custody and other collection protocols, NOP staff submitted
the samples for testing to an accredited laboratory. The laboratory found the presence of
methylene chloride in the samples of Descamex decaffeinated organic coffee. Given sampling
conditions, there is no mechanism by which methylene chloride would contaminate the coffee.

AMS does acknowledge that onc of the samples of Descamex coffee was mislabeled
“Blank” on the chain of custody form. The sample was not a blank, but rather, a product sample
to be tested for methylene chloride. A mislabeled sample on the chain of custody form does not
invalidate the positive test results for the four coffee samples. Further, the laboratory did use a
soil sample as a “method blank” to rule out contamination in the laboratory and this “method

blank” tested negative for methylene chloride.


CONCLUSION
The evidence indicates that the NOP’s December 30, 2014, Notice of Noncompliance and

Proposed Revocation to Descamex was appropriate due to the nature of the violations.

DECISION

The appeal is denied. Descamex’s organic certification is to be revoked. Attached to this
formal Administrator’s Decision is a Request for Hearing form. Descamex has thirty (30) days to
request an administrative hearing before an Administrative Law Judge. If Descamex does not
request a hearing in that period, this Decision will be implemented and the NOP will revoke
Descamex’s organic certification. In accordance with §205.662(f)(2) of the USDA organic
regulations, “A certified operation or a person responsibly connected with an operation whose
certification has been revoked will be ineligible to receive certification for a period of 5 years

following the date of such revocation.”

Done at Washington, D.C., on this

day of 742 ém pea _,2015.

Rex A. Barnes

Associate Administrator


operation’s certifier, the Organic Crop Improvement Association (OCIA). The second samples
were collected in April 2014 at the Descamex production facilities,
GRRE © ¢sting of both sample sets did not find residue of methylene chloride.

In response to this second point, AMS notes that the two negative test results Descamex
described (from samples collected in July 2013 and April 2014) are irrelevant to whether the
NOP acted appropriately in issuing the combined Notice of Noricompliance and Proposed
Revocation. The NOP issued the adverse action based on USDA laboratory testing of samples
taken during an NOP October 2014 visit to I Government
staff collected the samples as part of its investigation of a complaint alleging that Descamex used
methylene chloride to decaffeinate organic coffee. Any other test results asserted by Descamex
do not successfully rebut the violation cited in the Notice.

Further, AMS considers the July 2013 OCIA test results cited by Decamex in its appeal
to be invalid, due to procedural issues at the time of sample collection. As part of the complaint
investigation and at the NOP’s request, OCIA conducted an unannounced inspection of
Descamex production facilities on July 5, 2013. Descamex initially denied the OCIA inspector
access to all of its facilities, violating the USDA organic regulations. Further, afler the OCIA
inspector was allowed full access to Descamex facilities, he personally collected only one of the
seven coffee samples taken during the inspection. Six of the samples were taken by Descamex’
in-house laboratory and provided to the inspector, violating the USDA organic regulations.

For the third point in its appeal, Descamex argues that the USDA laboratory testing that
found residue of methylene chloride in Descamex decaffeinated organic coffee was flawed, due
to chain of custody issues, and because, again, the amount of methylene chloride detected was de

minimis and below the level triggering adverse action. Descamex claims that methylene chloride


Further, as the investigation that led to the appealed Notice of Noncompliance and
Proposed Revocation continued, NOP subsequently collected nine additional samples of organic
coffee decaffeinated by Descamex and shipped
Again, the samples were taken from intact bags of coffee and the chain of custody was
documented. All nine samples were found positive for methylene chloride. Staff collected a field
blank as a part of this sampling event, a sample of organic ofte iy

RR <<a ffeinatea by a different company. The field blank had no detectable methylene chloride.
As with the testing cited in the Notice of Noncompliance and Proposed Revocation, for these
samples, the laboratory also used a soil sample as a “method blank” to rule out contamination in
the laboratory and the sample tested negative for methylene chloride.

Finally, AMS reiterates that, contrary to Descamex’s argument, there is no FDA Action
Level for methylene chloride in coffee. Instead, under its regulations at 21 CFR 173.255, FDA
has established a tolerance for methylene chloride as a secondary direct food additive in
decaffeinated coffee (10 ppm). A secondary direct food additive is used for a technical effect in
food during processing and is ordinarily removed from the final product (¢.g., a processing aid).
FDA establishes Action Levels for poisonous or deleterious substances that unavoidably
contaminate food. FDA has not established an action level for methylene chloride.

As the fourth and final point in its appeal, Descamex argues that the combined Notice of
Noncompliance and Proposed Revocation violated Decsamex’ procedural and substantive due
process rights, as well as the USDA organic regulations, because NOP did not demonstrate that
the alleged violation was uncorrectable or willful, which are thresholds for proposing revocation
under the USDA organic regulations at §205,662, Descamex also noted that the Notice of

Noncompliance and Proposed Revocation did not reference mediation rights.


UNITED STATES DEPARTMENT OF AGRICULTURE
AGRICULTURAL MARKETING SERVICE
BEFORE THE ADMINISTRATOR

In re: )

Alejandro Marquez Mendez ) Administrator’s Decision
Descafeinadores Mexicanos, ) APL-008-15

S.A. de C.V. (dba Descamex) )

This Decision is in response to an appeal (APL-008-15) of a Combined Notice of
Noncompliance and Proposed Revocation issued by the U.S. Department of Agriculture
(USDA), Agricultural Marketing Service (AMS), National Organic Program (NOP) to
Descafeinadores Mexicanos, S.A. de C.V. (dba Descamex), located in Cordoba, Veracruz,
Mexico. The operation was deemed not in compliance with the Organic Foods Production Act of
1990 (OFPA)! and the USDA organic regulations.”

BACKGROUND

The Act authorizes the Secretary to accredit agents to certify crop, livestock, wild crop,
and/or handling operations to the USDA organic regulations (7 C.F.R. Part 205). Certifying
agents also initiate compliance actions to enforce program requirements, as described in
§205.662. The Act authorizes the NOP to enforce the USDA organic regulations. Persons
subject to the Act who believe they are adversely affected by a noncompliance decision, such as
a Combined Notice of Noncompliance and Proposed Revocation, may appeal such decision to

the AMS Administrator pursuant to §205.680 of the USDA organic regulations.

17 U.S.C. 6501-6522
27 CFR. Part 205



In response to this final point in the appeal, the Combined Notice of Noncompliance and
Proposed Revocation violated neither Descamex’ due process rights, nor the USDA organic
regulations. The USDA organic regulations at §205.660(b) state that the NOP may: “...initiate
suspension or revocation proceedings against a certified operation when the Program Manager
has reason to believe that a certified operation has violated or is not in compliance with the Act
or regulations in this part. The NOP is not bound by the USDA organic regulations at §205.662
(they apply only to certifying agents and State organic programs), but often uses the criteria set
forth there in in determining what type of response is appropriate to identified noncompliance.
Using the criteria at §205.662(c), the NOP determined that a Combined Notice of
Noncompliance and Revocation was appropriate, as correction in response to the presence of a
prohibited substance in an organic product would not be possible.

In proposing revocation, the NOP also took into account the complainant’s allegation of
willful violation and the coffee industry’s use of methylene chloride to decaffeinate conventional
coffee, as willful violation would warrant proposed revocation under the USDA organic
regulations at §205.662(d). As the violation was an uncorrectable noncompliance, and possibly a
willful noncompliance, the proposed revocation was appropriate. Descamex was provided the
opportunity to appeal the adverse action, and the appeal was timely allowed.

Finally, the NOP does not offer mediation when proposing adverse actions against
certified operations. The regulations at §205.662, which addresses mediation rights, govern only
certifiers and State organic programs. Thus, the NOP did not violate the USDA organic

regulations by not providing the right to request mediation in its Notice.


FINDINGS OF FACT

1. Descafeinadores Mexicanos, S.A. de C.V. is a certified organic operation located in
Cordoba, Veracruz, Mexico.

2. On December 30, 2014, the NOP issued Descamex a Combined Notice of
Noncompliance and Proposed Revocation. The adverse action was based on laboratory
samples showing the presence of a prohibited substance, methylene chloride, in coffee
decaffeinated by Descamex and then labeled for sale as organic.

3. On January 21, 2015, Descamex appealed the Notice; the appeal was accepted and was
acknowledged on January 28, 2015.

DISCUSSION

The NOP issued Descamex a combined Notice of Noncompliance and Proposed
Revocation. The Proposed Revocation was issued because laboratory samples showed the
presence of a prohibited substance, methylene chloride, in coffee decaffeinated by Descamex and
labeled for sale as organic. The NOP had received a complaint alleging that Descamex was using
methylene chloride to decaffeinate organic coffee, in violation of the USDA organic regulations,
During the complaint investigation, the NOP collected four samples of organic coffee
decaffeinated by Descamex from OA. OME | Testing found residues
of methylene chloride, which is prohibited for use in organic agriculture under the USDA
organic regulations.

The Descamex appeal contains four key points. First, Descamex argued that the
combined Notice of Noncompliance and Proposed Revocation was inappropriately cited, as
Descamex does not use methylene chloride in the production of organic coffee. To support this

point, Descamex contended that the OFPA and USDA instructions to certifiers do not prohibit


the de minimis presence of prohibited substances in organic agricultural products, especially if
such substances are ubiquitous in the environment, as is methylene chloride. Descamex noted
that the methylene chrloride levels detected were very low, and below Food and Drug
Administration (FDA) Action Levels for methylene chloride in coffee. As such, Descamex
claims that the laboratory results did not warrant a proposed revocation of organic certification,
but instead only notification about the residues.

In response to this first point, AMS notes the OFPA and the USDA organic regulations
do prohibit the sale or labeling of agricultural products as organic if the products contain residues
of prohibited substances. The USDA organic regulations at §205.671 state that an agricultural
product containing prohibited substances at levels greater than 5 percent of the Environmental
Protection Agency (EPA) tolerance may not be sold as organic. The NOP further clarifies the
requirement in an Instruction to certifiers, stating that if a substance has no EPA tolerance, but is
present at a level above the FDA Action Level in an agricultural product, that product cannot be
sold as organic.

The EPA has not established a tolerance for methylene chloride in coffee. The FDA has
not set an Action Level for methylene chloride in coffee, although it allows it to be used as a
secondary direct additive in conventional coffee. Because methylene chloride is a substance
prohibited for use in organic production and handling, and because there is no EPA tolerance and
no FDA Action level for methylene chloride in coffee, its presence renders coffee ineligible for
sale as organic.

The second point in Descamex’s appeal noted that two previous sampling events of its
decaffeinated organic coffee tested negative for the substance. The first samples were collected

in July 2013 at the Descamex production facilities during an unannounced inspection by the